Health Informatics
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JANELLE POBRE LERONHealth Informatics
Uploaded by
JANELLE POBRE LERONHealth Informatics
An Interprofessional Approach
SECOND EDITION
Ramona Nelson, PhD, RN-BC,
ANEF, FAAN
Professor Emerita, Slippery Rock University, Slippery Rock, Pennsylvania
President, Ramona Nelson Consulting, Allison Park, Pennsylvania
Nancy Staggers, PhD, RN, FAAN
President, Summit Health Informatics; Adjunct Professor, College of
Nursing and Department of Biomedical Informatics, University of Utah,
Salt Lake City, Utah
Table of Contents
Cover image
Title page
Copyright
Dedication
About the Authors
Contributors
Reviewers and Ancillary Writers
Acknowledgments
Preface
Uses of the book
Vendors, applications, foundations and institutions
Organization of the book
Teaching and learning package
Unit 1: Foundational Information in Health
Informatics
1: An Introduction to Health Informatics
Abstract
Introduction
Definition of health informatics
Topics and areas of study in informatics
Conclusion and future directions
Discussion Questions
Case Study
Case Study Questions
2: Theoretical Foundations of Health Informatics
Abstract
Introduction
Understanding theories and models
Additional informatics-related models
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
3: Evidence-Based Practice, Practice-Based Evidence, and Health
Informatics
Abstract
Introduction
Evidence-based practice
Evidence-based practice models
Stevens star model of knowledge transformation
Informatics and evidence-based practice
Relationship of EBP and PBE
Practice-based evidence
Informatics and practice-based evidence
Conclusion and future directions
Discussion questions
EBP case study
Discussion Questions
PBE Case study
Pressure Ulcer Case Study
Negative Association With Likelihood of Developing a Pressure Ulcer (Less
Likely)
Positive Association With Likelihood of Developing a Pressure Ulcer (More
Likely)
Discussion Questions
4: Models, Theories, and Research for Program Evaluation
Abstract
Introduction
Purposes of evaluation
Theories and frameworks
Methods, tools, and techniques
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
5: Technical Infrastructure to Support Healthcare
Abstract
Introduction
Electronic health record component model
System integration and interoperability
Networking systems
Other infrastructure models
Current challenges
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
Unit 2: Information Systems and Applications for
the Delivery of Healthcare
6: Electronic Health Records and Applications for Managing Patient
Care
Abstract
Introduction
Electronic health record components, functions, and attributes
Sociotechnical perspectives
Electronic health record applications used in the clinical setting
Electronic health record benefits
Stakeholder perspectives
Key issues
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
7: Administrative Applications Supporting Healthcare Delivery
Abstract
Introduction
Major Types of Applications
Conclusion and Future Directions
Discussion questions
Case Study
Michael H. Kennedy, Kim Crickmore, and Lynne Miles
Discussion Questions
8: Telehealth and Applications for Delivering Care at a Distance
Abstract
Introduction
Telehealth technologies
Telehealth clinical practice considerations for healthcare professionals
Telehealth operational and organizational success factors and barriers
Telehealth challenges: licensure and regulatory issues for healthcare
professionals
Telehealth and direct patient health services
Conclusion and future directions
Discussion questions
Case Study
Discussion Questions
9: Home Health and Related Community-Based Systems
Abstract
Introduction
Evolution and milestones
Practice models
Standardized datasets
Supporting home health with electronic health records and health information
technology
Standardized terminologies
Omaha system
Conclusion and future directions
Discussion questions
Case Study
Discussion Questions
10: Clinical Decision Support Systems in Healthcare
Abstract
Introduction
Clinical decision support types and examples
Clinical decision support impact
Clinical decision support best practices
Recent progress toward disseminating clinical decision support on a national
level
Research challenges
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
11: Public Health Informatics
Abstract
Introduction
Public health: A population perspective
The value of informatics for the domain of public health
Conclusions and future public health informatics strategies
Discussion questions
Case study
Discussion Questions
Unit 3: Participatory Healthcare Informatics
12: The Engaged ePatient
Abstract
Historical background and drivers of the epatient evolution
Convergence of epatients, clinicians, patient-centered models of care, and
informatics
Health 3.0 emerges
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
13: Social Media Tools for Practice and Education
Abstract
What is social media?
Social media tools
Social media statistics
Benefits of social media
Challenges of social media
Social media in education
Policy
Conclusion and future directions
Discussion questions
Case study
Social Media in Education and Healthcare
Discussion Questions
14: Personal Health Records
Abstract
Definitions of the personal health record
The development of the electronic personal health record
Principles of an ideal personal health record
Examples of existing personal health records
Current evidence of benefits of personal health records
Current use of personal health records
Barriers to personal health record adoption
The future of personal health records
Discussion questions
Case study
Discussion Questions
15: mHealth: The Intersection of Mobile Technology and Health
Abstract
Introduction
Driving forces of mobile health
Mobile health benefits and challenges
Future directions of mobile health and conclusions
Discussion questions
Case study
Discussion Questions
Unit 4: Managing the Life Cycle of a Health
Information System
16: Strategic Planning and Selecting an Information System
Abstract
Introduction
Strategic vision and alignment
Systems life cycle
Conclusion and future directions
Discussion questions
Case study
Key Considerations for System Selection
17: Project Management Principles for Health Informatics
Abstract
Introduction
The need for project management in healthcare organizations
Project, program, and portfolio management
Roles and responsibilities: project, program, and portfolio managers
Project management tools
Project and portfolio management software selection
Conclusions and future directions
Discussion questions
Case study
Discussion Questions
18: Contract Negotiations and Software Licensing
Abstract
Introduction
Overview of licensing agreements
Major steps or stages in the performance of a license agreement
Specific components of the licensing agreement
Conclusions and future directions
Discussion questions
Case study
Discussion Questions
19: Implementing and Upgrading an Information System
Abstract
Introduction
Reasons to implement or upgrade a healthcare information system
New implementation versus an upgrade
Implementation and the systems life cycle
Preparing for go-live
Go-live
Post-live maintenance
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
Case Study Follow-Up
Discussion Questions
20: Downtime and Disaster Recovery for Health Information
Systems
Abstract
Introduction
Downtime risk assessment
Downtime And Response Planning
Downtime policies and procedures
Information technology impact and planning
Disaster planning
Conclusion and future directions
Discussion Questions
Case Study
Discussion Questions
Unit 5: User Experience, Standards, Safety, and
Analytics in Health Informatics
21: Improving the User Experience for Health Information
Technology
Abstract
Introduction to improving the user experience
Definitions of terms and their relationships
The goals of usability
User-centered design
Human-computer interaction frameworks for health informatics
Selecting methods to improve the user experience
Formal user testing
Selecting a type of usability test
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
22: Informatics-Related Standards and Standards-Se ing
Organizations
Abstract
Introduction
Standardized healthcare terminologies relevant to patient care
Healthcare data standardization
Data exchange efforts
Application of standardized terminologies
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
23: Data Science and Analytics in Healthcare
Abstract
Introduction
Data science in healthcare
Characteristics of big data
Data science for clinical and translational research
Benefits of data science
Approaches to analyses
Knowledge discovery and data mining
Conclusions and future directions
Discussion questions
Case study
24: Patient Safety and Quality Initiatives in Health Informatics
Abstract
Introduction
Definitions
National initiatives driving adoption and use of health it
National efforts related to quality data standards
Evaluating quality and patient safety
Success factors and lessons learned
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
Unit 6: Governance Structures, Legal, and
Regulatory Issues in Health Informatics
25: Legal Issues, Federal Regulations, and Accreditation
Abstract
Introduction
Legal system
Fraud and abuse and billing issues related to electronic health record use
Accreditation
The intersection of new technology and regulation
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
26: Privacy and Security
Abstract
Introduction
Definitions and concepts
Legal and historical context
Principles, laws, and regulations guiding practice
The importance of information security
Current security vulnerabilities
Current security challenges
Managing security risks with security controls
Resources
Conclusions and future directions
Discussion questions
Case study
Discussion Questions
27: The Health Information Technology for Education and Clinical
Health Act, Meaningful Use, and Medicare Access and CHIP
Reauthorization Act of 2015
Abstract
Introduction
Federal initiatives to drive health information technology
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
28: Health Policy and Health Informatics
Abstract
Introduction
Developing and implementing health information technology policy
Driving forces for creating health information technology policy
Leadership competencies for developing and implementing health information
technology policies
Leading policy activities through organizational work and leadership
Discipline-specific policies: nursing
Conclusion and future directions
Discussion Questions
Case Study
Discussion Questions
29: Health Information Technology Governance
Abstract
Introduction
Health information technology governance: need and core components
Key insights
Recommendations
Conclusion and future directions
Discussion Questions
Case study
Discussion Questions
Unit 7: Education and Health Informatics
30: Informatics in the Curriculum for Healthcare Professionals
Abstract
Introduction and background
Teaching and learning in an evolving healthcare and technology environment
Framework for informatics curriculum
It takes a village: roles and competencies
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
31: Distance Education: Applications, Techniques, and Issues
Abstract
Introduction
Historical development
Terminology
Course delivery systems: course management systems
Instructional design for distance education and learning
Student (learner) support services
Issues
Conclusion and future directions
Discussion Questions
Case Study
Discussion Questions
32: Informatics Tools for Educating Healthcare Professionals
Abstract
Introduction
Comprehensive education information system
Computerized teaching tools
Impact on the teaching and learning process
Impact on the faculty role
Conclusion and future directions
Discussion Questions
Case study
Discussion Questions
33: Simulation in Healthcare Education
Abstract
Introduction
The simulation process
Application of simulation
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
Unit 8: International Health Informatics Efforts
34: International Efforts, Issues, and Innovations
Abstract
Introduction
Key initiatives in world regions
International organizations with ehealth involvement
International standards efforts
Global challenges to ehealth
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
Unit 9: Historical Implications and Future
Directions in Health Informatics
35: The Evolution of Health Informatics
Abstract
Introduction
The roots of informatics within the computer and information sciences
Establishing the specialty of health informatics
Recognition of the specialty
Naming the specialty—naming the discipline
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
36: Future Directions and Future Research in Health Informatics
Abstract
Introduction
Futures research (futurology)
The future of health informatics
Clinical informatics
Improving the user experience for health information technology
Analytics (big data) and data visualization
Predictive analytics
Data visualization
Conclusion and future directions
Discussion questions
Case study
Discussion Questions
Glossary
Index
Copyright
3251 Riverport Lane
St. Louis, Missouri 63043
HEALTH INFORMATICS: AN INTERPROFESSIONAL APPROACH,
SECOND EDITION
ISBN: 978-0-323-40231-6
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Notices
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Dedication
To my husband, Glenn M. Nelson, who always manages
to be there
To my daughters, who managed to pick wonderful
husbands,
Dorianne & Michael Hollis and Leslie-Ann & Kristopher
Bidelson
and
To my grandchildren, who are today’s joy and tomorrow's
hope,
Mackenzie, Hope, Ella, and Molly
Ramona Nelson
To my father, Forest Thorpe, who supported education for
women
during an age when it was deemed superfluous
and
To my husband, Bob Staggers, who has always been a
champion of strong women
Nancy Staggers
About the Authors
Ramona Nelson holds a baccalaureate degree in nursing from
Duquesne University and a master's degree in both nursing and
information science and a PhD in education from the University of
Pi sburgh. In addition, she completed a postdoctoral fellowship at
the University of Utah. Prior to her current position as president of
her own consulting company, Ramona was a Professor of Nursing
and Chair of the Department of Nursing at Slippery Rock University.
Today Ramona continues her association with Slippery Rock
University in the role of Professor Emerita. Her primary areas of
interest include informatics education for health professionals, social
media and empowered patients, and the application of theoretical
concepts in health informatics practice.
Her past publications include textbooks, monographs, book
chapters, journal articles, World Wide Web publications, abstracts,
and newsle ers. She has been recognized as a Nursing Informatics
Pioneer by the American Medical Informatics Association. In
addition, she was named a fellow in the American Academy of
Nursing in 2004 and in the National League for Nursing Academy of
Nursing Education Fellows.
Nancy Staggers is a nursing informatics pioneer who is actively
involved in informatics user experience research. Her education was
at the University of Wyoming and the University of Maryland
School of Nursing, culminating in a PhD with a concentration on
informatics and research. Her background includes both health
informatics practice and academia. She was a health informatics
executive in the Department of Defense and elsewhere, leading
enterprise acquisitions and installations of inpatient electronic health
records. Her academic career includes professorships at both the
University of Utah and the University of Maryland. Nancy’s
academic work began with developing nursing informatics
competencies and later leading teams to revise the American Nurses’
Association document on the scope and practice of nursing
informatics in the United States in 2002 and 2008. Her research
program focuses health IT support and redesign for complex
activities such as electronic medication administration records and
handoffs/care transitions. Recently she led a team on the user
experience community at the Healthcare Information and
Management Systems Society to identify nursing user experience
issues and solutions for nurses’ interactions with health IT. She was
elected as a fellow in the American Academy of Nursing in 1999 and
received the American Medical Informatics Association Virginia K.
Saba nursing informatics award in 2013 for her contributions to
informatics. She owns her own health informatics company, which
focuses on research consultations and international collaborations.
She is also adjunct professor of informatics at the Department of
Biomedical Informatics and College of Nursing, University of Utah,
and she teaches user experience research methods for the Health
Informatics program at the University of Alabama Birmingham.
Nancy publishes widely on health informatics topics, concentrating
on user experience research.
Contributors
Antonia Arnaert, RN, MPH, MPA, PhD Associate Professor,
Ingram School of Nursing, McGill University Montreal, Quebec,
Canada
Nancy C. Brazelton, RN, MS Application Service Director,
Information Technology Services, University of Utah Health Care,
Salt Lake City, Utah
Christine A. Caligtan, RN, MSN Health Data and Patient Safety
Clinical Specialist, Health Data Integrity, PatientsLikeMe,
Cambridge, Massachuse s
Robin L. Canowi , AB, JD Senior A orney, Vorys, Sater,
Seymour and Pease, LLP, Columbus, Ohio
Heather Carter-Templeton, PhD, RN-BC
Assistant Professor, Capstone College of Nursing, The University of
Alabama, Tuscaloosa, Alabama
Associate Professor and Reference Librarian, Health Sciences
Library, University of Tennessee Health Science Center, Memphis,
Tennessee
Diane Castelli, RN, MS, MSN Adjunct Clinical Nursing
Instructor Cape Cod Community College West Barnstable,
Massachuse s
Kathleen G. Charters, PhD, RN, CPHIMS Clinical Information
Systems Specialist, Defense Health Agency Healthcare Operations
Directorate, Clinical Support Division, Integrated System Support,
Measurements & Clinical Reporting, Falls Church, Virginia
Jon C. Christiansen, BS, JD A orney, TechLaw Ventures, PLLC,
Salt Lake City, Utah
Helen B. Connors, PhD, RN, DrPS (Hon), FAAN,
ANEF Executive Director, Center for Health Informatics; Associate
Dean, University of Kansas School of Nursing, Kansas City, Kansas
Vicky Elfrink Cordi, PhD, RN Clinical Associate Professor
Emeritus, The Ohio State University, Columbus, Ohio
Mollie R. Cummins, PhD, RN, FAAN Associate Dean for
Research and the PhD Program; Associate Professor, College of
Nursing; Adjunct Associate Professor, Department of Biomedical
Informatics, University of Utah, Salt Lake City, Utah
Andrea Day, RN, MS, PMP Informatics Nurse Consultant New
Market, Maryland
Mical DeBrow, PhD, RN Associate Director, Health Economics
and Outcomes Research, Boehringer Ingelheim Pharmaceuticals,
Houston, Texas
Guilherme Del Fiol, MD, PhD Assistant Professor, Department of
Biomedical Informatics, University of Utah, Salt Lake City, Utah
Vikrant G. Deshmukh, PhD, MS, MSc Adjunct Assistant
Professor, Population Health Sciences, University of Utah School of
Medicine; Adjunct Assistant Professor, College of Nursing,
University of Utah; Lead Principal Data Warehouse Architect,
Enterprise Data Warehouse, University of Utah Health Care, Salt
Lake City, Utah
Patricia C. Dykes, PhD, RN, FAAN, FACMI Senior Nurse
Scientist, Program Director, Center for Patient Safety Research and
Practice, Program Director, Center for Nursing Excellence, Brigham
and Women's Hospital, Boston, Massachuse s
William Sco Erdley, DNS, RN, CHSE
Simulation Education Specialist, The Behling Simulation Center,
Jacobs School of Medicine and Biomedical Sciences, University at
Buffalo, Buffalo, NY
Adjunct Professor, School of Nursing, Niagara University, Niagara
University, New York
David L. Gibbs, PhD, CPHIMS, CHPS, CISSP Assistant
Professor, Department of Health Information Management, Texas
State University, San Marcos, Texas
Bryan Gibson, DPT, PhD Assistant Professor, Department of
Biomedical Informatics, University of Utah, Salt Lake City, Utah
Teresa Gore, PhD, DNP, FNP-BC, NP-C, CHSE-A
Associate Professor and Director of Experiential Learning College of
Nursing, University of South Florida, Tampa, Florida
President, International Nursing Association for Clinical Simulation
and Learning (INACSL), Morrisville, North Carolina
Nicholas R. Hardiker, PhD, RN, FACMI
Professor of Nursing and Health Informatics, School of Nursing,
Midwifery, Social Work & Social Sciences, University of Salford,
Salford, England
Director, eHealth Programme, International Council of Nurses,
Geneva, Swi erland
Adjunct Professor, College of Nursing, University of Colorado,
Denver, Colorado
Angel Hoffman, MSN, RN Principal/Owner, Advanced Partners
in Health Care Compliance, Pi sburgh, Pennsylvania
Susan D. Horn, PhD Adjunct Professor, University of Utah School
of Medicine, Health System Innovation and Research Program, Salt
Lake City, Utah
Valerie M. Howard, EdD, MSN, RN Dean and University
Professor, School of Nursing and Health Sciences, Robert Morris
University, Moon Township, Pennsylvania
Sarah J. Iribarren, PhD, RN Postdoctoral Research Fellow, School
of Nursing, Columbia University, New York City, New York
Jonathan M. Ishee, JD, MPH, MS, LLM Assistant Professor,
School of Biomedical Informatics, University of Texas Health Science
Center; Partner, Vorys, Sater, Seymour and Pease, LLP, Houston,
Texas
David E. Jones, PhD Applied Public Health Informatics Fellow,
Utah Department of Health, Salt Lake City, Utah
Irene Joos, PhD, MSIS, MN, BSN, RN Professor & Former
Director, Online Learning, Department of Information Technology;
Adjunct Faculty, Department of Nursing, La Roche College,
Pi sburgh, Pennsylvania
Kensaku Kawamoto, MD, PhD, MHS Associate Chief Medical
Information Officer, University of Utah Health Care; Assistant
Professor, Department of Biomedical Informatics, University of
Utah, Salt Lake City, Utah
Jacob Kean, PhD, MA, BS Research Speech-Language Pathologist,
VA Salt Lake City Health Care System; Associate Professor,
Population Health Sciences, University of Utah School of Medicine,
Salt Lake City, Utah
Michael H. Kennedy, PhD, MHA, FACHE Associate Professor,
Department of Health Services and Information Management, East
Carolina University, Greenville, North Carolina
Tae Youn Kim, PhD, RN Associate Professor, Be y Irene Moore
School of Nursing, University of California, Davis, Sacramento,
California
Gerald R. Ledlow, PhD, MHA, FACHE Chair and Professor,
Department of Health Policy and Management, Jiann-Ping Hsu
College of Public Health, Georgia Southern University, Statesboro,
Georgia
Kim Leighton, PhD, RN, ANEF Assistant Dean, Research &
Simulation Faculty, Development, Institute for Research & Clinical
Strategy, DeVry Medical International, Iselin, New Jersey
Louis Luangkesorn, PhD Research Assistant Professor, Industrial
Engineering, University of Pi sburgh, Pi sburgh, Pennsylvania
Ann M. Lyons, PhD, RN Medical Informaticist, Data Science
Service, University of Utah, Salt Lake City, Utah
Kathleen MacMahon, RN, MS, CNP Telehealth Nurse
Practitioner, American Telecare, Minneapolis, Minnesota
Michele P. Madison, JD Partner, Morris, Manning and Martin,
LLP, Atlanta, Georgia
Shannon Majoras, JD Associate, Vorys, Sater, Seymour and Pease,
LLP, Cleveland, Ohio
E. LaVerne Manos, DNP, RN-BC Faculty, School of Nursing,
University of Kansas; Program Director, Interprofessional Master of
Science in Health Informatics and Post-Master's, Interprofessional
Certificate in Informatics Center for Health Informatics, University
of Kansas; Director of Nursing Informatics, Center for Health
Informatics, University of Kansas, Kansas City, Kansas
Karen S. Martin, RN, MSN, FAAN Health Care Consultant,
Martin Associates, Omaha, Nebraska
Cynthia M. Mascara, RN, MSN, MBA Principal Clinical
Consultant, Strategic Clinical Consulting, Cerner Corporation,
Kansas City, Missouri
Susan A. Matney, PhD, RN-C, FAAN Medical Informaticist,
Healthcare Data Dictionary (HDD) Team, 3M Health Information
Systems, Salt Lake City, Utah
Christine D. Meyer, PhD, RN Healthcare IT, Independent
Consultant, Bridgeville, Pennsylvania
Michele Mills, [Link], PMP, CPHIMS, FHIMSS Director,
Information Technology Services, University of Utah Health Care,
Salt Lake City, Utah
Sandra A. Mitchell, PhD, CRNP, FAAN Research Scientist,
Outcomes Research Branch, National Cancer Institute, Rockville,
Maryland
Judy Murphy, RN, BSN, FACMI, FHIMSS, FAAN Chief Nursing
Officer, Global Healthcare & Life Sciences, IBM, Washington, DC
Daniel A. Nagel, RN, BScN, MSN, PhD(c) Lecturer, Department
of Nursing & Health Sciences, University of New Brunswick, Saint
John, New Brunswick, Canada
Sco P. Narus, PhD Medical Informatics Director, Intermountain
Healthcare Associates; Professor, Department of Biomedical
Informatics, University of Utah, Salt Lake City, Utah
Ramona Nelson, PhD, RN-BC, ANEF, FAAN
Professor Emerita, Slippery Rock University, Slippery Rock,
Pennsylvania
President, Ramona Nelson Consulting, Allison Park, Pennsylvania
Sally Okun, RN, MMHS Vice President, Advocacy, Policy, and
Patient Safety, PatientsLikeMe, Cambridge, Massachuse s
Hyeoun-Ae Park, PhD Professor, College of Nursing, Seoul
National University, Seoul, South Korea
Mitra Rocca, Dipl. Inform. Med. Senior Medical Informatician,
Center for Drug Evaluation and Research U.S. Food and Drug
Administration, Silver Spring, Maryland
Kay M. Sacke -Fi gerald, BSN, RN, MEd, MSN, EdD Fi gerald
Consulting, Jenkintown, Pennsylvania
Lore a Schlachta-Fairchild, RN, PhD, FACHE, LTC (Ret.) U.S.
Army Nurse Corps Health Information Sciences Research
Program Manager, Joint Program Commi ee-1 (JPC-1), U.S. Army
Medical Research and Materiel Command/Department of Defense
Health Agency, Fort Detrick, Maryland
Rebecca Schnall, PhD, MPH, RN-BC Assistant Professor, School
of Nursing, Columbia University, New York, New York
Kumiko O. Schnock, PhD, RN Research Fellow, Division of
General Internal Medicine and Primary Care, Brigham and Women's
Hospital, Boston, Massachuse s
Charlo e A. Seckman, PhD, RN-BC, CNE Assistant Professor,
Course Director, Organizational Systems and Adult Health, School
of Nursing University of Maryland, Baltimore, Maryland
Joyce Sensmeier, MS, RN-BC, CPHIMS, FHIMSS, FAAN Vice
President, Informatics, Healthcare Information and Management
Systems Society, Chicago, Illinois
Catherine Janes Staes, BSN, MPH, PhD Assistant Professor,
Department of Biomedical Informatics, University of Utah School of
Medicine, Salt Lake City, Utah
Nancy Staggers, PhD, RN, FAAN President, Summit Health
Informatics; Adjunct Professor, College of Nursing and Department
of Biomedical Informatics, University of Utah, Salt Lake City, Utah
Teresa Stenner, MA Program Manager, Center for Health
Informatics, University of Kansas Medical Center, Kansas City,
Kansas
Kathleen R. Stevens, RN, MS, EdD, ANEF, FAAN Professor and
Director, Improvement Science Research Network, School of
Nursing, University of Texas Health Science Center, San Antonio,
Texas
Jim Turnbull, DHA, MBA, BA Chief Information Officer,
University of Utah Health Care, Salt Lake City, Utah
Karen B. U erback, MSN, RN Independent Consultant,
Homecare, Mitre, Ha iesburg, Mississippi
Dianna Vice-Pasch, MSN, RN, CCM, CTCP Associate Degree
Nursing Faculty Kentucky Community and Technical College
Systems Lexington, Kentucky
Judith J. Warren, PhD, RN, FAAN, FACMI Professor Emeritus,
School of Nursing, University of Kansas Medical Center, Kansas
City, Kansas
Charlene R. Weir, PhD, RN Associate Professor, Department of
Biomedical Informatics, University of Utah School of Medicine;
Associate Director, IDEAS Center of Innovation, Veterans Affairs
Salt Lake City, Salt Lake City, Utah
Kathy H. Wood, PhD, FHFMA, CHFP Assistant Professor,
College of Health, Human Services, and Science, Ashford University,
San Diego, California
Reviewers and ancillary writers
Reviewers
Joanna V. Bachour, MSN, RN Assistant Professor and Lab
Manager, MCPHS University, School of Nursing, Worcester,
Massachuse s
Carol J. Bickford, PhD, RN-BC, CPHIMS, FHIMSS,
FAAN Senior Policy Advisor, Department of Nursing Practice &
Work Environment, American Nurses Association, Silver Spring,
Maryland
Connie B. Bishop, DNP, MBA, RN-BC Clinical Assistant
Professor, College of Health and Human Services, School of
Nursing, North Carolina A&T State University, Greensboro, North
Carolina
Barbara Blackwell, EdD, RN-BC Director, School of Nursing (RN
and LPN School), Holy Name Medical Center School of Nursing,
Teaneck, New Jersey
Mary T. Boylston, RN, MSN, EdD, AHN-BC Professor of
Nursing, Nursing Department, Eastern University, St. Davids,
Pennsylvania
Kathleen M. Burke, PhD, RN Assistant Dean in Charge of
Nursing, Professor of Nursing, Adler Center for Nursing Excellence,
Ramapo College of New Jersey, Mahwah, New Jersey
Pat Callard, DNP, RN, CNL Associate Professor of Nursing,
College of Graduate Nursing, Western University of Health Sciences,
Pomona, California
Karen Chang, PhD, RN Associate Professor, School of Nursing,
College of Health and Human Services, Purdue University, West
Lafaye e, Indiana
Amanda Dorsey, MSHI, FHIMSS Assistant Professor, UAB MS in
Health Informatics Program, University of Alabama at Birmingham,
Birmingham, Alabama
Judith A. E en, PhD, RN, FACMI, FAAN Professor Emerita,
College of Nursing, The University of Arizona, Tucson, Arizona
Ma hew J. Fox, MSN, RN-BC Assistant Professor of Nursing,
Ohio University-Zanesville, Zanesville, Ohio
Robert L. Garrie, MPA, RHIA Associate Professor, Health
Services Administration, University of Alabama at Birmingham,
Birmingham, Alabama
Lynda R. Hardy, PhD, RN Associate Dean for Research, College
of Nursing, University of Tennessee, Knoxville, Knoxville, Tennessee
Gayle McGinty, MSN, RN Assistant Professor of Nursing,
MCPHS University, School of Nursing, Worcester, Massachuse s
Carol M. Pa on, PhD, FNP-BC, CRNP, CNE Informatics Health
Certificate, CNE, Associate Clinical Professor, Drexel University,
Philadelphia, Pennsylvania
Alison Pi man, RN, MSN, CPN Clinical Assistant Professor,
Texas A&M Health Science Center, College of Nursing, Bryan, Texas
Teresa L. Scherer, MS, RN Clinical Instructor, School of Nursing,
Idaho State University, College of Technology, Pocatello, Idaho
M. Kathleen Smith, MScEd, RN-BC, FHIMSS Managing Partner,
Informatics Consulting and Continuing Education, L.L.C., Weeki
Wachee, Florida
Nadia Sultana, MBA, RN, BC Clinical Assistant Professor,
College of Nursing, New York University, New York, New York
Lindsay Tucker, BA, AAA, CPC Training and Education
Manager, Moses Cone Health System, Adjunct Professor, Guilford
Technical Community College, Greensboro, North Carolina
Dorothea M. Winter, PhD, RN Professor of Nursing, Nursing
Department, Salisbury University, Salisbury, Maryland
ANCILLARY WRITER
Jane M. Brokel, PhD, RN, FNI Adjunct Faculty, College of
Nursing, University of Iowa, Iowa City, Iowa; Section Instructor,
School of Nursing and Health Sciences, Simmons College, Boston,
Massachuse s
Acknowledgments
Ramona Nelson; Nancy Staggers
First, we would like to acknowledge Kellie White, Executive Content
Strategist, whose overview and coordination of this second edition is
greatly appreciated. We also thank Danielle Frazier, Senior Content
Development Specialist, who was responsible for providing support
during the process of writing and editing; and especially Jodi
Willard, Senior Project Manager, whose a ention to detail was
invaluable during the editing process. Finally, we would like to
acknowledge Jeff Pa erson, Publishing Services Manager, and Ryan
Cook, Designer. Their expertise was imperative for developing a
polished and professional product.
Each chapter of this book is supported with Evolve resources. We
also wish to acknowledge the support of Umarani Natarajan, Senior
Project Manager, and Hariprasad Maniyaan, Multimedia Producer,
for the Evolve resources, as well as ancillary writer Jane Brokel and
various content experts for their development of these resources.
Finally, we would like to acknowledge the reviewers. Their many
suggestions, tips, and comments were invaluable in creating this
book.
Preface
Health informatics and our current information technology (IT)
environment are inherently interdisciplinary. Over our many years
of working in health informatics practice and teaching health
informatics content, we recognized the need for a health informatics
textbook that provides a solid overview of the field using an
interdisciplinary approach. Therefore the title, authors, and content
of this book reflect the comprehensive nature of contemporary
informatics practice. The contributors to this book are leaders in
health informatics and represent various disciplines and a wide
variety of se ings, areas of expertise, and positions.
Health Informatics: An Interprofessional Approach provides readers
with a comprehensive understanding of health informatics, its
practice, and relevant research on health informatics topics. Each
chapter opens with key terms, learning objectives and an abstract
that outlines the topics covered within the chapter. Chapter headings
give readers a conceptual framework for understanding the content
in the chapter. Each chapter ends with conclusions that include
thoughts about future directions for the topic. Every chapter
includes a set of discussion questions to encourage critical thinking
and to encourage the reader to consider how the content in the
chapter can be applied in the ever-changing world of healthcare.
Case studies with analytic questions demonstrate how informatics
applies in real-life practice.
Uses of the book
This textbook is an excellent resource for use within and across
various health disciplines. Every a empt has been made to be
culturally sensitive to the various disciplines within healthcare while
encouraging readers to recognize themselves as key members of an
interprofessional team. This book is wri en to be used for both
intradisciplinary and interdisciplinary informatics courses. The text
can span levels of education depending on the program of study,
depth of informatics material needed, and the needs of faculty and
students. This book is targeted to students needing introductory
health or nursing informatics knowledge. As with the first edition, it
is useful at several levels: for upper division or advanced
undergraduate courses, for RN to BSN/MSN programs, for
introductory health informatics content or courses in master’s
programs and, particularly, for DNP students.
Vendors, applications, foundations
and institutions
Vendors, health IT applications, commercial products, and
organizations and institutions are discussed throughout the
textbook. They are included for information purposes and to provide
readers with examples of the variety of resources available. No
endorsement of a specific company, product, or organization is
intended.
Organization of the book
The book is organized into nine units. The first unit is Foundational
Information in Health Informatics and focuses on material that is basic
to understanding the discipline as a whole. Content includes the
definition and significance of the field, theories and models,
evidence-based practice and practice-based evidence, program
evaluation, and technical infrastructures for health IT.
The second unit is Information Systems and Applications for the
Delivery of Healthcare. This unit begins with an overview of electronic
health records, followed by a discussion of financial and other
administrative applications and clinical decision support systems.
Remaining chapters focus on health IT in non–acute care se ings:
telehealth, home health, and public health informatics. This unit
provides readers with content on major health applications in
institutions and relevant se ings.
The third unit, Participatory Healthcare Informatics, recognizes the
shift toward patient engagement in recent years. Patients are now
more involved in their own healthcare and are equipped with health
IT applications. Topics in this unit include epatients, social media,
personal health records and, new to the second edition, mHealth
(mobile health). Readers are introduced to the impact of this
movement on patients, providers, and the patient-provider
relationship as well as the partnership between each of these groups
and health IT.
The fourth unit is entitled Managing the Life Cycle of a Health
Information System, and the first chapter outlines strategic planning
and selecting an information system. Salient topics are then
introduced to readers: project management, contract negotiations,
implementing and upgrading a system, and downtime and disaster
recovery. This material gives readers the knowledge and skills to
lead and participate in health informatics systems projects in every
phase of the systems life cycle. The chapters on contract negotiations
and project management are new to this edition.
The fifth unit, User Experience, Standards, Safety and Analytics in
Health Informatics, explains complex interactions among health IT
f p p g
and safety, user experience, and needed standards. This unit
introduces concepts and practical uses for data science and analytics,
which represent a major focus of health organizational leaders,
health professionals, and informatics specialists today. This unit
focuses on creating a culture of safety, effective and efficient health
IT interactions, and methods for knowledge building. The analytics
chapter provides new material on data science.
The sixth unit, Governance Structures, Legal, and Regulatory Issues in
Health Informatics, deals with local and national structures, laws, and
regulations important to health informatics. At the local level,
contributors discuss how organizations develop support structures
for managing health IT. On a national level, the development of
federal programs and regulations dealing with HITECH, MU,
MACRA, MIPS, and ACO are carefully explained. Other chapters
outline privacy and security concerns and health policy issues and
also provide the reader with directions for professional involvement
in these activities.
The seventh unit, Education and Health Informatics, focuses on the
role of education in informatics and the role of informatics in health
provider education. It includes chapters that discuss educational
applications and issues, educational tools, simulation, distributive
education, and informatics in the health curriculum.
The eighth unit, International Health Informatics Efforts, contains a
chapter on the aspects, initiatives, and progress of health informatics
worldwide.
The ninth unit, Historical Implications and Future Directions in Health
Informatics, provides an overview of the history of health informatics.
It then concentrates on future directions and future research needed
in the field of health informatics, including a unique section about
nanotechnology.
Teaching and learning package
Health informatics is a fast-changing field. Resources and emerging
developments related to each chapter are available on the Evolve
website. For example, new government reports and other important
documents are posted or referenced for easy student access. These
materials are targeted to all faculty, including those newer to the
field as well as those with additional experience in the discipline of
informatics. Each chapter includes a number of discussion questions
and a case study. These questions and case studies are carefully
designed to represent the reality of health informatics, including the
typical ill-defined problems common in informatics practice.
Numerous approaches are available to manage these challenges.
Thus the discussion questions and case studies can stimulate
discussion, and faculty and students can explore how the material in
the chapters can be applied for developing approaches for practice
situations. Students should be especially encouraged to consider
how these materials apply to their own experiences and situations.
For the Instructor
• TEACH Lesson Plans contain objectives and key terms from the
text. Topics from the book are mapped to Quality and Safety
Education for Nurses (QSEN) standards, American Association of
Colleges of Nursing (AACN) Essentials Series, concept-based
learning, and American Health Information Management
Association (AHIMA) competencies. These lesson plans tie in all of
the chapter resources for effective presentation of material and
include additional highlights and learning activities tied to content
within the chapters. Online Activities for each chapter provide
additional assignments to deepen students' understanding of the
content of the text.
• PowerPoint Presentations are available to accompany the TEACH
Lesson Plans. Pulling content and figures from the text, the
PowerPoint slides provide students with chapter highlights and
provide instructors with additional relevant topics of
conversation.
• A Test Bank containing more than 300 questions is compliant with
the NCLEX® standards and provides text page references and
cognitive levels. The ExamView software allows instructors to
create new tests; edit, add, and delete text questions; sort
questions; and administer and grade online tests.
• The Image Collection contains all of the art from the text for use in
lectures or to supplement the PowerPoint presentations.
For the Student
• Student Review Questions provide additional practice for
students trying to master the content presented within the text.
• Most chapters have Additional Readings to provide sources of
additional research on the subject.
UNIT 1
Foundational Information in
Health Informatics
1
An Introduction to Health
Informatics
Ramona Nelson; Nancy Staggers
Abstract
This chapter provides the reader with an introduction to health informatics as both a
discipline and a profession. It begins by introducing the reader to the significance of
health informatics. Health informatics is then defined, and example applications are
listed. The next section of the chapter provides an overview of the topics inherent in
the discipline and profession of health informatics. These topics are organized
around the nine units in the book.
The ultimate goal of health informatics is to empower populations,
communities, families, and individuals with the opportunity to improve the
quality and increase the quantity of their days by maximizing the use of
technology in healthcare.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Define healthcare informatics.
2. Discuss the significance of health informatics within healthcare
delivery.
3. Provide an overview of health informatics-related topics.
KEY TERMS
health informaticians 2
health informatics 2
Introduction
Almost 20 years after the Institute of Medicine (IOM) report To Err Is
Human1 was released, John T. James published a seminal article on the
same topic in The Journal of Patient Safety. Using a carefully designed
methodology, he analyzed data published from 2008 to 2011 to estimate
the number of preventable adverse events occurring in American
hospitals. James found that each year, an estimated 440,000 hospitalized
Americans experience a preventable adverse event that contributed to
their death. In addition, serious harm is estimated to be 10- to 20-fold more
common than lethal harm.2 These findings were reinforced in 2016 when
Martin Makary and Michael Daniel published a study in The BMJ entitled
“Medical Error—The Third Leading Cause of Death in the US.”2a
The numbers are astounding, but the personal consequences are even
greater for the people and the families who suffer such “preventable
events.” Dr. James, whose distinguished professional career was in
healthcare, maintains a website that provides some insight into his strong
interest in patient safety.3 The website is dedicated as follows:
This site is dedicated to my 19-year-old son, John Alexander James, who
died as a result of uninformed, careless, and unethical care by
cardiologists at a hospital in central Texas in the late summer of 2002.
In 2016, 3 years after publication of the James article, this same journal
published another research study in which the question is asked Can
electronic health records prevent harm to patients?4 Key points from this
research include the following:
• The investigators analyzed Medicare Patient Safety Monitoring System
(MPSMS) patient medical record data for 1351 hospitals from the years
2012 and 2013. They found 347,281 exposures to adverse events. Of these
exposures, 7820 adverse events actually took place, resulting in a 2.25%
occurrence rate.
• Of the patients, 13% (5876) received care that was captured by an
electronic health record (EHR).
• The analysis of these data demonstrated that cardiovascular, surgery,
and pneumonia patients whose complete treatment was captured in an
EHR were between 17% and 30% less likely to experience in-hospital
adverse events.5
The studies2,2a,4 taken together suggest that if EHRs were in use in
American hospitals, somewhere between 74,800 and 132,000 preventable
fatal hospital-based events each year might never occur.
Going forward, if health informaticians and knowledgeable healthcare
providers are fully involved in the design, selection, and implementation
of health information systems, these numbers are just the beginning of
what would be possible in terms of improved healthcare. Improved
patient safety is just one of the many reasons why the study of health
informatics is imperative for all healthcare professionals. Throughout this
book, other vital reasons will become obvious. Competent, compassionate
healthcare depends on healthcare providers who understand and can
maximize their use of health information technology (IT) and informatics
knowledge in providing care to patients. This book provides the
foundation required to develop that competence.
Definition of health informatics
Today health informatics is an exciting and well-established field. It is
recognized as both a discipline and a profession. As a discipline, it is a
field of study in the same sense that medicine, sociology, and pharmacy
are fields of study. Core disciplines, including informatics, along with
terminal competencies or learning outcomes, provide the framework for
developing curricula within the healthcare professions. Learning outcomes
include the skills, knowledge, and professional aptitudes expected of all
graduates within the profession. In 2003 the IOM identified five core
competences that should be achieved by all healthcare professionals:
• Delivering patient-centered care
• Working as part of interdisciplinary teams
• Practicing evidence-based medicine
• Focusing on quality improvement
• Using informatics6
Other professional groups and accrediting agencies are now including
an informatics-related requirement. For example, the American
Association of Colleges of Nursing (AACN) developed a group of
documents titled the Essentials Series.7–9 The Essentials outline the
necessary curriculum content and expected competencies of graduates
from baccalaureate, master’s, and doctor of nursing practice programs.
Each of these documents includes a technology or informatics requirement
and cites the IOM report as the rationale for this requirement.
Health informatics is also a profession within the healthcare arena.
Thousands of informaticians practice the specialty in varied roles that
include, for example:
• Installing and evaluating new technologies such as EHRs
• Developing mHealth (mobile health applications) for patients
• Analyzing users’ interactions with health IT to create applications that
mirror the way clinicians think and do work
• Leading telehealth initiatives in a region or nationally
• Developing and implementing national policies for health IT and
informatics
• Building terminologies to support interoperability
• Doing research on the effect of health IT on patients, providers, or
organizations
Although the existence of health informatics as both a discipline and as
a profession is well accepted, it is interesting to note there is currently no
consensus or generally accepted name and standard definition for this
profession. Current titles for members of this profession include health
informatics specialist, informaticist, or informatician (sometimes spelled
informaticien). Table 1.1 lists several accepted definitions and the source of
those definitions. The history, reasons, and issues presented by this lack of
consensus are discussed in detail in Chapter 35.
Table 1.1
Common Definitions of Health Informatics
Source Definition
AHIMA Health informatics is the scientific discipline concerned with the cognitive, information-processing, and
communication tasks of healthcare practice, education, and research, including the information science
and technology to support these tasks.28
HIMSS Health informatics is the interdisciplinary study of the design, development, adoption, and application of
IT-based innovations in healthcare services delivery, management, and planning as defined by the U.S.
National Library of Medicine.29
AMIA Biomedical informatics is the interdisciplinary field that studies and pursues the effective uses of
biomedical data, information, and knowledge for scientific inquiry, problem solving and decision
making, motivated by efforts to improve human health.30
US Health informatics is “the interdisciplinary study of the design, development, adoption, and application of
NLM IT-based innovations in healthcare services delivery, management, and planning.”31
In this book, health informatics is defined as an interdisciplinary
professional specialty and scientific discipline that integrates the health
sciences, computer science, and information science, as well as a number
of other analytic sciences, with the goal of managing and communicating
data, information, knowledge, and wisdom in the provision of healthcare
for individuals, families, groups, and communities. A review of this
definition as well as the definitions in Table 1.1 demonstrates three
common themes within each of these definitions. That is, health
informatics is:
• An interdisciplinary professional specialty
• Tied to the use of IT in healthcare
• Focused on assisting healthcare providers with tasks related to collecting
data, processing information, and applying that information to
processes such as problem solving, knowledge development, and
decision making
Health IT touches nearly every aspect of healthcare today, even less
obvious ones such as providing emotional support to patients. A few
examples include:
• Tele-intensive care units (ICUs). Patients in ICUs in more remote
geographical areas are monitored by experienced ICU nurses and
physicians using telehealth technology.
• Robotics. DaVinci is a widely used surgical robot guided by a surgeon.
It is used to translate hand movements during minimally invasive
surgery, using tiny instruments inserted into small incisions.
• Behavioral health at-a-distance. The U.S. Army has a telehealth network
that spans 50 countries. Behavioral health telehealth makes up 55% of
their services, followed by cardiology and dermatology.10
• Sensors. Sensors in long-term care se ings can help monitor residents’
health status, detect emergency situations, and contact health
providers.11 In the future, clinicians may monitor patients with wearable
sensors, such as clothing, after discharge.12
• Healthcare for islanders. People living on four islands off the coast of
Maine have no available healthcare providers. A 72-foot boat beams
health services via live video conferencing with a nurse.
Topics and areas of study in informatics
This book is divided into nine units outlining the key topics and areas of
study within health informatics. This section of the chapter is built around
these nine units. Each subsection presented here focuses on one of the nine
units, and begins by describing the theme of the unit. This is followed by
an example taken from professional reports, research studies, or a news
story. As you read each subsection, you are encouraged to think about
how informaticians using information technology could improve the
quality of healthcare and the satisfaction of both providers and patients,
while decreasing costs.
Unit 1: Fundamental Information in Health Informatics
The content of the first five chapters of the book can be applied to each of
the remaining chapters. These chapters introduce the reader to terms,
definitions, concepts, theories, and models that are used throughout the
book, thereby providing the mental infrastructure for understanding the
discipline of health informatics.
Why Informatics Is Needed in Healthcare: An
Example
The weblog GeriPal is an online community of interdisciplinary providers
interested in geriatrics or palliative care. In August 2013, they published an
article titled “Transfers from the hospital to nursing home: an F-grade for
quality.”13 The article reviews a study published in Journal of the American
Geriatrics Society.14 GeriPal describes the finding from this research as
follows: “A rather stunning study in the Journal of the American Geriatrics
Society suggests the quality of communication between the hospital and
the nursing home is horrendous.”13 Patients arrived at skilled nursing
facilities (SNF) with missing or inaccurate information on their health
status, their medication orders, and their functional abilities. The research
found that care was routinely delayed and nursing hours were wasted
trying to obtain the required information. Poor-quality discharge
communication was identified as the major barrier to safe and effective
transitions. Interestingly, nurses from the SNFs in the study identified a
specific list of information and components that they need to facilitate a
safe, high-quality transition. Nevertheless, the lack of an interoperable
healthcare system providing clear, concise patient data/information
between institutions makes the situation described in their study a
common occurrence in SNFs across the country. Healthcare providers and
informaticians who have a mental infrastructure and understand what is
possible are the first requirement for building such an interoperable
system.
Unit 2: Information Systems and Applications for the
Delivery of Healthcare
The Health Information Management Systems Society (HIMSS) provides a
searchable website for applications used in healthcare. As of this writing,
HIMSS listed 30 categories of applications ranging from Ambulatory to
Web/Internet Solutions. Under each of these categories are subcategories:
for example, under Operating Room, one can find Peri-Operative Systems,
Post-Operative Systems, Pre-Operative Systems, and Scheduling. The
point is that an enormous number of applications are used in healthcare
and more are being developed every day. As healthcare providers
discover and explore different applications used in healthcare, three
questions can be used to provide an overview of each application.
• What is the purpose of this application? Each healthcare application will
have a specific purpose or list of purposes: for example, a scheduling
system helps schedule staff or patients within a particular clinical unit.
• What functions can this application perform? Function is how an
application achieves its purpose: For example, can the scheduling
system assign staff to work shifts of any length or does it function with
predetermined shifts only?
• How is this application internally and externally structured? Internal
structure determines how efficiently and effectively the application
actually functions; for example, a poorly designed user interface can
increase the number of user errors. External structure determines how
the application fits into the environment, especially how the application
interfaces with other applications.
The six chapters in this unit explore the common applications used
across the healthcare se ings.
Healthcare Applications Improving Healthcare: An
Example
A study conducted in 2008 entitled The Balancing Act: Patient Care Time
Versus Cost explored how nursing time is distributed in a clinical se ing.15
This research correlated the time spent on various activities with the
nurses’ wages, thereby measuring the cost of nursing care. The authors
reported that $757,000 of nursing wages was spent on tasks such as
hunting for equipment. Nursing Times, in 2009, published an article based
on an online survey of over 1000 nurses16 entitled “Nurses Waste ‘an Hour
a Shift’ Finding Equipment.” A 2011 study from the Robert Wood Johnson
Foundation estimated that only 20% to 30% of a nurse’s time is actually
spent at the bedside, and as much as 70% of their time can be spent on
documentation, finding supplies, and carrying out other duties, such as
tracking down equipment.17
One informatics-based solution to this well-documented waste of
nursing time is the use of an autonomous mobile robot (AMR) with
tracking software, RFID (radio-frequency identification), and barcode
technology to manage supplies needed on a clinical unit. One example of
such a robot is RoboCourier®, developed by Swisslog (Fig. 1.1).
Automated robots such as RoboCourier® can safely and securely transport
laboratory specimens, medications, clinical supplies, and other materials
throughout the healthcare se ing, thereby allowing healthcare
professionals to focus on patient care instead of searching for the materials
they need to provide that care.18
FIG 1.1 RoboCourier® Autonomous Mobile Robot. Used with permission
of Swisslog.
As you consider this technology, think about how the robot would be
programed to automatically interface with elevators and doors so the
robot can move independently throughout the facility on programmed
paths with no human interference. Also consider how the robot would
know what supplies to deliver where. To gain the maximum benefit of
AMRs, they need to be interfaced with other information systems in the
hospital, thus diminishing the human effort needed to maintain needed
supplies on a clinical unit. For example, could the pharmacy system be
interfaced with the AMR so that new medication orders could be quickly
delivered to the clinical unit? Fig. 1.2 demonstrates an AMR in relation to
the people and information systems that direct the AMR as well as other
institutional systems that might be interfaced with the AMR.
FIG 1.2 RoboCourier® Autonomous Mobile Robot in a healthcare
setting with the people and information systems that direct the robot.
Used with permission of Swisslog.
Unit 3: Participatory Healthcare Informatics
(Healthcare on the Internet)
Since the beginning of healthcare, providers have been proactive in
meeting the needs of patients. Historically, patients and their families have
looked to healthcare providers both to assess/diagnosis their health
problems and to tell them what was needed. Today patients are no longer
exclusively dependent on providers to determine what is wrong and what
options they might consider in dealing with their health problem. Patients,
whether well or facing problems, are assuming an increasingly proactive
role in maintaining or obtaining a higher level of health. These proactive
patients are often referred to as ePatients. ePatients are equipped,
empowered, engaged, and electronically connected. They are informed
about their health and have gained much of that knowledge via the
internet. Knowledge is power, and as more patients are becoming
ePatients, the traditional relationship between the patient and the provider
is shifting from a parent–child-type relationship toward more collegial
ones.
Now providers and patients have access to much of the same
information. However, both patients and providers are overwhelmed by
the amount of quality information they can access. In addition, they differ
greatly by the scope of the information that each group needs to access.
Providers must focus on a much larger scope of data/information. First,
they need to be aware of the growing literature base across their specialty
and also the information available to patients. Second, they must be aware
of trends and changes across the broad area of healthcare delivery: for
example, providers need to be aware of the role that social media plays in
healthcare delivery.
Patients and their families can limit research to their own health issues
rather than all disorders within a specific specialty. When working
together in social media groups, individuals can become experts in every
sense of the word about their own expression of their specific health
problems.
However, when confronted with this massive amount of information,
providers have one significant advantage not available to most patients.
Their experience and education makes it much easier to assess the quality
of the information and incorporate new findings into their current
knowledge. Patients, on the contrary, must often spend a great deal of time
and effort correctly interpreting information and determining its
significance in terms of their health issues. This is especially true for
patients with a new health problem or diagnosis.
The solution may seem obvious. Working together as colleagues,
patients and providers can take advantage of each other’s strengths in
meeting the challenges presented by various healthcare problems. The
amount of responsibility for leading this effort will vary at different points
in the wellness–illness continuum. As patients move toward a high level of
health, they are increasingly responsible for maintaining their own health
through diet, exercise, and avoiding poor health habits. As they move
toward the other end of the continuum, with, for example, a severe acute
episode or illness, the provider has a higher level of responsibility.
However, even in these situations, patients and/or their families must sign
the consent form and, therefore, must make the final decision.
In Unit 3, the reader will explore the changing relationship between
ePatients and health informatics. As an introduction to the unit, these
authors suggest that the reader do a quick search of the internet for the
term ePatient and note the variety of examples presented by searching with
this one term.
Unit 4: Managing the Life Cycle of a Health
Information System
As the title suggests, Unit 4 is focused on the life cycle of a health
information system. Fig. 2.8 provides a model of this life cycle. The
systems life cycle (SLC) is one of the oldest and yet still widely used
methods for selecting/tailoring or building, implementing, and evaluating
software applications in the IT arena. The lifecycle has evolved over the
years in response to ever-changing scenarios and paradigm shifts
pertaining to the building or acquiring of software; however, its central
tenants are as applicable now as they ever were. Lifecycle stages have gone
through iterations, with different names and numbers of steps, but the
SLC is resilient as a tried and true method in a wide variety of se ings
including healthcare. Thus, learning about the SLC remains important to
students.18
Healthcare providers, whether they are informaticians or working in
other areas of the healthcare system, play a major role in the life cycle of
healthcare information systems. Acquiring new systems is a complicated
process that affects the entire facility. In the past, a common mistake has
been selecting healthcare systems that affect patient care with li le or no
input from providers across the healthcare team. Healthcare providers
often discover these new applications when they are requested to change
their practice to “work around” an issue with a new system in another
department. Therefore it is imperative that healthcare providers not only
understand the life cycle of healthcare information applications but also be
involved in systems selection.
Using the Systems Life Cycle: An Example
A few years ago, Mark McMurtrey, PhD, a faculty member at the
University of Central Arkansas, and a colleague were invited to serve as
consultants for the selection of a home health software application in a
medium-sized regional hospital. The 149-bed facility included an
emergency department; a hospice; intensive care, obstetrics, pediatrics
rehabilitation, and home units; an imaging center; primary care clinics; a
health and fitness center; and a wound healing center. After completing
this project, McMurtrey published a paper describing how the use of the
systems life cycle provided the project with a systemic and structured
process. He concluded the paper with the following statement: “While
both researchers hold terminal degrees, each learned quite a bit from the
application of principles taught in the classroom to the complexities
surrounding real-world utilization of them.”19, p. 23
Unit 4 contains five chapters exploring the application of life-cycle–
related principles to the complexities surrounding their real-world use in
healthcare. With this background, the reader is prepared to participate
actively and effectively in real-life use of the life cycle in healthcare.
Unit 5: User Experience, Standards, Safety, and
Analytics in Health Informatics
This unit is focused on discovering and using information and knowledge
to improve the way that healthcare is delivered, and in turn, to improve
healthcare outcomes. Currently, there is a large body of knowledge
concerning drug-drug and drug-diet interaction. In addition, there is
extensive knowledge about lab tests, diet, and drug interactions. The
human mind is not designed to remember this type of extensive detail. In
addition, when a computer is used for order entry, deciding the specific
medications, diagnostic tests, and diet to order for an individual patient
can carry a heavy cognitive load, thereby leaving less mental resources for
remembering details related to interactions. In such a situation, health
providers benefit from using a clinical decision support (CDS) system to
analyze the details and offer suggestions. However, a CDS system will not
make a difference unless the information the provider needs is presented
in a way that meshes with the mental workflow of the provider. In other
words, the provider must be able to use the information and knowledge.
Therefore this unit begins by discussing usability.
The process of discovering and using knowledge is highly dependent on
standards. It is only through standards that technologies interface and
interact. For example, it would be impossible to use a computer and a
printer if there were no standards on how these two pieces of technology
are connected. Every piece of technology becomes an isolated and useless
piece of equipment without an agreement on how the pieces of equipment
physically and logically communicate. This agreement is called a standard.
In this unit, current standards and the processes for establishing these
standards in healthcare are explored.
Establishing standards, analyzing data, discovering knowledge, and
making the information/knowledge useful to healthcare providers is
executed with the overall goals of providing safe, effective, quality care.
The unit ends with an analysis of methods, programs, and procedures
used to ensure safe, effective, quality care.
Using Big Data: A Real-Life Example
Dr. John D. Halamka is the chief information officer of Beth Israel
Deaconess Medical Center in Boston. In 2011 his wife, a healthy 49-year-
old Korean woman, was diagnosed with breast cancer. Using big-data
technology available at all Harvard hospitals, Dr. Halamka was able to ask
the big-data questions: Of the last 10,000 Asian women near age 50 who
were treated for the same tumor, what medications were used? Was
surgery or radiation necessary, and what were the outcomes? From his
queries, he was able to ascertain the most effective treatment approach for
a person with this history. His wife was treated successfully and is now
cancer free.20 The challenge for informatics is: How do we develop
information systems that can provide this level of care to patients in all
se ings?
Unit 6: Governance Structures, Legal, and Regulatory
Issues in Health Informatics
Unit 6 is built on the concept of governance, beginning with health
informatics governance at the federal level. The U.S. government and
related legal systems have established processes for achieving justice,
defense, promotion of the general welfare of citizens, and security. Unit 6
is built around these concepts. The first chapter explains how health
informatics-related legislation, programs, and regulations are developed
and implemented. Major legislation is analyzed, from the Health
Insurance Portability and Accountability Act (HIPAA) to the Health
Information Technology for Economic Clinical Health (HITECH) Act, soon
to be followed by the Medicare and CHIP Reauthorization Act (MACRA).
Healthcare leaders, including informaticians, and health IT users must
play active roles in developing these policies, as described in Chapter 28.
Finally, this unit concludes by describing how the concepts of governance
apply to the management and operation of a Health IT department.
Health Policy in Operation: An Example
The HITECH Act, which provided financial incentives for the adoption of
EHRs, was implemented in 2009 with the goal to modernize the IT
infrastructure of the U.S. healthcare system.21
• As of 2009, only 12% of hospitals had adopted a basic EHR system.22 By
2014, 75% of U.S. hospitals had adopted at least a basic EHR system, up
from 59% in 2013.
• The EHRs also showed significant improvement in functionality. By
2014, hospitals able to meet the stage 2 criteria used in the
implementation of the HITECH Act increased to 40.5%, up from 5.8% in
2013.23
• By 2013, 63% of physicians had implemented an EHR, and another 20%
were in the process of implementing one.21
Going forward, healthcare providers must be involved in governance at
the institutional, local, state, and federal levels. This unit provides the
foundation for that involvement as it relates to health informatics.
Unit 7: Education and Health Informatics
In today’s networked healthcare world, all healthcare professionals
require a foundational understanding of health informatics. However, a
significant number of healthcare professionals currently in the workforce
were educated before this was true, and this is especially true for faculty
teaching in health education programs today. According to AACN’s
report on 2013–14 Salaries of Instructional and Administrative Nursing
Faculty in Baccalaureate and Graduate Programs in Nursing, the average
age of faculty varied from 51.2 to 61.6.24 The Association of American
Medical Colleges (AAMC) reported in 2007 that the average age of
medical school faculty is growing older, a finding that held regardless of
degree, department type, rank, or demographic characteristic. At that time,
the average age of MD faculty teaching in the basic sciences was 52.9.25
This might explain why the introduction of computers in healthcare has
been a slow process, and the introduction of informatics into the
curriculum has been even slower. This unit begins by analyzing where
informatics fits in the curriculum for healthcare professionals.
The following three chapters in this unit discuss how technology is
changing the pedagogy of healthcare education. Initially technology made
the educational process more efficient. For example, using a computerized
spreadsheet is more efficient than using a paper-and-pencil gradebook and
calculating grades by hand. Moreover, technology is changing the teaching
and learning process. Distance education often uses more interactive
learning experiences in comparison to the more passive process of taking
notes during a lecture. Simulation provides the opportunity to analyze
one’s own performance and try again, and learning the same procedures
in the clinical se ing does not offer the “do-over” option. Professors are
increasingly seen not as authorities or all-knowing experts, but rather as
learning coaches encouraging the student to develop their own expertise,
knowledge, and skills.
Computerization is changing both healthcare delivery and healthcare
education. This Unit explores these changes and their interrelationship.
The interrelationship is illustrated in Fig. 1.3.
FIG 1.3 The interrelationship of education and informatics.
Unit 8: International Health Informatics Efforts
The need for health information systems that can function around the
world cannot be over emphasized. The desire to be in good health and the
need to deliver healthcare to those in need is universal. Although countries
and regions of the world demonstrate variation in their healthcare needs,
as well as how they pay for and deliver healthcare, globally, healthcare
needs, costs, and delivery are becoming more similar. With increased
travel, infectious diseases can quickly spread around the world. Chronic
diseases are a growing global health problem. The Population Reference
Bureau, with the mission of informing people around the world about
population, health, and the environment, reported in 2013 that global
health trends have undergone a dramatic shift since 1990. During this
period, chronic diseases, such as heart disease, cancer, and diabetes, have
replaced infectious diseases and malnutrition-related childhood illnesses
as the leading causes of death and disability across the globe, with the
exception of sub-Saharan Africa.26
From an international prospective, healthcare delivery systems around
the world face a core of common challenges. In 2015, Deloi e, an
international consulting company, identified a number of such global
challenges:
• Cost was the largest healthcare issue facing most countries in 2015.
Across the globe, there is increasing pressure to contain costs and
demonstrate value.
• Dynamic market forces, such as the increasing role of government,
workforce shortage, demand for improving access to care, and
consumerism, are requiring providers and health plans to rethink
traditional business models.
• Adoption of new digital health IT advances (e.g., EHRs, mHealth
applications, and predictive analytics) are transforming the way
physicians, payers, patients, and other healthcare stakeholders interact
and function within the healthcare system.
• The increased use of government regulation to protect patient health,
safety, and privacy is creating demand for innovative government
processes and partnerships.27
Fig. 1.4 provides an illustration of how these international health trends
and driving forces interact together, influencing the practice of health
informatics, which, in turn, through a recursive process, influences
international health trends and driving forces.
FIG 1.4 Example of international health trends and driving forces
interacting. EHR, Electronic health record; ePHI, electronic
protected health information; PHR, personal health record. Used with
permission of Deloitte Touch Tohmastu Limited.
This unit presents international health informatics initiatives, as well as
the international organizations involved in these initiatives and how
health practitioners are involved in the activities of these organizations. In
addition, international informatics implications are woven throughout
each chapter of this book as appropriate.
Unit 9: Historical Implications and Future Directions
in Health Informatics
Those who would prefer a be er future must take an active role in creating
that future. Those healthcare professionals who would prefer future
healthcare information systems that are effective, improved, and
innovative must take an active role in creating such systems. The work
creating these systems requires professionals who understand the past as a
foundation for creating a preferred future. The unit begins by using the
history of informatics to understand the current status of informatics. The
rich history of health informatics presents unique challenges and
opportunities. For example, the authors know of no other profession
where the educational programs for the discipline are housed in so many
different academic departments, schools, and/or colleges, ranging from
computer and/or information science to medicine and/or nursing.
Establishing a consensus on the level of education required, let alone the
competencies of the graduate, is a unique challenge for the profession of
health informatics. However, this diversity presents a unique opportunity
to define and develop interdisciplinary education.
The unit concludes by presenting the reader with specific research skills
for both predicting and creating the future, along with an understanding
of the driving forces influencing the future of health informatics.
Conclusion and future directions
Although health informatics is a young discipline, the use of technology in
healthcare is growing exponentially. Therefore all aspects of healthcare
from the relations between patient and provider to the financial models
used to pay for care are being redesigned by a process that might best be
described as disruptive innovation. In this world of rapid change,
healthcare students and providers often feel that they are unable to stay
current and no longer have control of their own practice. A strong
foundation in the concepts, principles, methods, and science of health
informatics will provide both future and current providers with the
knowledge and skills needed to maximize the benefits of technology,
while managing the challenges it presents. The goal of this book is to
provide that foundation.
References
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Discussion Questions
1. Health informatics is both a discipline and a profession. Describe how
health informatics as a discipline influences health informatics as a
profession, as well as how the profession influences the discipline.
2. Describe how health informatics content and related courses fits within
the curriculum for your discipline. For example, if you are a nurse or
student of nursing, explain how health informatics is integrated into the
curriculum for your profession.
3. Develop a definition of health informatics that might be used to describe
and explain it to a patient with limited literacy.
4. Select three units in the book. Read the abstract for each chapter in each
of the three units. Now write a paragraph summarizing each unit. At the
end of the three paragraphs, write a fourth paragraph describing the
interrelationships you can identify between these units.
Case Study
You are currently employed as a healthcare provider in a community
hospital in your local community. The local high school is designing a
learning unit for sophomores who have expressed an interest in computers
and other technology as a potential future career. The teacher, who has
designed this unit, has asked you to a end one of the classes as a guest
speaker discussing how computer-related technology is used in
healthcare. Design a 20- to 30-minute presentation that you might use in
meeting the teacher’s request.
Case Study Questions
1. What questions might you ask the teacher to assess the literacy levels
of the students?
2. The first 2 minutes of the presentation should be designed to grab the
student’s interest. What content would you include in these first two
minutes?
3. What are the 3 to 5 key points you would want to include in this
presentation?
4. What questions do you anticipate the students might ask and how
would you prepare to answer their questions?
2
Theoretical Foundations of Health
Informatics
Ramona Nelson; Nancy Staggers
Abstract
This chapter provides an overview of the technology-related literacies, theories, and
models useful for guiding practice in health informatics. For both providers and
patients, developing knowledge and related skills in health informatics requires first
a foundation in technology-related literacies. The chapter begins by exploring these
literacies and their relationship to health informatics. Next, the chapter defines and
explains components of grand, middle-range, and micro theories. Whether designing
effective and innovative technology-based solutions, implementing these approaches,
or evaluating them, truly nothing is as useful as a good theory to guide the process.
Specific theories relevant to informatics are outlined. Systems and complexity
adaptation theory provide the foundation for understanding each of the theories
presented. Information models from Blum, Graves, and Nelson outline the data,
information, knowledge, and wisdom continuum. The next section of the chapter
presents change theories including the diffusion of innovation theory. In the final
section of the chapter, the Staggers and Nelson model of the systems life cycle is
described, and its application is outlined.
Whether designing effective and innovative technology-based solutions,
implementing these approaches, or evaluating them, truly nothing is as
useful as a good theory to guide the process.
Judith Effken
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Explain the technology-related literacies and their relationship to
health informatics.
2. Use major theories and models underpinning informatics to analyze
health informatics-related phenomena.
3. Use major theories and models underpinning informatics to predict
health informatics-related phenomena.
4. Use major theories and models underpinning informatics to manage
health informatics-related phenomena.
KEY TERMS
a ributes 17
automated system 24
basic literacy 11
boundary 16
change theory 28
channel 22
chaos theory 18
closed systems 15
Complex Adaptive System (CAS) 18
complexity theory 18
conceptual framework 15
data 22
digital literacy 12
dynamic homeostasis 17
dynamic system 18
entropy 17
equifinality 17
FIT persons 12
fractal-type pa erns 18
health literacy 13
information 22
information literacy 12
information theory 21
knowledge 22
lead part 16
learning theory 25
negentropy 18
noise 22
open systems 15
phenomenon 14
receiver 22
reiterative feedback loop 18
reverberation 18
sender 22
subsystem 16
supersystem 16
systems life cycle (SLC) 31
target system 16
theoretical model 15
theory 14
wisdom 23
Introduction
Health informatics is a profession. In turn, the individuals who practice
this profession function as professionals. These statements may seem
obvious, but there are important implications in these statements that can
be easily overlooked. The professionals who practice a profession possess
a body of knowledge, as well as values and skills unique to that
profession. The body of knowledge, values, and skills guide the profession
as a whole, as well as the individual professional, in decisions related
directly or indirectly to the services provided to society by that profession.
Professional practice is not based on a set of rules that can be carefully
followed. Rather, the profession, through its professional organizations,
and the professional, as an individual, make decisions by applying their
knowledge, values, and skills to the specific situation. The profession and
the professional within that profession have a high degree of autonomy,
and are therefore responsible for the practice and the decision made
within that practice. This chapter provides an overview of the primary
technology-related literacies, the theories, and the models useful for
guiding the professional practice in health informatics.
Foundational Literacies for Health Informatics
For both providers and patients, developing their knowledge and related
skills in health informatics requires a foundation in the technology-related
literacies.
The discussion in this chapter focuses on basic literacy and technology-
related literacies that relate directly to the work of patients and healthcare
providers. Successful use of technology is dependent on basic literacy,
computer literacy, information literacy, digital literacy, and health literacy.
These specific literacies are both overlapping and interrelated as illustrated
in Fig. 2.1.
FIG 2.1 Overlapping relationships of technology-related literacies
and basic literacy. Printed with Permission of Ramona Nelson all rights reserved.
Definition of Basic Literacy
As illustrated in Fig. 2.1, basic literacy is the foundational skill. Without a
basic level of literacy, the other types of literacy become impossible and
irrelevant. UNESCO offered one of the first definitions of literacy. “A
literate person is one who can, with understanding, both read and write a
short simple statement on his or her everyday life.”1, p. 12 This definition is
still in frequent use today. In 2003 UNESCO proposed an operational
definition that a empted to encompass several different dimensions of
literacy. “Literacy is the ability to identify, understand, interpret, create,
communicate, and compute, using printed and wri en materials
associated with varying contexts. Literacy involves a continuum of
learning in enabling individuals to achieve their goals, to develop their
knowledge and potential, and to participate fully in their community and
wider society.”1 Although other UNESCO publications have provided
additional definitions of literacy, the 2003 definition continues to be the
more comprehensive definition.
In the United States, the U.S. Department of Education, Institute of
Education Sciences, National Center for Education Statistics conducts the
National Assessment of Adult Literacy (NAAL). The NAAL definition of
literacy includes both knowledge and skills. NAAL assesses three types of
literacy: prose, document, and quantitative.
• Prose literacy: The knowledge and skills needed to search,
comprehend, and use continuous texts such as editorials, news stories,
brochures, and instructional materials.
• Document literacy: The document-related knowledge and skills
needed to perform a search, comprehend, and use noncontinuous
texts in various formats such as job applications, payroll forms,
transportation schedules, maps, tables, and drug or food labels.
• Quantitative literacy: The quantitative knowledge and skills required
for identifying and performing computations, either alone or
sequentially, using numbers embedded in printed materials such as
balancing a checkbook, figuring out a tip, completing an order form,
or determining the amount.2
The focus of both the national and international definitions is the ability
to understand and use information in printed or wri en format. The
assumption is that this includes the ability to understand both text and
numeric information. Many people assume that if one can read and
understand information in printed format, presumably that individual
could read and understand the same information on a computer screen.
However, computer literacy involves much more than the ability to read
information from a computer screen. In fact, the term computer literacy with
its limited scope is outdated.
Definition of Computer Literacy/Fluency
Over 15 years ago, the National Academy of Science coined the term FIT
persons to describe people who are fluent with information technology.
That definition remains current. FIT persons possess three types of
knowledge:
• Contemporary skills are the ability to use current computer
applications such as word processors, spreadsheets, or an internet
search engine, using the correct tool for the right job (e.g.,
spreadsheets when manipulating numbers and word processors when
manipulating text).
• Foundational concepts are understanding the how and why of
information technology. This knowledge gives the person insight into
the opportunities and limitations of social media and other
information technologies.
• Intellectual capabilities are the ability to apply information
technology to actual problems and challenges of everyday life. An
example of this knowledge is the ability to use critical thinking when
evaluating health information on a social media site.3
Definition of Information Literacy
The Association of College and Research Libraries (ACRL), a division of
the American Library Association (ALA), initially defined information
literacy and has led the development of information literacy standards
since the 1980s. As part of this effort, they established standards of
information literacy for higher education, high schools, and even
elementary education. The ALA defines information literacy as a set of
abilities requiring individuals to recognize when information is needed
and have the ability to locate, evaluate, and effectively use the needed
information.4 This definition has gained wide acceptance. However, with
the extensive growth of new technologies, including different internet-
based information sources and social media, there have been increasing
calls to revise the definition and the established standards from over a
decade ago. “Social media environments and online communities are
innovative collaborative technologies that challenge the traditional
definitions of information literacy…information is not a static object that is
simply accessed and retrieved. It is a dynamic entity that is produced and
shared collaboratively with such innovative Web 2.0 technologies as
Facebook, Twi er, Delicious, Second Life, and YouTube.”5, p. 62
For example, it requires different types of knowledge and skills to
evaluate information posted on Facebook, versus Wikipedia, versus an
online peer-reviewed prepublished article, versus a peer-reviewed
published article. Professional students need different writing skills when
participating in an online dialog as opposed to preparing a term paper.
There are standards that apply to text messaging, especially if the message
is between healthcare colleagues or is being sent to a patient. Developing
appropriate policies, procedures, and standards are the challenges facing
healthcare leaders in the world of evidence-based practice, social media,
and engaged patients. Recognizing the changing world of information
creation, access, and use, ACRL has expanded the definition of information
literacy:
Information literacy is the set of integrated abilities encompassing the
reflective discovery of information, the understanding of how information is
produced and valued, and the use of information in creating new
knowledge and participating ethically in communities of learning.6
In line with the expanded definition, the ACRL developed a Framework
for Information Literacy for Higher Education (Framework).6 The
Framework grows out of their belief that information literacy as an
educational reform movement will realize its potential only through a
richer, more complex set of core ideas. While the Framework does not
replace the standards previously developed, it does provide a less
prescriptive approach for incorporating information literacy, knowledge,
and skills into education, including the education of health professionals.
Table 2.1 lists and gives a brief description of the six frames in the
Framework. As can be seen from the changing definition of information
literacy the internet and related apps, as well as technologies, are changing
the concept of information literacy. Arising from this change is the concept
of digital literacy.
Table 2.1
Framework for Information Literacy for Higher Education6
Frames Description
Authority Is Information resources reflect their creators’ expertise and credibility, and are evaluated based
Constructed and on the information need and the context in which the information will be used.
Contextual
Information The iterative processes of researching, creating, revising, and disseminating information vary,
Creation as a and the resulting product reflects these differences.
Process
Information Has Information possesses several dimensions of value, including as a commodity, as a means of
Value education, as a means to influence, and as a means of negotiating and understanding the
world.
Research as Research is iterative and depends upon asking increasingly complex or new questions whose
Inquiry answers in turn develop additional questions or lines of inquiry in any field.
Scholarship as Communities of scholars, researchers, or professionals engage in sustained discourse with
Conversation new insights and discoveries occurring over time as a result of varied perspectives and
interpretations
Searching as Searching for information is often nonlinear and iterative, requiring the evaluation of a range
Strategic of information sources and the mental flexibility to pursue alternate avenues as new
Exploration understanding develops.
Definition of Digital Literacy
The term digital literacy first appears in the literature in the 1990s.
However, to date, there is no generally accepted definition. While there is
no generally accepted definition, there are a number of national and
international Digital Literacy Centers supporting the development of
digital literacy. Some examples include:
• Syracuse University’s Center for Digital Literacy at h p://digital-
[Link]/
• University of British Columbia, the Digital Literacy Centre at
h p://[Link]/
• Microsoft Digital Literacy Curriculum at [Link]/en-
us/DigitalLiteracy
• National Telecommunications and Information Administration
Literacy Center at [Link]/
There are also a number of books published about digital literacy. Three
recognized definitions are published. The earliest of these is provided in a
White Paper commissioned by the Aspen Institute Communications and
Society Program and the John S. and James L. Knight Foundation, “Digital
and media literacy are defined as life skills that are necessary for
participation in our media-saturated, information-rich society.” These
skills include:
• Making responsible choices and accessing information by locating and
sharing materials and comprehending information and ideas.
• Analyzing messages in a variety of forms by identifying the author,
purpose, and point of view, and evaluating the quality and credibility
of the content.
• Creating content in a variety of forms, making use of language,
images, sound, and new digital tools and technologies.
• Reflecting on one’s own conduct and communication behavior by
applying social responsibility and ethical principles.
• Taking social action by working individually and collaboratively to
share knowledge and solve problems in the family, workplace, and
community, and by participating as a member of a community.7
The second, and most recognized definition of digital literacy, provided
by the ALA’s Digital Literacy Task Force, describes it as “the ability to use
information and communication technologies to find, understand,
evaluate, create, and communicate digital information, an ability that
requires both cognitive and technical skills.”8, p. 2
A digitally literate person:
• Possesses a variety of skills—cognitive and technical—required to
find, understand, evaluate, create, and communicate digital
information in a wide variety of formats
• Is able to use diverse technologies appropriately and effectively to
search for and retrieve information, interpret search results, and judge
the quality of the information retrieved
• Understands the relationships among technology, lifelong learning,
personal privacy, and appropriate stewardship of information
• Uses these skills and the appropriate technologies to communicate
and collaborate with peers, colleagues, family, and, on occasion, the
public
• Uses these skills to participate actively in society and contribute to a
vibrant, informed, and engaged community8
The third definition, published by Springer in a book focused on social
media for nurses, defined digital literacy as including:
• Competency with digital devices of all types including cameras,
eReaders, smartphones, computers, tablets, and video games boards.
This does not mean that one can pick up a new device and use that
device without an orientation. Rather, one can use trial and error, as
well as a manufacturer’s manual, to determine how to use a device
effectively.
• The technical skills to operate these devices, as well as the conceptual
knowledge to understand their functionality.
• The ability to creatively and critically use these devices to access,
manipulate, evaluate, and apply data, information, knowledge, and
wisdom in activities of daily living.
• The ability to apply basic emotional intelligence in collaborating and
communicating with others.
• The ethical values and sense of community responsibility to use digital
devices for the enjoyment and benefit of society.9
These three definitions have much in common, and together they
demonstrate that digital literacy is a more comprehensive concept than
computer or information literacy. The definition goes beyond the
comfortable use of technology demonstrated by the digital native. Digital
literacy is about understanding the implications of digital technology and
the impact it is having, and will have, on every aspect of our lives. “The
truth is, though most people think kids these days get the digital world, we
are actually breeding a generation of digital illiterates. How? We are not
teaching them how to really understand and use the tools. We are only
teaching them how to click bu ons. We need to be teaching our students, at all
levels, not just how to click and poke, but how to communicate, and
interact, and build relationships in a connected world.”10
Definition of Health Literacy
Although health literacy is concerned with the ability to access, evaluate,
and apply information to health-related decisions, there is also not a
consistent, generally accepted agreement on the definition of the term. In
2011, a published systematic review of the literature in Medline, PubMed,
and Web of Science identified 17 definitions of health literacy and 12
conceptual models. The most frequently cited definitions of health literacy
were from the American Medical Association, the Institute of Medicine,
and World Health Organization (WHO).11 Current definitions from the
Institute of Medicine, and WHO include:
• The Institution of Medicine uses the definition of health literacy
developed by Ra an and Parker and cited in Healthy People 2010.
Health literacy is “the degree to which individuals have the capacity
to obtain, process, and understand basic health information and
services needed to make appropriate health decisions.”12
• The WHO has defined health literacy as “the cognitive and social
skills that determine the motivation and ability of individuals to gain
access to, understand, and use information in ways which promote
and maintain good health.” Health literacy means more than being
able to read pamphlets and successfully make appointments. By
improving people’s access to health information and their capacity to
use it effectively, health literacy is critical to empowerment. It is the
degree to which people are able to access, understand, appraise, and
communicate information to engage with the demands of different
health contexts to promote and maintain good health across the life-
course.13
The focus in each of these definitions is on an individual’s skill in
obtaining and using the health information and services necessary to make
appropriate health decisions. These definitions do not fully address the
networked world of the internet. In recognition of this deficiency, Norman
and Skinner introduced the concept of eHealth as “the ability to seek, find,
understand, and appraise health information from electronic sources and
apply the knowledge gained to addressing or solving a health problem.”14,
e9
This definition acknowledges the need for computer fluency and the use
of information skills to obtain an effective level of health literacy.
However, this definition is not especially sensitive to the impact of social
media. For example, it does not address the individual as a
patient/consumer collaboratively creating health-related information that
others could use in making health-related decisions. There is increasing
evidence that patients bring to the dialog a unique knowledge base for
addressing a number of health-related problems.15 Creating the
comprehensive definition and model for assessment of health literacy
levels that includes the social media literacy skills needed for today’s
communication processes remains a challenge for health professionals. A
key resource in meeting the health literacy needs within the clinical se ing
and the community can be found at
h p://[Link]/outreach/consumer/[Link].
While each of the technology-related communication literacies
presented here focuses on a different aspect of literacy and has a different
definition, they all overlap and are interrelated. Fig. 2.1 demonstrates
those interrelationships. In this figure, basic literacy is depicted as
foundational to all other literacies. Digital literacy includes computer and
information literacy as well as other social media–related knowledge and
skills that were not initially included in the definitions of computer and
information literacy. For example, playing online games is not usually
considered part of information or computer literacy, but it clearly requires
digital literacy. Health literacy now requires both digital literacy and a
basic knowledge of health unrelated to automation. All of the literacies
require the ability to evaluate online information and, especially, to pay
a ention to information generated on social media sites.
Understanding these technology-related communication literacies and
integrating them into current policies and procedures is the challenge all
healthcare providers and informaticians face.
Understanding theories and models
A theory explains the process by which certain phenomena occur.16
Theories vary in scope depending on the extent and complexity of the
phenomenon of interest. Grand theories are wide in scope and a empt to
explain a complex phenomenon within the human experience. For
example, a learning theory that a empted to explain all aspects of human
learning would be considered a grand theory. Because of the complexity of
the theory and the number of variables interacting in dependent,
independent, and interdependent ways, these theories are difficult to test.
However, grand theories can be foundational within a discipline or
subdiscipline. For example, learning and teaching theories are
foundational theories within the discipline of education.
Middle-range theories are used to explain specific defined phenomena.
They begin with an observation of the specific phenomena. For example,
one might note how people react to change. However, why and how does
this phenomenon occur? A theory focused on the phenomenon of change
would explain the process that occurs when people experience change and
predict when and how they will respond in adjusting to the change.
Micro theories are limited in scope and specific to a situation. For
example, one might describe the introduction of a new electronic health
record (EHR) within a large ambulatory practice and even measure the
variables within that situation that could be influencing the acceptance
and use of the new system. In the past, micro theories, with their limited
scope, have rarely been used to test theory. However, this is changing with
the development of Web 2.0 and the application of meta-analysis
techniques to automatized natural language processing.
The development of a theory occurs in a recursive process moving on a
continuum from the initial observation of the phenomenon to the
development of a theory to explain that phenomenon. The process of
moving on this continuum can be divided into several stages, including
the following:
1. A specific phenomenon is observed and noted.
2. An idea is proposed to explain the development of the phenomenon.
3. Key concepts used to explain the phenomenon are identified, and the
processes by which the concepts interact are described.
4. A conceptual framework is developed to clarify the concepts and their
relationships and interactions. Conceptual frameworks can be used to
propose theories and generate research questions. The conceptual
framework can also be used to develop a conceptual model. A conceptual
model is a visual representation of the concepts and their relationships.
5. A theory and related hypothesis are proposed and tested.
6. Evidence accumulates, and the theory is modified, rejected, replaced, or
it gains general acceptance.
Many of the models used to guide the practice of health informatics and
discussed in this chapter can be considered theoretical models or
frameworks. Because theoretical frameworks explain a combination of
related theories and concepts, they can be used to guide practice and
generate additional research questions. With this definition, one can argue
that the concept of a theoretical framework can be conceived as a bridge
between a middle-range theory and a grand theory. A theoretical model is
a visual representation of a theoretical framework. Many of the models in
healthcare and health informatics use a combination of theories in
explaining phenomena of interest within these disciplines and fit the
definition of a theoretical framework.
Even though the terms theory and concept are consistently defined and
used in the literature, the terms conceptual and theoretical framework, as well
as the terms conceptual and theoretical models, are not. No set of consistent
criteria can be applied to determine whether a model is conceptual or
theoretical. As a result, researchers and informaticians will often publish
models without clarifying that the proposed model is either conceptual or
theoretical. In turn, it is possible for one reference to refer to a model as a
conceptual framework whereas another uses the term theory when it refers
to a model as a theoretical framework.
Theories and Models Underlying Health Informatics
Health informatics is an applied field of study incorporating theories from
information science; computer science; the science for the specific
discipline, such as medicine, nursing, or pharmacy; and the wide range of
sciences used in healthcare delivery. Therefore health professionals and
health informatics specialists draw on a wide range of theories to guide
their practice. This chapter focuses on selected theories that are of major
importance to health informatics and those that are most directly
applicable. These theories are vital to understanding and managing the
challenges and decisions faced by health professionals and informatics
specialists. In analyzing the selected theories, the reader will discover that
understanding these theories presents certain challenges. Some of the
theories overlap, different theories are used to explain the same
phenomena, and sometimes, different theories have the same name. The
theories of information are an example of each of these challenges.
The one theory that underlies all of the theories used in health
informatics is systems theory. Therefore this is the first theory discussed in
this chapter.
Systems Theory
A system is a set of related interacting parts enclosed in a boundary.17
Examples of systems include computer systems, school systems, the
healthcare system, and a person. Systems may be living or nonliving.18
Systems may be either open or closed. Closed systems are enclosed within
an impermeable boundary and do not interact with the environment.
Open systems are enclosed within a semipermeable boundary and do
interact with the environment. This chapter focuses on open systems,
which can be used to understand technology and the people who are
interacting with the technology. Fig. 2.2 demonstrates an open system
interacting with the environment. Open systems take input (information,
ma er, and energy) from the environment, process the input, and then
return output to the environment. The output then becomes feedback to
the system. Concepts from systems theory can be applied in
understanding the way people work with computers in a healthcare
organization. These concepts can also be used to analyze individual
elements such as software or the total picture of what happens when
systems interact.
FIG 2.2 An open system interacting with the environment. Copyright
Ramona Nelson. Reprinted with permission. All rights reserved.
A common expression in computer science is “garbage in garbage out,”
or GIGO. GIGO refers to the input-output process. The counter-concept
implied by this expression is that quality input is required to achieve
quality output. Although GIGO usually is used to refer to computer
systems, it can apply to any open system. An example of this concept can
be seen when informed active participants provide input for the selection
of a healthcare information system. In this example, garbage in can result
in garbage out or quality input can support the potential for quality
output. Not only is quality input required for quality output, but the
system must also have effective procedures for processing those data.
Systems theory provides a framework for looking at the inputs to a
system, analyzing how the system processes those inputs, and measuring
and evaluating the outputs from the system.
Characteristics of Systems
Open systems have three types of characteristics: purpose, structure, and
functions. The purpose is the reason for the system’s existence. The
purpose of an institution or program is often outlined in the mission
statement. Such statements can include more than one purpose. For
example, many healthcare institutions have three purposes: (1) provide
patient care, (2) provide educational programs for students in the health
professions, and (3) conduct health-related research. Computer systems
are often referred to or classified by their purpose(s). The purpose of a
radiology system is to support the radiology department. An EHR can
have several different purposes. One of the purposes is to maintain a
census that can be used to bill for patient care.
One of the first steps in selecting a computer system for use in a
healthcare organization is to identify the purposes of that system. Having
a succinct purpose answers the question “Why select a system?” Many
times, there is a tendency to minimize this step with the assumption that
everyone already agrees on the purposes of the system. When a system
has several different purposes, it is common for individuals to focus on the
purposes most directly related to their area of responsibility. Taking the
time to specify and prioritize the purposes helps to ensure that the
representatives from clinical, administration, and technology agree on the
reasons for selecting a system and understand the full scope of the project.
Functions, on the contrary, focus on the question “How will the system
achieve its purpose?” Functions are sometimes mistaken for purpose.
However, it is important to clarify why a system is needed, and then
identify what functions the system will carry out to achieve that purpose.
For example, a hospital may maintain patient census data including
admissions, discharges, and transfers through a computerized registration
system. Each time a department accesses the patient’s online record, the
name and other identifying information are transmi ed from a master file,
ensuring consistency throughout the institution. When selecting a
computer system, the functions for that system are carefully identified and
defined in writing. These are listed as functional specifications.
Specifications identify each function and describe how that function will
be performed.
Systems are structured to perform their functions. Two different
structural models operating concurrently can be used to conceptualize
healthcare technical infrastructures. These are hierarchical and web. The
hierarchical model is an older architectural model, and the terms, such as
mainframe, that are used to describe the model reflect that reality. The
location and type of hardware used within a system often follow a
hierarchical model; however, as computer systems are becoming more
integrated, information flow increasingly follows a web model. The
hierarchical model can be used to structure the distribution of the
computer processing loads at the same time as the web model is used to
structure communication of health-related data throughout the institution.
The hierarchical model is demonstrated in Fig. 2.3. Each individual
computer is part of a local area network (LAN). The LANs join together to
form a wide area network (WAN) that is connected to the mainframe
computers. In Fig. 2.3 the mainframe is the lead computer or lead part.
This structure demonstrates a centralized approach to managing the
computer structure.
FIG 2.3 Hierarchical Information System Model. Departmental
information systems; LAN, local area network. Copyright Ramona Nelson.
Reprinted with permission. All right reserved.
When analyzing the hierarchical model, the term system may refer to
any level of the structure. In Fig. 2.3, an individual computer may be
referred to as a system or the whole diagram may be considered a system.
Three terms are used to indicate the level of reference. These are
subsystem, target system, and supersystem. A subsystem is any system
within the target system. For example, if the target system is a LAN, each
computer is a subsystem. The supersystem is the overall structure in
which the target system exists. If the target system is a LAN, then Fig. 2.3
represents a supersystem.
The second model used to analyze the structure of a system is the web
model. The interrelationships between the different LANs function like a
web. Laboratory data may be shared with the pharmacy and the clinical
units concurrently, just as the data collected by nursing, such as weight
and height, may be shared with each department needing the data. The
internet is an example of a complex system that demonstrates both
hierarchical and web structures interacting as a cohesive unit. As these
examples demonstrate, a system includes structural elements from both
the web model and the hierarchical model. Complex and complicated
systems discussed later in this chapter can include a number of
supersystems organized using both hierarchical and web structures.
Boundary, a ributes, and environment are three concepts used to
characterize structure. The boundary of a system forms the demarcation
between the target system and the environment of the system. Input flows
into the system by moving across the boundary and output flows into the
environment across this boundary. For example, with a web model,
information flows across the systems. Thinking in terms of boundaries can
help to distinguish information flowing into a system from information
being processed within a system. Fig. 2.3 can be used to demonstrate how
these concepts can establish the boundaries of a project. Each computer in
the diagram represents a target system for a specific project. For example,
a healthcare institution could be planning for a new pharmacy information
system. The new pharmacy system becomes the target system. However,
as the model demonstrates, the pharmacy system interacts with other
systems within the total system. The task group selecting the new
pharmacy system will need to identify the functional specifications needed
to automate the pharmacy and the functional specifications needed for the
pharmacy system to interact with the other systems in the environment.
Clearly, specifying the target system and the other systems in the
environment that must interact or interface with the target will assist in
defining the scope of the project. By defining the scope of the project, it
becomes possible to focus on the task while planning for the integration of
the pharmacy system with other systems in the institution. A key example
is planning for the impact of a new pharmacy system in terms of the
activities of nurses who are administering medications.
In planning for healthcare information systems, a ributes of the system
are identified. A ributes are the properties of the parts or components of
the system. When discussing computer hardware, these a ributes are
usually referred to as specifications. An example of a list of patient-related
a ributes can be seen on an intake or patient assessment form in a
healthcare se ing. A ributes and the expression of those a ributes play a
major role in the development of databases. Field names are a list of the
a ributes of interest for a specific system. The datum in each cell is the
individual system’s expression of that a ribute. A record lists the
a ributes for each individual system. The record can also be seen as a
subsystem of the total database system.
Systems and the Change Process
Both living and nonliving systems are constantly in a process of change.
Six concepts are helpful in understanding the change process. These are
dynamic homeostasis, equifinality, entropy, negentropy, specialization,
and reverberation.
Dynamic homeostasis refers to the processes used by a system to
maintain a steady state or balance. This same goal of maintaining a steady
state can affect how clinical se ings respond when changes are made or a
new system is implemented.
Equifinality is the tendency of open systems to reach a characteristic
final state from different initial conditions and in different ways. For
example, two different clinics may be scheduled for the implementation of
a new EHR. One unit may be using paper records and the other unit may
have an outdated computer system. A year or two later, both clinical units
may be at the same point, comfortably using the new system. However,
the process for reaching this point may have been very different.
Entropy is the tendency of all systems to break down into their simplest
parts. As it breaks down, the system becomes increasingly disorganized or
random. Entropy is demonstrated in the tendency of all systems to wear
out. Even with maintenance, a healthcare information system will reach a
point where it must be replaced. Healthcare information that is transferred
across many different systems in many different formats can also
demonstrate entropy, thereby causing confusion and conflict between
different entities within the healthcare system.
Negentropy is the opposite of entropy. This is the tendency of living
systems to grow and become more complex. This is demonstrated in the
growth and development of an infant, as well as in the increased size and
complexity of today’s healthcare system. With the increased growth and
complexity of the healthcare system, there has been an increase in the size
and complexity of healthcare information systems. As systems grow and
become more complex, they divide into subsystems and then sub-
subsystems. This is the process of differentiation and specialization. Note
how the human body begins as a single cell and then differentiates into
different body systems, each with specialized purposes, structures, and
functions. This same process occurs with healthcare. If the mainframe in
Fig. 2.3 were to stop functioning, the impact would be much more
significant than if an individual computer in one of the LANs were to stop
functioning.
Change within any part of the system will be reflected across the total
system. This is referred to as reverberation. Reverberation is reflected in
the intended and unintended consequences of system change. When
planning for a new healthcare system, the team will a empt to identify the
intended consequences or expected benefits to be achieved. Although it is
often impossible to identify a comprehensive list of unintended
consequences, it is important for the team to consider the reality of
unintended consequences. The potential for unintended consequences
should be discussed during the planning stage; however, these will be
more evident during the testing stage that precedes the implementation or
“go-live.” Many times unintended consequences are not considered until
after go-live, when they become obvious. For example, e-mail may be
successfully introduced to improve communication in an organization.
However, an unintended consequence can be the increased workload from
irrelevant e-mail messages. Unintended consequences are not always
negative. They can be either positive or negative.
Unintended consequences is just one example of how difficult it is to
describe, explain, and predict events and maybe even control outcomes in
complex systems such as a healthcare institution. Starting in the 1950s,
chaos theory, followed by complexity theory, began to develop and was
seen as an approach for understanding complex systems. Both chaos and
complexity theory involve the study of dynamic nonlinear systems that
change with time and demonstrate a variety of cause-and-effect
relationships between inputs and outputs because of reiterative feedback
loops. “The quantitative study of these systems is chaos theory.
Complexity theory is the qualitative aspect drawing upon insights and
metaphors that are derived from chaos theory.”19 Box 2.1 outlines the
characteristics of chaotic systems. The characteristics of chaotic systems
provide a foundation for understanding how complex systems adapt over
time. Such systems are termed complex adaptive systems (CAS). There are
now several examples of how the concept of CAS is being use to
understand phenomenon of interest in the healthcare literature.23-30
Box 2.1
Characteristics of Chaotic Systems
Chaos is defined as a physical “mathematical dynamic system which is: (a)
deterministic (b) is recurrent and (c) has sensitive dependence on the
initial state.”20, p. 164 In turn, chaos theory can be defined as “the qualitative
study of unstable aperiodic behavior in deterministic, nonlinear
dynamical systems.”21, p. 2 Chaotic systems demonstrate the following
characteristics:
• They are dynamic systems in a constant state of nonlinear change. In a
linear system, the output is consistently proportional to the input.
Increase the input and the output increases at the same rate. In a
nonlinear system, the output of the system is not proportional to the
input.
• The reiterative feedback loop that exists within these systems has a
major effect on how inputs will affect outputs. A minor change in input
can create a major change in output. On the contrary, a major change in
input can result in minor changes in output.
• Their output is determined by the initial input, reiterative feedback
loops, and the dynamic changes that occur over time. “Although it looks
disorganized like random behavior, it is deterministic-like periodic
behavior. However, the smallest difference in any system variable can
make a very large difference to the future state of the system.”19, p. 15
• Fractal-type pa erns begin to emerge from these outputs. Fractals are
repeating nonregular geometric shapes such as snowflakes, trees, or
seashells. Thus out of chaos comes order.22
Complex Adaptive Systems
A Complex Adaptive System (CAS) is defined as an “entity consisting of
many diverse and autonomous parts which are interrelated,
interdependent, linked through many interconnections, and behave as a
unified whole in learning from experience and in adjusting (not just
reacting) to changes in the environment. Each individual agent of a CAS is
itself a CAS.”31 This definition is best understood by analyzing the
characteristics of a CAS.32–35
Characteristics of a CAS
Change occurs through nonlinear interdependencies. A CAS
demonstrates interrelationships, interaction, and interconnectivity of the
units within the system and between the system and its environment. A
change in any one part of the system will influence all other related
parts but not in any uniform manner. For example, a small inexpensive
change on a computer screen may make that screen easier to understand
and in turn prevent a number of very dangerous mistakes. On the
contrary, a major revision of an organization website may have minimal
impact on how the user of that site sees the organization or uses the site.
Control is distributed. Within a CAS, there is no single person or group
who has full control of the organization. It is the interrelationship and
interdependencies that produce a level of coherence that makes it
possible for the organization to function and even grow. Thus the
overall behavior cannot be predicted by reviewing the activities of one
section or part of the organization. Hindsight can be used to explain past
events, but foresight is limited in predicting outcomes. Therefore
solutions based on past practices may prove ineffective when presented
with a new version of a previous problem.
Learning and behavior change is constant. Individuals and groups within
a CAS are intelligent agents who learn from each other, probe their
environment, and test out ideas. They are constantly learning and
changing their ideas as well as their behavior.
Units or parts of a CAS are self-organizing. Self-organizing refers to the
ability of CAS to arrange workflow and pa erns of interaction
spontaneously into a purposeful (nonrandom) manner, without the help
of an external agency. Individuals and groups within a CAS are unique.
Individuals and groups with the CAS will have different and
overlapping needs, desires, knowledge, and personality traits. Order
results from the feedback inherent in the interactions between
individuals and groups as each moves through their own activities.
Behavior pa erns that were not designed into the system will emerge.
As these individuals and groups interact, the emerging pa erns of
interactions will include some degree of both cooperation and conflict.
Therefore these emergent behaviors may range from valuable
innovations to severe conflict issues.
The pa erns of interaction are for the most part informal yet well
established for the individuals functioning in the group. The pa erns of
behavior will have a major influence on the organization of workflow,
but are often not obvious to someone new in the group. In addition,
such behaviors are often not documented; for example, in a policy or
procedure. However, these emergent behaviors can be key to
understanding how a department or group actually functions. In
addition, emergent behaviors are constantly changing as both the
external and internal environment of the unit changes.
The adaptive process within complex organizations demonstrates
infinitely complex, unique emerging pa erns. For example, the go-live
process within or across complex organizations follows a similar but
unique process each time a new system is installed, even when the same
software is installed in a similar type of clinical unit in a new site. Sites
and units all have different workflows and organizational cultures to
which processes need to be tailored.
CASs exist in co-evolution with the environment. The concept of co-
evolution refers to the process whereby a CAS is continuously adapting
as it responds to its environment and, simultaneously, the environment
is constantly adapting as it responds to the changing CAS. They are
evolving together in a co-evolutionary interactive process.
The adaptive response of a complex system to environmental change
and the resulting environmental change from that adaptation includes
an element of unpredictability. The overall pa ern of adaptation that
emerges from the adaptive changes within each unit is unique to each
organization and impossible to predict completely. For example,
computerized provider order entry (CPOE) changed the workflow for
unit secretaries, nurses, physicians, and hospital departments. Each of
these units within the system is creating adaptations at the same time as
it is adjusting to changes occurring in the other units. A significant
number of these changes (whether they were seen as positive or
negative by individuals in the institution) are experienced as
unintended consequences.
A CAS includes both order and disorder. A certain level of order is
necessary for a CAS to be effective and efficient. However, the more
firmly order is imposed, the less flexibility the CAS has to adjust to
change. Systems that are too tightly controlled can become fragile. A
CAS needs to maintain some slack and redundancy to buffer against
environmental changes that are not anticipated. This balance between
creating a unified whole and an institution with enough flexibility to
adapt to the changing internal and external environment can be a
challenge when integrated healthcare institutions a empt to merge
hospitals, long-term care facilities, clinics, and other se ings into one
healthcare system. The larger and more diffuse the organization, the
more likely it is to include a degree of order and disorder and, therefore,
more potential to survive in some form. For example, individual
hospitals, clinics, and third-party payers may go out of business, but the
healthcare system as a societal institution will continue to exist in ever-
evolving ways.
The characteristics of a CAS interact together in a synergistic manner,
ensuring that a certain level of uncertainly is inherent in the management
of a CAS. The natural disposition of decision makers in such an
environment is to a empt to reduce the uncertainty. However, imposing
order and tightly regulating a CAS does not let the system take advantage
of the inherent ability to adapt, and, in the end, it creates a CAS that is less
resilient and less robust. Resilience is the ability to recover from a failure,
and robustness is the ability to resist failure. The more robust a system is,
the be er able it is to anticipate and avoid a failure. The more resilient a
system is, the be er able it is to recover quickly from a failure.
That being said, frameworks for understanding how to manage CASs
such as organizations and communities continue to evolve. One such
framework is the Cynefin Framework.34-39
Cynefin Framework for Managing Uncertainly in CAS
A CAS, such as a healthcare organization, will exist with a constantly
fluctuating balance between order and disorder. This can be thought of as
a continuum with any one system or part of the system moving between
order and disorder. The Cynefin Framework was developed to guide
organizational management on this continuum, and it provides a helpful
perspective for managing informatics-related projects within a healthcare
institution. The Framework consists of five domains, as depicted in Fig.
2.4.36 The first four domains (simple, complicated, complex, and chaotic)
require the leader or manager to determine the level of order or disorder
and adjust their management style to that reality. The fifth domain exists
when the manager/leader is unclear which of the other four domains are
predominant in a specific situation. As a situation moves toward the
ordered end on the continuum, one of two domains will predominate.
Those are the simple and complicated domains.
FIG 2.4 The Cynefin framework. From Snowden DJ, Boone ME. A leader’s
framework for decision making. Harv Bus Rev. 2007;86(11):68–76. Reprinted by permission
of Harvard Business Review. Copyright © 2007 Harvard Business School Publishing
Corporation. All rights reserved.
Simple Domain
A simple domain is highly ordered. Cause and effect are evident to the
people involved in the se ing. Processes are carried out using known
procedures that are effective and efficient. This process involves (1)
sensing or collecting the pertinent data, (2) categorizing the data, and (3)
applying the appropriate response. An example would be administering
medications on a clinical unit. The procedures are carefully designed to
ensure the five rights of the patient are effectively and efficiently met.
There are rules about what should be done if a patient refuses a
medication, is off the clinical unit, or some other usual issue occurs. With
this type of situation, everyone is expected to follow the procedure
carefully. The concept of best practices is most appropriate in these types
of situations. Often these types of processes or at least parts of their
procedures are excellent candidates for computerization. Because these
situations are highly ordered, they have li le flexibility. A change in the
environment of the unit can lead to chaos because there is no set
procedure to be followed. For example, the procedure for administering
medication may require that only registered nurses (RNs) open the
medication cart. However, what happens in a disaster if no RNs are
available? While micromanagement is contraindicated, the leadership in
these situations should stay in the information loop, watching for early
signs of change and avoiding a move to a chaotic domain.
Complicated Domain
In this domain, the relationship between cause and effect is known but it is
not obvious to everyone in the domain. As a result, knowledge and
expertise are very important for managing complicated problems. These
types of problems are managed by collecting and analyzing data before
responding. The expert will know what data are pertinent, as well as
different approaches for analyzing these data and different options for
responding. There is often more than one right answer. Different experts
may solve the problem in different ways. In addition, experts can identify
an effective solution but not be able to articulate every detail of the cause-
and-effect relationship. For example, health professional or a health
informatics specialist may be planning the educational program to
accompany a major system implementation in a healthcare se ing. In such
a situation, there is not one perfect answer but rather several excellent
options that can be used to prepare users for the new work environment.
In these cases, good practice is a more appropriate approach than best
practice because good practice is more flexible and able to tap into the
expertise of the expert. Forcing experts to use the “one right approach”
usually results in strong resistance.
Because experts are the dominant players, there are problems in the
complicated domain that a manager must consider. Innovative approaches
offered by nonexperts can be easily dismissed. This can be a significant
problem in hierarchical organizations such as healthcare. A group of
experts with different approaches can disagree and become bogged down
in “analysis paralysis.” In addition, all experts are limited in scope of
expertise, and experts are not always able to realize when they have
drifted out of their scope of expertise. As a situation moves toward the
disordered end on the continuum, one of two domains will predominate.
These are the complex and the chaotic domains.
Complex Domain
In the complex domain, the cause-effect relationship is not known. If the
cause-and-effect relationship is not known, what data are pertinent data is
also unknown. Decisions must be based on incomplete data in an
environment of unknown unknowns. The difference between a
complicated situation and complex situation can be demonstrated in
analyzing the difference between a computer and a person. A computer
expert can identify all of the parts of a computer and how they interact.
The expert can predict with high accuracy how a computer will react in
different situations. For example, a bad hard drive can prevent a computer
from booting, but the response of a person to different situations cannot be
predicted with the same accuracy. Because healthcare organizations are
CASs and always in flux, many important situations and decisions are
complex. In this domain, problems are not solved by imposing order.
Rather than collecting many data, be er solutions can emerge if the
manager probes by trying small, fail-safe solutions. For example, a large
medical center recently purchased a small rural hospital with li le to no
computerization in the clinical units. Imposing the information systems
installed in the medical center could produce significant resistance and
probably fail. Success is more likely if small pilot tests are conducted and
then used to pull key leaders and users in when analyzing the results. In
the analysis, pa erns and potential solutions will begin to emerge.
Obviously, this process is time consuming and a bit messy but not nearly
as messy as failure. However, there are leadership tools to utilize in a
complex domain as illustrated in Box 2.2.
Box 2.2
Management Tools in Complex Situations 3 6
1. Encourage open discussion so people are comfortable both speaking and
listening.
2. Set boundaries as clear simple rules: such as, meeting will always end
on time.
3. Watch for and use a ractors. Listen for ideas that resonate with people
to use as potential probes.
4. Encourage and look for new and novel ideas. For example, one provider
may notice that clicking on the patient’s address may tell that provider
how far the patient lives from the healthcare se ing. This piece of
information may be useful in making decisions about when to discharge
or meet with family.
5. Do not look for predetermined results. Let answers emerge.
Chaotic Domain
In the chaotic domain, there is no discernable relationship between cause
and effect; therefore it is impossible to determine and manage the
underlying problem. In healthcare, the term crash is often used for this
situation. For example, a patient is crashing or a computer crashed. In this
situation, the goal is to first stabilize the situation and then assess potential
causes. CPR will be tried before there is any a empt to determine why the
patient would have experienced a cardiac arrest. In a crisis, the manager
takes charge and gives orders. In our previous example dealing with
medication administration, the health professional or health informatician
may decide to unlock the medication cart for all patients and determine if
family or other staff may be able to give at least some of the medications.
In a chaotic situation, there is no time to seek input or second-guess
decisions. However, once the situation begins to stabilize, this can be a
unique opportunity for innovation. Organizations and individuals are
more open to change after a crisis: note, for example, the number of
patients who will change their lifestyle after they have experienced a
myocardial infarction. In Fig. 2.4, the fifth domain is the center domain,
existing between disorder and order.
Disorder Domain
Showden uses the term disorder to name this domain. Each of the other
domains is focused on the type of situation or state of the organization. In
the fifth domain, it is not the organization that is in disorder but rather the
leader. The leader does not know which domain is predominant. If the
leaders are aware of their confusion, they can begin by using the
Framework to assess the situation. However, managers do not always
realize what they do not know. If they do not realize the need to diagnosis
the situation, there is a tendency to continue using their preferred
management style.
While CASs are a unique type of system, all systems, whether they are
complex or simple, change, and in the process interact and/or co-evolve
with the environment. The basic framework of this interaction is shown in
Fig. 2.2. Input to the system consists of information, ma er, and energy.
These inputs are then processed, and the result is output. Understanding
this process as it applies to informatics involves an understanding of
information theory.
Information Theory
The term information has several different meanings. An example of this
can be seen in Box 2.3, taken from Merriam-Webster’s Collegiate Dictionary.40
Just as the term information has more than one meaning, information
theory refers to more than one theory.41 In this chapter, two theoretical
models of information theory are examined: the Shannon-Weaver
information-communication model and the Nelson data-information-
knowledge-wisdom model (DIKW) that evolved from Blum’s and
Graves’s initial work.
Box 2.3
Definition of Information
1. The communication or reception of knowledge or intelligence
2.
a. Knowledge obtained from investigation, study, or instruction;
intelligence, news; facts, data
b. The a ribute inherent in and communicated by one of two or more
alternative sequences or arrangements of something (as nucleotides in
DNA or binary digits in a computer program) that produce specific
effects
c. A signal or character (as in a communication system or computer)
representing data; (2) Something (as a message, experimental data, or
a picture), which justifies change in a construct (as a plan or theory)
that represents physical or mental experience or another construct
d. A quantitative measure of the content of information; specifically, a
numerical quantity that measures the uncertainty in the outcome of an
experiment to be performed
3. The act of informing against a person
4. A formal accusation of a crime made by a prosecuting officer as
distinguished from an indictment presented by a grand jury
Information. Merriam-Webster’s Collegiate Dictionary. h p://[Link]-
[Link]/dictionary/information; 2012.
Shannon-Weaver Information-Communication Model
Information theory was formally established in 1948 with the publication
of the landmark paper “The Mathematical Theory of Communication” by
Claude Shannon.42 The concepts in this model are presented in Fig. 2.5.
The sender is the originator of the message or the information source. The
transmi er is the encoder that converts the content of the message to a
code. The code can be le ers, words, music, symbols, or a computer code.
A cable is the channel, or the medium used to carry the message.
Examples of channels include satellites, cell towers, glass optical fibers,
coaxial cables, ultraviolet light, radio waves, telephone lines, and paper.
Each channel has its own physical limitations in terms of the size of the
message that can be carried. Noise is anything that is not part of the
message but occupies space on the channel and is transmi ed with the
message. Examples of noise include static on a telephone line and
background sounds in a room. The decoder converts the message to a
format that can be understood by the receiver. When listening to a phone
call, the telephone is a decoder. It converts the signal back into sound
waves that are understood as words by the person listening. The person
listening to the words is the destination.
FIG 2.5 Schematic diagram of a general communication system.
Reprinted with corrections from Shannon C, Weaver W. The mathematical theory of
communication. Bell Syst Tech J. 1948;27:379-423, 623-656.
<[Link]
%20A%20Mathematical%20Theory%20of%[Link]>. Reprinted with
permission of Alcatel-Lucent USA Inc.
Shannon, one of the authors of the Shannon-Weaver Information-
Communication theory, was a telephone engineer. He used the concept of
entropy to explain and measure the technical amount of information in a
message. The amount of information in a message is measured by the
extent to which the message decreases entropy. The unit of measurement
is a bit. A bit is represented by a 0 (zero) or a 1 (one). Computer codes are
built on this concept. For example, how many bits are needed to code the
le ers of the alphabet? What other symbols are used in communication
and must be included when developing a code?
Warren Weaver, from the Sloan-Ke ering Institute for Cancer Research,
provided the interpretation for understanding the semantic meaning of a
message.42 He used Shannon’s work to explain the interpersonal aspects of
communication. For example, if the speaker is a physician who uses
medical terms that are not known to the receiver (the patient), there is a
communication problem caused by the method used to code the message.
However, if the patient cannot hear well, he may not hear all of the words
in the message. In this case the communication problem is caused by the
patient’s ear.
The communication-information model provides an excellent
framework for analyzing the effectiveness and efficiency of information
transfer and communication. For example, a healthcare provider may use
CPOE to enter orders. Is the order-entry screen designed to capture and
code all of the key elements for each order? Are all aspects of the message
coded in a way that can be transmi ed and decoded by the receiving
computer? Does the message that is received by the receiving department
include all of the key elements in the message sent? Does the screen
designed at the receiver’s end make it possible for the message to be
decoded or understood by the receiver?
These questions demonstrate three levels of communication that can be
used in analyzing communication problems.43 The first level of
communication is the technical level. Do the system hardware and
software function effectively and efficiently? The second level of
communication is the semantic level. Does the message convey meaning?
Does the receiver understand the message that was sent by the sender?
The third level of communication is the effectiveness level. Does the
message produce the intended result at the receiver’s end? For example,
did the provider order one medication but the patient received a different
medication with a similar spelling? Some of these questions require a more
in-depth look at how healthcare information is produced and used. Bruce
Blum’s definition of information provides a framework for this more in-
depth analysis.
Blum Model
Bruce L. Blum developed his definition of information from an analysis of
the accomplishments in medical computing.44 In his analysis, he identified
three types of healthcare computing applications. Blum grouped
applications according to the objects they processed. The three types of
objects he identified are data, information, and knowledge. Blum defined
data as uninterpreted elements such as a person’s name, weight, or age.
Information was defined as a collection of data that have been processed
and then displayed as information, such as weight over time. Knowledge
results when data and information are identified and the relationships
between the data and information are formalized. A knowledge base is
more than the sum of the data and information pieces in that knowledge
base. A knowledge base includes the interrelationships between the data
and information within the knowledge base. A textbook can be seen as
containing knowledge.44 These concepts are well accepted across
information science and are not limited to healthcare and health
informatics.45
Graves Model
Judy Graves and Sheila Corcoran, in their classic article “The Study of
Nursing Informatics,” used the Blum concepts of data, information, and
knowledge to explain the study of nursing informatics.46 They
incorporated Barbara A. Carper’s four types of knowledge: empirical,
ethical, personal, and aesthetic. Each of these represents a way of knowing
and a structure for organizing knowledge. This article is considered the
foundation for most definitions of nursing informatics.
Nelson Model
In 1989 Nelson extended the Blum and Graves and Corcoran data-to-
knowledge continuum by including wisdom.47 This initial publication
provided only brief definitions of the concepts, but later publications
included a model.48 Fig. 2.6 demonstrates the most current version of this
model. Within this model, wisdom is defined as the appropriate use of
knowledge in managing or solving human problems. It is knowing when
and how to use knowledge in managing patient needs or problems.
Effectively using wisdom in managing a patient problem requires a
combination of values, experience, and knowledge. The concepts of data,
information, knowledge, and wisdom overlap and interrelate as
demonstrated by the overlapping circles and arrows in the model. Of note,
what is information in one context may be data in another. For example, a
nursing student may view the liver function tests within the blood work
results reported this morning and see only data or a group of numbers
related to some strange-looking tests. However, the staff nurse looking at
the same results will see the information and in turn see the implications
for the patient’s plan of care. The greater the knowledge base used to
interpret data, the more information disclosed from that data, and in turn
the more data points that may be generated. Data processed to become
information can create new data items. For example, if one collects the
blood sugar levels for a diabetic patient over time, pa erns begin to
emerge. These pa erns become new data items to be interpreted. One
nurse may notice and describe the pa ern, but a nurse with more
knowledge related to diabetes may identify a Somogyi-type pa ern, with
important implications for the patient’s treatment protocols. The concept
of constant flux is illustrated by the curved arrows moving between the
concepts. As one moves up the continuum, there are increasing
interactions and interrelationships within and between the circles,
producing increased complexity of the elements within each circle.
Therefore the concept of wisdom is much more complex than the concept
of data.
FIG 2.6 Revised Nelson data-to-wisdom continuum. Copyright © 2013
Ramona Nelson. Consulting. Reprinted with permission. All rights reserved.
The introduction of the concept of wisdom gained professional
acceptance in 2008 when the American Nurses Association included this
concept and the related model in Nursing Informatics: Scope and Standards of
Practice.49 In this document the model is used to frame the scope of practice
for nursing informatics. This change meant that the scope of practice for
nursing informatics was no longer fully defined by the functionality of a
computer and the types of applications processed by a computer. Rather
the scope of practice is now defined by the goals of nursing and nurse-
computer interactions in achieving these goals.
Using the concepts of data, information, knowledge, and wisdom makes
it possible to classify the different levels of computing. An information
system such as a pharmacy information system takes in data and
information, processes the data and information, and outputs information.
A computerized decision support system uses knowledge and a set of
rules for using that knowledge to interpret data and information and
output suggested or actual recommendations. A healthcare application
may recommend additional diagnostic tests based on a pa ern of
abnormal test results, such as increasing creatinine levels. With a decision
support system, the user decides whether the suggestion or
recommendations will be implemented. A decision support system relies
on the knowledge and wisdom of the user.
An computerized expert system goes one step further. An expert system
implements the decision that has been programmed into the computer
system without the intervention of the user. For example, an automated
system that monitors a patient’s overall status and then uses a set of
predetermined parameters to trigger and implement the decision to call a
code is an expert system. In this example, the data were converted to
information, a knowledge base was used to interpret that information, and
the decision to implement an action based on this process has been
automated. The relationships among the concepts of data, information,
knowledge, and wisdom, as well as information, decision support, and
expert computer systems, are demonstrated in Fig. 2.7.
FIG 2.7 Moving from data to expert systems. Modified from Englebardt S
and Nelson R. Health Care Informatics: An Interdisciplinary Approach. St. Louis, MO:
Mosby; 2002. Modified figure designed by Ramona Nelson Consulting and printed here
with her permission. All rights reserved.
In the model, the three types of electronic systems overlap, reflecting
how such systems are used in actual practice. For example, an electronic
system recommending that a medication order be changed to decrease
costs might be consistently implemented with no further thought by the
provider entering the orders. In this example, an application designed as a
decision support system is actually being used as an expert system by the
provider. Because there are limits to the amount of data and information
the human mind can remember and process, each practitioner walks a
tightrope between depending on the computer to assist in the
management of a situation with a high cognitive load and delegating the
decision to the computer application. This reality presents interesting and
important practical and research questions concerning the effective and
appropriate use of computerized decision support systems in the
provision of healthcare.
Effective computerized systems are dependent on the quality of data,
information, and knowledge processed. Box 2.4 lists the a ributes of data,
information, and knowledge. These a ributes provide a framework for
developing evaluation forms that measure the quality of data, information,
and knowledge. For example, healthcare data are presented as text,
numbers, or a combination of text and numbers. Good-quality health data
provide a complete description of the item being presented with accurate
measurements. Using these a ributes, an evaluation form can be
developed for judging the quality (including completeness) of a completed
patient assessment form or for judging the quality of a healthcare website.
The same process can be used with the a ributes of knowledge. Think
about the books or online references one might access in developing a
treatment plan for a patient or consider a knowledge base that is built into
a decision support system. What would result if the knowledge was
incomplete or inaccurate or did not apply to the patient’s specific problem
or if suggested approaches were out of date and no longer considered
effective in treating the patient’s problem? What if the knowledge was not
presented in the appropriate format for use?
Box 2.4
Attributes of Data, Information, and
Knowledge
Data
• Descriptive qualitative
• Measurable quantitative
Information
Quality
• Accurate
• Coherent
• Comprehensive or complete
• Objective or free from bias
• Verifiable
Usable
• Appropriate or relevant
• Economical
• Clear or understandable
Format
• Quantifiable
• Precise
• Organized for specific use
Available
• Accessible
• Secure
• Timely or current
Knowledge
• Accurate
• Relevant
• Type
Although this section has focused on computer systems, humans are
also open systems that take in data, information, knowledge, and wisdom.
Learning theory provides a framework for understanding how patients
and healthcare providers, as open learning systems, take in, process, and
output data, information, knowledge, and wisdom.
Learning Theory
Learning theory a empts to determine how people learn and to identify
the factors that influence that process. Learning has been defined in a
variety of ways, but for the purpose of this text, learning is defined as an
increase in knowledge, a change in a itude or values, or the development
of new skills. Several different learning theories have been developed.
Each theory reflects a different paradigm and approach to understanding
and explaining the learning process. Box 2.5 provides links to three sites
that demonstrate the wide range of theories and the various approaches to
classifying these theories.
Box 2.5
Databases: Learning Theories
Name of Organization URLs
Berkeley Graduate Division: GSI Teaching & h p://[Link]/gsi-guide-contents/learning-theory-
Resource Center research/
[Link] [Link]/
[Link] [Link]/theories/[Link]
These databases of different learning theories cannot be used to create a
comprehensive theory of the learning process. The theories are not
mutually exclusive. They often overlap and interrelate, yet they cannot be
combined to create a total theory of learning.
Learning theories are important to the practice of health informatics for
a variety of reasons. Health professionals and health informatics specialists
plan and implement educational programs to teach healthcare providers
to use new and updated applications and systems. A well-designed and
well-implemented educational program can result in competent healthcare
providers when it is able to satisfy all learning styles. Understanding how
people learn is especially helpful in developing computer-related
procedures that are safe and effective for healthcare providers and in
building decision support systems that provide effective and appropriate
support for healthcare providers who deal with a multitude of complex
problems. Adult learning theories are often used when planning for a
system implementation, whereas constructivist theories are often used in
planning for a distance-education program. Specific learning theories as
they relate to specific topics are presented in other chapters. For a listing of
the learning theories included in this book, please check the index under
the term learning theories. We will discuss four types of learning theories
used to demonstrate the major approaches to learning theory.
Cognitive and Constructionist Learning Theories
Learning theories that are included under the heading of information
processing theories divide learning into four steps:
1. How the learner takes input into the system
2. How that input is processed and constructed
3. What type of learned behaviors are exhibited as output
4. How feedback to the system is used to change or correct behavior
Data are taken into the system through the senses. First, if there is a
sensory organ defect, such as hearing loss, data can be distorted or
excluded. Second, data are moving across the semipermeable boundary of
the system. There are limits to how much data can enter at one time. For
example, if one is listening to a person who is talking too fast, some of the
words will be missed. In addition, the learner will screen out data that are
considered irrelevant or meaningless, such as background noise. Data
limits are increased if the learner is under stress. Individuals who are
anxious about learning to use a computer program will experience higher
data limits and thereby less learning.
If new information is presented using several senses simultaneously, it
is more likely to be taken in. For example, if a new concept is presented
using slides that are explained by a speaker, the combination of both
verbal and visual input makes it more likely that the learner will grasp the
concept. As data enter the system, the learner structures and interprets
these data, producing meaningful information. Previous learning has a
major effect on how the data are structured and interpreted. For example,
if a healthcare provider is already comfortable using Windows and is now
learning a new software program based on Windows, he or she will be
able to structure and interpret the new information quickly using
previously developed cognitive structures. This is one reason why
consistency in screen development can be very important for patient
safety. In contrast, if the new information cannot be related to previous
learning, the learner will need to build interpreting structures as he or she
takes in the new information. For example, if a person is reading new
information, she may stop at the end of each sentence and think about the
content in that sentence. She is building interpretive cognitive structures
while importing the data. If this same learner is hearing the new
information at the same time she is taking notes, she may have difficulty
capturing the content she is trying to record. The more time that is needed
to interpret and structure data, the slower the learner will be able to
import data. Assessment of the learner’s previous knowledge can help the
instructor to identify these potential problems. Relating new information
to previously learned information will help the learner to develop
interpreting structures and in turn learn the information more effectively.
Describing learning as a process of building interpretive cognitive
structures while learning new content is consistent with constructionist
theory explained below. By combining what is known with the new
information the learner goes beyond the information that was provided in
the learning experience. Using organizing structures such as outlines,
providing examples, and explaining how new information relates to
previously learned concepts encourages the learner to develop chunks and
increases retention. An “aha moment” is the sudden understanding that
occurs when the new information fits with previous learning and the
student gains a new insight on the discussion.
Social constructivism focuses on how group interaction can be used to
build new knowledge.50 Group discussion in which learners share their
perceptions and understanding through peer learning encourages new
insight, as well as retention of the newly constructed knowledge. There is
limited research on how groups such as interprofessional health teams
actually learn via the group construction process. Two studies at
Massachuse s Institute of Technology and Carnegie Mellon University
found converging evidence that groups participating in problem-solving
activities demonstrate a general collective intelligence factor that explains
a group’s performance on a wide variety of tasks. “This ‘c factor’ is not
strongly correlated with the average or maximum individual intelligence
of group members but instead with the average social sensitivity of group
members, the equality in distribution of conversational turn-taking and
the proportion of females in the group.”51, p. 686 Certain characteristics of the
individuals within the group and the group’s ability to work together as a
whole can influence the effectiveness of the group. “A group’s interactions
drive its intelligence more than the brain power of individual members.”52
Approaches to assessing and measuring the c facture within a group are
now being explored with hopes that this measure could be used to support
the effective of groups or teams.53,54
Information once taken into the system is retained in several different
formats. The three most common formats are episodic order, hierarchical
order, and linked. For example, life events are often retained in episodic
order. A list of computer commands is also retained in episodic order.
Psychomotor commands learned episodically can become automatic. An
example of this can be seen in the simple behavior of typing or the more
complex behavior of driving a car. Cognitive learning tends to be retained
in hierarchical order. For example, penicillin is an antibiotic. An antibiotic
is a medication. Finally, information is retained because it is linked or
related to other information. For example, the concept “paper” is related to
a printer. The process by which information is retained in long-term
memory (LTM) can be reinforced by a variety of teaching techniques.
Providing the student with an outline when presenting cognitive
information helps to reinforce the learner retaining the information in
hierarchical order. Telling stories or jokes can be used to reinforce links
between concepts. Practice exercises that encourage repeated use of
specific keystroke sequences or computer commands assist with long-term
retention of psychomotor episodic learning including muscle memory.
While LTM can retain large amounts of information, two processes can
interfere with the storage of information in LTM. First, new information or
learning may replace old information. For example, healthcare providers
may become very proficient with a computerized order-entry system.
However, over time they may forget how to use the manual system to
place orders. This can be a problem if the manual system is the backup
plan for computer downtime. Second, previously learned information can
interfere with the learning of new information. This can be seen when a
new computer system is installed and new procedures are implemented.
Experienced users of the old system must remember not to use the old
procedures that were part of that system. This can be especially difficult if
the previous learning has become automatic psychomotor commands. If
the instructor for the new system includes clues to remind the experienced
users of the change, the process of replacing old learning with new
information can be reinforced.
When planning educational programs for healthcare users, the health
professional and health informatics specialist must first plan for intake of
the new information via short-term memory (STM) and then for transfer of
the new information to LTM. Several factors assist in moving information
from STM to LTM. A list of these factors and examples of each can be seen
in Table 2.2. Information that is stored in LTM is used in critical thinking,
problem solving, decision making, and a number of other mental
processes.
Table 2.2
Planning for Long-Term Retention of New Information
Principle Example
Distribute the Online learning should be designed so that the content is divided into logical units, with learners
learning over encouraged to spread the learning over a period, and not all of the content is available from the
time beginning.
Plan to retain Before teaching new content, explain to the learners why the information will be important to
the information their performance and when they will need to recall the new information.
Review the When presenting a list of new ideas, stop after each idea is explained, and list each of the ideas
materials that have already been explained. Include practice sessions or self-assessment tools that reinforce
the learning.
Increase the This does not mean increasing the time scheduled for class but increasing the amount of time the
time spent on learner is actively working on the content to be learned with readings before class or exercises
the task after class.
Learned behaviors are exhibited as output. Three types of output or
behaviors are usually considered: cognitive, affective, and psychomotor.
Cognitive behaviors reflect intellectual skills. They include critical
thinking, problem solving, decision making, and a number of other mental
processes. These are the skills used when designing a protocol for a user of
an automated healthcare information system or for troubleshooting a
computer system that is not functioning correctly.
Affective skills relate to values and a itudes. Planning for the learning
of appropriate values and a itudes is often overlooked, and yet these can
have a major impact on the implementation of an automated healthcare
information system. Computerizing healthcare delivery requires change.
This change can be stressful for healthcare providers. Training programs
may focus exclusively on how to use the system without time to discuss
how to integrate the new system into patient care. There may be limited
discussion of the benefits of change and li le support for the development
of positive a itudes toward a new system. Development of positive values
and a itudes can also be important to the ongoing maintenance of
automated systems in healthcare.74 Positive a itudes encourage users to
suggest new and innovative uses for computer systems.
Psychomotor skills involve the integration of cognitive and motor skills.
These types of skills require time and practice to develop. When new
healthcare information systems are implemented, the institution is
interested in measuring the impact of the new system. However, while
new users are in the process of developing the psychomotor skills that are
part of using the new system, it is ineffective to measure either the impact
of a new system or user satisfaction. During this period, the focus should
be on supporting the users’ adjustment, tracking, and troubleshooting
problems. Any decision to make significant changes to a new system based
on user feedback must be evaluated carefully.
Adult Learning Theories
In 1970, Knowles coined and defined the term andragogy.55 Andragogy is
the art and science of helping adults to learn. Knowles’s model proposed
that adults share a number of similar learning characteristics and that
these characteristics can be used in planning adult educational programs.
Table 2.3 lists a number of these characteristics and provides examples of
how they can be used to plan for teaching adult users.50,56-58
Table 2.3
Adult Learning Characteristics and Related Applications
Learning Characteristics Application
Adults are self-directed. If they do not see the relevance of new information, learners will not
focus on remembering that information. Explain in practical terms
when and how the new information will be used.
Adults have accumulated a number of When teaching a new system, ask the learners to provide examples
life experiences and cognitive structures. from their experience and use these examples to correct
These are used to interpret new learning. misconceptions, as well as to reinforce how the new system will
function.
Adults are practical and look for Orientation to a new system should occur no more than 4 weeks before
immediate application of learning. actual implementation.
Adults are more interested in learning When teaching adults about computer applications, use real-life
how to solve problems than in retaining examples and scripts that can be expected to occur on the clinical unit.
facts.
Adult learners expect to be treated with When explaining a new system, ask the learners what they already
respect and have their previous learning know about the new system. Listen to their comments and concerns
acknowledged. about the screen design and how it will or will not support safe
practice.
Learning Styles
All learners are not alike. They learn in different ways. They vary in how
they take in and process information. There are preferential differences in
seeing and hearing new information. Some learners process information
by reflecting, whereas others process it by acting. Some learners approach
reasoning logically, whereas others are intuitive. Some learners learn by
analyzing, whereas others learn by visualizing. Learning theories
concerning learning styles a empt to explain these differences.
Experiential learning theory is one example.59 The first stage of Kolb’s
theory involves concrete experience. For example, the learner may view a
demonstration of a new healthcare information system.
As the learner begins to understand how the system works, he begins to
think about how the system would work in his healthcare se ing. This is
the second stage, or reflection. In this stage, the learner reflects or thinks
about the concrete experience. As the learner continues to think, he begins
to form abstract conceptualizations of how the system functions. This is
the third stage. Finally, the learner is ready to try using the system: this is
the fourth stage, when the learner uses his abstract conceptualization to
guide action. In Kolb’s model, these four stages exist on two intersecting
continuums. These are Concrete Experience–Abstract Conceptualization
(CE-AC) and Reflective Observation–Active Experimentation (RO-AE).
There are individual differences in how learners use each of these four
stages in their individual learning approaches, but all learners ultimately
learn by doing. Using this model, Kolb developed a learning-assessment
tool to identify individual learning styles. The intersection of the two
continuums forms four quadrants, Diverger, Assimilator, Converger, and
Accommodator, representing four individual learning styles. The learner
plots a score along the CE-AC scale and along the RO-AE scale to identify
which quadrant reflects his or her learning style.
A second, more widely used measure of individual learning styles is the
Myers–Briggs Type Indicator.60 This theory uses four continuums:
Thinking–Feeling, Sensing–Intuition, Extroverted–Introverted, and
Judging–Perceptive. A series of questions is used to determine where the
learner falls on each of the four continuums. For example, a learner may be
Thinking, Sensing, Extroverted, and Judging. The combination of where
the learner falls on each of the four continuums is then used to form a
composite picture of the learner’s individual learning style.
A health professional and health informatics specialist plan and
implement educational programs for a variety of groups within the
healthcare delivery system. These may include physicians, nurses,
unlicensed personnel, administrators, and others. These groups vary
widely in learning ability, education, motivation, and experience.
However, a great deal of variation exists among the learners within each
group. Learning styles help to explain these differences and are helpful in
planning instructional strategies that are effective for individual learners
within a group. Each of the four types of learning theories discussed in
this chapter provides insights into effective approaches to teaching. Box
2.6 lists examples of principles that can be derived from these theories.
Box 2.6
Theory-Based Learning Principles
• Each learner is an individual with his or her own approach to learning.
• Making new information meaningful to the individual learner supports
retention.
• Only so much input or new information can be handled at one time.
• Scheduling learning over time and ensuring adequate time on task
improves learning.
• Active engagement and participation in the learning task supports long-
term retention.
• Conceptual learning is enhanced with concrete realistic examples.
• Learning is enhanced when the teaching method includes the cognitive,
affective, and psychomotor domains in concert.
• Learning takes place intentionally and unintentionally.
• Learning is contagious. A core of knowledgeable users creates a learning
environment.
Change Theory
Each of the theories presented in this chapter includes an element of
change. Change theory is the study of change in individuals or social
systems such as organizations. Understanding change theory provides a
framework for effectively planning and implementing change in social
systems and organizations. Healthcare information systems have a major
impact on the structure and functions of healthcare delivery systems. They
bring about significant change. The approach to managing the change
process may result in a more effective and efficient healthcare delivery
system or it may result in increased dissatisfaction and disruption. Health
professionals and health informatics specialists play a major role in
planning for, guiding, and directing these changes.
The change process can be analyzed from two perspectives. The first
perspective is demonstrated by Kurt Lewin’s theory, which focuses on
how a change agent can guide the change process. This is referred to as
planned change. The second perspective focuses on the process by which
people and social systems make changes. Research in this area has
demonstrated that people in various cultures follow a similar pa ern
when incorporating innovation and change. Both of these perspectives
provide a framework for understanding how people react to change and
guiding the change process.
Planned Change
Kurt Lewin is frequently recognized as the father of change theory.61 His
theory of planned change divides change into three stages: unfreezing,
moving, and refreezing.62 As demonstrated in the discussion of
homeostasis, systems expend energy to stay in a steady state of stability. A
system will remain stable when the restraining forces preventing change
are stronger than the driving forces for change. Initiating change begins by
increasing the driving forces and limiting the restraining forces, thereby
increasing the instability of the system. This is the unfreezing stage. The
first stage in the life cycle of an information system involves evaluating the
current system and deciding what changes, if any, need to be made. The
pros and cons for change reflect the driving and restraining forces for
change. If changes are to be made, the restraining forces that maintain a
stable system and resist change must be limited. At the same time, the
driving forces that encourage change must be increased. For example,
pointing out to users the limitations and weaknesses with the current
information management system increases the driving force for change.
Also pointing out the advantages offered by a new system can increase
driving forces for change.
Asking for user input early in the process before decisions have been
made can decrease the restraining forces. However, this is true only if the
users believe they are heard and accept that their representative is really
representing their interests. If, however, the users believe their
representatives are only “going through the motions of asking,” resistance
to change will be increased. In addition, at this point when questions are
being asked, it can be very effective to anticipate who the objectors might
be and include them in the process. Once a decision is made to initiate
change, the second stage, moving, begins.
The moving stage involves the implementation of the planned change.
By definition, this is an unstable period for the social system. Anxiety
levels can be expected to increase. The social system a empts to minimize
the impact or degree of change. This resistance to change may occur as
missed meetings, failure to a end training classes, and failure to provide
staff with information about the new system. If the resistance continues, it
can cause the planned change to fail. Health professionals and health
informatics specialists as change agents must anticipate and minimize
these resistive efforts. This can be as simple as providing food at meetings
or a planned program of recognition for early adopters. For example, an
article in the institution’s newsle er describing and praising the pilot units
for their leadership will encourage the driving forces for change. It is
important at each stage of the change process to evaluate and make
needed changes to the initial plans; however, it is especially important
during the moving phase to identify changes in the system and procedures
that need to be modified. The goal is to avoid in the next phase
“refreezing” a bad procedure or system.
Once the system is in place or the change has been implemented,
additional energy is needed to maintain the change. This is the refreezing
stage, and it occurs during the maintenance phase of the information
system life cycle. If managed effectively by the change agent, this phase is
characterized by increased stability. In this stage, the new system is in
place, and forces resistant to change are encouraged. Examples include
training programs for new employees, a yearly review of all policies and
procedures related to the new system, and continued recognition for those
who become experts with the new system.
In the current healthcare environment, several new information
applications may be implemented at the same time. Not all of these
implementations will affect everyone to the same degree. Different
individuals and clinical units can be at different stages of change with
different implementations. Taken together, the overall scope of change will
create a sense of anxiety or excitement throughout the organization. It is
important for health professionals and health informatics specialists to
monitor the amount of change and the resulting tension in placing and
planning for ongoing implementations.
Health professionals and informaticians may find helpful newer change
models that have been built on Lewin’s premises. For example, Conner’s
book Managing at the Speed of Change outlines key concepts to facilitate
change in complex organizations:
• Create a burning platform for change (the burning need for change).
• Identify key stakeholders and clearly define their roles in the change.
• Hold managers responsible and accountable for specific elements of
change.
• Assess organizational culture, capacity, resistance, and responsiveness
to create an effective plan for change.63
Find out how change has taken place in the past. Determine what
worked in specific areas and what did not. Build on what has worked in
the past. Understanding the culture and communication pa erns of
various units is critical to successful change management.
Diffusion of Innovation
The diffusion of innovation theory, developed by Evere Rogers, explains
how individuals and communities respond to new ideas, practices, or
objects.64-66 Diffusion of innovation is the process by which an innovation is
communicated through certain channels over time among members of a
social system. Innovations may be either accepted or rejected. Healthcare
automation, with new ideas and technology, involves ongoing diffusion of
innovation. By understanding the diffusion of innovation process and the
factors that influence this process, health professionals and health
informatics specialists can assist individuals and organizations in
maximizing the benefits of automation.
Social systems consist of individuals within organizations. Both the
individuals and the organization as a whole vary in how they respond to
innovations. Based on their responses, individuals can be classified into
five groups—innovators, early adopters, early majority, late majority, and
laggards—with the number of individuals in each group following a
normal distribution. Innovators are the first 2.5% of individuals within a
system to adapt to an innovation. These individuals tend to be more
cosmopolitan. They are comfortable with uncertainty and above average in
their understanding of complex technical concepts. These are the
individuals who test out a new technology; however, they are too far
ahead of the social group to be seen as leaders by other members of the
social system. Some of their ideas become useful over time, whereas others
are just passing fads. Therefore they are not usually able to sell others on
trying new technology. This is the role of the early adopters.
Early adopters are the next 13.5% of individuals in the organization.
They are perceived by others as thoughtful in their adoption of new ideas
and, therefore, serve as role models for others. Because of their leadership
role within the organization, the support of early adopters is key when
introducing new approaches to automation. If the early adopters accept an
innovation, the early majority are more likely to follow their example. The
early majority are the next 34% of individuals in an organization. Members
of the early majority are willing to adapt to innovation but not to lead.
However, acceptance by the early majority means that the innovation is
becoming well integrated in the organization. This is sometimes referred
to as the tipping point.
The late majority is the next group to accept an innovation. The late
majority makes up 34% of the individuals within the organization. Most of
the uncertainty that is inherent in a new idea must be removed before this
group will adapt to an innovation. They adopt the innovation, not because
of their interest in the innovation, but rather because of peer pressure.
The late majority is followed by the last 16% of individuals in the
organization. These are the laggards. Laggards focus on the local
environment and on the past. They are resistant to change and will change
only when there is no other alternative. They are suspicious of change and
change agents. Change agents should not spend time encouraging
laggards to change but rather should work at establishing policies and
procedures that incorporate the innovation into the required operation of
the organization.
Just as individuals vary in their response to innovation, organizations
also vary. Five internal organizational characteristics can be used to
understand how an organization will respond to an innovation.67
• Centralization: Organizations that are highly centralized, with power
concentrated in the hands of a few individuals, tend to be less
accepting of new ideas and, therefore, less innovative.
• Complexity: Organizations in which many of the individuals have a
high level of knowledge and expertise tend to be more accepting of
innovation. However, organizations of this type can have difficulty
reaching a consensus on approaches to implementation.
• Formalization: Organizations that place a great deal of emphasis on
rules and procedures tend to inhibit new ideas and innovation.
However, once a decision has been made to move ahead, this
tendency toward rules and procedures does make it easier to
implement an innovation.
• Interconnectedness: Organizations in which there are strong
interpersonal networks linking the individuals within the
organization are be er prepared to communicate and share
innovation. This can be seen, for example, in organizations in which
Web 2.0 tools are an integral part of organizational communication.
• Organizational slack: Organizations with uncommi ed resources are
be er prepared to manage innovation. These resources may be people
and/or money. With the current emphasis on cost control, healthcare
institutions have ever decreasing organizational slack.
These characteristics help to explain how an organization as a whole
will respond to innovation; however, they can be analyzed at both an
individual and an organizational level. For example, adapting to new
software involves a certain degree of complexity. Think about what is
involved when an individual must select a new e-mail application. Now
think about what is involved if an organization decides to select a new
clinical documentation application.
The perceived a ributes of the innovation, the nature of organizational
communication channels, the innovative decision process, and the efforts
of change agents influence the possibility that an innovation will be
adapted, as well as the rate of adoption. Five a ributes can be used to
characterize an innovation.
• Relative advantage: Is the innovation seen as an improvement over the
current approach? For example, has the need to standardize with one
patient documentation system forced certain clinical units to give up
certain functionality? Alternatively, is the new system seen as an
upgrade with new functionality?
• Compatibility: Does the innovation fit with existing values, workflow,
and individual expectations? For example, will the new application
cause certain tasks to be shifted from one department to another?
• Complexity: Is the innovation easy to use and understand? If yes, the
innovation can be seen as a minor change. If no, the innovation will be
seen as a major change.
• Trialability: Can the innovation be tested or tried before individuals
must make a commitment to it? Although trialability can be an
advantage in encouraging innovation, it can be difficult to conduct a
trial of a computer application in a large, complex organization such
as a healthcare institution.
• Observability: Are the results of using the innovation visible to others?
If each of these five questions related to the five innovative a ributes can
be answered with a “yes,” it is more likely that the innovation will be
adopted and that the adoption will occur at a rapid rate. If, on the
contrary, an innovation is not gaining acceptance, these characteristics can
be used as a framework for evaluating the source of the problem. For
example, it may take more time to document a patient assessment with the
new system compared with the previous system. Thus nurses will prefer
the previous system because of the relative advantage.
The decision of individuals and organizations to accept or reject an
innovation is not an instantaneous event. The process involves five
stages.68 These stages can be demonstrated when a healthcare institution
considers using blogs and wikis to support internal communication for all
professional staff. The first stage of the innovation decision process is
knowledge. In the knowledge stage, the individual or organization
becomes aware of the existence of the innovation. Managers become aware
of other institutions that are using these tools and begin to learn about the
possible advantages. Mass communication channels are usually most
effective at this stage. For example, the institution’s newsle er may carry a
story about blogs and wikis and how staff might use these tools to support
patient care and institutional goals. If the change agent does not have
access to formal mass communication channels to reach all professional
staff, the knowledge stage can be significantly delayed. Although personal
information moves quickly via informal communication channels,
cognitive information involving the processing of information and
knowledge does not move as quickly through these types of channels.
Once individuals become aware of an innovation, they begin to develop
an opinion or a itude about it. This is the persuasion stage. During the
persuasion stage, interpersonal channels of communication are more
important, and early adopters begin to play a key role. In the persuasion
stage, a itudes are not fixed but are in the process of being formed. The
health professional and health informatics specialist should work closely
with early adopters in developing and communicating positive a itudes to
others in the organization.
Once these a itudes become more fixed, individuals make a decision to
accept or reject the innovation. This is the decision stage. It is at this point
that individuals will decide to try these tools for themselves. For each
person this decision can occur at a different point. The early adopters will
decide to try the system before the early majority. In testing out the
system, most people begin to discover new features or functions of the
system. They also begin to discover potential problems. As they gain a
be er understanding of how to use the new functions, they also discover
challenges, modifications, and adjustments that need to be made. Readers
and health professional and health informatics specialist needs to be
sensitive to these modifications because they will take on an added
significance when formal and informal policies and procedures are
developed. For example, workarounds can begin to develop at this point.
Once the decision has been made to accept the innovation, the
implementation stage begins. The development of formal policies and
procedures related to the innovation is a clear indication that the
implementation stage is in place. The final stage is confirmation. At this
point, the innovation is no longer an innovation. It has either been rejected
or become the standard procedure. For example, certain key
interinstitutional communication will depend on staff using these tools.
Using Change Theory
Effective change requires a champion or champions with a clear vision, a
culture of trust, an organizational sense of pride, and the intense
involvement of the people who must live with the change. Ongoing,
visible support from leaders for these champions is critical. The champion
must have the institutional resources to support the change process. These
resources include leadership skills; personnel, including change agents;
money; and time. The change agent uses change theory to understand and
manage reactions to change throughout the change process. Reactions to
change may be negative, such as resistance, frustration, aggression,
acceptance, indifference, ignoring, and organized resistance. Alternatively,
the reaction to change can be positive, such as an increase in excitement
and energy, a sense of pride, supporting and encouraging others,
involvement in demonstrating how the innovation improves the
organization, and overall acceptance. Change agents usually encounter
both positive and negative reactions during the change process. It is
usually more effective to support the positive reactions to change than it is
to spend time and effort responding to the negative reactions.
The Systems Life Cycle Model
The most common change for health professionals and informaticians is
the introduction of or upgrade to a health information system. A
commonly used model of the stages within this change is the systems life
cycle (SLC) model. This model is used in project management to describe
stages or phases of an informatics project and it guides system
implementation from initial feasibility through a more completed stage of
maintenance and evaluation of the products. Most authors use the title
“systems development life cycle” to describe the model. However, the
term development is too limiting in health informatics because we often
purchase systems or applications from vendors and customize them rather
than developing them from scratch.
Various iterations of the systems life cycle have been published, and no
agreement exists about the numbers and types of stages in the life cycle.
The number of stages ranges from three (preimplementation,
implementation, and postimplementation) to at least seven. Project
managers may even sort and combine phases to suit their needs according
to the complexity and type of project being planned. Deficiencies in past
models include:
• The depiction of the life cycle as a circular process, beginning with
analysis, cycling through planning, develop/purchase/implement,
maintain/evaluate, and returning to analysis. This would indicate a
return to the original baseline, which is not the case after
implementation. Instead, a new life cycle builds on previous
installations and organizational learning.
• The development step does not indicate a choice to purchase a system,
a common strategic choice today.
• Evaluation is listed only at the postimplementation phase. Instead,
evaluation should be built into the process at the beginning of the
cycle, and each phase should include evaluation.69
• Testing is de-emphasized as one aspect of the implementation process.
This step is critical in any upgrade or implementation, so it should be
a separate step.
An entire life cycle can last many years. The average life cycle is about a
decade, but some systems may be in place for longer periods; for example,
the original inpatient system in the military is being replaced after two
decades. Other systems may evolve continually for several decades with
upgrades, module additions, and technology platform changes.
Staggers and Nelson Systems Life Cycle Model
The Staggers and Nelson systems life cycle model (SLCM) depicted in Fig.
2.8 incorporates the steps listed above; combines them with previous work
from Thompson, Snyder-Halpern, and Staggers; and expands the steps to
include a new, important consideration, the depiction of the cycle as a
spiral.70 Once an organization completes the SLCM, it does not return in
circular fashion to the assessment stage. Instead, reassessment occurs
based on the organization’s development into a new operating baseline
(see Fig. 2.8). Two notions are used from work first published by
Thompson and colleagues outlining an expanded SLC.70 The first is a step
divided into purchase or development. The second is that evaluation
occurs at every stage of the SLC versus relegating evaluation to the end of
the cycle. The steps of the life cycle are outlined as follows:
FIG 2.8 The Staggers and Nelson systems life cycle model.
1. Analyze. The existing environment and systems are evaluated. Major
problems and deficiencies are identified using informal or formal
methods. A readiness assessment may be done. The feasibility of the
system is determined, and system requirements are defined. Analysts or
informaticians may interview key system users or potential users and
consult with information technology (IT) personnel. A part of the initial
analysis is to understand the organizational culture, how the organization
handled change in the past, and to determine the number of other changes
the organization is encountering to understand how a technology change
will fit (or not) into their priorities. Formal research projects (e.g.,
observing users interacting with applications, determining workflow in
specialty areas such as the operating room) or formal surveys or focus
groups may be conducted to determine needs. Workflow analyses are
important to perform even though they are time consuming. Deficiencies
in the existing system are addressed with specific proposals for
improvement. Benefits include engaging staff in the change process, and
potential problems in processes can be identified. Gaps are noted, and
current capabilities and limitations are outlined. Initial user and system
requirements are formulated.
2. Plan. The proposed system is comprehensively planned. Planning
includes strategic levels, such as whether the system will be developed
internally, purchased, and tailored or designed and developed jointly with
a vendor. The analysis and planning phases are the most time consuming
of any project and are often estimated to require about 70% of a project’s
time and resources from start to initial implementation. Workflow
analyses and process reengineering may be completed as a basis for
determining the scope of system functions and the flow of information and
activities within care processes. This is time intensive but worth the effort.
In this process, the staff becomes involved, and everyone begins to see
where the bo lenecks and other issues are. Potential problems can often be
avoided through this analysis. Other topics to consider in this step include
planning for project governance, key stakeholders, hardware, operating
systems, databases, interface engines, programming (if needed), tailoring
methods, marketing and communications, support for go-live, support for
extensive testing, project maintenance, evaluation and success factors,
security and privacy, and systems integration and IT support, such as
integration into the call center, on-call support for clinicians, and physical
construction.
3. Develop or purchase. At this stage, the system is purchased or new system
development begins. New components and programs are obtained and
installed. For vendor-supported solutions, extensive tailoring occurs. This
step may not be distinct from steps 1 and 2, depending on the type of
development and tailoring the organization decides to employ. For
instance, the organization may use user-centered techniques that include
iterative design and evaluation with actual end users. Training is designed
but may be carried out as part of the implementation stage.
4. Test. In this stage, extensive testing occurs just before implementation
and go or no-go decisions are made about deadlines. The system should be
tested intensively before implementation in as close to normal situations as
possible. Simulated units are ideal. Ideally, adjustments are made at this
stage to correct gaps in the scope of system functions or work processes.71
Toward the end of this step, marketing and communication efforts are
accelerated to make users aware of the impending change.
5. Implement or go-live. The system is implemented using a selected method
best suited to the organization and its tolerance for risk. Communication
and training plans are executed. Mass user training is completed. The plan
for conversion or go-live is implemented. For larger projects, the go-live
can include a command center to coordinate activities for the few days or
weeks. Users begin to use the system for their activities such as patient
care.
6. Maintain and evolve. Once the system has been formally acknowledged as
passing user acceptance testing, typically at 90 or 120 days after going live,
it enters a maintenance stage. Here, the project is considered routine and is
integrated into normal operations in IT, clinical, and business areas.
However, the system is not static: it evolves over time. For example, a
project in the maintenance stage should have regular upgrades to maintain
software currency and have system change requests completed.
7. Evaluate. Evaluation occurs at each step of the SLCM, as may be seen in
Fig. 2.8. The evaluation stage actually begins in the planning stage of the
project. The system should be tested intensively before implementation in
as close to normal situations as possible. A simulated unit is ideal. Ideally,
adjustments are made at this stage to correct gaps in the scope of system
functions or work processes. Evaluation techniques are discussed in
Chapter 4.
8. Return to analyze. Unlike the methods depicted in most systems, in life
cycle models, the organizational baseline has matured and does not return
to the preimplementation baseline. Thus the SLCM is typically a spiral of
ongoing analysis, refinement with installation of upgrades and
enhancements, and new projects building on the initial work. Atypically, a
project may have a formal end through deinstallation or replacement with
a new system. If that occurs, it would be at this step in the SLCM.
Additional informatics-related models
Although informatics is a new discipline, various models have proven
useful to leaders within this field. An overview of several key models and
theories used within the discipline has been provided. Currently there is
no single comprehensive, generally accepted theoretical or conceptual
model of health or nursing informatics. A number of models have been
introduced, some defining an overall model of informatics and some
dealing with a specific aspect of informatics. For example, Graves and
Corcoran, discussed earlier, defined an overall model, whereas Garcia-
Smith proposed an integrated model to predict a successful clinical
information system (CIS) implementation.72 Selected models are included
in Table 2.4.
Table 2.4
Selected Models of Nursing Informatics
IRO, The Informatics Research; NI, nursing informatics.
Conclusion and future directions
Healthcare is an information-intensive service. Computerization and the
use of technology provide an effective and efficient means to manage large
volumes of data and information with knowledge and wisdom. However,
the move to an electronic healthcare system is changing every aspect of
healthcare. With this degree of change come excitement, anxiety,
resistance, and conflict. Health professionals and health informatics
specialists function at the very core of this change. They play a major role
in implementing, managing, and leading healthcare organization as they
move forward with automation. To play this role, they work directly with
the clinical, administrative, and technical people in the organization. For
health professionals and health informatics specialists to provide effective
leadership, they must understand the institution’s vision and values and
the people and processes within these organizations. The theories
presented in this chapter provide a foundation for supporting and
managing the enormous degree of change experienced by the healthcare
system and the people within any healthcare system.
Informatics incorporates a number of other disciplines and, therefore,
theories from those disciplines have been effectively used to guide
research within the field of informatics. This chapter is an introduction to
the use of theory in informatics and not a comprehensive analysis of
theories that have or can be used to deal with questions of importance to
informatics. Several theoretical and conceptual models used in health
informatics are described elsewhere in this book and are not repeated in
this section. For example, the model of biomedical informatics developed
by the American Medical Informatics Association is included in Chapter
35 Staggers’s model of human-computer interaction is included in Chapter
21. In the future, one can expect to see additional models developed as the
field of informatics continues to mature and as developments in healthcare
and technology continue to evolve.
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Discussion questions
1. Describe the technology-related literacies and explain their relationship
to health informatics.
2. Using Shannon and Weaver’s model of information as a framework,
describe several ways in which miscommunication can occur between
healthcare providers working together in a clinical se ing. Use this same
framework to suggest how technology could be used to decrease this
miscommunication.
3. Use Blum’s model of information to explain the process used by
healthcare providers for diagnosing and managing or treating
healthcare problems. Identify the implication of this model for the
development of decision support systems to support the patient care
process.
4. Some have argued that the data-to-wisdom continuum cannot be used to
define the scope of clinical practice because computers cannot process
wisdom. Identify and describe whether this is a fallacy.
5. This chapter includes four types of learning theories. Use each of these
types of learning theories to explain how to design and implement a
staff education program to support a go-live implementation in a major
medical center.
6. The responses of individuals to innovation have been classified into five
groups. List and describe the five groups. Now describe how each group
should be managed when planning for a major change within a
healthcare institution.
7. List and explain the five internal organizational characteristics that can
be used to predict how an organization will respond to a change in
automation. Now use these same characteristics to predict how the U.S.
healthcare system will respond to the automation of healthcare over the
next 5 years.
Case study
A good friend of yours is director of patient services at a 220-bed
community hospital. Last year the hospital merged with a much larger
medical center. One of the upsides, as well as one of the challenges, is the
rapid introduction of new health information systems. The goal is to bring
the hospital “up to speed” within 3 years. At present, CPOE is being
implemented. The general medical and surgical units went live last month.
The intensive care unit and pediatrics and obstetrics units are scheduled to
go-live next month. The plan is to work out any kinks or problems on the
general units and then go-live in the specialty units.
Most of the physicians, nurse practitioners, and physician assistants
initially complained but are now becoming more comfortable with the
computers and are beginning to integrate the CPOE process into their
daily routines. Several physicians are now requesting the ability to enter
orders from their offices, and others are looking into this option.
However, three physicians have not commented during this process but
are clearly resisting. For example, after performing rounds and returning
to their offices, they called the unit with verbal orders. After being
counseled on this behavior, they began to write the orders on scraps of
paper and put these in the patient’s charts or leave them at the nurses’
station. When they were informed that these were not “legal orders,” they
began smuggling in order sheets from the nonactivated units. In addition,
they have been coercing the staff nurses on the units to enter the orders for
them. This has taken two forms. Sometimes they sign in and then ask the
nurses to enter the orders. Other times they ask the nurses to put the
orders in verbally and then they confirm the orders. The nurses feel caught
between the hospital’s goals and the need to maintain a good working
relationship with these physicians.
Discussion Questions
1. How would you use the theories presented in this chapter to
diagnosis the problems demonstrated in this case. List your diagnoses
and explain your analysis.
2. What actions would you recommend to your friend and what reason
(theories) would you use as a basis for your recommendations?
3
Evidence-Based Practice, Practice-
Based Evidence, and Health
Informatics
Kathleen R. Stevens; Susan D. Horn; Jacob Kean; Vikrant G. Deshmukh; Sandra A. Mitchell;
Ramona Nelson
Abstract
This chapter links evidence-based practice (EBP) and practice-based evidence (PBE)
with informatics by exploring the central, shared construct of knowledge. The
discussion offers a foundation for understanding EBP and PBE, as well as their
interrelationships. It describes how EBP and PBE are supported and integrated
through a variety of current informatics applications. The chapter concludes by
exploring opportunities for applying informatics solutions to maximize the
advantages offered by the synergistic implementation of EBP and PBE in providing
cost-effective, safe, quality healthcare for individuals, families, groups, and
communities.
High-quality cost-effective care requires health information systems that
present the evidence needed for providers to make best-practice decisions
at the point of care and then capture the data by which the effectiveness of
those decisions can be measured.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Explore trends in evidence-based quality improvement.
2. Discuss the implications of evidence-based quality improvement for
various levels and types of healthcare organizations as well as across
multiple professions.
3. Review effective models in structuring evidence-based practice (EBP)
initiatives.
4. Define the goals and analyze processes employed in practice-based
evidence (PBE) designs.
5. Analyze the strengths and weaknesses of observational designs in
general and of PBE specifically.
6. Identify the roles and activities of the informatics specialist in PBE in
healthcare environments.
7. Discuss the synergistic role of EBP and PBE in developing informatics-
based solutions for managing patients’ care needs.
KEY TERMS
clinical practice guidelines (CPGs) 44
comparative effectiveness research 54
evidence-based practice (EBP) 38
knowledge transformation 42
practice-based evidence (PBE) 38
Introduction
Informatics solutions and tools hold great potential for enhancing
evidence-based clinical decision making and for measuring the
effectiveness of those decisions in real time. The field of informatics and
the concepts of evidence-based practice (EBP) and practice-based
evidence (PBE) intersect at the crucial junction of knowledge for clinical
decisions, with the goal of transforming healthcare to be reliable, safe, and
effective.
A foundational paradigm for informatics is the framework of data,
information, knowledge, and wisdom discussed in Chapter 2. This
framework indicates that as data are organized into meaningful
groupings, the information within those data can then be seen and
interpreted. The organization of information and the identification of the
relationships between the facts within the information create knowledge.
The effective use of knowledge, such as the process of providing
personalized care to manage human healthcare needs, is wisdom.
Computerization offers the opportunity to collect, organize, label, and
deliver efficiently and effectively evidence-based information and
knowledge at the point of decision making, thereby making it possible for
clinicians to apply concepts from EBP at the point of care. As that care is
delivered, patient-specific data can be captured through documentation in
the patient’s electronic health record (EHR), thereby providing a feedback
loop for evaluating the effectiveness of those patient-care decisions. In
addition, these data can be aggregated across patients, demonstrating the
effectiveness of evidence-based decisions across groups of patients in a
variety of different se ings.
A prime challenge to achieve this ideal is the complexity of issues
surrounding standardized terminology in healthcare and the lack of a
common framework across the field of EBP and PBE. Standardized
terminology is requisite for naming, classifying, tagging, locating, and
then analyzing evidence to use that evidence in practice.
Evidence-based practice
Knowledge is at the heart of EBP. Within the EBP paradigm, knowledge
must be transformed through a number of forms to increase its utility at
the point of care.1 The ultimate goal of EBP is improving systems and
microsystems within healthcare, with these improvements based on
science. Using computerized methods and resources to support the
implementation of EBP holds great potential for improving healthcare.
Delivering evidence to the point of patient care can align care processes
with best practices that are supported by evidence.
The evolution of EBP underscores its potential impact on quality of care
and health outcomes. In a well-known report, To Err Is Human, experts
noted that almost 100,000 patients were being harmed annually by the
healthcare system.2 When this report was issued, 100,000 deaths was seen
as unbelievably high. Today experts consider 100,000 deaths as a severe
underestimation.3 One of the latest estimates published in 2013 reported
400,000 deaths resulting from preventable medical error, with serious
harm 10 to 20 times more common than lethal harm.4
As an immediate response to the Institute of Medicine (IOM)* report,
national leaders identified the gap between what is known about best care
and what is widely practiced in the 2001 report titled Crossing the Quality
Chasm (Chasm).5
In the Chasm report, more than 100 surveys of quality of care were cited,
showing that scores on the “report card” for healthcare performance were
poor. Box 3.1 presents findings from these surveys, comparing current care
to what was deemed the best care or standards of care. These results
indicated that significant improvement was needed if every patient is to
receive high-quality care at all times. To achieve this goal, the report
pointed to EBP as a critical solution to redesigning and improving
healthcare.
Box 3.1
Institute of Medicine Findings on 2001 Level of
Current Care Compared With Standards of Care
• 47% of myocardial infarction patients did not receive beta blockers
• 50% of children with asthma did not receive wri en instructions
• 48% of elderly did not receive annual influenza vaccine
• 63% of smokers were not advised to quit smoking
• 84% of Medicare patients with diabetes were not tested with the A1c
blood test
Data from Institute of Medicine. Crossing the quality chasm: A new health system for the 21st
Century [Commi ee on Health Care in America & Institute of Medicine]. Washington, DC:
National Academies Press; 2001.
Another set of reports demonstrating this challenge is the National
Healthcare Quality Report (NHQR) and the National Healthcare
Disparities Report (NHDR) produced by the Agency for Healthcare
Research and Quality (AHRQ). These reports, published annually since
2003, have provided an annual snapshot of the quality of care across the
country.6 Beginning in 2014, findings on healthcare quality and healthcare
disparities were integrated into a single document titled the National
Healthcare Quality and Disparities Report (QDR). This report highlights the
importance of examining quality and disparities together to gain a more
comprehensive picture of healthcare. “The report demonstrates that the
nation has made clear progress in improving the health care delivery
system to achieve the three aims of be er care, smarter spending, and
healthier people, but there is still more work to do, specifically to address
disparities in care.”6 For example, patient safety improved, as
demonstrated by a 17% reduction in rates of hospital-acquired conditions
between 2010 and 2013. However, across a broad range of measures,
recommended care is delivered only 70% of the time.
Solutions to the healthcare quality gap are offered in the Chasm report.5
The IOM expert panel issued recommendations for urgent action to
redesign healthcare so that it is safe, timely, effective, efficient, equitable,
and patient centered, often referred to as the STEEEP principles.5 Each of
the STEEEP redesign principles is described further in Table 3.1.
Table 3.1
Descriptions of the STEEEP Principles for Redesigning Healthcare
Principle Description
Safe Avoid injuries to patients from the care that is intended to help them.
Timely Reduce wait time and sometimes-harmful delays for both those who receive and those who give care.
Effective Provide services based on scientific knowledge to all who could benefit, and refrain from providing
services to those not likely to benefit.
Efficient Avoid waste, including waste of equipment, supplies, ideas, and energy.
Equitable Provide care that does not vary in quality because of personal characteristics such as gender, ethnicity,
geographic location, and socioeconomic status.
Patient Provide care that is respectful of and responsive to individual patient preferences, needs, and values,
centered and ensure that patient values guide all clinical decisions.
Adapted from Institute of Medicine. Crossing the quality chasm: A new health system for
the 21st Century (Committee on Health Care in America & Institute of Medicine).
Washington, DC: National Academies Press; 2001:39-40.
The Chasm report continues to be a major influence, directing national
efforts targeted at transforming healthcare. For example, the STEEEP
recommendations are now reflected in health profession education
programs. The American Association of Colleges of Nursing (AACN)
educational competencies include requirements for programs to prepare
nurses who contribute to quality improvement.7 AACN Essentials specify
that professional nursing practice be grounded in translation of current
evidence into practice and further point to the need for knowledge and
skills in information management as being critical in the delivery of
quality patient care.7 Likewise, the Accreditation Council for Graduate
Medical Education (ACGME) requires medical education in quality
improvement.8 The STEEEP principles are also reflected in clinical practice
resources, such as the AHRQ Health Care Innovations Exchange, in which
the elements of STEEEP are employed as selection criteria for inclusion in
this unique clearinghouse.9
Quality of care and EBP are conceptually linked, and they form the hub
of healthcare improvement. The descriptions and definitions of each reflect
the overlap of these concepts and offer reference points against which to
expand the understanding of them. In particular, the focal point of both is
the use of knowledge in practice.
The definition of quality of care includes two key connections to EBP and
knowledge that in turn provide a strong linking point for informatics.
First, quality healthcare services increase the likelihood that the goals of
care or desired outcomes will be reached. This implies that processes of
EBP must assist clinicians in knowing which options in health services are
effective. The strongest cause-and-effect knowledge is discovered through
formal research. Second, EBP is connected to quality insofar as healthcare
is consistent with current knowledge. Using knowledge presumes
accessibility to it at the point of care. The overlap of EBP and knowledge is
further underscored by the definition of the STEEEP principle “effective.”
In the STEEEP framework, effectiveness is defined as evidence-based
decision making, suggesting, “Patients should receive care based on the
best available scientific knowledge.”5, p. 62 Knowledge is the point of
convergence across the areas of EBP, informatics, and improvement. Using
informatics approaches can make evidence available and accessible at the
point of care.
EBP is put into action during clinical decision making. The primary
impetus for EBP in healthcare is that clinicians should select the option
that is most likely to be effective in improving the patient’s health
problem. This option is supported by best available research evidence.
Clients present a plethora of actual and potential health problems that
need to be managed or resolved (e.g., living with asthma, succeeding in
the face of learning disabilities, and preventing obesity). Currently, many
clinical actions are not based on best available scientific knowledge and,
therefore, offer the client care that is not as effective as it could be.5 The
essential role of the healthcare provider is to select and apply interventions
having the greatest potential to improve the client’s situation and to
implement the most effective strategies for changing the microsystem or
system of care. Clinicians choose from and interpret a huge variety of
clinical data and information while facing pressure to decrease
uncertainty, risks to patients, and costs. Knowledge underlies these
decisions and plays a primary role in the care provided.
Evidence-based clinical decision making can be described as a
prescriptive approach to making choices in diagnostic and intervention
care, based on the idea that research-based care improves outcomes most
effectively. Research-based care provides evidence about which option is
most likely to produce the desired outcome. EBP is seen as a key solution
in closing the gap between what is known and what is practiced.
However, important questions lie between accepting this as true and the
clinician’s and system’s ability to enact it: How do clinicians know which
interventions will most likely diminish or resolve the health problem and
help the client reach his or her health goal? What resources are available to
apply EBP principles directly in clinical decision making? Answering these
questions begins with analyzing the different models of EBP.
Evidence-based practice models
A number of EBP models are useful in understanding various aspects of
EBP and elucidating connections between informatics and EBP. An
overview of models in the field reflects several challenges for developing
informatics approaches. The primary challenge is the lack of a common
framework that could be used to consistently organize and implement EBP
principles.
Prominent EBP models can be grouped into three categories of models
for designing and implementing systematic approaches to strengthen
evidence-based clinical decision making.10 Table 3.2 describes the critical
a ributes and provides examples in three categories.
Table 3.2
Models for Evidence-Based Practice
From Mitchell SA, Fisher CA, Hastings CE, et al. A thematic analysis of theoretical
models for translational science in nursing: mapping the field. Nurs Outlook.
2010;58(6):287-300. Used with permission.
The first category includes models that focus on EBP, research use, and
knowledge transformation principles. These models emphasize a
systematic approach to synthesizing knowledge. The models specify a
series of processes designed to:
1. Identify a question, topic, or problem in healthcare.
2. Retrieve relevant evidence to address the identified issue.
3. Critically appraise the level and strength of that evidence.
4. Synthesize and apply the evidence to improve clinical outcomes.
Some models in this category emphasize the process by which research
findings can be developed into a more useful form, such as a clinical
practice guideline or standards of care, which can then be used to guide
clinical decision making in the practice arena. Other models reflect a PBE
approach by addressing outcomes evaluation to determine whether the
EBP change has produced the expected clinical outcomes or to compare
actual practice and ideal practice (thereby identifying unacceptable
practice variation).
The second category includes models that offer an understanding of the
mechanisms by which individual, small group, and organizational
contexts affect the diffusion, uptake, and adoption of new knowledge, as
well as innovation, which is essential to the design of EBP initiatives.
These models propose that specific interventions serve to accelerate the
adoption of practices that are based on best evidence. Examples of such
interventions include:
• Facilitation
• Use of opinion leaders
• Real-time feedback about patient outcomes
• Audit feedback about clinicians’ variation from established practice
standards
Thus within these models, feedback regarding both patient and
practitioner outcomes is seen as a change strategy.
A third category of models and frameworks postulates that formalized,
bidirectional, and ongoing interactions among practitioners, researchers,
policy-makers, and consumers accelerate the application of new
discoveries in clinical care. This ongoing interaction increases the
likelihood that researchers will focus on problems of importance to
clinicians. Such models simultaneously address the generation of new
knowledge (discovery) and uptake. This collaboration supports the
exchange of expertise and knowledge to strengthen decision making and
action for all involved parties.10
Each EBP model described previously has perspectives that may prove
valuable in designing and advancing informatics approaches to EBP. The
following section examines the application of one of these models, the
Stevens ACE Star Model of Knowledge Transformation,1 which will be
used to demonstrate how an EBP model can:
1. Guide the transition from the discovery of new information and
knowledge to the provision of care that is based on evidence.
2. Identify how computerization and informatics principles can be used to
make this transition realistically possible in a world in which information
and knowledge are growing at an explosive rate.
Stevens star model of knowledge
transformation
The Star Model provides a framework for converting research knowledge
into a form that has utility in the clinical decision-making process. The
model articulates a necessary process for reducing the volume and
complexity of research knowledge, evolving one form of knowledge to the
next, and incorporating a broad range of sources of knowledge throughout
the EBP process.
The model addresses two major hurdles in employing EBP: (1) the
volume of current professional knowledge and (2) the form of knowledge
that healthcare professionals a empt to apply in practice. In both
instances, informatics-based solutions have been created. The Star Model
explains the key concept of knowledge transformation. Knowledge
transformation is defined as the conversion of research findings from
discovery of primary research results, through a series of stages and forms,
to increase the relevance, accessibility, and utility of evidence at the point
of care to improve healthcare and health outcomes by way of evidence-
based care.1
When considering the volume of knowledge, experts point out, “no
unaided human being can read, recall, and act effectively on the volume of
clinically relevant scientific literature.”5, p. 25 It is estimated that in medicine,
more than 10,000 new research articles are published annually. Even the
most enthusiastic clinician or researcher would find it challenging to stay
abreast of this volume of literature. When considering the form of
knowledge as a barrier, it is clear that most research reports are not
directly useful in a clinical se ing but must be converted to a form
applicable at the point of care. Research results, often presented in the
form of statistical results, exist in a larger body of knowledge. The
complexity and lack of congruence across all studies on a topic create a
barrier when using this as a basis for clinical decision making. The Stevens
Star Model addresses the transformation that is necessary for converting
research results from single-study findings to guidelines that can be
applied and measured for effect. Discussion of this model is expanded in
the next section, with specific electronic resources for each form of
knowledge identified and described.
In the Star Model, individual studies move through four cycles, ending
in practice outcomes and patient outcomes. The knowledge transformation
process occurs at five points, which can be conceptualized as a five-point
star as shown in Fig. 3.1. These five points are discovery research, evidence
summary, translation to guidelines, practice integration, and evaluation of
process and outcome.1 A description of each point is provided below,
along with identification and descriptions of computerized resources and
examples.
FIG 3.1 ACE Star Model of Knowledge Transformation. Copyright
Stevens KR. ACE Star Model of EBP: Knowledge Transformation. San Antonio, TX:
Academic Center for Evidence-Based Practice, University of Texas Health Science Center
at San Antonio; 2004. Used with expressed permission.
Point 1: Discovery Research
Primary research on Point 1 represents the knowledge produced through
primary discovery. In this stage, knowledge is in the form of results from
single research studies. Over the past 3 decades, health-related research
has produced thousands of research studies on a wide variety of health-
related issues. However, the clinical utility of this form of knowledge is
low. The cluster of primary research studies on any given topic may
include both strong and weak study designs, small and large samples, and
conflicting or converging results, leaving the clinician to wonder which
study is the best reflection of cause and effect in selecting effective
interventions. Point 1 knowledge is less useful in clinical decision making
because there may be hundreds of research studies on a given topic, with
the overall collection being unwieldy. Further, the group of studies does
not necessarily converge on a consensus of the intervention most likely to
produce the desired outcome. Instead, one study may show that the
intervention was successful, whereas another shows no difference between
control and experimental conditions.
Initially, health sciences researchers focused on applying results from
primary research studies directly in patient care, detailing ways to move a
single study into practice. However, since there may be multiple studies
on a given topic, this strategy is no longer considered appropriate for most
interventions. Table 3.3 illustrates part of the challenge in moving research
into practice with this approach. In this example, the clinician seeks to
locate current evidence about falls prevention in the elderly. A CINAHL
literature search on the topic “falls prevention” returned more than 14,000
articles to consider. Even when the search strategy was limited to
“research,” more than 6500 articles remained on the list. This volume of
literature is far too great to have clinical utility.
Table 3.3
Literature Search and Knowledge Forms on “Falls Prevention”
Star Point form of Knowledge Search Results
Point 1: Discovery research CINAHL search for “falls” 14,627 citations
Limit search to “research” 6991 citations
Point 2: Evidence summary Limit search to “systematic reviews” 250 citations
Focus on “prevention in elderly” Limit to prevention in elderly 6 systematic reviews
Point 2: Evidence Summary
Table 3.3 illustrates the striking advantage of knowledge management
through knowledge transformation stages, in particular evidence
summaries. Evidence summaries include evidence synthesis, systematic
reviews (SRs), integrative reviews, and reviews of literature, with SRs
being the most rigorous approach to evidence summary. Before evidence
summaries were developed, the clinician was left to deal with the many
articles located via a bibliographic database search: in this case, thousands
of articles. However, if the research knowledge has been transformed
through evidence synthesis, the resulting SR will contain this
comprehensive knowledge base in a single article. The EBP solution to the
complexity and volume of literature seen in Point 1 is the Point 2 evidence
summary. In this second stage of knowledge transformation, a team
locates all primary research on a given clinical topic and summarizes it
into a single document about the state of knowledge on the topic. This
summary step is the main knowledge transformation that distinguishes
EBP from simple research application and research use in clinical practice.
The importance of this transformation cannot be overstated: SRs are
described as the central link between research and clinical decision
making.30 Key advantages of SRs are summarized in Box 3.2. Returning to
Table 3.3 and our example on falls, once the literature search is
transformed into “systematic reviews,” the volume of located sources is
decreased to 250 citations. Once a narrowed clinical topic is applied, the
search yields six SR on falls prevention in the elderly, thereby
transforming over 14,000 pieces of knowledge into manageable resource.
Box 3.2
Advantages of Systematic Reviews
A rigorous systematic review:
• Reduces information into a manageable form
• Establishes generalizability—participants, se ings, treatment variations,
and study designs
• Assesses consistencies across studies
• Increases power in cause and effect
• Reduces bias and improves true reflection of reality
• Integrates information for decisions
• Reduces time between research and implementation
• Offers basis for continuous updates
From Mulrow CD. Rationale for systematic reviews. Br Med J. 1994;309(6954):597-599. Reproduced
with permission from BMJ Publishing Group Ltd.
An SR combines results from a body of original research studies into a
clinically meaningful whole to produce new knowledge through synthesis
and can use the statistical procedure meta-analysis to combine findings
across multiple studies. Evidence summaries communicate the latest
scientific findings in an accessible form that can be readily applied in
making clinical decisions; that is, evidence summaries form the basis upon
which to build EBP. When developing an evidence summary, one must
keep in mind that nonsignificant findings can be as important to practice
as positive results. However, nonsignificant findings tend not to be
published and so are underrepresented in the literature.
Conducting sound evidence summaries requires scientific skill and
extensive resources: often more than a year’s worth of scientific work.
Therefore evidence summaries are often conducted by scientific and
clinical teams that are specifically prepared in the methodology. The
dominant methodology for SRs is published in the Cochrane Handbook for
Systematic Reviews of Interventions.31
The process of narrowing down the publications for computerization is
facilitated by computerized methods using Covidence (available at:
h ps://[Link]/) to screen publications and by using reference
managers such as EndNote. The state of the science in informatics points
to the fact that the field is nascent; as such, research conducted on key
aspects remains in the descriptive and correlational phases of scientific
development: causal studies that test interventions are scarce. This can
preclude the use of the SR method to summarize effect sizes across
multiple studies. In fact, Weir et al. contend that researchers rushed to
perform experimental studies for computerized provider order entry
(CPOE) before the phenomenon was understood.32,33 With newer fields
such as informatics, qualitative and descriptive studies are needed first.
Then causal and comparative research and subsequent integrative reviews
and SRs can be conducted to summarize the science of health informatics.
Resources and Examples
Major computerized resources for locating SRs include the Cochrane
Database of Systematic Reviews, the AHRQ, as well as the general
professional literature. The Cochrane’s primary strategy is the production
and dissemination of SRs of healthcare interventions. This group
established the “systematic review” as a literature review, conducted
using rigorous approaches that synthesize all high-quality research
evidence to reflect current knowledge about a specific question. The
scientific methods are specified by the Cochrane Collaboration, and its
design is considered the gold standard for evidence summaries. As of
March 2016, the Cochrane Database of Systematic Reviews included 6471
SRs.34 Using an example of falls prevention, the most accessed Cochrane
Review in 2014 is entitled “Interventions for Preventing Falls in Older
People Living in the Community.” The findings from this SR are
summarized in Box 3.3. The evidence summary offers powerful
knowledge about what interventions are likely to be most successful. Note
that in this example 62 trials (Point 1 studies) were located, screened for
relevance and quality, and meta-analysis was used to consolidate results
into a single set of conclusions. However, the recommendations for
practice from the SR are not yet action-oriented. For this to happen, it is
necessary to translate a conclusion into an actionable recommendation by
moving knowledge to Point 3 on the Star model.
Box 3.3
Example of Stevens Star Point 2: Systematic
Review
This Cochrane Review looked at the healthcare literature to establish fall
prevention interventions effective for older people living in the
community. The review analyzed 159 randomized controlled trials with
79,193 participants.
The following selected interventions are likely to be beneficial in
reducing falls:
• Group and home-based exercise programs including balance and
strength training and Tai Chi. Overall, exercise programs aimed at
reducing falls.
• Interventions to improve home safety.
• An antislip shoe device worn in icy conditions.
• Taking vitamin D supplements does not appear to reduce falls with the
exception of persons who have lower vitamin D levels in the blood
before treatment.
• Gradual withdrawal of medications for improving sleep, reducing
anxiety, and treating depression (psychotropic medication).
• Cataract surgery in women having the operation on the first affected eye.
• Insertion of a pacemaker in people with frequent falls associated with
carotid sinus hypersensitivity.
• In people with disabling foot pain, the addition of footwear assessment,
customized insoles, and foot and ankle exercises to regular podiatry
reduced the number of falls but not the number of people falling.
• The evidence relating to the provision of educational materials alone for
preventing falls is inconclusive.
Data from Gillespie LD, Robertson MC, Gillespie WJ, et al. Interventions for preventing falls in
older people living in the community. Cochrane Database Syst Rev. 2012;9:CD007146.
doi:10.1002/14651858.CD007146.pub3.
Point 3: Translation to Guidelines
In the third stage of EBP, translation, experts are called on to consider the
evidence summary, fill in gaps with consensus expert opinion, and merge
research knowledge with expertise to produce clinical practice guidelines
(CPGs). This process translates the research evidence into clinical
recommendations. The IOM defines clinical guidelines as “systematically
developed statements to assist practitioner and patient decisions about
appropriate healthcare for specific clinical circumstances.”35
CPGs have evolved during the past 20 years from recommendations
based largely on expert judgment to recommendations grounded
primarily in evidence. Expert consensus is used in guideline development
when research-based evidence is lacking.36 CPGs are commonly produced
and sponsored by a clinical specialty organization. Such guidelines are
present throughout all organized healthcare in the form of clinical
pathways, nursing care standards, and unit policies. An exemplar of the
development of CPGs in nursing is Pu ing Evidence into Practice in
Oncology.37 This program engages scientists and expert clinicians in
examining evidence, conducting evidence summaries, generating practice
recommendations, and developing tools to implement the guidelines.
These online guidelines are accessible to clinicians and are also published
in nursing literature.38
Crucial criteria for well-developed CPGs are (1) the evidence is explicitly
identified and (2) the evidence and recommendation are rated. To assist in
rating evidence, several taxonomies have been developed. One such
taxonomy was developed by the Center for Evidence Based Medicine in
the United Kingdom. This rating system identifies SRs as the uppermost
strength of evidence.39
Also included and counted as evidence is consensus of expert opinion,
which is rated the weakest strength of all levels of evidence. However, if
no other evidence exists, this may serve to support clinical decision
making. Well-developed CPGs and care standards share several
characteristics: a specified process is followed during guideline
development; the guideline identifies the evidence upon which each
recommendation is made, whether it is research or expert opinion; and the
evidence is rated using a strength-of-evidence rating scale. Fig. 3.2
illustrates a strength-of-evidence rating hierarchy.40 The higher the
evidence is placed on the pyramid, the more confident the clinician can be
that the intervention will cause the targeted health effect.
FIG 3.2 Strength-of-evidence hierarchy. RCT, Randomized
controlled trial. From Stevens KR, Clutter PC. Strength of evidence rating. Academic
Center for Evidence-Based Practice. [Link] 2007. Used with
permission.
A number of EBP approaches emphasize the usefulness of CPGs in
bridging the gap between primary research findings and clinical decision
making.30 CPGs are systematically developed statements to assist
practitioners and patients in decisions about appropriate healthcare for
specific clinical circumstances.35 CPGs are seen as tools to help move
scientific evidence to the bedside. To increase the likelihood that the
recommended action will have a positive impact on the clinical outcome, it
is imperative that guidelines are based on best available evidence,
systematically located, appraised, and synthesized (i.e., evidence based).
Resources and Examples
Today the AHRQ provides the National Guideline Clearinghouse, a
searchable database of more than 2500 CPGs entered by numerous
sources. Although this knowledge management database can be easily
used to locate a wide variety of CPGs, the user must examine the
information presented with the CPG to determine that the CPG is current,
was developed systematically, and is based on best evidence.
Other guidelines can be located on the U.S. Preventive Services Task
Force (USPSTF) segment of the AHRQ website.41 These recommendations
focus on screening tests, counseling, immunizations, and
chemoprophylaxis and are based on evidence summary work performed
by the AHRQ.
Critical appraisal of the various forms of knowledge is important.
However, for clinical decision making, appraisal of guidelines is crucial for
effective clinical care. A number of standards for critical appraisal of CPGs
are available and can be used to examine CPGs as clinical agencies
consider adoption into practice. An excellent example of a systematic
approach is the instrument used to assess practice guidelines developed
by the Appraisal of Guidelines for Research and Evaluation (AGREE)
enterprise.42 The 23-item AGREE II instrument developed by this
international collaboration is reliable and valid. It outlines primary facets
of the CPG to be appraised: scope and purpose, stakeholder involvement,
rigor of development, clarity and presentation, application, and editorial
independence. Even though the instrument is not easily used by the
individual clinician, it is helpful to groups and organizations charged with
adoption of specific CPGs. Box 3.4 identifies key elements to be examined
when appraising a CPG.
Box 3.4
Critically Appraising a Clinical Practice
Guideline
1. Why was this guideline developed?
2. What was the composition (expertise and disciplinary perspective) of
the panel that developed the guideline?
3. What entity provided financial sponsorship?
4. What decision-making processes were used in developing the guideline?
a. What clinical question was the guideline developed to address?
b. How was the evidence used in the guideline gathered and evaluated?
c. Were gaps in the evidence explicitly identified?
d. How explicitly is the available evidence linked to the
recommendations in the guideline?
e. If lower levels of evidence were incorporated (e.g., expert opinion) in
the guideline, are these instances labeled explicitly, and are the
reasons for the inclusion of expert opinion, the line of reasoning, and
the strength of extrapolation from other data clearly identified?
f. How are patient preferences incorporated into the guideline?
g. Is cost effectiveness considered?
h. What is the mechanism and interval for updating the guideline?
Recommendations flowing from evidence are rated in terms of strength.
The USPSTF uses a schema for rating its evidence-based
recommendations.41 It grades strength of recommendations according to
one of five classifications (A, B, C, D, and I). The recommendation grade
reflects the strength of evidence and magnitude of net benefit (benefits
minus harms). Table 3.4 defines each grade and indicates the suggestion
for practice.
Table 3.4
U.S. Preventive Services Task Force Grade, Definition, and
Suggestion for Practice
Grade Definition Suggestion for Practice
A The USPSTF recommends the service. There is high certainty that the Offer/provide this service.
net benefit is substantial.
B The USPSTF recommends the service. There is high certainty that the Offer/provide this service.
net benefit is moderate or there is moderate certainty that the net
benefit is moderate to substantial.
C The USPSTF recommends selectively offering or providing this Offer or provide this service for
service to individual patients based on professional judgment and selected patients depending on
patient preferences. There is at least moderate certainty that the net individual circumstances.
benefit is small.
D The USPSTF recommends against the service. There is moderate or Discourage the use of this service.
high certainty that the service has no net benefit or that the harms
outweigh the benefits.
I Evidence is lacking, of poor quality, or conflicting, and the balance of If the service is offered, patients
benefits and harms cannot be determined. should understand the uncertainty
about the balance of benefits and
harms.
Reprinted with permission of the Agency for Healthcare Research and Quality.
US Preventive Services Task Force. Grade definitions.
[Link] October
2014.
Professional groups within the agency can move forward with
confidence that all research evidence has been systematically gathered and
amassed into a powerful conclusion of what will work. The evidence
summary is ve ed through clinical experts, and interpretations are made
for direct clinical application. In instances where there is a gap in the
evidence summary, the experts consider evidence of lower rating and
finally add their own expertise into the fully developed CPG. Box 3.5
presents an example of Point 3 in the form of a CPG for preventing falls in
the elderly. Note that both the evidence and the recommendation are
rated.
Box 3.5
Example of Stevens Star Point 3: Clinical
Practice Guidelines for Preventing Falls in the
Elderly
Multifactorial Interventions
Strong—All older people with recurrent falls or assessed as being at
increased risk of falling should be considered for an individualized
multifactorial intervention. (Evidence level I)
Strong—In successful multifactorial intervention programs, the following
specific components are common (Evidence level I):
• Strength and balance training
• Home hazard assessment and intervention
• Vision assessment and referral
• Medication review with modification/withdrawal
From National Collaborating Centre for Nursing and Supportive Care. CPG for the Assessment and
Prevention of Falls in Older People. London, United Kingdom: National Institute for Clinical
Excellence. <h ps://[Link]/guidance/cg161>; 2004; Updated 2013, Reviewed January
2016.
A number of available rating scales convey the strength of the
recommendation. Coupled with strength of evidence, the clinician can use
“Level 1” evidence and “Grade A” recommendations to support clinical
decisions. The USPSTF adopted a system linking strength of evidence with
strength of recommendation as follows: strength of the evidence as “A”
(strongly recommends), “B” (recommends), “C” (no recommendation for
or against), “D” (recommends against), or “I” (insufficient evidence to
recommend for or against).43 Box 3.6 presents three examples of USPSTF
recommendations, along with the grade of each recommendation.
Box 3.6
Examples of Star Point 3 USPSTF Clinical
Recommendations and Grades
Ocular Prophylaxis for Gonococcal Ophthalmia
Neonatorum
Release Date: July 2011
Summary of Recommendation
• The USPSTF recommends prophylactic ocular topical medication for
all newborns for the prevention of gonococcal ophthalmia
neonatorum.
Grade: A Recommendation
From US Preventive Services Task Force (USPSTF). Ocular prophylaxis for
gonococcal ophthalmia neonatorum. USPSTF.
<h p://[Link]/uspstf/[Link]
>; 2011.
Prevention of Falls in Community-Dwelling Older
Adults
Current Recommendations
Release Date: May 2012
• The USPSTF recommends exercise or physical therapy and vitamin D
supplementation to prevent falls in community-dwelling adults aged
65 years or older who are at increased risk for falls.
Grade: B Recommendation
• The USPSTF does not recommend automatically performing an in-
depth multifactorial risk assessment in conjunction with
comprehensive management of identified risks to prevent falls in
community-dwelling adults aged 65 years or older because the
likelihood of benefit is small. In determining whether this service is
appropriate in individual cases, patients and clinicians should
consider the balance of benefits and harms based on the circumstances
of prior falls, comorbid medical conditions, and patient values.
Grade: C Recommendation
From US Preventive Services Task Force (USPSTF). Prevention of falls in
community-dwelling older adults. USPSTF.
<h p://[Link]/uspstf/[Link]>;
2012.
Screening for Prostate Cancer
Current Recommendation
Release Date: May 2012
• The USPSTF recommends against prostate-specific antigen-based
screening for prostate cancer.
Grade: D Recommendation
This recommendation applies to men in the general U.S. population,
regardless of age. This recommendation does not include the use of the
prostate-specific antigen test for surveillance after diagnosis or treatment
of prostate cancer; the use of the prostate-specific antigen test for this
indication is outside the scope of the USPSTF.
From US Preventive Services Task Force (USPSTF). Screening for prostate
cancer. USPSTF.
<h p://[Link]/Page/Document/Recomm
endationStatementFinal/prostate-cancer-screening>; 2012. From National
Collaborating Centre for Nursing and Supportive Care. CPG for the
Assessment and Prevention of Falls in Older People. London, United
Kingdom: National Institute for Clinical Excellence.
<h p://[Link]/>; 2004.
As evidenced by the discussion, the translation of guidelines into
practice is a labor-intensive process involving a significant cognitive load.
In the busy world of healthcare, clinicians cannot routinely take the time to
search out CPGs and then translate their application to individual patients.
However, using CPGs to design clinical decision support (CDS) systems in
EHRs can make it possible for busy clinicians to access evidence-based
guidelines that have been individualized to the patient’s needs and status
at the point of care.
Point 4: Practice Integration
Once guidelines are produced, the recommended actions are clear. Next,
the challenge is to integrate the clinical action into practice and thinking.
This integration is accomplished through change at individual clinician,
organizational, and policy levels. Integration inevitably involves change
and integration of evidence into a myriad of health IT tools such as CDS,
Infobu ons, order sets in EHRs, and evaluation of compliance using data
warehouses or other big data sources. As advances and best practices
emerge, it is essential that all members of the healthcare team be actively
involved in making quality-improvement and health IT changes.
Healthcare providers are called on to be leaders and followers in
contributing to such improvement at the individual level of care, as well as
at the system level of care, together with other disciplines.44
Patient preference must be taken into account at the point of integration,
with patient and family circumstances guiding individualized EBP.
Integration may not be straightforward because underlying evidence and
science of healthcare is yet incomplete. In addition, computerized tools
may not be available to assist in the process. As EHRs increasingly include
social and behavioral determinants of health and as personal health
records expand, health IT should be able to integrate patient preferences in
a more electronic and systematic manner. In reviewing the USPSTF’s
highly developed, well-grounded recommendations presented in Box 3.6,
it becomes clear that clinical judgment must be used, and
individualization to patient circumstances and preferences occurs in
moving the evidence-based recommendations into practice. It is at this
point in the transformation of knowledge that the whole of the EBP
definition becomes clear: EBP is the integration of best research
knowledge, clinical expertise, and patient preference to produce the best-
practice decisions.
Resources and Examples
The AHRQ Health Care Innovations Exchange provides a venue for
sharing “what works at our place” along with the evidence of how the
innovation was tested.9 The Health Care Innovations Exchange was
created to speed the implementation of new and be er ways of delivering
healthcare. This online collection of more than 700 innovation profiles
supports the AHRQ’s mission to improve the quality of healthcare and
reduce disparities. The Health Care Innovations Exchange offers frontline
health professionals a variety of opportunities to share, learn about, and
hasten adoption of tested innovations. It also contains more than 1500
quality tools suitable for a range of healthcare se ings and populations.
Innovation profiles and quality tools are continuously entered into the
Exchange. Box 3.7 presents an example of an innovation profile.
Box 3.7
Example of Star Point 4: An Innovation
Fall-Prevention Tool Kit Facilitates Customized Risk-
Assessment and Prevention Strategies, Reducing
Inpatient Falls
What They Did
Periodic assessment, specific risk factors, and customized interventions
Computerized program produces tailored prevention recommendations
Individualized care plan, educational handout, and bedside alert poster
Did It Work?
Significantly reduced falls, particularly in in persons aged > 65
Evidence Rating
Strong: Cluster randomized study comparing fall rates
AHRQ, Agency for Healthcare Research and Quality. Adapted from Dykes P. Interprofessional
Nursing Quality Research Initiative. AHRQ Health Care Innovations Exchange.
h p://[Link]/[Link]?id=3094.
Increasingly, agencies are raising the standard of excellence in local
policies and procedures by moving toward EBP guidelines. Health IT
approaches to integrate EBP guidelines into care hold promise of placing
such best practices into point-of-care decision making. For example, as
clinical summaries and evidence-based order sets can be available in
EHRs, credible practice guidelines can be linked and available via CDS
applications.
Point 5: Evaluation
The fifth stage in knowledge transformation is evaluation. Practice changes
are followed by evaluation of the impact on a wide variety of outcomes,
including safety, effectiveness of the care in producing desired redesign of
care, patient outcomes, population outcomes, efficiency and cost factors in
the care (short term and long term), and satisfaction of both healthcare
providers and patients. Evaluation of specific outcomes is at a high level of
public interest.5,6 As a result, quality indicators are being established for
healthcare improvement and public reporting. Additional information on
how EHRs and computerization can be used to provide evaluation data is
discussed under PBE later in this chapter and in Chapter 23. Chapter 10
provides detailed information about integrating EBP into CDS
applications.
Resources and Examples
Among the significant entities establishing quality indicator sets is the
AHRQ, through its National Healthcare Quality & Disparities Report
(QDR), introduced at the beginning of this chapter.6 These reports provide
a comprehensive overview of the quality of healthcare received by the U.S.
population, as well as disparities in care experienced by different racial,
ethnic, and socioeconomic groups. The reports are based on more than 250
measures of quality and disparities covering a broad array of healthcare
services and se ings. Key selection criteria include measures that are the
most important and scientifically supported. With these measures the
QDR present in summary statements and chart form a snapshot of how
our healthcare system is performing and the extent to which healthcare
quality and disparities have improved or worsened over time.
Selected examples of summary statements include:
• Access improved—after years without improvement, the rate of
uninsured patients among adults ages 18-64 decreased substantially
during the first half of 2014.
• Quality improved for most NQS priorities—healthy living improved,
led by doubling of selected adolescent immunization rates from 2008
to 2012.
Fig. 3.3 is a summary chart showing trends across the NQS priorities
from the QDR.
FIG 3.3 Example of Star Point 5. Summary of trends across
national quality strategy priorities. Number and percentage of all
quality measures that are improving, not changing, or worsening
through 2012 overall and by NQS priority. (Source:
[Link]
[Link].)
Another influential entity establishing quality measures is the National
Quality Forum (NQF). This nonprofit organization brings together a
variety of healthcare stakeholders, including consumer organizations,
public and private purchasers, physicians, nurses, informaticians,
hospitals, accrediting and certifying bodies, supporting industries, and
healthcare research and quality improvement organizations. The NQF’s
mission includes consensus building on priorities for performance
improvement, endorsing national consensus standards for measuring and
reporting on performance, and education and outreach.45 An example of
an NQF-endorsed measure for patient safety is presented in Box 3.8.
Box 3.8
Example of Star Point 5 From the National
Quality Forum
Patient Safety Measure
#0674: Percent of Residents Experiencing One or More Falls with Major
Injury (Long Stay) (Centers for Medicare & Medicaid Services):
Description: This measure reports the percentage of residents who have
experienced one or more falls with major injury during their episode of
nursing home care ending in the target quarter (3-month period). Major
injury is defined as bone fractures, joint dislocations, closed head injuries
with altered consciousness, or subdural hematoma. Long-stay residents
are identified as residents who have had at least 101 cumulative days of
nursing facility care.
Measure Type: Outcome
Level of Analysis: Facility
Se ing of Care: Post-Acute/Long-Term Care Facility: Nursing
Home/Skilled Nursing Facility
Data Source: Electronic Clinical Data
Adapted from National Quality Forum (NQF). Patient Safety 2015 Final Report. February 2016.
h p://[Link]/Publications/2016/02/Patient_Safety_2015_Final_Report.aspx; 2016.
An important collection of quality measures is assembled in the
National Quality Measures Clearinghouse (NQMC), an initiative of the
AHRQ.46 The NQMC is a database and website for information on
evidence-based healthcare quality measures and measure sets. Its purpose
is to promote widespread access to quality measures by the healthcare
community and other interested individuals. The key targets are
practitioners, healthcare providers, health plans, integrated delivery
systems, purchasers, and others. The aim is to provide an accessible
mechanism for obtaining detailed information on quality measures and to
further their dissemination, implementation, and use to inform healthcare
decisions. Box 3.9 presents a measure from the NQMC. Computerized
tools for analyzing the big data in these national databases and teasing out
the factors influencing healthcare outcomes will provide a basis for
evidence in the search for other levels of EBP.
Box 3.9
Example of Star Point 5 From the National
Quality Measures Clearinghouse
Fall Risk Management
The percentage of Medicare members 65 years of age and older who had a
fall or had problems with balance or walking in the past 12 months who
were seen by a practitioner in the past 12 months and who received fall
risk intervention from their current practitioner.
From National Quality Measures Clearinghouse (NQMC). Measure Summary: fall risk management.
h ps://[Link]/summaries/summary/43758; 2015.
Informatics and evidence-based practice
Informatics and IT hold great promise for achieving full integration of EBP
into all care, for every patient, every time. The EBP frameworks provide a
foundation upon which informatics solutions can be constructed to move
evidence into practice. As seen in the examples addressing each point in
the Stevens ACE Star Model, knowledge can be sorted and organized into
its various forms. The national efforts cited here resulted in the availability
of a number of significant web-based information resources to support
each point on the Star Model. New and innovative knowledge
management tools are still being developed.
Informatics can greatly add to support of EBP, patient-centered care,
and transitions of care across se ings. Such technology can greatly assist in
the exchange of health information for continuity and quality of care.
Health informatics is also essential in improving healthcare decision
making by using integrated datasets and knowledge management.
The success of improvement through best (evidence-based) practice
could be boosted with greater understanding of the context in which such
changes are being made. Once the knowledge is transformed into
recommendations (best practices), integration of EBP into practice requires
change at levels that include the patient and family, individual provider,
microsystem, and macrosystem. The good intentions of an individual
provider to use practice guidelines in decision making can be either
supported or thwarted by the clinical information systems at the point of
care.
Successful models for integrating EBP into practice are emerging. For
example, the national team performance training, Team Strategies and
Tools to Enhance Performance and Patient Safety (TeamSTEPPS), has been
promoted across military healthcare since 1995, with a “civilian” rollout
initiated in 2006.47 The program is built on a solid evidence base from
human factors engineering and solves urgent problems arising from team-
based care. The program demonstrated improvements in communication
and teamwork skills among healthcare professionals leading to
improvements in patient care.
In an AHRQ report, the role of health IT in quality measurement was
described.48 Past quality processes were conducted via manual chart entry,
manual chart abstraction, and analysis of administrative claims data. In
locations with existing health IT, advances are seen. As information
systems are created and expanded, the ability to pull meaningful data
from the point of care is increasingly computerized. A major potential for
health IT is to evolve existing measures into electronic measures and
computerized data collection.48
The long-term goal for improving health IT–enabled quality
measurement is to achieve a robust information infrastructure that
supports national quality measurement and reporting strategies. Key goals
include interoperability that ensures that EHRs can share information for
care coordination, patient-centered care, and cost savings. Such
interoperability relies on harmonizing standards. Information exchange,
integrating interoperability standards into vendor products, and data
linkage are critical for advancement.48
A number of challenges must be overcome to achieve the next
generation of health IT–enabled quality measurement. First, consensus
among quality stakeholders is required to move forward on topics such as
the purpose of measurement; achieving patient-centricity in a fragmented
health delivery system; alignment of incentives; ownership and funding;
increased information exchange; and ensuring privacy, security, and
confidentiality. Second, measurement challenges to be overcome include
measures valuable to consumers, measures to assess value, measures for
specialty uses, and accounting for variations in risk in measurement.
Third, technology challenges to be overcome include expansion of
eMeasures; advancement in measure capture technologies; advancement
in patient-focused technologies, health information exchange,
interoperability, and standards; internet connectivity; and aggregation and
analysis. Importantly, the report concludes with a call for stakeholder
input to inform pathways to achieving the next generation of quality
improvement, an important opportunity in which healthcare providers
can engage.48
The health informatics research agenda published in 2008 includes an
expansion to interdisciplinary teams and reflects farsighted goals related
to research needed in evidence-based quality improvement.49 The shifting
emphasis on performance improvement and EBP results in the need for
research that tests innovations in real-world se ings. When the conditions
for standardization and interoperability of EHRs are satisfied, patient-
specific data can be connected across healthcare se ings. Once this occurs,
knowledge discovery about coordination and care processes can be
expanded using data generated routinely from care se ings using PBE
principles. By organizing the informatics approach of data, information,
knowledge, and wisdom into the EBP knowledge transformation and
application in real-world se ings, the field of quality improvement and
EBP translation into practice can be advanced.
Relationship of EBP and PBE
The goal of EBP is to achieve safe, cost-effective quality outcomes by using
research-based evidence to direct patient-care decisions. However, to be
fully effective, EBP requires the feedback loop provided by practice to
determine if the goals of EBP have been achieved in the real world of
healthcare delivery. Because evidence should drive practice and the data
from the practice environment is the ultimate test of the evidence that was
used, models of EBP and PBE often overlap. Leaders need to foster a
shared learning culture where evidence drives practice, and the real world
of the practice se ing provides the ultimate evidence for improving
healthcare. With the increasing interoperability of health IT, a shared
learning culture extends beyond the local department or institution with
the opportunity to create generalizable knowledge to improve care
worldwide. Typical PBE questions are:
• Are treatments used in daily practice associated with intended
outcomes?
• Can we predict adverse events in time to prevent or ameliorate them?
• What treatments work best for which patients?
• With limited financial resources, what are the best interventions to use
for specific types of patients?
• What types of individuals are at risk for certain conditions?
Answers to these questions can help clinicians, patients, researchers,
healthcare administrators, and policy-makers learn from and improve real-
world, everyday clinical practice. An important emerging approach to
knowledge building, including knowledge about the effectiveness of EBP
guidelines, can be obtained from clinical data through the application of
PBE research design techniques.
EHRs and PBE Knowledge Discovery
Increased adoption of EHRs and other health information systems has
resulted in vast amounts of structured and textual data. Stored on servers
in a data warehouse (a large data repository integrating data across
clinical, administrative, and other systems), the data may be a partial or
complete copy of all data collected in the course of care provision. The
data can include billing information, physician and nursing notes,
laboratory results, radiology images, and numerous other diverse types of
data. In some se ings, data describing individual patients and their
characteristics, health issues, treatments, and outcomes have accumulated
for years, forming longitudinal records. The clinical record can also be
linked to repositories of genetic or familial data.50–52 These data constitute
an incredible resource that is underused for scientific research in
biomedicine and nursing.
The potential of using these data stores for the advancement of scientific
knowledge and patient care is widely acknowledged. However, clinical
concepts are typically represented in the EHR in a way that supports
healthcare delivery but not necessarily research. For example, pain might
be qualitatively described in a patient’s note and EHR as “mild” or
“be er.” This may meet the immediate need for documentation and care,
but it does not allow the researcher to measure differences in pain over
time and across patients, as would measurement using a pain scale.
Clinical concepts may not be adequately measured or represented in a way
that enables scientific analysis. Data quality affects the feasibility of
secondary analysis.
Knowledge Building Using Health Information
Technology
PBE studies are observational studies that a empt to mitigate the
weaknesses traditionally associated with observational designs. This is
accomplished by exhaustive a ention to determining patient
characteristics that may confound conclusions about the effectiveness of an
intervention. For example, observational studies might indicate that
aerobic exercise is superior to nonaerobic exercise in preventing falls.
Nevertheless, if the prescribers tend to order nonaerobic exercise for those
who are more debilitated, severity of illness is a confounder and should be
controlled in the analysis.
PBE studies use large samples and diverse sources of patients to
improve sample representativeness, power, and external validity. In
general, there are 800 or more subjects. PBE uses approaches similar to
community-based participatory research by including frontline clinicians
and patients in the design, execution, and analysis of studies, as well as
their data elements, to improve relevance to real-world practice. Finally,
PBE uses detailed standardized structured documentation of
interventions, which is ideally incorporated into the standard electronic
documentation.
This method requires training and quality-control checks for reliability
of the measures of the actual process of care. Statistical analysis involves
correlations among patient characteristics, intervention process steps, and
outcomes. PBE can uncover best practices and combinations of treatments
for specific types of patients while achieving many of the presumed
advantages of randomized controlled trials (RCTs), especially the
presumed advantage that RCTs control for patient differences through
randomization. Frontline clinicians treating the study patients lead the
study design and analyses of the data prospectively based on clinical
experience. The characteristics of PBE are summarized in Table 3.5.
Table 3.5
Characteristics of Practice-Based Evidence
Characteristic Practice-Based Evidence
Description Participatory research approach requiring documentation of predefined processes and outcome
data and analysis
Goal Determine the effectiveness of multiple interventions on multiple outcomes in actual practice
environment
Design Observational (descriptive)
classification
Temporal Prospective
aspects
Typical sample 800-2000 +
size
Practice-based evidence
Practice-Based Evidence Features and
Challenges
PBE is an innovative prospective research design that uses data gathered
from current practice to identify what care processes work in the real
world. EBP is about using evidence to guide practice. PBE is about obtaining
evidence from practice.
PBE studies mitigate the weaknesses usually associated with traditional
observational designs in four main ways:
1. Exhaustive a ention to patient characteristics to address confounds or
alternative explanations of treatment effectiveness.
2. Use of large samples and diverse sources of patients to improve sample
representativeness, power, and external validity.
3. Use of detailed standardized structured documentation of interventions
with training and quality-control checks for reliability of the measures of
the actual process of care.
4. Inclusion of frontline clinicians and patients in the design, execution,
and analysis of studies and their data elements to improve ecological
validity.
PBE studies require comprehensive data acquisition. By using bivariate
and multivariate associations among patient characteristics, process steps,
and outcomes can be identified. At the same time PBE study designs are
structured to minimize the potential for false associations between
treatments and outcomes. These studies focus on minimizing biasing
effects of possible alternative factors or explanations when estimating the
complex associations between treatments and outcomes within a specific
context of care.53 However, the identified associations between treatment
and outcome are not considered causal links. To the extent that the
research design can measure and statistically control for these confounders
or alternative explanations, the associations still inform causal judgments.
In other words, the PBE approach does not infer causality directly like
RCTs, but several sources indicate the strength of the evidence that a
causal link exists. First, alternative hypotheses regarding possible causes
are tested using the large number of available variables to identify
additional potential variables that may be influencing outcomes. Results
can be used to drill down to discover potential alternative causes and to
generate additional specific hypotheses. Analyses continue until the
project team is satisfied that they cannot think of any other variables to
explain the outcomes. Second, one can test the predictive validity of
significant PBE findings by introducing findings into clinical practice and
assessing whether outcomes change when treatments change, as predicted
by PBE models. Third, studies can be repeated in different healthcare
se ings and assessed to determine if the findings remain the same.
Underlying the common criticism of observational studies (that they
demonstrate association but not causation) is an unchallenged assumption
that the evidence for causation is dichotomous; that is, something either is
or is not the cause. Instead, the evidence for causation should be viewed as
a continuum that extends from mere association to undeniable causation.
While observational studies cannot prove causation in some absolute
sense, by chipping away at potential confounders and by testing for
predictive validity in follow-up studies, we move upward on the
continuum from mere association to causation. PBE studies offer a
methodology for moving up this continuum.
Research design involves a balance of internal validity (the validity of
the causal inference that the treatment is the “true” cause of the outcome)
and external validity (the validity that the causal inference can be
generalized to other subjects, forms of the treatment, measures of the
outcome, practitioners, and se ings). Essentially, PBE designs trade away
the internal validity of RCTs for external validity.54 PBE designs have high
external validity (generalizability) because they include virtually all
patients with or at risk for the condition under study, as well as potential
confounders that could alter treatment responses. PBE designs a empt to
minimize threats to internal validity by trying to collect information on all
patient variables—demographic, medical, nursing, functional, and
socioeconomic—that might account for differences in outcome. By doing
so, PBE designs minimize the need for compensating statistical techniques
such as instrumental variables and propensity scoring to mitigate selection
bias effects, unknown sources of variance, and threats to internal validity.
PBE study designs a empt to capture the complexity of the healthcare
process presented by patient and treatment differences in routine care;
PBE studies do not alter or standardize treatment regimens to evaluate the
efficacy of a specific intervention or combination of interventions, as one
usually does in an RCT or other types of experimental designs.55,56 PBE
studies measure multiple concurrent interventions, patient characteristics,
and outcomes. This comprehensive framework provides for consequential
analyses of significant associations between treatment combinations and
outcomes, controlling for patient differences.
Steps in a PBE Study
Table 3.6 outlines the steps involved in conducting a PBE study and gives a
brief description of what each step involves. Once a clinical issue is
identified, PBE methods begin with the formation of a multidisciplinary
team, often with representatives of multiple sites. Participation of
informaticians on the team is critical to ensure that the electronic
documentation facilitates data capture for the research and clinical practice
without undue documentation burden.
Table 3.6
Steps in a Practice-Based Evidence Study
CSI, Comprehensive Severity Index; PCT, project clinical team.
Create a Multisite, Multidisciplinary Project Clinical
Team
One factor that distinguishes PBE studies from most other observational
studies is the extensive involvement of frontline clinicians and patients.
Frontline clinicians and patients are engaged in all aspects of PBE projects;
they identify data elements to be included in the PBE project based on
initial study hypotheses, extensive literature review, and clinical
experience and training, as well as patient experience. Many relevant
details about patients, treatments, and outcomes may be recorded in
existing EHRs; however, the project clinical team (PCT) often identifies
additional critical variables that must be collected in supplemental
standardized documentation developed specifically for the PBE study.
Clinicians and patients also participate in data analyses leading to
publication. Front-to-back clinician and patient participation fosters high
levels of clinician and patient buy-in that contribute to data completeness
and clinical ownership of study findings, even when findings challenge
conventional wisdom and practice. Such ownership is essential to
knowledge translation and best practice.
Control for Differences in Patient Severity of Illness
Controls for Patient Factors
PBE designs require recording the treatment that each subject receives as
determined by clinicians in practice rather than randomizing subjects to
neutralize the effect of patient differences. PBE studies address patient
differences by measuring a wide variety of patient characteristics that go
beyond race, gender, age, payer, and other variables that can be exported
from administrative, registry, or EHR databases, and then accounting for
patient differences through statistical control.
The goal is to measure all variables contributing to outcomes to have the
information needed to control for patient differences. This is the major
reason for including frontline clinicians and patients in PBE study design
and implementation. There always remains the possibility that some
patient characteristic may be overlooked, but PBE’s exhaustive patient
characterization minimizes significantly the chances of not being able to
resolve unknown sources of variance because of patient differences.
One critical component of the PBE study design is the use of tools for
measuring the degree of illness such as the Comprehensive Severity Index
(CSI).53,57-66 In PBE studies, the CSI can be used to measure how ill a patient
is at the time of presentation for care, as well as over time. Degree of illness
is defined as extent of deviation from “normal values.” CSI is
“physiologically-based, age- and disease-specific, independent of
treatments, and provides an objective, consistent method to define patient
severity of illness levels based on over 2,200 signs, symptoms, and physical
findings related to a patient’s disease(s), not just diagnostic information,
such as ICD-9-CM coding alone.”67, p. S132 The validity of CSI has been
studied for over 30 years in various clinical se ings and conditions such as
inpatient adult and pediatric conditions, ambulatory care, rehabilitation
care, hospice care, and long-term care se ings.58,65 Patient diagnosis codes
and data management rules are used to calculate severity scores for each
patient overall and separately for each of a patient's diseases (principal
and each secondary diagnosis).
CSI and other measures of patient key characteristics, such as level and
completeness of spinal cord injury, severity of stroke disability, or severity
of traumatic brain injury, control for patient differences. Using these
patient differences can help to account for treatment selection bias or
confounding by indication in analyses.
Controls for Treatment and Process Factors
Treatment in clinical se ings is often determined by facility standards,
regional differences, and clinician training. Therefore, like patient
differences, treatment differences must be recorded during a PBE study.
The goal is to find measurable factors that describe each treatment to be
compared. Examples include the medications dispensed and their dosage;
rehabilitation therapies performed and duration on each day of treatment;
content, mode, and amount of patient education; and nutritional
consumption.
PBE identifies be er practices by examining how different approaches to
care are associated with outcomes of care, while controlling for patient
variables. PBE does not require providers to follow treatment protocols or
exclude certain treatment practices. However, characteristics of treatment,
including timing and dose, require detailed documentation. These
characteristics must be defined by the PBE team and measured in a
structured, standard manner for all participating sites and their clinicians.
Consistency is critical for minimizing variation in data collection and
documentation.67
The level of detail found in routine documentation of interventions may
be insufficient. Each PBE team must assess the level of detail afforded by
routine documentation and determine whether supplemental
documentation is necessary.67 Further, point-of-care documentation or
EHR data are pilot tested to ensure complete representation of variables.
Pilot testing ensures that point-of-care documentation or EHR data
collection captures all elements that clinicians suggest may affect the
outcomes of their patients. If a variable is not measured, it cannot be used in
subsequent analyses.
Controls for Outcome Factors
Multiple outcomes can be addressed in a single PBE project; projects are
not limited to one primary outcome, as is the case in other study designs.
In particular, PBE studies incorporate widely accepted, standard
measures. For example, the Braden Scale for Risk of Pressure Ulcer
Development is commonly collected in PBE studies, and it has been used
as both a control and an outcome variable.65-67 Although PBE projects
incorporate as many standard measures as possible, they also include
outcome measures specific to the study topic. Additional patient outcomes
commonly assessed in PBE studies are condition-specific complications,
condition-specific long-term medical outcomes (based on clinician
assessment or patient self-report), condition-specific patient-centered
measures of activities and participation in society, patient satisfaction,
quality of life, and cost.68
Some outcomes (e.g., discharge destination [home, community, and
institution], length of stay, or death) are commonly available in
administrative databases. Other outcome variables (e.g., repeat stroke,
deep vein thrombosis, pain, electrolyte imbalance, and anemia) are found
in traditional paper charts or EHR documentation but typically are
available only up to discharge from the care se ing.
Implement Intensive Data Collection and Check
Reliability
Using the data elements identified in step 2, historical data are collected
from the EHR. Direct care providers document the specific elements of
treatment at point of care. For example, if the treatment includes physical
therapy, the type, intensity, and duration are precisely recorded during
each therapy session. If the healthcare provider offers patient counseling
or education, the teaching methods, instructional materials, topical
content, and duration of each teaching session are recorded. The
informatics specialist is a critical partner in designing the data capture to
prevent the need for parallel documentation. If the documentation is too
burdensome, clinicians will not comply with documentation requirements
and the data will be incomplete. Therefore the design of the data collection
is critical to the success of this research approach. The fact that these data
collection formats are defined by the frontline clinicians helps to ensure
that the data collection formats are specifically designed so that data can
be documented easily and quickly.
Create a Study Database
The elements of data collected are compiled into a study-specific database
with the assistance of informatics personnel. Data sources include existing
or new clinician documentation of care delivered. Patients drop out of a
PBE study if they leave the care se ing before completion of treatment or
drop out during follow-up.68 Patients who withdraw from a treatment do
not distort results of PBE study findings because PBE studies follow
patients throughout the care process, taking date and time measurements
on all therapies. Hence, if a patient withdraws from care of the study,
investigators can use the existing data in the analyses, controlling for time
in the study. PBE studies have a huge advantage because of their large
sample size, number of information points, and more complete
comparison of subjects who complete therapy and subjects who withdraw.
Successively Test Hypotheses
PBE studies use multivariable analyses to identify variables most strongly
associated with outcomes. Detailed characterization of patients and
treatments allows researchers to specify direct effects, indirect effects, and
interactions that might not otherwise become apparent with less detailed
data. CSI (overall, individual components, or individual severity
indicators) can be used in data analysis to represent the role of comorbid
and co-occurring conditions along with the principal diagnosis. If a
positive outcome is found to be associated with a specific treatment or
combination of treatments, the subsequent methodological approach is to
include confounding patient variables or combinations of variables in the
analysis in an a empt to “disconfirm” the association. The association may
remain robust or variables may be identified that explain the outcome
more adequately.
In PBE studies, data include many clinical and therapeutic variables,
and a selection procedure is applied to decide on significant variables to
retain in regressions. Only variables suggested by the team based on the
literature and team members’ education and clinical experience and with
frequencies equal to or greater than 10 to 20 patients in the sample are
usually allowed.
Analyses conducted using PBE databases are iterative. Counterintuitive
findings are investigated thoroughly. In fact, counterintuitive and
unexpected findings often lead to new discoveries of important
associations of treatments with outcomes.
Large numbers of patients (usually > 1000 and often > 2000) and
considerable computing power are required to perform PBE analyses.
When multiple outcomes are of interest and there is li le information on
effect size of each predictor variable, sample size is based on the project
team’s desire to find small, medium, or large effects of patient and process
variables.
Validate and Implement Findings
See the exemplar in Box 3.10 showing how a PBE study of stroke
rehabilitation culminated in validation studies and changes in the
standard of care in a healthcare system. Because PBE studies are
observational, the conclusions require prospective validation before they
can be incorporated into clinical guidelines and standards of care.
Validation of PBE findings can use a continuous quality improvement
approach consisting of systematic implementation of the interventions
found to be be er in conjunction with monitoring of their outcomes. If the
findings from the outcome assessment replicate the findings of the initial
retrospective stage in multiple se ings and populations, the intervention
would be a candidate for incorporation into clinical guidelines as a care
process that has established efficacy and effectiveness. This is in contrast to
interventions that only have RCT evidence, which generally indicates only
efficacy.
Box 3.10
Practice-Based Evidence Exemplar: Stroke
Rehabilitation
An integrated healthcare system determined that outcomes were highly
variable for patients following a stroke. Rehabilitation professionals in the
geographic region were polled to determine the local standards of care,
and the interventions were quite diverse. A regional task force was
convened representing 8 hospitals from 2 care-delivery systems, as well as
an independent hospital. The task force was led by a rehabilitation nurse
and a physical therapist. A PBE study was initiated to determine what
combinations of medical devices, therapies (e.g., physical therapy,
occupational therapy, and speech therapy), medications, feeding, and
nutritional approaches worked best for various subtypes of stroke
patients in real-world practices. A multidisciplinary project clinical team
was convened of physicians, nurses, social workers, psychologists,
physical therapists, occupational therapists, recreational therapists, and
speech-language therapists. Poststroke patients and caregivers were also
invited to participate.
The first decisions of the group addressed the outcome variables,
including the Functional Independence Measure (FIM) scale score, length
of stay in rehabilitation, discharge disposition, mortality, and morbidity
(contracture, deep vein thrombosis, major bleeding, pulmonary embolism,
pressure ulcer, and pneumonia). Each profession identified possible
interventions and developed documentation for the components of the
intervention and the intensity (e.g., number of repetitions for each exercise
maneuver and time required). Documentation was incorporated into the
standard EHR documentation. Over a 2-year period, 1461 patients were
studied ranging from 18.4 to 95.6 years of age. Collected patient-related
data included age, gender, race, payer, stroke risk factors, and FIM scores.
Detailed process and outcome data were collected. Severity of illness was
determined using the CSI scale. There were significant differences in the
average severity of illness at the 8 sites. There was also heterogeneity in
the intensity of therapies, use of tube feedings, and use of psychotropic
and opioid medication. Following control for severity of illness, univariate
and multivariate analysis of the data determined that factors were
positively and negatively associated with the FIM scores at discharge.
After additional studies to replicate findings, the participating hospitals
initiated the following policy changes in the treatment of stroke patients.
Several of these are novel interventions that would not have been
identified without the PBE study method. Continuous quality
improvement monitoring was implemented to document adherence and
outcomes:
• Early rehabilitation admission: patients are admi ed to rehabilitation as
soon as possible, and therapies begin in the intensive care unit if
possible
• Early gait training by physical therapy: patients are put in a harness on a
treadmill for safety, but gait training is initiated as soon as possible,
even in the most affected patients
• Early feeding: if patients are not able to eat a full diet, early enteral
feedings (nutritional supplements, tube feeding) are initiated
• Opioids for pain: opioids are ordered at admission for any time the patient
misses therapy because of pain
Source: Horn SD, DeJong G, Smout RJ, Gassaway J, James R, Conroy B. Stroke rehabilitation
patients, practice, and outcomes: is earlier and more aggressive therapy be er? Arch Phys Med
Rehab. 2005;86(12 suppl 2):S101-S114.
Limitations and Strengths of Practice-Based
Evidence Studies
PBE methods work best in situations where one wishes to study existing
clinical practice. However, there are no limitations related to conditions or
se ings for use of PBE study methods. Of course, the technique can be
time consuming in terms of conducting the initial PBE steps, as well as
data extraction. Although the relevant variables may change, PBE study
designs have been found to work in various practice se ings, including
acute and ambulatory care, inpatient and outpatient rehabilitation,
hospice, and long-term care, and for adult and pediatric patients.
Informatics and practice-based evidence
As more healthcare systems move toward EHRs, data elements needed for
PBE, and especially for CSI, can be captured in structured, exportable
formats, while also being used for clinical documentation of care. This
concept is implemented already in health systems in Israel and in various
PBE studies in the United States.69 However, transitioning to EHRs
presents its own challenges, especially for data-intensive PBE studies.
EHRs can facilitate data acquisition, but they are not always research-
friendly because many desired data elements are in text, such as clinical
notes, and cannot be exported easily. If EHR data cannot be exported
directly, they must be abstracted manually or alternatively, processed
using Natural Language Processing (NLP) methods.70 Whereas manual
abstraction from EHR can be more labor intensive than abstracting paper
charts are, when relying on NLP methods, a bulk of the effort is spent on
training the computer algorithms to extract the needed data elements. In
addition, EHR modifications for optimization of point-of-care data
documentation and abstraction are costly and time consuming, potentially
slowing down planning and implementation of PBE studies based on
routine electronic data capture. With HITECH, EHRs have become
pervasive in clinical practice.71 Over time, new EHR exporting and
reporting software are emerging and making EHR data abstraction less
labor intensive.
Examination of CSI elements themselves may show a reduced set that
differentiates severity, as well as the full set. It is possible that two valid
data elements would each contribute clinically unique information but be
fully redundant with respect to their ability to differentiate severity in a
population. For example, unresponsive neurological status and fever ≥ 104
degrees are clinically unique indicators of severity in pneumonia. If these
indicators differentiate only the same most gravely ill pneumonia patients
from the rest of the population, they provide redundant information with
respect to the severity of pneumonia. In this case, it may be possible to use
only one of the two indicators in CSI scoring, reducing the information
burden to compute a CSI score and increasing efficiency.
PBE requires a multidisciplinary team approach for comparative
effectiveness research and ensures inclusion of a wide spectrum of
variables so that differences in patient characteristics and treatments are
measured and controlled statistically.67
The next step for comparative effectiveness research is to conduct more
rigorous, prospective large-scale observational cohort studies. National
efforts such as the Patient-Centered Outcomes Research Institute’s
(PCORI) Clinical Data Research Networks (CDRN) can enable
comparative effectiveness research and PBE by providing informatics
solutions for sharing data across multiple institutions.72 From a PBE
perspective, rigor entails controlled measurement of outcomes related to
multiple intervention combinations and a variety of patient characteristics
in diverse clinical se ings.67 PBE studies address questions in the real
world where multiple variables and factors can affect the outcomes; they
can fit seamlessly into everyday clinical documentation and, therefore,
have the potential to influence and improve the evidence in EBP in real-
world clinical environment of patient care.
Conclusion and future directions
Healthcare continues to be a dangerous experience for many patients.
Moreover, many healthcare providers and other healthcare decision
makers continue to underuse interventions demonstrated to be effective at
improving health outcomes.6,73 The problem is not uncaring disinterested
providers, but a lack of organizational infrastructure and information
systems designed to support the implementation of EBP and PBE. Green is
well recognized for asking the question “If it is an EBP, where’s the
practice-based evidence?” 74 Going forward, only by creating well-
designed healthcare information systems that present the evidence needed
for providers to make best-practice decisions at the point of care, and then
capturing the patient-care data by which the effectiveness of those decision
can be measured, will we have information systems that truly support
high-quality cost-effective care.
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49 Bakken S., Stone P.W., Larson E.L. A nursing informatics research
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50 Duvall S.L., Fraser A.M., Rowe K., Thomas A., Mineau G.P.
Evaluation of record linkage between a large healthcare provider
and the Utah Population Database. J Am Med Inform Assoc.
2012;19(e1):e54–e59.
51 Sla ery M.L., Kerber R.A. A comprehensive evaluation of family
history and breast cancer risk: the Utah Population Database. J Am
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52 Hu H., Correll M., Kvecher L., et al. DW4TR: a data warehouse for
translational research. J Biomed Inform. 2011;44(6):1004–1019.
53 Horn S.D., DeJong G., Ryser D.K., Veazie P.J., Teraoka J. Another
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57 Horn S.D., Sharkey P.D., Kelly H.W., Uden D.L. Newness of drugs
and use of HMO services by asthma patients. Ann Pharmacother.
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58 Averill R.F., McGuire T.E., Manning B.E., et al. A study of the
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59 Clemmer T.P., Spuhler V.J., Oniki T.A., Horn S.D. Results of a
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60 Horn S.D., Torres Jr. A., Willson D., Dean J.M., Gassaway J., Smout
R. Development of a pediatric age- and disease-specific severity
measure. J Pediatr. 2002;141:496–503.
61 Willson D.F., Horn S.D., Smout R., Gassaway J., Torres A. Severity
assessment in children hospitalized with bronchiolitis using the
pediatric component of the Comprehensive Severity Index. Pediatr
Crit Care Med. 2000;1:127–132.
62 Ryser D.K., Egger M.J., Horn S.D., Handrahan D., Gandhi P., Bigler
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Horn R.A. The relationship between severity of illness and
hospital length of stay and mortality. Med Care. 1991;29:305–317.
64 Gassaway J.V., Horn S.D., DeJong G., Smout R.J., Clark C. Applying
the clinical practice improvement approach to stroke
rehabilitation: methods used and baseline results. Arch Phys Med
Rehabil. 2005;86(12 suppl 2):S16–S33.
65 Carter M.J., Fife C.E., Walker D., Thomson B. Estimating the
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individuals excluded from a typical wound-care population in
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treatment processes, patient characteristics, and outcomes in
outpatient physical therapy practice. Arch Phys Med Rehabil.
2009;90(8):1349–1363.
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Discussion questions
1. Review the three categories of EBP models and discuss how these
models might be used to guide the development of EBP.
2. Discuss why computerization is required if EBP is to become reality in
clinical se ings.
3. How can the design of a healthcare information system support or
thwart the use of EBP guidelines at the point of care? Give examples
from your own experience if possible.
4. Explore the AHRQ Health Care Innovations Exchange at
[Link]/[Link]. Discuss how automation and
informatics-based tools could be used to bring resources from this site to
the point of care.
5. Analyze the following statement and determine whether you do or do
not support it: “With the development of a fully integrated national
health information system, big data reflecting patient outcomes will
replace the role of research studies in developing EBP guidelines.”
6. Why is the informatician a critical member of the PBE team? What
essential skills should this team member have?
7. You are a member of a PBE team that will study the prevention and
management of ventilator-associated pneumonia. Describe how you
would apply the steps of PBE to this problem.
EBP case study
You are consulting with the education and practice development team in a
large tertiary care hospital serving a region comprising mostly rural
communities. The team is responsible for strengthening the
implementation of EBP based on outcomes. Over the next 2 years, it must
set performance objectives to (1) strengthen screening for pain, depression,
and adverse health behaviors (smoking, excess alcohol intake, and body
mass index [BMI] greater than 30) at intake for all adult admissions; (2)
implement comprehensive geriatric assessment for all those over age 65
hospitalized for more than 7 days or readmi ed within less than 3 days
following discharge; and (3) promote care-team performance.
The hospital has 200 adult admissions each week and has implemented
an electronic health record. Guideline dissemination generally occurs
through educational venues or via the electronic policy and procedure
manual. The method of documentation for narrative notes is
documentation by exception using subjective, objective, assessment, and
plan (SOAP) and the hospital has made extensive use of checklists to
complement the documentation system.
Discussion Questions
1. Using clinical guidelines and standards of care, identify what data
elements should be included in the EHR assessment and evaluation
screens if these goals are to be achieved.
2. Identify how information system defaults and alerts could be used to
achieve these goals.
3. Once screening has been improved, what are the next steps in
improving patient outcomes?
4. How could the electronic health record be designed to support these
outcome-related goals?
PBE Case study
Pressure Ulcer Case Study*
A PBE study involving 95 long-term care facilities in the United States
determined that nursing interventions for pressure ulcer (PrU) prevention
and management were highly variable among facilities and that nearly
30% of patients at risk for developing a PrU developed an ulcer during the
12-week study. Characteristics and interventions associated with higher
and lower likelihood of PrU development are summarized in the
following table.
Research findings were used to develop PrU prevention protocols that
included standardized documentation of important data elements and
CDS tools. Four long-term care facilities that participated in the study and
shared a common EHR (all members of the same provider network) took
the first step in changing practice by sharing study findings with clinical
staff, who spend the most one-on-one treatment time with nursing home
residents and thus are often the first members of the care team to observe
changes in residents’ nutritional intake, urinary incontinence, and mood
state. Concurrently, local study leaders worked with their software vendor
to incorporate standard documentation for nurses and the CDS tools for
staff.
Negative Association With Likelihood of Developing a
Pressure Ulcer (Less Likely)
Patient Factors
Patient new to long-term care
Treatment Factors
Use of disposable briefs for urinary incontinence for > 14 days
Nutrition
Use of oral medical nutritional supplements for > 21 days
Tube feeding for > 21 days
IV fluid supplementation
Medications
Antidepressant medication
Facility Staffing Patterns
RN hours ≥ 0.5 h/resident/day
CNA hours ≥ 2.25 h/resident/day
LPN turnover rate < 25%
Positive Association With Likelihood of Developing a
Pressure Ulcer (More Likely)
Patient Factors
Higher admission severity of illness
History of PrU in previous 90 days
Significant weight loss
Oral eating problems
Treatment Factors
Use of urinary catheter
Use of positioning devices
Discussion Questions
1. What are the steps of the PBE process related to this case study?
2. As the health professional or informatics specialist working with the
clinical team in the four long-term care facilities, identify the
following:
a. Elements to incorporate into the documentation that address factors
identified in the original study.
b. CDS tools that could be incorporated into computer systems.
3. How can the cost effectiveness of the new documentation
requirements and standards of care be efficiently evaluated?
CNA, Clinical nursing assistant; CDS, clinical decision support; IV,
Intravenous; LPN, licensed practical nurse; PBE, practice-based evidence;
PrU, pressure ulcer; RN, registered nurse.
*This case study is fictional; factors are consistent with findings reported in Sharkey S,
Hudak S, Horn SD, Spector W. Leveraging certified nursing assistant documentation and
knowledge to improve clinical decision making: the on-time quality improvement
program to prevent pressure ulcers. Adv Skin Wound Care. 2011;24(4):182-188.
*Effective July 1, 2015, the National Academy of Science, Engineering, and Medicine
voted to change the name of the Institute of Medicine to the National Academy of
Medicine. In March 2016 the National Academy of Sciences announced that the division
of the National Academies of Sciences, Engineering, and Medicine (the Academies) that
focuses on health and medicine was renamed the Health and Medicine Division (HMD)
instead of using the name Institute of Medicine (IOM). In this textbook you may see any
of these three names used depending on the date of the publication or report.
4
Models, Theories, and Research for
Program Evaluation
Charlene R. Weir
Abstract
Evaluation is an essential component in the life cycle of all health information
technology (health IT) applications and a key to successful translation of these
applications into clinical se ings. In planning an evaluation, the central questions
must be asked regarding purpose, scope, and focus of the system. This chapter
focuses on the larger principles of program evaluation with the goal of informing
health IT evaluations in clinical se ings. The reader is expected to gain sufficient
background in health IT evaluation to lead or participate in program evaluation for
applications or systems.
Formative evaluation and summative evaluation are discussed. Three levels of theory
are presented, including scientific theory, implementation models, and program
theory (logic models). Specific scientific theories include social cognitive theories,
diffusion of innovation, cognitive engineering theories, and information theory. Six
implementation models are reviewed: Predisposing, Reinforcing, and Enabling
Constructs in Educational Diagnosis and Evaluation-Policy, Regulatory, and
Organizational Constructs in Educational and Environmental Development
(PRECEDE-PROCEED); Promoting Action on Research Implementation in Health
Services (PARiHS); Reach Effectiveness Adoption Implementation Maintenance (RE-
AIM); Consolidated Framework for Implementation Research (CFIR); Sociotechnical
Model; and quality improvement. Program theory models are discussed with an
emphasis on logic models.
A review of methods and tools is presented. Relevant research designs are discussed
for health IT evaluations, including time series, multiple baseline, and regression
discontinuity. Methods of data collection specific to health IT evaluations, including
ethnographic observation, interviews, and surveys, are then reviewed.
Evaluation of health information technology (health IT) programs and
projects can range from simple user satisfaction for a new menu or full-
scale analysis of usage, cost, compliance, patient outcomes, and
observation of usage to data about patient's rate of improvement.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Identify the main components of program evaluation.
2. Discuss the differences between formative and summative evaluation.
3. Apply the three levels of theory relevant to program evaluation.
4. Discriminate program evaluation from program planning and
research.
5. Synthesize the core components of program evaluation with the
unique characteristics of informatics interventions.
KEY TERMS
evaluation 60
formative evaluation 61
logic model 67
program evaluation 60
summative evaluation 61
Introduction
The outcome of program or project evaluation is information that is both
useful at the program level and generalizable enough to contribute to the
building of science. In the applied sciences, such as informatics, evaluation
is critical to the growth of both the specialty and the science. In this
chapter program evaluation is defined as the “systematic collection of
information about the activities, characteristics, and results of programs to
make judgments about the program, improve or further develop program
effectiveness, inform decisions about future programming, and/or increase
understanding.”1 Health information technology (health IT) interventions
are nearly always embedded in the larger processes of care delivery and
are unique for three reasons. First, stakeholders’ knowledge about the
capabilities of health IT systems may be limited at the beginning of a
project. Second, the health IT product often changes substantially during
the implementation process. Third, true implementation often takes 6
months or longer, with users maturing in knowledge, skills, and external
influences, such as new regulations or organizational initiatives, occurring
over that period. Identification of the unique contribution of the health IT
application, therefore, is often difficult and evaluation goals frequently go
beyond the health IT component alone. In this chapter the health IT
component of evaluation is integrated with overall program evaluation;
unique issues are highlighted for evaluating health IT itself.2 The chapter is
organized into three sections: (1) purposes of evaluation, (2) theories and
frameworks, and (3) methods, tools, and techniques.
Purposes of evaluation
The purpose of evaluation determines the methods, approaches, tools, and
dissemination practices for the entire project being evaluated. Therefore
identifying the purpose is a crucial first step. Mark, Henry, and Julnes
provided four main evaluation purposes as listed in Box 4.1.
Box 4.1
Main Purposes of Program Evaluation
• Program and organizational improvement
• Assessment of merit or worth
• Knowledge development
• Oversight and compliance
Adapted from Mark M, Henry G, Julnes G. Evaluation: An Integrative Framework for Understanding,
Guiding and Improving Policies and Programs. San Francisco, CA: Jossey-Bass; 2000.
Usually an evaluation project is not restricted to just one of these
purposes. Teasing out which purposes are more important is a process for
the evaluator and the involved stakeholders. The following sections
represent a series of questions that can clarify the process.
Formative Versus Summative Evaluation
Will the results of the evaluation be used to determine whether the goals of the
program have been met? This question refers to a common classification of
evaluation activities that fall into two types: (1) formative evaluation and
(2) summative evaluation. The difference is in how the information is used.
The results of the formative evaluation are used as feedback to the
program for continuous improvement.3,4 The results of the summative
evaluation are used to evaluate the merit of the program. Formative
evaluation is a term coined by Scriven in 1967 and expanded on by a
number of other authors to mean an assessment of how well the program
is being implemented and to describe the early experiences of
participants.5 Topics for formative evaluation include the fidelity of the
intervention, the quality of implementation, the characteristics of the
organizational context, the resources involved, the usability of a particular
design, and the types of personnel. Needs assessments and feasibility
analyses are also included in this general category. Box 4.2 outlines several
questions that fall into the category of formative evaluation for health IT.
Box 4.2
Questions to Pose During Formative Evaluation
• What is the nature and scope of the problem that is being addressed by
health information technology?
• What is the extent and seriousness of the need?
• How well is the technology working, and what is the best way to deliver
it?
• How are participants (and users) experiencing the program?
• How did the intervention change after implementation?
In contrast, summative evaluation refers to an assessment of the
outcomes and impact of the program. Effectiveness, direct outcomes, and
adverse events analyses are the types of measures included in this
category. Some questions that fall into the summative evaluation category
are listed in Box 4.3.
Box 4.3
Questions to Pose During Summative
Evaluation
• To what degree were the outcomes affected by the product?
• What is the cost effectiveness of the product?
• What were the unintended consequences of the product?
Dividing the evaluation process into the formative and summative
components is somewhat arbitrary because they can be, and often are,
conducted concurrently. They do not necessarily differ in terms of
methods or even in terms of the content of the information collected.
Formative evaluation is especially important for health IT products where
the overall goal is improvement. Because health IT products are
“disruptive technologies,” they both transform the working environment
and are themselves transformed during the process of implementation.6
Many writers in the informatics field have noted the paucity of
information on implementation processes in published studies. In a meta-
analysis of health IT by researchers at RAND, the authors noted:
In summary, we identified no study or collection of studies, outside of those
from a handful of health IT leaders that would allow a reader to make a
determination about the generalizable knowledge of the system’s reported
benefit. This limitation in generalizable knowledge is not simply a matter of
study design and internal validity. Even if further randomized, controlled
trials are performed, the generalizability of the evidence would remain low
unless additional systematic, comprehensive, and relevant descriptions
and measurements are made regarding how the technology is utilized, the
individuals using it, and the environment it is used in.7, p. 4
Although wri en in 2006, this statement is still relevant today.
Generalizability and Scope
Will the results of the evaluation be used to inform stakeholders of whether a
particular program is “working?” This question refers to issues of the
generalizability and scope of the project. It is also a question of whether
the evaluation is more of a program evaluation or a research study as the
criteria regarding “working” varies by this approach. An evaluation of a
locally developed project usually would be considered a program
evaluation. In contrast, if the program was designed to test a hypothesis or
research question and described, measured, or manipulated variables that
could be generalized to a larger population, then the results of the
evaluation study are more like research. However, both approaches use
systematic tools and methods. For example, if the program to be evaluated
is a local implementation of alerts and decision support for providers at
the point of care to evaluate skin breakdown, then the stakeholders are the
administrators, nurses, and patients who are affected by use of the
decision support program. The evaluation questions would address the
use of the program, the impact on resources, satisfaction, and perhaps
clinical outcomes. The evaluation would likely use a before-and-after
design and a more informal approach to assess whether the decision
support “worked.” However, if the evaluation question is whether or not
computerized guidelines affect behavior in general and under what
conditions, then the specific stakeholders ma er less and the ability to
generalize beyond the contextual situation ma ers more. A more formal,
research-based approach is then used. This question is really about what is
to be learned. Vygotsky called these two approaches “pa erning” versus
“puzzling.”8 In the pa erning approach, the comparison is between what
went before at the local level and in the new program, whereas in the
puzzling approach, the task is to understand why the two options work
and to puzzle through the differences.
Another way to address this issue is to imagine that evaluation activities
fall along a continuum from “program evaluation” to “evaluation
research.” Program evaluation tends to have a wide scope, using multiple
methods with a diverse range of outcomes. Evaluation research tends to be
more targeted, using more selected methods and fewer outcomes. On the
program-evaluation end of the continuum, evaluation can encompass a
range of activities including but not limited to needs assessment, program
model development, tracking and performance monitoring, and
continuous quality improvement. On the research end of the continuum,
activities include theory testing, statistical evaluation of models, and
hypothesis testing. However, at both ends of the continuum and in
between, evaluators can use a variety of research designs, rigorous
measurement methods, and statistical analyses.
Program Continuance Versus Growth
Will the results of the evaluation be used to make a decision about continuing the
program as is or about expanding it to a larger or different se ing if it has
generalizable knowledge? Answering the question of whether a program will
be continued requires a focus on the concerns and goals of stakeholders, as
well as special a ention to the contextual issues of cost, burden, user
satisfaction, adoption, and effectiveness. Answering this question also
requires an assessment about the manner in which the program was
implemented and its feasibility in terms of resources and efforts. Does the
program require ongoing and intense training of staff and technicians?
Does it require unique hardware requirements that are a one-time or
ongoing cost? Does the program have “legs” (i.e., can it exist on its own
once implemented)? Are the benefits accrued available immediately or is it
a long-term process?
One specific example to determine whether the program should be
continued is to assess whether or not it contributes to the institution being
a “learning organization.”9,10 This approach focuses on performance
improvement and the following four areas of concern (modified for health
IT):
1. What are the mental models and implicit theories held by the different
stakeholders about the health IT product?
2. How does the health IT product promote mastery or personal control
over the work environment?
3. What is the system-level impact of the health IT product? How does the
intervention support a system thinking approach?
4. How does the health IT product create a unified vision of the
information environment?
Addressing these questions requires understanding of how individuals
view the future computerized environment and whether or not they have
come to a shared system-level vision.
Theories and frameworks
The use of theory in evaluation studies is controversial among evaluators,
as well as in the informatics community. On the one hand, some authors
note that evaluation studies are local, limited in scope, and not intended to
be generalizable. On the other hand, other authors argue that theory is
necessary to frame the issues adequately, promote generalizable
knowledge, and clarify measurement. This author argues that theory
should be used for the la er reason. Theoretical perspectives clarify the
constructs and methods of measuring constructs and bring forward an
understanding of the mechanisms of action.
For the purposes of this chapter, theoretical perspectives will be divided
into three levels of complexity. At the most complex level are the social
science, cognitive engineering, and information science theories. These theories
are well established, have a strong evidence base, use validated measures,
and have well-understood mechanisms of action. This chapter discusses
some well-known social science theories, as well as two health IT–specific
adaptations of these theories that have had significant validation. At the
next level are the program implementation models, which are less complex
and consist of a conceptual model. The models are often used to describe
processes, but few studies a empt to validate the models or test models
against each other. Finally, at the most basic level are the program theory
models, which are program specific and intended to represent the goals and
content of a specific project. All evaluations for health IT products should
develop a program theory model to guide the evaluation process itself.
The descriptions below are brief and are intended to provide an overview
of the possibilities at each level.
Social Science Theories
There are myriad theories relevant to both the design of interventions and
products and the structure of an evaluation. A short description is
provided here for the purpose of context. These social science theories
include social cognitive theories, diffusion of innovation theory, cognitive
engineering theories, and information theories.
Social Cognitive Theories
The social cognitive theories include the theory of planned behavior11; its
close relative, the theory of reasoned action12; and social cognitive theory.13
These theories predict intentions and behavior as functions of beliefs about
the value of an outcome, the likelihood that the outcome will occur given
the behavior, and the expectations of others and self-efficacy beliefs about
the personal ability to engage in the activity. The empirical validation of
these theories is substantial, and they have been used to predict intentions
and behavior across a wide variety of se ings.
Diffusion of Innovations Theory
Another very commonly used model in informatics is diffusion of
innovations theory by Rogers.14,15 In this model, characteristics of the
innovation, the type of communication channels, the duration, and the
social system are predictors of the rate of diffusion. The central premise is
that diffusion is the process by which an innovation is communicated
through certain channels over time among the members of a social system
organization. Individuals pass through five stages: knowledge, persuasion,
decision, implementation, and confirmation. Social norms, roles, and the
type of communication channels all affect the rate of adoption of an
innovation. Characteristics of an innovation that affect the rate of adoption
include relative advantage as compared with other options; trialability, or
the ease with which it can be tested; compatibility with other work areas;
complexity of the innovation; and observability, or the ease with which the
innovation is visible.
Cognitive Engineering Theories
The cognitive engineering theories are also widely used in informatics,
particularly naturalistic decision making (NDM),16-18 control theory,19 and
situation awareness (SA).20 These theories focus more on the interaction
between the context and the individual and are more likely to predict
decision making, perception, and other cognitive variables. NDM is a
broad and inclusive paradigm. SA is narrower and is particularly useful in
supporting health IT design.
SA combines the cognitive processes of orientation, a ention,
categorization or sense making, and planning into three levels of
performance. These activities are thought to be critical to human
performance in complex environments. Endsley refers to a three-level
system of awareness: (1) perception, (2) comprehension, and (3) projection.
She defines shared SA as the group understanding of the situation.20 For
example, in one study of health IT, higher SA was significantly associated
with integrated displays for intensive care unit (ICU) nursing staff.21,22
Table 4.1 presents the core components of SA and associated definitions.
Table 4.1
Levels of Situational Awareness
Level Description
Perception of the What is present, active, salient, and important in the environment? A ention will be
elements in the driven by task needs.
environment
Comprehension of the Classification of the event is a function of activation of long-term memory. The
current situation cognitive processes of classification and task identification drive meaning.
Projection of future status Expectations of outcomes in the future, are driven by implicit theories and knowledge
about the causal mechanisms underlying events.
Information Theory
One of the most influential theories is Information Theory, published in
1948 by Claude Shannon.23 Shannon focused on the mathematical aspects
of the theory. Weaver, an oncologist, focused on the semantic meaning of
the theory.24 Information theory identifies the degree of uncertainty in
messages as a function of the capacity of the system to transmit those
messages given a certain amount of noise and entropy. The transmission
of information is broken down into source, sender, channel, receiver, and
destination. Because information theory is essentially a theory of
communication, information is defined relative to three levels of analysis:
1. At the technical or statistical level, information is defined as a measure of
entropy or uncertainty in the situation. The question at this level is: How
accurately are the symbols used in the communication being transmi ed?
2. At the semantic level, information is defined as a reduction of uncertainty
at the level of human meaning. The question here is: How well do the
symbols that were transmi ed convey the correct meaning?
3. At the effectiveness level, information is defined as a change in the goal
state of the system. The question here is: How well does the perceived
meaning effect the desired outcome?25
This simple framework can provide an effective evaluation model for
any system that evaluates the flow of information. For example, Weir and
McCarthy used information theory to develop implementation indicators
for a computerized provider order entry (CPOE) intervention.26
Information Foraging Theory
Information foraging theory is a relatively new theory of information
searching that is very useful for analyzing web searching.27 Information
foraging theory is built on foraging theory, which studies how animals
search for food. Pirolli and Card noticed similar pa erns in the processes
used by animals to search for food and the processes used by humans to
search for information on the internet. The basic assumption is that all
information searches are goal directed and constitute a calibration between
the energy cost of searching and the estimated value of information
retrieved. The four concepts listed in Box 4.4 are important to measure.
Empirical work on foraging theory has validated its core concepts.28
Box 4.4
Four Concepts of Foraging Theory
1. Information and its perceived value
2. Information patches or the temporal and spatial location of information
clusters
3. Information scent or the presence of cues value and location of
information
4. Information diet or the decision to pursue one source over another
Information Technology Theories
Two well-developed information technology theories are specifically used
in the IT domain. As is true of many IT theories, they are compiled from
several existing theories derived the basic sciences to improve their fit in
an applied se ing.
Information System Success
Information System Success is an IT model that integrates several formal
theories is DeLone and McLean’s multifactorial model of IT success
developed with the goal of improving scientific generalization.29 Their
theory was originally developed in 1992 and revised in 2003 based on
significant empirical support. The model is based on Shannon and
Weaver’s communication theory24 and Mason’s information “influence”
theory.30 DeLone and McLean used Shannon and Weaver’s three levels of
information: (1) technical (accuracy and efficiency of the communication
system), (2) semantic (communicating meaning), and (3) effectiveness
(effect on the receiver). These three levels correspond to DeLone and
McLean’s constructs of (1) “system quality,” (2) “information quality,” and
(3) effects listed as use, user satisfaction, and net benefits or outcomes.
DeLone and McLean revised the model in 2003 to include recent literature
and added a fourth level—“service quality”—referring to the degree to
which users are supported by IT staff. Fig. 4.1 depicts an adaptation of the
updated 2003 model that adds user satisfaction, user characteristics, and
task effectiveness to the original model.
FIG 4.1 A model of information system success. Adapted from J Manag
Inf Syst. 1993;19(4):9-30. Copyright © 1993 M.E. Sharpe, Inc. Reprinted with permission.
All Rights Reserved.
Unified Theory of Acceptance and Use of Technology
Unified theory of acceptance and use of technology (UTAUT) is an
adaptation of the social cognitive theories within the field of informatics.31
UTAUT is depicted in Fig. 4.2, and explains users’ intentions to use an
information system as a function of performance expectancy or self-
efficacy beliefs, effort expectancies, social influence, and facilitating
conditions. Significant moderators of these variables of intentions are
gender, age, and the degree to which usage is mandated. This model
integrates social cognitive theory,13 theory of reasoned action,12 and
diffusion of innovations theory.14
FIG 4.2 An example of unified theory of acceptance and use of
technology. From Venkatesh V, Morris M, Davis G, Davis F. User acceptance of
information technology: toward a unified view. MIS Quart. 2003;27(3):425-478.
Venkatesh and Davis conducted a systematic measurement meta-
analysis that tested eight major models of adoption to clarify and integrate
the adoption literature.32 All of the evaluated models were based to some
degree on the social cognitive models described above but adapted to the
question of IT adoption and use. Empirical studies showed that UTAUT
explained around 70% of the variance in intention to use, significantly
greater than any of the initial models alone did. Two key findings of this
work are important. First, Venkatesh et al. found that the variables
associated with initial intentions to use are different from the variables
associated with later intentions.31,33,34 Specifically, the perceived work
effectiveness constructs (perceived usefulness, extrinsic motivation, job fit,
relative advantage, and outcome expectations) were found to be highly
predictive of intentions over time. In contrast, variables such as a itudes,
perceived behavioral control, ease of use, self-efficacy, and anxiety were
predictors only of early intentions to use.
Second, the authors found that the variables predictive of intentions to
use are not the same as the variables predictive of usage behavior itself.31
They found that the “effort factor scale” (resources, knowledge,
compatible systems, and support) was the only construct other than
intention to significantly predict usage behavior. Finally, these authors
found that the model differed significantly depending on whether usage
was mandated or by choice. In se ings where usage was mandated, social
norms had a stronger relationship to intentions to use than the other
variables.
Program Implementation Models
Program implementation models refer to generalized, large-scale
implementation theories that are focused on performance improvement
and institution-wide change. Six models are reviewed here: Predisposing,
Reinforcing, and Enabling Constructs in Educational Diagnosis and
Evaluation-Policy, Regulatory, and Organizational Constructs in
Educational and Environmental Development (PRECEDE-PROCEED),
Promoting Action on Research Implementation in Health Services
(PARiHS), Reach Effectiveness Adoption Implementation Maintenance
(RE-AIM), Consolidated Framework for Implementation Research (CFIR),
Sociotechnical Model, and Quality Improvement.
PRECEDE-PROCEED Model
The le ers in the PRECEDE-PROCEED model represent the following
terms: PRECEDE Predisposing, Reinforcing, and Enabling Constructs in
Educational Diagnosis and Evaluation; PROCEED Policy, Regulatory, and
Organizational Constructs in Educational and Environmental
Development. This model was originally developed to guide the design of
system-level educational interventions, as well as for evaluating program
outcomes. It is a model that addresses change at several levels, ranging
from the individual to the organization level. According to the model the
interaction between the three types of variables produces change:
• Predisposing factors that lay the foundation for success (e.g., electronic
health records or strong leadership)
• Reinforcing factors that follow and strengthen behavior (e.g., incentives
and feedback)
• Enabling factors that activate and support the change process (e.g.,
support, training, computerized reminders, and templates or exciting
content)
The model has been applied in a variety of se ings, ranging from public
health interventions, education, and geriatric quality-improvement and
alerting studies.35 Fig. 4.3 illustrates the model applied to a health IT
product.
FIG 4.3 An adaptation of the PRECEDE-PROCEED model for a
health IT product. From Green LW, Kreuter MW. Health Program Planning: An
Educational and Ecological Approach. 4th ed. Mountain View, CA: McGraw-Hill; 2005.
Reprinted with permission of McGraw-Hill Companies Inc.
Promoting Action on Research Implementation in
Health Services
The PARiHS framework outlines three general areas associated with
implementation (Fig. 4.4):
FIG 4.4 The PARiHS model. From Kitson AL, Rycroft-Malone J, Harvey G,
McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence
into practice using the PARiHS framework: theoretical and practical challenges. Implement
Sci. 2008;3:1.
1. Evidence: Establishing the efficiency and effectiveness of the intervention
through expert contribution, literature reviews, surveys, usability testing,
and cognitive task analyses.
2. Context: Enhancing leadership support and integrating with the culture
through focus groups and interviews.
3. Facilitation of the implementation process: Skill level and role of facilitator
in promoting action, as well as frequency of supportive interactions.36
These three elements are defined across several subelements, with
higher ratings suggestive of more successful implementation. For instance,
a high level of evidence may include the presence of randomized
controlled trials (i.e., the gold standard in research), high levels of
consensus among clinicians, and collaborative relationships between
patients and providers. Context is evaluated in terms of readiness for
implementation, including consideration of the context’s culture,
leadership style, and measurement practices. High ratings of context may
indicate an environment focused on continuing education, effective
teamwork, and consistent evaluation and feedback. Finally, the most
successful facilitation is characterized by high levels of respect for the
implementation se ing, a clearly defined agenda and facilitator role, and
supportive flexibility.37 Successful implementation (SI) is thus
conceptualized as a function (f) of evidence (E), context (C), and facilitation
(F), or SI = f(E, C, F).38 The PARiHS framework suggests a continuous
multidirectional approach to evaluation of implementation. Importantly,
evaluation is viewed as a cyclic and interactive process instead of a linear
approach. The concept of facilitation has been gaining significant
traction.39
Reach Effectiveness Adoption Implementation
Maintenance
RE-AIM was designed to address the significant barriers associated with
implementation of any new intervention, and it is particularly useful for
informatics. Most interventions meet with significant resistance, and any
useful evaluation should measure the barriers associated with the
constructs (Reach, Effectiveness, Adoption, Implementation, and
Maintenance). These constructs serve as a good format for evaluation.40,41
First, did the intervention actually reach the intended target population? In
other words, how many providers had the opportunity to use the system?
Alternatively, how many patients had access to a new website? Second, for
effectiveness, did the intervention actually do what it was intended to do?
Did the wound care decision support actually work as intended every
time? Did it identify the patients it was supposed to identify? Or, did the
algorithms miss some key variables in real life? Third, for adoption, what
proportion of the targeted staff, se ings, or institutions actually used the
program? What was the breadth and depth of usage? Did they use it for all
relevant patients or only for some? Fourth, for implementation, was the
intervention the same across se ings and time? With most health IT
products there is constant change to the software, the skill level of users,
and the se ings in which they are used. These should be documented and
addressed in the evaluation. Finally, for maintenance, time should be
identified a priori to assess maintenance, as well as whether usage
continues, and by whom and in what form. For health IT interventions, it
is especially useful to look for unintended consequences, as well as
workarounds during implementation and maintenance in particular.
Consolidated Framework for Implementation
Research
The authors of the CFIR reviewed dozens of implementation theories and
consolidated the constructs having evidence of effect on implementation.42
The consequent model is an overarching consolidated framework,
consisting of five major domains: intervention characteristics, outer se ing,
inner se ing, individual characteristics, and implementation processes.
About 38 constructs were identified across the five major domains, and
they include many of the constructs identified in the preceding theories.
Although the model is thought to apply to health services
implementations broadly, it is particularly applicable to informatics
interventions. Readers may be interested in a step-by-step guide for use of
this model, sample studies, and more details about the model which are
available at h p://cfi[Link]/[Link].
Sociotechnical Model for Informatics Interventions
The sociotechnical model described by Si ig and Singh describes eight
areas to be addressed in a sociotechnical implementation and evaluation.
These include (1) hardware and software, (2) people, (3) clinical content,
(4) human-computer interface, (5) workflow and communication, (6)
internal organizations features, (7) external rules and regulations, and (8)
measurement and monitoring. These categories are a compilation of other
models and serve as a general taxonomy to organize an evaluation.43
Quality Improvement
Evaluation activities using a quality-improvement framework are often
based on Donabedian’s classic structure-process-outcome (SPO) model for
assessing healthcare quality.44,45 Donabedian defines structural measures of
quality as the professional and organizational resources associated with the
provision of care, such as IT staff credentials, CPOE systems, or staffing
ratios. Process measures include the tasks and decisions imbedded in care,
such as the time to provision of antibiotics or the proportion of patients on
deep vein thrombosis (DVT) prevention protocols. Finally, outcomes are
defined as the final or semifinal measurable outcomes of care, such as the
number of amputations due to diabetes, the number of patients with DVT,
or the number of patients with drug-resistant pneumonia. These three
categories of variables are thought to be mutually interdependent and
reinforcing. A model for patient safety and quality research design
(PSQRD) expands on this well-known, original SPO model.46 For more
details on this model, see Chapter 24.
Program Theory Models
Program theory models are the most basic and practical of the evaluation
models. They are the implicit theories of stakeholders and participants of
the proposed program. A detailed program theory identifies variables, the
timing of measures and observations, and the key expectations that reflect
their understandings. Most importantly, a program theory model serves as
a shared vision between the evaluator team and the participants, creating a
unified conceptual model that guides all evaluation activities.
Six Steps
Program theory evaluation is recommended practice for all program
evaluations and an important approach regardless of whether the program
is the implementation of a new documentation system or an institution-
wide information system. Invariably, various participants will have
different ideas about what the program is and why it works.47 Creation of
a program theory model serves to align the various stakeholders into a
single view. The Centers for Disease Control and Prevention’s six-step
program evaluation framework is one of the best examples in current
use.48 It recommends the following six steps:
1. Engage stakeholders to ensure that all partners have contributed to the
goals of the program and the metrics to measure its success.
2. Describe the program systematically to identify goals, objectives, activities,
resources, and context. This description process involves all stakeholders.
3. Focus the evaluation design to assess usefulness, feasibility, ethics, and
accuracy.
4. Gather credible evidence by collecting data, conducting interviews, and
measuring outcomes using a good research design.
5. Justify conclusions using comparisons against standards, statistical
evidence, or expert review.
6. Ensure use and share lessons learned by planning and implementing
dissemination activities.
Logic Models
A logic model is a representation of components and mechanisms of the
program as noted by the authors of the W.K. Kellogg Foundation’s guide
to logic models:
Basically, a logic model is a systematic and visual way to present and
share your understanding of the relationship among the resources you
have to operate your program, the activities you plan, and the changes or
results you hope to achieve. The most basic logic model is a picture of
how you believe your program will work. It uses words and/or pictures to
describe the sequence of activities thought to bring about change and how
these activities are linked to the results the program is expected to
achieve. 49,p.1
The basic structure of a logic model is illustrated in Fig. 4.5. The logic
model starts with a category of “inputs,” which include staff, resources,
prior success, and stakeholders. In health IT the inputs are the programs,
software, the IT staff, hardware, networks, and training. “Outputs” include
the activities that are going to be conducted, such as training,
implementation, software design, and other computer activities.
Participation refers to the individual involved. Outcomes are divided into
short, medium, and long outcomes or short-term versus long-term
outcomes. The goal is to make sure that the components of the program
are easy to see and the mechanisms are made explicit.
FIG 4.5 Example of a logic model structure. From University of Wisconsin–
Extension, Cooperative Extension, Program Development and Evaluation website. Logic
model. <[Link] 2010.
The specific methods used to apply a model are not prescribed although
creating a logic model is recommended. Use of a wide range of methods
and tools is encouraged. Engaging the stakeholders is the first step, and
that process could involve needs assessment, functionality requirements
analyses, cognitive task analyses, contextual inquiry, and ethnographic
observation, to name a few approaches. In all cases, the result is the ability
to provide a deep description of the program, the expected mechanisms,
and the desired outcomes. Once there is agreement on the characteristics
of the program at both the superficial level and the deeper structure,
designing the evaluation is straightforward. Agreement among
stakeholders is needed not only to identify concepts to measure, but also
to determine how to measure them meaningfully.
Leaders and managers should agree on health IT goals and metrics early
in the implementation process. Because health IT products are unique,
creating a shared vision and a common understanding of the meaning of
the evaluation can be challenging. Using an iterative process for
implementation can mitigate the problem where design and
implementation go hand in hand and the stakeholder’s vision is addressed
repeatedly throughout the process.
Methods, tools, and techniques
The need for variety in methods is driven by the diversity in population,
types of projects, and purposes that are characteristic of research in
informatics. Many evaluation projects are classified as either qualitative or
quantitative. This division may be somewhat artificial and limited, but
using the terms qualitative and quantitative to organize methods helps to
make them relatively easy to understand. A central thesis of this section is
that the choice of method should fit the question and multiple methods are
commonly used in evaluations.
Quantitative Versus Qualitative Questions
Because evaluation is often a continuous process throughout the life of a
project, the systems life cycle is used to organize this discussion.
Evaluation activities commonly occur during the planning, analysis,
implementation, and maintenance stages of a project (see Chapter 2 for
more details about these stages and others in the systems life cycle). At
each stage, both quantitative and qualitative questions might be asked. At
the beginning of a project, the goal is to identify resources, feasibility,
values, extent of the problem to be solved, and types of needs. The
methods used to answer these questions are essentially local and project
specific. During the project, evaluation questions focus on the intensity,
quality, and depth of the implementation as well as the evolution of the
project team and community. Finally, in the maintenance phase of the
project, the questions focus on outcomes, cost-benefit value, or overall
consequences.
Table 4.2 presents a matrix that outlines the different stages of a project
and the types of questions that might be asked during each stage. The
questions are illustrations of possible evaluation questions and loosely
categorized as either qualitative or quantitative.
Table 4.2
Evaluation Research Questions by Stage of Project and Type of
Question
Health IT, Health information technology.
Qualitative Methods
Many individuals believe that qualitative methods refer to research
procedures that collect subjective human-generated data. However,
subjective data can be quantitative, such as the subjective responses to
carefully constructed usability questionnaires used as outcome end points.
Diagnostic codes are another example of quantitative forms of subjective
data. Qualitative methods, rather, refer to procedures and methods that
produce narrative or observational descriptive data that are not intended
for transformation into numbers. Narrative data refers to information in the
form of stories, themes, meanings, and metaphors. Collecting this
information requires the use of systematic procedures where the purpose
is to understand and explore while minimizing bias. There are several very
good guides to conducting qualitative research for health IT evaluation
studies.50 The BioMed Central editors now require authors in most
informatics journals to self-evaluate their qualitative articles based on the
RATS criteria, which also provide good advice for reporting. RATS
guidelines are (1) relevance of the study question, (2) appropriateness of
qualitative method, (3) transparency of procedures, and (4) soundness of
interpretive approach. More detail on these guidelines is available.51,52
Structured and Semi-Structured Interviews
In-person interviews can be some of the best sources of information about
an individual’s unique perspectives, issues, and values. Interviews vary
from a very structured set of questions conducted under controlled
conditions to a very informal set of questions asked in an open-ended
manner. Typically, evaluators audio-record the interviews and conduct
thematic or content coding on the results. For example, user interviews
that focus on how health IT affects workflow are especially useful. Some
interviews have a specific focus, such as in the critical incident method.53
In this method, an individual recalls a critical incident and describes it in
detail for the interviewer. In other cases the interview may focus on the
individual’s personal perceptions and motivations, such as in motivational
interviewing.54 Finally, cognitive task analysis (CTA) is a group of
specialized interviews and observations where the goal is to deconstruct a
task or work situation into component parts and functions.55-57 A CTA
usually consists of targeting a task or work process and having the
participant walk through or simulate the actions, identifying the goals,
strategies, and information needs. These la er methods are useful for user
experience studies outlined in Chapter 21.
Observation and Protocol Analysis
An interview may not provide enough information, and, therefore,
observing users in action at work is necessary to understand fully the
interactions of context, users, and health IT. Observation can take many
forms, from using a video camera to a combination of observation and
interview where individuals “think aloud” while they work. The think-
aloud procedures need to be analyzed both qualitatively for themes and
quantitatively for content, timing, and frequency.58 This method is integral
to usability evaluations as outlined in Chapter 21.
Interviews, CTAs, and observation are essential in almost every health
IT evaluation of users. Technology interventions are not uniform and
cannot simply be inserted into the workflow in a “plug and play” manner.
In addition, the current state of the literature in the field lacks clarity about
the mechanisms of action or even delineating the key components of
health IT. Thus understanding the user’s response to the system is
essential. For more information about the user experience, see Chapter 21.
Ethnography and Participant Observation
Ethnography and participant observation are derived from the field of
anthropology, where the goal is to understand the larger cultural system
through observer immersion. The degree of immersion can vary, as can
some of the data collection methods, but the overall strategy includes
interacting with all aspects of the context. Usually ethnography requires
considerable time, multiple observations, interviews, and living and
working in the situation if possible. It also includes reading historical
documents, exploring artifacts in current use (e.g., memos and minutes),
and generally striving to understand a community. These methods are
particularly useful in a clinical se ing, where understanding the culture is
essential.50,59
Less intensive ethnographic methods are also possible and reasonable
for health IT evaluations. Focused ethnography is a method of observing
actions in a particular context. For example, nurses were observed during
patient care handoffs and their interactions with electronic health records
were recorded. From these observations, design implications for handoff
forms were derived.60,61
Quantitative Methods
Research Designs
Quantitative designs range from epidemiologic, descriptive studies to
randomized controlled trials. Three study designs presented may be
particularly useful for health IT and clinical se ings. Each of these designs
takes advantage of the conditions that are commonly found in health IT
projects, including automatically collected data, the ubiquitous use of pre-
post design, and outcome-based targets for interventions.
Time Series Analysis
This design is an extension of the simple pre-post format but requires
multiple measures in time prior to and after an intervention such as health
IT. Evidence of the impact is found in the differences in mathematical
slopes between measures during the pretest and pos est periods. This
design has significantly more validity than a simple pre-post one-time
measure design and can be very feasible in clinical se ings where data
collection is automatic and can be done for long periods with li le increase
in costs. For example, top-level administrators might institute a decision
support computerized program to improve patient care for pain
management. A straightforward design is to measure the rate of
compliance to pain management recommendations during several periods
about 12 months before and several periods up to 12 months after
implementation, controlling for hospital occupancy, patient acuity, and
staffing ratios. This design is highly recommended for health IT
implementations where data can be captured electronically and reliably
over long periods.62,63
Regression Discontinuity Design
A regression discontinuity design is similar to a time series analysis, but it
is a formal statistical analysis of the pa ern of change over time for two
groups. This design is particularly suited to community engagement
interventions, such as for low vaccination rates in children or seat belt
reminders. Participants are divided into two nonoverlapping groups based
on their prescores on the outcome of interest. The example used above of
compliance with pain management guidelines in an inpatient surgical unit
may also be applicable. Providers with greater than 50% compliance to
pain guidelines are put in one group and those with less than 50%
compliance with pain guidelines are in the other group. Those with the
lowest compliance receive a decision support intervention such as a
computerized alert and a decision support system to assess and treat pain,
whereas the rest do not. Post measures are taken some time after the
intervention, and the difference between the predicted scores of the low
compliance group and their actual scores as compared to the
nonintervention group is noted. The validity of this design is nearly as
high as a randomized controlled trial, but this design is much easier to
implement because those who need the intervention receive it. However,
this design requires large numbers, which may not be available except in a
system-wide or multisite implementation.64
Multiple Baseline With Single Subject Design
This design adds significant value to the standard pre-post comparison by
staggering implementation systematically (e.g., at 3-month intervals) over
many se ings but the measurement for all se ings starts at the same time.
In other words, measurement begins at the same time across five clinics,
but implementation is staggered every 3 months. Fig. 4.6 illustrates the
pa ern of responses that might be observed. The strength of the evidence
is high if outcomes improved after implementation in each se ing and
they followed the same pa ern.65 Readers may also find other quasi-
experimental research designs useful for health IT research in the
comprehensive textbook by Shadish and colleagues.65
FIG 4.6 Example of a multiple baseline study.
Instruments
Data are commonly gathered by using instruments. User satisfaction,
social network analyses, and cost-effectiveness tools are discussed briefly
next.
User-Satisfaction Instruments
User satisfaction is commonly measured as part of health IT evaluations
but is a complex concept. It is thought to be a proxy for adoption;
however, it is used as a proxy for system effectiveness. In the first
conception, the constructs of interest would be usability and ease of use, as
well as whether others use it (usability and social norms). In the second
conception, the constructs of interest would refer to how well the system
helped to accomplish task goals (usefulness). One of the most common
instruments for evaluating user satisfaction is the UTAUT.32 This well-
validated instrument assesses perceived usefulness, social norms and
expectations, perceived effort, self-efficacy, ease of use, and intentions to
use. Reliability for these six scales ranges from 0.92 to 0.95.
A second measure of user satisfaction focuses on service quality
(SERVQUAL) and assesses the degree and quality of IT service. Five scales
have been validated: reliability, assurance, tangibles, empathy, and
responsiveness. These five scales have been found to have reliability of
0.81 to 0.94.66
A third measure is the system usability scale (SUS), which is widely
used outside health IT.67 It is a 10-item questionnaire applicable to any
health IT product. Bangor et al. endorsed the SUS above other available
instruments because it is technology agnostic (applicable to a variety of
products) and easy to administer, and the resulting score is easily
interpreted.68 The authors provide a case study of product iterations and
corresponding SUS ratings that demonstrate the sensitivity of the SUS to
improvements in usability.
Social Network Analysis
Methods that assess the linkages between people, activities, and locations
are likely to be very useful for understanding a community and its
structure. Social network analysis (SNA) is a general set of tools that
calculates the connections between people based on ratings of similarity,
frequency of interaction, or some other metric. The resultant pa ern of
connection is displayed as a visual network of interacting individuals.
Each node is an individual and the lines between nodes reflect the
interactions. Although SNA uses numbers to calculate the form of the
networked display, it is essentially a qualitative technique because the
researcher must interpret the pa erns of connections and describe them in
narrative form. Conducting an SNA is useful if the goal is to understand
how an information system affected communication between individuals.
It is also useful to visualize other connections, such as the relationship
between search terms or geographical distances.69 For example,
researchers used SNA to examine patient care handoffs from the
emergency department to inpatient areas, finding that each handoff
entailed 11 to 20 healthcare providers.70
Cost-Effectiveness Analysis
Cost-effectiveness analysis (CEA) a empts to quantify the relative costs of
two or more options. Simply measuring additional resources, start-up
costs, and labor would be a rudimentary cost analysis. A CEA is different
from a cost-benefit analysis, which gives specific monetary analysis. A
simple CEA shows a ratio of the cost divided by the change in health
outcomes or behavior. For example, a CEA might compare the cost of
paying a librarian to answer clinicians’ questions as compared with
installing Infobu ons per the number of known questions. Most CEA
program evaluations will assess resource use, training, increased staff
hiring, and other cost-related information. A full economic analysis
requiring a consultation with an economist is not necessarily needed. The
specific resources used could be delineated in the logic model, unless it
was part of hypothesis testing in a more formal survey. The reader is
directed to a helpful textbook if further information is needed.38
Conclusion and future directions
Evaluation of health IT programs and projects can range from simple user
satisfaction for a new menu to full-scale analysis of usage, cost,
compliance, patient outcomes, observation of usage, and data about
patients’ rate of improvement. Starting with a general theoretical
perspective and distilling it to a specific program model is the first step in
evaluation. Once overall goals and general constructs have been identified,
then decisions about measurement and design can be made. In this
chapter, evaluation approaches have been framed, focusing on health IT
program evaluation to orient the reader to the resources and opportunities
in the evaluation domain. Health IT evaluations are typically
multidimensional, longitudinal, and complex. Health IT interventions and
programs present a unique challenge, as they are rarely independent of
other factors. Rather, they are usually embedded in a larger program. The
challenge is to integrate the goals of the entire program while clarifying
the effect and importance of the health IT component. In the future, health
IT evaluations should become more theory driven and the complex nature
of evaluations will be acknowledged more readily.
As health IT becomes integrated at all levels of the information context
of an institution, evaluation strategies will necessarily broaden in scope.
Outcomes will not only include those related to health IT but also span the
whole process. The result will be richer analyses and a deeper
understanding of the mechanisms by which health IT has its impact. The
incorporation of theory into evaluation will also result in knowledge that
is more generalizable and the development of health IT evaluation science.
Health practitioners and informaticians will be at the heart of these
program evaluations because of their central place in healthcare, IT, and
informatics departments.
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Discussion questions
1. Of the levels of theory discussed in this chapter, what level would be
most appropriate for evaluation of electronic health records? Would the
level of theory be different if the intervention was for an application
targeting a new scheduling system in a clinic? Why?
2. What is the difference between program evaluation and program-
evaluation research?
3. Assume that you are conducting an evaluation of a new decision
support system for preventative alerts. What kind of designs would you
use in a program evaluation study?
4. Using the life cycle as a framework, explain when and why you would
use a formative or summative evaluation approach.
5. What are the basic differences between a research study and a program
evaluation?
6. Review the following article: Harris A, McGregor J, Perencevich E, et al.
The use and interpretation of quasi-experimental studies in medical
informatics. J Am Med Inform Assoc. 2006;13:16-23. Explain how you
might apply these research designs in structuring a program evaluation.
Case study
A 410-bed hospital has used a homegrown provider order-entry system
for 5 years. Leaders recently decided to put in bar code administration
software to scan medications at the time of delivery in order to decrease
medical error. The administration is concerned about medication errors,
top-level administration is concerned about meeting the Joint Commission
accreditation standards, and the IT department is worried that the
scanners may not be reliable and may break, increasing their costs. The
plan is to have a scanner in each patient's room; nurses will scan the
medication when they get to the room and scan their own badges and the
patient’s armband. The application makes it possible to print out a list of
the patients with their scan pa erns, and the nurses sometimes carry this
printout because patient’s armbands can be difficult to locate or nurses do
not want to disturb patients while they are sleeping. The bar code software
was purchased from a vendor and the facility has spent about a year
refining it. The IT department is responsible for implementation and has
decided that it will implement each of the four inpatient se ings one at a
time at 6-month intervals.
The hospital administration wants to conduct an evaluation study. You
are assigned to be the lead on the evaluation.
Discussion Questions
1. What is the key evaluation question for this project?
2. Who are the stakeholders?
3. What level of theory is most appropriate?
4. What are specific elements to measure by stakeholder group?
5
Technical Infrastructure to Support
Healthcare
Sco P. Narus
Abstract
This chapter introduces the technical aspects supporting electronic health records
(EHRs) and related infrastructure components. Complementing the functional
components discussed elsewhere, this chapter introduces terms such as clinical data
repository, master person index, interface engine, and data dictionary, as well as other
technical components necessary for EHRs to function. Recent material about national
efforts related to the infrastructure and electronic data sharing, such as eHealth
Exchange and local information exchange networks, is also reviewed.
A sound understanding of the technical attributes of health IT components,
as well as how they interact, is essential for successful system
implementations to support the needs of clinician users and the safe,
effective care of patients.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe the key technical components of electronic health records and
their interrelationships.
2. Define interoperability and its major elements.
3. Contrast networking arrangements such as regional health
information organizations (RHIOs), health information exchanges
(HIEs), and health information organizations (HIOs).
4. Provide information about newer technical models such as cloud
computing and application service providers (ASPs).
5. Synthesize current challenges for informatics infrastructure.
Key terms
application service provider (ASP) 83
architecture 75
clinical data repository (CDR) 76
cloud computing 84
data dictionary 79
electronic health record (EHR) 75
health information organization (HIO) 82
infrastructure 75
interface engine (IE) 81
interoperability 78
knowledge base 80
master person index (MPI) 77
regional health information organization (RHIO) 82
service-oriented architecture (SOA) 86
Introduction
Understanding the information technology (IT) architecture underlying a
healthcare organization's information systems is foundational to
understanding how that system actually functions. Decisions about the
technical infrastructure have important consequences for the overall
system, in terms of both functional capabilities and support for clinical
workflow. Many aspects of a clinical IT infrastructure are unique to the
healthcare se ing or have different properties or priorities. Understanding
the needs of a clinical data repository (CDR) or health data interface
network as compared with their counterparts in other industries can mean
the difference between successful and failed implementations.
Electronic health record component
model
The electronic health records (EHR) may be thought of as a collection of
several key components.1 Each of these components contributes to overall
system functionality. In older EHRs, these components were often
bundled, making it difficult if not impossible to separate components from
each other. Components of modern technologies are often developed
separately but may follow a common architectural design philosophy so
that the components can be integrated easily. Each component could also
be enhanced independent of the others as long as the component
integration design was followed. Often the technical responsibility of the
informatician is to manage the component design and implementation life
cycle, so understanding the component model and integration strategy is
essential (Fig. 5.1). The following sections describe common EHR
components and important considerations for each component.
FIG 5.1 The electronic health-record component model. CDSS,
Clinical decision support system; HIE, health information exchange;
MPI, master person index; RHIO, Regional Health Information
Organization. Dotted lines denote “foreign key” relationships. For
example, the dotted line between the Repository and the MPI
denotes that a patient whose data exists in the Repository must first
exist in the MPI.
Clinical Data Repository
The clinical data repository (CDR) is the storage component for all
instance data of patient clinical records. By instance data, we mean actual
pieces of information collected by manual or automated means for a
specific patient at a point in time. Data stored in a repository may be lab
results, medication orders, vital signs, and clinical documentation. The
data may be stored as free text or unstructured documents or as coded and
structured elements (e.g., as columnar data in a relational database or as
elements of a detailed model within an object-oriented database). Data
within the repository are considered the most essential aspect of the EHR:
without these data, the other components of the EHR are meaningless.
Therefore important aspects of the repository include accessibility,
reliability, and security.
Accessibility means the ability to efficiently retrieve data stored within
the repository. The repository must provide access methods that allow
users of the repository (through, e.g., clinical applications and decision
support rules) to find information using criteria that are meaningful to the
users. For example, the repository should be able to distinguish data based
on patient characteristics such as a patient identifier or encounter number.
Data should also be classified by type, such as lab results, medications,
and allergies, to permit easy and quick retrieval of a specific category of
data. Other important data a ributes that help with accessibility include
dates (e.g., date recorded and date observed), data owners and entry
personnel (e.g., ordering physician, charting nurse, and case manager),
and location of service or data entry. The access methods for the repository
should be robust enough to support current and future users’ access
needs.
Repository reliability refers to the dependability and consistency of access
to the repository. In a critical healthcare se ing, a repository needs to
support its users on a 24/7 basis. There is li le tolerance for downtime.
Inconsistent repository performance—for instance, longer wait times for
data retrieval during high usage times of the day—also affects the
reliability of the repository. Because of its importance to the functions of
all EHR components, the repository reliability is a major factor in
determining the perceived reliability of the EHR. Various architectural and
procedural models, including redundancy of storage hardware and access
routes, system backup policies, and regular performance reviews and
maintenance, may be employed to increase the reliability of the repository.
Security is essential to the repository because of both the sensitive
nature of the data within and the critical role data play in the healthcare
environment. Regulations, such as the Health Insurance Portability and
Accountability Act (HIPAA),2 and sound ethical practices demand that
organizations provide a high level of privacy and security for the health
information they handle. The repository must incorporate security
measures, such as data encryption, secure access paths, user
authentication, user and role-based authorization, and physical security of
the repository itself, to prevent, to the extent possible, inadvertent and
intentionally inappropriate access to data. Some security methods may
conflict with accessibility and reliability goals, such as when a measure
interferes with needed access to a patient’s data. (Chapter 26 discusses
both privacy and security in more detail.) EHR implementers must weigh
the benefits and costs of each, but good system design can mitigate
conflicts while supporting the needs of the healthcare se ing.
Central Versus Distributed Storage
One characteristic that can be used to distinguish repository models is
central versus distributed storage. In the central storage model, a single
repository is used to store all (or most) clinical data, and it is used as the
primary source for reviewing data. There may still be departmental or
function-specific clinical information systems, as well as automated data
collection devices, that are used to gather data. Some of these systems may
even store copies of their information in their own repositories, but these
data are also forwarded to the central repository and stored there. In the
case of a healthcare enterprise with multiple facilities, potentially
consisting of inpatient and outpatient areas, the central model could store
information from each of these facilities in one repository. This model
improves the ability of a single application to display data from multiple
original sources and locations, and it provides the capability to perform
clinical decision support (CDS) more efficiently across multiple data types
(e.g., combining lab results with medication administration and nutrition
data to provide input for medication ordering). Central storage usually
requires that data collected from secondary systems be transformed
(mapped) to a common storage model and terminology before being
stored in the repository. This model does not imply that data cannot be
replicated to other locations for safety and disaster recovery purposes.
In the distributed storage model, each data collection application stores
its information in its own repository, and data are federated (joined)
through a real-time data access methodology. In this case, a results review
application may have to access separate repositories for the lab,
microbiology, or radiology, for example, to provide a composite view of
information. In the previous example of an enterprise with multiple
facilities, each facility might store its own data in a facility-based
repository. The distributed model provides some reliability to the EHR
because, for example, if one repository goes down, the user may still be
able to access information from the other repositories. It also allows the
most efficient storage and access for particular data types and lessens the
complexity of having to map data from one system to another. However,
the distributed model produces many single points of failure for each
repository, limits performance because of the multiple data access paths
that may be required, and makes integrated tasks such as CDS much more
difficult.
Encounter-Based Versus Longitudinal-Based Storage
Another characteristic that can be used to distinguish repository models is
encounter-based versus longitudinal-based storage. Encounter-based (or
episodic) storage was typically used in older, hospital-based EHRs. In this
model, data are collected according to the current patient encounter (e.g.,
clinic visit or hospital admission) and then are usually purged or archived
from the repository when the patient is discharged. If the patient has a
future encounter with the facility, data may need to be collected
completely anew, including patient history, allergies, and previous
medications. Encounter-based storage is very efficient in terms of system
performance for supporting the current encounter because the data in the
repository are always the most current and reflect only what has been
collected as relevant to the present circumstances. In this case, the
repository’s storage space can be quite small. However, because data are
purged, some duplication of effort is inherent in this model: data collected
during a previous visit may still be relevant and will need to be collected
again. There is also a chance that pertinent information from a previous
encounter may be lost if a clinician omits collecting it in a subsequent visit.
A longitudinal-based repository, on the contrary, stores data across all
encounters. It is often referred to as a “cradle to grave” or “womb to tomb”
repository because data may extend over the entire lifespan of an
individual. Advantages of the longitudinal-based repository are that
clinicians have access to all data collected on a patient from all clinical
interventions, and data that do not change and are relevant across all
encounters, such as allergies, family medical history, and past procedures,
do not need to be reentered at each visit. As with the central (versus
distributed) storage model, the longitudinal record may contain data from
multiple facilities and health enterprises as well. Access to historical data
may be helpful in automated CDS. The disadvantage is that a patient’s
record (and therefore the entire repository) can grow tremendously large
with data that become less relevant over time.
Master Person Index
The master person index (MPI), also known as the master patient index or
master member index, is the repository for the information used to
uniquely identify each person, patient, or customer of a healthcare
enterprise. One or more registration systems may be used at each visit to
collect identifying information about the patient, which is then sent to the
MPI to match against existing person records and resolve any conflicting
information. The MPI stores demographic information about the patient,
such as names, addresses, phone numbers, date of birth, and sex. Other
organizational identifiers, such as social security number, driver’s license
number, and insurance identification, also may be stored. Identifiers from
within the healthcare enterprise, such as individual facility medical record
numbers, are stored as well. (This is often a vestige of paper medical
record systems that used facility-specific identifiers for each patient.)
The MPI record is updated as any information added. The MPI then
serves as both the master of all information collected, forming what is
often referred to as the “golden record” for a person, and the source for
distinguishing a patient from all other patients in the system. The la er
point is important because it helps to ensure that clinical and
administrative data are a ributed to the correct patient during healthcare
encounters. Each MPI record will have a unique patient identifier or
number that is used in the repository to associate a clinical record with the
appropriate patient and is used by applications to properly retrieve and
store information for the right patient. The MPI will typically support
standard access methods for storing and retrieving data (e.g., Health Level
Seven [HL7] Admit/Discharge/Transfer messages) so that systems that
need to use the MPI can rely on a common interface mechanism. A user-
facing patient selection application connected to the MPI is typically
provided in the EHR so that EHR users can search for and find a particular
patient for use in clinical documentation, review, and patient management
applications.
Clinical Applications
Clinical applications provide the user-facing views of the EHR to
clinicians. When clinicians think and talk about the EHR, they usually are
referring to these applications. Applications are provided in a variety of
technologies and user-interface paradigms, including web-based
applications, “rich clients” installed on a user’s desktop, and mobile apps.
A “rich client” (also called a fat, heavy, or thick client) is a client-server
architecture or network that provides rich functionality independent of the
central server. In contrast, a “thin client” refers to a client-server
architecture that is heavily dependent on a server’s applications.
When supplied by a single vendor, applications are typically “wrapped”
inside a single desktop framework that provides global EHR functions,
such as user authentication and patient selection, and then launches the
individual applications as part of a clinical workflow. When supplied by
different vendors, applications can still share user patient context by using
technologies such as Clinical Context Object Workgroup (CCOW),
provided the vendor supports such functionality.3,4 CCOW is an HL7
standard protocol designed to enable different applications to work
together in real time at the user interface level. The CCOW standard exists
to facilitate interoperability across disparate applications.
Clinical applications can be divided into four broad areas of
functionality: review and reporting, data collection, patient management,
and clinician productivity. For more information on individual
applications in the patient care se ing, refer to Chapters 6, 7, and 8.
Review and Reporting
One of the most widely used functions of an EHR is review and reporting
of clinical data in the repository. In general, a review application is
typically focused on one area of clinical data (e.g., a lab results review
application or a vital signs review module). On the contrary, a reporting
application often has a broad range of clinical data that displays to the
user (e.g., a 24-hour rounds report that combines lab, vitals, medications,
intake and output [I/O], invasive line status, assessments, and plan in one
view). A reporting application also typically allows much more user
customization for selecting content and layout. A review and reporting
application is optimized for display of data and does not necessarily allow
direct data entry. However, to improve clinical workflow the application
may provide a simple, one-click shortcut to a data collection application to
edit or enter new data. A more sophisticated review and reporting
application may also provide links from displayed data to more detailed
information about that data, such as might be found with an Infobu on.5–9
In more complex graphical user interface environments, the review and
reporting application might provide functionality for graphing results,
creating timeline associations between data points, and incorporating
baseline, average, and goal parameters. The ability of the review and
reporting application to support more advanced data display functions
will depend significantly on the granularity of data stored in the
repository; primarily text-based storage will limit the amount of
functionality, whereas highly coded and structured data will allow
increased possibilities. The performance and overall display capabilities of
the applications are affected by the repository’s central versus distributed
and encounter-based versus longitudinal-based storage characteristics.
Data Collection
The ability of clinical applications to collect data in the healthcare
environment has improved dramatically as new technologies have become
available. Older clinical information systems were typically text-based
screens that required heavy use of a computer keyboard or 10-key pad for
navigation and data entry. More modern graphical user interfaces allow a
variety of input and screen navigation possibilities. Some systems may
even allow direct collection of information from devices such as blood
pressure monitors and weight scales, even by use of wireless (Wi-Fi)
connections. Data are usually collected one patient at a time, and stored in
the repository. Data may be collected in narrative form as unstructured
notes or in a much more granular form as coded and structured data. For
example, a vital signs assessment is typically collected in a structured
format so that blood pressure, heart rate, and temperature may be used in
a variety of reporting and CDS applications. The need for standardized
terms and languages are discussed in detail in Chapter 22.
Data collection applications often are linked to review functions so that
the clinician can see the status of the patient and then add new or updated
information. More advanced clinical workflows such as activity
documentation (e.g., medication administration) may involve
computerized decision support and computerized documentation flow
processes to improve data collection. As with review and reporting
applications, links to detailed information about the data to be collected
(Infobu ons) may be provided to assist the clinician with evidence-based
and regulatory and accreditation requirements for documentation. For
example, in a medication administration application, an Infobu on linked
to a particular drug might provide information on potential side effects,
adverse effects, and therapeutic effects to assess for a particular patient.
Patient Management
Some clinical applications fit within a category that deals with clinician
cognitive tasks, particularly around therapeutic and care delivery
responsibilities. Ordering and care planning are examples of patient
management responsibilities that are increasingly being supported by
health information technology (health IT) applications. Each of these
responsibilities requires an elevated cognitive load to process the amount
of available patient information, as well as the number of potential
decisions a clinician can make. Successful EHRs will provide appropriate
capabilities within patient management applications to support clinicians’
abilities to appropriately adopt these applications and support their
cognitive tasks.10 Quite often patient management applications will
provide in-line access to review and reporting applications to improve the
ordering and care planning process. The use of standard terminologies
from a central data dictionary (discussed below) within these applications
ensures that appropriate items are used by clinicians and communicated
to other members of the care team. CDS systems and access to knowledge
resources (discussed below) may also be employed to enhance decision
making.
Clinician Productivity
EHRs often provide clinicians with functionality to assist with care process
tasks that cut across many patients and address clinical workflow.
Examples include care coordination and physician signature applications,
as well as interclinician messaging and notification functions. Point-of-care
analytic applications that address quality issues are also becoming
popular, particularly because of national health IT initiatives such as
Meaningful Use.11,12 These applications, often called “dash boards,”
provide information on a clinician’s patient population to monitor care
and outcomes according to desired goals, and can compare progress over
time or against either standard criteria or other similar clinicians. For
example, this type of application might report that one physician’s
patients with a specific diagnosis average an extra day in the hospital but
also show a lower average readmission rate compared with other patients
with the same diagnosis.
Data Dictionary
A key component of many modern EHRs is a data dictionary that contains
the medical vocabulary terms used to store data within the repository.
These same terms are used by the EHR applications to collect and display
clinical data. (The data dictionary and/or its content may also be referred
to as “master reference data” in some systems.) In its simplest form, the
data dictionary can be viewed as a list of the health terms and their
definitions needed by the EHR, which is usually stored in one or more
database tables. The dictionary might contain information such as terms
for diagnoses, medications, lab tests, and clinical exam measures. Each of
the terms may be assigned a specific code that is independent of how the
term is represented to a user. For example, a diagnosis of dyspnea might
be assigned a code of 1234. The actual representation for the term dyspnea
(medical concept) could be “dyspnea” (English medical text
representation), “shortness of breath” (English common text name), or
“SOB” (English abbreviation of shortness of breath). In this case, all of the
representations would have the same definition and dictionary code
because they are equivalent. Medical concepts from standard
terminologies such as International Classification of Diseases (ICD)-9, ICD-
10, or Systematized Nomenclature of Medicine (SNOMED) are also added
to the data dictionary so that these terms can be used in applications and
in the repository.
The data dictionary is particularly useful in the EHR because it is the
central source for defining all terms and their corresponding codes used
by the EHR. Instead of hard-coding these terms and codes within
applications, the data dictionary allows more flexibility at application
runtime to access new and updated terms as they become available over
the lifetime of the EHR. For example, as new medications and diagnoses
are created, they can be added easily to the data dictionary and made
accessible to all applications within the EHR. If instead these terms were
hard-coded within an application, the programs would have to be updated
and recompiled to make the terms available. In addition, all instances
where the terms are used would potentially have to be updated (e.g., if
two or more applications were exposing medication information). This
leads to a greater maintenance burden for the EHR and can potentially
lead to errors if term sources are not kept synchronized.
The data dictionary also provides the ability to create term relations.
These relations take the form of hierarchical or associative relations.
Hierarchical relations are the most common and can be used to describe
domains and subdomains for terms. For example, a domain term for
“diagnosis” can be created, and then subdomains of “cardiovascular
diagnosis,” “respiratory diagnosis,” and “endocrine diagnosis” could be
defined. Within each of these subdomains, additional subdomains may be
defined for more granular categorization, but eventually the domains
would list individual diagnosis terms, such as “hypertension” or
“pneumonia.” The domain relationships are useful in applications and
decision support logic when, for example, a user wants to narrow a
disease search in a problem list application to just cardiovascular diseases
or when a decision support rule broadly defines an inclusion statement
such as “IF Ordered_Drug Is_A Cardiovascular_Drug THEN …,” where
“Ordered_Drug” is an instance of a drug ordered for a patient,
“Cardiovascular_Drug” is defined as the domain for all cardiovascular
drugs, and “Is_A” is the relationship used by the data dictionary to define
hierarchical domain relationships between parent and child terms.
Associative relations can be used to define other useful, nonhierarchical
relationships between terms. For example, we could associate the
diagnosis term hypertension with the drug-domain term beta blocker, by
creating a relationship called “can be treated by.” In this case, because
“beta blocker” is a domain, we can assume that all terms within this
domain would inherit the “can be treated by” relationship with
hypertension. Another example of an associative relationship is a link
created between two different coding systems that might describe similar
terms. For example, a local laboratory information system (LIS) might
contain its own coding for all lab tests it performs. However, the EHR and
other external systems might use a standard lab terminology such as
Logical Observation Identifiers Names and Codes (LOINC).13-15 In this
case, the dictionary could define a mapping relationship between the
terms in each of the systems so that information could be shared between
the systems while maintaining the semantic meaning of the terms.
One final note about data dictionaries concerns the desire or need to
provide a unique code for each term in the dictionary. The unique code is
necessary because the same term representation might be used to describe
different concepts. For example, the word temperature might be used by a
patient to describe having a “high temperature” (chief complaint),
whereas a nurse might use this word to chart a physical measurement of
“body temperature” (observation). These are different concepts, and the
concept codes ensure that they remain distinct. Other reasons to use
unique codes are because term representations may change over time or
multiple representations for the same term may be allowed depending on
the user or display context. In these cases, the code would remain the
same. Last, it is usually much faster to search for codes rather than
representations within a repository when they follow a strict numeric or
alphanumeric syntax. This makes the repository and thus applications
more responsive to user access, although the overhead of translating
stored codes to user-readable term representations must be considered.
Knowledge Base
A knowledge base (or knowledge repository) is a component within the
EHR that stores and organizes a healthcare enterprise’s information and
knowledge used by the enterprise for clinical operations. This information
might range from simple material such as lists of orderable items, available
services, or policy documents, to richer content such as order sets and
searchable medical subject ma er, to highly complex knowledge such as
clinical guidelines and decision support rule sets.
Knowledge base content is usually organized by a aching metadata
(information describing the content) to content items, allowing
categorization of the knowledge content based on contextual need. The
content itself usually follows a defined metadata model (detailed data
format description) so that it can be consumed easily by applications. In
some cases, the content may be human readable, such as content
consisting of medical journal articles that are indexed by subject ma er. In
other cases, the content may be machine consumable; that is, the content
may be read by a computer program and used to automatically produce
an output, such as a logic statement that might be executed by a decision
support engine to produce a suggestion or alert from a clinical guideline.
Often the data dictionary is used to supply coded content and index
information within the knowledge base. This ensures that the knowledge
base remains synchronized with the patient data repository and clinical
applications.
The knowledge base’s content (often known as knowledge “artifacts”)
allows an EHR to become a “content-driven” system as opposed to a
system whose knowledge is hard-coded in software programs. When
knowledge such as treatment protocols, drug-drug interaction rules, and
descriptive content is hard-coded in clinical applications, it is much more
difficult and costly to update those applications. By separating the
knowledge artifacts from the software and providing access through
linkage services, clinical programs can keep pace with the rapidly
changing and expanding medical environment, as represented by
approaches such as evidence-based practice and precision medicine.
One example of a knowledge-based environment is use of the
Infobu on standard: the Infobu on allows clinical applications to link
dynamically to contextually relevant content located either within or
outside a provider organization.5 The content provider may update this
content as newer information is discovered or produced, but the
applications that link to the content through the Infobu on do not need to
be changed because the interface (link) remains the same, providing a
more robust EHR. Content-driven systems can also use local knowledge
about a healthcare enterprise’s operations to optimize workflows and
enhance clinician interactions with the EHR.
As the content within a knowledge base grows, knowledge management
tools become necessary to maintain the information.16 Authoring tools that
allow knowledge content to be created and updated and then facilitate the
review process are particularly useful.17,18 In addition, governance policies
and procedures must be instituted to ensure the integrity of and promote
and coordinate the use of the knowledge within the repository.
Clinical Decision Support System
A CDS system, discussed in detail in Chapter 10, provides the technical
means to combine general medical and health knowledge with specific
data about a patient and current clinical context to assist a clinician in
making appropriate treatment choices and to alert healthcare providers
about relevant information and important events. For example, during the
ordering process, a clinician might be alerted about a potential drug-drug
interaction that was found by the CDS system when a newly submi ed
prescription was compared with the patient’s current medications. The
CDS system also might be used to advise a clinician on the preferred
treatment actions for a diabetic patient, based on the institution’s best
practice guidelines and the patient’s current medical state. In addition, a
hospital staff member might be alerted about a critically abnormal lab
result that could affect medical care.
The CDS system typically consists of (1) an inference engine that runs
rules or logic (programs), (2) methods for receiving or pulling data from
clinical sources, and (3) a communication system for notifying users or
other systems about decision support results. The CDS system may be tied
to a knowledge base to receive its rules, in which case the rules can be
updated as needed without having to change or recompile CDS code. The
CDS system also may contain hard-coded rules that must be changed by
recompiling code, or the logic may be based on machine-learning
algorithms that dynamically update as new information is processed by
the system.
Data services may be used by the CDS system to access clinical data in
the repository. Sometimes these data are automatically sent to the CDS
system by a “data drive” mechanism that automatically triggers a feed to
the CDS system whenever data are stored in the repository. Clinical
applications also may supply data directly to the CDS system for real-time
decision support; for instance, when a clinician is in the process of
performing an action and needs assistance from the CDS system before
making a final judgment. Quite often, even if data are automatically sent to
the CDS system through a data drive mechanism or directly from an
application, the rules to process the data require additional information
from the repository. In this case, the CDS system may use data access
services to retrieve the needed repository data.
The CDS system may need a queuing mechanism to support rules that
will be triggered later. For example, a rule processed on a lab result might
trigger an output that says to wait for a new lab value in 24 hours before
making a final recommendation to the clinician. If another lab result is not
found within 24 hours, the rule will provide a different output
recommendation, such as “order a new lab X.” Another use for the queue
is to support “stateful” clinical protocols, that is, protocols that remember
the state of the patient from a previous point in time and use this
information to make recommendations later.
Once a rule is run, the output result must be communicated to the
appropriate recipients. The CDS system might store a decision support
result in the data repository if the rule was triggered without direct user
input so that a clinician can see the result later. There might also be a
mechanism for notifying a specific user of a result through e-mail, text
message, or other communication pathway. When accessing the CDS
system directly from a clinical application, the CDS system must have a
method for communicating its results back to the application, usually
through a service or application programming interface (API). CDS
systems are explained in additional detail in Chapter 10.
System integration and interoperability
The EHR is often only one piece of a larger health information system
environment within a healthcare enterprise. In fact, larger institutions may
run two or more EHRs. Because no single EHR today can provide all of the
functionality needed in most healthcare facilities, the ability to share
information between systems is necessary. Departmental and ancillary
systems for the lab, pharmacy, radiology, registration, and billing, for
example, must be able to pass information to and receive information from
the EHR. Integrating these systems is typically the responsibility of an
interface engine (IE) (see the “Interface Engine” section). The different
methods for storing and communicating data used by health information
systems now necessitate interoperability standards to ensure proper
communication.
Interface Engine
Older intersystem communication methodologies used point-to-point
connections to allow different systems to share data and information; that
is, a specialized interface was created between one system (A) and another
system (B). The interface between systems A and B only knew how to
translate between these two systems and could not be used to “talk” to
another system. This method is fine if there are few systems in the
network. However, as the number of systems grows, the number of
connections multiplies rapidly. For a network with N systems where all of
the systems are interconnected, there are N × (N − 1)/2 connections; for
example, a network with six systems would have 6 × (6 − 1)/2 = 15
connections. Each system in the network must individually expose N − 1
interfaces to be fully interconnected with all other systems in the network.
In practice, this means that for a network with 6 systems and 15
connections, 30 interfaces must be maintained. If a system in the network
is replaced, all of its N − 1 interfaces must be replaced, too.
Because of the cost and complexity of point-to-point interfaces, modern
information systems often employ an interface engine (IE). An IE allows
each network data source to have one outbound interface that can then be
connected to any receiving system on the network. The IE is able to queue
the messages from a data source, transform the messages to the proper
format for the receiving systems, and then transmit the messages to
appropriate systems. Acknowledgment and return messages also can be
routed as appropriate by the IE.
IEs use proprietary software or standard programming languages such
as Java to write routines for translating one system’s data message model
into another system’s model. Most of today’s IEs support standard
messaging interfaces such as HL7 and X12. The IE must also translate
terminology between systems because, quite often, systems will use
different vocabularies or coding methods to represent comparable
concepts. Sophisticated IEs will use external sources such as a standard
data dictionary to provide the necessary terminology translation services.
This allows the IE to remain up to date on the latest coding conventions
and translations for the systems on the network.
The following scenario explains how an IE could be used to integrate an
EHR with various ancillary systems. At the beginning of a clinical
encounter, the patient is registered in the facility’s registration system. The
collected demographic information and encounter identifiers are
transmi ed by the registration system to the IE, which then transforms
and forwards this information to the EHR and the LIS. During the
patient’s visit, the physician uses the EHR to order a laboratory test. The
lab order message is appended with the correct patient identifiers and
routed through the IE to the LIS. The EHR uses a proprietary coding
system for lab tests that the physician orders; these are mapped to LOINC
codes that the LIS uses. When the lab completes processing of the test, the
lab results are returned by the LIS to the EHR via the IE. The IE also
branches LIS administrative information for the test to the facility’s billing
system for reimbursement purposes.
This scenario describes a somewhat simple network of five interfaces. In
reality, the registration system may be tied to many more systems that
need demographic and patient identifier information. The EHR will
provide order messages not only to an LIS but also to departmental
systems for radiology, pharmacy, and nutrition, for example. Each
department system’s results may need to be routed to several receiving
systems for storage, processing, and reporting; the EHR will typically need
an inbound interface from each of these diagnostic systems. The effect
when one or more of the systems on the network is replaced must be
considered. An IE greatly improves the ability to address this complicated
network environment in an efficient and usually less costly manner.
Interoperability Standards
System and data sharing or interoperability has long been a problem for
EHRs. Most EHRs and departmental and ancillary systems have been
wri en using proprietary programming and data storage schema. This has
made it difficult to share data between systems. When trying to connect
two systems, integrators must first agree on a common exchange
mechanism and message format (called syntactic interoperability). Then,
to ensure that the data passed between the two systems are
understandable by the receiving system, the content of the message must
be mapped to a comparable and comprehensible model and terminology
in the receiving system (called semantic interoperability).
Some of the most widely used clinical messaging standards are
produced by the HL7 organization.19 Virtually all major clinical
information systems in the United States support at least part of the HL7
version 2.x message standard, providing a common method for connecting
EHRs and departmental and ancillary systems. The version 2.x standard
specifies the format for messages but does not specify a standard for the
content. The HL7 version 3 standard uses a much more formal
specification to define messages, and it is based on the Reference
Information Model (RIM). The RIM and the Clinical Document
Architecture (CDA) can be used to ensure be er semantic interoperability
between systems. Version 3, initially published in 2005, is not as widely
implemented in clinical information systems in the United States as is
version 2.x because of its added complexity and significant
implementation costs. Most clinical interface engines support the HL7
standards.
Many national and international terminology standards have been
developed to support the exchange of clinical data and promote the
semantic interoperability of systems. Most of these standards were started
around a specific clinical domain but may have been expanded to cover
additional domains as the terminology was adopted. For example, LOINC
was originally developed to describe clinical laboratory data, but it has
been expanded to cover other clinical observations such as vital signs.
SNOMED CT was originally developed as a nomenclature for pathology.
It has been extended to become a highly comprehensive terminology for
use in a wide variety of applications, including EHRs. Other terminology
standards include ICD-9 and ICD-10, Current Procedural Terminology
(CPT), RxNorm, and nursing terminologies such as Nursing Interventions
Classification (NIC), Nursing Outcomes Classification (NOC), and North
American Nursing Diagnosis Association (NANDA). For additional
information on terminology standards, refer to Chapter 22.
Networking systems
In the previous section, we discussed system interoperability within the
walls of a single institution. However, there is a growing desire and need
to share patient information between institutions for quality, financial, and
regulatory purposes. In fact, sections of the Meaningful Use criteria in the
2009 Health Information Technology for Economic and Clinical Health
(HITECH) Act specifically call for sharing of clinical data between
healthcare providers and with public health organizations.11 Various
organizational models for sharing data have been developed at the local,
regional, and national level.
Regional Health Information Organization, Health
Information Exchanges, and Health Information
Organizations
One of the earliest models for a data sharing network was the regional
health information organization (RHIO). An RHIO is typically
characterized as a quasi-public, nonprofit organization whose goal is to
share data within a region. RHIOs were quite often started with grant or
public funding. Health information exchanges (HIEs) followed RHIOs,
and they are differentiated from them by having an anchor provider
organization and, usually, by being started because of financial incentives.
The anchor organization often provides a data-sharing mechanism to
affiliated providers. In practice, the operating characteristics of RHIOs and
HIEs may be quite similar, and the distinctions are only in the terminology
used.
Health information organizations (HIOs) are the latest models, and
they support the 2009 HITECH Act mandate for health information
sharing between EHRs. The role of the HIO is to facilitate data exchange
according to nationally recognized standards. This may mean that the HIO
only provides guidance to the organizations in an information exchange
network or that the HIO assumes the technical responsibility for providing
the exchange mechanism.
To facilitate data sharing, the information exchange network is designed
as either a centralized or a distributed data architecture (although hybrids
of the two are also sometimes deployed). In the centralized model, the
participants on the networks push their data to a central repository housed
in one location. Organizations then retrieve data from the repository as
needed. In a distributed model, the network participants keep their data
and provide a mechanism to answer requests for specific data. In either
model, the network must provide the ability to match patients between
organizations correctly. Without this matching functionality, the network
participants are unable to share information accurately. The network may
use a global MPI that can map patient identifiers between organizations. In
addition, to provide syntactic and semantic interoperability of the data, the
network participants must agree on standards for information exchange.
These standards may be similar to those discussed in the previous section
on interoperability standards. Last, the exchange network must provide
appropriate security mechanisms to authenticate and authorize
appropriate use, prevent unwanted access, and accommodate necessary
auditing and logging policies.
To connect to the information exchange network, participants may
simply treat the network as another interface on their local IEs. This allows
participants to use existing methods for sharing data, particularly if a
centralized model is used and data are pushed to the central repository. In
the case where a distributed model is used and participants must accept
ad hoc, asynchronous data requests, some additional effort may be
required to effect data sharing. Another model for linking to the exchange
network is to provide a service layer that accepts ad hoc requests for data.
The data request services are accessible by network participants, often in
the same way that web pages are made available as URLs on the World
Wide Web. This method is becoming more popular and is particularly
advantageous in the distributed exchange model because it be er supports
pulling data from an organization as it is needed.
eHealth Exchange
The Office of the National Coordinator (ONC) for Health Information
Technology facilitated the development of a national “network of
networks” whose purpose was to enable healthcare provider organizations
and consumers to share information across local information exchange
networks. The eHealth Exchange (formerly known as the Nationwide
Health Information Network [NwHIN]) created a set of policies and
national standards that allows trusted exchange of health information over
the internet.20 The effort is now managed by a nonprofit industry coalition
called The Sequoia Project (formerly HealtheWay). The Exchange includes
organizations from all 50 states and four federal agencies (Department of
Defense [DoD], Veterans Health Affairs [VHA], Health and Human
Services [HHS], and Social Security Administration [SSA]) and allows
sending and requesting health information from participating
organizations. An initial implementation of the information exchange
architecture called CONNECT was demonstrated in 2008, with
participation by various public and private entities,21 and it includes
components for core services (e.g., locating patients, requesting
documents, and authentication), enterprise services (e.g., MPI, consumer
preferences management, and audit log), and a client framework
(application components for building test and user interfaces to
CONNECT). A simplified implementation of the exchange architecture
called Direct allows two organizations to share medical information
through common methods, such as e-mail-like protocols.22 These methods
require a provider directory to ensure secure, point-to-point routing of
messages.
ONC has developed a Shared Nationwide Interoperability Roadmap23
that gives further direction for the technical and operational infrastructure
that must be developed to advance true system-wide interoperability. This
Roadmap addresses not only data syntax and semantic standards but also
identity resolution, data security, access authorization, directories, and
resource locators. Most recently, ONC released an Interoperability
Standards Advisory, whose purpose is to “coordinate the identification,
assessment, and determination of the ‘best available’ interoperability
standards and implementation specifications…[to meet] clinical health IT
interoperability needs.”24 Readers may view the entire document at:
[Link]/sites/default/files/2016-interoperability-standards-
advisory-fi[Link]. New material from the ONC’s Standard Advisory
panel may be viewed at: [Link]/providers-
professionals/standards-interoperability or by browsing for
“interoperability standards,” inpu ing the current year and “ONC.”
Other infrastructure models
The previous sections on the EHR component model and system
integration focused on technical infrastructure that may be deployed
locally within an organization. Other models exist that can also supply this
infrastructure, but from sources outside an organization’s walls.
Application Service Provider
Rather than purchasing and installing an EHR, some institutions opt to
partner with an application service provider (ASP) for their clinical
application needs. An ASP is a company that hosts an EHR or
departmental system solution for a healthcare enterprise and provides
access to the application via a secure network. Users of the application are
usually unaware that they are connecting to a vendor’s offsite computing
facilities. An ASP model relieves the healthcare enterprise from having to
host and support the technical components of the EHR, which may lead to
lower capital infrastructure costs. This obviously helps smaller facilities
that lack funding for a complete IT shop, but it also may be financially
beneficial for larger facilities because of the economies of scale that an ASP
vendor can provide over many customers.
On the contrary, the ASP model implies some loss of control of the EHR.
ASP customers must be content with their data being stored at the
vendor’s offsite location. They must also accept that versions of application
software, functionality, configurations, and levels of support typically will
be what the majority of the other ASP customers are using. Last, it may be
more difficult to integrate with other IT systems at the local site because
the ASP vendor may not support interfaces for a healthcare enterprise’s
entire portfolio of departmental and ancillary systems. Interfaces may be
more difficult to develop and maintain because the ASP vendor controls its
half of each interface and may not prioritize projects in sync with the
customer’s needs.
Cloud Computing
A growing trend in IT is the concept of cloud computing. Although the
term cloud computing is somewhat new, the basic idea behind it goes back
decades. It can be traced to early suggestions that computing would
someday be like other public utilities, and IT consumers would plug into
networks of applications and physical resources in the same way that
electricity and phone lines are accessed. Computing resources would be
supplied by either public organizations or a few private enterprises and
shared by the consumer community.
The term cloud was a ached to this concept because early networking
diagrams enclosed these “public” computing resources within a figure of a
cloud to represent resources outside of an organization’s physical walls
and because of the ability for these resources to change location without
affecting the consumer’s ability to access them. Although we often still
consider clouds as being available in a public space (i.e., accessible by
many consuming individuals and organizations), a cloud may also be
private (i.e., deployed within the walls of single organization for use by
that organization’s various entities). Cloud computing can be separated
into three models: software as a service (SaaS), infrastructure as a service
(IaaS), and platform as a service (PaaS).25
In the SaaS model, service providers run applications (services) at one or
more locations and make these applications available to consumers.
Consumers connect to the services through a cloud client, often something
as simple as a web browser. This eliminates the need for consumers to host
and support the applications themselves. The SaaS provider can also use
economies of scale to provide multiple servers and sites that host
applications, potentially increasing the efficiency, performance, and
reliability of the applications. SaaS applications may be as simple as a
service that provides a single function, such as Google Maps, or an
application that covers an entire set of workflow requirements. The ASP
model described in the previous section may be considered a type of SaaS.
In clinical computing, SaaS might be used to provide an entire EHR or
EHR function (e.g., scheduling and lab results review from a lab services
provider) or more focused functions within an EHR application such as
drug-drug interaction checking during the ordering process, information
retrieval for clinical descriptions of diagnoses and abnormal lab results, or
terminology mapping between coding systems.26
The most utility-like example of cloud computing is IaaS. In this model,
the cloud provider makes computing machinery available to consumers
from large pools of resources. The IaaS provider can scale the computing
resources to the needs of the consumer. This practice has become simpler
with the growing use of virtual machines, which can be installed as multiple
instances on physical hardware and simulate most of the characteristics of
an operating system and its environment. The consumer is responsible for
deploying the operating system, applications, databases, and tools, for
example, and then supporting those installed assets. Users may connect to
the assets deployed on the IaaS resources through the internet or via a
virtual private network. The IaaS provider can help organizations to lessen
the cost of ownership of physical resources and offload the need to employ
local technical personnel to maintain equipment.
The PaaS model is a simplification of the IaaS model, in which the cloud
provider deploys an entire platform for running the customer’s computing
needs. This may include the operating system, application server, web
server, and database, for example. The consumer then installs or develops
software on the resources provided. The PaaS provider supports the
computing resources supplied by its cloud, while the cloud user supports
the assets built on top of it.
Current challenges
Even though most of the technologies discussed so far have existed for
decades, many technical challenges and barriers remain for
implementation in the clinical environment. For the EHR repository,
primary challenges remain around the robustness of storage architectures.
With transitions to patient-centered longitudinal records, the size and
content scope of the repository has grown considerably. Additionally, as
new data types are added to the EHR to capture information about clinical
encounters and patient health that is more detailed (particularly to meet
the expanding requirements of Meaningful Use), the repository must be
able to handle new information that was not anticipated in its original
design. These facts demand that the database and storage mechanisms be
flexible.
Databases must be able to scale in size to accommodate large amounts of
online data. As they grow in size, they must retain performance
characteristics that do not slow down the workflow of the clinical
environment. Some database architectures and their storage services
require new designs and recompilations as new data types are added.
Some are not designed for the volumes of information that may be stored.
Careful consideration of repository architecture must be performed before
system selection to ensure that the system will meet the ongoing needs of
the healthcare organization. Consider that patient data will have a lifetime
measured in decades, whereas the technology will be enhanced or
replaced on a 5- to 10-year, or less, life span. There must be a graceful way
to transition the data in the repository to new technology without loss of
information.
Data integration and interoperability remain the most difficult
challenges in health information systems. The lack of standards, or the lack
of implementation of standards, is a significant barrier. Expanding federal
requirements around data exchange are forcing EHR vendors to abandon
proprietary data architectures and adopt accepted standards for many
types of data, but considerable work still needs to be accomplished to
ensure semantic interoperability of data. This issue, coupled with older,
outdated repository architectures, may leave some health IT vendors, and,
therefore, their customers, without a path forward for their systems.
Some underlying system architectures make the EHR component model
described earlier in the chapter difficult, impractical, or impossible to
implement. Component APIs and services may be inflexible and require
considerable effort to add new components, particularly if a different
development group or vendor supplies those components. This issue
reflects a lack of system integration standards (to accompany the lack of
data integration standards discussed previously). Because of this, quite
often, a health IT vendor must supply all pieces of the component model,
locking customers into a single solution that may lack the needed
robustness in one or more of the components.
Finally, one of the most vexing challenges for health IT has been the
ability for clinical applications to integrate well with clinical workflow.
Informatics professionals address these workflow issues during system
analysis and usability activities to improve application adoption by
clinicians. Additional information for understanding usability activities is
included in Chapter 21. Still, a thorough analysis and usability assessment
may not ensure acceptance in all environments. Some amount of
application adaptability is often necessary to tailor the system to specific
se ings and for specific individuals. On the contrary, allowing for
application customization at the facility, department, and user level may
be quite difficult to accomplish and support (depending on the system
architecture and technical abilities of the application support staff), and it
can lead to nonstandard implementations that may prove costly to operate
and maintain. Upgrades to nonstandard and highly tailored applications
can also be extremely challenging. How well application providers
support customization is an important consideration in system selection. It
can have significant consequences on overall clinical IT systems
infrastructure. Too li le customization may mean that multiple
applications must be added to the infrastructure to address the specific
needs of each department or unit. More liberal customization, besides
adding user complexity, may force larger manual and automated
governance structures on the organization to ensure that individual
solutions still support organizational policies and goals. In either case, the
underlying technology of the clinical applications has a profound effect on
the ability of users to do customization. In some cases, a programmer must
change or add source code to make local adaptations. In other cases, tools
supplied with the application allow configuration changes that can be
incorporated more easily and quickly in the application, but obviously
with limits to the scope of customization.
Conclusion and future directions
The technical infrastructure of a health information system includes
several key components that are unique to the healthcare environment. A
sound understanding of the a ributes of these components, as well as how
they interact, is essential for a successful system implementation that
supports the needs of the clinician users. No single off-the-shelf system
today can support all needs of the healthcare environment. Therefore it is
critical that the technical architecture be capable of supporting multiple
system connections and data interoperability. More functionality will also
become available from third-party vendors, and infrastructures should be
designed to support linking these capabilities directly to the clinical
workflow. It should also be expected that the desire, and requirement, to
share data outside an institution’s walls would expand. The informatics
role will continue to grow as the need to understand new technologies, as
well as how they can be combined with existing systems and exploited in
the healthcare environment, gains heightened importance.
Many new technologies are being explored or contemplated for health
IT infrastructure. Most of these technologies are not new to other
industries; healthcare has been much slower to adopt IT in general. In
some cases, these technologies have been implemented in organizations
that possess strong informatics experience and/or financial resources, but
they have not been employed more widely. Certainly, the increasingly
technology-savvy clinicians practicing at healthcare institutions are
demanding functionality that looks more like what they use daily in web-
based applications, smartphones, and tablet computers.
Mobile Apps
The growing use of mobile electronic devices has resulted in an explosion
of smarter technologies for operating systems, user interfaces, and
applications. Apple advertised more than 1.5 million apps available for its
iPhone and iPad as of July 2015. Google advertises 1.6 million apps for its
Android operating system, which is used in smartphones and tablets.
Over 165,000 of the available mobile apps can be categorized as mobile
health (mHealth) applications, and that number is growing (see Chapter
15 for detailed information). The apps range from personal health and
fitness, to medical reference materials, to radiology image and diagnostic
results viewers, to robust clinical documentation tools.
A valuable aspect of these apps is that they are easily installed on a
user’s device. They are typically much cheaper than applications that run
on laptop and desktop computers. The ability to “carry” the app anywhere
the user goes and remain connected to an institution’s network (through a
cellular or wireless network) is appealing to clinicians who roam to several
locations throughout their workday. The volume, ease of installation, and
low cost of apps can provide a much more “democratic” user voice in the
selection of apps that are most useful or appealing to the user. The
lightweight nature of mobile apps and the use of common user interface
and application programming interface standards may make it easier for
healthcare institutions to develop their own apps, customized to local
needs.
There are challenges, however, to the use of mobile apps in the
healthcare se ing. First, the small screen factor of mobile devices limits the
amount of information that may be displayed or collected. This can mean
scrolling or paging through many screens to eventually get to the
information needed by the clinician. It also may be easier to miss
important information on the screen because of the smaller font and image
sizes. Wireless networking may be another challenge for healthcare
institutions. The increasing number of mobile devices in a healthcare
facility, coupled with the “cha y” nature of many mobile apps, may
overwhelm a hospital or clinic network. Organizations may need to
develop support for virtual private networks to accommodate users who
wish to use their mobile devices and apps outside the institution’s walls.
IT departments also must be able to handle devices brought into a facility
by clinicians who are not employed by the organization, leading to
potentially significant support and security issues. Finally, although the
“democratization” of apps referred to earlier may seem at first blush to be
a positive trait, a healthcare institution must be concerned with the
support, data, process standardization, and security issues that may ensue.
If clinicians are free to choose any app (e.g., for charting vital signs or
ordering), will those apps be able to access and store data in the
institution’s required format, run decision support rules required for
patient safety and quality reporting, and share information with co-
workers and referral partners?
Service-Oriented Architecture
There has been much hype for years in the IT industry in general about
service-oriented architecture (SOA), and healthcare has certainly been an
active topic area in the discussion. SOA can be described as an architecture
design pa ern in which services are business oriented, loosely coupled
with other services and system components, vendor and platform
independent, message based, and encapsulated with internal architecture
and program flow that are hidden from the service user. SOA services are
most evident today as web-based (URL) services that are accessed through
Hypertext Transfer Protocol (HTTP). Extensible Markup Language (XML)
and JavaScript Object Notation (JSON) are commonly used as the message
formats. The interface to a web service, including its allowed input
parameters and return data, is often described using the Web Services
Description Language (WSDL).27 SOA fits in the SaaS category of cloud
computing, but it has much more highly defined design and
implementation pa erns.
What this means to IT is potentially a more decentralized approach to
system design in which solution providers concentrate on specific aspects
of a business need. System architects can pull together many business
services to meet the larger application needs of the organization without
having to worry about the complexity inside the service code. Reuse is a
key benefit of SOA because services may be used by different consumers
for a variety of applications. Because the services are loosely coupled with
each other and with other aspects of the service user’s system, service code
may be changed and enhanced without necessarily having to change other
aspects of the overall consuming system. Changes can easily be
communicated to service users through updates in a service’s WSDL.
The SOA design philosophy has been researched in healthcare for a
number of years. A joint effort by HL7 and the Object Management Group
(OMG) to develop standards for healthcare services has resulted in the
Healthcare Services Specification Project (HSSP).28,29 HSSP has been
investigating several health IT functional areas that could become the
building blocks for EHR services. One example is CDS.30 By exposing CDS
services over the web, users would be able to access CDS content from a
variety of sources without having to maintain the content locally. Other
areas being pursued by HSSP include services for terminology mediation
and clinical data access and update.
Because no single vendor product can meet all needs of a healthcare
enterprise, vendors and market segments (e.g., pharmacy fulfillment and
HIE) are also incorporating SOA principles in their architectures in order
to more easily and quickly provide functionality to users. Whether a major
EHR product will ever be entirely composed of SOA services supplied by
third-party providers is an open question, but it is likely that health IT
infrastructures will provide increased support for services as standards
continue to emerge and service providers become more numerous and
relevant to the healthcare community.
One emerging technology that is capturing the a ention of the provider,
vendor, and standards communities is Fast Healthcare Interoperability
Resources (FHIR).31 Currently a draft HL7 standard, FHIR combines
features from HL7 v2, v3, and CDA with a foundation in existing web
messaging standards such as HTTP, XML, JSON, and REST
(representational state transfer). As its name implies, it is designed to
provide a faster path to system interoperability. The common building
blocks of FHIR are called “Resources.” Resources describe a specific type
of exchange, which includes the type of information being exchanged (e.g.,
patient demographics, conditions, and medications) and the type of
interaction (e.g., search, read, and update). The ease of use of the standard
has encouraged several major electronic medical record (EMR) vendors to
begin building FHIR interfaces to their systems, demonstrating a long-
sought desire for open, nonproprietary services that others may use to
access data and build third-party applications.
Open Source Software
Open source software (OSS) can be defined as software whose source code
is made available to users, who then may be able to examine, change, and
even redistribute the code according to the software’s open source license.
OSS is often developed in a public forum in which many programmers
from different organizations, or acting as independent agents, contribute
to the code base. There is typically a central code repository where all
contributors place their updates and where users can download the latest
versions of code or compiled objects. Users may also keep a list of bug
reports and feature requests. Open source advocates believe that OSS may
be more secure, bug-free, interoperable, and relevant to specific user needs
than proprietary (vendor) software is because a more heterogeneous
group of individuals with varying uses for the software has direct access to
the source code. Some noted examples of OSS are the Apache HTTP web
server, the Linux and Android operating systems, the Eclipse software
development platform, the Mozilla Firefox web browser, and the
OpenOffice software suite.
Several examples of OSS exist in the healthcare arena. EHR applications
include OpenMRS, a multi-institution project led by the Regenstrief
Institute and Partners In Health, a Boston-based philanthropic
organization,32 and OpenEHR, an ONC-certified ambulatory EHR.33 The
U.S. Department of Veterans Affairs is seeking to develop an open source
version of its VistA EHR.34 The openEHR Foundation is developing open
clinical archetypes (standard data models) to promote sharable and
computable information.35 Open source, standards-based CDS tools and
resources are being developed as part of OpenCDS.36,37 Mirth Connect is
an OSS IE that is built for HL7 integration.38 Apelon provides its
terminology engine, Distributed Terminology System (DTS), as an open
source platform39; 3 M Health Information Systems has announced that it
has made its health data dictionary available through open source.40,41
FHIR (described above) is another example of OSS. These examples, and
the many more in development or production, point to a future health IT
infrastructure environment with wider clinician collaboration and less
expensive software licensing costs. However, organizations need to be
aware that “open source” does not mean free; they must budget for local
customization, implementation, training, support, and hardware costs.
SMART
Through its Strategic Health IT Advanced Research Projects (SHARP), the
ONC funded the Harvard-based Substitutable Medical Applications,
Reusable Technologies (SMART) Platforms project.42 The goal of SMART is
to provide a health IT platform based on core services that allows apps to
be substituted easily. Inspired by the boom in mobile apps for cell phones
and tablets, researchers have developed an application ecosystem in which
data can be accessed easily and presented to apps constructed for specific
purposes. The apps can be bundled to provide an entire health IT solution.
Institutions can decide which apps their “containers” will deploy for their
clinicians based on local needs and specific app aspects such as security
capabilities. The API is open source, allowing anyone to develop new
applications, which can then be provided to the user community as open
or closed source code. A government-funded effort initially, it will be
interesting to see whether the SMART platform will be adopted widely by
the healthcare provider and vendor community or if a similar effort may
compete with SMART. A recent initiative with FHIR, SMART on FHIR43,
has combined the open application technology of SMART with the open-
exchange standard in FHIR, to provide interesting new possibilities for
health application development.
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Discussion questions
1. Describe the role of the informatician in designing and implementing the
EHR technical infrastructure as outlined by the component model
discussed in the chapter.
2. How does a data dictionary influence the design and implementation of
an EHR? How does the data dictionary enhance and restrict the EHR?
3. In what circumstances might a clinical infrastructure based on either
third-party service providers or mobile applications be desirable? What
cautions would we place on these technologies in the same
circumstances?
4. How do incentive programs such as Meaningful Use affect, both
positively and negatively, technical infrastructures in healthcare
se ings?
5. Assume that you are leading a group developing a CDS system for your
organization. Choose a particular clinical environment and set of clinical
problems you want to address and describe the types of interfaces you
would need with other components in the clinical infrastructure in order
to be successful.
6. What would be potential areas of concern for an EHR that heavily used
third-party services to supply critical clinical functionality, such as
decision support or medical reference links?
7. Meaningful Use criteria mandate that healthcare organizations be able to
share data with other healthcare providers and public health
organizations. These mandates have expanded over time. Describe how
you would design the technical infrastructure to support this expansion
so that new data-sharing criteria are easily incorporated into the system.
8. Vendors often design “closed” infrastructures to lock customers into
their products. What would be positive and negative aspects, from the
healthcare organization’s viewpoint, of having such an infrastructure?
9. As opposed to the closed infrastructure of most vendor systems, open
source systems may allow multiple groups to contribute to the
underlying system code and architecture. Describe the positive and
negative aspects of this approach for the healthcare organization.
Contrast this with the SMART or SMART on FHIR approach.
10. The Infobu on standard for access to knowledge resources is receiving
growing interest from health IT vendors and users. If more medical
knowledge resources are made available through this standard, how
might this change the nature of EHR applications, CDS systems, and
local knowledge development and storage?
CDS, Clinical decision support; EHR, electronic health record; FHIR,
Fast Healthcare Interoperability Resources; SMART, Substitutable Medical
Applications, Reusable Technologies.
Case study
An integrated delivery network (IDN) serving a large urban and rural
demographic area is using separate EHR systems in its inpatient and
outpatient se ings. Some of the specialty departments have also
purchased their own systems for documentation. Unfortunately, this
means that information collected in the inpatient se ing is not available
when patients are seen in the IDN’s outpatient clinics (and vice versa). The
clinicians need this information to be be er informed about their patients
and to provide optimal care. In addition, Meaningful Use requirements for
problems, medications, and allergies, as well as new chronic disease care
initiatives that the IDN is implementing for its patient population, are
being hindered by the separate systems. The clinicians have been given
accounts on both EHRs, but this is cumbersome for the users because they
must be trained on multiple systems, they use valuable time logging into
different systems and navigating for information, and there is a potential
safety issue if the user selects different patients on the two EHRs. A
coordinated decision support environment has also been difficult to
implement because the two EHRs use different coding systems and do not
share most of their information. This means, for example, that admission
rules for congestive heart failure patients cannot be linked to the
ambulatory medication list and recent vital signs measurements to run the
IDN’s standard care process models.
The IDN realizes that it will not be able to replace either EHR in the near
future and that, even if it could, there will still be issues with integrating
information from the specialty care systems. It decides on a strategic plan
to create a CDR that is fed with high-value data from each of the clinical
systems. The outpatient EHR’s MPI already was being used as the master
unique identifier for most of the IDN’s systems, so it can be incorporated
with the new CDR. A robust IE is implemented to supply data from the
clinical systems to the CDR. To normalize the different terminologies used
on their various systems, the IDN engages a terminology-services vendor
to provide a central data dictionary for the CDR and map the concepts
from the current systems to the central standard terminology. The IE uses
the terminology services to normalize inbound data to the CDR from the
other systems.
The second phase of the strategic plan is to build a CDS system on top of
the CDR to develop and maintain enterprise patient-care rules. As rules
are executed, their results will be both sent through the IE to the existing
EHRs and stored in the CDR; storing the decision support results in the
CDR provides a link to supporting data from all clinical systems, which
can help with rule triage and maintenance. Another effort in this phase is
to provide clinician views into the CDR. The IDN plans to build data
services, possibly based on FHIR resources, that can be called by third-
party EHRs to display longitudinal, enterprise-wide patient data from
within the EHRs. Several simple web- and mobile-based viewing
applications using the data services will also be developed and will be
available in a stand-alone mode or as callable modules within the current
EHRs. The IDN will use SMART to provide the user and patient context
from the EHR to these viewing apps so that the clinicians will not have to
log in twice and find the patient.
Discussion Questions
1. Describe the advantages and disadvantages of the situation in the case
study.
2. You are the chief medical informatics officer for the organization. You
are asked to comment about how the technical plans will affect
clinicians. Based on the case study, how do you respond?
3. The organization receives a $3 million gift from an informatics
benefactor. You are an informatician in the organization. What would
your technical priorities be to remedy the issues in the case study?
CDR, Clinical data repository; CDS, clinical decision support; EHR,
electronic health record; IDN, integrated delivery network; IE, interface
engine; SMART, Substitutable Medical Applications, Reusable
Technologies.
UNIT 2
Information Systems and
Applications for the Delivery of
Healthcare
6
Electronic Health Records and
Applications for Managing Patient
Care
Charlo e A. Seckman
Abstract
The electronic health record (EHR) is one of the most significant innovations
introduced in healthcare over the past several decades. Today almost all healthcare
providers are using computerization to share patient data and information across
facilities locally, nationally and, eventually, internationally. Although there is
concern about how to establish a nationwide interoperable system, and many issues
still need to be resolved related to EHR implementation and adoption, the long-term
benefits to organizations, healthcare providers, patients, and consumers cannot be
ignored. This chapter explores the evolving nature of the EHR to include essential
components and functions, how these components are used in the clinical se ing,
and the benefits related to cost, access, quality, safety, and efficiency of care. A
discussion of key issues that influence the implementation and adoption of these
systems and future directions concludes this chapter.
In the future, the electronic health record (EHR) will play a pivotal role in
personalized medicine as a medium for data, information, knowledge and
wisdom exchange, and exploration.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Analyze terms and definitions associated with the electronic health
record (EHR).
2. Describe the essential components and a ributes of an EHR.
3. Define federal requirements in the context of EHR adoption and the
impact on health practitioners.
4. Examine EHR applications used in the clinical se ing.
5. Analyze the benefits of an EHR related to cost, access, quality, safety,
and effectiveness.
6. Evaluate stakeholder perspectives and key issues that affect EHR
adoption.
7. Explore future directions for EHR adoption and integration.
KEY TERMS
ancillary system 98
Bar Code Medication Administration (BCMA) 96
clinical decision support (CDS) systems 94
clinical documentation 96
computerized provider order entry (CPOE) 95
data integrity 102
disruptive technology 103
electronic health record (EHR) 91
electronic medical record (EMR) 91
electronic medication administration record (eMAR) 95
Health Information Technology for Economic and Clinical Health
(HITECH) Act 93
niche applications 97
patient-generated health data (PGHD) 104
radio frequency identification (RFID) 96
stakeholders 99
Introduction
The complex nature of the current U.S. healthcare system has created a
challenging environment for managing patient data and information.
Traditional paper systems can be easier to use for documenting a single
episode of care, but access to these records is limited, reporting is
extremely cumbersome, and trending of data across patient visits or types
over time is nearly impossible. Provider specialty practices create
treatment silos that often hinder continuity of care. Healthcare providers
and hospitals endeavor to keep current with billing regulations to receive
optimal reimbursement. This requires vigilant monitoring of private
insurance contracts and changes in governmental mandates. Some
clinicians find it difficult to maintain competencies and gain access to
information about the latest medical techniques and research. Add to this
the introduction of personal computers, mobile devices, and the internet,
which have boosted consumer demands and a variety of healthcare
delivery concerns.
The robust nature of the electronic health record (EHR) has the potential
to address many of these issues and transform the way we collect, store,
access, process, manage, and report patient data. Government and
financial incentives are being offered to expedite the implementation and
expansion of EHR systems. However, despite all of the a ention on this
technology, different views still exist about what an EHR is, what it does
or should do, and how it should be used.
Early Terms and Definitions
Multiple labels and definitions have been used throughout the years to
refer to electronic systems used in healthcare. Early terms focused on
using the words computer and record to merge the idea of a paper chart
with technology, but computers provided much more functionality than
did traditional methods. These early terms were not sufficient to describe
this emerging phenomenon. For example, specific terms and acronyms
such as computer patient records (CPRs), computer-based patient records
(CBPRs), and computer health records (CHRs) were used to identify
systems that contained select automated components of the patient’s
medical record. The acronym CPR was not popular in the health
community because it also represents the term cardiopulmonary
resuscitation. Generic names such as hospital information system (HIS) or
medical information system (MIS) were adopted to represent the
management of a larger body of data and information throughout a
specific hospital or healthcare system.
Later definitions for electronic systems in healthcare often focused on
the system’s distinctive purpose, content, ownership, and functional
differences. This is especially true for technology used in specialty areas
such as nursing, pharmacy, laboratory, radiology, and other support
departments. For example, a laboratory information system (LIS) would be
used to collect, store, process, and manage laboratory data and would be
controlled by the laboratory department personnel, whereas a pharmacy
system would provide medication inventory, control, and dispensing for
pharmacy personnel. Specific clinical departmental systems will be
discussed in more detail later in the chapter. Acronyms such as CBPR or
CPR referred to a larger collection of information about the patient, such as
orders, medications, treatments, laboratory and diagnostic test results, and
other information related to overall patient care. Although the terms imply
a patient-owned record, access and input to the record are typically
controlled by the healthcare provider. As computer technology continued
to progress and more functionality became available, a need surfaced for
clarity and refinement in terms and definitions relating to EHR systems.
Electronic Medical Record Versus Electronic Health
Record
More recently, terms such as electronic medical record (EMR) and
electronic health record (EHR) have emerged. These are often used
interchangeably, but it is important to understand the differences between
them. Sewell and Thede defined the EMR as “an electronic version of the
traditional record used by the healthcare provider.”1 Hebda and Czar
described the EMR as an electronic information resource used in
healthcare to capture patient data.2 In essence, an EMR can be viewed as
the electronic version of a patient’s paper chart. The EMR is what most
clinicians think of as the automated medical record system used in the
clinical se ing, and it represents an episodic view of patient encounters.
This type of system, seen in hospitals, hospital corporations, and clinician
practices, is predominately controlled by the healthcare provider. The
EMR is not just one system but may integrate and/or interface with
multiple other systems and applications used by the facility, such as
registration, patient scheduling, order entry, clinical documentation,
radiology, laboratory, and other departmental systems. The patient
usually does not interact with or provide input into the EMR, although
software vendors are working to incorporate portals that provide patient
access to test results, scheduling features, e-mail interaction with
clinicians, and the ability to add, correct, and update health information.
How is this different from an EHR? In 2008, the National Alliance for
Health Information Technology (NAHIT), as a division of the U.S.
Department of Health & Human Services (HHS), convened to clarify and
define key health information technology (health IT) terms. The EHR was
defined as “An electronic record of health-related information on an
individual that conforms to nationally recognized interoperability
standards and that can be created, managed, and consulted by authorized
clinicians and staff across more than one healthcare organization.”3 This
suggests the availability and use of communication standards, such as
nomenclatures, vocabularies, and coding structures, to share patient data
across multiple organizations, facilities and providers.4 In comparison, the
EMR is limited to information exchange within a single organization or
practice, whereas the EHR has the ability to exchange information outside
the healthcare delivery system.5
The Healthcare Information and Management Systems Society (HIMSS)
provides a similar definition of the EHR as a longitudinal electronic record
of patient health information produced by encounters in one or more care
se ings.6 The implication is that every person will have a birth-to-death
(and even prenatal and postmortem) record of health-related information
in electronic form from multiple sources, such as physician office visits,
inpatient and outpatient hospital encounters, medications, allergies, and
other medical services that support care, as well as personal input from the
consumer perspective. This means that components of the EMR would
ultimately be part of the larger EHR. Other definitions stress the
importance of the EHR as a way to automate and streamline workflow for
healthcare providers, support patient care activities, and provide decision
support, quality management, and outcomes reporting.7-11 Despite the
clarification provided by these definitions, many are still using the terms
EMR and EHR interchangeably. In addition, these definitions are often
directed toward the needs of the healthcare provider and lack reference to
patient and consumer interaction or integration of personal health records
(PHRs).
At this point, it is important to mention the PHR as a component of the
EHR. This type of record is primarily patient or consumer controlled and
is discussed in more detail in Chapter 14. The ultimate goal is that PHR
development conform to nationally recognized standards and be
integrated into larger systems, allowing the individual to view, manage,
and share personal health information with providers. As part of the EHR,
this could provide a more comprehensive record of a person’s medical
history and overall health.
In summary, EHR has become the preferred term for the lifetime patient
record that would include data from a variety of healthcare specialties and
provide interactive access and input by the patient. The term EHR is
distinct in meaning from the term EMR. As with other expressions in the
past, the term EMR may eventually fade away. Although some
disagreement exists on exactly what the terms EHR and EMR mean or
how an interoperable lifetime patient record will work, the EHR is clearly
a complex tool that will continue to grow and evolve.12
Electronic health record components,
functions, and attributes
Present-day electronic systems in most organizations typically include
patient demographics, financial data, order information, laboratory and
diagnostic test results, medications and allergies, problem lists, and
clinical documentation. Beyond these basic features, an EHR should also
incorporate clinical events monitoring, preventive care recommendations,
and decision support tools that enhance the quality, safety, efficiency, and
effectiveness of patient care. In 2003, the HHS formed a group called the
EHR Collaborative, to support rapid adoption and to develop standards
for EHR design in preparation for this initiative.13 This group included
sponsors from the following organizations:
• American Health Information Management Association (AHIMA)
• American Medical Association (AMA)
• American Nurses Association (ANA)
• American Medical Informatics Association (AMIA)
• College of Healthcare Information Management Executives (CHIME)
• eHealth Initiative (eHI)
• HIMSS
• National Alliance for Health IT (NAHIT), later disbanded
The EHR Collaborative held forums and gathered input from
stakeholder communities such as healthcare providers, insurance
companies, HIT vendors, researchers, pharmacists, public health
organizations, and consumers. EHR Collaborative organizations, along
with the Institute of Medicine (IOM) and Health Level Seven (HL7), were
tasked to design a standard for EHRs. As a result, the IOM released a
report on July 31, 2003, called Key Capabilities of an Electronic Health Record
System.14 This report identified eight essential care delivery components
for an EHR, with an emphasis on functions that promote patient safety,
quality, and efficiency. These essentials still apply today. In recent years,
the U.S. Department of Defense added dentistry and optometry records as
EHR components needed to provide a more comprehensive picture of
overall health status.15 See Table 6.1 for a list of essential EHR components
and their descriptions. Each component of an EHR incorporates unique
functions and a ributes that contribute to the integration of a
comprehensive patient record.
Table 6.1
Summary of the Electronic Health Record Essential Components and
Functions for Care Delivery
Adapted from Institute of Medicine, Committee on Data Standards for Patient Safety:
Board of Health Care Services. Key Capabilities of an Electronic Health Record System:
Letter Report. Washington, DC: The National Academies Press; 2003.
In addition to the various components and functions, there are 12 key
a ributes prescribed by the IOM14 as the gold standard components of an
EHR. These a ributes serve as guidelines to organizations and vendors
involved in the design and implementation of EHRs and include the
information shown in Box 6.1.
Box 6.1
The Institute of Medicine’s Key Attributes of
an Electronic Health Record
1. Provides active and inactive problem lists for each encounter that link to
orders and results; meets documentation and coding standards.
2. Incorporates accepted measures to support health status and functional
levels.
3. Ability to document clinical decision information; automates, tracks,
and shares clinical decision process/rationale with other caregivers.
4. Provides longitudinal and timely linkages with other pertinent records.
5. Guarantees confidentiality, privacy, and audit trails.
6. Provides continuous authorized user access.
7. Supports simultaneous user views.
8. Access to local and remote information.
9. Facilitates clinical problem solving.
10. Supports direct entry by physicians.
11. Cost measuring/quality assurance.
12. Supports existing/evolving clinical specialty needs.
Adapted from Institute of Medicine, Commi ee on Data Standards for Patient Safety: Board of Health Care
Services. Key Capabilities of an Electronic Health Record System: Le er Report. Washington, DC: The
National Academies Press; 2003.
Sociotechnical perspectives
Since the late 1990s, the design, implementation, and adoption of EHR
systems has received a great deal of a ention as a method to reduce
medical errors, increase patient safety, and improve the quality of care.16-18
The underlying assumption is that an EHR will save time, provide real-
time access to patient information at the point of care, facilitate the work of
the clinician, provide decision support capabilities, support clinical care
and research, and improve quality and safety of care.9,19-22 This section
explores factors that influence EHR adoption, federal requirements using
MU as an example, and the health practitioner’s role in EHR adoption.
Electronic Health Record Adoption
More recently, new regulations have emerged to guide adoption of EHRs
in the United States. Numerous strategies and incentives are being used to
expedite implementation, adoption, and MU of EHR systems. This section
will explore requirements for MU, the EHR Adoption Model, and the
health practitioner role in both EHR adoption and MU.
Federal EHR Requirements
National mandates and guidelines from collaborative working groups
were not enough to accelerate the development and adoption of health IT.
In 2009 the American Recovery and Reinvestment Act was passed, and it
included a critical component addressing healthcare technology called the
Health Information Technology for Economic and Clinical Health
(HITECH) Act. The HITECH Act authorized programs designed to
improve healthcare quality, safety, and efficiency using health IT.23 More
details about the HITECH Act and MU criteria, as well as other related
legislation can be found in Chapter 27. Of importance to this chapter, the
provision was targeted to stimulate the adoption of EHRs and the
development of secure health information exchange (HIE) networks. It
includes incentives for healthcare providers through MU of certified
EHRs. The purpose of MU is more than just implementing an EHR; it is
also to leverage the technology to improve quality, safety, and efficiency in
patient care. MU objectives are being implemented in three stages. Criteria
for each stage vary based on whether the EHR system is implemented in
ambulatory practices or hospitals. The first stage began in 2011 and
focused on electronic data capture and tracking of key clinical conditions,
communication, data sharing and coordination of care, reporting public
health information and quality measures, and engaging patients and
families.24,25 A set of core and optional objectives along with clinical quality
measures must be meet in order to receive incentive payments.
Requirements for Stage 2 MU were released by the Federal Register in
August 2012, with reporting that began as early as fiscal year 2014. The
focus of this stage is to encourage patient engagement and the robust use
of health IT through continuous quality improvement efforts, HIE
networks, and structured data capture. Along with employing Stage 1
objectives, healthcare providers and hospitals need to address an
additional set of core, optional, and clinical quality measures. In a broader
sense, the expectation for Stage 2 involves expanded EHR functionality to
support quality improvement, patient safety, structured information
exchange, population health, and research.24,26 Stage 3 criteria were
released for comment in late 2015, but implementation was delayed until
2017. Stage 3 will combine and expand on the objectives for the first two
stages to support further quality initiatives; improve safety, efficiency, and
patient outcomes; address population health requirements; provide
enhanced decision support; and promote patient-centered HIE.24
Electronic Medical Record Adoption Model
In 2005, the HIMSS Analytics group developed an EMR Adoption Model
(EMRAM) to track the progress of health IT adoption rates in hospitals
and, more recently, ambulatory facilities.27 The systems and functions
required for each stage for U.S. hospitals are shown in Table 6.2. Although
originally developed for the United States, the EMRAM is also being used
in Europe and Canada.28,29 This model provides realistic and achievable
measures in seven stages that coincide with MU requirements. The model
assists organizations by providing a sequenced implementation structure
for IT adoption to align with business strategies, benchmarking data to
compare progress with other facilities, and an approach that maps to MU
objectives. EMRAMs for physician practice and ambulatory facilities are
similar, with modifications specific to those se ings.
Table 6.2
HIMSS Analytics United States Electronic Medical Record Adoption
Model 2005–12
Stage Cumulative Capabilities
Stage Complete EMR; CCD transactions to share data; data warehousing in use; data continuity with emergency
7 department, ambulatory, outpatient; data analytics
Stage Physician documentation (structured templates); full CDS system (variance and compliance); closed-loop
6 medication administration (pharmacy-CPOE-barcode-eMar)
Stage Full radiology-PACS
5
Stage CPOE; CDS system (clinical protocols)
4
Stage Clinical documentation to include flow sheets, vitals, nursing notes, eMar; CDS system (error checking);
3 PACS available outside Radiology
Stage CDR with Controlled Medical Vocabulary, CDS system; may have document imaging; health information
2 exchange
Stage Major ancillary systems installed that include Laboratory, Radiology, and Pharmacy
1
Stage No ancillary systems installed
0
Adapted from Healthcare Information and Management Systems Society (HIMSS)
Analytics. HIMSS Analytics EMR Adoption Model (EMRAM).
<[Link] 2015.
CCD, Continuity of care document; CDR, clinical data repository; CDS, clinical decision
support; CPOE, computerized provider order entry; eMar, electronic medication
administration record; EMR, electronic medical record; PACS, picture archiving and
communication system.
Health Practitioner Role in Electronic Health Record
Adoption and Meaningful Use
Healthcare users play an important role in EHR adoption and MU.
Interdisciplinary participation is important throughout the systems life
cycle, from identifying strategic needs to selecting a system (see Chapters
16 and 17) to implementing (see Chapter 19) to maintaining systems (see
Chapter 20). Practitioners can serve various roles as they may lead efforts,
serve on key commi ees, participate in tailoring a system to local
workflow, participate in testing systems, or be super users during
implementations or upgrades. Once a system change is implemented,
clinical users have a responsibility to report any issues with functionality,
usability, workflow, or effect on patient care.
A typical EHR is designed to allow access and input by a variety of
healthcare providers as a way to manage care. In the same way, fulfillment
of the MU objectives requires active involvement and contributions from
multiple disciplines to produce high-quality patient outcomes. Although
early incentives were directed toward hospitals, clinics, and physician
practices, all health practitioners are integral to the collection of MU data
through the use of EHR technology.30 For example, nursing care is a
primary reason for hospitalization, so nurses’ roles in addressing the MU
objectives should not be underestimated. Nurses are the single largest
group of employees in the hospital se ing, where labor costs are often
bundled with room and supply fees.31 With the threat of a nursing
shortage, executives are pressured to find ways to increase productivity
while they struggle to recruit and retain qualified healthcare personnel.
The adoption of an EHR system can enhance access to patient information,
provide more accurate and complete documentation, improve data
availability, and provide decision support capabilities, often leading to
increased staff productivity and satisfaction.2,21,32
Many health practitioners are involved in providing care coordination
and patient education, key objectives of the MU requirements. Health
practitioners assist in designing clinical decision support (CDS) systems
that can be used to enhance patient adherence to disease management.
Other activities include developing data set standards to improve
outcomes, increase patient safety, and evaluate quality of care. Many are
engaged in local, regional, and national strategic initiatives to improve
care coordination using EHRs and an HIE.25,33,34 Although the initial
incentives have resulted in expanding the installed base of EHRs in the
United States, how the HITECH Act will affect the role of each group of
health professionals in the future is yet to be determined. What is clear is
that patient care should be a collaborative effort guided by
interdisciplinary teams that work together with the patient to provide the
best possible outcomes.
Electronic health record applications
used in the clinical setting
An EHR is composed of multiple applications. In different se ings, an
EHR may vary in terms of integration between the components, data
presentation, usability, and clinical workflow. This section discusses the
various applications currently used in the clinical se ing, including
computerized provider order entry (CPOE), Electronic Medication
Administration Record (eMAR), Bar Code Medication Administration
(BCMA), clinical documentation, specialty applications, and CDS.
Computerized Provider Order Entry
Computerized provider order entry (CPOE) is a component of the larger
EHR system. The “P” in CPOE initially stood for physician, but because
advanced practice registered nurses, physician assistants, and other
healthcare providers also write orders, this “P” refers to prescriber,
practitioner, or provider. CPOE is software designed to allow clinicians to
enter a variety of orders, such as medications, dietary services, consults,
admission and discharge orders, nursing orders, lab requisitions, and
other diagnostic tests, via a computer.
For many years, handwri en orders were interpreted and entered into
the computer system by unit secretaries, nurses, and pharmacists.
Transcription errors such as a misplaced decimal point and illegible
handwriting were major causes of error. Incomplete orders were a
problem that caused additional steps in the nursing workflow. The idea
behind CPOE was for prescribers, such as physicians, dentists, osteopathic
doctors, anesthesiologists, nurse practitioners, and physician assistants, to
enter orders directly into the computer. During the ordering process,
alerts, such as drug allergy warnings, and other decision support rules
should be available to assist the healthcare provider. Once an order is
entered, the CPOE system interfaces or integrates with other EHR
components, such as a laboratory or pharmacy system, to process the
order. In fact, the term order entry can be misleading, as CPOE is truly an
orders management system that allows orders to be entered, processed,
tracked, updated, and completed.
The 1999 IOM report To Err Is Human: Building a Safer Health System18
and demands from special interest groups put pressure on physicians and
other prescribers to enter their orders directly into EHRs. Financial
incentives offered through the HITECH Act and MU objectives in all
stages were designed to enforce the use of CPOE and systematic adoption
of EHR functionality. The mandate for EHR adoption, and specifically
CPOE, as a means of reducing medical and medication errors continues to
receive much a ention.17,18,35 Studies have consistently demonstrated the
benefits of CPOE on reducing medication errors. Early landmark studies
found that the implementation of CPOE decreased the length of hospital
stay, lowered costs, improved quality of care, improved the
appropriateness of drug dosing, and decreased the number of allergic
reactions.35-38 Mekhjian et al.39 conducted a pre- and post-CPOE
implementation comparison study at a large university medical center and
found significant reductions in transcription errors, faster medication
turnaround times, and timely reporting of results. Bates et al.40 went
further by evaluating the effect of CPOE with decision support tools on
different types of medication errors and reported a significant reduction in
overall errors. Other studies that focused on CPOE implementation
suggest that medical and medication errors can be reduced along with
improving data integrity, accuracy, workflow, and patient outcomes.41-44 In
essence, CPOE combined with CDS capabilities such as checking for drug
interactions, drug-allergy interactions, and dosing ranges can significantly
reduce many serious medication errors.45
Physician resistance, financial constraints, and other issues make CPOE
compliance challenging. In a landmark study, Ash et al.17 identified
unintended consequences of CPOE that lead to medical errors related to
(1) the process of entering and retrieving information and (2) methods of
communication and coordination. Koppel et al.46 also researched CPOE-
related factors that may increase the risk of medication errors and found
that new errors were reported because of fragmented data and processes,
lack of integration among systems, and human-computer interaction
issues.
Using CPOE can be time consuming during order entry, and design
efficiencies are needed to entice clinicians to enter their own orders. For
example, before CPOE, many providers used standard handwri en order
sheets for their patient population. Order sets were developed to include
all or most of the information required to process multiple orders at one
time. In a study comparing the use of traditional order entry methods and
standardized order sets, researchers reported that using order sets had the
potential to reduce errors, decrease order-entry time, and eliminate
variations in order presentation.47
The lack of decision support or overuse of alerts was another issue. In an
early study, Payne et al.48 found that in 42,641 orders generated, there was
an 88% override rate for critical drug interaction alerts and a 69% override
rate for drug-allergy interaction alerts among ordering practitioners. This
prompted concern that too many alerts could cause the ordering
healthcare provider to become immune to the warnings and ignore them.
Recommendations to address unintended consequences, user resistance,
and decision support issues focused on providing education to healthcare
providers and consumers, designing systems that support communication
and clinical workflow, early user participation in the implementation
process, continuous safety monitoring, and the use of qualitative
multidisciplinary research methods to provide deeper insight into the
benefits and issues surrounding CPOE and EHRs.49,50
Electronic Medication Administration Record
The electronic medication administration record (eMAR) provides a
medium to view and document medication use for individual patients.
This system takes the place of using medication cards or a Kardex. When
medication orders are entered into the CPOE system, this information is
sent to the pharmacy system for verification and dispensing by the
pharmacist. New orders appear on the patient’s medication list in the
eMAR and include information about the drug name, administration time,
dose, and route. Usually the eMAR contains all types of medication and
intravenous fluid orders, with the ability to sort the list in a variety of
ways. For example, users can display scheduled, as needed (prn), pending,
past due, or completed medications and can query the list for specific
entries. Some systems will color code medication order types for quick
sorting and identification. Efforts to decrease medication administration
errors use an eMAR in combination with bar coding devices. An example
of an eMAR screen is shown in Fig. 6.1.
FIG 6.1 Example of an eMAR. Copyright © 2012 Allscripts. Used with
permission.
Bar Code Medication Administration
Bar Code Medication Administration (BCMA) is a method used to
address patient safety and reduce errors that occur during the actual
administration of medicines. This system is most effective when combined
with CPOE, a pharmacy dispensing system, and the eMAR. Although
CPOE has been successful in reducing transcription-related medication
errors, it was not designed to prevent errors that may occur during the
actual administration of a drug to the patient. In 2004, the U.S. Food and
Drug Administration (FDA) indicated that the use of BCMA had the
potential to reduce medication errors and recommended that bar coding
become standard on patient identification bands and medication labels.51
Bar codes can then be read by optical scanners or bar code readers.
Research findings in the area of BCMA support advantages such as easy to
use, improved satisfaction with medication documentation, a reduction in
medication error rates, and avoidance of potential adverse drug events.52-56
The medication administration process with BCMA in the clinical
se ing starts with the nurse scanning his or her badge, the patient’s
wristband bar code, and the medication bar code. The scanner verifies the
five “rights” of medication administration—right patient, right drug, right
dose, right time, and right route—and documents the actual
administration in the eMAR.
Radio frequency identification (RFID) is also being used for medication
administration. This technology uses electronic tags embedded in an
identification badge or band to track and monitor activities. Passive RFID
works in a similar way to regular bar coding with the use of a scanner.
Active RFID does not require a scanner; rather, it automatically transmits
signals to a computer or wireless device without disturbing the patient.
This technology is becoming more common in hospitals to track patient
care activities, including medication dispensing and administration.57
Clinical Documentation
Clinical documentation applications provide a medium for recording,
managing, and reporting patient care activities by a variety of disciplines.
The format for documenting may differ by application and organizational
preference. Although many clinicians still embrace the richness of
narrative notes, advantages exist to using standardized vocabularies and
taxonomies for documenting patient care, as discussed in detail in Chapter
22. Structured notes using standardized language may come in the form of
pull-down menus, decision trees, or key words embedded in a sentence.
Some systems contain functionality to store and retrieve predefined notes
of normal findings. Some organizations may use “charting by exception,”
wherein normal values and entries are predefined and selected according
to established guidelines so clinicians need to document only abnormal
findings.
Clinical documentation systems should have functionality to support
workflow processes and the creation of plans of care. Often electronic flow
sheets or grids are used to record vital signs and other procedures quickly.
An effective documentation system includes decision support rules that
alert the clinician about abnormal values, missing content, or additional
assessments that are needed. Rules can also be wri en to remind
healthcare providers to verify essential information (e.g., new orders, or
allergies). Many systems provide the ability to graph numeric data, such
as vital signs and lab values. Problem lists, allergies, medications, and
other critical information about a patient can be extracted and displayed
on a single summary screen to assist the busy clinician. Depending on the
type of data collected, various clinical, administrative, and research reports
can be generated.
Overall, clinical documentation systems should support be er
communication between healthcare providers, promote professional
accountability, and streamline workflow. Access to literature sources,
policies and procedures, clinical guidelines, and standards of care can be
functionally incorporated to support evidence-based practice (EBP) using
applications such as Infobu ons or the EBP InfoBot (discussed under
Clinical Decision Support section). Additional information about EBP is
included in Chapter 3. Electronic documentation makes it easier to search,
query, and extract data for reports. This information can be used for
quality-improvement initiatives, critical-incident reviews, resource
management, long-term planning, clinical research, and to address the
requirements of the accreditation process.
Specialty Applications
Many of the basic EHR components, such as CPOE, eMAR, and clinical
documentation, are available to all healthcare providers, but in most
se ings, there is a need for unique functionality beyond what is provided
in these applications. Specialty or niche applications are software
programs created to address the requirements of specific departments and
groups of users. Although many niche applications can function as stand-
alone systems, integration with or interface to the hospital-wide EHR is
preferred to decrease redundancy, enhance communication, and provide a
more comprehensive patient record. Some examples of specialty
department systems include perioperative or surgical services, maternity
care, neonatal intensive care, and the emergency department (ED).
A surgical information system (SIS) incorporates functionality to
improve clinical, operational, and financial outcomes throughout the
entire perioperative experience. Functionality may include operating room
scheduling; management of equipment, supplies, and inventory;
documentation for nurses and anesthesiologists; patient and specimen
tracking; and administrative reporting capabilities.
A maternity care information system (MCIS) is another type of niche
system used to address the needs of obstetrics staff. An MCIS is used to
support clinical protocols for maternity care, track mother and baby
progress, capture fetal-uterine monitoring data, and record results of
Doppler blood flow and other diagnostic tests. Key features of this system
include electronic forms for documenting and reporting all aspects of
antenatal, intrapartum, and postnatal care, as well as normal, healthy, or
adverse pregnancy outcomes. Likewise, a neonatal information system
(NIS) that interfaces with the EHR would contain much of the same
information found in the primary system. Unique to an NIS would be
growth charts, nutritional calculations, monitor parameters, and coding
structures specific to the needs of critically ill newborns. Clinical staff in
these specialty units can benefit from user-defined logbooks, resource
utilization, quality improvement, and statistical reports designed for their
specific needs.
The ED has unique computer needs related to clinical workflow,
documentation of triage and patient encounters, tracking of patient
location and treatment progress, charge capture and reimbursement
management, clinical rules for risk mitigation, and patient education and
referral. Once again, not unlike other niche systems, the emergency
department information system (EDIS) is designed to improve clinical,
operational, and financial outcomes throughout the entire ED experience.
However, EDISs are often integrated into a facility’s EHR because EDs are
the portal into acute care; these integrated data are then readily available
to acute care providers and areas.
Clinical Decision Support
CDS systems are tools and applications that assist the healthcare provider
with some aspect of decision making. These applications are discussed in
detail in Chapter 10. Of importance here, CDS systems are crucial
components of EHRs, linked to at least CPOE in the form of alerts related
to duplicate orders, allergies, and medication dosing errors. A CDS system
could also provide alerts related to changes in a patient’s condition and
reminders about important tasks such as follow-up visits, preventive care,
immunizations, and updates to critical patient information.58
Some EHRs may contain external web links to resources to assist with
clinical decision making (see, for example, the discussion of Infobu ons in
Chapter 10). Many healthcare systems also have internal intranets that
provide links to policies and procedures, clinical guidelines, and evidence-
based protocols. In 2006, the National Institutes of Health (NIH) in
collaboration with the National Library of Medicine (NLM) developed a
personalized decision support application called the EBP InfoBot.59 This
system was designed to augment a patient’s EHR automatically by
searching various literature sources and providing information that could
be used to develop plans of care and assist with decision making.
Operating behind the scenes are rule sets programmed to extract key data
from the patient’s medical record, map free text data to standardized
terminology, and create a series of EBP-type queries from extracted data.
These questions are used to search multiple NLM databases, internal
standards of care and guidelines, and other external clinical resources, and
then provide a summary of the information based on clinical user-group
preference directly into the EHR. The application functions in real time
and provides flexibility to adapt to the requirements of the decision maker.
Overall, the EBP InfoBot decreased provider search time, reduced
information overload, and provided current and timely resources to
support decision making at the bedside. An example of the EBP InfoBot
summary screen is shown in Fig. 6.2. Ideally, at a minimum, the CDS in
EHRs should be accurate, be available to the clinician at the point of care,
provide timely and up-to-date information, and be incorporated easily
into daily care processes and workflow.
FIG 6.2 EBP InfoBot. (EBP Infobot developed by the National
Library of Medicine (NLM) in collaboration with the National
Institutes of Health, Clinical Center (NIHCC) Patient Care Services.
Screenshot used with permission from NLM.)
Ancillary Systems
An ancillary system usually refers to software applications used by
patient care support departments such as laboratory, radiology, and
pharmacy. Other departments such as cardiology, respiratory, physical
therapy, and material management may have their own software
applications as well. LISs and radiology information systems (RISs) were
available long before the concept of EHR systems was introduced. Both
LISs and RISs are designed to address the specific needs of the department
related to collecting, processing, and reporting test results along with
managing resources and costs. The LIS consists of several components
related to the laboratory subdepartments, including hematology,
chemistry, microbiology, blood bank, and pathology. The LIS may also
interface with other devices, such as blood analyzers, for direct input of
blood test results. Coding structures are used to track and identify
resources and provide cost data for billing. Logical Observation Identifier
Names and Codes (LOINC) is a universal coding system used to identify
laboratory and other clinical observations, whereas the Systematized
Nomenclature of Medicine (SNOMED) coding structure is commonly used
in pathology. These standard languages are discussed in more detail in
Chapter 22.
The RIS is similar to the LIS in that it incorporates data from multiple
services that include X-rays, fluoroscopy, mammography, ultrasound,
magnetic resonance imaging (MRI) scans, computed tomography (CT)
scans, and other special procedures. It also uses coding structures such as
Current Procedural Terminology (CPT) or International Classification of
Diseases (ICD) to identify procedures, resources, and billing. However, the
global standard for the transmission, storage, and display of medical
imaging information is Digital Imaging and Communications in Medicine
(DICOM). The RIS may integrate data from a picture archiving and
communication system (PACS), which stores digital versions of diagnostic
images for display in the EHR.
The pharmacy department typically has a system to assist with
inventory, prescription management, billing, and dispensing of
medications. The FDA requires that all drugs be registered and reported
using a National Drug Code (NDC). The NDC and SNOMED C axis are
examples of coding structures that would be used in a pharmacy system.
RxNorm is another standard mandated by the Office of the National
Coordinator for Health related to MU reporting and data exchange.
Clinical screening can be done by monitoring medication usage
throughout the hospital and identifying potential adverse drug events.
Prescriptions can be tracked along with printing of labels and medication
instructions for patients or staff. The pharmacy system can provide patient
drug profiles that include current and past medications, allergies, and
contraindications. These features are designed to enhance patient safety. A
closed-loop medication management system connects the pharmacy
system to the CPOE, eMAR, and bar coding systems.
Electronic health record benefits
Most health policy initiatives are designed to address a triad of concerns
that focus on cost, access, and quality. For example, concerns regarding the
increasing cost of prescription drugs became the focus of Medicare reform
legislation in 2003. Recent policy directed toward the adoption of EHR
systems also highlights these concerns. The HITECH Act (2009) and the
Patient Protection and Affordable Care Act (2010) addressed the need for
EHR adoption to improve the quality, safety, and efficiency of care. With
this in mind, the benefits of an EHR will be presented in terms of cost,
access, and quality, safety, and efficiency of care delivery.
Cost
Cost savings is always a big motivator, especially if a healthcare provider
or institution wants to stay in business. Numerous studies focusing on
direct cost savings related to EHR use reported a positive financial return
on investment for the healthcare organization.60-64 Other cost benefits
include increased productivity, efficiency in billing, improved
reimbursement rates, improved verification of coverage, faster turnaround
for accounts, lower medical record costs, support for pay-for-performance
bonuses, and enhanced regulatory requirement compliance.61,64-66 Benefits
to patient care were also seen related to lower costs associated with disease
management and decreased length of stay.65,67
Access
An EHR provides be er and faster access to patient care information.
Looking for paper charts that mysteriously disappear from the nurses’
station or waiting for medical records to retrieve an old record are events
of the past. An EHR allows simultaneous access to patient records and
restricts users’ access to only the information that they are permi ed to
view. Many systems contain functionality such as graphs and charts that
trend on demand and tools that facilitate comparison of current and past
data. Another benefit is that clinicians have access to drug information,
decision support tools, and resources to supplement patient care. Alerts
and triggers that warn users of drug interactions and allergies can prevent
medication errors. Clinical research often involves reviewing chart data,
and can be a cumbersome process if done manually. The EHR provides a
more effective and efficient method to access and aggregate data for
research. As EHR adoption continues to expand, this will improve data
access across multiple facilities and provide be er continuity of care.
Quality, Safety, and Efficiency of Care Delivery
One of the main reasons to adopt an EHR is the potential to improve the
quality, safety, and efficiency of care delivery. Quality is an ambiguous
term that has a variety of meanings. Quality as it relates to EHR
technology is fostered through be er management of health information
and improved data integrity. This may take the form of providing data
that are readable, organized, accurate, and complete. Quality could also
refer to increased staff and patient satisfaction, improved care
coordination, and support for benchmarking. Safety and efficiency are
much easier to quantify. Reducing medication errors has been a major
focus of CPOE implementation and BCMA. Systems that support clinical
decision making and provide early warnings of changes in patient status
can be used to avert medical errors. Diagnosis and treatment options can
be explored using decision support technology. Clinical and operational
efficiencies in communication, workflow, documentation, and
administrative functions are reported benefits of EHR adoption.
Stakeholder perspectives
In most organizations, the implementation of an EHR will affect multiple
groups or stakeholders that share a stake in the outcome of this endeavor.
Stakeholders may have similar concerns about the technology but different
needs and approaches for resolution. It is important to consider many
perspectives; essential stakeholders may include consumers, nurses and
other healthcare providers, healthcare administration and organizations,
insurance payers, and state and national governments.
Consumers
Healthcare consumers or patients have a unique vantage point for
evaluating the effect of EHRs. They see multiple providers in a variety of
se ings and recognize gaps in care coordination. They often provide the
same information repeatedly and are aware of tests being duplicated
because the results were lost or inaccessible. They notice when individual
arrangements must be made to hand carry a CD-ROM or paper record
from one se ing to another.
In 2011, the National Partnership for Women & Families conducted a
national survey to determine patients’ expectations regarding EHRs and
health IT. The survey included patients who met two criteria: (1) they had
an ongoing relationship with a main doctor and (2) they knew if their
physician was using either electronic or paper record system. The survey
was repeated in 2014 with 2045 adults, representing 68% of the adult
population in the United States after the data were weighted to represent
the demographics of the national adult population.68 Consumers quickly
and intuitively recognized that health IT can contribute directly to fewer
medical errors, lower costs, and be er health outcomes.69,70 They see the
benefits that technology has brought to other areas of their lives and
understand how private and secure health IT can improve our nation’s
healthcare system.68 The key findings from the 2014 survey are provided in
Box 6.2.
Box 6.2
Key Findings From Engaging Patients and
Families: How Consumers Value and Use
Health Information Technology
1. Patients who used or did not use an EHR believe that EHRs have greater
effect and usefulness for both themselves and their doctors compared
with paper record systems.
2. The numbers of patients with online access to the information in their
providers’ EHRs is growing rapidly, moving from 26% in 2011 to 50% in
2014.
3. Patients and consumers want even more functionality, expressing a
desire for easy, electronic methods to communicate with doctors, as well
as tools that help manage their health or the care of a loved one.
4. The more patients experience the benefits of EHRs, the more they
trusted providers to protect their privacy. The more they trust that their
privacy is protected, the more they use and benefit from EHRs.
EHR, Electronic health record.
Source: National Partnership for Women & Families. Engaging patients and families: How
consumers value and use health IT. Washington, DC. December, 2014. Available from:
<h p://[Link]/research-library/health-care/HIT/engaging-patients-and-
[Link]/>.
Nurses
Nurses constitute one of the largest groups of users of the EHR, and their
perspective is critical to the successful integration of current and future
technology. There are mixed reviews on user satisfaction related to
individual systems, but nurses must, in most cases, embrace the EHR as a
way to enhance consistency and quality of care.71-73 Several studies
reported that nurses’ perception of an EHR was positive and that, overall,
the system increased productivity, improved performance, enhanced
effectiveness, was easy to use, and supported clinical care and
research.71,74,75 Other reported benefits involve improvements related to
centralized access to patient information, clinical documentation,
monitoring patient status, and resources for patient education.
Nurses are responsible for distributing medications to patients under
their care. Because the EMR and EHR usually interface with a pharmacy
system, eMAR, and bar coding technology, the potential exists to decrease
administration-related medication errors. Knowledge-based systems may
include functionality that integrates clinical guidelines or protocols to
assist nurses in the development of critical pathways and plans of care.
Nurse leaders struggle to measure quality outcomes required by the
Joint Commission (TJC), the Centers for Medicare & Medicaid Services
(CMS), and other regulatory agencies. The EHR provides the ability to
access data and compare across institutions for benchmarking. Stefan76
suggested several quality metrics that nurse leaders should evaluate when
implementing an EHR, including timely access and documentation of
patient information, EBP alerts, effect on length of stay, discharge follow-
up with patients, and accuracy of documentation for reimbursement and
regulatory agencies.
Healthcare Providers
In a recent study of EHR use in primary care practices, physicians and staff
reported increased efficiencies related to billing and care coordination,
access to current and past medical records, storing of patient information,
and overall office operations.77 Doyle et al.78 concurred with these findings
and concluded that EHRs used in the healthcare provider’s examination
room facilitate a partnership between physician and patient through
collaboration of treatment plan options, and increase patient teaching by
sharing of online medical information. In other studies, physicians also
reported improvements in prescribing and medication safety when
ePrescribing and decision support tools were available.79,80 EHRs that
provide tools for comprehensive documentation, warnings for changes in
patient status, medication alerts, and follow-up and preventive care
reminders improve decision making, which can reduce liability for the
physician.81 In addition, automated reporting capabilities enhance
compliance to quality and regulatory requirements.82
Overall, healthcare providers reported favorable opinions about the
EHR, citing many potential benefits related to clinical, organizational, and
consumer outcomes.65 Clinical benefits are often seen through the
reduction of medical and medication errors, be er health and disease
management, and enhanced quality of care. Financial needs of the
physician practice are streamlined and more efficient with electronic
access to payer information and reporting to facilitate compliance with
regulatory requirements. Workflow, communication, and coordination of
care activities improve when there is easier access to records and other
resources. Consumers also benefit from EHR technology when there is
collaborative interaction between patients and physicians, more timely
access to personal health information, and online access to educational
materials.70
Healthcare Organizations
A current question for healthcare organizations is how to stay financially
viable in a healthcare environment determined to control escalating
healthcare costs. Added to this burden is the mandate to implement
comprehensive EHR systems to meet MU criteria and reap the benefits of
available incentives. Depending on the size and complexity of each
organization, costs for implementing EHR technology are a significant
investment. Beyond the initial expense for the hardware and software are
fees associated with consultants and programmers to assist with
implementation, licensing, maintenance, and providing staff time away
from regular duties to participate in the process. For the healthcare
executive, implementing EHR systems has the potential to improve
operational efficiency, strengthen communication throughout the
organization, increase patient safety, support compliance with regulatory
requirements, improve medical record security and storage, improve care
coordination, enhance the quality of care, and provide faster turnaround
for procedure authorization, billing, and claims submission.
Healthcare executives and leaders must look at leveraging this
technology not only to control costs but also to improve the quality of care.
The successful implementation of information systems requires an
understanding of the technical, cultural, and organization factors that
influence change. Healthcare executives must also reflect beyond single-
facility implementation to the possible benefits of system integration that
will foster collaboration at local, national, and international levels.
Insurance Payers
The EHR provides several benefits for insurance companies through be er
disease management and reporting of services. Pay-for-performance
requirements are supported and can be submi ed in a timely manner.
Claims that are incorrectly coded or that lack coding standards can
confuse payers when they a empt to reimburse organizations for services.
Systems that integrate patient data with coding and billing structures can
provide data to control costs and manage expensive procedures.
State and National Governments
Over the past 20 years, the cost of healthcare in the United States has risen
to nearly $2.6 trillion, and it is expected to grow faster than the national
income.83 One proposed measure for cost containment focuses on
improving coordination and quality of care. The implementation of a
nationwide interoperable EHR is recommended as a solution that would
significantly reduce medical errors, improve care quality, and save the U.S.
healthcare system major expense.18,84 The United States is behind other
developed nations in deploying technology of this magnitude. A major
challenge is how to support the sharing of patient data across multiple
organizations, requiring a nationwide technology infrastructure and
communication standards, such as standardized nomenclatures,
vocabularies, and coding structures.4 Although the initial expenditures for
such a system would be high, the anticipated benefits to our nation would
be the ability to identify and address safety issues in a timely fashion,
notify patients and populations at risk for disease or environmental
exposure, detect epidemics, and prepare for bioterrorism a acks.85 A
clinical dataset of essential information would be available, allowing
researchers to explore preventive and curative solutions that address the
nation’s health and healthcare issues. Ultimately, the adoption of a
nationwide EHR system would assist government agencies to improve
overall healthcare for all U.S. citizens.
Key issues
The actual and potential benefits of an EHR are promising, but challenges
also exist. This section focuses on several issues associated with EHR
adoption related to cost, ownership, data integrity, privacy and
confidentiality, standards, organizational culture, user experience, patient
access, and patient-generated health data (PGHD).
Cost
The cost to implement and maintain an EHR is a major barrier. There are
basically five financial components to consider when purchasing a system:
(1) hardware, (2) software, (3) design and implementation assistance, (4)
training, and (5) ongoing maintenance.86 Physicians in a large private
practice can expect to spend an estimated $162,000 or more to purchase
and implement a certified EHR along with first-year maintenance expenses
around $85,000.87 This does not include the ongoing maintenance costs or
hiring of technical staff to keep the system running on a daily basis. If a
practice is using paper records, additional staff may be needed to enter
previous patient data into the new system. Providers with a noncertified
EHR will need to replace or update the system to meet standards, and data
conversion may be necessary to move from the old system to the new
system.
For hospitals and healthcare corporations, EHR technology expenses can
range from $1 million to $100 million or more depending on the size of the
facility, software vendor selection, and functionality purchased. Annual
maintenance is an added expense that can be approximately 18% to 20% of
the purchase price. In both scenarios, financial planning for initial and
ongoing training, technical support, and software upgrades must be
considered. The bo om line is that implementing and maintaining an IT
system is very expensive. Currently, each healthcare organization
purchases its own EHR; connections to other facilities are less common,
although this trend is changing with the use of HIE. It is unclear who will
be responsible for the electronic links that will form the infrastructure for
local, regional, or national EHRs of the future.
Ownership
Ownership of the patient record is another issue. Traditional health
records have always been the property of the service institution. Patient
access to this record could be permi ed, but sometimes at a cost. A
comprehensive, interoperable EHR would cross institutional boundaries
and include patient interaction, making ownership more complex. Because
healthcare providers use many of the same data, many questions are
currently unanswered: for example, What data will be shared? How will
users access these data? Who will be responsible for updating and
ensuring data accuracy? Who will store the shared data? Should the
concept of ownership and access be completely separate concepts so that
those responsible for storing, updating, and ensuring data accuracy are
considered data stewards as opposed to the owners of these data? For
example, the patient may own the data but the responsibilities of data
stewardship may reside with a healthcare institution. Would patients and
consumers have access to the data or a subset of the data? What role
would the government play in monitoring the access, quality, security,
privacy, and confidentiality of patient records?
Consumer consent and access are critical elements of the EHR adoption
initiative that has significant implications for healthcare organizations and
the issue of ownership. Some healthcare providers may be uncomfortable
with the prospect of patients reading their notes and may alter what and
how they document to accommodate consumer access. Consumer consent
is required for health professionals to retrieve or share patient records to
ensure that personal information is not accessed inappropriately. This rule
could affect quality of care if the consumer is concerned about
confidentiality and denies permission. Ultimately, ownership may be
driven by who has control and access to the data; or ownership may
become irrelevant as access becomes the driving force in answering these
many questions.
Data Integrity
Data integrity refers to the accuracy and consistency of stored and
transmi ed data that can be compromised when information is entered
incorrectly or deliberately altered or when the system protections are not
working correctly or suddenly fail. As EHR adoption expands to include
data from multiple healthcare entities, more opportunities for human error
exist. Poor screen designs that are confusing and cumbersome and lack of
system training often lead to data entry errors. How this will be monitored
and who is responsible for correcting inaccurate information will be an
issue. Critical patient information, such as allergies, medical history, and
medications, should always be validated and updated at each episode of
care. Education on how to use the EHR should be provided to all staff
before implementing a new system, when changes are made to an existing
system, and during orientation for new employees. Stringent security
measures that include audit trails, penalties for fraudulent activities, and
detailed policies and procedures are other measures that protect data
integrity.
Data integrity can also be affected if a system is not working correctly or
suddenly fails. Unfortunately, users do not always recognize when a
feature is not functioning, such as a broken alert or incorrect calculations,
and this leads to inaccuracies in data. When an interface from one
application to another is not working, this also may not be readily
noticeable. For example, a physician is able to enter orders using CPOE,
but the interface to the pharmacy department system fails and medication
orders are not received or dispensed, or orders do not arrive in the
laboratory and the blood is not drawn. A healthcare provider may
discover the problem only when it is time to administer medications or
when test results are not available. These kinds of problems ultimately
affect patient care. If the interface resumes functioning, the orders may
cross over, but depending on the time the order was placed, some data
may be lost or corrupted or a new order may have been placed. Support
mechanisms, such as the customer help desk maintaining automated,
sortable records of issues reported, along with rigorous system testing, is
extremely important to ensuring data integrity.
Privacy and Confidentiality
Despite advances in technology and robust software that limits access to
computerized health information, privacy and confidentiality continue to
be major concerns for both the healthcare professional and consumer. With
the expansion of the EHR and HIE as a driving force to automate and
share health information, clinicians may find government and regulatory
requirements for controlled access to patient information too restrictive or
an invasion of privacy. In this respect, providers may be less inclined to
use the EHR or more cautious when documenting patient care to avoid
litigation. As with facilities, consumers can also be bombarded with
computer breaches, such as viruses, spyware, and hackers. Some
consumers do not trust that health IT will be any different from traditional
healthcare. They fear that a large-scale EHR system could allow access to
personal data without adequate protection against unauthorized use of
information. Some consumers prefer that sensitive health information
(such as psychiatric care) never be shared, which creates problems because
this can represent critical information missing from a medical record.
Before a nationwide interoperable EHR can be fully implemented, major
issues related to privacy and security need to be addressed. This topic is
discussed in more detail in Chapter 26.
Standards
In a famous commentary on hospitals in 1863, Florence Nightingale wrote,
“In a empting to arrive at the truth, I have applied everywhere for
information, but in scarcely an instance have I been able to obtain hospital
records fit for any purposes of comparison. If they could be obtained they
would enable us to decide many other questions besides the ones alluded
to. They would show subscribers how their money was being spent, what
amount of good was really being done with it, or whether the money was
not doing mischief rather than good.”88, p. 176 Over 150 years later, these
same issues with extracting data for comparisons still exist. Healthcare
professionals have been discussing the need for standardized vocabularies
and terminologies for many decades. Implementation has been hindered
by numerous factors related to disagreement on which terminologies to
use, lack of standards to harmonize multiple coding structures, cultural
and language barriers, interpretation of meaning, threats to autonomy,
and user resistance. The benefits of standardization allow for a mutual
understanding of terms and improved communication among healthcare
professionals along with a common way to collect and aggregate data. A
universal language would allow us to consistently capture, represent,
access, and communicate clinical data, information, and knowledge across
all se ings. Although progress is underway, standards continue to be an
issue for EHR adoption.
Organizational Culture
The healthcare environment is filled with many cultures, subcultures, and
traditions, and the implementation of an EHR is almost always disruptive
to the sociocultural system. A disruptive technology is an innovation that
replaces long-held traditional ideas and ways of doing things. This type of
technology can improve or replace a product in ways that are unexpected
and often opens up new market demand, which leads to lower-priced
products or products designed for a different set of consumers. Cell
phones, e-mail, Twi er, and Facebook have significantly changed our
interpersonal, professional, and business communications. In this respect,
a disruptive technology such as the EHR may challenge and/or alter social
and cultural norms. How these cultures respond to change will vary based
on belief systems, values, roles within the healthcare team, and computer
knowledge.
Healthcare organizations are challenged with issues surrounding the
evolving nature of EHR technology, one of the most important of which is
user acceptance. Whether in a hospital se ing or private practice, nurses,
physicians, and other caregivers are required to use an EHR as part of
their daily routine, but some find it difficult to comply. Reasons for this
vary from lack of computer skills to complexity of application, poorly
designed systems, lack of available hardware, or difficulty adjusting to
change. Caregivers often indicate that documenting in the computer
interferes with routine workflow or takes away from valuable time with
patients. When CPOE was enforced by some institutions, physicians
complained that entering orders in the computer was a task beneath them
because this was traditionally secretarial work. This also had an effect on
the role of nurses because they no longer had to interpret and validate
handwri en orders. Physicians entered these orders in isolation, and the
computer forced them to be more specific during the entry process.
Nurses’ workflow changed because they no longer had a paper form to
alert them when new orders became available. Although the computer can
provide new order alerts, it requires frequent access to the electronic
record. Checking the computer more often was disruptive to care, and new
procedures were needed to avoid mistakes and delays. These types of
reasons for resistance must be addressed for an EHR adoption to be
successful. Acceptance of this technology is dependent on effective
leadership, user involvement, the ability of the system to integrate with
workflow, the ability of the users to adapt and change workflow processes,
and timely education and technical support.
User Experience
A significant amount of time is spent by all healthcare providers in
processing and documenting patient-related data, but using an EHR
system for these activities can be perceived as a frustrating experience.89
Research on human-computer interaction has identified several issues
related to the usability of EHRs. In an early study by Despont-Gros et al.90
on human-computer interaction models, they reported user acceptance to
be a reliable concept to reflect evaluation of clinical information systems.
Problems with usability related to complex human-computer interfaces,
poorly designed decision support tools, and lack of training are
recognized as obstacles that lead to significant medical errors and
resistance to accept the technology.17,89,91,92
The complexities of EHR technology add concerns that new types of
errors are beginning to emerge. Many clinicians complain that information
systems increase their workload, which decreases productivity and
efficiency. In a landmark study, Ash et al.17 reported that EMR systems
could have a negative effect on communication and teamwork because of
the linear processing of computer systems, which conflicts with the more
fluid iterative and interruptive nature of providing care. They also
concluded that cognitive workload increased with unnecessary clerical
tasks, overly structured data entry requirements, and fragmented patient
data retrieval formats. Addressing issues related to user experience is
complex and requires early user involvement and a ention to system
design and testing.92 User experience concepts are discussed in detail in
Chapter 21.
Patient Access to the Electronic Health Record
Consumer demand for access to personal protected healthcare information
(PHI) is increasing. The EHR has the potential to enhance patient-provider
communication and outcomes through electronic messaging, scheduling,
reminders, access to laboratory and test results, tracking of progress, and
educational resources. Despite these advancements, barriers still exist
related to providing consumer access to all data stored in the EHR, such as
clinical notes. Cost is a major issue because most hospitals and private
practices may lack funding and/or technology resources and support to
implement a system for full patient access.93 The EHR was not originally
created for consumer use, and it requires a great deal of redesign and
financial investment to allow outside access.
Another consideration is that patients are often seen in a variety of
hospitals, other healthcare entities, and by multiple providers. Information
is not usually centrally located in one system but fragmented across
several different facilities and practices. The technical infrastructure to
integrate (or interface) data from these disparate systems is difficult, as
well as costly.94
Recent reports of health insurance and government data violations fuel
concerns over privacy, confidentiality, and security of personal health
data. The Health Information Portability and Accountability Act (HIPAA)
security rules for electronic health data were established to require entities
to take appropriate “administrative, physical, and technical safeguards to
ensure the confidentiality, integrity, and security of electronic protected
health information.”95 Providers are at risk for lawsuits if strict precautions
are not taken and patient data is compromised.93,96 Caine and Tierney
reported that privacy concerns can cause patients to lose trust in
providers, withhold important information, or avoid seeking care.96 This is
especially true for patients with sensitive problems such as mental health
issues or HIV. Capturing patient preferences related to who can access
specific information within an EHR can be difficult to manage and
administer.97
Consumers have a legal right to request access to PHI, but, as mentioned
earlier, control of the data is still debatable. Even if access to PHI is
available, consumers may be restricted from viewing certain entries, such
as physician notes, and the ability to easily update or correct information
is rare. Some providers resist allowing patients real-time access to health
records but defend their own right to access all PHI to provide
comprehensive care.93,94 In addition, providers are concerned that patients
may not have the knowledge or skills to interpret the information in the
health record. In a pilot study of 688 veterans who used a PHR, physicians
reported that sharing notes and other health information with patients can
be “confusing or harmful,” and they were less likely to encourage the use
a PHR.98
Tension between provider and consumer expectations with EHR access
is evident. There is concern that patient access to EHR data will be
interpreted as unlimited access to providers. Disagreements related to e-
mail use and what can be addressed online versus routine office visits can
lead to dissatisfaction with care.93,94,96 The fear of increased workload or
workflow interruptions may hinder online engagement by clinicians.
Some clinicians are concerned that consumers may find mistakes in the
record, which could prompt legal action, or that patient access to their data
would lead to unnecessary worry. Consumer expectations related to data
access also filters into the clinical se ing. In a recent study of hospitalized
patients who were provided real-time access to select EHR data reported
positive results related to patient empowerment and clinician optimism.
Findings indicated that concerns related to increased workload,
identifying mistakes, and patient confusion were unsupported.99 Other
studies have reported that patients are more comfortable during office
visits when the physician shares online data and invites interaction with
computer.100
Consumers who lack computer skills may have difficulty accessing and
using EHR systems. A common practice is to provide patients with a link
to an EHR portal without any training on how to navigate the site. Chronic
illnesses, debilitating diseases, or pain can hinder interest or ability to
access a portal. Once access is achieved, consumers may lack the
knowledge to interpret the medical results or information provided. Some
providers prefer to delay release of test results in a portal until after they
discuss findings with the patient verbally. Advocates for immediate and
timely access to data contend that there is a need to provide information to
consumers in a format that does not require medical training.94 Despite the
need for more effective communication, the task of translating complex
interprofessional language into common terms may lead to resistance by
healthcare professionals.
Patient-Generated Health Data
Patient-generated health data (PGHD) are defined as “health-related data
created, recorded, or gathered by or from patients (or family members or
care givers) to help address a health concern” (para 1).101 Although most
EHR systems that provide a patient portal “push” data for viewing, few
offer the flexibility and functionality to capture PGHD to augment care.
Traditional methods of gathering PGHD through daily logs and journals
are common but are rarely directly entered into an EHR by patients.
Technology has a pivotal role in the collection of large amounts of PGHD
using mobile devices such as smartphones, laptops, and computers, to
wearable items such as wristbands, clothing, belt clips, and patches.102-104
PGHD transmi ed or entered into an EHR portal provides an opportunity
to monitor and track progress and actively engage patients in care
management. Despite these benefits, use of PGHD is met with some
scrutiny by healthcare professionals.
There are several major concerns associated with PGHD related to
volume, quality of data, privacy, and security.102,105 The volume of data
reported by patients can be overwhelming to providers, leading to
information overload and workflow concerns. Discerning which data are
pertinent or not could be very time consuming. Detailed data might be
useful in gaining insight into a patient problem but could also hinder
effective analysis because of challenges associated with screening large
amounts of data. This also raises questions about who is responsible for
checking the data, when and how often, and what are the liabilities if
timely review and response to data does not occur.
Patients may provide more detail than needed, as well as deviate from
the actual problem to include experiences of others or data unrelated to
their condition.105 Patients may not be aware of which data should be
included when reporting an issue or decide not to report a change because
they think it is not important to their condition. Some patients may try to
manipulate data to force a certain outcome such as obtaining certain
prescription medications. In addition, personal opinions or inappropriate
comments could be problematic and cause discomfort for healthcare
providers. In a study of patients with diabetes, a significant number of
errors related to underreporting of glucose readings, overreporting or
adding readings that were not measured, and recording values incorrectly
were found.106 Underreporting and overreporting indicated a need for
patients to fill in the blanks to comply with the health provider’s
directions. Incorrect data entry was a concern because treatment options
may be unrelated to status and cause harm or ineffective disease
management.
As with patient access to EHR data, privacy and security is a major
concern with PGHD as well. Whether direct entry into a portal or
transmi ed through a device, assurance is critical that the data is from an
authenticated source and linked to the correct patient through a secure
portal.102 Some EHR vendors are beginning to integrate data from PGHD
sources directly or through questionnaires, but there is still a need for
technologies with the ability to transform and filter PGHD into meaningful
information to improve decision making and clinical outcomes.102,107
Conclusion and future directions
EHR has become the preferred term for the lifetime patient record that
would include healthcare data from the consumer and a variety of
provider sources. The IOM identified eight essential care delivery
components for all EHRs: (1) administrative processes, (2) communication
and connectivity, (3) decision support, (4) health information and data, (5)
order entry management, (6) patient support, (7) results management, and
(8) population health management.14 Dentistry and optometry records
were added to this list by the Department of Defense.15
Common EHR applications used in the clinical se ing include CPOE,
eMAR, BCMA, clinical documentation, specialty applications, and CDS.
The HITECH Act (2009) established programs to accelerate EHR adoption,
one of which offers financial incentives for hospitals and healthcare
providers who adopt certified EHR technology and comply with federal
MU objectives. How the HITECH Act followed by the MACRA Act will
address the needs of health practitioners is unclear, but many are actively
involved in local, regional, and national initiatives to improve the quality,
safety, and efficiency of care using technology. Current research findings
indicate that EHR benefits related to cost, access, quality, safety, and
efficiency of care delivery support healthcare policy initiatives driving
adoption. Despite the many advances in technology, there are still
numerous issues to resolve associated with implementation costs,
ownership, data integrity, privacy and confidentiality, organizational
culture, user experience, patient access, PGD, and the development of an
infrastructure to support a nationwide EHR. Future directions are
promising for the EHR for personalizing care, supporting research efforts,
and mobilizing care coordination across national and international
boundaries.
In the future, the EHR will play a pivotal role in personalized medicine
as a medium for data, information, knowledge exchange, and exploration.
Advanced computing and systems integration will provide powerful
evaluation tools to facilitate healthcare providers and consumers in the
decision-making process. Genetic testing, along with access to an
interoperable EHR, can be used to diagnose, prevent, and treat preexisting
and potential health issues based on our unique biological responses,
resulting in highly individualized care. Genomics and phenotyping will
likely hold the key to disease detection and treatment with the promise of
designer medications that target the unique characteristics of each
individual.108,109 In the future, an individual’s genome sequence may be
part of a comprehensive medical record, not unlike recording medications
and allergies.108
Customized medications will likely eliminate prescribing drugs or doses
that do not work, minimize side effects, and decrease costs. Other
treatments, such as diet and exercise, can be personalized to avoid much
guesswork and trial and error. For example, if a patient’s genetic code
reveals a risk for colon cancer, then preventive measures can start earlier.
More frequent exams, colonoscopies, and diets that promote colon health
can be the focus of care. In addition to personalizing care, the EHR will
contain a wealth of information related to disease, interventions, and
treatment responses that can be used for research. The emergence of dental
informatics and the development of dental repositories will provide data
for a more comprehensive EHR record.110,111 Data mining of these huge
databases can reveal pa erns and predictions on how to reverse or prevent
disease.
The EHR continues to be an evolving concept with global and national
implications. In 2014, the Office of the National Coordinator for Health
Information Technology (ONC) reported that three out of four (76%)
hospitals had adopted at least a basic EHR system. This represented an
increase of 27% from 2013 and an eightfold increase since 2008.112 As of
early 2015, using the HIMSS EMRAM, EHR adoption rates in U.S.
hospitals were progressing with approximately 32.3% at Stage 5 and
another 23.6% at Stage 6 or above.27 The rate of adoption by physician
practices and clinics was much lower, with 33.98% at Stage 1 and 28.68% at
Stage 2. Although hospitals may be in a be er position to fulfill MU
objectives, additional support and guidance may be needed to achieve
nationwide implementation goals. Many other countries, such as Canada,
Australia, England, and Finland, have focused their efforts on building an
infrastructure and developing systems that support health information at a
national level.113 The European Commission has launched several
initiatives to improve the safety and quality of care through information
sharing at an international level, such as the eHealth Action Plan that
supports standardization of EHR content and structure, and the Smart
Open Services (SOS) project that recommends allowing healthcare
provider access to critical medical information for consumers traveling
abroad.113-115 EHR adoption has the potential to reach beyond the borders
of this nation to meet the needs of a mobile society.
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Discussion questions
1. It is anticipated that EHR functionality will expand to allow consumers
to enter data into the system along with direct input of other types of
PGD. What are some benefits and challenges associated with this change
from the perspective of consumers, providers, and healthcare
organizations?
2. Historically, patient records maintained by healthcare institutions did
not contain financial data such as charges or incident reports. Should
this segregation of patient data be maintained with the implementation
of EHRs?
3. Increasingly, patients expect full access to their EMRs and EHRs. What
limitations, if any, would be in the best interest of patients? For example,
should healthcare providers have access to new test results for 3 full
business days before these are posted for patient viewing?
4. How does the introduction of a CPOE system affect communication
between healthcare providers (e.g., between pharmacists and physicians
or nurses, or between nurses and physicians)? What modifications, if
any, should be made in the workflow of the different healthcare
providers to adjust for this change in communication pa erns?
5. Discuss the advantages and disadvantages associated with
implementing and using a regional and national EHR.
CPOE, Computerized provider order-entry; EHR, electronic health
record; EMR, electronic medical record.
Case study
A large healthcare enterprise in the Mid-Atlantic region that was created
by a merger owns two acute care hospitals, a rehabilitation center, an
outpatient surgical center, and three long-term care facilities. Each of these
institutions uses a different EMR system. Admi ing privileges extend to
550 physicians, who have office systems that interface with at least one of
the acute care EMR systems. The vision is to create an environment to
support communication, care coordination, and data sharing across the
organization in preparation for a regional EHR system. The organization is
moving quickly to take advantage of the incentives offered by the
government and meet mandatory requirements. Executives decided to
focus on the acute care facilities first and use lessons learned there to
integrate the other centers later. Hospital A uses certified EHR
applications and has implemented ancillary systems, CPOE, and clinical
documentation, whereas Hospital B has a highly customized, beloved old
mainframe computer that is outdated and no longer supported by the
vendor. Instead of selecting a new system for both hospitals, the software
programs used in Hospital A are being implemented in Hospital B.
Discussion Questions
1. You are the vice president of Patient Care Services for both acute care
hospitals. Who would you identify as stakeholders in the
implementation and why? What steps would you take to minimize
user resistance?
2. According to the U.S. EMR Adoption Model, at what stage of
implementation would you classify Hospital A? After both hospitals
are using the same system, what would you recommend
implementing next?
3. The EHR is not fail-proof, and human error is an issue. Discuss
potential decision support tools and functionality that could be
implemented to increase patient safety.
CPOE, Computerized provider order entry; EHR, electronic health
record; EMR, electronic medical record.
7
Administrative Applications
Supporting Healthcare Delivery
Michael H. Kennedy; Kathy H. Wood; Gerald R. Ledlow
Abstract
This chapter addresses the administrative applications within health information
systems that are designed to facilitate the delivery of healthcare, such as financial,
practice management, supply chain and materials management, human resources, and
business intelligence systems.
If a health care system cannot effectively track the total cost of all materials
used to treat an individual patient and aggregate data to determine the cost
of treating groups of patients, managing the cost of health care is not
possible.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Outline the evolution of financial information systems (FISs) in
healthcare organizations.
2. Discuss the basic FISs and their application in healthcare organizations.
3. Compare and contrast practice management systems (PMSs) and
integrated healthcare systems.
4. Describe and explain the a ributes of an efficient supply chain (materials
management) system in a healthcare organization.
5. Appraise how a quality supply chain system supports the operation and
management of clinical systems.
6. Describe the human resources management actions associated with the
subsystems typically deployed with a human resources information
system.
7. Define business intelligence.
8. Distinguish between enterprise-level and application-level business
intelligence.
KEY TERMS
accountable care organization (ACO) 118
accounts payable 113
accounts receivable 113
assets 113
business intelligence (BI) 127
charge description master file 122
claims denial management 114
claims processing and management 114
financial information system (FIS) 112
fixed asset management 115
general ledger 113
incentive management 126
materials management 121
open shift management 126
patient accounting 114
pay for performance (P4P) 118
payroll 113
practice management systems (PMSs) 119
predictive scheduling 126
supply chain management (SCM) 114
supply-item master file 122
transaction history file 122
vendor master file 122
Introduction
Health information systems are “complexes or systems of processing data,
information and knowledge in healthcare environments.”1, p. 270 These
environments comprise a variety of se ings, including hospitals, ambulatory
se ings, long-term care facilities, and managed care organizations.
Typically, the applications within health information systems are
categorized as clinical or administrative. This chapter focuses on the
administrative applications within health information systems designed to
facilitate the management of healthcare delivery. The chapter considers in
turn financial, practice management, supply chain management (SCM),
human resources, and business intelligence (BI) systems.
Vendor Resource Guides
The applications required to process information in healthcare se ings are
primarily provided by vendors. The vendor market for hospital information
systems alone in 2013 had total revenues of almost $14 billion, with the top
five vendors in terms of revenue being McKesson ($3.4 billion), Cerner ($2.9
billion), Siemens ($1.8 billion), Epic Systems Corporation ($1.7 billion), and
Allscripts (almost $1.4 billion). These revenue statistics were based upon
published earnings reports, direct contact with vendors, research of websites,
and estimates for privately held companies or to exclude nonhealth
revenues.2
The Healthcare Information and Management Systems Society (HIMSS)
([Link]) prepares an annual comprehensive report of healthcare IT
applications titled “Essentials of the U.S. Hospital IT Market” based upon the
HIMSS Analytics Database. Quarterly “Essential Briefs”
([Link]/research-list) address emerging health technology
interest areas.
Vendors that deploy a comprehensive suite of applications are referred to
as enterprise vendors. Specialized applications are provided by niche
vendors and are listed separately. When specialty vendors and vendors
targeting nonhospital markets are included, the health information system
marketplace becomes a confusing morass of products whose capabilities are
difficult to assess. Fortunately, professional organizations such as the
HIMSS, hard copy and online content publishers such as Health Data
Management ([Link]), and trade and technology
research companies such as Gartner ([Link]) and KLAS
([Link]) help stakeholders assess their options and make
informed decisions.
HIMSS provides an online product and directory service
([Link]/product-and-service-directory/) in the form of a searchable
database with an exhaustive list of healthcare IT companies, products, and
services. Clicking on a product category results in the retrieval of vendor
names, contact information, and brief descriptions for featured products and
services offered. HIMSS Analytics ([Link]) is a wholly
owned not-for-profit subsidiary of HIMSS that offers services to providers
and healthcare IT companies. Hospitals and other providers that participate
in an annual study gain access to the HIMSS Analytics Database and a
number of benefits free of charge, including an Electronic Medical Record
Adoption Model Score, benchmarking reports, and hospital profiles. The
HIMSS Analytics Database is available by subscription to healthcare IT
companies, which may also purchase ad hoc data reports.
In addition to publishing a monthly magazine of the same name and
maintaining an extensive website, Health Data Management maintains a
resource guide (h p://[Link]) by subject
category. Similar to the HIMSS online conference exhibitor guide, clicking on
a subject category returns vendor names, contact information, and brief
descriptions of the products and services offered.
Gartner and KLAS provide fee-based ratings services. Gartner states, “We
deliver the technology-related insight necessary for our clients to make the
right decisions, every day.”3 KLAS declares, “Healthcare technology is
rapidly changing, and KLAS is dedicated to being the source that holds
vendors accountable and amplifies the voice of your peers.”4 This is done by
monitoring vendor performance based on feedback from healthcare
providers and by conducting independent analyses of products and services.
KLAS publishes a Best in KLAS Awards report annually for software,
professional services, and medical equipment. KLAS’s reports should be
used with some caution, as the vendors cited by KLAS represent the
rankings of just one ratings service, but they do serve as a resource.
Additional information about these services is included in Chapter 19.
Major Types of Applications
Financial Systems
A financial information system (FIS) is a system that stores and records
fiscal (financial) operations within an organization that are then used for
reporting and decision making. Healthcare organizations, like any other
business, must perform various “financial” types of functions to remain
viable. These involve the following components:
• A customer (patient) purchasing the product (receiving the service).
• Salespeople (healthcare personnel) providing the service or product.
• A facility to receive the service or product (healthcare facility).
• Supplies needed for a procedure (materials management).
• Payment received by the healthcare organization for the product
(service) received (receivables).
• Monies received to be deposited in accounts (accounting).
• Payment made to healthcare personnel and support staff for services
performed (payroll).
• Expenses paid (payables) to external constituents that made it possible to
perform a procedure (e.g., mortgage and utilities).
The architecture of a typical FIS is illustrated in Fig. 7.1. As Rogoski noted,
FISs can no longer be regarded as “back-office” systems.5 Although it is true
that financial functions are usually not a ma er of life or death for the
patient, an ill-fi ed FIS can be life or death for the fiscal viability of the
organization. Therefore one must choose wisely and update the FIS often to
keep up with the ever-changing regulations and variations that affect the
revenue and profitability of the organization.
FIG 7.1 Financial information system architecture. (Healthcare
Financial Management Association Certification Professional Practicum
PowerPoint.)
Evolution of Healthcare Financial Information System
Automated FISs were the first type of systems used in many healthcare
facilities. The main purpose of these initial FISs was basic bookkeeping and
payroll. Basic accounting systems were then put into place to help with the
billing function. As Latham quotes, “Cash is king, so cash flow is the
lifeblood of the kingdom.”6, p. 1 To get cash flow, charges must be captured
and collected from the patient or the patient’s third-party payment system.
Entering charges and creating claims to send to insurance companies and
patients were some of the first, and easiest, functions for an FIS. Payroll was
also a very simple function for an FIS to perform. There was no need for
analytics or importing to spreadsheets, and reporting functions were
limited.6 Healthcare organizations embraced the basic financial functions to
remain financially viable. Fig. 7.1 shows how financial transactions fit within
the FISs.
Some of the basic financial systems required by healthcare organizations
and other businesses are general ledger, payroll, patient accounting, claims
processing, claims denial management, contracts management, and fixed
asset management.
General Ledger
The general ledger consists of all financial transactions made by the
healthcare organization. This is similar to a personal checking ledger where
any checks wri en or deposits made are recorded in the account. Numerous
financial areas need to be tracked. Therefore a healthcare organization will
maintain various subsidiary ledgers. Each of these ledgers tracks customer
and vendor names, dates of transactions, types of transactions, and balances
remaining. The FIS managing the general ledger must be able to track and
report information in a variety of ways to meet the needs of the decision
makers. Types of financial data that need to be tracked include:
• Assets: Assets are property items that can be converted easily into cash.
Assets are classified as tangible and intangible. Tangible assets include
current and fixed assets such as inventory or buildings and equipment.
Intangible assets include nonphysical resources such as copyrights or
computer systems.
• Accounts payable: Accounts payable are the monies that are owed to
vendors and suppliers for items purchased on credit (very similar to
using a personal credit card and then paying back the amount on a
monthly basis). These usually occur in the form of invoices or
statements. This would fall under the category of disbursements in
many systems. Because many vendors offer discounts when paid by a
certain date, the FIS needs to be able to track the dates that payments
need to be made in order to receive the discount or avoid the penalties
that may be applied for late payments.
• Accounts receivable: The opposite of accounts payable, accounts
receivable are monies that are owed to the institution. The vast majority
of the dollars owed to the healthcare organization come in the form of
patient-generated revenues. Once claims have been submi ed to
insurance companies (if the patient is covered by insurance), the
remaining balance is sent to the patient for payment. The FIS has to be
able to track the amount owed by the insurance, minus any negotiated
rate such as managed care contracting, and the remaining balance owed
by the patient. Ideally, the system estimates the amounts owed up front
so the collection process can begin at the time of the visit.
Payroll Application
The application that handles compensation payments to employees is the
payroll system. This is also referred to as a disbursement system. The FIS
application must be able to deduct taxes, benefits, possibly savings amounts,
and other deductions. At the onset of FISs for payroll, the minimal functions
could be performed. In advanced systems, automatic payroll deposits and
much more can be performed. In addition, overtime pay, pay rates, and
payroll histories must be tracked and reported. At the end of the calendar
year, the system must be able to generate W2 forms for the employee to use
in income tax preparation.
Patient Accounting Application
A patient accounting application tracks the accounting transactions related
to patient services. All charges incurred because of the patient visit need to
be tracked and added to the patient’s financial record. This can include
inpatient fees if the patient is hospitalized, healthcare provider (e.g.,
physicians and nurse practitioners) and medication fees associated with the
treatment, and procedure costs, including surgeries, radiology, and whatever
else is necessary for the care of the patient. The procedural and diagnostic
codes also become part of the patient billing record in order to complete the
information necessary for the insurance payer to submit payment for the
claim. Without critical information such as charges and coding, the claim
process is delayed, resulting in reduced cash flow for the healthcare
organization.
The collection process can begin at the time of the visit. This statement
implies that the patient can receive services without paying anything up
front. This is the reality in emergencies. Because of the Emergency Medical
Treatment and Active Labor Act (EMTALA), patients must be treated in the
case of emergency regardless of their ability to pay. This can lead to
hundreds of thousands of dollars outstanding that the healthcare facility will
try to collect after the service has been performed. Therefore the collection
process in healthcare is much different from the process in a traditional
business that requires payment before the product or service is provided.
The FIS also needs to be able to track outstanding balances and assist in
tracking these for the patient accounts personnel who will be a empting to
collect the balances. The older the balances are, the more difficult they are to
collect. The FIS needs to be able to differentiate the balances based on several
factors, including, but not limited to, amount, payer, age of the account, and
so forth. The features needed in FISs are now much more complex than in
the past. For example, managers now may need to track the revenue
generated by staff as a measure of productivity.
Claims Processing and Management System
As patients present for registration and admission, a single healthcare facility
must be prepared to bill numerous insurance companies (third-party payers)
representing hundreds of coverage and payment plans across government
and private insurance. Some patients have primary coverage and
supplemental coverage (e.g., Medicare as primary insurer and another
insurer for supplemental coverage). Other patients receiving charity care or
those with no insurance are categorized as private pay patients.
Claims processing and management is the submission of the insurance
claim or bill to the third-party payer, either manually or electronically, and
the follow-up on the payment from the payer. The application must be able
to keep each of the payer types separate and know the requirements of how
to bill the claims, who to bill for the balances, or if the balances need to be
wri en off and not billed to anyone. Collections can be very challenging for
the healthcare facility. Many new standards have been adopted for claims
processing, but numerous different standards and requirements must be
followed for the various insurance companies and plans.
Sending “clean” claims is the key to ge ing payment quickly. Clean claims
are those claims that contain all critical information such as patient
demographics, charges, procedures performed, procedural and diagnostic
coding, and other information required by the insurance company to remit
prompt payment. Timely claims processing and collection are key to the
fiscal health of institutions so they can meet the financial obligations in their
disbursements and accounts payable functions. The claims-processing
application must review the claim before it is submi ed to ensure that all
necessary data fields are complete and accurate. If the claim is not clean, it
will be denied, creating a delay and generating increased labor costs to
correct errors before payment can be received for the service provided.
Claims Denial Management Application
Denials from insurance companies are tracked, and they require follow-up.
The claims denial management application can prevent denials imposed by
the insurance carrier in a variety of ways. For example, the application can
issue an alert on a request by clinical personnel for a patient to stay an
additional day in his or her current patient status (i.e., observation, inpatient)
if that request is likely to be denied by the insurer. The submi ed insurance
claim for a patient’s stay may also be denied for improper coding or missing
information. When the denial occurs, the application must track the update
and the progress on having the denial reversed. Because a claim or request
was denied initially does not mean that the decision cannot be reversed.
Persistence and proper documentation can be the deciding factors leading to
reversal. Documentation must be detailed and included with the denial
reversal request to be effective.7 In addition, the communications that took
place between each area of patient care must be documented, collected, and
stored in an orderly manner for the proof to be shown. This is just one
example of why the FIS must be carefully integrated with the clinical
systems.
Contract Management Application
Healthcare organizations have a variety of contracts they must track,
including those for supply chain management (SCM) and managed care.
These types of contracts affect the bo om line of the organization, so the
contracts must be tracked and managed for the organization to obtain
maximum financial gain. SCM contracts include group purchasing, where
healthcare systems negotiate a price for using a standard vendor. Vendor
price comparisons and usage need to be tracked, and the system must ensure
that employees are adhering to the purchasing policies. Additional SCM
functions can include providing incentives for healthcare providers to reduce
the cost of their preferred supplies. For example, some surgeons may have
particular instruments or supplies they prefer for surgical procedures. These
supplies may be much more expensive than an alternative brand. The FIS
could help the organization track the supply costs and the costs for
procedures and provide reports for physicians to accompany requests for
their assistance in reducing those costs.
Managed care contracting can be very challenging and complex. The
contracts can be numerous, and each contract can have different terms. The
FIS needs to be able to track these contracts and manage the terms and
results of each contract individually. For example, when a patient is covered
by a nongovernmental insurance plan, the insurance company may have
negotiated an agreed-upon amount for reimbursement per service or per
patient. The insurance and patients need to be billed according to that
contract’s terms, and any negotiated discount should not be billed.
Fixed Asset Management Application
Fixed asset management applications manage the fixed assets in a healthcare
facility that cannot be converted to cash easily, sold, or used for the care of a
patient, such as land, buildings, equipment, fixtures, fi ings, motor vehicles,
office equipment, computers, software, and so forth. Each fixed asset must be
tracked by location, person, age, and other factors. In a healthcare
organization, the assets can be issued to a person, a procedure room, a
department, and others. Therefore the FIS must handle the vast number of
assets and the various areas in which the assets can be located. This system
tracks depreciation, maintenance agreements, warranties related to the
assets, and when assets will need to be replaced.
Even though healthcare FISs during the first decade of the twenty-first
century supported a number of improvements in the business processes,
including patient scheduling, laboratory and ancillary reporting, medical
record keeping and reporting, and billing and accounting, many
opportunities still remain to improve efficiency, productivity, and quality,
such as fiscal decision support.8
Financial Reporting
One of the primary functions of an FIS is providing the reports that
demonstrate the financial condition of the organization. The most common
reports for healthcare organizations are summarized in Table 7.1. Note that
the titles may vary depending on whether the organization is for profit or
not for profit.
Table 7.1
Financial Statements
For Profit Not for Profit
Balance sheet Statement of financial position
Income statement Statement of operations
Statement of cash flows Statement of cash flows
The income statement or statement of operations is a good representation
of the bo om line, or money left over (net income or loss), of the
organization (Table 7.2). This report lists all revenues (monies coming in) and
expenses (monies going out), and these are often compared with those of
prior years and with the budget plan.
Table 7.2
Income Statement
Revenue $1,195,450.25 100.00%
Cost of goods sold 870,175.83 72.79%
Gross margin $325,274.42 27.21%
Overhead 29,879.65 2.50%
Net ordinary income (loss) $295,394.77 24.71%
Interest expense 1269.08 0.11%
Interest income 5387.08 0.45%
Net income (loss) $299,512.77 25.05%
From Healthcare Financial Management Association Certification Professional Practicum
PowerPoint.
The balance sheet or statement of financial position shows a glimpse of the
organization’s financial condition at any given point in time (Table 7.3). The
FIS needs to pull the financial data from assets, liabilities, and equity to
present the report so the organization can determine whether the numbers in
the categories are balanced. Balance sheet data are based on a fundamental
accounting equation (Assets = Liabilities + Owner’s equity), so each side
must “balance” to show the financial condition of the organization.
Table 7.3
Balance Sheet
From Healthcare Financial Management Association Certification Professional Practicum
PowerPoint.
The cash flow statements show whether the organization will be successful
in paying its bills (have more money than it owes). Table 7.4 provides an
example of a cash flow statement. Fig. 7.2 illustrates how the cash flow
statement reconciles with the income statement.
FIG 7.2 Statement of cash flows and reconciliation with income
statement. (Healthcare Financial Management Association Certification
Professional Practicum PowerPoint.)
Table 7.4
Statement of Cash Flows
Cash Flow from Operations $1800.00
Net income $ 259.00
Adjustments $1541.00
Depreciation expense $(100.00)
Accounts payable $130.00
Credit card account $50.00
Patient credits $0.00
Sales tax payable $1.23
Accounts receivable $986.77
Inventory asset $473.00
Cash Flow from Investing $(1000.00)
Equipment $(1000.00)
Cash Flow from Financing $1500.00
Opening balance equity $2000.00
Owner’s equity $(500.00)
Draw $(500.00)
Investment $0.00
Net Change in Cash $2300.00
From Healthcare Financial Management Association Certification Professional Practicum
PowerPoint.
A healthcare organization keeps track of certain financial ratios to help it
evaluate its financial condition; these can be important when borrowing for
future capital investments. The FIS must be able to calculate and report ratios
on demand so that at any given time the organization can assess its financial
condition. Ratios are classified into several categories, such as solvency, debt,
management or turnover, profitability, and market value. Several ratios are
unique to the healthcare industry (Table 7.5), such as length of stay and bed
occupancy. Average length of stay in the United States for most procedures
is 4.8 days. Decision makers can analyze the length of stay for their hospitals
to determine whether they are on track for most procedures. Keep in mind,
however, that a shorter length of stay does not necessarily mean lower costs.
Bed occupancy provides a quick glance at how many inpatient beds are
being used. The occupancy is typically higher during flu season and other
epidemics. The other ratios reported in Table 7.5 are typical of financial ratios
for any organization. Accounts receivable days in a healthcare organization
are generally higher than in other organizations because the services are
provided before payment is made by the patient or insurance company.
Table 7.5
Sample of Financial Ratios
Healthcare Financial Management Association Certification Professional Practicum
PowerPoint.
x, Denotes ratios whose result commonly is greater than 1.
Challenges with Financial Information Systems
One of the challenges that large healthcare organizations face with the
implementation of FISs is ensuring that the various systems in place at
numerous locations are integrated. Larger healthcare organizations can
include 20 or more facilities. Within each of these facilities can be numerous
sub-facilities. The different financial systems, applications, and SCM systems
can become very complicated when they are merged and the information
systems do not interface well.5
The purpose of healthcare organizations is to provide quality patient care.
While generating maximum revenue is not its defining purpose, an
organization must generate income to stay in business and advance new
programs and services. What this means is that patient care systems can be
seen by some as a higher priority compared with FISs. Decision makers may
have a more challenging time realizing the return on investment or
understanding the importance of the investment in FISs because IT software
applications such as patient accounting or revenue are considered an
intangible asset. The key is to ensure the integration of the various
applications.9 If an information system meets the requirements needed for
patient care and includes integrated applications such as patient accounting,
the organization will have the best of both worlds. True integration supports
the effective transfer of captured data across all applications. This leads to
improved efficiency and enhanced cash flow, and the total cost of ownership
is lower.9
Analyzing Accountable Care Organizations and Pay for Performance
Historically healthcare was financed using a “fee-for-service” approach.
With this approach, each time a service (e.g., an office visit, an injection,
delivery of a baby, or surgery) is completed, payment is provided. There are
two key problems with this approach. First, such an approach encourages
the provider to increase the amount of services performed. For example, a
healthcare system that does more procedures is able to make more money
compared with a healthcare system that is more conservative. Second, such
an approach does not consider the quality of the service provided. With a
fee-for-service approach, a postoperative infection provides the healthcare
institution with additional income because they can now charge to treat that
infection. “The predominant fee-for-service system under which providers
are paid leads to increased costs by rewarding providers for the volume and
complexity of services they provide. Higher intensity of care does not
necessarily result in higher quality care, and can even be harmful.”10, p. 1 As
healthcare costs have increased and problems with healthcare safety have
become more obvious, there have been increasing efforts to use a different
approach to funding healthcare.
During the 1990s, a managed care approach was introduced to reduce
excessive and unnecessary care. By paying providers a lump sum per patient
to cover a given set of services, there was no advantage for increasing the
amount of service provided. In addition, poor quality could increase the
institution’s cost with no financial gain. However, this approach presented
new concerns because a managed care approach motivated payers to control
costs by restricting services. Concerns about compromised quality and
constraints on patients having access to providers of their choice led to a
backlash.10
The most recent regulation affecting healthcare finance to date is the
Affordable Care Act (ACA). Officially called the Patient Protection and
Affordable Care Act (PPACA), and sometimes called ObamaCare, the ACA is
a U.S. law aimed at reforming both the healthcare delivery system and the
health insurance industry. The ACA includes a number of provisions
designed to encourage improvements in patient outcomes as a basis for
payment. For example, Medicare’s Hospital Readmissions Reduction
Program reduces payments by 1% to hospitals that have excessively high
rates of avoidable readmissions for patients experiencing heart a acks, heart
failure, or pneumonia.10
Another key aspect of the ACA is the concept of pay for performance. The
concept of pay for performance ties payment to the quality of the care
provided or to patient outcomes as opposed to the service delivered. The
most familiar program that pay for performance (P4P)is the voluntary
accountable care organization (ACO). An ACO is a network of doctors and
hospitals that share responsibility for providing care to a specific group of
patients and in return receives bonuses when these providers keep costs
down and meet specific quality benchmarks.10
Three other P4P programs include value-based purchasing, physician
quality reporting, and Medicare Advantage plan bonuses.10 These programs
are intended to provide financial incentives for physicians and healthcare
organizations to have accountability over controlling costs while gaining
more efficiency and higher quality in their operations. Healthcare
organizations are also going beyond the clinical aspect of healthcare by
looking at social determinants (e.g., age, gender, geographical location,
socioeconomic position, nutritional habits, drug uses or abuses, and work
environment) that may cause health issues in certain populations.
Since the inception of the ACA in 2010, over 440 Medicare ACOs have
been created nationwide. Of the Medicare ACOs initiated, 54% lowered
expenditures and generated $383 million in net savings for Medicare,
resulting in significant shared savings payments for the ACOs. Public
reporting is one of the requirements for the Medicare Shared Savings
Program (MSSP).11 As ACOs continue to grow in numbers, their overall
financial viability will be determined.
There are challenges to the participants in these P4P programs. One of the
key challenges is determining the quality “perceived” by patients because
this can vary tremendously because of opinions and expectations. In
addition, complying with the structural suggestions such as adding health
information technology can be costly, so the participants would need to
know how much they are receiving in incentives to determine if the costs of
the structural changes result in an overall positive gain financially.
As regulations and financial incentives continue to be put into place,
healthcare organizations need a means to track the effect of such regulations.
Tracking demographics and social determinants will allow any trends to be
discovered. The FIS will provide tools to help the healthcare organizations
and the ACOs analyze the feasibility and results of the shared savings in the
P4P incentive, as well as to track information for the prevention of health
issues.
Financial Information Systems Integration
Financial systems matured much faster than clinical systems (CSs) did12;
therefore the degree of integration of the FIS with CSs was somewhat
limited. However, there are several advantages to integration within the FIS
and across CSs. For example, this approach eliminates duplication of effort,
which also reduces the number of potential errors. Williams points out the
following benefits of integration:
• A transition is provided between front-end and back-end operations.
• Information required for billing such as demographics and insurance
can be gathered and verified at the point of service or admission so that
the information is immediately available for patient care and financial
personnel.
• Eligibility checking for insurance can be done online; automated
charging is supported, eliminating the need for charge entry.
• Availability of clinical records with detailed charges that have been
secured through proper access allows staff to respond to questions from
patients, payers, or others without having to access paper charts.12
All of these features of integration improve the bo om line, which is the
aim in healthcare finance. In addition to the basic accounting systems, such
as general ledger, accounts payable, and accounts receivable, FISs handle
functions that are more complex such as activity or project management.
Advanced revenue cycle IT, or new generation, is often referred to as
integrated “bolt-ons.”9 TechTarget describes a bolt-on as a product or system
similar to an add-on but one that can be a ached securely to an existing
system.13 Besides integrated bolt-ons, there are workflow rules engines,
advanced executive scorecards, and single-database clinical and revenue
cycle systems.9 Workflow rules engines help to manage workflow. For
example, documents can be stored in a document management system and
e-mail or event reminders can be automatically sent to the people involved
with the tasks. Advanced executive scorecards are strategic management
tools that aggregate data from electronic health records (EHRs) in concert
with an FIS, thereby providing a snapshot of how the healthcare institution
is performing in certain areas. For example, the snapshot may show a
quarterly increase in the hospital’s cost to deliver a baby. Investigating these
data may demonstrate an increase in C-sections or a decrease in babies
delivered by midwifes. These “scores” can then be compared with the data
of other hospitals offering obstetrical services. A single-database clinical and
revenue cycle system is a system used to ensure accuracy, availability, and
data integrity for patient care and billing for the healthcare organization.
When changes are made to information contained within the database, those
changes are managed throughout the system. In other words, the user does
not need to make the change in multiple locations; the database management
system will do that for the user to ensure that all necessary changes have
been made. This is particularly important when dealing with procedures,
documentation for those procedures, and the charges that accompany those
procedures. In line with the original accounting systems, these advanced
systems are designed to improve billing by reducing billing errors,
improving the timeliness of billing to cash collected, decreasing the cost of
collections, providing real-time eligibility for services, and providing
improvements to current operational efficiencies via other functions.9
Improvement in cash flow has remained a constant goal since the onset of
FIS. Adaptability and flexibility in healthcare is the key to successful patient
care and quality, and the same applies to FIS choices. An example of the
revenue cycle is provided in Fig. 7.3.
FIG 7.3 Revenue cycle function. (Healthcare Financial Management
Association Certification Professional Practicum PowerPoint.)
One of the more recent IT tools used to positively affect the revenue cycle
is a communication management system. The variety of communications
(e.g., patient care, insurance coverage, and patient admission), the method of
communication (e.g., face to face, phone, fax, and internet), and the number
of people engaged in communications make organizing and tracking
communications a complex process. As Cruze points out, communications
surrounding care of the patient and payment can be very difficult to track
and retrieve.7 A centralized management tracking system could assist in this
area. An audit trail needs to be very detailed, and include all
communications that capture and travel with the patient, as well as the
authorizations associated with each step. In other words, these
communications need to be captured, indexed, and archived for future
retrieval.7
Efficiency Tools
Decision makers need tools to capture productivity for various activities
within the financial services area of the organization. For example, collecting
balances from the patient may fall within the responsibilities of a handful of
employees. At the front end (before services are received), patients who have
been preregistered can be asked for payment on the estimated amount owed.
At the back end (after services have been received), patients who have a
remaining balance after insurance has paid will need to pay that balance.
How does an organization know which employees are having success at
collecting payments? The reporting tools must provide a snapshot of the
data so the decision makers can immediately analyze financial events within
a particular area.
In addition to reporting tools, the application needs to be able to assist end
users with the questions that need to be asked, and when. For example, if a
patient has an outstanding balance from a previous visit, the patient access
personnel may need to know whether they should request payment.
Information needed should be readily available and easy to access. When
adaptable and flexible designs between clinical and financial systems are
combined, powerful analytics are deployed via the web to every desktop;
many activities are self-service, freeing up valuable time and resources for
the healthcare organization.9
Managing services has become more complex. For example, capturing
charges has increased in complexity just as medical care has.9 As a result,
there needs to be a seamless flow of charges as a natural by-product of the
care process to help reduce lost, late, or duplicate charges. These new
functions require an investment in an upgraded system to handle revenue
cycle management.14 A dashboard provides users with a visual analysis of
specific data points so an organization can gauge how it is performing in
certain areas (it is called a dashboard because it resembles the visual data
points provided on an automobile dashboard). Efficiency may be improved
by applications that allow for coding edits or overriding default values as
needed, that are easy to use, and that include executive dashboards
capabilities.14
Practice Management Systems
Practice management systems (PMSs) are very similar to the information
systems supporting integrated healthcare systems, only on a smaller scale.
These applications focus on the services provided in a healthcare provider’s
office compared with the services provided in a large healthcare system or
hospital. Similar to the hospital revenue cycle management system, the PMS
is designed to collect patient demographic and insurance information,
manage appointment scheduling, document the reason for the visit and
patient care procedures performed for the patient, post charging information
for the billing process, and manage collection and follow-up. As with
inpatient or acute care systems, PMSs require integration. The primary
differences between PMSs and information systems supporting hospitals are
specific provider scheduling templates and types of visits, transaction or
line-item provider billing compared with account-driven hospital billing,
and provider-based medical record content (orders, referrals, provider
documentation, and problem lists) that differs from the typical
comprehensive hospital medical record.15 The charges from a medical
practice office are connected to codes used for practice management billing
and include Healthcare Common Procedure Coding System (HCPCS) and
Current Procedural Terminology (CPT). Therefore the information system
must be able to generate claims using this type of coding, usually through an
electronic submission. Electronic medical records (EMRs) have become much
more common modules within a PMS as the U.S. government has
implemented incentives supporting EHRs (discussed in Chapter 27). An
explanation of the difference between an EMR and an EHR can be found at
[Link]/buzz-blog/electronic-health-and-medical-records/emr-vs-
ehr-difference/. Information on the episodes of care maintained in the EMR
can be passed along to the hospital or health center should the patient need
to be admi ed. Sharing this information helps to ensure that the information
in the EMR becomes part of the EHR. However, this is often not a “plug and
play” environment. Creating a successful interface to share data between the
EMR of a practice and a hospital or health center information system is a
complex process. Chapter 5 includes additional information on health
information exchanges (HIEs) and health information organizations (HIOs)
and the issues involved with these.
In outpatient se ings, healthcare providers can spend much of their time
documenting the details of the patient visit. There are a variety of ways to
accomplish this, including documenting and recording what is being said
and done while the patient is in the examination room, dictating and
transcribing based on wri en notes, or using voice recognition software
during or after the visit. Traditionally, visit notes were often transcribed by a
third party, leaving room for error through misreading of handwriting or
mishearing of dictation. There is also a time delay until the documentation
becomes part of the patient record because of the multiple processes
required. The healthcare provider is required to review and sign off on the
final documentation, but time constraints can encourage the provider to rush
and perhaps overlook some details.
A method using more enhanced technology and providing quicker
turnaround is voice recognition. Voice recognition software capabilities have
greatly improved over the last few years. Voice recognition eliminates the
need for a third party and allows healthcare providers to input information
themselves, saving steps, time, and money. The application allows text to be
viewed in real time, and providers can edit and approve it immediately. The
time savings can result in much more timely billing and improved cash flow
versus waiting for dictated notes to be approved after being transcribed.
Patient Outreach System
Some practices specialize in providing preventive care to manage patients
with chronic illnesses. In these practices, an electronic registry of the clinic’s
entire patient population can be used in a patient outreach system. The
registry includes the demographic and medical record information needed to
notify patients, and an automated reminder capability.16 Patient outreach
systems should incorporate evidence-based, specialty-specific protocols—or
recommended care guidelines—for chronic and preventive care. Then, once
the outreach system identifies patients due for preventive screenings and
follow-up care for chronic diseases, the patients are contacted via an
automated phone messaging system or another computerized method.
Online Billing and Payment Tool
Collections in a practice can be just as challenging as collections in a hospital,
except that few emergency cases occur in a provider practice se ing,
allowing office staff to determine the acceptability of denying services to a
patient until a payment plan has been established. In addition to routine
collection practices, implementing an online billing and payment tool (e.g.,
using a credit card to pay online) can help to improve the management and
collection of fees owed by patients. Conley states that the healthcare facility
can realize increased patient satisfaction and improved staff efficiencies by
implementing an online payment tool.17 Benefits for the patient and the
provider’s office are outlined in Box 7.1.
Box 7.1
Benefits of Implementing an Online Payment
Tool for Patients and Provider Offices
• Self-management of their open accounts
• Ability to pay outstanding balances
• Secure communication on a 24/7 basis with the business office (the practice
will determine the turnaround time of communications to the patient)
• Ability to update address or demographic changes
• Ability to update changes to insurance coverage (which often occur
annually)
• Preregister for services or appointments
• Enhanced customer service capabilities
• Ability for staff to accept payments in person or over the phone
• Ability for staff to view the patient statement exactly as submi ed to the
patient, which helps to improve communications and efficiencies for
payment collection
Data from Conley C. Improve patient satisfaction and collections with efficient payment processes.
Emdeon Express Winter Edition, <h p://[Link]/2009/02/its-no-secret-that-
[Link]>; 2009.
Hospital–Healthcare Provider Connection
PMSs integrated with the hospital information system can be more efficient
for healthcare providers in a clinic or private practice. According to Cash,
physicians, nurse practitioners, physician assistants, and others with staff
privileges who participate in the hospital network have certain expectations
about the IT, including that it should:
• Provide a single sign-on to an integrated information system from all key
system entry points.
• Automate the provider’s day as much as possible using mobile access
(automation means that access is available wherever the clinician is and
that the information is in a useful format).
• Have 24/7 support for any device, anywhere.
• Provide a dashboard to view critical clinical and financial information with
the ability to act on it immediately.18
• Healthcare provider dissatisfaction can occur if the information system:
• Slows performance of the task
• Reduces the ability to bill insurance or the patient
• Adds more administrative duties to clinical responsibilities
A Matter of Perspective
All healthcare providers have patient care as a top priority. Whereas the
provider’s focus may be on care of the patient, office personnel must focus
on receiving maximum payment for the care of that patient. The records
stored at the practitioner level must be accessible and transferable to the
hospital in the case of an admission or referral. HIEs are making this possible
for referrals, consultations, admissions, discharges, and transfers. IT
solutions such as EMRs, digital storage of patient data, voice recognition
software, and e-mailing of correspondence can offer efficiency, cost savings,
and improved patient care, which should be the priorities of practice
management.19
Supply Chain Management
SCM includes the acquisition of materials of care and the logistics or
movement of those materials to caregiving facilities and organizations.
Routinely, health systems deploy information system solutions to support
the functions of SCM.
Healthcare Supply Chain and Informatics
What is a supply chain? The Council of Supply Chain Management
Professionals defines supply chain in two ways: (1) starting with
unprocessed raw materials and ending with the final customer using the
finished goods, the supply chain links many companies together, or (2) the
material and informational interchanges in the logistical process stretching
from acquisition of raw materials to delivery of finished products to the end
user. All vendors, service providers, and customers are links in the supply
chain.20
A supply chain is much more than procurement of materials. Many times,
the potential advantages of SCM are missed because the term is thought to
relate only to the supply side of an organization or to the purchasing of
materials. In addition, SCM is not:
• Inventory management
• Logistics management
• Forming partnerships with suppliers
• A strategy for shipping
• A logistics pipeline
• A computer system
The healthcare supply chain is complex, with requirements that go across,
for example, the equipment for operating suites, pharmaceuticals, and
medical and surgical supplies for all se ings. In any health system with
hospitals, clinics, and employees ordering from the supply chain, thousands
of transactions occur daily across hundreds of vendors. Medical and surgical
supplies, pharmaceuticals, and equipment are the “technology” that enables
the delivery of healthcare services. These technologies couple with clinician
knowledge and expertise within an appropriate healthcare facility function
to provide efficacious services to patients.
Materials management in healthcare is the storage, inventory control,
quality control, and operational management of supplies, pharmaceuticals,
equipment, and other items used in the delivery of patient care or the
management of the patient care system. As such, materials management is a
subset of the larger function of SCM. It should be noted that the term
materials management is also sometimes used as a synonym for the healthcare
supply chain.
Typically, an organization named Materials Management or Central
Supply in the hospital bears the burden of having the right item at the right
place at the right time. The leading professional association, the Association
for Healthcare Resource and Materials Management or AHRMM, lists
common functions of the supply chain in healthcare. Several of these
functions occur in the Purchasing Department, which is a key department
within Materials Management.
As a department within Materials Management, Purchasing traditionally
controls or participates in several functions21:
• Budgeting
• Replenishing inventory
• Evaluating and selecting capital
• Negotiating
• Maintaining the Materials Management Information System (MMIS)
• Reviewing product use and analyzing value
• Maintaining vendor relationships
• Monitoring the product selection process to ensure selection is
competitive
• Coordinating with Finance to ensure reimbursement of products
• Providing information to end users regarding product use, costs, and
alternatives
All of these items can be a part of the SCM strategy, but the
misconceptions behind what is considered SCM have slowed
implementation. As healthcare institutions increasingly need to understand
and control actual costs, SCM and in turn materials management is now an
area of growth because of the potential for cost savings.22 Because the
acquisition, logistics, and management of materials in healthcare are
complex, a sophisticated information system is required to provide effective,
efficient, and efficacious materials as needed.
The sophistication in automating this process has increased tremendously
since the late 1990s. Applications now include electronic catalogs;
information systems such as enterprise resource planning (ERP) systems
from vendors such as Infor ([Link]) or McKesson
([Link]); warehousing and inventory control systems from
vendors such as TECSYS ([Link]) and Manha an
([Link]); exchanges from vendors such as Global Health Exchange
(GHX) ([Link]); and integration with other systems such as clinical,
revenue management, and finance. An innovative technology in this area is
radio frequency identification (RFID); more information can be found at
[Link]/[Link].
With increased automation, these systems have improved supply chain
performance and management in healthcare, with more innovations
expected in the future. The healthcare supply chain is an untapped resource
of financial savings and revenue enhancement opportunities.23 Recognizing
these opportunities, HIMSS advocated for more improvements in a white
paper titled Healthcare ERP and SCM Information Systems: Strategies and
Solutions. HIMSS indicated that ERP systems will be tools for quality and
safety because they integrate capabilities such as procure-to-pay, order-to-
cash, and financial reporting cycles. These functions should help institutions
match needed materials with care in a more timely and cost-effective
manner.24
Integrated Applications in Supply Chain Management
The importance of these ERP and SCM systems should be apparent,
including the technology associated with them, such as bar code scanners
and electronic medication cabinets (e.g., Pyxis [[Link]/our-
products/medication-and-supply-management/medication-and-supply-
management-technologies/pyxis-medication-technologies/pyxis-medstation-
system] and Omnicell [[Link]]). The basic components of an
integrated healthcare supply chain system include the following:
• Supply item master file: A list of all items used in the delivery of care
for a healthcare organization that can be requested by healthcare service
providers and managers. This file typically contains between 30,000 and
100,000 items. Fig. 7.4 shows a supply-item master file.
FIG 7.4 Extract sample of a supply item master file. (Dr. Jerry Ledlow,
personal files.)
• Charge description master file: A list of all prices for services (e.g.,
Diagnosis-Related Groups [DRGs], HCPCS, and CPT) or goods
provided to patients that serves as the basis for billing.
• Vendor master file: A list of all manufacturers or distributors (vendors)
that provide the materials needed for the healthcare organization along
with the associated contract terms and prices for specific items. This file
typically contains 200 to 500 different vendors or suppliers.
• Transaction history file: A running log of all material transactions of the
healthcare organization. In a computerized system, it is a running list of
all supplies and materials being used to deliver care or manage the
operations of the institution.
These four files must be integrated to support the operations and
management of the supply chain. The integration necessary in the modern
healthcare organization is illustrated in Fig. 7.5 as a diagram of interfaces
across supply chain, clinical, and financial systems.25
FIG 7.5 Wire diagram of healthcare supply chain information systems.
(Dr. Jerry Ledlow, personal files.)
Supply Cost Capture
As a survey of supply chain progress26 demonstrates, “In all industries, not
just healthcare, three out of four chief executive officers consider their supply
chains to be essential to gaining competitive advantage within their
markets.”27, p. 2 According to Moore, if the trend in the cost of the healthcare
supply chain continues to grow at the current rate, supply chain could equal
labor cost in annual operating expenses for hospitals and health systems
between 2020 and 2025.28 Clearly, maximizing efficiency of the healthcare
supply chain is an increasing concern.
Consider supply charge capture events in which patient-specific supplies
are ordered for the care of that patient and the items are then billed
separately to the patient. “Every year, hospitals lose millions of dollars when
items used in the course of a patient’s care somehow slip through the system
without ever being charged or reimbursed.”29, p. 1 Point-of-use technology, or
capturing charges when supplies or materials are used, allows healthcare
institutions to increase productivity, increase accountability, and reduce
downtime through improvements in their internal supply chain. Automated
dispensing machines for medications or supplies can be used to decentralize
store operations, capture charges, and bring supplies and materials to
employees without compromising security and accountability.30 These
systems, if integrated with a solid business process, can enhance efficiency
and effectiveness of the healthcare supply chain.
Strategic factors associated with supply success and enhancement are
important as well. These include the following27:
• Information system usefulness, electronic purchasing, and integration
• Leadership supply chain expertise
• Supply chain expenditures
• Provider level of collaboration
• Nurse and clinical staff level of collaboration
• Leadership team’s political and social capital
• Capital funds availability
This section has provided a high-level overview of technology in materials
management. Box 7.2 details specific considerations for automating SCM and
materials management.31
Box 7.2
Process Standardization
Process Standardization in Conjunction with Utilization
of an Information System
• Develop standard (or more standardized) processes for:
• Item master and charge description master maintenance and
synchronization
• Supply stock selection, reduction, compression, and management
• Supply charge item capture (accurate and timely)
• Accountability measures for Central Supply and clinical units
• Standardize clinical/floor stocked supplies replenishment processes
• Daily reconciliation of pharmaceuticals and medical/surgical supply
items, especially supply charge capture items
• Taking into consideration:
• Clinical unit needs
• Physical layout variations may require modification to an accepted
standard
• The business process must be efficient before a technological solution
can be integrated into the process
• “One-size” solution will not fit all
Process Standardization in Process Improvement:
Balancing Trade-Offs
• Competing goals exist between various stakeholder groups; trade-offs will
be required to find the proper balance that best meets all needs
• Clinician Goals
• Does not impede caregivers or patient care delivery
• Minimize rework
• Right supplies, right place, right time
• Supply Chain Managers/Central Supply Goals
• Improve accuracy for supplies consumed
• Improve timeliness for supply consumption
• Efficient use of labor
• Revenue and Cost Avoidance Goals
• Procure and acquire material wisely with contracted compliance goals
• Efficient management of materials considering utilization rates,
preferences, expiration dates and Food and Drug Administration
requirements
• Reduce number of supply charge capture items
• Improve accuracy for charge capture
• Improve timeliness for charge capture
• Improve charge capture rate
From Ledlow JR, Stephens JH, Fowler HH. Sticker shock: an exploration of supply charge capture
outcomes. Hosp Topics. 2011;89(1):9. Reprinted by permission of the publisher (Taylor & Francis Ltd,
h p://[Link]/journals).
Human Resources Information Systems
Human resources information systems (HRISs) leverage the power of IT to
manage human resources. They integrate “software, hardware, support
functions and system policies and procedures into an automated process
designed to support the strategic and operational activities of the human
resources department and managers throughout the organization.”32, p. 58 The
authors distinguish between operational, tactical, and strategic HRISs.
Operational HRISs collect and report data about employees and the
personnel infrastructure to support routine and repetitive decision making
while meeting the requirements of government regulations. Tactical HRISs
support the design of the personnel infrastructure and decisions about the
recruitment, training, and compensation of persons filling jobs in the
organization. Strategic HRISs support activities with a longer horizon such
as workforce planning and labor negotiations. In contrast, Targowski and
Deshpande state that generic HRISs typically include the following
subsystems defined by function: recruitment and selection from among
candidates; administration of personnel processes; time, labor, and
knowledge management; training and career development; administration of
compensation and benefits for active workers and pensions for retirees;
payroll interface; performance evaluation; transitioning and outplacement;
labor relations; organization management; and health and safety.33
Human Resources Information Systems as a
Competitive Advantage
Khatri argues that the management of human resources in healthcare
organizations is a central function because the healthcare and administrative
services delivered are based on the knowledge of staff delivering these
services.34 Human resources management should focus on employee
training, as well as developing and refining the work systems to improve the
work climate and the quality of service to customers. Although healthcare
organizations should include the effective management of human resources
as part of strategic planning, most fail to do so. Khatri offers three reasons
why many healthcare organizations do not employ optimal human resource
practices. First, he argues that the responsibilities and activities of human
resources personnel are institutionalized and undervalued in many
healthcare organizations. Second, the provider culture of healthcare focuses
on the clinical delivery of care with less a ention paid to the effective
management of resources. Finally, lack of expertise and low skills in the
human resource function have limited the ability of human resource
managers to engage effectively in strategic and operational planning.
Khatri’s premise is that improving human resource capabilities should help
human resource managers engage more effectively in managing human
resources.34
Khatri further proposed five dimensions of human resources capability.
The first four are a competent human resources executive in the C-suite, a
skilled human resources staff, an organizational culture that elevates human
resources to a central function, and commitment to continuous learning. An
integrated, computerized HRIS is the final capability.34
Human Resources Information Systems Vendors
Vendors may offer comprehensive or component human resource
information system applications to healthcare organizations. Three examples
of vendors with comprehensive human resource information system
solutions are listed alphabetically in Box 7.3. Vendors offering component
solutions that provide some but not all of the components of a complete
human resources information system compete with those of the enterprise
human resources suites for the component services that they offer. Two
examples of vendors offering component solutions are:
Box 7.3
Sample Vendors Offering Comprehensive
Human Resources Information Systems
• Infor Healthcare Human Capital Management
([Link]/solutions/hcm/)
• McKesson Human Capital Management
([Link]/providers/health-systems/department-
solutions/enterprise-resource-planning/mckesson-human-capital-
management/)
• Oracle PeopleSoft Human Capital Management
([Link]/us/products/applications/peoplesoft-enterprise/human-
capital-management/overview/[Link])
• API Healthcare ([Link])
• Kronos Workforce HR/Payroll ([Link])
Human Resources Subsystems
The human resources subsystems described below reflect a modification of
the subsystems described by Targowski and Deshpande, and they represent
a taxonomy of functions typically described by the vendor websites for
HRISs.33
Personnel Administration
The centralized and integrated management of employee data is a key
feature of HRISs. Personnel records are maintained and updated with
information such as employee identification and demographics, dates of
service, position and job code, location code, and employment status
(permanent or temporary, full time, or part time). Systems also maintain
records of licensure, credentials, certifications, and skill proficiency levels.
Increasingly, self-service capabilities allow employees to maintain a personal
profile with the ability to access and modify personal information such as
name, address, contact information, marital status, and information about
dependent family members.
Managing Human Resources Strategically and Operationally
HRISs can be used to address, in whole or in part, the challenge of managing
human resources from a strategic and operational perspective. First, strategic
management of human resources can be accomplished by accurately
reflecting the organizational structure of the healthcare institution. This can
be accomplished by using a wiring diagram to illustrate the hierarchy of
positions in the organization, the job descriptions associated with each
position, and whether the positions are filled or vacant. This analysis is then
used to support the recruiting process for vacant positions. Functions that
support this process include posting job announcements and application
forms; providing status reports for submi ed applications; maintaining
interview schedules; and providing selection tools such as dynamic
interview guides, multistage testing, computer adaptive testing, and mini
simulations. Once a decision is made, the formal job offer le er and new
employee benefits can be viewed online. Vendors who offer these types of
functionality include Kronos (h p://[Link]/hiring-
software/[Link]) and Oracle’s PeopleSoft
([Link]/us/products/applications/peoplesoft-enterprise/human-
capital-management/[Link]).
HRISs should also have the capability to assist employees in transitioning
out of the organization when discharged, displaced by reductions in the
workforce, or retiring.33
Staffing and Scheduling
Staffing and scheduling replaces the subsystem “time, labor, and knowledge
management” as a more accurate representation of the activities supported
by this HRIS subsystem. Staffing and scheduling are two different activities.
Staffing involves the assignment of personnel to job positions while ensuring
that they are qualified by virtue of degree, licensure, certification, training,
and experience. Scheduling involves the assignment of qualified personnel to
a scheduling template within a work area in the organization to fulfill the
mission of that organization. Scheduling of personnel such as nursing staff is
extremely challenging, so much so that nurse scheduling can be considered a
definitive representative of the archetypal multishift scheduling problem
found in operations research and management sciences literature.
Each of the vendors discussed in Box 7.3 offers both staffing and
scheduling modules. Other modules manage scheduling for staff
development and facilitate self-scheduling in conjunction with temporary
staff management to fill openings in the schedule. Key requirements for
staffing and scheduling include cost-effective staffing while meeting
constraints imposed by required qualifications, scheduling visibility, and
matching the level and number of caregivers to patient classification and
acuity levels as mandated by law or regulation. An example of an enterprise
staffing and scheduling product focused on nurse scheduling is McKesson’s
ANSOS One-Staff. Functions provided by these systems include:
• Staff schedules derived from patient acuity and workload data collected
by the software.
• Hospital schedules automatically generated to meet core coverage goals
while enforcing scheduling rules customized to meet schedule
constraints and accommodate individual scheduling preferences.
• Synchronous staffing data provided to managers to ensure that nurse-to-
patient staff ratios are met.
• Web-based self-scheduling.
• Productivity and labor cost reporting.35
Once scheduled, employees’ time and a endance are tracked. Key
elements include accurate time collection, implementation of user-defined
pay rules, compliance with a variety of labor laws, and expeditious
identification of productivity or overtime issues.
Just as schedules must be explicitly developed, time-off policies must be
proactively managed because of their effect on the schedule. These time-off
policies are designed to meet the requirements of federal labor laws such as
the Family and Medical Leave Act (FMLA) and state and local laws. In
addition to meeting legal and regulatory constraints, time-off policies must
enforce organizational policy for vacation, maternity leave, and sick leave.
The software used to do this is referred to as “leave management” or
“absence management” and is typically a rules-based application designed
to manage absence requests while interfacing with workload scheduling.
Because of the difficulty of scheduling in healthcare, flexible scheduling
solutions are becoming increasingly common. API Healthcare provides
software incorporating three solutions representative of many scheduling
systems:
• Open shift management: This is a web-based self-scheduling solution in
which the nurse manager broadcasts openings in the schedule to
qualified staff via a number of instant communication tools. Staff
members respond by tendering schedule and shift requests for
consideration and approval.
• Incentive management: This involves the use of monetary and point-
based rewards for staff who volunteer to fill openings in the schedule.
• Predictive scheduling: Predictive modeling is used to forecast bed
demand while accounting for variables such as bed turnover, changes in
patient acuity, workload distribution, and variability caused by shift,
day of the week, month, and seasonality.36
Another vendor, CareSystems ([Link]/), is a relatively
new entry into the healthcare staffing and scheduling arena, with a suite of
products that manage time and a endance, assess patient acuity and
estimated nurse workload, and employ intelligent scheduling algorithms to
create optimal nursing schedules.
Training and Development
The three comprehensive vendors featured in Box 7.3 also addressed staff
training and development. IT solutions should be able to be used as the
infrastructure to plan and manage employee training, to serve as the delivery
mechanism synchronously and online, and to link training with the
developmental plan for each employee by identifying shortfalls in skills and
competencies and then recording when those shortfalls have been
remediated.33
Compensation, Benefits, and Pension Administration-Payroll Interface
Compensation and benefit plans can vary from company to company. They
include various plans like flexible and non-flexible healthcare plans, short-
and long-term disability plans, saving plans, retirement plans, pension plans
and Flexible Spending Accounts.33, p. 46
When coupled with personnel administration and staffing and scheduling
systems and supported by timekeeping and absence management software,
the management of compensation, benefits, and pension administration
becomes more accurate and less time consuming.
One example of a vendor offering integrated compensation, benefits, and
payroll applications is Oracle’s PeopleSoft
([Link]/us/products/applications/peoplesoft-enterprise/human-
capital-management/[Link]). The PeopleSoft Enterprise
eCompensation system permits managers to view and update employees
records online; receive alerts and decision support when changes in salary
and benefits are being considered; receive reports on individuals, as well as
groups of employees; and permit employees to view and maintain their own
records as appropriate.
Performance Evaluation
Talent management and performance management are terms used by several
vendors. From the healthcare provider’s perspective, the focus is on
recruiting and training employees and developing competencies required to
fulfill institutional goals and objectives. The individual career goals of
employees are also considered. Information capabilities in this area include:
• Profiling employee competencies and any gaps.
• Identifying when employee and organizational goals are met.
• Identifying top performers.
• Managing dashboards to display unit performance.
Infor’s Human Capital Management suite includes modules for talent
acquisition, goal management, and performance management.37
Underrepresented Subsystems
Labor relations and health and safety have received less a ention from
vendors developing information for managing human resources, whereas
web-based expense and travel applications have become more prevalent in
healthcare organizations. These areas may represent future directions for
ERP systems.
Business Intelligence Systems
Since the late 1990s, healthcare institutions have been building data
warehouses and integrating data. Along with the technical aspects, data
warehousing includes improving data quality, developing protocols for
governance, and facilitating the employment of appropriate analytic
measures. This is difficult because of practice variation and changes to the
standards of practice over time. As quoted in an article by Erickson,38 Dick
Gibson, the CIO of Legacy Health, notes,
We generate and use data like any other industry, but health care does not
lend itself to the use of discrete data because the outcomes are necessarily
fuzzy and ongoing. Airlines have seats, schedules and know if you landed on
time. In health care, we know if you are alive but the big money goes to
broad sets of descriptive terms around patient care that are very
qualitative.38, p. 29
These descriptive terms can be captured more succinctly by the use of
diagnostic and procedural codes, but data quality and integration is a
problem because of the number of procedures and number of providers
engaged in the delivery of care.38
Many organizations are turning to business intelligence (BI) software to
provide tools to effectively manage and use their massive amounts of data.
BI software is purported to lead to an improvement in financial (particularly
revenue cycle) and operational performance, as well as patient care.39
Implementing BI in healthcare that successfully integrates financial and
clinical data is regarded as one of the four pillars of the Value Project
undertaken by the Healthcare Financial Management Association.40 Business
intelligence (BI) is defined as the “acquisition, correlation, and
transformation of data into insightful and actionable information through
analytics, enabling an organization and its business partners to make be er,
timelier decisions.”41, p. 142 However, Glaser and Stone warn that for the BI to
be most effective, the BI tools must be placed in the hands of the people who
actually do the work, training must be done initially and throughout the
project so that users will have time to use the basic functions and expand
their knowledge, questions that arise throughout the analysis must be
reviewed and answered, and the BI should be used for long-term planning.39
Glaser and Stone describe the BI platform as “a stack—one technology on
top of another.”39, p. 69 Their description was used to construct Fig. 7.6.
Effective management of this stackable technology involves making the
business case for BI, establishing implementation targets, enlisting BI
champions, governing effectively, and establishing BI roles to include data
stewards, data owners, business users, and data managers.39
FIG 7.6 Business intelligence platform. (Data from Glaser J, Stone J. Effective
use of business intelligence. Healthc Financ Manag. 2008;62(2):68-72.)
As with the other information systems discussed in this chapter, BI
systems may be part of an enterprise system, provided as component
software, or employed at application level. Most of the major healthcare
information system vendors have BI software imbedded in their products.
For example, McKesson has Enterprise Intelligence; Cerner has Knowledge
Solutions; and Allscripts has EPSi Integrated Performance Management.
KLAS lists the following vendors in this category of software, but they are
not part of an enterprise healthcare information system. Instead, they
provide BI solutions intended to support analytics in conjunction with
enterprise software or they provide analytics for a segment of the healthcare
marketplace.
• Dimensional Insight ([Link]) provides a BI platform specific
to healthcare called HealthcareAware BI ([Link]/healthcare-
analytics/) and targeted solutions for physician and surgical
management, Meaningful Use, and general ledger cost analysis.
• IBM Cognos ([Link]/software/analytics/cognos/) offers a
tailored line of analytic solutions, with Cognos Analytics providing
large-scale capabilities and Cognos Express targeting midsize
companies and work groups.
• Information Builders WebFOCUS Business Intelligence and Analytics
Platform ([Link]/products/intelligence)
advertises capabilities similar to Dimensional Insight and IBM Cognos.
• Greenway Health ([Link]/solution/analytics-data-
insight/) offers analytic solutions for improving the management of
ambulatory practices.
Given the cost, time, and complexity of the large-scale implementation of
enterprise BI, application-level BI should be employed strategically to
address “key processes, functions, or service lines.”42, p. 95Application-level BI
software provides some of the data integration and visualization of
enterprise packages, analyzes existing data that may be overlooked in
traditional reporting, and creates actionable knowledge. However, some
caution is necessary. Glaser and Stone note that ad hoc, smaller-scale
analysis may lead to the creation of data silos, inefficient or repetitive
management of data, and unnecessary duplication.39 These are appropriate
cautions, but application-level BI can complement the development of
enterprise BI by producing results in the interim as the enterprise capabilities
are developed.42
Conclusion and Future Directions
Given the magnitude of the investment in health information systems, and
that administrative applications are more mature than clinical applications, a
salient question is whether these administrative applications have made
healthcare delivery more productive. In “Unraveling the IT Productivity
Paradox—Lessons for Healthcare,” Jones, Heaton, Rudin, and Schneider
explore the paradoxical relationship between “the rapid increase in IT use
and the simultaneous slowdown in productivity.”43, p. 2243 Several lessons
emerge from the authors’ analysis:
• Mismeasurement partially contributed to the paradox. The authors
suggest, “assessment of the value of healthcare outputs could be
improved through the more sophisticated use of clinical data to
understand access, convenience, and health outcomes.”43, p. 2244
• New information technology often requires redesign of the processes
that were previously tailored to the technology or manual system just
replaced.
• New information technology compromises productivity when it fails to
be user centered.
• Finally, healthcare organizations can no longer afford to have an
abundance of untapped data that fails to improve decision making.
Improvements in healthcare information systems, BI, and analytics must
continue to improve the quality of decision making.43
Administrative systems in this chapter were listed as separate applications
because they evolved independently of CSs. Many of the future benefits will
accrue from integrating data from all systems. For example, if a healthcare
system cannot effectively track the total cost of all materials used to treat an
individual patient and aggregate data to determine the cost of treating
groups of patients, managing the cost of healthcare is not possible. As new
information becomes available for decision making, healthcare professionals
on both the administrative and the clinical sides of the organization will need
to learn new interprofessional approaches to using these data in making
decisions.
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Discussion questions
1. Explain why healthcare facilities would require the use of a financial
information system, and provide examples of this type of system.
2. Describe how a decision maker would use the financial information system
reporting function to make decisions, and provide a summary of what the
various reports tell the decision maker.
3. Explain the importance of physicians using a practice management system,
and provide examples of tools that can be used at the point of care.
4. Describe and defend three principles of a quality supply chain
management system with regard to patient care and support of clinicians
providing care.
5. Discuss how self-service applications are typically deployed in human
resources information systems.
6. Discuss the advantages and disadvantages of using business intelligence at
the application level as opposed to the enterprise level.
Case Study
Michael H. Kennedy, Kim Crickmore,a and Lynne Milesa
Managing the flow of patients and bed capacity is challenging for any
hospital, especially for unscheduled admissions. For Zed Medical Center, a
large regional referral center in the South and a member of the University
Health System Consortium, the challenge is even greater. As the flagship
hospital for a multihospital system with more than 750 licensed beds and a
Level 1 trauma center with 50-plus trauma beds, approximately 70% of
annual admissions are unscheduled.
The vice-president for Operations has a PhD in Nursing, is a fellow of the
Advisory Board Company, and has more than 20 years’ tenure at Zed
Medical Center. Three of the ten departments under her purview (Patient
Care Coordinator, Bed Control, and Patient Transfers) are directly engaged
in managing patient flow and bed capacity. The division is also responsible
for system-wide care coordination for patients discharged to skilled nursing
facilities, to home health, and to home without planned service delivery.
Current operational goals include (1) decreasing the current length of stay by
0.3 days from 5.7 to 5.4 days and (2) “ED to 3”—a slogan incorporating the
intention to place patients from the emergency department into a bed within
3 hours of the decision to admit. With the Centers for Medicare & Medicaid
Services clarifying penalties for readmissions within 30 days, Zed Medical
Center has been preparing to effectively manage readmissions based on CMS
guidelines.
The eight staff members assigned to Patient Transfers coordinate with
hospitals within the region wanting to transfer patients to Zed Medical
Center. They take calls, connect outside transfers with accepting physicians,
and arrange transport. The accepting physician determines the patient’s
needed level of care, special care needs (e.g., diabetic), and the time frame for
transfer. The Patient Transfer Department uses the TransferCenter module of
TeleTracking ([Link]) to manage the transfer and admission
of patients. After a patient has been accepted for admission by the admi ing
physician, Bed Control makes the bed assignment. The staff members of Bed
Control assign incoming patients to specific beds once the Patient Placement
Facilitators from the Patient Care Coordinator Department identify the
nursing unit to which patients should be assigned. This determination is
made based on the level of care required, physician preferences in choice of
nursing unit, and the scope of care supported by the nursing units. The Bed
Control Department uses the Capacity Management Suite of the
p p y g
TeleTracking software. The PreAdmitTracking module keeps track of bed
status with an “electronic bedboard,” which provides a graphical user
interface through which planned admissions, transfers, and discharges can
be annotated. The status of a bed freed by patient discharge for which a
cleaning request has been made is also noted (dirty, in progress, or cleaned).
The Bed Tracking module uses the medical center’s paging network to notify
the environmental services staff of a cleaning request and the unit director of
the unit that a patient is incoming. The TransportTracking module
automatically dispatches patient transport requests via phone or pager.
Discussion Questions
1. How are patients prioritized for bed assignment?
2. Describe some of the advantages and disadvantages of this new
software. Include the stated organizational goals in your answer.
3. Discuss how this software might share data with other institutional
applications to provide a dashboard view of census-type activity.
aKim Crickmore and Lynne Miles are past Advisory Board members for the East Carolina University
Health Services Management Program.
8
Telehealth and Applications for
Delivering Care at a Distance
Lore a Schlachta-Fairchild*; Mitra Rocca; Vicky Elfrink Cordi; Andrea Day; Diane Castelli;
Kathleen MacMahon; Dianna Vice-Pasch; Daniel A. Nagel; Antonia Arnaert
Abstract
Rapid advances in technology development and telehealth adoption are opening
new opportunities for healthcare providers to leverage technology for improved
patient outcomes. Telehealth provides access to care and the ability to export clinical
expertise to care for patients regardless of their geographic location. This chapter
presents telehealth technologies and programs, as well as telehealth practice
considerations such as licensure and malpractice challenges. As telehealth advances,
healthcare providers will require competencies and knowledge to incorporate safe
and effective clinical practice using telehealth technologies into their daily workflow.
Growth in telehealth could result in a future where access to health care is
not limited by geographic region, time, or availability of skilled health care
professionals.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Discuss the historical milestones and leading organizations in the
development of telehealth.
2. Explain the two overarching types of telehealth technology
interactions and provide examples of telehealth technologies for each
type.
3. Describe the clinical practice considerations for telehealth-delivered
care for health professionals.
4. Analyze operational and organizational success factors and barriers
for telehealth within healthcare organizations.
5. Discuss practice and policy considerations for health professionals,
including competency, licensure and interstate practice, malpractice,
and reimbursement for telehealth.
6. Describe the use of telehealth to enable self-care in consumer
informatics.
7. Discuss future trends in telehealth.
KEY TERMS
digital literacy 147
telehealth 131
telehealth competency 137
telemedicine 131
telenursing 131
uHealth 148
Introduction
Rapid advances in technology development and telehealth adoption are
opening new opportunities for healthcare providers to use technology for
improved patient outcomes. Before we discuss these technologies and
outcomes, it is important to explore the definitions of telehealth-related
terminology.
Telehealth encompasses a broad definition of telecommunications and
information technology–enabled healthcare services and technologies.
Often used interchangeably with the terms telemedicine, eHealth, or mHealth
(mobile health), telehealth is “the use of electronic information and
telecommunications technologies to support long-distance clinical health
care, patient and professional health-related education, public health, and
health administration.”1 Telehealth is being used in this text to encompass
all of these other terms. Telemedicine is the use of medical information
exchanged from one site to another via electronic communications for the
health and education of the patient or healthcare provider and for
improving patient care, treatment, and services.2 Telenursing is the use of
telehealth technology to deliver nursing care and conduct nursing
practice.3,4
Telehealth enables the delivery of clinical care regardless of the
geographic location of the patient or the healthcare provider. Well-
established telehealth programs and evidence-based research supports the
effective use of telehealth across most disciplines and specialties within
healthcare (i.e., teleradiology, teledermatology, telepathology, and
telenursing).5–10 Telehealth services provide access to health assessment,
diagnosis, intervention, consultation, supervision, and information across
distance.11 As a result, telehealth is now being integrated into routine care
delivery of patients around the globe. Fig. 8.1 depicts how telehealth can
change healthcare delivery. Telehealth services can be classified as clinical
or nonclinical. Clinical telehealth services include, for example, diagnosis;
patient communication and education; disease management, triage and
advice; remote monitoring; caregiver support; and provider-to-provider
teleconsultations. Examples of nonclinical telehealth services include
distance education for healthcare consumers or clinicians, video
conferencing or conference call meetings, research, healthcare
administration, and healthcare management.
FIG 8.1 How telehealth changes healthcare delivery. Copyright 2010
iTelehealth Inc. All Rights Reserved.
Providing care to underserved populations is a challenge, especially in
rural areas or in areas with a shortage of healthcare professionals. Patients
may face physical, financial, geographic, and other barriers to accessing
care. However, telehealth can overcome many of these barriers. Telehealth
proponents seek to improve the quality, access, equity, and affordability of
healthcare in the United States and globally by using telehealth.11
Healthcare professionals using telehealth can export their clinical expertise
to patients regardless of geographic location.
Telehealth technologies include a simple telephone conversation
between a healthcare provider and a patient or a sophisticated robotic
surgery on a patient across continents. Telehealth technologies include but
are not limited to telephones; facsimile machines; e-mail systems;
cellphones; mobile apps; video conferencing; web-based, remote patient-
monitoring devices; transmission of still images; and internet applications
(eHealth) including patient portals, remote vital signs monitoring,
continuing medical education, and direct consumer applications such as
online physician consultations via the internet.
Telehealth is used in a variety of se ings, among which are rural
hospitals, home health agencies, and with patients at home, in prisons, at
dialysis centers, and in nursing homes; telehealth is also used to provide
care to astronauts in space.11,12 The benefits of remote monitoring,
diagnosis, and intervention are recognized in numerous scientific studies
g g
and include increased access to care, decreased costs of healthcare,
increased healthcare provider productivity, and a high level of patient
satisfaction.3,13 Further, the advantages of telehealth to patients are
numerous, and they include:
• Decreased travel time or distance and removal of travel barriers
• More immediate access to care
• Early detection of disease processes or health issues
• Ownership of healthcare and feelings of empowerment
• Long-term health and independence
• Caregiver reassurance
• Patient satisfaction with healthcare
Examples of Successful Telehealth Programs
The following four examples of telehealth programs demonstrate the wide
range of such programs currently providing services to patients at a
distance.
• Rochester General Health System, Rochester, New York, developed a
clinic-based telehealth program in 2008. Its healthcare providers use a
video conferencing system for live patient consults with remote
physician specialists. They have the capability to send video images and
12-lead digital ECGs. The Director of Telehealth coordinates and
schedules 34 physicians and 5 midlevel healthcare providers who see
patients remotely.
• The Department of Defense (DOD), and in particular, the U.S. Army, has
been using telemedicine since 1992. Its Telehealth Network spans 50
countries and territories from America Samoa to Afghanistan, across 19
time zones. It has 22 service lines available, with behavioral health
telehealth making up 55% of telemedicine services, followed by
cardiology, teledermatology, infectious diseases, neurosurgery, pain
management, and orthopedic surgery. Although commonly
implemented in day-to-day military healthcare se ings, limited
resources and austerity of the environment are among the challenges the
DOD faces in providing telemedicine in field or operational se ings. 14
• Sea Coast Mission Telehealth Program, Bar Harbor, Maine, provides
seagoing health services to islanders living on four islands with no
healthcare providers available. Daily use of live video conferencing from
a 72-foot boat, the Sunbeam V, occurs with the support of a boat crew
that includes a nurse. The telehealth nurse has developed excellent
clinical and technical skills to work proficiently in an austere
environment. The goal is to diagnose sick patients in a timely manner so
that they can be transferred off the island for access to a higher level of
medical care on the mainland. Maine Sea Coast Mission’s most recent
project has been to implement health centers with video conferencing
systems on four islands (Frenchboro, Matinicus, Swan’s Island, and Isle
au Haut), providing access to remote health/education services year
round (Sharon Daley, registered nurse (RN), personal communication,
March 2010).
• University of Miami, Miller School of Medicine, Miami, Florida,
provides both live video conferencing and store-and-forward capability
via its telehealth program, which provided medical support after the
2010 Haiti earthquake. One unique aspect is the Teledermatology
Program for private cruise ships that uses expert dermatologists to
evaluate an array of skin problems such as lesions, burns, infections, and
rashes seen by physicians aboard cruise ships. The Clinical Telehealth
Coordinator provides online training to cruise ship staff to use digital
cameras to capture and transmit images via a dermatology software
application. Images are then reviewed by the dermatologist and patient
reports with diagnosis and recommendations are sent back
electronically to the cruise ship physician within a specific time frame.15
Telehealth Historic Milestones
In contrast to the common perception that telehealth is new and futuristic,
it actually has a long history. The first documented report of healthcare
delivery at a distance dates back to 1897 in The Lancet, when a case of
croup was diagnosed over the telephone. In the United States, modern
telehealth programs began in 1964, with a closed-circuit television link
between the Nebraska Psychiatric Institute and the Norfolk State Hospital
for teleconsultations. Shortly thereafter, in 1965, a cardiac surgeon in the
United States transmi ed a live video feed of a surgical case to spectators
in Geneva, Swi erland, via satellite. The surgeon discussed his case and
answered live questions from the spectators in Geneva.16
The National Aeronautics and Space Administration (NASA) led
telehealth initiatives in the 1960s with the transmission of physiologic
signals from astronauts in space to command centers on Earth. NASA also
funded several telehealth research programs in the late 1960s and early
1970s that contributed to the profession as a whole.17 A landmark study
completed by Kaiser Permanente in 1997 concluded that “technology in
healthcare can be an asset for patients and providers and has the potential
to save costs; therefore, this technology must be a part of continuous
planning for quality improvement,”18, p. 45. The researchers were emphatic
about the benefits of telehealth, inspiring many of today’s telehealth
programs.
From July 2003 to December 2007, the U.S. Department of Veterans
Affairs (VA) conducted a home telecare program analysis to coordinate
care of chronically ill veterans and reduce long-term care admissions. The
program evaluation was highly successful, realizing a reduction in long-
term care bed days and inpatient hospital admissions among participants.
Further, the veteran participants reported a high level of satisfaction. Costs
to provide the program were and are substantially less than other VA
programs or nursing home care. The program is now known as Care
Coordination/Home Telehealth and is a routinely offered VA service to
support aging veterans with chronic conditions.19
To determine the effectiveness of telehealth, the Whole System
Demonstrator program in the United Kingdom was launched by the
National Health Service in 2008. At the time, the study was the largest
randomized controlled trial of telehealth in the world, involving more
than 6000 participants. The study confirmed that telehealth promotes well-
being and should be a part of any complete healthcare system.20
In 2011, the Alaska Native Tribal Health Consortium (ANTHC) met a
significant milestone, seeing their 100,000th telehealth case since the
beginning of the statewide program in 2001. Originally developed as a
care supplement to Alaskans in rural areas, the telehealth solution
developed by ANTHC has been adopted by the Indian Health Service
throughout the United States, in the Maldives, as well as by Canada in an
international space station.21
Today, telehealth has advanced well beyond that first phone call in 1897,
to become more widespread with the ubiquitous use of mobile technology
and the introduction of parity laws providing for reimbursement of
telehealth services at the same rate as in-person services.
Leading Telehealth Organizations
Starting in the 1990s, a number of professional, industry, and government
organizations provided the leadership needed to initiate effective
telehealth programs. These leaders include the American Nurses
Association (ANA), United States federal government agencies, the
American Telemedicine Association (ATA), and the International Council
of Nurses (ICN).
American Nurses Association
With the advent of technology and rapidly emerging telehealth practice in
the twentieth century, healthcare professionals sought guidance on
incorporating telehealth into their care offerings. Multidisciplinary
standards were needed to create a cohesive unity for telehealth across
professions. To address the expansion and to create unified definitions and
policies and a standard of care, the ANA brought together the
Interdisciplinary Telehealth Standards Working Group. This group was
composed of 41 representatives from different healthcare organizations
and professional associations. The report of the interdisciplinary team,
Core Principles on Telehealth, represents a “sense of the profession” as a
whole.22 The purpose of the core principles is to create a baseline standard
of quality telehealth care.
United States Federal Government Agencies
NASA, the VA, the U.S. DOD, and other government agencies have
continued to lead the United States in telehealth research and programs.
As an early adopter of telehealth, the VA operates the nation’s largest
telehealth program. The widespread adoption and positive research
findings regarding telehealth led the U.S. government to establish the
Office for the Advancement of Telehealth (OAT), a division of the Office of
Rural Health Policy within Health Resources and Services Administration
(HRSA) at the U.S. Department of Health & Human Services (HHS). OAT
promotes the use of telehealth technologies for healthcare delivery,
education, and health information services, and it increases the use and
quality of telehealth delivery through:
• Fostering partnerships within HRSA and with other federal agencies,
states, and private sector groups to create telehealth projects
• Administering telehealth grant programs
• Providing technical assistance
• Evaluating the use of telehealth technologies and programs
• Developing telehealth policy initiatives to improve access to quality
health services
• Promoting knowledge exchange about “best telehealth practices”1
American Telemedicine Association
The ATA is a nonprofit organization founded in 1993 and headquartered
in Washington, DC. The mission of ATA is to “promote professional,
ethical and equitable improvement in healthcare delivery through
telecommunications and information technology” through education,
research, and communication.23 ATA is a mission-driven, nonprofit
organization that seeks to incorporate telehealth seamlessly into healthcare
so that it is not necessarily a separate program but integrated into
healthcare delivery as a whole. The ATA has published a number of
telemedicine practice guidelines that form a foundation for telehealth
practice that are based on empirical and clinical practice evidence.24
International Council of Nurses
Representing more than 130 national nursing organizations, including the
ANA, Canadian Nurses Association, and associations of more than 134
countries, the ICN initiated the Telenursing Network in 2008. As
telenursing advances, this virtual collaboration is serving to share
competencies and other jointly developed telenursing resources.
Telehealth technologies
Telehealth technologies enable the exchange of all types of data (i.e., voice,
video, pictures of wounds, pathology or radiology images, and device
readings) between patients and healthcare providers or between
healthcare providers on behalf of patients. Early telehealth technologies
were “stand-alone” systems in which a telehealth encounter occurred and
data were stored in a telehealth system database. With the increasing
adoption of electronic health records (EHRs), telehealth technologies are
being increasingly integrated with the EHRs. Telehealth services can be
delivered using two overarching types of technologies: synchronous (or
real-time) technologies or asynchronous (or store-and-forward)
technology.
Synchronous or “Real-Time” Technologies
Synchronous, real-time telehealth uses live, two-way interactive
telecommunications technology and/or patient monitoring technologies to
connect a healthcare provider to a patient for direct care, to other
healthcare providers for consultation and collaboration, or to a
combination of the two. The most commonly used synchronous telehealth
employs video conferencing or telephone-based interaction.
Video Conferencing
Video conferencing integrates audio, video, computing, and
communications technologies to allow people in different locations to
collaborate electronically face to face, in real time, and to share
information, including data, documents, sound, and picture. Interactive
video conferencing in telehealth enables patient-provider consultations,
provider-specialist discussions, and health education. The technology
requires live presence of the healthcare provider and patient or provider
and medical specialist in an interactive environment.
A real-time live environment can include:
• Video conferencing units with a codec (compressor-decompressor)
capable of encoding and decoding the video conferencing data
stream.
• Peripheral cameras such as high-definition cameras with remote
control pan, tilt, and zoom.
• Video display devices such as computer monitors, television sets such
as ultra–high density plasma or LCD displays, and LCD projectors are
used to show the images received from the video conferencing codec.
• Audio components (microphones and speakers), a network
connection, and the user interface—before the availability of high-
bandwidth internet connections, signals were carried over point-to-
point connections established via Integrated Services Digital Network
(ISDN) lines and plain old telephone service (POTS). The internet has
now simplified some of the connectivity issues and the high-
bandwidth requirement of video conferencing.
Patient Monitoring Technologies
Patient monitoring technologies, including home telehealth (also known as
telehomecare), use devices to remotely collect and send biometric data to a
home health agency or a remote diagnostic testing facility for
interpretation by a healthcare provider. Such applications might include a
specific vital sign device, such as blood glucose monitor, digital scale,
thermometer, heart electrocardiogram (ECG), blood pressure monitor,
pulse oximeter, or peak flow meters, or a variety of monitoring devices for
homebound patients. Such services can be used to supplement the use of
visiting nurses.25 Use of monitoring devices will also allow patients to
become more involved in, and in many cases to oversee, the monitoring
process.
Patient monitoring technologies for home telehealth consist of two major
components: hardware and software. The hardware includes a base station
where the patient interacts by entering data and answering questions, and
it applies various medical devices that are used to gather patient data. The
software enables healthcare providers and technicians to configure the
hardware, receive data, and monitor the patient.
Telecommunications can be wired, such as POTS or direct service line
(DSL), or wireless, such as cellular (sometimes seen as code division
multiple access, broadband, satellite, Bluetooth, infrared (IrDA), Wi-Fi (or
IEEE Standard 802.11), mobile broadband wireless access (IEEE Standard
802.20), or Worldwide Interoperability for Microwave Access (IEEE
Standard 802.16). mHealth and mobile health are umbrella terms that
incorporate mobile or wireless telecommunications for transmi ing
telehealth-related data and services. Both the telecommunication and the
hardware can be incorporated in the medical device.
Fig. 8.2 provides a diagram of the components of a telehealth system:
FIG 8.2 Personal health ecosystem. BB, Broadband; PERS,
personal emergency response system; POTS, plain old telephone
service. Copyright 2010 Continua Health Alliance. All Rights Reserved.
1. Personal health devices monitor basic vital signs such as blood
pressure, weight, pulse, oxygen level, and blood sugar values and
transmit data via a wired or wireless connection via devices or
sensors.
2. The aggregation and computation manager is a critical component
of the connected health system, enabling individual monitoring
devices to log data in an EHR for personal and clinician review. The
aggregation manager collects and transmits data from an
individual’s personal health devices to a server using wired or
wireless connections. The aggregation manager itself can be a cell
phone, a personal computer (PC), a dedicated device, or a personal
health record (PHR).
3. The health service center is a physical location where a patient’s
digital information is collected, stored, analyzed, and distributed. It
can be the doctor’s office, the home of a family member, or another
type of healthcare-related facility.
Asynchronous or “Store-and-Forward” Technology
“Store-and-forward” technology transmits telehealth-related information,
video, images, and audio files when healthcare providers and patients are
not available at the same time. The sending healthcare provider or patient
prepares an electronic consult package, which includes the patient’s
history, related diagnoses, and digital images such as x-rays, video, and
photos. This package is either e-mailed or placed on a web server for the
receiving healthcare provider to access when his or her schedule allows.
The receiving provider reviews the package, follows up with clarification
questions, and provides a diagnosis, recommendations, and a treatment
plan. The receiving provider’s response is transmi ed electronically back
to the sending provider or patient. Store-and-forward technologies can be
used in dermatology, radiology, pathology, dentistry, cardiology, wound
care, home monitoring, pediatrics, and ophthalmology, as well as other
areas. A store-and-forward technical environment can include:
• A personal desktop, laptop computer, tablet, or smartphone for the
sender
• A personal desktop, laptop computer, tablet, or smartphone for the
receiver
• Telecommunication technologies such as local area network (LAN)
and wireless communications
• Digital peripheral medical devices such as digital cameras, x-ray
equipment, glucometers, vital sign monitors, and wearable sensors
embedded in T-shirts or wristwatches
• Software such as a web-based application, encrypted e-mail, specially
designed store-and-forward software, an EHR, a PHR, and an
electronic data repository
Technical Standards in Telehealth
Until recently, the demand for telehealth-based medical devices was not
sufficient to create unified, global technical standards. However, technical
standards that were developed for associated markets have benefited
telehealth. For example, use of American National Standards Institute
(ANSI) H.32x standards enabled wide-scale video conferencing
interoperability, which led to further growth in non-healthcare businesses.
Not only has telehealth benefited from the video conferencing standards,
but it is also benefiting from a reduction in the cost of equipment, as well
as the improved ability to conduct interactions between parties
independent of the particular hardware used. In addition, development of
Health Level Seven (HL7), which provides global interoperability
standards for health information technology (health IT), and Digital
Imaging and Communications in Medicine (DICOM) standards for
imaging has also been of great benefit for telehealth.26
In 2006, a group of healthcare technology companies formed the
Continua Health Alliance (CHA) to establish interoperable personal
telehealth solutions and technical design guidelines. The goal is to agree
on a set of common technical guidelines to build interoperable sensors,
home networks, telehealth platforms, and health and wellness services.
CHA also has developed a technical certification program based on these
guidelines. Technologies that are certified by CHA have been technically
tested and validated to work together and be interoperable.26
In February 2014, the CHA announced a partnership with the mHealth
Summit to create a new global entity, the Personal Connected Health
Alliance (PCHA), under the Health Information Management Systems
Society (HIMSS) corporate umbrella, to represent the consumer voice in
connected health. PCHA brings together a unique combination of
expertise and resources focused on plug-and-play interoperable personal
health devices and services that provide new opportunities for consumers
to engage in health self-improvement and connect with their social
networks and healthcare providers in the pursuit of be er health. 27
An example of such a standard is ZigBee/IEEE 802.15. This standard is
targeted at applications requiring a low data rate, long ba ery life, and
secure networking. ZigBee/IEEE 802.15 has become a useful wireless
connectivity standard for home or facility-based telehealth. ZigBee allows
telehealth devices and sensors to operate longer and with smaller power
sources, enabling miniature sensors to transmit health data. ZigBee is also
a very low cost and easily installed network capability, providing usability
and requiring minimal technical support. The ZigBee Alliance offers two
specifications (ZigBee and ZigBee RF4CE) that serve as the base
networking system to facilitate its interoperable market standards.28
Telehealth and Health Information Technology
A need exists to integrate all relevant medical device images and data
from the telehealth technology with the patient’s EHR. The
interoperability of these systems could dramatically streamline a
healthcare provider’s workflow and improve the healthcare. The need to
increase the adoption and effective use of telehealth and mHealth
technologies has been identified as a major goal in the Federal Health IT
strategic plan (2015–20).29
A key to telehealth success is healthcare providers’ access to patients’
health records at the time of a telehealth encounter—just as it is with in-
person care. Telehealth networks serve to establish a link between
provider EHRs and securely move clinical information that is exchanged
among patients, hospitals, and healthcare providers. Telehealth health
information exchange (HIE) is expected to lead to the next generation of
health IT interoperability across and among healthcare enterprises.
Existing telehealth infrastructure will also serve as a highway for EHRs
and information exchange between and among rural and remote areas.30
Telehealth clinical practice
considerations for healthcare
professionals
Healthcare providers have used the telephone as a communication tool for
patient interaction for decades. Adding to the complexity of remote care
delivery now, it is increasingly common to use computers, remote
monitoring devices, and interactive audio and video conferencing for
patient interactions. With expanding telehealth technology capability, new
and more efficient models of care are facilitated, allowing for removal of
time and distance barriers.
Equal To or Better Than In-Person Care?
Telehealth is considered to be so effective that in 1997, the World Health
Organization (WHO) announced that it has become part of the WHO's
“health for all” strategy and should be made available to all people.31
Provider-patient encounters via telehealth were examined and found to be
as effective as standard face-to-face visits held in a provider’s office or
clinic. In 2008 Dr. Gregory Jicha, assistant professor of neurology at the
University of Kentucky’s Sanders-Brown Center on Aging, led a study
called Telemedicine Assessment of Cognition in Rural Kentucky.
The goal of the project was to adapt and validate the UDS [National
Institute on Aging’s Uniform Data Set, a standard set of questions asked of
every patient being screened for Alzheimer disease] and other measures
for diagnosing mild cognitive impairment (MCI) and early dementia in the
telemedicine setting. An important aspect of the goal was to determine
whether the telemedicine consultations were as effective as face-to-face
meetings with a doctor.32, p. 32
Jicha stated, “developing and validating this telemedicine approach for
diagnosing and treating MCI and early dementia will become a model for
clinician-researchers at other centers serving rural populations.”32, p. 32 Per
Jicha’s perception of using telemedicine to expand healthcare resources,
“the bo om line is, our goal is to ensure that though telemedicine is not
be er than an in-person evaluation, it’s as good as an in-person
evaluation.”32, p. 34
Two studies from 2012 (one in the United Kingdom and the other in
Quebec, Canada) concluded that “telemedicine is increasingly seen as an
efficient and cost-effective means for improving clinical outcomes and
increasing patient involvement in their own care.”33, p. 59 Both studies
demonstrated two important factors that influence healthcare
professionals’ acceptance of telemedicine: training and support.
Telehealth Clinical Competency
As healthcare providers’ use of broader technological tools increases, so
does the need to ensure telehealth competency to provide safe and
optimal patient care. As healthcare further embraces telehealth to gain
efficiencies, improve access to care, and reduce costs, there must be a focus
on educating and preparing healthcare providers in telehealth technology,
techniques, skills, coordination, and “on camera” communications. A
telehealth clinical encounter involves multiple new components and
competencies, including coordinating healthcare provider and patient
scheduling, telepresenting skills (i.e., steps needed to facilitate a
telemedicine encounter between a patient and remote healthcare
provider), the exchange of prior medical record and new telehealth
information, and an understanding of video and audio technology.
From initial academic preparation through ongoing continuing
education requirements, healthcare providers practice in a dynamic field
with ongoing changes in care delivery. All healthcare providers are
required and expected to maintain and update clinical competency in the
care they render to patients. Telehealth also requires competency for
optimal healthcare delivery. A number of professional associations
identified specific competencies required. As described earlier in this
chapter, the ANA and 41 major healthcare provider organizations
developed and endorsed core principles for telehealth delivery beginning
in 1998.22 A year later the ANA created and published Competencies for
Telehealth Technologies in Nursing.34 In 2001, with further expansion in
telehealth, the ANA endorsed the development of telehealth protocols.35
These protocols were developed to encompass the needs and concerns of
both clients and practitioners. On an international level, the ICN published
the research-based, validated International Competencies for Telenursing
based on an international survey of practicing telenurses in 36 countries
around the globe.4
The National Initiative for Telehealth Framework of Guidelines (NIFTE
Guidelines) was a critical milestone in development of telehealth not just
for those who authored the guidelines in Canada, but globally.36 This
highly important and superbly designed framework was developed in
Canada by a multistakeholder interdisciplinary group. The NIFTE
Guidelines are designed to assist individuals and organizations to develop
telehealth policies, standards, and procedures. NIFTE examines and offers
principles and suggested guidelines for five overarching content areas
related to telehealth:
• Clinical standards and outcomes
• Human resources
• Organizational readiness
• Organizational leadership
• Technology and equipment
Canadian nurses have also provided over a decade of telenursing
leadership and developed extensive practice guidelines for nurses who are
becoming or presently in telenurse roles.37
In November 2011, the ATA developed an expert opinion consensus
document on interactive video conferencing. The Expert Consensus
Recommendations for Videoconferencing-Based Telepresenting defines
requirements for serving as a telepresenter in a live, synchronous
telehealth encounter. As with all patient interactions, processes for patient
registration, consent, clinical information, reimbursement information, and
privacy are applicable to telehealth encounters.38 The ATA also developed
Telemedicine Standards and Guidelines for Diabetes, Telemental Health,
Teledermatology, Home Telehealth, and Telepathology.
Confidentiality, Privacy, and Informed Patients
Patient confidentiality and privacy are paramount when using technology
for the transmission of health data and live video presentation of the
patient to geographic environments at a distance from the patient’s
location. The requirements for ensuring confidentiality, privacy, and
informing patients receiving care via telehealth are the same as for in-
person care. This is particularly true when the possibility exists of others
being present in a room but off camera. A ending to the presence of others
at either the sending or receiving locations is an additional, important
privacy task for healthcare providers using telehealth. Another important
concern is ensuring that patients are being adequately informed and
educated regarding telehealth consultation, assessment, and evaluation via
video conferencing technology.4,35
Scope of Clinical Practice
For healthcare professionals the use of technology does not alter the
practitioner’s inherent standards of practice, ethics, scope of practice, or
legalities of practice.35,37 Healthcare professionals may use telehealth for
patient consultations or for consultation with other healthcare providers.
When telehealth is used for patient consultations, the healthcare
professional’s credentialing and clinical privileges must be completed at
the site where the patient is located. The practitioner will need education,
training, and technical support for the necessary technologies before,
during, and after telehealth consultations.
The decision to refer a patient to a healthcare professional for
consultation via telemedicine or telehealth is determined by multiple
factors:
1. Does the service requested provide telemedicine or telehealth
access as an option?
2. What is the level of the practitioner’s expertise and comfort with
telemedicine or telehealth?
3. Is the patient’s diagnosis appropriate for telemedicine or telehealth
consultation?
4. Going forward, who will manage the patient’s plan of care and how
will this be managed?
As with any in-person patient encounter, documentation is of major
importance. Appropriate documentation for telemedicine consults at both
the sending and the receiving sites is essential for providing accurate and
optimal continuity of care for the patient. Both sites need current patient
demographic information, billing information, and consultant notes.
Referring practitioners need consultant notes in a timely manner to carry
out the patient’s plan of care. After a telehealth consult, evaluation of
telehealth processes and patient satisfaction is essential. The quality
assurance and evaluation processes identify how to improve telehealth
procedures, safety, effectiveness, and quality of care.35
Types of Clinical Telehealth Applications
In the past 15 years, telehealth specialty areas, such as telecardiology,
teledentistry, teledermatology, home telehealth and remote monitoring,
teleICU, telemental health, teleopthalmology, telepediatrics, teleradiology,
telestroke, telewoundcare, and teletrauma, have been successfully
developed and implemented in a variety of healthcare se ings. Other
telehealth programs outside the hospital se ing include emergency
preparedness, disaster response, correctional telemedicine, forensic
telemedicine, telerehabilitation, and school telehealth.
A complete remote physical examination can be achieved by viewing
images and hearing sounds. Healthcare providers can assess and treat a
variety of healthcare problems such as cardiac or respiratory illnesses by
listening to digital heart, lung, or bowel sounds live; by sending the data
over a video conferencing system; or by using a computer with internet
connection to the computer of another clinician, who can then assess the
information. The healthcare provider can use video scopes to conduct ear,
nose, throat, oral cavity, eye, pelvic, or rectal exams; cameras or
microscopes for skin examinations; radiology images to diagnose
orthopedic injuries; and computed tomography (CT) scans of the head to
rule out bleeding, brain injuries, or skull fractures. Teleradiology is one of
the most commonly used and accepted telehealth applications, where
digital images are captured and transmi ed to the radiologist, who makes
a diagnosis, sends a report, and stores the image. Healthcare providers can
send complete readings for a 12-lead digital ECG to a cardiologist to
diagnose heart problems or send a digital spirometry reading to a
pulmonologist to diagnose respiratory lung capacity.
Telehealth operational and organizational
success factors and barriers
Despite the advancements in telehealth technologies, significant barriers
and gaps exist in the successful implementation of robust, integrated
healthcare technology delivery systems.
B.E.L.T. Framework
In planning for implementation of telehealth technology, four main
components must be considered: bandwidth, education, leadership, and
technology (B.E.L.T.). The B.E.L.T. framework (Fig. 8.3) is a metaphoric
representation of these four interrelated components, and it may be used
to guide planning at macro, meso, or micro levels of implementation.
FIG 8.3 The B.E.L.T. framework. Copyright McGill University School of
Nursing. Montreal, Quebec.
Bandwidth includes elements of telecommunication technology,
including information transmission and connectivity to move and store
digital data. Infrastructure and telecommunication architecture in some
geographic areas may limit use of telehealth applications and have direct
implications for access to and delivery of healthcare. This is particularly
problematic for rural, isolated, and underserved regions.39
Education encompasses the preparation of both the existing workforce
and future healthcare providers in developing competencies in the
adoption and use of telehealth technologies. Although research was done
in some areas of competency development, particularly in healthcare
informatics and telenursing, scant research has been completed about the
broader use of telehealth technology to inform curriculum development
and education of healthcare providers.4,40 Patient safety in telehealth
technology use is one aspect of healthcare delivery that is essential to
professional practice and relates to competencies in clinical decision
making.
Leadership reflects a broad range of management, change theory, and
policy aspects that affect operationalizing telehealth technologies. Barriers
to successful telehealth adoption frequently relate to factors such as
resistance to technology, lack of interoperability, information security,
stakeholder support, reimbursement, and financial commitment.39,40
Technology and interoperability spans a large number of considerations
such as the choices and types of telehealth software, hardware, and
devices available for care. To date, telehealth platforms have limited
capacity to address the range of health conditions experienced across the
population lifespan, resulting in a narrow focus on overall individual
health, fragmentation of care, and duplication of effort for data retrieval
and documentation. Because many current telehealth technologies are not
interoperable and cannot be integrated into a single environment to
support holistic care, data silos are created where information on the same
individual may be contained in different systems and cannot be accessed
in an efficient, seamless manner. This further fragments care, leads to
duplication of services (e.g., repeat of blood work, diagnostics), and
creates unnecessary cost. Another limitation is that most current telehealth
technologies focus on direct delivery of clinical services to individuals and
do not readily support the broader goals of primary healthcare, such as
enhancing health promotion, prevention opportunities, or generating
necessary epidemiologic data needed to evaluate and inform healthcare
delivery.
Operationalizing Telehealth
Several critical steps exist for success of telehealth programs and services.
The first is planning, which includes a needs assessment and analysis to
define patient populations and healthcare problems in which telehealth
services can have a positive impact. A work environment with staff
prepared to implement telehealth using specific standards and guidelines
is the second important factor for success. Technology preparedness is a
third factor for telehealth success. User-friendly technology that enables
quality clinical decision making, as well as responsive and accessible
technical support, are also crucial factors.41 The final, critical step is
learning how to implement, manage, and support a telehealth project or
program. This becomes more complicated when clinical specialties are
involved. New telehealth programs should begin with one focused
specialty application, such as teledermatology, and not add other
specialties until the initial program has been implemented successfully.
Specific procedures are listed in Table 8.1, and project steps are outlined
below.
Table 8.1
Telehealth Procedures
Provider and Patient “Real-
Preparation Follow-Up, Quality, and Safety
Time” Telehealth Encounter
Provider credentialing completed at Provider is knowledgeable and Review plan of care conveyed by
patient site and remote site competent in healthcare needs provider or consultant and
being addressed during patient- instructions provided regarding
to-provider telemedicine visit treatment plans, with time for patient
and family questions and answers
Referral reviewed as appropriate for Introduce patient to all Complete any necessary forms (e.g.,
specialty service and accepted by individuals that will be in the patient consent to treat form; Health
telespecialist patient room and to any Information Portability and
individuals at the evaluating Accountability Act [HIPAA] forms)
physician's location and share reimbursement
information with both patient and
physician sites
Knowledgeable regarding scheduling Identify camera and Provide patient and family with
procedures and policies of facility and microphone locations to patient consulting physician contact
scheduling resources and explain any potential for information, as needed for follow-up
audio or video delay
Obtain and review preconsult clinical Presenting site provider is Schedule follow-up appointments,
information and testing knowledgeable of exam treatments, etc. as ordered by
requirements, including patient physician
preparation, patient
positioning, and use of
peripheral devices (i.e.,
electronic stethoscopes,
Doppler, digital cameras, etc.)
Obtain reimbursement information, such Provide support to patient and Provide the referring primary care
as copies of insurance cards, Medicare family and be alert to nonverbal provider with the telemedicine
cards, etc. body language encounter documentation
Provide patient with the appropriate Provide time within the clinical Evaluate outcomes of the
forms for “consent to treat” and HIPAA visit for patient and family telemedicine encounter, quality of
compliance information questions and answers encounter, and patient satisfaction
and assess for improvements for
future telemedicine encounters;
clinical effectiveness is one of the
factors associated with success in
telemedicine
Contact patient to explain a telemedicine Educate patient and family of
encounter and provide directions to the their right and ability to
telemedicine site terminate the telemedicine
clinical visit at any time
Ensure that equipment and technology
has been tested and is in safe working
order, provider and patient have clear
audio and video of each other,
extraneous noises are reduced, and any
necessary peripheral devices and
supplies are accessible at time of
encounter
Assess and prepare for cultural,
language, or disability issues
Establish a backup plan and be prepared
to enact it in the event of technical
problems
Telehealth Acceptance and Training
As with other educational trends, telehealth technology education has
moved toward online courses or certificate education programs in the
United States and globally. Online and on-site telehealth training courses
are available through several federally funded Telehealth Resource
Centers. Additional information about the resource centers can be found at
[Link]/. The ATA, located at
[Link]/, provides annual meetings with scientific
research presentations, special interest groups, educational webinars,
educational products, training program accreditations, white papers, and
policies.
According to Duclos et al., the success of any telehealth program by
providers relates to its acceptance by providers who use it.42 Healthcare
providers who use telehealth in their practice should know how telehealth
technologies work and should understand their capabilities in providing
patients with be er access to healthcare services.
Opportunities abound for clinicians to become adept with telehealth
technologies, beginning with a basic proficiency in using room-based
video conferencing systems on PCs and mobile video conferencing
systems on iPads and smartphones. It is advantageous for healthcare
providers to learn to use medical devices with video scopes a ached for
patient assessments, and video or digital cameras for exams. Providers
need to be comfortable using a variety of audio, video, and medical device
tools, video conferencing systems, and computer hardware and software
applications. New technical challenges often emerge for clinicians, such as
using a video ophthalmoscope to view retinal images inside the eye and
on a display monitor. Another challenge can be hearing new heart sounds
from a digital stethoscope with different high- and low-pitched sounds
because of magnification. Clinicians may encounter workflow changes
with telehealth software applications in paperless environments. Digital
literacy training may also be required for clinicians, which includes
knowledge of basic computer skills and communication technologies,
basic skills to navigate the internet for up-to-date health information, and
the ability to access web-based telehealth software applications. For
example, healthcare providers who are fluent in using digital cameras to
take dermatology images and who are internet savvy can access online
resources to identify a skin lesion or obtain the latest treatment for the
lesion.
In the 2005 International Telenursing Survey, telenurses were found to
have various job skills and to work in more than 30 clinical telehealth
se ings, ranging from nurse call centers to urban and rural hospitals,
public and private health clinics, schools, prisons, community health
centers, military facilities, native tribe reservations, and private physician
and nurse practitioner practices.43 Specific telehealth knowledge regarding
equipment, workflow, clinical processes, and technology training is
different for each clinical se ing.
Scheduling dedicated time for healthcare providers’ telehealth training
is an obstacle and is one of the major barriers to a successful telehealth
program. Actual hands-on training is beneficial, using telehealth case
scenarios similar to those the healthcare provider would typically
encounter. As mentioned earlier, clinical workflow is modified when
telehealth technologies are implemented. Healthcare providers can adjust
by continuing to use the same patient exam rooms for the telehealth
patient, using similar medical devices for in-person and telehealth exams,
training with telehealth technologies, and interacting with the same
physicians and specialists for telehealth consultations as for in-person
referrals.
Telehealth Implementation
There are three phases for successful telehealth program implementation:
preimplementation, implementation, and postimplementation.
Preimplementation Phase
Implementing telehealth technologies in any clinical se ing is no different
than implementing other twenty-first century technologies (see Chapter 17
on project management and Chapter 19 on systems implementation). As
with any informatics project, a team effort is critical to its success.
Clinicians will first need to decide what types of telehealth programs
provide access to remote healthcare specialists for their patients. Important
preimplementation steps are listed in Box 8.1. Forming an administrative
or executive team is advisable to oversee the project goals, budget,
progress, and growth. The facility may already have a formal commi ee in
place to oversee all IT projects and, if so, can tailor the governance to
incorporate telehealth. The executive team should include the following:
Box 8.1
Telehealth Preimplementation Steps
• Identify remote physician specialists and other clinical consultants who
are willing to provide remote assessment and advice for treatment
• Meet standards and requirements for safe use of telemedicine
equipment: installation in designated telehealth rooms; biomedical and
electrical engineering help may be required
• Select appropriate telehealth equipment to use for telehealth
examinations, including disposable accessories such as nonlatex gloves,
gel, measurement tapes, alcohol wipes, gowns and cover sheets, and
extra camera ba eries
• Identify electrical and cable sources for power outlets and secure
internet access
• Designate telehealth exam rooms or areas
• Identify 24/7 technical support for clinicians at both sending and
receiving sites
• Develop policies and procedures
• Train interdisciplinary team and staff end users on telehealth equipment
• Set up and test telehealth scenarios before beginning telehealth
consultation
• Hospital or facility administrator
• Clinical director (often a physician)
• Chief Information Officer
• Director of information technology and/or director of education
• Telehealth and telecommunications administrator
• Vendor account managers (may be only at the operational level below)
A second level of management for the telehealth program is an
operational interdisciplinary team including the following:
• Project manager
• Clinical champion (often a physician)
• Telehealth director or program manager
• Information technology engineer or support technician
• System administrator (if software is involved)
Super users and vendor trainers will also initiate, train, and support
new staff for the telehealth project. The interdisciplinary teams are the
change agents that assist in developing policies, procedures, evaluation
criteria, and permission forms before beginning to use telehealth.
Implementation Phase
Once the equipment is configured or tailored, the implementation phase
involves equipment and software testing with mock telehealth patients
and remote specialists, and then piloting the project by identifying a
patient needing a teleconsult. Equipment testing with mock patients
should encompass all staff testing all of the telehealth equipment available.
Equipment testing should also be conducted periodically after the initial
implementation. After identifying differences between standard and
telehealth patient encounters, daily use of telehealth equipment for routine
patient exams is recommended so that providers become knowledgeable
and comfortable using the various telehealth examination tools (electronic
stethoscope, video otoscope or ophthalmoscope, digital ECG or
spirometry software, video exam camera, telehealth software applications,
and audio or video conferencing systems). The goal is for a clinician to
present a patient, capture and send patient data, retrieve patient
information from stored telehealth software applications, and respond to
cases and add patient encounters if needed.
Postimplementation Phase
As with any other informatics project, evaluation criteria address
adequacy of training; implementation, equipment, technology, or training
issues; and program outcomes. A program of quality assurance and
process improvement should be part of the evaluation process so that
iterative progress toward implementation-phase telehealth program
success can be achieved.
Telehealth programs of any size experience similarities in success and
failure. Table 8.2 lists common success factors and barriers to successful
telehealth program implementation.
Table 8.2
Success Factors and Barriers to Telehealth Implementation
Barriers to Successful Telehealth
Key Success Factors for Telehealth
Implementation
High-level organizational members (board of directors, No designated or dedicated project manager;
administrator, medical director, champion physician, nurse not enough time or resources dedicated to
administrator, nurse educator, program director) who have manage project
identified a need for telehealth and are able to provide support and
finances throughout all phases of implementation, training, and
maintenance of the telehealth program
Designated and dedicated telehealth project manager or Interdisciplinary team not designated or
coordinator prepared properly
Designated interdisciplinary telehealth team Funding limited
Adequate facility network infrastructure to support the telehealth Lack of communication between
system or method selected and prepare setup for the telehealth administrative management,
program prior to installation interdisciplinary team, and participants
Project management to include and allow time for professional Failure to identify remote clinical partners to
telehealth education and refresher training classes, including whom to refer patients or to provide
participation for professional telehealth conferences, telehealth telehealth services; may be due to
webinars, telehealth video training, and provision of telehealth reimbursement issues, lack of understanding
resource information as to how telehealth works, practice and
licensing issues in that state
Initiate telehealth program at local facility and then introduce to Poor telehealth equipment selection for
affiliated remote facilities specialty; poor quality and usability of
telehealth equipment purchased
Provide staff with educational tools such as workflow diagrams, Missing parts of equipment and supplies
charts, digital photos, manuals, and descriptive pathways for how during installation or patient encounter
to initiate an urgent or nonurgent telehealth consult
Provide education, training, and program development for No designated telehealth area due to limited
teleconsultants room availability
Schedule appointments for follow-up teleconsults with dates and Ergonomically poor placement of
times for physician and patient equipment, limited connectivity or lighting
in telehealth area, poor cable management,
limited counter size, small room, no storage
cart for equipment, equipment not secure
Patient privacy and confidential information forms should be No pretraining on telehealth system prior to
completed prior to teleconsult telehealth installation
Provide on-site dedicated technical support throughout all phases Healthcare providers not familiar with
of implementation and provide online support for main site, remote computer literacy (i.e., basic use of keyboard,
site, and teleconsultants personal computer, mouse, navigating
software, data, or handling images captured)
Training not formalized, no schedule
confirmed to allow for all participants to be
trained, not enough time provided for
hands-on training or practice of case
scenarios
Staff resistant to training, no incentives, and
no understanding of telehealth or
technology advantages
Off-hour shifts not trained or invited to
participate in training sessions
Telehealth challenges: licensure and
regulatory issues for healthcare
professionals
Telehealth enables physicians, advanced practice registered nurses
(APRNs), nurses, pharmacists, and other allied health professionals to
offer their clinical services remotely. State lines and geographic boundaries
have no effect on the potential of the technology to deliver telehealth
services. For example, radiologists can read x-ray reports from other
countries; mental health professionals can provide care telephonically or
with real-time video; and chronically ill patients can be monitored from a
distance with telehealth. Despite technological advances, legal and
regulatory challenges exist. Provider licensure and the credentialing and
privileging processes in facilities remain the biggest hurdles to telehealth
adoption in the United States.
Licensure
Both the 1997 and 2001 Telemedicine Reports to Congress by OAT
identified licensure as a major barrier to the development of telemedicine
and telehealth.44 The cost and procedural complexity of current
professional licensing policies preclude widespread adoption of telehealth.
Currently, many health professionals must a ain separate licenses in each
state where services are rendered. Licensure authority defines who has the
legal responsibility to grant a health professional the permission to
practice his or her profession.45 Under Article X of the U.S. Constitution,
states have the authority to regulate activities that affect the health, safety,
and welfare of their citizens.45 Regulating the delivery of healthcare
services is one such activity. Exceptions to state licensure requirements
include physician-to-physician consultations, educational and medical
training programs, border state recognition programs, government
employees practicing in military or federally funded facilities such as VA
hospitals and clinics, and natural disaster and emergency situations.45
Legislation such as the 2011 service members’ Telemedicine and E-
Health Portability Act (STEP Act) facilitates the provision of telemedicine
and telehealth services. The STEP Act removes the individual state
licensing requirements to allow a licensed medical professional in one
state to treat a patient in another.46 As of this writing, the STEP Act rules
apply only to military and federal personnel, although it is a beginning in
terms of advancing telehealth services into the mainstream. Fortunately,
major advancements are occurring to streamline licensure requirements.
These regulatory alternatives include licensure by endorsement, state
compacts and mutual recognition, reciprocity, registration, and limited
licensure (Table 8.3).
Table 8.3
Telehealth Professional Licensure Options
Licensure
Description
Option
Endorsement Allows a state to grant licenses to health professionals licensed in other states that have equivalent
standards. States may require additional documentation or qualifications before endorsing a license
issued by another state.45–48
Mutual The distant state's licensing board accepts the licensing policies of the health professional's home
recognition state.47 Federal healthcare agencies operate under this type of system. An analogous licensing
system would be the mutual recognition of driver's licenses between states.
Reciprocity A process in which two states voluntarily enter into a reciprocal agreement to allow the health
professional to practice in each state without having to become licensed in both states. It does not
involve additional review of the health professional's credentials, as endorsement does, and it does
not require the participating states to agree to a standardized set of rules or procedures, as mutual
recognition does. The negative aspect of this model is that it leaves the healthcare provider subject
to different regulations in each state and therefore subject to different sets of laws. This can lead to
legal issues of liability and wider exposure to potential malpractice opportunity.49
Registration The health professional licensed in one state informs the authorities of other states that he or she
wishes to practice in those states part time. The provider is licensed in the home (originating) state
but still is accountable to uphold the legal stipulations and regulations of the guest (distant) states.
Similar to reciprocity, the provider would still be subject to the guest state's malpractice rules as
well as the home state's rules and regulations.
Limited The health professional obtains his or her medical licensure in the home state and then obtains a
licensure second “limited” licensure in the guest state. The limited license allows for specific scope of services
to be delivered under particular circumstances.49
National Individual states would voluntarily incorporate the same set of national standards into their laws.
licensure Given that most medical professionals pass the same national exam within their particular
discipline, it stands to reason that standards of care and practice guidelines should not differ from
state to state. Regulatory processes could be retained at the state or national level. For example, the
American Medical Association could take full responsibility for the licensing of all physicians at a
national level and similarly nurses could be licensed to practice nationally by their national
organization, and likewise with other health professions (e.g., pharmacists, dentists, physical
therapists). However, disciplinary actions or other procedural activities could be administered at
the state level.
Nursing has been the most successful healthcare provider group to
adopt the mutual recognition model, referred to as the multistate Nurse
Licensure Compact.47 The Nurse Licensure Compact law became effective
on January 1, 2000, with three states initially participating. As of early
2016, 25 compact states existed. Compact status applies only to RN
licensure. If RNs hold a license in one of the compact states, they may
practice in any of the 25 compact states, greatly facilitating telehealth
interactions across state boundaries. The latest list of compact states is
available at: [Link]/[Link]. International
nurses on a visa who apply for licensure in a compact state may declare
either the country of origin or the compact state as the primary place of
residency. If the foreign country is declared as the primary place of
residency, a single-state license will be issued by the compact state.48 A
mutual recognition model is being discussed for APRNs at the time of this
writing. However, currently, APRNs who practice using telehealth across
state boundaries must first apply for RN licensure (or endorsement) in the
distant state and then apply for advanced practice status, which involves
extensive credentialing and privileging processes.47
Credentialing and Privileging
Credentialing is the process of establishing the qualifications of licensed
professionals and assessing their background and legitimacy. For example,
if a physician does a telehealth consult from a hospital in State X but the
patient resides in a skilled nursing facility in State Y, that physician must
be credentialed by both facilities (i.e., the hospital and skilled nursing
facility) and must also be licensed in both States X and Y. Each facility
could have very different processes and rules for becoming credentialed.
Similar to the need for licensing in multiple states, the need for
credentialing in multiple, separate healthcare facilities is an obstacle to
telehealth services. In May 2011, the Centers for Medicare & Medicaid
Services (CMS) modified the existing credentialing and privileging
regulations effective July 5, 2011. The new rule under part 42 CFR 410.78 of
the CMS regulations allows hospitals or Critical Access Hospitals (CAHs)
to use information from a distant-site hospital or other accredited
telemedicine entity when making credentialing or privileging decisions for
the distant-site physicians and practitioners.45 Regarding the legal risks
and liabilities associated with these changes, the governing body of each
hospital and CAH must weigh the risks and benefits of opting for this
more streamlined process of credentialing and privileging telemedicine
providers.45 Modifications still need to be made to allow Medicare and
Medicaid beneficiaries who reside in urban or metropolitan areas to be
eligible to receive the same services.
Reimbursement
Telemedicine is often viewed as a cost-effective alternative to the more
traditional face-to-face method of providing medical care.45 As such, states
in the United States have the option to determine whether or not to cover
telemedicine- and telehealth-delivered care, what types of telehealth to
cover, where in the state it can be covered, how it is provided and covered,
what types of telehealth practitioners and providers may be covered and
reimbursed (as long as such practitioners and providers are “recognized”
and qualified according to Medicare and Medicaid statute and regulation),
and how much to reimburse for telemedicine services (as long as such
payments do not exceed the Federal Upper Limits).49
Reimbursement by insurance companies for medical services is based on
Medicare’s Current Procedural Terminology (CPT) codes billing system.
As of 2012, Medicare telehealth services can be furnished only to an
eligible telehealth beneficiary from an eligible originating site. In general,
originating sites must be located in a rural Health Professional Shortage
Area (HPSA) or in a county outside of a Metropolitan Statistical Area
(MSA). The originating sites authorized by the statute include hospitals,
skilled nursing facilities, offices of physicians or licensed healthcare
practitioners, rural health clinics, community mental health centers, CAHs,
CAH-based dialysis centers, and federally qualified health centers.50
Medicaid reimbursement for telehealth varies by state, with some states
electing not to reimburse for telehealth services. Internationally, in
countries that provide government-based universal healthcare, telehealth
adoption is flourishing, and reimbursement has become a national
budgetary decision. Providing more access to more citizens while at the
same time reducing costs and more efficiently distributing clinical
expertise using technology is a desired goal for any country’s health
service. Thus countries such as Canada, those in the European Union,
Japan, China, and India are all expanding their telehealth capabilities and
services.
Malpractice and Liability
Legal issues of liability and malpractice are a burden for the telemedicine
practitioner, as they face additional vulnerability and uncertainty related
to malpractice exposure in multiple states. They likely face additional
expenses for malpractice insurance and for legal defense if a suit were filed
in a distant state.51 Legal issues involve traditional jurisdictional issues,
including:
• The place of treatment dilemma (is this the patient’s location or the
provider’s?)
• Lack of an established, bona fide doctor-patient relationship similar to
the situation with cybermedicine (medical care via the internet)
• Violating a particular state’s specific regulations related to standards
of care
• Failing to secure appropriate informed consent from a patient
• Negligence that may arise from technical glitches such as distorted
images or poor sound quality of a particular device resulting in injury
or misdiagnosis45
The traditional concepts of negligence, duty of care, and practicing
within one’s scope of legal license still apply to telehealth as they do in
traditional face-to-face encounters. Initial case law in telemedicine and
telehealth to date is limited, primarily involving telephone triage and
teleradiology. In telephone triage, if advice was given and a poor patient
outcome occurred, the triage service and professionals are at risk for
malpractice. In teleradiology (as is the case with in-person and in-house
radiology readings), if a diagnosis of a lump or a mass is missed on an
image, the radiology service and professional would be at risk for
malpractice. As telehealth usage increases, further legal cases will
illuminate and clarify these issues.
Telehealth and direct patient health
services
While telehealth applications typically involve provider-to-provider
teleconsults, patients and other healthcare consumers can use telehealth
directly to support their healthcare decision making. Specifically,
applications facilitate direct, online patient telemedicine care; provide
remote patient telehealth visits and monitoring; and link consumers with
online healthcare information.52 As the technology used to deliver
telehealth services becomes easier to use and more affordable, the
technology is increasingly being used by patients in interaction with their
healthcare providers and at times in directing their own care.
Patient-to-Provider Telehealth-Delivered Care
Increasingly, individuals find it difficult to obtain timely care for urgent
health concerns from their healthcare provider. Even though more
Americans have expanded health insurance coverage under the Affordable
Care Act, more people are going to hospital emergency rooms (ER) for
care because they are unable to get an appointment with primary care.53
Online telehealth direct care is one growing solution, and the use of video
conferencing for telehealth visits is increasing. Manha an Research’s
Taking the Pulse US v11.0 study indicated that nearly 7% of physicians use
online video conferencing to communicate with their patients.52 In the
study, physicians consider telehealth a method for consulting with
patients about nonurgent issues or connecting with geographically
dispersed patient populations that may not have nearby access to
specialists. The study also found that certain specialty healthcare
providers, such as psychiatrists and oncologists, are more likely to use
video conferencing.
IHS Technology (formerly Information Handling Services Technology)
predicts there will be cumulative growth of nearly 25% a year over the
next 5 years to 5.4 million video consultations between primary care
providers and their patients by 2020 from 2015’s 2 million video
consultations.54 Adapt TeleHealth is an example of this healthcare delivery
approach. Once a community or clinic identifies a need for psychiatric
services, it contracts with Adapt TeleHealth to meet its mental health
needs. It purchases a consistent number of hours per week, which are
fulfilled by an Adapt TeleHealth mental health provider.55 Other direct
patient care technologies focus more on providing a platform for a
healthcare provider’s office to provide care via telemedicine. Companies
such as Secure Telehealth,56 TelaDoc,57 and Online Care Anywhere58 are
examples of platforms for direct online medical care.
Asynchronous applications using store-and-forward technologies or
online diagnostic surveys are gaining in popularity. Virtuwell59 (at
[Link]) originated with HealthPartners in Minnesota and
offers online, 24/7 direct care in 11 states. First, an online survey asks
consumers to identify their chief concern. Responses are sent to a nurse
practitioner who reviews the information and responds within 30 minutes
via text or e-mail with a diagnosis, potential remedies, and tips for
preventing the condition in the future. If a prescription is needed, the
nurse practitioner can send it to a local pharmacy. Forty common
conditions, including bladder and yeast infections, are treated by
Virtuwell’s nurse practitioners.
Another asynchronous telemedicine company is RelayHealth,60
providing an online solution to connect consumers with their healthcare
providers. Their Medical Home support package provides a secure patient
portal to facilitate easy online clinical communications, enabling patients
to benefit from care coordination, including patient visits and
consultations, prescription renewal, appointment scheduling, PHR
management, delivery of lab results, referral requests, and access to
medically reviewed information.
Delivering Direct Care Using Health Monitoring Tools
and Biometric Sensors
A number of healthcare applications use information and communication
core components to help patients stay safe in their homes and
communicate vital healthcare data to providers (Box 8.2).61 Peripheral
health monitoring tools such as blood glucose monitors, pulse oximeters,
blood pressure and ECG monitors, and electronic scales, already described
as components of a telehomecare visit, fit this definition. They are the
backbone of a viable remote disease management program. More recently,
a group of assistive technology devices dubbed “sensor technologies”
emerged, adding a layer of connectedness between patients and their
healthcare providers through monitoring patients’ activity levels and
physiologic parameters. Both forms of biometric sensors are described
further.
Box 8.2
Biometric Sensor and Monitoring Device
Overview
Purposes
• Detect changes in pa erns that signal improvement or early failings
• Signal need for urgent or emergency help
• Integrate with websites or mobile units to promote communication
• Have ubiquitous monitoring for peace of mind for older adult and
family
• Keep an inventory of supply levels for medications and other resources
• Coach and monitor exercise effectiveness and participation in games
Information Potentials
• Physical: motion, location, and activity
• Physiologic/medical: pulse, temperature, sweat, and blood chemistry
• Social: telephone or web interaction counts or identification
• Memory support: monitoring cooking stoves and adherence to regimens
• Communication safety issues: stove use, fire, and unsecured doors
Communication
• Devices and protocols networked to connect to computers
• Statistical and computational paradigms for analysis
• Applications for interaction with emergency rescuers, healthcare
providers, and social networks
Monitoring Target Examples
• Restlessness as indicator of disturbed sleep
• Gait changes as indicator of drug side effect or physical debility
• Extended bedrest as indicator of depression or physical debility
• Pill counts as indicator of adherence or side effect issues
Remote Telehealth Home Visits and Monitoring
Devices
Telehealth systems previously used interactive video conferencing
between healthcare providers and patients; however, the ability to self-
manage care is a driving fiscal concern.61,62 The prevalence of chronic
health conditions and multiple chronic health conditions has risen in the
United States. More than 25% of all Americans and more than 65% of all
older Americans are estimated to have at least two chronic physical or
behavioral health problems. Treatment for people living with these
multiple chronic conditions accounts for nearly 66% of the nation’s
healthcare costs. As the U.S. population ages, the number of these patients
continues to grow. This growing challenge has become a major public
health issue that is linked to lower health outcomes and rising healthcare
costs.63 Use of telehealth technologies for remote home care and digital
monitoring instruments are gaining momentum to address chronic
illnesses and to promote safety for seniors living independently.
As mentioned earlier, the most widespread U.S. telehealth program is
the VA Coordinated Care Home Telehealth (CCHT).64 Built upon Wagner’s
Chronic Care Model, CCHT is characterized by “the use of health
informatics, disease management and home telehealth technologies …
with the specific intent of providing the right care in the right place at the
right time.”65 The range of technologies for CCHT includes videophones,
messaging devices, biometric devices, digital cameras, and telemonitoring
devices.61 The videophones and video telemonitors facilitate synchronous
face-to-face encounters with a healthcare provider through regular
telephone lines or through computer links and the internet. Digital
monitoring devices such as Bluetooth blood pressure cuffs and
glucometers and digital images are also part of the comprehensive CCHT
system and transmit timely healthcare data via asynchronous store-and-
forward technologies.
The most common VA home telehealth devices connect a patient to a VA
hospital using messaging devices that collect information about symptoms
and vital signs from the patient’s home. Care coordinators then link
patients to treatment, hospitalization, or clinic appointments. In addition,
the VA now employs an interactive patient portal and electronic PHR
called MyHealtheVet,66 which is discussed in detail in Chapter 14.
Other initiatives in the public sector involve the use of telehealth
technologies with patients who are receiving care through home health
agencies, senior living facilities, and other community-based delivery sites.
For example, Suncrest Home Health Agency in Nashville, Tennessee, used
Philips-developed telemonitoring devices to create a comprehensive heart
failure home care program.67 Provider telestations allowed vital sign
collection, health assessment surveys, and tracking symptoms,
medications and compliance with care protocols.68 Within 8 months of
implementing their Heart Failure telehealth program, Suncrest Home
Health Agency was able to reduce hospital heart failure readmission rates
by 50%.67
Sensor Technology
Like monitoring devices, sensor technology has the potential to manage
disease and promote a safe and healthy environment for seniors.68 A
sensor is a device that detects and responds to some type of input from the
physical environment. The specific input could be light, heat, motion,
moisture, pressure, or any one of a great number of other environmental
phenomena. The output is generally a signal that is converted to human-
readable display at the sensor location or transmi ed electronically over a
network for reading or further processing.69 The use of sensor technology
has increased as the acute medical care paradigm evolves to wellness and
a focus on public health. Wellness mobile devices enable healthcare
professionals to have access to comprehensive real-time patient data at the
point of care or anywhere there is cellular network coverage. Recently, a
growing interest has developed for proactive wellness products and
health-related smartphone applications.70
At the 2014 International Consumer Electronics Show, LG and Garmin
introduced devices that track bodily functions ranging from heart rate and
blood pressure to a patient’s oxygen saturation. It is believed that by 2018,
130 million wearables will be acquired by the public.71 For example, the
Apple Watch, Google Glass, and Fitbit are on the leading edge of
consumer “wearables”—technology that combines electronic sensors with
everyday apparel. Now shirts, socks, and other accessories are being
reimagined to collect, analyze, and use personalized data. Smart clothing,
also known as e-textiles, is developed for use in a number of applications.
They can measure and report vital signs for inpatient or outpatient
healthcare, fitness training, or the handling of hazardous materials. They
can track the status and position of soldiers on the ba lefield, or monitor
the alertness of drivers, air traffic controllers, or construction workers. The
following smart clothing products are soon to be available or on the
market:
1. AiQ Smart Clothing Company produces a line of smart apparel,
including conductive gloves for smudge-free touchscreen use and
clothes that give off evenly distributed heat.
2. The line of designer Pauline Van Dongen offers a Wearable Solar
Clothing Collection. These coats and dresses integrate solar cells
that can charge a smartphone or other electronic device.
3. SmartSox help prevent amputations in diabetes patients who have
lost sensation in their feet. They incorporate fiber optics and sensors
to monitor temperature, pressure, and the angles of joints in the
feet, and alert the wearer or caregiver of any developing problems.
4. Exmobaby is designed for newborn and infants. Sensors monitor
vital signs and movement and send this information to 3G.
5. Researchers in Spain have developed an intelligent hospital gown
that wirelessly measures body temperature, heart rate, patient
location, and whether the patient is si ing, standing, lying down,
walking, or running. Although currently in use only in hospitals,
the development includes the mobile units, which would move
with the patients.
6. OMSignal uses a small data module to create real-time connectivity
and data acquisition through fitness shirts. Even fashion icon Ralph
Lauren has used the technology in a line of polos, with plans to add
dress shirts.72
Other nontextile sensor applications being developed for healthcare
include Google’s Project Iris, a smart contact lens that can monitor glucose
levels in diabetics. Fitness devices such as Nike’s FuelBand can track steps
taken and coach users to push a workout further. Even ingestible
computers (capsules with minuscule sensors) are available such as the one
from Proteus Digital Health, to help track a patient’s responses to various
medications.71
Additionally, several examples exist for current sensor technology to
promote a safe and healthy environment in the smart home. A smart home
or intelligent house61 would use radio frequency identification (RFID)
technology.73 RFID technology uses a microchip to uniquely identify and
track objects, record and update information, and make all of this
accessible through a global network.74 Depending on their use, RFIDs can
be active or passive and are capable of being ingested, implanted, or
a ached externally. Although concerns about potential privacy and
security breaches exist, RFID benefits include unlimited sight connection
and rapid information processing, predicting be er utility than other
technologies such as bar coding. Monitoring hand-washing practices,
transmi ing neuromuscular stimulation data, and authenticating
medications have the potential to transition from the hospital to the smart
home.
Telehealth Technology and Healthcare Consumers
The proportion of American adults seeking information about a health
concern from a source other than their physician dropped to 50% in 2010,
down from 56% in 2007.75 At first glance, readers may assume that
consumers are not seeking information about their healthcare needs;
however, the drop is actually a ributed to an 18% decline in their use of
print sources: books, magazines, and newspapers. Adults, especially the
elderly and those with chronic disease conditions, have increased their
internet use for seeking health information, contributing to their
engagement in self-care. The Pew Internet and American Life Project noted
that 59% of Americans go online every year to search for healthcare
information.76 Online healthcare resources aid consumers by supporting
shared decision making with healthcare providers, providing personalized
self-management tools and resources, building social support health
networks, delivering tailored accurate health information, and increasing
health literacy.77
Health information websites have been available to consumers since the
mid-1990s.78 Websites such as WebMD, a publicly traded company, and
the National Institutes of Health’s MedlinePlus, a federal government site,
have provided healthcare information to a broad population of consumers,
including the public, employers, employees, health plans, and healthcare
providers. More recently, however, some health websites have moved
beyond one-way communication and developed innovative features and
interactive tools that enable consumers to greatly increase their self-
knowledge and promote greater safety and independence. Tools such as
drug interaction checkers, symptom checkers, various health-related
calculators, pill identifiers, patient forums, fitness trackers, and PHRs are
becoming more prevalent and helping consumers to gain more control
over their health. 78
Everyday Health (at [Link]) is another example of
an interactive, consumer-based website. Everyday Health collaborated
with professional experts from Harvard University, Cleveland Clinic, and
the American Association of Family Practitioners and commercial
enterprises to provide consumers with healthcare information. They have
also developed interactive consumer-oriented tools that include websites,
mobile applications, and social media assets, designed to provide
consumers and healthcare professionals with access to the most trusted
health and wellness content tailored to meet their daily needs. For
example, consumers can use assessment and tracking tools and online
calculators, speak live with a pharmacist, find drugs and treatments, and
create a personal health plan. Additional information concerning
interactive consumer-oriented resources is included in Chapters 12, 13,
and 14.
eHealth Literacy: Critical Element for Telehealth
Adoption
The proliferation of online healthcare resources has prompted the need to
develop a national and international quality standards agenda to help
health professionals and consumers alike access and evaluate high-quality
online health information that is accurate, current, valid, appropriate,
intelligible, and free of bias.79–81 Health consumer advocates indicate the
need for eHealth literacy (an extension of digital literacy) as a way of
evaluating the information and services delivered using IT tools. eHealth
literacy is defined as “a set of skills and knowledge that are essential for
productive interactions with technology-based health tools.”82
Experts identified six skills for eHealth literacy. 83 These skills are:
• Traditional literacy—ability to read text, understand wri en passages,
and speak and write a language coherently.
• Computer literacy—ability to operate a computer.
• Information literacy—ability to obtain and apply relevant information.
• Media literacy—means of critically thinking about media content, and
defined as a process to develop metacognitive reflective strategies by
means of study.
• Health literacy—skills required to interact with the health system and
engage in self-care.
• Scientific literacy—understanding of the nature, aims, methods,
application, limitations, and politics of creating knowledge in a
systematic manner.
Taken together, these six literacy types combine to form the
foundational skills required to optimize consumers’ experiences with
eHealth.83 Nelson, Joos, and Wolf added to this list a broad overarching
competency for interacting with all things digital. They noted that
consumers need digital literacy or competency with digital devices of all
types; technical skills to operate devices and conceptual knowledge to
understand their functionality; ability to creatively and critically use
devices to access, manipulate, evaluate, and apply data, information,
knowledge, and wisdom in activities of daily living; ability to apply basic
emotional intelligence in collaborating and communicating with others;
ethical values and sense of community responsibility to use digital devices
for the enjoyment and benefit of society.84
Digital literacy skills are critical for future telehealth adoption for both
consumers and healthcare providers. As the internet, telehealth, and other
technology-based applications become a consistent part of healthcare,
viewing these tools in light of the skills required for people to engage them
becomes essential if the power of information technology is to be used to
promote health and deliver effective healthcare. Additional information
about the types and effects of literacy in health informatics is included in
Chapter 2.
Conclusion and future directions
Currently, telehealth services are being provided in diverse se ings from
islands off the coast of Maine to across the United States for remote care of
military veterans. Two major types of telehealth exist: asynchronous and
synchronous. Applications include teleradiology, teleconsulting,
telepathology, telesensors, and remote home visits. Telehealth has the
potential to decrease care costs and speed treatments, but the field also has
challenges, including issues regarding licensure, standards,
reimbursement, credentialing and privileging, and lack of integration with
other health IT, especially EHRs.
Growth in telehealth could result in a future where access to healthcare
is not limited by geographic region, time, or availability of skilled health
professionals. The potential to realize comprehensive, integrated, and
seamless delivery of healthcare services through virtual environments
capable of spanning a broad range of prevention and health promotion
interventions has already been made possible through advances in
telehealth technology. Conditions exist for expanding telehealth to other
sectors for sustainable telehealth, including rising healthcare costs,
increasing prevalence of chronic diseases, an aging population, demands
for improved access to healthcare, and global shortages of health
professionals.39,40,85–88 Creation of telehealth ecosystems and novel
healthcare models requires interdisciplinary and intersectoral approaches
spanning technology, education, and health management (Fig. 8.4).
FIG 8.4 The CuRE framework. Copyright 2012 Daniel Nagel and Antonia
Arnaert. All Rights Reserved.
The Canada-India Centre of Excellence for uHealth Research and
Education (CuRE) framework in Fig. 8.4 depicts the CuRE. It provides a
uHealth (ubiquitous health) view for operationalizing future global
collaboration in advancing telehealth.
Policy decisions to adopt and implement telehealth technology in
healthcare delivery are influenced by many drivers, such as global
socioeconomic contexts, political motivations, capacity of technology to
address healthcare needs, and fundamental understandings of telehealth
capabilities.85,89 Inconsistencies in telehealth research methods and data
reporting have had an effect on empirical data available to evaluate
telehealth technology in the areas of cost benefit, effectiveness, and patient
engagement.86,87 Issues of authentication, data security, and practical
aspects of telecommunication infrastructure remain critical challenges for
the adoption and broader use of telehealth technologies.90,91
A consistent and coordinated approach in tracking healthcare
technology use is lacking; therefore the effectiveness of telehealth is
difficult to determine. Much available information on use and trends has
been generated through industry and market analysis rather than through
independent research. Significant challenges exist in tracking telehealth
technology use and trends in healthcare, including:
1. How telehealth is defined: terms such as telehealth, telemedicine, and
informatics are frequently and inconsistently used interchangeably
in the literature.
2. The variety in modalities of telehealth technologies being used and
the capacity to which they are used.
3. The vastly different contexts in which telehealth may be employed,
such as varying models and se ings for healthcare delivery,
geographic regions, and cultural se ings.85,89,91
Telehealth Industry Growth
One market research firm valued the market for remote patient
monitoring, one form of telehealth care, in the United States at about $7.1
billion in 2010, and anticipated market growth to $22.2 billion by 2015.92
Healthcare technology usage in Canada during 2010 includes delivery of
260,000 telehealth encounters and 2500 patients enrolled in telehomecare
services, reflecting a 35% annual growth during the previous 5 years.93 In
Europe, outpatient telehealth services are provided by either public or
private hospitals. A report provided to the European Commission in 2011
indicated that 8% of hospitals provided telemonitoring to patients.93
Continued global growth in telehealth is anticipated as technology evolves
and the need for cost-effective healthcare delivery increases in both
developed and developing countries.39,40,85,94
Rapid advances in technology continue to expand the reach of
healthcare delivery and the potential services available. Initially telehealth
relied on internet connections; however, a shift to mHealth formats has
occurred, particularly in developing countries. Growth in the mobile
phone industry in countries such as China and India has increased 321%
compared with 46% in developed countries.95 In India, use of cellular
phones is estimated at 742 million phones, with many of these new
“mobile citizens” living in poorer and rural areas with scarce
infrastructure and facilities, low literacy levels, and low internet access.96
mHealth capabilities now provide a wide range of wireless monitoring
opportunities to transmit information for a variety of health conditions,
such as diabetes and cardiovascular diseases. mHealth has also increased
access to healthcare for persons and communities in rural and isolated
regions.85 A recent endorsement of 4G standards in wireless
telecommunications by the International Telecommunications Union, a
branch of the United Nations, will have significant implications for speed
and quantity of data transmission and for the future capacity of mHealth
technologies in health care delivery.
Telehealth to uHealth
At present, a lack of integrated, secure technology “spaces” exists to
facilitate migration of data between the various telehealth platforms,
eHealth technologies, and mHealth devices for effective and efficient
support of healthcare delivery. This gap in interoperability largely reflects
industry strategies to protect proprietary rights; however, the lack of
interoperability between technologies limits sharing of health information
and the ability to implement a cohesive model of healthcare delivery in a
virtual environment.39
Advancements in “cloud computing” technology, a more integrated
wireless telecommunication architecture that supports accessible and
seamless transmission and storage of digital data, may make it possible to
facilitate a connection between healthcare information systems and to
expand the capacity of healthcare delivery.90,91
Further research and development has focused on ubiquitous (uHealth)
technologies that integrate core components of computers, wireless
networks, sensors, and other modalities (such as mHealth devices) to
create an environment to monitor, respond to, and assist in meeting the
healthcare needs of individuals.97,98 An example of uHealth is the
development of smart home systems that provide persons with health
concerns a safer environment in which to live more independently.97 As
the elderly population increases and people live longer with complex
health conditions uHealth innovations can be used to detect changes in
health status, communicate pertinent patient information, and alert
healthcare providers to facilitate efficient interventions.98
Improve Healthcare Provider Shortages and Access
to Care
As telehealth expands, further integration with informatics will continue.
Telehealth encounters will be integrated within PHRs and EHRs. Self-care
data will also be integrated into data repositories for individuals and
populations. As the global population increases, the supply and
distribution of healthcare providers can be optimized using telehealth to
provide services regardless of the geographic location of those in need.
Shortages in primary care providers and nurses, for example, can benefit
from redistribution of portions of clinical expertise using telehealth as the
export mechanism.4,43
Future migration of telehealth to uHealth will require practicing
healthcare-provider licensure models that are not only interstate, but also
international, enabling healthcare providers to practice in countries that
have healthcare needs that can be met using telehealth technologies. This
will require cooperation on the part of politicians, governments, and
policy-makers on behalf of fully operationalized telehealth.99,100
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telehealth nursing services. Nurs Econ. 2011;29(5):265–277.
89 Miller E.A. Solving the disjuncture between research and practice:
telehealth trends in the 21st century. Health Policy. 2007;82(2):133–
141.
90 Nkosi M.T., Mekuria S.M. Cloud computing for enhanced mobile
applications. Cloud Comput Technol Sci. 2010;31:629–633.
doi:10.1109/CloudCom.2010.31:629-633.
91 Thuemmlar C., Fan L., Buchanan W., Lo O., Ekonomou E., Khedim
S. E-health: chances and challenges of distributed, service oriented
architectures. J Cyber Security Mobil. 2012;1(1):37–52.
92 Kalorama Information. Remote Patient Monitoring Systems May Help
Overstressed ICUs.
h p://[Link]/about/[Link]?id=2339.
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93 European Commission (EC). eHealth Benchmarking III: SMART
2009/0022. h ps://[Link]/digital-agenda/sites/digital-
agenda/files/ehealth_benchmarking_3_final_report.pdf. 2011.
94 Canada Health Infoway. Telehealth Benefits and Adoption: Connecting
People and Providers Across Canada. Canada Health Infoway; 2010.
h ps://[Link]-
[Link]/Documents/telehealth_report_2010_en.pdf.
95 Pew Research Center. 10 Facts About Technology Use in the Emerging
World. h p://[Link]/fact-tank/2015/03/20/10-facts-
about-technology-use-emerging-world. 2015.
96 CNN. Mobile Phone: Weapon Against Global Poverty.
h p://[Link]/2011/10/09/tech/mobile/mobile-phone-
poverty/. 2011.
97 Agoulmine N., Deen M.J., Lee J.S., Meyyappan M. U-Health smart
home: innovative solutions for the management of the elderly and
chronic diseases. IEEE Nanotechnol Magazine. 2011;5(3):6–11.
98 O o C., Milenkovic A., Sanders C., Jovanov E. System architecture
of a wireless body area sensor network for ubiquitous health
monitoring. J Mobile Multimed. 2006;1(4):307–326.
99 Miller E.A. Solving the disjuncture between research and practice:
telehealth trends in the 21st century. Health Policy. 2007;82(2):133–
141.
100 Schlachta-Fairchild L., Castelli D., Pyke R. International telenursing: a
strategic tool for nursing shortage and access to nursing care. In:
Jordanova M., Lievens F., eds. Proceedings of Medetel, the
International Society of Telemedicine and eHealth Annual
Conference; Luxembourg: Luxexpo; 2008:399–405.
Discussion questions
1. What licensure model would be most useful to support telehealth
clinical practice across international boundaries; for example, Canadian
doctors or nurses (virtually) seeing and treating U.S. patients or U.S.
pharmacists and occupational therapists (virtually) seeing and treating
Australian patients?
2. How do the different models for delivering healthcare, including
covering the cost of that healthcare, affect the telehealth programs in
different countries?
3. What actions can individual healthcare providers take in the next 3 years
to advance the benefits of telehealth for their profession?
4. Why has the telehealth adoption taken so long in the healthcare industry
when Skype, cellphones, and other video conferencing applications have
been used in personal and business interactions for decades?
5. How much does usability affect you and your friends when deciding to
accept or reject the use of a new technology? Does this also apply in
your role as healthcare provider?
6. What actions can individual healthcare providers take to improve their
patients’ eHealth literacy?
7. What needs to occur on an international basis for uHealth to be
operationalized?
8. What are the first five steps you would take to start a telehealth program
or application in the healthcare facility where you work?
9. What key success criteria for telehealth programs are “must have” and
what criteria are “nice to have” when considering a new telehealth
initiative?
10. What factor or factors will be most important in driving the exponential
growth of telehealth in the future?
Case Study
Mrs. Smith is 82 years old and is diagnosed with hypertension, diabetes,
and congestive heart failure. Her two children live in California, whereas
she lives in North Carolina in a small family home on 10 acres of land in
the Blue Ridge Mountains. Mrs. Smith has been in the hospital four times
in the last year because of congestive heart failure. As her eyesight and
mobility get worse with age, she has found it a challenge to stay on her
medical plan and to do her shopping for the right foods she knows she
should be eating. Mrs. Smith’s health plan, Purple Cross of North
Carolina, assigned a nurse case manager to address her situation. Purple
Cross provided a digital scale and a remote monitoring device that record
Mrs. Smith’s condition every day by uploading her weight and
transmi ing the answers to a series of questions on a touch screen kiosk.
The case manager also coordinated delivery of Meals on Wheels,
providing low-sodium, diabetic-compliant dinners to Mrs. Smith on an
ongoing basis. The case manager calls Mrs. Smith twice a week, taking the
time to educate her about her medications, her activities, and the disease-
specific elements that will keep her healthy and out of the hospital. When
the case manager identifies that Mrs. Smith can no longer organize her
daily medications, a digital medication dispenser will be provided that
will keep her on her medication regimen. The medication dispenser will be
preloaded with Mrs. Smith’s medications and will issue a subtle doorbell
tone when it is time to take her medicines. With the combination of remote
and real-time (telephonic) support persons and technologies, Mrs. Smith is
able to remain in her home and avoid further inpatient admissions.
Discussion Questions
1. Which components are critical to Mrs. Smith staying safely in her
home?
2. Describe whether Mrs. Smith’s regimen might be augmented using
telehealth applications.
*The views, opinions, and/or findings contained in this publication are those of the
author and do not necessarily reflect the views of the Department of Defense and should
not be construed as an official DoD/Army position, policy, or decision unless so
designated by other documentation. No official endorsement should be made. Reference
herein to any specific commercial products, process, or service by trade name, trademark,
manufacturer, or otherwise, does not necessarily constitute or imply its endorsement,
recommendation, or favoring by the U.S. Government.
9
Home Health and Related
Community-Based Systems
Karen S. Martin; Karen B. U erback
Abstract
Home care and related community-based systems located in the United States are
changing rapidly. Information technology is accelerating those changes. This chapter
will address (1) home health, palliative care and hospice, community based public
health, nurse-managed health centers, and other community-based practice models;
(2) the electronic health records (EHRs) and information systems used at community
and home-based practice sites; and (3) the value of the clinical data and information
that can be generated by these information systems. Core values of community-based
clinicians include patient-centered care and services that are of high quality, efficient,
and cost effective. Information systems began with billing systems and evolved to
point-of-care solutions in the 1990s. The Outcome and Assessment Information Set
(OASIS), Hospice Item Set (HIS), and patient-experience surveys are examples of
home health and hospice standardized datasets. Using standardized terminologies is
another strategy that complements community-based core values. The Omaha
System, one of the standardized terminologies developed by home health nurses and
recognized by the American Nurses Association, is described, and a clinical example
illustrates how practice, documentation, and information management can enhance
the quality of community-based care.
No matter how dreary and gray our homes are, we people of flesh and
blood would rather live there than in any other country, be it ever so
beautiful. There is no place like home.
Baum LF. The Wonderful Wizard of Oz. Chicago, IL: George M. Hill Co.; 1900.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe home health, palliative care and hospice, public health,
nurse-managed health centers, and other practice models.
2. Summarize the supporting electronic health records (EHRs) and
information systems used at community and home-based practice
sites.
3. Specify the value of the clinical data and information that can be
generated by information systems used at practice sites.
KEY TERMS
home health 154
hospice care 155
Hospice Item Set (HIS) 157
Intervention Scheme 161
nurse-managed health center 155
Omaha System 159
Outcome and Assessment Information Set (OASIS) 156
outcomes-based quality-improvement (OBQI) 158
palliative care 155
Problem Classification Scheme 160
Problem Rating Scale for Outcomes 161
standardized datasets 156
Introduction
Home care and related community-based systems located in the United
States are changing rapidly and becoming increasingly linked to other
providers in the healthcare community. Information technology (IT),
related technological advances, the emphasis on big data, the transition to
value-based care, and other national initiatives are accelerating these
changes. Numerous references describe home health research, economics,
and patient personal preference, suggesting that the home is the optimal
location for diverse health and nursing services.1a–6 Patient residences
include houses, apartments, dormitories, trailers, boarding and care
homes, hospice houses, assisted-living facilities, shelters, and cars.
Although residences are the primary location where care is provided,
many home care and related community-based organizations offer
services at workplaces, schools, churches, community buildings, and other
sites.
This chapter addresses home health, palliative care and hospice,
community-based public health, nurse-managed health centers, and other
community-based practice models; the supporting electronic health
records (EHRs) and information systems used at the practice sites; and the
value of the clinical data and information that can be generated by these
information systems. The assessment, planning, intervention, and
evaluation services that are part of these models range from promoting
wellness and preventing disease to care of the sick and dying. Ideally,
these services are captured in EHRs so that they can be quantified,
analyzed, and used to measure the outcomes of care. Formal caregivers
include nurses, social workers, physical and occupational therapists,
speech-language pathologists, registered dietitians, home health aides,
chaplains, physicians, and others. A team approach and interprofessional
collaboration are required to address the intensity of the patient’s and
family’s needs. Although the term patient is used consistently in this
chapter, client, customer, consumer, and member are alternative terms often
used in home health and community-based systems.
Evolution and milestones
Home health and community-based systems have a long and
distinguished history in this country. In the early years, care for those who
were ill or dying was typically informal and provided by the women who
lived in the household or neighborhood. Home health provided by formal
caregivers originated in the 1800s and was based on the district nursing
model developed by William Rathbone in England. In many communities,
the initial programs evolved into visiting nurse associations (VNAs). The
movement expanded rapidly in the United States, resulting in the
formation of 71 agencies before 1900 and 600 by 1909.7–9
In 1893, Lillian Wald and Mary Brewster established the Henry Street
Se lement House in New York City and developed a comprehensive
program that was staffed by nurses and social workers. One of Wald’s
most impressive innovations was to convince the Metropolitan Life
Insurance Company to include home visits as a benefit and to examine the
cost effectiveness of care, a partnership that continued until 1952.7–9
Public health departments were established and expanded during the
early years of the 20th century. Health department staff members were
primarily nurses who focused on care of immigrants, milk banks for
mothers and babies, communicable disease, and environmental issues.
They were concerned about consistent practice standards, the patient
record, and the collection of statistics.10
Home health services were included as a major benefit when Medicare
legislation was enacted in 1965 and resulted in significant changes
nationally. The benefit was designed to provide intermi ent, shorter visits
with temporary lengths of stay to persons age 65 and older; health
promotion and long-term care services were not reimbursed. Nurses
continued to represent the largest group of agency staff members;
however, involvement of other professions was required. When a patient
was admi ed to service, the home health agency was required to develop a
plan of care, obtain the signature of a physician, and follow additional
regulations.11
Hospice care was introduced in the 1970s. Florence Wald is
acknowledged as the founder of the hospice movement in the United
States; she established the Connecticut Hospice with interprofessional staff
in 1974. The concept of hospice grew from a commitment to provide
compassionate and dignified care to people who were at the end stage of
life; the program offered care in the comfort of home, with an emphasis on
quality of life. Medicaid reimbursement for hospice care began in 1980,
and Medicare reimbursement began in 1983; reimbursement determines
many aspects of the hospice programs.10,12–14
Nurses employed in home health and community-based se ings were
concerned about documentation, standardization, and accountability in
addition to practice. Their concerns were similar to those of other
healthcare professionals. Physicians advanced systems for nomenclature
and classification beginning with the International Classification of
Diseases (ICD) in 1893. In 1966, physician Avedis Donabedian described
the well-known structure, process, and outcome framework for evaluating
the quality of medical care.15 Another physician, Lawrence Weed,
developed a problem-oriented medical record in 1968 that was adaptable
to computerization.16 In 1986, Mary Elizabeth Tine i developed and
published a tool to measure mobility problems in elderly patients.17 In
1990, Pamela Duncan developed a balance measure referred to as
“functional reach” that is especially useful for her physical therapist
colleagues who work in community se ings. Functional reach can serve as
a measure of frailty in elders to predict fall risk and help identify
appropriate interventions.18 Numerous studies have been conducted to
confirm the value of Tine i’s and Duncan’s tools and original research.
During the last 25 years, many other respected and validated tools have
been adopted into practice, including the use of required standardized
data sets for home health and hospice. These tools ensure that objective
data are captured as care is being delivered.
Practice models
Home Health
Home health is the delivery of intermi ent health-related services in
patients’ places of residence with the goal of promoting self-care and
independence rather than institutionalization. The intensity of services has
increased dramatically as hospital stays have become shorter and patients
are discharged with serious illnesses or soon after surgery and with
complex treatment needs. The care delivered often focuses on supporting a
safe transition back to the home following an episode of illness or
exacerbation that required an inpatient or extended care facility stay.4
Home health interventions include medication reconciliation; teaching
and coaching to improve the ability of patients, families, and caregivers to
manage independently; coordination of care with other healthcare
providers and community resources; and early detection of decline or
exacerbation. Common treatments and procedures now include
ventilators, renal hemodialysis, and intravenous therapy for antibiotics,
chemotherapy, and analgesia, as well as delivery of total parenteral
nutrition and blood products.
An estimated 12,200 Medicare-certified home health agencies provide
services across the country.5,19–22 As the largest payer, Medicare accounts
for 45% of total home health reimbursement. Medicaid, state and local
governments, private pay, and private insurance are the other sources.
Home health agencies provide services to approximately 12 million
patients who ranged in age from infants to elders. More than 85% of all
home health patients are over age 65. Recipients of home health services
have diverse needs. Joint replacement with rehabilitation services and
heart failure top the list for patients discharged from hospitals to home
health. Diabetes, rehabilitation services, and heart failure are listed most
often for all home health patients.5,19–22
Palliative Care and Hospice
Hospice care involves the delivery of services by teams of
interprofessional clinicians for those who have exhausted curative
treatment measures. Palliative care focuses on quality of life for patients
and their families facing the problem associated with life-threatening
illness. Whereas palliative care often begins once a cure is no longer
possible and may be somewhat long term, hospice care is limited to
patients with life expectancies of 6 months or less. Both palliative and
hospice care involve holistic care, an emphasis on dignity, and being
surrounded by the comforts of home and family. However, the programs
have differences. Typically, palliative care services are focused on comfort,
quality of life, and end-of-life or advanced care planning. Hospice involves
symptom management with the goal of providing as much comfort and
dignity as possible at the end of life. Hospice programs include
bereavement follow-up for families after a patient’s death. In this country,
a stigma may be associated with end-of-life care. It is associated with
giving up and the refusal to accept death as a natural process, although
this is changing as evidenced by the growth in hospice programs.6,23–25
There were approximately 5800 hospice programs in 2013; about 3700
were Medicare-certified. More than 1.5 million patients received hospice
services in 2013, with an average stay of 72 days. The average length of
stay is increasing as hospice becomes more widely accepted. As the largest
payer, Medicare accounted for 87% of hospice expenditures in 2013, with
Medicaid and private insurance paying the rest.6,13,24,25
Community-Based Public Health
The basis of community-based public health practice is the individual,
family, and community. Public health nurses and other clinicians provide
services that address and include health education and wellness
campaigns, immunization clinics, screening events, parent-child health
and safety, communicable disease, family planning, environmental health,
substance use, and sexually transmi ed disease. Approximately 2800 city,
county, metropolitan, district, and tribal health departments exist in the
United States. Since 2008, local health departments have lost 51,700 of
approximately 155,000 positions because of decreasing budgets, layoffs,
and a rition. Many public health nursing positions have been lost because
of lack of funds.26 In this chapter the emphasis is on computerization to
support these types of public health services that are provided to
individuals and families in the community.27
Public health services can also be directed toward the community with a
focus on the whole population and primary prevention. Principles of
public health and epidemiology or causality, as well as community
assessment and public policy, are usually components of these types of
public health programs. Chapter 11 focuses on public health informatics
with an emphasis on population health of communities, countries, and
global health.
Nurse-Managed Health Centers
Community health nurses, as well as advanced practice registered nurses,
including clinical nurse specialists, nurse practitioners, and certified nurse
midwives, provide care at urban and rural centers called nurse-managed
health centers. These centers may have collaborative agreements with
physicians and other interprofessional colleagues. Many centers are part of
or associated with educational institutions. They provide clinical
experiences for students and are located in underserved areas. Target
populations include pregnant teens, fragile elders, low-income mothers
and children, and others who may be underinsured or uninsured. Nurse-
managed health centers offer primary care services, preventive care,
chronic illness care, and care for specific conditions such as obesity. More
than 250 centers exist in the United States; Philadelphia has more than any
other city.28
Other Practice Sites
School, faith community, and occupational health nurses, as well as other
clinicians, provide healthcare in noninstitutionalized se ings. School
nurses typically participate in classroom instruction, screen the school
se ing for safety hazards, provide medications in collaboration with
parents and healthcare providers, work with children who have special
needs, monitor immunization status, and provide and follow-up on
screening procedures. Faith community nurses may function as case
managers when they help their parishioners to obtain needed healthcare
services, food, shelter, and supplies. Some provide educational and
surveillance interventions for those who have chronic illnesses such as
diabetes and cardiovascular disease. Occupational health nurses are often
employed by businesses with a high risk of injury or with an emphasis on
health promotion and wellness such as smoking cessation, weight loss,
and regular exercise.
Similarities Among Practice Models
Because community-based clinicians have the opportunity to work with
patients and their families over time, they embrace core values that
influence their practice. Interprofessional collaboration and a seamless
healthcare environment are essential. Practice is based on the consumer
movement: people have rights and responsibilities, must be
knowledgeable about their own healthcare, and must participate as
partners in healthcare decisions. These values are linked to themes of
access, cost, quality, and IT.
The power of the patient and family is an important core value. When a
nurse or other healthcare professional enters a patient’s home, the patient
and family are in charge, not the clinician. Clinicians immediately observe
indicators and collect data about patients’ lifestyles, resources, and
motivation. While providing care, clinicians identify patients’ strengths
and incorporate those strengths in the care process. The goal of
community-based practice se ings is to provide patient-centered care and
include patients, their families, and their caregivers in care planning and
delivery. In the hospital or long-term care facility, the nurse gives
medications, changes dressings, and controls many aspects of care. In the
home, nurses assist patients to provide their own care or assist family
members or informal caregivers to provide that care.10,29,30
Clinicians who work in community se ings need skills that demonstrate
dedication, flexibility, and independence. Although they develop plans for
their day and for each visit or encounter, those plans often need to be
adapted and modified. It may not be possible to accomplish Plan A, so
Plan B, C, or D may be substituted at a moment’s notice. Colleagues,
equipment, and references are not readily available to the extent that they
are in hospitals and long-term care facilities. Selected help and supplies
may be available in the trunk of a car or via cellphone, in the EHR, from
the internet, or from a pager request. Clinicians always need to consider
their safety. Environments may be difficult, dysfunctional, or even
dangerous. Many patients and families welcome clinicians, although that
does not always happen. Clinicians need to develop and rely on their basic
education, ongoing education, life experiences, and common sense to
function self-sufficiently and to enjoy their work responsibilities.
The Triple Aim model for healthcare was published in 2008 (Box 9.1).
However, the primary concepts of the model have been the foundation
and core values of home health and related community-based services
from their inception: services that are patient centered, of high quality,
efficient, and cost effective. Although the size, staffing, organization, board
structure, and financial arrangements of the practice models summarized
in this chapter vary markedly, all deal with limited financial resources.
Clinicians who work in community se ings must be very knowledgeable
about costs and funding. Frequently they help patients and families
understand and manage health-related financial issues. In many
situations, Medicare and Medicaid funding regulations are the primary
determinant of the type and length of home health and hospice services.
Private insurance companies determine their own guidelines but typically
follow Medicare’s policies. Ever-changing regulations and reimbursement
pa erns, interest in private pay services, and the aging population
contribute to altered services. Agencies that provide Medicare- and
Medicaid-certified services must meet strict national regulations. Most
states have additional licensing rules.11
Box 9.1
The Triple Aim for Healthcare
• Be er care for individuals, described by the six dimensions of healthcare
performance: safety, effectiveness, patient-centeredness, timeliness,
efficiency, and equity.
• Be er health for populations, through a acking “the upstream causes of
so much of our ill health,” such as poor nutrition, physical inactivity,
and substance abuse.
• Reducing per-capita costs.
Adapted from Berwick DM, Nolan TW, Whi ington J. The triple aim: care, health, and cost. Health
Aff. 2008;27(3):759-769.
Standardized datasets
Standardized datasets are required in Medicare-certified and hospice
se ings, and are found in other community-based se ings. The concept of
a standardized dataset in the community began more than 25 years ago
with the Resident Assessment Instrument (RAI). This approach was
adopted in response to a public outcry about the poor quality of care
occurring in long-term or extended nursing facilities, and to the
government’s effort to bring visibility and transparency to care provided
in these institutions. Over time, the use of standardized datasets has
expanded from long-term care to home health, renal dialysis units, and
other care se ings. This approach provides a means to collect patient
characteristics and measurements in a standardized manner that allows
data aggregation for analysis. The aggregated data offer the opportunity
for data-driven decision making related to care delivery and correlating
payment systems to a predicted level of care needed by the patient.31,32
Standardized datasets have evolved largely without the adoption of
standardized point-of-care and reference terminologies in practice se ings.
Although standardized terminologies in medicine have existed for
centuries, the adoption of standardized terminologies in nursing and the
other health professions began to take root about 45 years ago. However,
adoption in practice has been limited and even more limited among the
information systems commonly purchased by home health, hospice, and
other community-based care se ings. Although standardized datasets
have served an important purpose, healthcare providers need additional
strategies to achieve the care communication and coordination necessary
to transform healthcare and achieve the Triple Aim for healthcare (see Box
9.1). Strategies need to include a focus on patient-centered care, best
practices and evidence-based care, interprofessional care teams, and a
value-based approach that can be quantified, analyzed, and used to
measure the outcomes of care.3,4,33,34
Outcome and Assessment Information Set
The Outcome and Assessment Information Set (OASIS) is the
standardized dataset that home health agency clinicians complete with
their patients.35 It is designed to determine payment and measure the
quality and outcomes of practice. OASIS consists of 80-plus questions and
response sets; collection requirements vary according to specific times
during the process of care (i.e., admission, transfer, resumption of care,
follow-up, or discharge). An example of a question is M1240: Has the
patient had a formal Pain Assessment using a standardized pain
assessment tool? A second example is M1242: Frequency of Pain
interfering with patient’s activities or movement.
Public reporting, another benefit of the data and outcomes collected
using the OASIS dataset, began in 2003. It allows the public to compare the
outcomes of home health agencies in a local community to the state and
national outcome averages.36
The OASIS dataset has undergone three major revisions. It is currently
known as OASIS-C1/ICD-10.35 Each major revision has involved
modifications to the data collected, including exclusions, modifications,
and additions. The latest iteration of the expanded dataset included
reporting on key process measures and the transition from the use of ICD
CM 9 to ICD CM 10 for diagnosis coding. These process measures will
continue to evolve in support of the efforts to harmonize quality measures
across care se ings to improve data collection and analysis.
In 2014, the U.S. Congress passed the Improving Medicare Post-Acute
Care Transitions Act (IMPACT). The new law requires that long-term care,
skilled nursing, home health, and inpatient rehabilitation providers begin
submi ing standardized and interoperable data in 2019. The data collected
will be used to evaluate and change payment methodologies between and
among care se ings to increase alignment with value-based purchasing
initiatives.37
Hospice Item Set
The Affordable Care Act of 2010 required that the Secretary of Health and
Human Services publish selected quality measures that must be reported
by hospice programs. Those measures are referred to as the Hospice Item
Set (HIS). The approach to develop a standardized dataset for hospice
agencies has been industry driven rather than mandated by the CMS
(Centers for Medicare & Medicaid Services). The Conditions of
Participation for Hospice, effective in 2008, describe the expectation that
the hospice industry determine the appropriate measures to collect and
report nationally.38 This approach reflects the fact that hospices had been
collecting and reporting key quality measures through their associations
and other data analysis partners for almost 20 years.13,14,24 The CMS
mandated that hospices begin their reporting processes with two
measures: one that is patient related and one that is structural. It is
expected that the number of measures will increase as the industry
continues to identify, propose, and refine a dataset.13,14,24
Patient-Experience Surveys
Home health agencies, hospices, skilled nursing facilities, and dialysis
centers are required to submit patient-experience surveys. These surveys,
referred to as Consumer Assessment of Healthcare Providers and Systems
(CAHPS), are designed to measure the interpersonal value of healthcare
experienced by patients and contribute to their ability to make informed
decisions about health plans and care providers.39 Surveys provide an
additional source of standardized data for aggregation and offer visibility
and transparency about the care provided. It is expected that they will
become increasingly important in the future because patient experience
represents one of the key tenets of the Triple Aim for healthcare (see Box
9.1).
Supporting home health with electronic
health records and health information
technology
Challenges related to distance, communication, productivity, and
interprofessional practice are inherent in home health and related
community-based services. Because of these challenges, agency providers
are embracing national and global trends. Many trends focus on
technology that facilitates communication and collaboration, such as
cellular telephones, telehealth, remote patient monitoring, fall-detection
device technology, sophisticated information systems, and point-of-care
devices. The point-of-care devices are designed to make patient records
available in the home when care is being provided and capture clinicians’
documentation in real time, thereby supporting that care.27,29,34,40–42
The core values and practice models of community-based services have
direct implications for technology and information systems. Systems must
be designed to support the data, information, knowledge, and wisdom
continuum as described in Chapter 2, and have interprofessional practice
with the patient, family, and community as the central focus.43–46
Information systems used in community practice se ings are evolving
into next-generation systems. Software vendors are exploring the
relationship of the design and function of their systems to improve their
capabilities to support interprofessional practice, communication and
collaboration, clinical decision support (CDS), and the ability to share
information across care se ings. Vendors and their healthcare provider
customers are not only starting to share information with other providers
but also encouraging patients to use personal health records to store their
data in a longitudinal care record and plan.42,45,47–49 In addition,
information systems are viewed as a critical factor to achieving the Triple
Aim for healthcare. Next-generation systems are expected to support the
simplicity and connectivity that are essential to connecting caregivers
across diverse locations and care se ings. Interoperability and data
exchange are required if all members of the healthcare team engage in a
ubiquitous approach to care planning, collaboration, transparency, and
efficiency in healthcare. Such developments are necessary for home health
and community-based providers to have sharable and comparable data
and participate in big data initiatives.33,50–52
Information systems were first adopted by home health agencies in the
early 1980s. The development and use of these systems in home health,
hospice, and other community-based se ings have generally evolved in
the following historical sequence to (1) support billing, (2) collect data at
the point of patient care to support the financial needs of the business, (3)
manage and support collection of standard clinical datasets, and (4)
provide CDS. This evolution is analogous to the progression described in
the data, information, knowledge, and wisdom continuum.
Billing Solutions
Initially, data within systems moved in one direction from the home
health, hospice, or community-based agency to the third-party payer as an
electronic claim. The payer, upon receiving the claim, reviewed and paid
the claim. As financial systems and electronic capabilities advanced,
bidirectional exchange of claims information management became
commonplace. This allowed the payer to receive the electronic claim and
return an acknowledgment of payment to the healthcare provider
electronically.
Point-of-Care Solutions
The next milestone for information systems used by home health agencies
and, to a lesser degree, by hospice services occurred as agencies
recognized the value of capturing the clinicians’ documentation that
supported the interaction with the patient at the point of care. The
principal value of these systems was to enable electronic capture of the
service date and time for billing and payroll purposes.
In 1998, the value of point-of-care systems changed for home health
agencies because of Medicare’s transition from a cost-based
reimbursement system to a prospective payment system. The prospective
payment system was predicated on the use of a standardized assessment
dataset designed to predict the patient’s resource needs; the results of the
dataset were associated with a payment rate. The standardized dataset
OASIS was discussed earlier in this chapter.
Agencies that were computerized expected their software vendors to
incorporate the OASIS dataset into their point-of-care systems to enable
their clinicians to capture the information once, prepare, and then submit
to their respective states for aggregation by the CMS. Home health
agencies that had not adopted point-of-care solutions experienced a
significant data-entry burden to remain in compliance with regulations. As
a result, agencies accelerated their adoption of point-of-care information
systems and EHRs as a strategy to reduce the regulatory burden and
streamline their operations.
In addition to supporting the change in payment methodology, the
collection of the OASIS dataset created an opportunity to introduce an
outcomes-based quality-improvement (OBQI) process to home health.
OBQI is a risk-adjusted and outcome-reporting tool used across time and
viewed as a means to further move the risk from the payer to the
healthcare provider by assigning a value-based purchasing facet to the
model. OBQI represents the next step in evolving the payment system
from fee for service to capitation or payment for care of a population. Fig.
9.1 depicts a continuum that illustrates the onset of CMS reimbursement
through the transition of payment risk from the payer to the healthcare
provider.
FIG 9.1 Transition of risk from payer to healthcare provider.
(Centers for Medicare & Medicaid Services [CMS]. Oasis-C
educational resources. CMS. [Link]
Initiatives-Patient-Assessment-
Instruments/HomeHealthQualityInits/[Link];
2010.)
As adoption of OBQI grew, provider agency managers and
administrators recognized the value of mining OASIS data and converting
it to information to support business and operational decision making in
their organizations. The information was transformed into knowledge
involving the care their staff delivered, potential opportunities for
improvement, and marketing their successes.43,44
An expected result of having information represented by OASIS and the
HIS is the goal of understanding the following three questions:
• What is causing the outcomes?
• How can the outcomes be improved?
• How much improvement can realistically be expected?
Efforts to answer these questions have identified the need to know more
about the processes being used to deliver care, specifically what care
processes contributed to positive clinical outcomes. The knowledge of the
outcomes has resulted in a need for increased predictability, visibility, and
transparency in the use of best practices and evidence-based practice
protocols.
In 2010, the OASIS dataset was revised to improve the quality of
responses to outcome questions. Specifically, 16 process measures were
added to the dataset. The data collected about these process measures are
intended to clarify how best practices and evidence-based practice affect
outcomes.36,38,42,53 The CMS and other payers are using this knowledge to
transition to payment methodologies that support value-based purchasing,
bundled payments, and accountable care, each of which are contributing
to the increasing need for payer and agency provider collaboration to
ensure the best possible patient outcomes at the lowest possible costs.34,53
This transition has already had an impact on practice and is predicted to
have an even greater effect across the care continuum in the future.
Clinical Decision Support Systems
CDS systems are part of the next frontier for home health and other related
community-based practice se ings. Rouse described these systems as
applications that analyze data and help healthcare providers make clinical
decisions.54 CDS systems generally use one of two approaches: (1)
presenting best practices and evidence-based practice options to the
clinician by finding and displaying what is known about the patient to a
knowledge base using rule sets and an interface engine, or (2) using a
process of machine learning that presents or displays best practices and
evidence-based practice options to the clinician after analyzing the data
entered and comparing them to similar pa erns or scenarios that exist in
the system. These systems have been challenging to implement because
they are dependent on understanding the clinicians’ workflow. Clinicians’
workflow usually varies among patients and lacks structured clinical
concepts, characteristics that are required to develop a knowledge base or
machine learning.54 In addition, standardized terminologies are required
to develop effective CDS systems. The next goal for CDS systems is to
achieve rapid learning systems that can support quick and widespread
adoption of evidence-based practice. When these learning systems are
used, the time needed to implement best practices and evidence-based
practice will be significantly reduced. Reaching this goal will require
health information networks that are capable of collecting and supporting
analysis of large amounts of data in simple, clear terms and returning the
findings to clinicians though CDS systems at the point of care.33 See
Chapter 10, for a more detailed discussion of CDS systems.
Standardized terminologies
The American Nurses Association (ANA) recognizes 12 reference and
point-of-care or interface terminologies. These terminologies are described
in detail in Chapter 22 and the references that accompany that chapter.
Use of standardized terminologies is increasing in response to diverse
factors. The national initiative to link reimbursement to value instead of
volume serves as an important factor because providers will need
quantitative data to confirm improved patient outcomes.47,48,55–57 As noted
by the Alliance for Nursing Informatics, the use of standardized nursing
and other health terminologies:
…is necessary and a prerequisite for decision support, discovery of
disparities, outcomes reporting, improving performance, maintaining
accurate lists of problems and medications, and the general use of and
reuse of information needed for quality, safety, and efficiency.55, p. 66
It is critical that point-of-care terminologies are mapped to reference
terminologies to the enable current and future interoperability and data
sharing described in this chapter. The point-of-care terminologies
recognized by the ANA have been or are being mapped.
Ideally, students are introduced to the 12 terminologies in their entry
programs and clinical sites during their basic education, and they become
somewhat familiar with them. In addition, students should understand the
difference between reference terminologies, including Systematized
Nomenclature of Medicine—Clinical Terms (SNOMED CT) and Logical
Observation Identifier Names and Codes (LOINC), and point-of-care
terminologies as discussed in Chapter 22.
Similarities and differences are evident when the terminologies are
compared and contrasted.56,58–60 Those that are especially pertinent to this
chapter are summarized. Many authors note that whereas point-of-care
terminologies were initially intended for use in specific se ings (i.e.,
community, acute, or long-term care), healthcare delivery has changed
dramatically, and boundaries have blurred. It is possible to implement
most of the terminologies across the continuum of care. Developing a
structure that is computer compatible was not the initial goal in the
development of point-of-care terminologies. With the IT explosion and
proliferation of software vendors, relationships are evolving between the
terminologies and software developers of clinical information systems.
When discussing point-of-care terminologies, it is important to remember
the distinction between the terminologies and the individual software
applications that may incorporate a terminology. Any one terminology can
be used in the development of systems by multiple developers and
vendors.
Omaha system
The Omaha System is an example of a point-of-care terminology
recognized by the ANA that is mapped to SNOMED CT and LOINC, two
of the reference terminologies. The Omaha System was initially developed
(1) for home health and community-based use, (2) to operationalize the
problem-solving process, (3) to provide a practical, easily understood,
computer-compatible guide for daily use in community se ings by
interprofessional clinicians, and (4) to provide a tool to quantify, analyze,
and use to improve the quality of care. From the early home health,
hospice, public health, and school health focus, adoption began to expand
in the 1990s, with both automated applications and paper-and-pen forms.
Current use represents the continuum of care; it has extended far beyond
the early community-based se ings. More than 22,000 interprofessional
clinicians, educators, and researchers use the Omaha System in the United
States and a number of other countries with various types of software
based on the Omaha System. Details about the application, users, clinical
examples (case studies), inclusion in reference terminologies, research,
best practices and evidence-based practice, and listserv are described in
publications and on the website ([Link])29,61,62
Description
The Omaha System consists of the Problem Classification Scheme, the
Intervention Scheme, and the Problem Rating Scale for Outcomes.
Reliability, validity, and usability were established when the fourth
federally funded research project was completed in 1993 (Box 9.2). The
three components, designed to be used together, are comprehensive,
relatively simple, hierarchical, multidimensional, and computer
compatible. Since the first developmental research project in 1975, the
Omaha System has existed in the public domain; thus the terms,
definitions, and codes are not held under copyright. They are available for
use without permission from the publisher or developers and without a
licensing fee. However, the terms and structure must be used as
published.29,61
Box 9.2
Development of the Omaha System
As early as 1970, the clinicians and administrators of the Visiting Nurse
Association (VNA) of Omaha, Nebraska, began addressing practice,
documentation, and information-management concerns. Their goal was to
identify a strategy that would translate theory into practice and share
pertinent qualitative and quantitative data with healthcare professionals
and the public. At that time, clinicians were not using computers, and
there was no systematic nomenclature or classification of patient problems
and concerns, interventions, or patient outcomes to quantify clinical data
and integrate with a problem-oriented record system. These realities
provided the incentive for initiating research and involving community
test sites throughout the country. Between 1975 and 1993, the staff of VNA
of Omaha conducted four extensive, federally funded development and
refinement research studies that established reliability, validity, and
usability. The work of Larry Weed was recognized. Avedis Donabedian,
who developed the structure, process, and outcome approach to
evaluation, was a valuable consultant.
Data from Donabedian A. Evaluating the quality of medical care. Milbank Q. 1966;44(2):166-206;
Martin KS. The Omaha System: A Key to Practice, Documentation, and Information Management.
Reprinted 2nd ed. Omaha, NE: Health Connections Press; 2005.
The conceptual model is based on the dynamic, interactive nature of the
problem-solving process, the clinician-client relationship, and concepts of
diagnostic reasoning, clinical judgment, and quality improvement (Fig.
9.2). The patient as an individual, a family, or a community appears at the
center of the model, reflecting a patient-centered approach. The central
location suggests the many ways in which the system can be used, the
importance of the patient, and the essential partnership between patients
and clinicians.
FIG 9.2 Omaha System model of the problem-solving process. From
Martin KS. The Omaha System: A key to practice, documentation, and information
management. Reprinted 2nd ed. Omaha, NE: Health Connections Press; 2005.
The system was intended for use by nurses and all members of
healthcare delivery teams. The goals of the research were to (1) develop a
structured and comprehensive system that could be both understood and
used by members of various disciplines, (2) foster collaborative practice,
and (3) generate accurate and consistent aggregate data. Therefore the
system was designed to guide practice decisions, sort and document
pertinent patient data uniformly, and provide a framework for an agency-
wide, interprofessional clinical information management system capable
of meeting the daily needs of clinicians, managers, and
administrators.29,46,61–63
Problem Classification Scheme
The Problem Classification Scheme is a comprehensive, orderly,
nonexhaustive, mutually exclusive taxonomy designed to identify diverse
patients’ health-related concerns. Its simple and concrete terms are used to
organize a comprehensive assessment, an important standard of
interprofessional practice. The Problem Classification Scheme consists of
four levels. Four domains appear at the first level and represent priority
areas. Forty-two terms, referred to as client problems or areas of patient
needs and strengths, appear at the second level. The third level consists of
two sets of problem modifiers: health promotion, potential and actual, as
well as individual, family, and community. Clusters of signs and
symptoms describe actual problems at the fourth level. The content and
relationship of the domain and problem levels are outlined in Box 9.3 and
are further illustrated by the clinical example in Box 9.4. Understanding
the meaning of and relationships among the terms is a prerequisite to
using the scheme accurately and consistently to collect, sort, document,
analyze, quantify, and communicate patient needs and strengths.
Box 9.3
Domains and Problems of the Omaha System
Problem Classification Scheme
Environmental Domain
Material resources and physical surroundings both inside and outside the
living area, neighborhood, and broader community:
• Income
• Sanitation
• Residence
• Neighborhood/workplace safety
Psychosocial Domain
Pa erns of behavior, emotion, communication, relationships, and
development:
• Communication with community resources
• Social contact
• Role change
• Interpersonal relationship
• Spirituality
• Grief
• Mental health
• Sexuality
• Caretaking/parenting
• Neglect
• Abuse
• Growth and development
Physiological Domain
Functions and processes that maintain life:
• Hearing
• Vision
• Speech and language
• Oral health
• Cognition
• Pain
• Consciousness
• Skin
• Neuro-musculo-skeletal function
• Respiration
• Circulation
• Digestion-hydration
• Bowel function
• Urinary function
• Reproductive function
• Pregnancy
• Postpartum
• Communicable/infectious condition
Health-Related Behaviors Domain
Pa erns of activity that maintain or promote wellness, promote recovery,
and decrease the risk of disease:
• Nutrition
• Sleep and rest pa erns
• Physical activity
• Personal care
• Substance use
• Family planning
• Health care supervision
• Medication regimen
From Martin KS. The Omaha System: A Key to Practice, Documentation, and Information Management.
Reprinted 2nd ed. Omaha, NE: Health Connections Press; 2005.
Box 9.4
John T. Little: A Man Who Received Home
Health Services
Kelly S. Nelson, PT, DPT, PCS, CWS
Assistant Professor, Department of Physical Therapy,
School of Pharmacy and Health Professions, Creighton University
Omaha, Nebraska
Information Obtained during the First Visit/Encounter
John T. Li le, age 79 years, had a fracture of his left femur that was
surgically repaired with a pin 2 weeks ago. John spent 5 days in the acute
care hospital followed by 9 days at the subacute rehabilitation facility. He
was discharged to his home yesterday.
During the home health nurse's first visit, John's wife seemed relatively
well informed. In John's presence she stated, “I am going to need help
caring for him. It's a difficult time for us.” The nurse summarized the
agency's services including interprofessional providers, and the goals of
care for both Mr. and Mrs. Li le. The couple agreed when the nurse
suggested that a home health aide visit to provide personal care.
John was resting in a hospital bed with an overhead trapeze and
removable side rails. The equipment was set up before he came home. He
moved in the bed with difficulty and needed assistance to roll or sit up.
Mrs. Li le could not find the mobility technique instructions that they
were given yesterday. John, his wife, and the nurse discussed plans and
goals for the physical therapist's visit later today and the occupational
therapist's visit tomorrow.
The nurse indicated that the surgical site and John's skin were in
excellent condition and offered evidence-based suggestions about bed
mobility and prevention of skin shearing and breakdown. Mrs. Li le
reported that she could manage John's diet, fluid intake, and elimination.
She said she would appreciate the use of a raised toilet seat and a shower
chair.
Although John was reluctant to admit that he had pain, he rated it as a 4
on a 0-to-10 pain scale. Mrs. Li le administered pain medication at least
three times a day and as needed, indicating that she “would not wait for
John to look miserable.” She described how she evaluated John's pain and
would use the pain scale as the nurse instructed. The nurse showed Mrs.
Li le a web site describing evidence-based pain management and gave
her some printed instructional materials. Mrs. Li le agreed to keep the
nurse informed as John's need for pain medications changed and if other
symptoms such as constipation occurred. The nurse mentioned several
methods for achieving nonpharmacological pain relief and asked the
couple to discuss their preferences before the nurse's next visit. They said
they would do so.
Application of the Omaha System:
Domain: Physiological
Problem: Pain (High Priority Problem)
Problem Classification Scheme
Modifiers: Individual and Actual
• Signs/Symptoms of Actual: expresses discomfort/pain
• compensated movement/guarding
Intervention Scheme
Category: Teaching, Guidance, and Counseling
Targets and client-specific information:
• anatomy/physiology (diagnosis and surgery in relation to pain, joint,
and pain management)
• relaxation/breathing techniques (consider options and decide)
Category: Surveillance
Targets and client-specific information:
• signs/symptoms—mental/emotional (a itude, emotions)
• signs/symptoms—physical (ability/willingness to move)
Problem Rating Scale for Outcomes
Knowledge: 3—basic knowledge (knows pain causes, need for medication,
but not other options)
Behavior: 3—inconsistent knowledge (not tried additional options for pain
relief, but willing)
Status: 3—moderate signs/symptoms (caused by injury and surgery)
Problem: Neuro-Musculo-Skeletal Function (High
Priority Problem)
Problem Classification Scheme
Modifiers: Individual and Actual
Signs/Symptoms of Actual:
• limited range of motion
• gait/ambulation disturbance
• difficulty transferring
• fractures
Intervention Scheme
Category: Teaching, Guidance, and Counseling
Targets and client-specific information:
• occupational therapy care (plan of care)
• physical therapy care (plan of care)
Category: Surveillance
• durable medical equipment (bed set-up adequate, needs raised toilet
seat and shower chair)
• mobility/transfers (bed mobility)
• signs/symptoms—physical (surgical site, skin condition)
Problem Rating Scale for Outcomes
Knowledge: 3—basic knowledge (recalls some instructions, can't find
handout)
Behavior: 2—rarely appropriate behavior (limited mobility/activity)
Status: 2—severe signs/symptoms (minimal activity)
Domain: Health-Related Behaviors
Problem: Personal care (High Priority Problem)
Problem Classification Scheme
Modifiers: Individual and Actual
Signs/Symptoms of Actual:
• difficulty with bathing
• difficulty with toileting activities
• difficulty dressing lower body
• difficulty dressing upper body
• difficulty shampooing/combing hair
Intervention Scheme
Category: Case Management
Targets and client-specific information:
• paraprofessional/aide care (schedule 3 times/week)
Problem Rating Scale for Outcomes
Knowledge: 4—adequate knowledge (knows help needed)
Behavior: 4—usually appropriate behavior (requested assistance)
Status: 2—severe signs/symptoms (care is difficult because of John's
physical condition)
Problem: Medication Regimen
Problem Classification Scheme
Modifiers: Individual and Actual
Signs/Symptoms of Actual:
• unable to take medications without help
Intervention Scheme
Category: Teaching, Guidance, and Counseling
Targets and client-specific information:
• medication action/side effects (reports of pain, movement, non-verbal
cues)
• medication administration (scheduling doses appropriately)
Category: Surveillance
Targets and client-specific information:
• signs/symptoms—physical (discussed effectiveness, constipation,
other symptoms; will use pain scale)
Problem Rating Scale for Outcomes
Knowledge: 4—adequate knowledge (informed about pain medication,
watch for changing needs)
Behavior: 4—usually appropriate behavior (good administration schedule)
Status: 3—moderate signs/symptoms (pain scale = 4)
Intervention Scheme
The Intervention Scheme is a comprehensive, orderly, nonexhaustive,
mutually exclusive taxonomy designed for use with specific problems. It
consists of three levels of actions or activities that are the basis for care
planning and services, providing the structure and terms to organize care
plans and actual care. An important standard of interprofessional practice
is providing interventions and leaving a data trail about the care that was
provided. Four broad categories of interventions appear at the first level of
the Intervention Scheme. An alphabetical list of 75 targets or objects of
action and 1 “other” appear at the second level. Client-specific information
generated by clinicians is at the third level. The contents of the category
and target levels are outlined in Boxes 9.5 and 9.6, respectively, and are
further illustrated by the clinical example in Box 9.4. The Intervention
Scheme enables clinicians to describe, quantify, and communicate their
practice, including improving or restoring health, describing deterioration,
or preventing illness.
Box 9.5
Categories of the Omaha System Intervention
Scheme
Teaching, Guidance, and Counseling
Activities designed to provide information and materials, encourage
action and responsibility for self-care and coping, and assist the
individual, family, or community to make decisions and solve problems.
Treatments and Procedures
Technical activities such as wound care, specimen collection, resistive
exercises, and medication prescriptions that are designed to prevent,
decrease, or alleviate signs and symptoms for the individual, family, or
community.
Case Management
Activities such as coordination, advocacy, and referral that facilitate
service delivery; promote assertiveness; guide the individual, family, or
community toward use of appropriate community resources; and
improve communication among health and human service providers.
Surveillance
Activities such as detection, measurement, critical analysis, and
monitoring intended to identify the individual, family, or community’s
status in relation to a given condition or phenomenon.
From Martin KS. The Omaha System: A Key to Practice, Documentation, and Information Management.
Reprinted 2nd ed. Omaha, NE: Health Connections Press; 2005.
Box 9.6
Targets of the Omaha System Intervention
Scheme
• anatomy/physiology
• anger management
• behavior modification
• bladder care
• bonding/a achment
• bowel care
• cardiac care
• caretaking/parenting skills
• cast care
• communication
• community outreach worker services
• continuity of care
• coping skills
• day care/respite
• dietary management
• discipline
• dressing change/wound care
• durable medical equipment
• education
• employment
• end-of-life care
• environment
• exercises
• family planning care
• feeding procedures
• finances
• gait training
• genetics
• growth/development care
• home
• homemaking/housekeeping
• infection precautions
• interaction
• interpreter/translator services
• laboratory findings
• legal system
• medical/dental care
• medication action/side effects
• medication administration
• medication coordination/ordering
• medication prescription
• medication set-up
• mobility/transfers
• nursing care
• nutritionist care
• occupational therapy care
• ostomy care
• other community resources
• paraprofessional/aide care
• personal hygiene
• physical therapy care
• positioning
• recreational therapy care
• relaxation/breathing techniques
• respiratory care
• respiratory therapy care
• rest/sleep
• safety
• screening procedures
• sickness/injury care
• signs/symptoms—mental/emotional
• signs/symptoms—physical
• skin care
• social work/counseling care
• specimen collection
• speech and language pathology care
• spiritual care
• stimulation/nurturance
• stress management
• substance use cessation
• supplies
• support group
• support system
• transportation
• wellness
• other
From Martin KS. The Omaha System: A Key to Practice, Documentation, and Information Management.
Reprinted 2nd ed. Omaha, NE: Health Connections Press; 2005.
Problem Rating Scale for Outcomes
The Problem Rating Scale for Outcomes consists of three five-point,
Likert-type scales used to measure the entire range of severity for the
concepts of Knowledge, Behavior, and Status. Each of the subscales is a
continuum that provides a framework for measuring and comparing
problem-specific patient outcomes at regular or predictable times.
Evaluation is an important interprofessional standard of practice.
Suggested times include admission, specific interim points, and discharge.
The ratings are a guide for the clinician as patient care is planned and
provided. The ratings offer a method to monitor and quantify patient
progress throughout the period of service. The content and relationships
of the scale are outlined in Table 9.1 and are further illustrated by the
clinical example in Box 9.4. Using the Problem Rating Scale for Outcomes
with the other two schemes creates a comprehensive problem-solving
model for practice, education, and research.
Table 9.1
Omaha System Problem Rating Scale for Outcomes
From Martin KS. The Omaha System: A Key to Practice, Documentation, and Information
Management. Reprinted 2nd ed. Omaha, NE: Health Connections Press; 2005.
Clinical Example from Practice
The John T. Li le clinical example (see Box 9.4) depicts the use of the
Omaha System with a patient and his home health nurse. It describes
evidence-based and community-based practice, introduces the system as a
standardized terminology, summarizes interprofessional practice, and
offers details about EHRs, standards, and other concepts. Many additional
references describe the application and value of using point-of-care
documentation.29,46,61–63
Interpretation of the Clinical Example
The clinical example illustrates the following:
1. Patient-centered care and the power of the patient and the family: These are
core values of home health and other community-based services. The
nurse asks for John and Mrs. Li le to provide information about his status
and asks them to share their preferences about pain relief during the next
visit.
2. Evidence-based practice: The nurse follows the agency’s evidence-based
standards of practice in relation to skin care and medication management.
3. Interprofessional practice: The nurse, John, and Mrs. Li le discuss plans
for the home health aide, physical therapist, and occupational therapist.
4. Practice and documentation using a standardized terminology: The nurse uses
the Omaha System to guide the assessment (Problem Classification
Scheme), care plan (Intervention Scheme), and care delivery (Intervention
Scheme). In addition, the nurse selects the baseline Knowledge, Behavior,
and Status ratings (Problem Rating Scale for Outcomes) that will guide
evaluation during future visits. Other members of the care team will also
use the Omaha System. Although not described in the clinical example, the
nurse would have completed the OASIS dataset and entered billing,
supplies, and other data.
5. Practice, documentation, and information management linkages:
a. All members of the care team use one integrated EHR for
documentation and can follow the data trail about John’s progress.
They can revise the care plan and interventions as needed to improve
the quality of care they provide.
b. John’s data will be analyzed and added to aggregate data. Outcome
reports will be available to members of the care team, as well as to
agency managers and administrators. As data are transformed to
information and knowledge, quality of care can be monitored and
improved as part of the agency’s quality-improvement program.
c. Requests for orders and regular reports will be sent to John’s referring
medical staff, who are external members of the care team.
6. External monitoring and quality control:
a. Aggregate data about John and the home health agency’s other
patients will be submi ed to CMS and other external third-party
payers for reimbursement. In turn, they may select John’s EHR for
review, and a site visitor may accompany a team member on a home
visit to observe John’s care.
b. John’s EHR may be selected for review by accreditation site visitors.
They may also make a home visit to observe care. Many home health
agencies are accredited by the Joint Commission, Community Health
Accreditation Program (CHAP), or the Accreditation Commission for
Health Care. The number of health departments that are accredited is
increasing rapidly.
Examples of Electronic Health Record Screen Images
Three screen images are presented in Fig. 9.3 to illustrate a limited portion
of John T. Li le’s EHR. Specifically, they depict pain assessment, problem
identification, and care planning. The images are examples that enable the
reader to visualize the application of concepts presented in this chapter.
Note that the focus of the images varies but does not depict John’s entire
clinical record or other software modules that the home health agency
would use. The images are part of McKesson Corporation’s information
system. McKesson Corporation and nine additional vendors are listed in
Box 9.7 as examples of companies that sell information system solutions to
diverse home health, hospice, and other community-based organizations
in the United States. Note that these 10 companies are examples only;
many additional companies sell information systems and niche software to
similar organizations.
Box 9.7
Companies That Sell Information Systems
Supporting Community-Based Care
• AllScripts
• Brightree, Inc.
• Cerner Corporation
• Champ Software, Inc.
• Delta Health Technologies, LLC
• HEALTHCAREfirst
• HealthMedx
• HealthWyse
• Homecare Homebase
• McKesson Corporation
FIG 9.3 A, Pain assessment. B, Problem identification. C, Care
planning. Copyright McKesson Corporation.
Conclusion and future directions
The healthcare delivery system in the United States is under enormous
pressure to change and create a more transparent, collaborative, efficient,
and patient-centered system.57 Adoption of EHRs and enabling the
exchange of clinical information between members of the care team and
across disparate systems are critical to achieving the goals of the U.S.
Department of Health & Human Services, the Office of the National
Coordinator for Health Information Technology, and the Triple Aim for
healthcare.33
Home health, hospice, and other community-based care providers are
actively engaged in envisioning and testing models of care. The evolving
communication and collaboration models are designed to support safe
transitions between care se ings, effectively manage patient populations,
and participate in accountable care organizations to achieve be er clinical
outcomes, be er patient experiences, and lower costs. Accurate and
consistent data generated by information system solutions and capable of
being transformed into information, knowledge, and wisdom are key to
each of these initiatives. The information system solutions should support
patients across the care continuum and into their homes to ultimately
enable them to successfully self-manage their care needs. It is critical to
seamlessly share and update a common plan of care, including
medications, allergies, problems, planned interventions, and goals and
results.29,33,47,48,61
When considering the longer term, there is an opportunity to quantify
and aggregate information about common patient populations, create
knowledge of effective care teams and treatment approaches, and share
the knowledge in real time or near real time with the care team. Rapid
learning systems and delivering wisdom to the healthcare community
represent the opportunity ahead.
References
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2 Naylor M.D., Van Cleave J. The transitional care model for older
adults. In: Meleis A.I., ed. Transitions Theory: Middle Range and
Situational Specific Theories in Research and Practice. New York, NY:
Springer; 2010:459–464.
3 Humphrey C.J., U erback K.B. The role of evidence-based clinical
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Discussion questions
1. The focus of this chapter is home health and related community-based
systems. What are your experiences with such se ings? Do you expect
to have more contact with them in the future?
2. Patient-centered care is an important theme in this chapter. Think about
your experiences in practice se ings. Describe whether you consider
your experiences to be patient centered.
3. Describe your interest in and experience with standardized
terminologies. List at least three positive and three negative experiences
with standardized terminologies. What can be done to transform the
negative experiences to positive ones?
4. Describe your interest in and experience with point-of-care
documentation. List at least three positive and three negative
experiences with point-of-care documentation. What can be done to
transform the negative experiences to positive ones?
Case Study
The ABC Home Health Agency is a nonprofit, Medicare-certified
organization established in the mid-1950s in a small Midwestern city. It is
accredited by the Accreditation Commission for Health Care, Inc. The
agency offers a continuum of preventive and therapeutic services that have
an individual, family, and community focus. Clinicians provide services to
patients ranging in age from infants to elders. The agency employs
supervisory, administrative, IT, and support staff, as well as 45 clinicians:
25 nurses, 10 home care aides, 5 homemakers, 3 physical therapists, 1
occupational therapist, and 1 social worker. Staff members are on call 24
hours a day.
ABC Home Health Agency services include (1) skilled home health and
hospice; (2) home care aide and homemaker; (3) private duty, including
nursing, personal care, and respite care; (4) wellness, flu, and
immunization clinics; (5) school health; (6) jail health; and (7) durable
medical equipment.
There are two hospitals with about 100 beds and 15 physicians within
the service area. The Agency has a good working relationship with both
hospitals and the physicians. Many patients followed by the Agency have
been referred from these services. Last year the Agency provided 20,345
home visits.
The Agency has used an automated billing, statistical, and financial
management information system for 15 years. Clinicians enter all patient
data using an unstructured, narrative, automated software system. The
previous director, who has just retired, did not believe that the cost was
justified to implement an EHR capable of capturing discreet clinical data to
support tracking patient-specific assessment information, identifying the
specifics of care, and generating outcome measures. You have just been
hired as the new director. The board of directors asks you to investigate
purchasing an EHR and submit your recommendations to them.
Discussion Questions
1. Should you introduce the clinicians to standardized terminologies and
involve them in discussions about EHRs before contacting potential
software vendors? Or should you contact vendors, select the best
software, and tell the clinicians what you selected?
2. What steps would you need to complete before reporting to the board
of directors?
3. What strategies will likely increase your chances of success? What
strategies will increase your chances of failure?
10
Clinical Decision Support Systems
in Healthcare*
Kensaku Kawamoto; Guilherme Del Fiol
Abstract
Clinical decision support (CDS) is a key component of a variety of health information
systems and a core component of electronic health record (EHR) systems. By
providing the right information to the right person at the right time and at the right
location, CDS systems can support effective clinical decision making and improve
clinical care. CDS, encompassing various types of intervention modalities, has been
shown to be effective for many decades. Important considerations in implementing
CDS systems include the application of best practices and the incorporation of
knowledge management capabilities. Despite its benefits, significant challenges limit
the widespread adoption and impact of CDS. These challenges include a healthcare
payment model that has traditionally rewarded volume over quality and the
difficulty of scaling CDS capabilities across healthcare systems and their information
systems. In recent years, several prominent efforts ensued to develop standards-
based approaches to disseminating CDS on a national level. Moving forward, a need
exists to capitalize on these ongoing initiatives to make advanced CDS available on a
national scale.
Since shortly after computers were first introduced into clinical settings in
the 1960s and 1970s, clinical decision support (CDS) has been shown to
be a powerful tool for positively affecting care delivery and patient
outcomes.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe why clinical decision support is needed and its impact.
2. Explain the major types of clinical decision support.
3. Analyze best practices for clinical decision support.
4. Synthesize the current adoption status and the barriers to the wide
adoption of clinical decision support.
5. Outline recent progress toward disseminating clinical decision
support on a national level.
KEY TERMS
Bayesian knowledge base 171
clinical decision support (CDS) 170
decision making 170
expert system 175
Introduction
Since the early days of health information technology (IT), the central
goals of leveraging IT in medicine have been to help clinicians in their
decision-making process to prevent errors, to maximize efficiency, to
enable evidence-based care, and ultimately to improve health and
healthcare. Over time, tools that support the clinical decision-making
process have been generally designated as clinical decision support
(CDS) systems.
According to the classic Institute of Medicine (IOM) report To Err Is
Human, as many as 98,000 people die in hospitals in the United States
every year due to preventable healthcare errors.1 Many consider this a
conservative number; more recent research has estimated that more than
400,000 people die prematurely every year due to preventable errors.2
More than 15 years after the IOM report was issued, li le has changed.
Consumer Reports, addressing the same question, reported that “based on
our review of the scant evidence, we believe that preventable medical
harm still accounts for more than 100,000 deaths each year—a million lives
over the past decade.”3, p. 2 Furthermore, a study by McGlynn et al. showed
that, on average, patients in the United States receive only 54.9% of
recommended medical care processes.4 To a great extent, errors in
healthcare are caused by process errors, information overload, and
knowledge gaps.1,5 Several factors further aggravate this problem,
including rapidly evolving domain knowledge, an aging population
having multiple comorbidities, and an increasingly complex healthcare
delivery system. Ultimately this leads to a clinical information overload
that significantly exceeds the human cognitive capacity.6,7
Many healthcare errors can be prevented, particularly through process
improvement measures enabled by computerized information systems
coupled with CDS tools. In fact, a large number of studies have shown that
CDS tools help clinicians and patients adopt evidence-based care
whenever applicable.8 As a result, several relevant reports and regulations
have called for the use of health IT to support healthcare decision making,
such as the IOM’s Crossing the Quality Chasm,9 the National Quality
Forum’s (NQF’s) Driving Quality and Performance Measurement—A
Foundation for Clinical Decision Support,10 the United States EHR
Meaningful Use incentive program,11 and the IOM’s The Future of Nursing:
Leading Change, Advancing Health.12
Definition of Clinical Decision Support
Multiple definitions of CDS have been proposed, but in general these
definitions have evolved from a narrow scope, typically focused on alerts
and reminders, to a broader scope that encompasses a much wider set of
tools that provides patient-specific information to support clinical decision
making. According to Osheroff, CDS comprises a variety of tools and
interventions that “provide clinicians, staff, patients, or other individuals
with knowledge and person-specific information, intelligently filtered or
presented at appropriate times, to enhance health and health care.”13, p. 141
Similarly, the NQF defined CDS as “any tool or technique that enhances
decision-making by clinicians, patients, or their surrogates in the delivery
or management of health care.”10, p. 1 In light of these definitions, CDS can
support several aspects of patient care decision making such as the
following:
• Reminding about a specific care need (e.g., patient due for an
immunization).
• Alerting about a specific care action that may impose risk to the
patient (e.g., a drug interaction).
• Providing intelligent views of a patient’s record that help cultivate a
be er understanding of the patient’s status (e.g., intensive care
reports, chronic disease management dashboards).
• Providing tools that assist in implementing and documenting
decisions more efficiently and accurately (e.g., documentation tools,
order sets, medication reconciliation tools).
• Providing clinicians and patients with seamless access to patient-
specific reference information available in online knowledge
resources.
• Providing access to information about similar patients in the
population along with their treatments and outcomes.
• Integrating information from nontraditional sources into the clinical
workflow, such as patient self-reported outcomes, vital signs collected
via wearable sensors, and patient dietary information, as well as
relevant data about the patient’s environment, such as air pollution
and infectious disease rates.
• Applying advanced analytics to estimate risks for a specific
individual, such as risk for hospital readmissions, risk for
cardiovascular events, and risk for falls.
History
Since the early 1970s, when the first studies demonstrating the impact of
CDS were published by groups at the Regenstrief Institute in Indiana and
the La er-Day Saints (LDS) Hospital in Salt Lake City, CDS has become
one of the holy grails of health informatics. Although designed more than
3 to 4 decades ago, these examples of CDS are still relevant and some of
them are still in use.
De Dombal Computer-Aided Diagnosis of Acute
Abdominal Pain
According to a systematic review by Johnston et al.,14 the first study to
compare CDS with clinician performance was published in 1972 by de
Dombal et al. on the diagnosis of acute abdominal pain.15 The system
comprised a Bayesian knowledge base and provided diagnostic
probabilities as output.16 An evaluation was conducted over an 11-month
period at a general hospital in the United Kingdom, during which patient
admissions due to acute abdominal pain were assessed independently by a
physician and by the computer-aided diagnostic system.15 The system’s
overall diagnostic accuracy was significantly higher than that of the most
senior member of the clinical team (91.8% vs. 79.6%). The results of this
seminal study demonstrated the strong potential of using computers to
assist decision making for patient care.
Computer Reminders at Regenstrief Institute
One of the seminal randomized trials assessing the impact of a broad CDS
intervention was published in 1976 by McDonald.17 In this study,
physicians at the Regenstrief Institute received patient-specific reminders
about 390 patient management protocols on a myriad of clinical
conditions. These reminders were automatically generated by the
computer based on the patients’ EHR and logic encoded in computable
form. When a patient had a clinic visit, applicable reminders were printed
and a ached to the patient’s chart. The study showed that physicians
reacted to 51% of the events when exposed to reminders versus 21% when
not exposed to reminders.
Clinical Decision Support Examples from the HELP
System
A comprehensive set of CDS examples is provided by the HELP (Health
Evaluation Through Logical Processing) System, a clinical information
system developed in the late 1960s and used well into the 21st century at
the LDS Hospital in Salt Lake City, Utah.18 The HELP System includes a
broad range of CDS tools that can be classified into the following four
categories:
1. Alerts as a response to the presence of certain clinical data, such as life-
threatening laboratory test results.
2. Tools that critique clinicians’ decisions, such as the presence of drug
interactions in medication orders.
3. Tools that provide on-demand diagnostic or therapeutic suggestions,
such as computer protocols for ventilator management and antiinfective
selection assistance.
4. Retrospective quality assurance tools.
Several of these CDS tools have demonstrated a significant impact on
clinicians’ decisions and patient outcomes, such as appropriate use of
perioperative antibiotics, reduced postoperative wound infections,
reduced hospital length of stay when clinicians received alerts for life-
threatening conditions, and increased survival rate in patients with acute
respiratory distress syndrome (ARDS) when computer protocols were
utilized for ventilator management. A compendium of the HELP CDS
tools and a summary of the effects of these tools on clinicians’ decisions
and patient outcomes are available in an article by Haug et al.18
Clinical decision support types and
examples
Several taxonomies have been developed to classify CDS systems. A recent
taxonomy was developed by the NQF as an extension of a functional
taxonomy developed by researchers at Partners HealthCare.19 The
taxonomy is composed of four functional categories: triggers, input data,
interventions, and action steps. Triggers are the events that initiate a CDS
rule (e.g., a drug prescription). According to the NQF taxonomy, CDS can
be triggered by an explicit request from a user, updates to a patient’s data,
user interactions with an EHR system, or a specific time. Input data are the
additional data used in the background to constrain or modify the CDS,
such as patient conditions, medications, diagnostic tests, and the care plan.
Interventions are the possible actions that result from the CDS system, such
as sending a message to a clinician, displaying relevant clinical knowledge
or patient information, and logging that a particular event took place.
Action steps are actionable alternatives offered to the CDS user, such as
collecting or documenting information (e.g., reason to override an alert,
completion of care recommended by CDS), requesting an order, and
acknowledging a CDS recommendation. The complete NQF taxonomy is
available in the NQF consensus report Driving Quality and Performance
Measurement—A Foundation for Clinical Decision Support.10
One of the most current and comprehensive taxonomies was developed
by Wright et al. using a Delphi method with 11 CDS experts.20 The
taxonomy classifies CDS types from the user (“front end”) perspective into
six overarching categories: medication dosing support, order facilitators,
point-of-care alerts and reminders, relevant information display, expert
systems, and workflow support. Each of these categories is broken down
into subtypes, leading to a total of 53 CDS types. The following sections
describe each of the six overarching categories and provide real-life
examples.
Medication Dosing Support
This category includes tools that assist clinicians in finding and monitoring
the most appropriate doses for medication orders. Tools vary from simple
“pick lists” with allowed dose options to more complex dose calculation
algorithms based on parameters such as patient weight, height, renal
function, and hepatic function (Fig. 10.1). Researchers at the Brigham and
Women’s Hospital designed several medication dosing support tools for a
broad range of medications within their computerized provider order
entry (CPOE) system.21
FIG 10.1 Dose adjustment recommendation for a gentamicin order
in a patient with impaired renal function. The adjusted dose takes
the patient’s creatinine clearance and weight into account. From the
computerized provider order entry system at Brigham and Women’s Hospital, Boston.
Order Facilitators
Broader than medication dosing support tools, order facilitators are tools
that assist clinicians in the order entry process in general. Order sets are
perhaps the most common example in this category.22 They assist
clinicians by providing a set of commonly used orders for a specific
condition (e.g., community-acquired pneumonia) or service (e.g., internal
medicine hospital admission orders, vascular surgery postoperative
orders). In addition to expediting the order entry process, order sets may
help to reduce errors and promote consistent care, reducing unnecessary
variability, enabling more complete orders, and reducing the need for
verbal orders. Most currently available CPOE systems provide order set
capabilities.19 Fig. 10.2 depicts a community-acquired pneumonia order set
within the HELP2 system at Intermountain Healthcare.22
FIG 10.2 CPOE system with a community-acquired pneumonia
order set. From the HELP2 system at Intermountain Healthcare, Salt Lake City.
Point-of-Care Alerts and Reminders
Point-of-care alerts and reminders raise the clinician’s or the patient’s
a ention to important conditions or recommendations based on the
patient’s clinical data. One of the most common types of CDS, available in
most CPOE and drug prescription systems, is an alert that notifies
clinicians when a drug being prescribed interacts with other drugs the
patient is already receiving. Similar examples include duplicate therapy
alerts, drug allergy alerts, and an alert when a patient’s condition
contraindicates the use of a particular drug. Similar to alerts, reminders are
messages that aim to raise the clinician’s a ention to a particular patient’s
need to receive certain care, such as immunizations, cancer screening, fall
prevention, and pain assessment. Fig. 10.3 shows a set of patient care
reminders generated by the VistA EHR system at the Veterans Health
Administration (VHA).
FIG 10.3 A set of care reminders (bottom right of screen)
presented within the VHA’s VistA Computerized Patient Record
System. Copyright Veterans Health Administration. All Rights Reserved.
When designed appropriately, alerts have shown significant reduction
in errors.21 However, overuse of the alert mechanism may lead to a
problem known as alert fatigue, where clinicians tend to ignore alerts
because they are frequently false positives and not clinically significant.23
Fig. 10.4 illustrates one way in which drug-drug interaction alerts may be
presented without interrupting clinicians’ workflow and therefore
minimize alert fatigue. Other approaches to reducing alert fatigue include
prioritizing alert display and improving the precision of the alert logic
through contextual information about the patient, healthcare provider,
and care se ing to prevent false-positive alerts.24
FIG 10.4 A medication prescription system coupled with
noninterruptive drug interaction checking. Pairs of interacting drugs
are color-highlighted. Different colors denote different levels of
interaction severity. The figure also shows Infobutton links adjacent
to each drug that clinicians can click to retrieve context-specific
information. From the HELP2 system at Intermountain Healthcare, Salt Lake City.
Relevant Information Display
A different category of CDS addresses clinicians’ information overload in
the process of care in both patient information and domain knowledge.
This broad category includes CDS tools that provide seamless access to
relevant patient information or summarize prominent aspects of a
patient’s record to help clinicians understand the patient’s condition and
status. Intensive care daily reports that assist clinicians in patient rounds
are one example of such tools. Another example is disease management
dashboards that summarize relevant data for managing a specific
condition. Fig. 10.5 shows a disease management dashboard developed at
Duke University to assist the management of patients with chronic
conditions such as diabetes, hypertension, and chronic kidney disease.25
FIG 10.5 Chronic disease management module in use at the Duke
University Health System. The system presents relevant data
associated with evidence-based care recommendations. Copyright Duke
University Health System. All Rights Reserved.
In addition to the need for seamless access to relevant patient
information, clinicians frequently raise domain knowledge questions when
making patient care decisions. Research has shown that clinicians raise
about two questions for every three patients seen and that more than half
of these questions go unanswered.26 With the advent of the World Wide
Web, several online health knowledge resources became accessible
through desktop and mobile devices. Although these resources provide
answers to most of the clinicians’ questions, significant barriers limit their
use at the point of care.27 In essence, the amount of time it typically takes
for clinicians to find their answers is not compatible with the busy clinical
workflow.28 To facilitate access to these resources and reduce barriers to
their use in patient care, researchers have been enabling access to these
resources within EHR systems through an increasingly popular approach
to CDS known as “Infobu ons.”29 Leveraging contextual a ributes about
the patient, clinician, care se ing, and clinical task at hand within an EHR,
Infobu ons anticipate clinicians’ information needs and provide
automated links to relevant online knowledge resources. For example, a
physician prescribing a medication for a patient who has chronic kidney
disease might want to know if the medication is contraindicated or if its
dose needs to be adjusted based on the patient’s condition. An Infobu on
positioned beside the drug name within the EHR would provide access to
this kind of information from an external drug knowledge resource. Fig.
10.6 shows an example of Infobu ons within the HELP2 drug prescription
module used at Intermountain Healthcare.30
FIG 10.6 User interface presented to a physician who clicks an
Infobutton beside the drug amoxicillin, when prescribed to an adult
patient. The left side has a navigation panel with automated context-
specific links to relevant resources. The right side contains the
content itself, which was retrieved from external online resources.
Copyright 2012 Truven Health Analytics Inc. and Intermountain
Healthcare. All Rights Reserved.
Expert Systems
Expert systems provide diagnostic or therapeutic advice based on patient
parameters. They typically contain more sophisticated computer logic than
other forms of CDS and are less frequently found in commercial EHR
systems.20 Within informatics, the term expert system is also used to classify
computerized systems that go beyond decision support and actually
automate the decision-making process. This use of the term is described in
Chapter 2.
The antibiotic assistant and ventilator management protocols described
in the section titled CDS Examples from the HELP System are examples of
this category of CDS. Another example is diagnostic decision support
systems such as Iliad,31 Quick Medical Reference (QMR),32 and Dxplain.33
These systems propose a list of candidate diagnoses based on a patient’s
signs and symptoms. Although diagnostic CDS tools have achieved a quite
reasonable level of diagnostic accuracy, especially for differential
diagnoses,34 their use has been limited primarily to educational
purposes.35,36
Workflow Support
The last category of CDS tools comprises tools that aid in important steps
of the patient care workflow, such as care transitions, patient
documentation, and orders. These workflow steps are susceptible to
various types of errors and inefficiency that can be tackled with CDS. For
example, medication errors in care transitions can be prevented with
medication reconciliation tools37; structured documentation templates may
facilitate consistent and efficient documentation38; and automatic steps in
the ordering workflow, such as order approval, routing, and termination,
may improve the overall efficiency and safety of the ordering process.39,40
Clinical decision support impact
Evidence of Effectiveness
Numerous research studies have evaluated the impact of CDS. In 2011,
Jaspers et al. synthesized the findings from 17 high-quality systematic
reviews of the impact of CDS on healthcare practitioner performance and
patient outcomes.8 Within these systematic reviews, 57% of 91 unique
studies reported improved practitioner performance and 30% of 82 unique
studies reported improved patient outcomes.8 Improved practitioner
performance was not always associated with a statistically significant
improvement in patient outcomes, at least in part because studies of CDS
interventions often lack large sample sizes and the associated statistical
power required to reliably identify improvements in patient outcome
metrics.
Examples of Clinical Decision Support Impact
Studies
As one classic example of a CDS intervention resulting in positive
outcomes, a study at Brigham and Women’s Hospital in Boston found that
a CPOE system with various CDS capabilities reduced nonintercepted
serious medication errors by 86%, with increasing benefits seen with the
introduction of additional CDS capabilities.21 In another classic example,
also described in the section titled CDS Examples from the HELP System,
the use of a rule-based CDS system for the mechanical ventilation of
patients with ARDS resulted in a 60% survival rate compared to an
expected survival rate of approximately 35%.41 In another example, the
impact of the antibiotic assistant developed by Evans et al. was assessed in
a pre-post study. Compared to the preintervention period, use of the
antibiotic assistant led to significant improvements in a variety of clinical
measures, including antibiotic-susceptibility mismatches and adverse
events caused by antiinfective agents.42 Moreover, patients who received
antiinfective therapy according to the regimens recommended by the CDS
system had significantly reduced length of stay (10.0 days vs. 16.7 days,
p < 0.001) and significantly lower total hospital costs ($26,315 vs. $44,865,
p < 0.001) compared to patients who were not managed according to the
CDS system’s recommendations.42
Not all CDS interventions result in the desired outcomes, however. For
example, in a randomized controlled trial involving 29 health centers, an
external CDS system for diabetes management that was accessible through
the EHR system did not result in any clinically significant changes in
practitioner performance or patient outcomes.43 In another example, a
stand-alone CDS system designed to guide referrals for patients at
increased risk for hereditary breast cancer was found to have limited
impact in a randomized controlled trial involving 86 primary care
practices, primarily due to the limited use of the tool by clinicians.44 Last, a
randomized controlled trial involving 60 primary care practices found no
significant impact when a CDS system for asthma and angina
management was made available to intervention clinicians as a separate
path within their practices’ EHR systems.45
Financial Impact of Clinical Decision Support
As with any investment, a healthcare institution should consider the
expected financial impact when making decisions related to CDS
investment. To the extent that CDS can facilitate desired changes in clinical
practice pa erns and patient outcomes, CDS can lead to positive returns
on investment, for example, by reducing medical errors and lengths of
stay. The VHA estimated that its health IT investments have resulted in
more than $3 billion in net benefits, with CDS serving as an important
catalyst for the return on investment.46 In this analysis, CDS provided a
financial return on investment to the VHA in reduced costs related to
preventable adverse drug events, avoided admissions, and redundant or
unnecessary laboratory and radiology tests.47
In assessing the financial impact of CDS, it is important to recognize that
the financial benefits of CDS may accrue to stakeholders other than those
investing in CDS. For instance, if a healthcare delivery organization invests
in CDS to support influenza and pneumococcal vaccinations and the rate
of hospitalizations for these conditions decreases, the organization may
lose money because of the decrease in revenue-generating hospitalizations,
whereas society, patients, and health insurers would likely benefit from
the investment. In another example, if a healthcare delivery organization
invests in CDS systems to ensure that low back pain results in expensive
diagnostic imaging and surgical procedures only when clearly warranted,
it may lose money because of the decrease in revenue-generating
radiologic exams and surgeries; again, society, patients, and health
insurers would likely benefit from the investment. Thus when assessing
the financial impact of CDS, it is important to assess the impact in terms of
the different stakeholders involved, particularly patients, healthcare
delivery organizations, and health insurers.
In the case of organizations such as the VHA that serve as both a
healthcare delivery organization and a health insurer, the financial
incentives of the major stakeholder groups may align well. Other health
organizations’ incentives do not align as well but, as discussed later,
healthcare payment models are beginning to change toward models in
which the financial incentives of the key stakeholders are be er aligned.
Currently, however, because of the healthcare payment models in the
United States, the issue of misaligned financial incentives will likely
continue to be an important issue in the financial case for CDS.
Clinical Decision Support Adoption
Despite four decades of substantial evidence demonstrating the ability of
well-implemented CDS to improve practitioner performance and patient
outcomes, most commercial EHR systems and healthcare delivery
organizations in the United States have implemented only basic CDS
capabilities, such as alerts for drug-drug interactions and drug allergy
contraindications.13 According to a systematic review, 24% of all studies on
the impact of health IT on patient care were conducted at four healthcare
organizations in the United States: the Regenstrief Institute, Brigham and
Women’s Hospital/Partners HealthCare, the U.S. Department of Veterans
Affairs, and LDS Hospital/Intermountain Health Care.47 Characteristics
common to these four organizations are use of homegrown EHR systems
that were developed and implemented gradually; a strong informatics
culture; and strong clinician engagement in the system design,
development, and implementation process. Unfortunately, the approach
taken at these organizations with internally developed systems is unlikely
to be feasible for disseminating CDS to most healthcare se ings. Hence the
broad dissemination of CDS remains one of the most significant challenges
and prominent areas of research in healthcare informatics.
Challenges and Barriers to Clinical Decision Support
Adoption
The dissemination of CDS is limited by a significant set of barriers, which
collectively make CDS interventions not easily replicable. The most
prominent barriers include the following:
• Lack of incentives: As discussed earlier, a key reason for the limited
adoption of CDS is a healthcare payment model that often fails to
reward the provision of higher-quality care and therefore investments in
quality-enhancing technologies such as CDS. Within healthcare systems,
CDS interventions often do not provide financial benefit to the
individuals and organizations that must invest the resources to
implement CDS.
• Implementation challenges: Successful CDS requires a well-designed
implementation plan supported by a strong organizational culture and
strategy. In fact, a recent meta-analysis identified local user involvement
in the CDS development process as one of the key factors associated
with successful CDS.48 CDS implementations are an ongoing cycle
requiring constant monitoring and updating of the underlying clinical
logic to reflect changes in domain knowledge, local practices, workflow,
and regulations. Ideally CDS should be seen as an integral component of
a healthcare organization’s quality and value improvement strategy that
is operationalized as an organization-wide clinical knowledge
management effort.49,50
• Low EHR adoption: Because CDS generally requires that a core
information system such as an EHR or CPOE system be in place first, a
barrier to CDS adoption has been the limited adoption of EHR and
CPOE systems. However, this scenario is changing rather rapidly
worldwide, partially due to incentives such as the Meaningful Use
program in the United States. After the inception of this program, the
rate of hospitals in the United States that have at least a basic EHR
system increased from 9% in 2008 to 76% in 2014, with increasing use of
advanced functionality.51 Similarly, the adoption of EHR systems by
office-based physicians increased from 17% in 2003 to 78% in 2013.52
• Multiple data sources with li le information exchange: Most CDS logic
requires data that are typically fragmented across multiple data sources,
such as laboratory; pharmacy; radiology; billing; admission, discharge,
and transfer (ADT); and EHR systems. Moreover, a patient may have
relevant data for CDS stored with many different healthcare
organizations. These data sources are typically not shared with the EHR
providing the CDS or not shared in a format that can be readily used by
the CDS system. As a result, many implementations of CDS require
additional data entry by users. In turn, li le or no need for data entry is
often suggested as a facilitator of successful CDS interventions.48,53
Therefore a fundamental requirement for CDS adoption is the ability to
exchange information with multiple data sources, ideally through a
standards-based approach.
• Lack of adequate CDS tools and capabilities in most EHR systems: As
mentioned earlier, most EHR systems offer only basic CDS capabilities
and do not necessarily replicate successful CDS interventions developed
and evaluated with “homegrown” or internally developed EHR
systems. This limitation compromises the impact of CDS in most
healthcare organizations that rely on commercial EHR systems.
• “Cookbook medicine”: There is a belief among many physicians that the
use of CDS reduces medicine from an art to a “cookbook” approach to
patient care.54 However, with the increased emphasis on evidence-based
practice, standards of care, and best practices, this a itude is changing.
• Lack of a framework for sharing CDS logic and capabilities: As discussed later
in this chapter, another important barrier to widespread CDS adoption
has been the limited ability to scale most existing CDS logic and
capabilities across healthcare organizations and health information
systems.13 This includes the lack of a business model for sharing CDS
logic and capabilities, lack of a legal framework covering potential
liability implications associated with CDS recommendations, lack of a
widely adopted formalism for representing and sharing CDS
knowledge, and lack of widely available, standards-based CDS tools and
infrastructure.
Clinical decision support best practices
While CDS interventions can profoundly impact clinical care, in a
significant minority of cases they fail to result in meaningful
improvements. Given the significant effort and cost that can be associated
with implementing a CDS intervention, there has been major interest in
identifying best practices for CDS to help maximize the likelihood that a
CDS initiative will lead to the desired outcomes. In other words,
substantial work has been done to make CDS more of a science than an art.
These best practices also aim at contributing to the replicability and wide
dissemination of CDS interventions.
As an important source of CDS best practices, seasoned experts have
compiled guides for CDS best practices, two of which are discussed here.
First, in 2003, Bates et al. published “Ten Commandments for Effective
CDS: Making the Practice of Evidence-Based Medicine a Reality.”55 These
10 commandments are as follows:
1. Speed is everything.
2. Anticipate needs and deliver in real time.
3. Fit into the user’s workflow.
4. Li le things can make a big difference.
5. Recognize that physicians will strongly resist stopping.
6. Changing direction is easier than stopping.
7. Simple interventions work best.
8. Ask for additional information only when you really need it.
9. Monitor impact, get feedback, and respond.
10. Manage and maintain your knowledge-based systems.55
A second notable source of CDS best practices is Improving Outcomes
with CDS: An Implementer’s Guide, which was authored by experts in the
field and published in 2011 by the Healthcare Information and
Management Systems Society (HIMSS).56 This book synthesizes best
practices into worksheets to guide the reader through the CDS
implementation and evaluation process. It also provides a practical
framework for designing and implementing CDS interventions that
follows the “CDS Five Rights,” which refers to providing the right
information to the right person using the right CDS intervention format,
delivered through the right channel and at the right point in the workflow.
As a complement to these best practice guides, some researchers have
a empted to quantitatively analyze the features of CDS interventions that
are strongly associated with, and therefore potentially explain, the success
or failure of those interventions. In particular, a systematic review led by
Kawamoto analyzed 70 randomized controlled trials of clinician-directed
CDS interventions to assess the degree to which the trial outcomes
correlated with the presence or absence of CDS intervention features
suggested as important by domain experts.53 Through a multiple logistic
regression analysis, this study found that a single feature was by far the
most critical: the automatic provision of CDS as a part of clinician
workflow (adjusted odds ratio 112.1, p < 0.00001). Although there were
CDS interventions that included this feature but had no impact, the CDS
interventions that were not automatically part of the clinician’s workflow
failed to result in a significant improvement in clinical practice. This
finding suggests that unless a CDS intervention is provided automatically
to end users as a part of their routine workflow, there is a high likelihood
that the CDS intervention will remain unused and therefore will not have
an opportunity to affect patient care positively. In addition, this study
found that providing CDS along with a recommendation at the time and
location of decision making, rather than just an assessment, were
additional independent predictors of a positive outcome.
Recent progress toward disseminating
clinical decision support on a national
level
As noted throughout the chapter, CDS has the potential to significantly
enhance the efficiency and effectiveness of healthcare delivery. Indeed,
while CDS is not a silver bullet, it is a critical and largely underused
resource for improving care and reducing costs, especially when
implemented according to known best practices. Thus disseminating
comprehensive CDS on a national level is a critical challenge. A number of
initiatives are being developed to tackle the challenges and barriers to CDS
adoption. The following sections review a series of relevant initiatives and
progress that should contribute to overall CDS adoption.
Value-Based Payment Models
The recent trend with perhaps the most significant potential to spur
nationwide adoption of advanced CDS is the current shift of healthcare
payment from a fee-for-service model to approaches that reward the
delivery of be er quality and be er outcomes at lower cost. Driven by the
fundamental problem that the historical fee-for-service payment model
leads to unsustainable and relentless increases in healthcare costs, health
insurers are increasingly moving toward models of payment in which
healthcare delivery organizations are reimbursed less for care volume and
more for care value (outcomes relative to costs). For example, a RAND
Corporation technical report from 2011 catalogs nearly 100 implemented
and proposed payment reform programs and predicts accelerated
payment reform moving forward.57 Although it is difficult to predict how
quickly and how deeply these changes will ultimately be adopted, this
shift will likely have a profound impact on the degree to which healthcare
delivery organizations are motivated to implement CDS-supported
process changes to improve care quality and reduce care costs.
Meaningful Use Incentives for Electronic Health
Record and Clinical Decision Support Adoption
In 2009 the U.S. federal government established a law providing
approximately $30 billion in incentives for clinicians and hospitals to make
“Meaningful Use” of EHR systems.11 In 2012, the regulations related to this
law were relatively limited with respect to CDS, requiring only that
compliant EHR systems implement a handful of CDS interventions and
support a standard approach for integrating context-relevant information
resources, typically referred to as Infobu ons.58 With the exception of the
Health Level Seven (HL7) Context-Aware Knowledge Retrieval Standard
(also known as the “Infobu on Standard”), the 2015 Meaningful Use EHR
certification requirements do not specify standards for the implementation
of CDS capabilities. Part of the problem is the low level of maturity and
adoption of most CDS standards. Perhaps most important are the
Meaningful Use program’s powerful incentives for healthcare delivery
organizations to adopt EHR systems. As EHR systems are critical enablers
of robust and widely distributable CDS, this federal program significantly
increases the prospect of a national base of EHR systems through which
advanced CDS capabilities can be shared and widely used.
Statewide Health Information Exchanges
As noted in Chapter 5, health information exchanges (HIEs) enable the
secure exchange of health information among healthcare providers in a
defined region, often through secure web portals that enable authorized
clinical access. Beyond EHR systems, HIEs can provide a platform to
deliver CDS to clinicians on a large scale. The U.S. federal government has
invested more than $500 million in recent years in support of statewide
HIEs.59 As such, this increase in the potential capabilities and reach of
HIEs presents an additional opportunity for enabling CDS on a national
scale.
Clinical Decision Support Standards
In general, there are two complementary approaches to sharing CDS
across a large number of healthcare delivery organizations: (1) sharing
structured CDS knowledge resources (e.g., order sets, alert definitions)
and (2) sharing CDS capabilities over a secure internet connection (e.g.,
sending anonymous patient data to a secure web server, which returns
evidence-based care recommendations).60 In both approaches, a critical
element is that common standards are used by the various interacting
health information systems so that the approach can scale widely and be
implemented at relatively low cost. In recognizing this need, a number of
CDS standards that are required for a national approach to CDS have
recently been developed and adopted by international standards
development organizations such as HL7. Interested readers can obtain
further details regarding the current state of CDS standards in a recent
review article.61
National Clinical Decision Support and Knowledge
Management Initiatives
To underscore the degree to which the national dissemination of advanced
CDS has become an explicit priority for many relevant stakeholder groups,
a number of efforts were initiated in recent years in which the nationwide
dissemination of CDS is the explicit goal. The CDS Consortium, for
example, is a public-private collaborative effort sponsored by the Agency
for Healthcare Research and Quality (AHRQ) to assess, define,
demonstrate, and evaluate best practices for knowledge management and
CDS that can scale across multiple healthcare se ings and EHR technology
platforms.62 This effort includes demonstrations of how the CDS
interventions developed at one institution can be accessed over a secure
internet connection and integrated with the different EHR systems of
different healthcare delivery organizations. The CDS Consortium research
contract began on March 5, 2008, with a 5-year grant that ended in July
2013 ([Link]/cird/cdsc/[Link]).63
Furthermore, the NQF, responsible for the development of the various
quality measures required for EHR Meaningful Use compliance, has also
placed significant focus on how CDS could improve healthcare provider
performance with regard to the national quality measures developed by
the group.10 Also, the U.S. Office of the National Coordinator for Health
Information Technology recently sponsored an effort known as Advancing
CDS; one of the primary deliverables was a proposed national framework
for CDS content sharing and an initial pilot implementation of that
framework.64 Finally, a multistakeholder effort known as Health
eDecisions actively worked to identify, define, and harmonize standards
that facilitate the emergence of systems and services whereby shareable
CDS interventions can be implemented at scale,65 and a follow-on effort
known as Clinical Quality Framework is harmonizing these CDS
interoperability standards with standards for electronic clinical quality
measurement.66 An important goal of these efforts is to develop and
validate a standards-based approach to CDS scaling that can be
incorporated into future federal regulations and programs.
Open Source, Freely Available Resources
As a practical ma er, the implementation of a common standards-based
approach to CDS can be facilitated by resources that are freely available in
the public domain. In recognition of this potential enabling role of open
source, freely available CDS resources, several CDS stakeholders have
launched efforts to collaboratively develop such resources. One such
initiative is known as OpenInfobu on ([Link] [Link]), which
is sponsored by the VHA to develop an open source solution for
supporting context-sensitive information retrieval in a standards-
compliant manner.67 An additional initiative in this area is OpenCDS
([Link]), which is a multistakeholder collaborative effort to
develop standards-based, open source resources to enable CDS at scale.67
Research challenges
Despite four decades of research, we are still in the infancy of CDS, and
notable challenges must still be addressed to fully realize its benefits. To
help focus effort toward achieving this goal, Si ig et al. compiled a list of
the top 10 grand challenges in CDS through a consensus-building process
(Box 10.1).68
Box 10.1
Top 10 Grand Challenges in Clinical Decision
Support
Improve the Effectiveness of Clinical Decision Support
Interventions
1. Recognize the need for improvements in human-computer interfaces for
delivering CDS.
2. Implement tools that automatically summarize the patient’s clinical
data, helping clinicians to understand the patient’s condition and status.
3. Prioritize and personalize CDS recommendations to the user.
4. Account for patient’s comorbidities.
5. Leverage the large amount of narrative text typically available in EHR
systems.
Create New Clinical Decision Support Interventions
1. Help organizations prioritize CDS content development and
implementation.
2. Leverage large clinical databases to create CDS.
The third category addresses some of the barriers to the wide adoption of
CDS.
Disseminate Existing Clinical Decision Support
Knowledge and Interventions
1. Disseminate CDS best practices.
2. Create a framework for sharing CDS knowledge and capabilities.
3. Create online CDS repositories.
Adapted from Si ig DF, Wright A, Osheroff JA, et al. Grand challenges in clinical decision support. J
Biomed Inform. 2008;41(2):[Link], Clinical decision support; EHR, electronic health record.
One particular area of interest receiving significant a ention is the desire
to leverage large and heterogeneous data sources, also known as “big
data,” through advanced analytic and visualization methods.69 To develop
research on big data, the U.S. federal government has allocated a
significant amount of research funding to the National Science Foundation
(NSF) and the National Institutes of Health (NIH). Big data could advance
CDS in several ways, including leveraging of free text data through natural
language processing (NLP); the use of nontraditional data sources (e.g.,
patient self-reported data, wearable sensor data, environmental data);
identification of similar patients in a population along with their
treatments and outcomes; and the use of predictive analytics to identify
patients at high risk of undesirable events such as hospital readmission,70
who can then be targeted for appropriate management through CDS.
Population-based CDS is also another important area of research need.
Historically, volume-based payment models provided healthcare systems
with li le or no incentive to improve the care of populations as a whole.
With the increasing shift to value-based payment models, however,
healthcare systems are starting to face much greater incentives for
improving health at the population level. As such, the efficient and
effective improvement of population health will likely represent a growing
focus of CDS efforts moving forward.
Another area of growing interest is CDS interventions to promote
patient-centered care (PCC), defined by the IOM as “care that is respectful
of and responsive to individual patient preferences, needs and values,
ensuring that patient values guide all clinical decisions.”9 Intelligent tools
are needed to help patients understand their conditions and care
alternatives, prioritize and carry out their care goals, and engage in shared
decision making with their providers.71-73 A systematic review reported by
the AHRQ found an overall positive effect of PCC health IT interventions
on healthcare processes, clinical outcomes, responsiveness to the needs
and preferences of individual patients, promoting shared decision making,
and improving patient-clinician communication.74 However, studies
reported a number of barriers for using these applications to enable PCC,
such as lack of usability, low computer literacy in patients and clinicians,
lack of standardization, workflow issues, and problems with
reimbursement.
Conclusion and future directions
Since shortly after computers were introduced into clinical se ings in the
1960s and 1970s, CDS has been shown to be a powerful tool for positively
affecting care delivery and patient outcomes. What has been lacking,
however, is a business environment conducive to widespread CDS and
technical approaches that enable large-scale CDS knowledge sharing.
Today there are a number of changes taking place that address both of
these critical challenges. Therefore there is a real opportunity for relevant
healthcare stakeholders to come together and realize the vision of
advanced CDS that is available ubiquitously and at low cost to support
improved healthcare across the nation.
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Ahead. Burlington, VT: Academic Press; 2007:469–502.
50 Hongsermeier T., Kashyap V., Sordo M. Knowledge management
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56 Osheroff J.A., Teich J.M., Levick D., et al. Improving Outcomes with
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Discussion questions
1. Describe examples of CDS that are available within your organization.
2. Identify the most important barriers to CDS adoption at your
organization.
3. Explain how healthcare reimbursement reform will affect healthcare
organizations’ use of CDS moving forward.
4. What recommendations do you have for the use of CDS to improve care
value at your organization?
5. What opportunities do you see for CDS to facilitate the work of
healthcare professionals?
6. When implementing a CDS system, what should the appropriate
relationship be between local values and standards and national
standards?
Case study
Imagine that you have been appointed Director of Clinical Decision
Support at a healthcare delivery system. This healthcare system consists of
several large hospitals and multiple outpatient clinics and uses the same
EHR system across the enterprise. There has been limited CDS activity at
the institution prior to your arrival. Now, with the increasing need to
provide increased care value, the appropriate use of CDS is an institutional
priority. The current CDS available at your institution consists primarily of
off-the-shelf drug-drug interaction and drug allergy alerting, which is the
source of significant clinician complaints due to the rate of false-positive
alerts. There is a strong sense within the institution’s administration that
IT in general and CDS specifically should be leveraged to improve care
value and to enable the institution to influence its clinical practice pa erns
more systematically and more rapidly. You have a reasonable budget and
adequate staff to make meaningful changes and you do have support from
key institutional stakeholders, including healthcare system executives, the
nursing informatics officer, and the chief medical informatics officer. You
have been asked to devise a strategic plan for CDS at your institution
within 3 months of your arrival and to have concrete “wins” within 12 to
18 months.
Discussion Questions
1. Describe the approaches you would use to ensure that all aspects of
patient care were considered when developing a CDS system. How
would you prioritize the efforts of your CDS team? Potential areas on
which to focus include areas in which payment rates are tied to
national quality measures, CDS interventions that meet Meaningful
Use requirements, readmissions for congestive heart failure and other
care events for which payers are increasingly not reimbursing, and
areas that have been identified as institutional priorities for clinical
improvement.
2. How would you balance the need to deliver desired CDS capabilities
quickly against the benefits of establishing robust infrastructure to
enable future deliverables to be implemented more quickly?
3. Identify one area for quality and value improvement. Define the CDS
interventions that you would implement to address this area of need.
Describe how your approach aligns with the best practices discussed
in this chapter, such as the CDS Five Rights, the CDS 10
commandments, and the desire to use standards-based, scalable
approaches. How would you systematically measure the impact of
these CDS interventions?
*Acknowledgments: Kensaku Kawamoto (KK) has served as a consultant or paid speaker
on CDS for the Office of the National Coordinator for Health IT, ARUP Laboratories,
McKesson Health Solutions, ESAC, Inc., JBS International, Inc., Inflexxion, Inc., Intelligent
Automation, Inc., Partners HealthCare, Hospital Sírio-Libanês, HL7 International,
Massachuse s General Hospital, the RAND Corporation, and the Mayo Clinic. KK
receives royalties for a Duke University-owned CDS technology for infectious disease
management known as CustomID that he helped develop. KK was formerly a consultant
for Religent, Inc. and a co-owner and consultant for Clinica Software, Inc., both of which
provide commercial CDS services, including use of a CDS technology known as
SEBASTIAN that KK developed. KK no longer has a financial relationship with either
Religent or Clinica Software. Guillherme Del Fiol was supported by grant number
K01HS018352 from the AHRQ. He has served as a paid speaker on CDS for HL7
International and Hospital Sírio-Libanês.
11
Public Health Informatics
Catherine Janes Staes
Abstract
The chapter includes a description of the importance and unique features of public
health practice and explores the differences between clinical and public health
practice. It includes social and political challenges that affect public health
informatics. A list of several major public health data systems is provided to help the
reader understand the scope of information generated and used by public health, but
these data systems alone are not informatics applications that transform data to
knowledge. To illustrate public health informatics applications, the chapter includes
a description of surveillance systems, immunization information systems, and the
role of public health in a health information exchange. The chapter includes a
description of the workflows associated with these systems and the value of
information technology (IT), decision support, and standards. The next section
describes the opportunities to leverage the electronic health record (EHR) to meet
and promote public health goals. EHRs can be used to manage a population of
patients in a single clinical practice or in a more complex medical home model. EHR
data are used to generate and track quality performance measures important for
preventing disease, reducing healthcare costs, and improving outcomes such as the
Healthcare Effectiveness Data and Information Set (HEDIS) measures that concern
antibiotic use, influenza vaccination, cancer screening, body mass index assessment,
and other quality metrics. In addition, EHRs can be used to deliver patient-specific
alerts for preventive or screening interventions. Finally, there is a discussion about
the future of public health informatics and the need to leverage new technologies and
paradigms to meet new challenges and resource constraints in the 21st century.
Public health informatics is the specialty where informatics methods and
tools are used to solve public health problems or support population and
public health goals.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Summarize critical public health functions and common workflows
that may be supported by information technology.
2. Analyze the sociopolitical context for public health and other factors
that influence the implementation of informatics solutions.
3. Critique key public health applications for infectious and chronic
diseases.
4. Describe current efforts to improve the exchange of information
between public health and clinical systems.
5. Explain why cloud computing is critical to the future of public health
informatics.
KEY TERMS
immunization information systems (IISs) 193
information ecology 198
information supply chain 198
public health 185
public health information 190
public health surveillance 191
Introduction
The public health informatics specialty uses informatics methods and tools
to solve public health problems or support population and public health
goals. This definition transcends the walls of a public health department
and recognizes that population and public health practice occurs in the
community, in clinical sites, and in a variety of other se ings outside the
domain of a health department. Rapidly evolving technologies, standards,
and partnerships have created new opportunities for monitoring and
improving population health and preventing injury and disease. This
chapter explains how informatics concepts can be applied to populations,
with the goals of limiting health problems and promoting health.
Public health: A population perspective
Public health is the science, art, and practice of protecting and improving
the health of populations. It has contributed substantially to improvements
in health status throughout the world. For example, during the 20th
century, life expectancy at birth among U.S. residents increased 62%, from
47.3 years in 1900 to 78.8 years in 2014.1 Unprecedented improvements in
population health status were observed at every stage of life across a
variety of different metrics.1a While the average life span of persons in the
United States increased by 30 years, 25 years of this gain were a ributable
to advances in public health.2 Advances in medical diagnostic modalities,
antibiotics, and other treatments and therapies are important, but
prevention of death, illness, and disability can be a ributed to public
health strategies that reduce harmful exposures and promote health. For
example, the Centers for Disease Control (CDC) and Prevention profiled
10 great public health achievements that affected health in the United
States3:
• Vaccine-preventable diseases
• Prevention and control of infectious diseases
• Tobacco control
• Maternal and infant health
• Motor vehicle safety
• Cardiovascular disease prevention
• Occupational safety
• Cancer prevention
• Childhood lead poisoning prevention
• Public health preparedness and response
These achievements required multifaceted health policy, legal, taxation,
and prevention program strategies applied in the community, the
workplace, and the home. As an example, the recognition of tobacco use as
a health hazard and the subsequent public health antismoking campaigns
resulted in changes in social norms to prevent initiation of tobacco use,
promote cessation of tobacco use, and reduce exposure to environmental
tobacco smoke.3 During the 30 years following the initial 1964 Surgeon
General's report on the health risks of smoking, the prevalence of smoking
among adults decreased from around 50% to 20%, and an estimated 1.6
million deaths from smoking were prevented.4 Today, 50 years after the
initial 1964 Surgeon General report, (1) research continues to newly
identify diseases caused by smoking, including diabetes mellitus,
rheumatoid arthritis, and colorectal cancer; (2) prevention efforts are still
ongoing toward a goal of eliminating cigare e use; and (3) new health
threats must be addressed concerning the emerging use of e-cigare es.5,6
Despite the above achievements of the 20th century, the unprecedented
improvements in sanitation and control of infectious diseases, and the fact
that the United States spends more money on healthcare than any other
nation in the world, the U.S. population still ranks near the bo om on
most standard measures of health status when compared with other
developed nations.7 In a call to do be er, Schroeder states that the
pathways to be er health do not generally depend on be er healthcare
and that even in those instances in which healthcare is important, too
many Americans do not receive it, receive it too late, or receive poor-
quality care.7 In particular, though, Schroeder calls for improved efforts to
address the behavioral pa erns that affect health in the 21st century. Given
that smoking and the constellation of poor diet and physical inactivity
were the “actual cause” of about one-third of all deaths in the United
States in 2000,8 public health efforts in the 21st century need to tackle these
and other modifiable behavioral risk factors to substantively affect
population health. Going forward, public health priorities and activities
will continue to evolve as the following occur:
• New problems arise, such as prescription drug abuse, organisms
resistant to antimicrobial therapies, the spread of Ebola, or violent
bioterrorism events seen on and after September 11, 2001.
• New priorities are recognized, such as the need to address the rising
rates of obesity, gun violence, and behavioral risk factors, and the
need to improve preparedness for natural and human-made disasters,
and ensure food safety.
• A continued need exists to prevent and control infectious and chronic
diseases, injuries, and behaviors (such as smoking) that cause high
rates of morbidity and mortality.
To address these challenges, public health involves a diverse set of
professionals and agencies that all have one common goal: to improve
people's health and protect them from health risks. The professionals
specialize in public health nursing, behavioral science and health
education, epidemiology, environmental health, injury control,
biostatistics, emergency medical services, health services, international
health, maternal and child health, nutrition, public health laboratory
practice, public health policy, and public health clinical practice. The
agencies involved include local (city and county), state, and tribal health
departments and federal agencies such as the CDC, the Food and Drug
Administration (FDA), the Environmental Protection Agency (EPA), and
the Census Bureau. The CDC includes the National Center for Health
Statistics, the National Institute for Occupational Safety and Health, and
other centers that focus on domains such as injuries, infectious disease,
genomics, and global health. These governmental public health agencies
partner with healthcare delivery systems and others to ensure the
conditions for population health (Fig. 11.1).
FIG 11.1 The public health system: government and some of its
potential partners. From Committee on Assuring the Health of the Public in the 21st
Century. The Future of the Public's Health in the 21st Century. Washington, DC: The
National Academies Press; Copyright 2002 National Academy of Sciences.
When asked to define public health, people often mention service
functions, such as “where you go to get your child immunized or to get a
birth or death record,” or job duties, such as “employing disease detectives
that respond to outbreaks and inspectors who check restaurants.” While
correct, these responses are incomplete. Public health agencies provide
direct clinical services similar to any healthcare organization but also
provide services, such as outbreak management and surveillance, that are
not otherwise performed in a community.9 A broad spectrum of public
health practice is largely invisible to the general public because much of
the goal of public health is to stop hazardous situations from arising.10
When public health strategies function well, hazardous events do not
occur, which creates a paradox: You often do not get grateful patients or
communities when problems are prevented.10 Some less visible examples
of public health activities include monitoring of air and water, prevention
and control of injuries, building of safe roadways, protection of the food
supply, proper disposal of solid and liquid waste and medications, rat
control and mosquito abatement, surveillance of infectious and chronic
diseases, and prevention and preparedness research (Fig. 11.2). This
diverse set of activities can be summarized in the core functions and
essential services for effective public health systems that were defined by
the Institute of Medicine (IOM) Commi ee for the Study of the Future of
Public Health. There are many opportunities to use informatics strategies
with these services.
FIG 11.2 The visible and invisible work of public health. Copyright 2010
Catherine States. Reprinted with permission.
The IOM framework developed in 1988 holds true today.10 Public health
agencies should perform three core functions: (1) assessment: “to regularly
and systematically collect, assemble, analyze, and make available
information on the health of the community, including statistics on health
status, community health needs, and epidemiologic and other studies of
health problems”10, p. 7; (2) policy development: “to exercise its
responsibility to serve the public interest in the development of
comprehensive public health policies by promoting use of the scientific
knowledge base in decision-making”10, p. 8; and (3) assurance: “to assure
their constituents that the services necessary to achieve agreed upon goals
are provided, either by encouraging actions by other entities (private or
public sector), by requiring such action through regulation, or by
providing services directly.”10, p. 8 “The commi ee recommends each public
health agency involve key policy-makers and the general public in
determining a set of high-priority personal and communitywide health
services that governments will guarantee to every member of the
community. This guarantee should include subsidization or direct
provision of high-priority personal health services for those unable to
afford them.”10, p. 8 The essential services related to these functions are
described in Box 11.1.
Box 11.1
Core Functions and the Ten Essential Services
for Effective Public Health Systems
Core Function: Assessment
Essential Services
• Monitor health status to identify community health problems.
• Diagnose and investigate health problems and health hazards in the
community.
Core Function: Policy Development
Essential Services
• Inform, educate, and empower people about health issues.
• Mobilize community partnerships to identify and solve health problems.
• Develop policies and plans that support individual and community
health efforts.
Core Function: Assurance
Essential Services
• Enforce laws and regulations that protect health and ensure safety.
• Link people to needed personal health services and assure the provision
of healthcare when otherwise unavailable.
• Assure a competent public health and personal healthcare workforce.
• Evaluate effectiveness, accessibility, and quality of personal and
population-based health services.
• Research for new insights and innovative solutions to health problems.
From Commi ee for the Study of the Future of Public Health. The Future of Public Health.
Washington, DC: The National Academies Press; 1988.
Public health practice differs from clinical practice in important ways
that help illustrate core public health principles. Most notably, public
health is focused on prevention and maintaining the health of populations
rather than treating individuals after they become injured or ill. The
primary goal of clinical care is to obtain the best possible outcome for the
individual receiving care. This paradigm leads to saving “one life at a
time.” In contrast, the primary goal of public health practice is to affect
population health and ensure a healthy community. This is performed by
encouraging healthy behaviors, focusing on prevention, and balancing
individual autonomy with limitations on individuals that protect those
individuals or others. For example, this balance is seen in smoking and
helmet laws designed to limit exposures to known risks for injury and
disease. The policies and strategies are designed to save “millions of lives
at a time.”
The diagnostic tools used in the two domains differ. Clinical providers
measure the health of an individual using tools ranging from a stethoscope
to sophisticated imaging or laboratory modalities. In contrast,
epidemiologists and public health officers measure the vital status of a
community using birth and death records, surveys, and surveillance data
to understand the distribution and determinants of disease and health in
their community. A list of the major surveys performed by the National
Center for Health Statistics is available on its website.11 Other important
systems will be described later in the chapter.
The breadth of entities involved in medical and public health practice
differs. A clinical provider primarily interacts with people and data
associated with hospitals, laboratories, and other clinical care se ings. In
contrast, public health practitioners may perform work in a clinical se ing
but the assessment, policy development, and assurance functions often
involve schools, the legislature, the workplace, correctional facilities, food
establishments, water systems, the community at large, and many other
se ings.
Public health interventions focus on events earlier in the causal pathway
of disease (Fig. 11.3). While medical care addresses the diagnosis and
treatment of disease, public health interventions focus on creating a safe
environment to avoid or reduce exposure to hazards, promote healthy
behaviors, and reduce the prevalence of risky behaviors and other risk
factors. For example, public health practitioners focus on safely removing
leaded paint in a child's community to avoid lead poisoning and advocate
or require the use of helmets to prevent head injuries.
FIG 11.3 Causal pathway of disease. Reproduced from Public health 101 for
informaticians, Koo D, O'Carroll P, LaVenture M, 8, 585–97, 2001 with permission from
BMJ Publishing Group Ltd.
Public health practice differs from clinical practice in one additional
significant way. The risk reduction strategies employed by public health
are based on a population perspective to determine priorities and evaluate
success. Three models for risk reduction are discussed extensively in The
Future of the Public's Health in the 21st Century12 and illustrated in Fig. 11.4.
These models are based on three central realities in the development of
effective population-based prevention strategies. First, disease risk is a
continuum rather than a dichotomy. There is no clear division between
risk for disease and no risk for disease regarding levels of blood pressure,
cholesterol, alcohol consumption, tobacco consumption, physical activity,
diet and weight, lead exposure, and other risk factors. Second, most often,
only a small percentage of any population is at the extremes of high or low
risk. The majority of people fall in the middle of the risk distribution.
Exposure of a large number of people to a small risk can yield a more
absolute number of cases of a condition than exposure of a small number
of people to a high risk. Third, an individual's risk of illness cannot be
considered in isolation from the disease risk for the population to which
he or she belongs.
FIG 11.4 Models for risk reduction. Printed with permission from Committee
on Assuring the Health of the Public in the 21st Century. The Future of the Public's Health
in the 21st Century. The National Academies Press; Copyright 2002 National Academy of
Sciences.
Fig. 11.4 illustrates the hypothetical impact on the distribution of risk in
a population when efforts are focused on only those at highest risk (see
Fig. 11.4A), when strategies are employed to shift the mean level of risk for
the entire population (see Fig. 11.4B), or when strategies a empt to limit
variation in risk and tighten the distribution around the population mean
(see Fig. 11.4C). American society experienced the second approach to
disease prevention and health promotion when measures were taken to
promote sanitation and food and water safety in the early 20th century
and more recently when implementing policies about seat belt use,
unleaded gasoline, and vaccination.12 The second and third models (see
Fig. 11.4B and C) are common strategies for evaluating quality
improvement in the clinical se ing. The clinical informatics strategies for
assessing systems and process improvement are very useful in thinking
about the application of informatics to population health.
Social and Political Challenges That Affect Public
Health Informatics
Many aspects of public health are inherently governmental functions. As a
result, the architecture of public health reflects the constitutional structure
of the United States. The founding fathers of the United States did not
envision a need for a national-level public health system. Such a vision
was beyond the grasp of even our greatest thought leaders at the end of
the 18th century. Further, the framers of the Bill of Rights saw the need to
limit federal powers. The Tenth Amendment to the U.S. Constitution
essentially states that any powers that are not reserved for the federal
government or not prohibited for the states are in the realm of the states'
authority. Because of the limits on federal authority and the relatively late
development of a national public health infrastructure, public health laws
and functions evolved primarily as state and local government functions.
The lead government agency for public health, the CDC, was not created
until after World War II, long after the value of public health regulations
for control of contagion were recognized. While the CDC evolved into its
role as a national public health agency through its work in the 1950s and
1960s, its legislative authority is limited by the Tenth Amendment.
Congress has not mandated, nor could it require, states to cooperate with
the CDC except in situations where there is a threat to national security.
So, how does the CDC get states and local governments to work with it
toward national interests? It must use grants and contract vehicles to
persuade states to work with the national government, including sharing
of data. With respect to informatics, this means that the CDC cannot
require states to maintain specific kinds of information systems or even to
send data to the CDC. Data exchange with the federal government is
voluntary and driven by obligations and incentives that are embedded in
CDC-administered grants and contracts with the states.
An example of voluntary cooperation between the states and the federal
government is the National Notifiable Disease Surveillance System
(NNDSS). While states have all agreed to contribute data to the NNDSS to
allow the country to track infectious diseases, integration of these data is
difficult because each state is its own arbiter of the types of data it collects
for each notifiable disease and even of the types of tests and findings
considered relevant for reporting a condition. This immensely complicates
the creation of a nationwide view of the impacts of disease.
In the same way that the national government has limitations on its
authority in ma ers of public health, many state governments have similar
challenges with municipal authorities. In states that provide for local
Home Rule (Fig. 11.5), municipal governments have a broad delegation of
authority, which may include authority for public health functions. In
Home Rule states, state governments can regulate many aspects of health
through the counties. However, state governments may have less control
over city public health departments, which may adopt their own business
practices for health investigations and use information systems that differ
from those of state agencies. In general, it is large municipalities (such as
New York, Baltimore, and Los Angeles) in which local public health
officials may wield significant resources. In states without Home Rule,
public health activities within the state tend to be more centralized and
managed at the state level.
FIG 11.5 Distribution of U.S. states that allow Home Rule. (Data from
American City County Exchange. Federalism, Dillon Rule and Home Rule.
[Link]
[Link]; January 2016.)
As a result of the history and structure of public health departments,
public health authority and activity is largely a county function in the
United States, but the responsibility for planning and policy is largely at
the state and federal levels. This creates a continuing series of problems
with data standardization, data ownership, lack of willingness to share
data across levels of government, complexities with data integration, and
system planning and development. In contrast, in countries with a strong
national authority for public health issues, such as Canada, Great Britain,
or China, a single information system can be used across the country to
manage specific public health issues or even the entire public health
enterprise. In the United States, informatics solutions must allow state and
local governments to be the stewards of their own computational
resources and data.
Sociological Context of Public Health
While public health, nursing, and medicine share a similar set of facts
about disease, health, prevention, and treatment, each has a different
approach to these problems and a different worldview. The worldview of
a clinical practitioner is often patient-centric, which is reflected in the
knowledge artifacts they produce and the computer systems developed to
support their work. In contrast, public health software systems reflect the
language and worldview of population health. Systems are developed to
serve specific operational needs and, as a result, focus on one type of
public health activity or another. For example, public health departments
might use one system to track patients with sexually transmi ed diseases
and another to track patients receiving immunizations.
In public health systems, data are typically captured about one event
(disease, lead test result, immunization administered) at a time, often
without the ability to directly link reports about an individual across
different systems. The difference in the worldview of public health and the
design of public health information systems complicates the tasks
associated with sharing data across systems and, in particular, the task of
integrating clinical systems with public health systems.
A second difference in worldview concerns the sharing of information.
In many public health practice circumstances, clinical systems send data
about an individual to a public health system without incurring any direct
benefit for the patient or the healthcare provider. For example, information
about patients is included in the hospital discharge datasets sent to the
public health system, but this sharing of information does not benefit the
patient or healthcare provider directly. In contrast, data movement in the
clinical system occurs primarily for patient benefit or reimbursement. The
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
recognizes and supports these differences, but sometimes clinicians are
reluctant to share information because of their different worldview and
training.
In 2003 the CDC published the following guidance:
The Privacy Rule permits covered entities to disclose protected health
information (PHI), without authorization, to public health authorities or
other entities who are legally authorized to receive such reports for the
purpose of preventing or controlling disease, injury, or disability. This
includes the reporting of disease or injury; reporting vital events (e.g.,
births or deaths); conducting public health surveillance, investigations, or
interventions; reporting child abuse and neglect; and monitoring adverse
outcomes related to food (including dietary supplements), drugs, biological
products, and medical devices [45 CFR 164.512(b)]. Covered entities may
report adverse events related to FDA-regulated products or activities to
public agencies and private entities that are subject to FDA jurisdiction [45
CFR 164.512(b)(1)(iii)].
To protect the health of the public, public health authorities might need to
obtain information related to the individuals affected by a disease. In
certain cases, they might need to contact those affected to determine the
cause of the disease to allow for actions to prevent further illness. Also,
covered entities may, at the direction of a public health authority, disclose
protected health information to a foreign government agency that is acting
in collaboration with a public health authority [45 CFR 164.512(b)(1)(i)].13
It is the job of the public health informatician to develop tools or
methods to translate the data representations generated by the public
health and the clinical worldviews. This translation is necessary to enable
interoperability and support the various uses of the information. For
example, clinical records are usually patient centered whereas public
health may request aggregated information such as the number of
encounters for influenza-like illness during the week.
Two questions should be considered in the field of public health
informatics:
• How can information and communication technologies improve the
effectiveness of public health agencies?
• How can information and communication technologies improve the
health of the American public?
It is important to understand that there is a difference between these
questions. Improvements in population health will require addressing
both of these questions and considering the goals, breadth of data quality,
sources, needs, and the sociopolitical and governmental context in which
informatics solutions are being applied. The Public Health Informatics
Institute (PHII) has been instrumental in articulating the business
processes within public health agencies to address the first question. A list
of its resources is available at [Link].
The value of informatics for the domain
of public health
To demonstrate the value of informatics for the domain of public health, it
is useful to explore current public health methods, applications, and
processes. The descriptions will help the reader understand the value of
informatics and the challenges encountered in the real world. A single
chapter on the topic of public health informatics cannot begin to describe
the breadth of public health systems, but examples will be instructive. The
sections that follow describe surveillance as a public health method,
immunization information systems as a public health application, and
health information exchange and public health reporting as public health
processes.
Surveillance
Public health surveillance is the ongoing collection, analysis,
interpretation, and dissemination of data for a stated public health
purpose.14 The primary goal of surveillance is to provide actionable health
information to public health staff, government leaders, and the public to
guide public health policy and programs.14 Hence surveillance activities
and the information generated guide decisions and monitor progress.
These are critical for meeting all three functions required of a public health
system: assessment, policy development, and assurance. It is important to
note that surveillance is an activity that often requires partnerships with
private and public entities in the community and legislation to enforce it.
Surveillance is difficult to delegate to others in the community, so it has
generally been a public health department activity.
While new technologies, health reforms, and national security concerns
affect surveillance efforts in the 21st century, the following specific goals of
surveillance have not changed over time:
• Recognize cases or clusters of disease or injury to (1) trigger
investigations, (2) trigger interventions to prevent disease
transmission or to reduce morbidity, and (3) help ensure the adequacy
of medical diagnosis, treatment, and infection control.
• Measure trends; characterize diseases, injuries, and risk factors; and
identify high-risk population groups or geographic areas toward
which needed interventions can be targeted.
• Monitor the effectiveness of public health programs, prevention and
control measures, and intervention strategies, which includes
providing information to determine when a public health program
should be modified or discontinued.
• Develop hypotheses leading to analytic studies about risk factors for
disease and injury and disease propagation or progression.
• Provide information to the public to enable individuals to make
informed decisions regarding personal behaviors and to healthcare
providers to ensure that they base their care of individual patients on
the most current surveillance information available.14
Currently, surveillance of infectious diseases (through case reporting or
sentinel surveillance) is performed at the local level where control efforts
are localized and may be urgent. Surveillance of noninfectious events is
typically managed by state health agencies because the interventions
involved are often statewide and long term (such as cancer screening and
prevention campaigns) and there are more resources to support electronic
systems for vital records, immunization and cancer registries, newborn
screening for heritable disorders, electronic laboratory reporting, and so
forth. In addition, state agencies usually manage the hospital discharge
datasets, claims data, and other administrative data that are generated
from clinical encounters and shared with public health. State agencies
conduct surveys for the Behavioral Risk Factor Surveillance System
(BRFSS) and the Pregnancy Risk Assessment Monitoring System
(PRAMS). Finally, the CDC and other federal agencies, such as the FDA,
EPA, and the U.S. Department of Agriculture (USDA), monitor national
trends and support state activities, conduct national surveys (e.g., National
Health and Nutrition Examination Survey, National Health Interview
Survey, Bureau of Labor Statistics' annual survey of work-related injuries
and illnesses, federal tracking of coal workers' pneumoconiosis), interface
with the World Health Organization (WHO) on global health concerns,
and use data to generate research hypotheses.14
The range of events under surveillance span the causal pathway of
disease (see Fig. 11.3), including environmental exposures (e.g., folate
levels in fortified grains, fluoride levels in water, air and water quality, air
lead levels in indoor firing ranges), hazards (e.g., leaded paint in older
housing, toxic releases), behaviors and risk factors (e.g., prescription drug
abuse, smoking, cancer screening, use of sunscreen, use of helmets when
biking), exposure (e.g., needlestick injuries, newborns of mothers infected
with hepatitis B, children in households with smokers), presymptomatic
phase (e.g., blood lead levels in children), apparent disease or injury (e.g.,
persons diagnosed with hepatitis, tuberculosis, traumatic brain injury),
and death. In their blueprint for surveillance in the 21st century, public
health epidemiologists note that surveillance methods should match
surveillance goals, data should be collected in the least expensive manner
possible, and data should flow in an efficient, timely, and secure manner
as defined by local, state, and federal laws.14 High-quality data are needed
if surveillance information is to be relied on, but data quality should match
its use. Perfecting data can be costly and may not be necessary. With this
in mind, the authors of the blueprint matched purposes for surveillance
with methods commonly used (Table 11.1)14 and noted that systems
should be evaluated for efficiency and security as well as timeliness,
sensitivity, positive predictive value, simplicity, and flexibility of the
system for the level of public health agency using the data.15 In the 21st
century, surveillance systems should also be evaluated on their
sustainability and scalability to meet other needs and interoperate with
existing systems.
Table 11.1
Examples of Matching Surveillance Purposes With Methods
Purpose Method
Provide case management; notify exposed partners; provide Case reporting to local and state health departments
prophylaxis to contacts; detect outbreaks; quarantine by clinicians, healthcare facilities, and laboratories
exposed contacts; isolate cases; take regulatory actions to
prevent exposures by others; target interventions to
remediate hazards to exposed persons
Monitor common diseases for which detection of every case Sentinel surveillance (collection of detailed
is not needed (e.g., influenza, Lyme disease) information about a subset of cases) or sampling of
suspected cases for full investigation
Monitor population vital statistics Birth and death certificate reporting to states
Monitor population cancer incidence Case reporting to state health department cancer
registries by clinicians, healthcare facilities, and
pathology laboratories
Monitor prevalence of childhood vaccination rates Reporting of all childhood vaccinations by clinicians
to state immunization information systems
Monitor population prevalence of risk factors and health- Public health telephone, school-based, community,
related conditions or other self-report surveys; public health
examination surveys; analysis of de-identified
electronic health record data, hospital data, claims
data, and other clinical encounter data
Measure population levels of environmental and Public health or community and worker surveys;
occupational risk factors environmental monitoring and modeling;
biomonitoring
Monitor antibiotic resistance in communities Electronic laboratory reporting
Monitor characteristics and quality of care for health events Quality improvement registries (e.g., Paul Coverdell
and conditions (e.g., myocardial infarction, stroke, cardiac National Acute Stroke Registry)
arrest, diabetes)
Detect evidence for an unreported change in community Analysis of de-identified clinical data by public
health or track situational awareness during public health health to detect changes in population health
emergencies (syndromic surveillance)
Evaluate effectiveness of public health programs and Trend analysis of vital statistics reports, case reports,
interventions; monitor health trends in a population vaccination prevalence, clinical and billing data,
population survey data, worksite injury and death
reports, law enforcement records, special surveys
Characterize the epidemiology of specific diseases or Analysis of population data or case-based data to
injuries and develop hypotheses about and target describe disease or injury characteristics and risk
interventions toward their risk factors factors
Adapted from Smith PF, Hadler JL, Stanbury M, et al. Blueprint version 2.0: updating
public health surveillance for the 21st century. J Public Health Manag Pract 2012,
[Link] [Epub ahead of print].
To improve the timeliness with which outbreaks are detected (influenza
outbreaks in particular), informatics researchers have been testing new
signals for event detection, evaluating statistical models for finding
significant events among normal variation, and devising new strategies for
visualizing information and engaging a broader community. Table 11.2
illustrates the relationship between illness-related events and the variety of
surveillance systems that may capture those events. The quest to identify
early events must balance the potentially less predictive quality of the
information with improved opportunities to identify infections and
p pp y
outbreaks and then implement control measures to prevent further spread.
Events that occur earlier in the chain of illness-related events may be less
specific and lead to false-positive signals. The quality of the detected
signals must be evaluated before they are routinely used in public health
practice.
Table 11.2
Relevant Surveillance Systems for Illness-Related Events
CDC, Centers for disease control and prevention.
Finally, there are new opportunities to use personal health records
(PHRs) and social media to monitor indicators of health status and
a itudes and beliefs in the community. For example, researchers at
Harvard University have shown that online social networks may be an
efficient platform for bidirectional communication with and data
acquisition from populations with diseases, such as diabetes, that affect
public health.16 Unadjusted aggregate A1c levels reported by users from
the United States closely resembled aggregate levels reported in the 2007–
08 National Health and Nutrition Examination Survey (respectively, 6.9%
and 6.9%, p = 0.85).16
In a second example, researchers archived and analyzed more than 2
million Twi er posts containing keywords such as “swine flu” and
“H1N1” during the 2009 outbreak. These researchers found that user-
generated content from the participatory web and social media tools has
the potential to serve as a near-real-time source of data to trigger a public
health response and serve as a vehicle for knowledge dissemination to the
public.17 These authors believe that “infodemiology” data can be collected
and analyzed in near real time and have the potential for analysis of
queries from internet search engines to predict disease outbreaks (e.g.,
influenza); monitor people's status updates on microblogs, such as Twi er,
for syndromic surveillance; detect and quantify disparities in health
information availability; and identify and monitor public health–relevant
publications on the internet (e.g., antivaccination sites, news articles,
expert-curated outbreak reports). Such automated tools may be useful for
measuring information diffusion and knowledge translation and for
tracking the effectiveness of health marketing campaigns.18
Immunization Information Systems
Immunization information systems (IISs) are confidential, population-
based, computerized databases that record all immunization doses
administered by participating healthcare providers to persons residing
within a given geopolitical area.19 As one of the best examples of a public
health informatics application, they interact with both clinical and public
health systems, have successfully implemented vocabulary and messaging
standards, can be used to deliver public health decision support in a
clinical se ing, and provide information useful for making public health
policy and programmatic decisions. IISs are an important tool in achieving
and maintaining effective vaccination coverage levels greater than 90% for
universally recommended vaccines among young children (Box 11.2).20
IISs represent the successful blending of multiple standards (including
data, messaging, policy, interface, privacy, and so forth) managed by
multiple governing bodies (Box 11.3).
Box 11.2
Immunization Information System Objectives
• Primary objective: Reduce, eliminate, or maintain elimination of cases of
vaccine-preventable diseases.
• Sample of sub-objectives for Healthy People 2020:
• Increase the percentage of children aged 19 to 35 months who receive
the recommended doses of DTaP, polio, MMR, Hib, hepatitis B,
varicella, and pneumococcal conjugate vaccine (PCV). (Baseline: 44%
of children aged 19 to 35 months in 2009 received the recommended
doses of DTaP, polio, MMR, Hib, hepatitis B, varicella, and PCV;
Target: 80%)
• Maintain the vaccination coverage level of 2 doses of measles-mumps-
rubella (MMR) vaccine for children in kindergarten (Baseline: 95% of
children enrolled in kindergarten for the 2009–10 school year received
2 or more doses of MMR vaccine; Target: 95%)
• Increase the percentage of adults aged 18 and older who are
vaccinated annually against seasonal influenza (Baseline: 38% of
adults aged 18 years and older were vaccinated against influenza
during the 2010–11 influenza season; Target: 70%)
From The US Department of Health and Human Services. Immunization and Infectious Diseases.
h p://[Link]/2020/topicsobjectives2020/[Link]?topicid=23.
Box 11.3
Sample Immunization Information System
Standards and Guidelines and the Relevant
Governing Body
• Core Data Elements: National Vaccine Advisory Commi ee
• ISS Functional Standards 2013–17: Immunization Information Systems
Support Branch, CDC/NCIRD
• IIS Operational Best Practice Guidelines: American Immunization
Registry Association
• Implementation Guide for Immunization Messaging: HL7 version 2.5.1:
CDC Immunization Information Systems Support Branch
• HL7 Standard Code Set (CVX—Vaccines Administered): CDC's National
Center of Immunization and Respiratory Diseases
CDC, Centers for disease control and prevention; NCIRD, National
Center for Immunization and Respiratory Diseases; HL7, health level
seven; IIS, immunization information system.
From Centers for Disease Control and Prevention (CDC). IIS web resources. CDC.
h p://[Link]/vaccines/programs/iis/resources-refs/[Link]; 2012.
IISs are in routine use throughout the United States. In 2008, 75% of
children under 6 years of age had two or more immunizations recorded in
a fully operational, population-based IIS (see Objective IID-18).20 The
Healthy People goal is to reach 95% by 2020 because vaccines are among
the most cost-effective clinical preventive services.20 Childhood
immunization programs provide a very high return on investment. For
example, for each birth cohort vaccinated with the routine immunization
schedule21 (this includes DTap, Td, Hib, polio, MMR, Hep B, and varicella
vaccines), society saves 33,000 lives, prevents 14 million cases of disease,
reduces direct healthcare costs by $9.9 billion, and saves $33.4 billion in
indirect costs.20
At the point of clinical care, an IIS can provide consolidated
immunization histories for use by a vaccination provider in determining
appropriate client vaccinations.19 When children receive vaccines in a
variety of clinical se ings, which is common, missing records can lead to
repeated vaccinations (overimmunization) and added costs. In addition,
an IIS can evaluate the consolidated record and provide recommendations
based on the immunization schedules published and updated annually by
the CDC.19 Since the vaccine schedules are updated every year, analysts
must access the CDC website to view the most current vaccine schedules
and assess their structure and complexity for implementation in a decision
support application. The schedules represent rule-based logic that may
initially appear simple because it is primarily based on age. However, the
schedule quickly becomes more complicated when one reads the
footnotes, considers the required time lapse between vaccine doses, and
determines whether a different schedule is required if a child or adult is
overdue and needs “catch-up” vaccines. Embedded decision support can
determine the vaccines due today and forecast the vaccines required in the
future to help in scheduling appointments.
At the population level, an IIS provides aggregate data about
vaccinations that are useful for surveillance and program operations and
can guide public health actions to improve vaccination rates and reduce
vaccine-preventable disease.19 An IIS can also provide information for
health plans and healthcare providers that need to track and report quality
measures, such as the HEDIS measures.22 Finally, IISs have provided
previously unrealized critical functionality in public health emergencies.
For example, only days after Hurricane Katrina in September 2005, the
Houston-Harris County Immunization Registry was connected to the
Louisiana Immunization Network for Kids Statewide, which provided
immediate access to the immunization records of children forced to
evacuate the New Orleans, Louisiana, area.23 One year later, more than
18,900 immunization records were found by persons querying the system,
representing avoided vaccinations.23 The researchers estimated a cost
savings of more than $1.6 million for vaccine alone and $3.04 million for
vaccine plus administration fees.23 Similarly, during a recent measles
outbreak, the registry was instrumental in helping to prioritize contact
tracing efforts. Named contacts with no measles vaccination information in
the registry could be prioritized for intensive phone calling efforts to
ensure that appropriate control measures were implemented.
Health Information Exchange
To succeed in its mission and carry out core functions, public health
entities rely on data and partnerships with healthcare and other se ings in
a community. Health information exchange (HIE) initiatives and
organizations provide an infrastructure to improve the required
communication between public health and community partners. In the
past, the primary aim of an HIE was to bring unavailable clinical data from
patients' disparate health records to the point of care where clinicians and
their patients need it most. The motivation for exchanging health data has
been to create a complete health record to address safety and quality
concerns, gain efficiencies, reduce duplication of effort and control costs,
notify participants about problems and potential drug seekers, and
perform research. Box 11.4 includes HIE applications for achieving these
public health benefits. When public health agencies participate in an HIE,
they can both provide and receive value from their participation. Public
health benefits from participating in an HIE include the following
additional benefits:
Box 11.4
Potential Health Information Exchange
Applications for Use in Public Health
• Mandated reporting of lab findings
• Nonmandatory reporting of lab data
• Mandated reporting of physician diagnoses
• Nonmandatory reporting of clinical data
• Public health investigation
• Clinical care in public health clinics
• Population-level quality monitoring
• Mass casualty events
• Disaster medical response
• Public health alerting: patient level
• Public health alerting: population level
Adapted from Shapiro JS, Mostashari F, Hripcsak G, Soulakis N, Kuperman G. Using health
information exchange to improve public health. Am J Public Health. 2011:101(4):616-623.
• More timely and complete receipt of disease reports.
• Faster transmission of be er information to public health case
managers (for communicable disease control, newborn screening
follow-up).
• Easier identification and analysis of gaps in preventive health services
(immunization, Papanicolaou smears) and of pa erns that could
improve performance.
• Easier identification and analysis of follow-up failures (treatment of
sexually transmi ed diseases, environmental evaluation of lead
poisoning) and of pa erns that could improve performance.
• Analysis and display of geographic distribution of illness or injury to
focus public health interventions or services.
• Analysis and display of the temporal and geographic epidemic
spread.
• Improved ability to communicate with selected healthcare provider
and patient populations.24
Public health also provides value to HIE partners.24,25 Public health can
provide patient information (e.g., immunization records, newborn
screening results, tuberculosis clinical findings, child health clinic records)
and epidemiologic information to improve diagnosis (e.g., distribution
and incidence of Lyme disease to improve a clinician's estimation of
pretest probability). A public health agency may serve as a trusted neutral
party for confidential health information or may maintain a community
master person index that can support the HIE using identifiers generated
by healthcare organizations, birth records, and other sources.26 Public
health involvement in an HIE can reduce the cost and labor of reporting.
Finally, public health can provide personalized patient care information
available in the community and alert healthcare providers to urgent
community health issues.
Public Health Reporting
In the United States, public health reporting to perform surveillance and
implement control measures has been going on since the 18th century
when tavern owners were asked to report persons with illness to a local
board of health. Today, public health reporting to recognize and control
communicable disease in a community is a quintessential public health
activity. The rules concerning the diseases that should be reported and the
actions to take if reporting is necessary vary among the 50 states, may vary
among cities or counties within a state, may vary by disease, and
sometimes vary by reporting entity (i.e., whether the reporter is a
laboratory or a clinician) and other factors. As shown in Fig. 11.6, a local
health department is often the agency responsible for (1) receiving reports
from laboratories, clinicians, hospitals, and other reporters (e.g., schools,
daycare centers); (2) investigating the situation; and (3) implementing
control measures. Information gathered during the investigation informs
the public health response and helps establish whether to count the event
for surveillance purposes.
FIG 11.6 Overview of the current public health reporting process.
Copyright 2010 Catherine States. Reprinted with permission.
Local and state agencies may share a single web-based system or the
two levels of governmental public health may have separate systems.
Either way, more data are collected during an investigation than are
needed for “notification” from the local to state health department. The
information shared is often summary information ascertained after
completing the investigation. Depending on the information available
from the completed investigation, a disease report may be classified as a
“confirmed” or a “probable” case, for example. This classification is used
when summarizing surveillance data to consistently report similar events
over time while still quantifying the unconfirmed but relevant events.
The information used by the state health department for surveillance is a
subset of the information gathered during an investigation. When
information is sent to the CDC as a “notifiable report,” the record is de-
identified and filtered again to include only the data needed for national
surveillance. Finally, the set of conditions included in the NNDSS is not
reported in every local and state jurisdiction and does not include all
conditions reported everywhere.27
There are many complexities associated with the detailed processes of
public health reporting but the high-level process shown in Fig. 11.7
illustrates a set of activities that is commonly carried out across the United
States. Informatics solutions may be applied to each step in the process.
For example, the first step in public health reporting concerns the
publishing of reporting criteria (e.g., specifications). Currently, the
guidance and regulations that laboratories and other reporters need to
follow are described on websites and posters, and can often be found by
using search terms such as “communicable disease reporting regulations
for [state A or city B].” The information cannot be processed by electronic
systems; it changes periodically, especially during an outbreak; and it
differs among states and between states and the CDC. Case reporters must
interpret the criteria expected and maintain the reporting criteria in their
systems. This situation could be improved using knowledge management
strategies that allow public health authorities to author structured content
and disseminate the laboratory and clinical reporting specifications in both
a human-readable format and a structured format for use by automated
laboratory and clinical systems. This strategy is being employed using the
Reportable Condition Knowledge Management System (RCKMS), which is
under development by the Council of State and Territorial Epidemiologists
(CSTE).28
FIG 11.7 Process of public health case health reporting. Copyright
2010 Catherine States. Reprinted with permission.
Several factors make it difficult for clinicians, laboratories, and others to
identify reportable conditions. Underreporting is common when manual
processes are involved and reporting relies on clinicians to remember to
report.29 Studies have shown a lack of knowledge among clinicians about
reporting requirements.30 In addition, even as the use of detection logic is
becoming more common in laboratory and clinical systems, the sensitivity
and specificity of logic can vary by reportable condition. For example, a
single lab test result is sufficient for detecting chlamydia, a clinical
diagnosis is required for identifying culture-negative tuberculosis or
suspected measles, and a combination of laboratory and clinical findings is
required to identify chronic hepatitis B infection.31 There are informatics
opportunities for defining and publishing detection logic (including codes
such as International Classification of Diseases 10 [ICD-10], Logical
Observation Identifiers Names and Codes [LOINC], and Systematized
Nomenclature of Medicine-Clinical Terms [SNOMED-CT]) and using
surrogate markers for reportable events, such as administration of
hepatitis B immune globulin to a newborn as an indicator of an infected
mother.
Challenges in the process of reporting a case or lab result to public
health agencies result in delayed reporting, inefficient data gathering with
incomplete reports, variable data collection, and nonstandard formats
used to transfer the information (e.g., fax, phone, email, mail, web forms,
electronic laboratory reports). Some of these challenges are being
addressed by increased use of electronic health records (EHRs),
Meaningful Use incentives, and Health Level Seven (HL7) standards.
While these factors improve the capabilities for the sender, there are also
challenges on the receiving end of the transaction. Health departments
must receive, sort, filter, deduplicate, and consolidate information that
arrives “at their doorstep” via fax, phone, online web forms, and electronic
messaging systems and from records routed from their state or other local
health department colleagues using statewide electronic disease
surveillance systems. Health departments often manage a large volume of
reports using manual processes.
For example, in an observational study of workflow in a local health
department, 3454 reportable conditions were manually entered into an
electronic data system during an 18-month period of time.32 In a
prospective evaluation of the information being received, 18% of the
reports were for other counties, 3% were not reportable, 16% were
duplicates, and 18% were updates on previously reported cases.32
Personnel resources are used to manage all of the paper arriving to find
the new, relevant information among all incoming paper.
In an ideal world, a health department would receive complete
information in a timely manner only once and updates and duplicates
would be managed automatically. There are numerous informatics
opportunities to do the following:
• Enable the use of specifications (computable logic) to define where
and how reports should be sent, the urgency of reporting, and the
information to include in a report.
• Automate information extraction of additional information in the
EHR.
• Improve standardization of message structure and content.
• Enable secure information exchange.
• Create public health information systems to receive case reports and
allow access by local and state public health entities.
Systems are being built to receive laboratory reports, but this is only part
of the information required to manage persons with communicable
diseases in municipalities, counties, and states.
The processes associated with performing an investigation and
implementing control measures (such as excluding a person with
salmonella from food service or daycare or vaccinating contacts of a
person with meningitis) can be complex. Decisions must be made on
incomplete and evolving information, and guidelines are often
ambiguous. The situation could be improved by
• Automated linkage between clinical and electronic lab reports with
information concerning updated or redundant reports
• Improved quality of the information in a report (e.g., include
additional associated lab findings needed for investigation)
• Improved tools to explore the existing information33
• Decision support tools that improve the management of new
information and apply guidelines
The processes associated with aggregating information across
jurisdictions and sharing subsets of information with a higher authority
could be addressed using new strategies. Currently, aggregation occurs by
copying information and sending it up the chain. However, “central”
aggregation is defined differently among different stakeholders and does
not adequately support sudden unanticipated needs. Currently, ad hoc
queries must be initiated or informal communication and data aggregation
may be required. A goal for future systems should be the ability to
perform dynamic aggregation across jurisdictions and to access complete
data in their native environments, with appropriate permissions (Fig.
11.8). In addition, future systems should allow surveillance data to be
more accessible to healthcare systems and the community for decision
support in near real time.
FIG 11.8 An example of dynamic aggregation across local health
departments (LHDs) and state and national departments of health.
Copyright 2010 Catherine States. Reprinted with permission.
In summary, case reporting and management will benefit from
computable knowledge managed and served by public health authorities
about what, how, where, and when to report; automated event detection;
electronic, standardized information exchange; improved systems for
receiving and integrating case reports; and the ability to access disparate
systems with appropriate permissions to dynamically aggregate data
across jurisdictions and respond to new situations, data, and priorities.
Conclusions and future public health
informatics strategies
Transforming Practice With New Strategies
As discussed in this chapter, public health IT reflects the division of
authority for population health between national, state, and local
governments. In the past, this division was less important because records
systems were largely paper based. Each department could have its own
approach to information management and the departments to which it
reported or with which it shared information had to manually convert
information from one format to another. Given the complexities of data
collection in the past, public health practitioners focused on information
gathering to ensure the validity of the information supply chain for its
own program. There was no way to reuse data across programs and it was
not deemed highly important since the costs of reuse were almost as high
as the costs of primary data collection and the validity of “reused” data
could not be assured.
As public health practice moves into the future, the concept of the
information supply chain needs to evolve toward an alternative model: an
information ecology. Public health departments will receive, from a
variety of sources, data that are repurposed for population health uses.
Electronic data elements collected for one purpose (as part of one
information supply chain) will be linked with other data to create an
integrated environment. The old paradigm of public health programs
se ing up systems that measured specific factors, with primary data
collection for surveillance, will be replaced by systems that generate
healthcare, environmental, and commerce data that are relevant to public
health. Perhaps the biggest change for public health is the idea that public
health systems need to “give to get.” In the past, federal, state, and local
governments used legislative authority to mandate reporting to public
health. Over the past few years, the government has increased efforts to
implement syndromic surveillance by incentivizing healthcare providers
to report emergency room data and other data to public health
departments through the Meaningful Use regulatory process.34 Efforts to
require transmission of these data are controversial for both hospitals and
provider organizations because of the cost involved and the lack of return
for their efforts.
In the future, public health departments will need to partner with other
data producers, add value to the data received, and republish those data to
contribute to the local information ecology. An example of this approach
concerns public health alerting in EHRs. Working with GE Healthcare, the
CDC demonstrated an alternative approach based on a web services
model that integrates syndromic surveillance in clinical workflows using
decision support.35 When a clinician sees a patient with a new complaint,
he or she considers the following question: “Could this patient's
symptoms be caused by an infectious disease?” Public health departments
might answer this question by publishing “disease weather maps” for
their local regions that clinicians could consult.36 This type of decision
support, whereby community-level information is summarized and
displayed, is important but insufficient. Work can go further to create an
interdependent system.
What would be most useful to clinicians is an individual specific
interpretation of the current “epidemiologic weather.” How could this be
obtained? What if, instead of merely sending data to local public health
departments when required, information systems could harness the power
of computerized knowledge systems to highlight pa erns of data
indicative of the types of symptoms a patient might be experiencing to
assist the practitioner in determining whether they match the pa ern of a
known public health problem? At the public health department, data
would be stored to track the nature of symptoms in a community and the
individual data would be matched to public health alerts in the region. If
the symptoms are consistent with a known problem, the sending electronic
records system might receive an alert from the public health system
through secure messaging processes, informing the clinician that the
patient may be part of a public health outbreak. This type of cycle defines
information ecology: the public health department integrates with clinical
care and provides interpretations of data generated by and sent from
healthcare providers, which justifies the provider's costs of extraction and
transmission of information.
In addition to increasing access to data from healthcare systems, the
public health system has the opportunity to use data from an increasingly
connected environment to measure and affect health in the community.
Mobile devices with global positioning system (GPS) locators are tools for
people to find their way, but could also be tools for governments to assess
how active their citizens are in daily life. Do the regulations that try to
make neighborhoods more walkable result in more people walking? In the
past, observers would use clipboards and might sample streets or survey
persons about how often they walk. But now a more efficient and accurate
method for determining whether people are walking might be to see how
many phones are moving around the community at walking speeds.
Walkability might be defined by the pa erns in which the phones move.
Cellular phone companies have these data and they sell them for
commercial use. Legislators and other policy makers need to consider how
private business can be incentivized (or regulated) to provide this type of
information to public health.
Similarly, in the past, understanding dietary pa erns of a community
has required extensive in-person or mail surveys to ascertain food
consumption. These methods are expensive and time consuming and limit
the use of such data for public health purposes. An alternative approach
that uses existing sources of data to inform population dietary habits
would be to analyze shoppers' purchasing habits. Many stores use
shopper cards to track purchasing decisions and behaviors. These same
data could be used by public health officials to monitor consumption of
fresh fruits and vegetables, salt, and sodas and to identify other dietary
needs and risks. The use of such data raises many privacy issues at an
individual level.
However, public health operations may not always need individual-
level data. Many policy issues could be addressed by geocoding the data
and anonymizing data clustering at a home or work location. If one can
understand that a particular neighborhood is a “hot spot” for sugary
beverage use or salt intake, then targeted efforts can be made to work
within the community to change the community's values and habits to
promote health. As described earlier, the population perspective assumes
that individuals have levels of risk that are reflected in their community.
Disease prevention strategies focused on a community do not require that
public health officials know that Mrs. Jones drinks too much soda. Public
health officials need to know where to conduct an education campaign in
schools to reverse trends of students who often prefer sugared beverages
over healthier ones.
Advancing the Technical Infrastructure
The future of public health requires new advanced information
technologies and infrastructures. However, public health departments,
particularly local health departments, are resource-challenged
environments. Departments often do not have the IT resources to take on
new initiatives to connect themselves to clinical care systems or other
sources of data, such as schools or occupational health entities that could
provide the value-added capabilities discussed above. State governments
may provide funding for IT, but it may be only for specific programs to
capture very limited data. Likewise, federal public health programs
provide their less-funded state colleagues with task-specific IT. While the
availability of such technology might provide secondary benefits to local
and state public health departments, the funding typically comes with
contractual requirements that prevent technology resources from being
used for other tasks. How can this problem be addressed and resolved?
How can there be a future for public health informatics if resources are a
continuing problem?
The CDC's first effort at helping the public health community to
coordinate information management technologies was the Public Health
Information Network (PHIN). This program proposed a set of
communication and vocabulary standards for public health software
designed to promote interoperability and support reuse of information.
The PHIN program had a number of elements, including a standardized
vocabulary based on the HL7 version 3.0 Reference Information Model
(HL7 v3 RIM), solutions for composing value sets of standard codes for
applications, an interoperability solution for transforming messages from
one vocabulary to another, and a message transport solution called the
Public Health Information Network Messaging System (PHIN-MS) for
securely sending data from one public health department to another.37 The
success of the PHIN program was limited, except with regard to its
transport solution, which was widely adopted. In general, the advantages
of adopting one set of standards for vocabulary for public health systems
were offset by the costs of implementation and the lack of fit between the
HL7 v3 RIM vocabulary model and public health workflows. Public health
departments found it easier and cheaper to continue to use their existing
information management tools than to develop new tools based on the
CDC standards or to convert existing tools to those specifications. PHIN
continues to evolve as a program.38 However, the question of whether a
standards-based approach alone can achieve the ends of interoperability at
a reduced cost remains open.
Standards are critical, but by themselves may not be adequate to
provide the level of support needed to advance public health informatics.
A flawed environment for acquiring systems results in agencies
duplicating each other's efforts to develop and implement systems.
Jurisdictions often implement proprietary, stand-alone systems that
preclude data exchange, which is fundamentally important for
surveillance and two-way communication. An alternative to individual
jurisdictions creating the specifications for and purchasing software on
their own, with inherent inefficiencies, may be the use of open source and
collaborative development methods. Collaborative development can take
many forms. In a project funded by the Robert Wood Johnson Foundation,
a group of state laboratories at state public health departments
collaborated to develop a set of shared business process specifications for a
laboratory information system.39 These shared specifications were then
used to guide shared open source development of a laboratory
information system, where different jurisdictions assumed responsibility
for different modules of the final product. This same group went on to
work collaboratively to develop its own information exchange solutions
and worked as a group to modify the CDC's PHIN-MS software to support
routing hubs (PHIN-MS was initially designed to support only point-to-
point communications).
A service-oriented architecture (SOA), explained in Chapter 5, and open
source methods may be useful in shared development. If a set of standard
functions based on an enterprise architecture view can be developed to
support public health applications, then these components could be reused
to support a wide variety of additional public health applications. This
concept is the foundation of the “service-oriented” systems approach. A
critical issue is developing a set of modular programs designed to work
together. These might include data transport tools like PHIN-MS,
interoperability engines, standardized vocabularies, databases, master
person indexes, and other critical components. Importantly, this set of
components should be open source software that is available to potential
developers at low or no cost. In an open source environment, public health
departments with significant capabilities for developing software can
work together to advance the field as a whole.
Currently the goal of many vendors of public health information
systems (and other software systems as well) is to a empt to lock
departments into proprietary systems, guaranteeing future revenue
streams. Open source methodologies can help to prevent this situation.
Some examples of successful open source software systems are40
• The community version of the TriSano case management application;
• OpenELIS, which is the public health laboratory information system
described above; and
• OpenMRS, an enterprise-level medical records application that is
widely used in Africa for public health applications.
Many public health departments, particularly local ones, have no
significant capabilities to develop IT and typically lack the resources to
hire vendors to support development or customization efforts. One
approach to this lack of capability may be to move public health systems
to the “cloud.” As explained in Chapter 5, cloud computing systems
migrate the location of software to a remote site where resources can be
shared by different users. Examples of cloud-based software systems
include [Link], Facebook, and other web applications. These
applications operate as software as a service (SaaS), where the developer
a empts to present an integrated single application or a tightly integrated
suite of applications.41 BioSense 2.042 is an example of a SaaS application
for public health. In this application, each state can receive, parse, store,
and analyze data streams from the EHR systems in hospital emergency
departments, as required by the government's Meaningful Use program.
Without this service, each state develops its own infrastructure to receive
emergency department data. BioSense 2.0 allows states to rapidly develop
procedures and use data sent in a prescribed format from the healthcare
system, without the requirement to create their own infrastructure to
manage the information. The system also allows states to share data across
jurisdictions when necessary. For example, when a Super Bowl game
draws large numbers of fans from cities in one region of the country to
another, this creates a need to link emergency room data from those cities
to detect outbreaks that may occur after the event, when people have
returned home.
The approach to computing that may be the most relevant to public
health is platform as a service (PaaS).43 PaaS architecture is based on
virtualization of an entire computer operating system. For example, a PaaS
system might allow a user to access a functional “PC” (entire version of
the latest version of Windows, for example) on a remote computer. This
“PC” might have the entire library of relevant and most up-to-date public
health programs on it. PaaS architecture would allow each public health
department to select the applications it deems most relevant to its own
workflows. These programs should draw on a public health SOA that
would facilitate the creation of new public health applications.
Applications could share databases and services for transforming and
managing data. Because the operating system for each PC is identical, the
task of configuring and managing software would be greatly simplified. A
suite of applications could be created based on off-the-shelf components
that work well together and public health departments could access and
use this suite from any location with high-speed internet service.
Moreover, the task of interoperability between users and jurisdictions
would become greatly simplified as the network se ings and application
configurations would be known and standardized. Importantly, the
degree of standardization afforded by PaaS architecture might help to
create a market for public health applications that would rapidly foster
improvement and expansion through competition among vendors. Lenert
and Sundwall provide further discussion of issues related to the market
and to SaaS versus PaaS systems for public health.43
Another future direction for public health informatics includes the
integration of community-based information into EHRs or other aggregate
databases. For example, Bazemore and colleagues recommend including
community social, economic, occupational, and environmental factors that
influence population health.44 These factors are termed “community vital
signs,” and data are available from sources such as the U.S. Census
surveys. Integrating these data would provide context-informed care in
the future.
In conclusion, this chapter described the importance and unique
features of public health practice and differentiated public health practice
from clinical practice. The social, technical, and political challenges of
public health and public health informatics were highlighted. The value of
informatics tools in supporting public health's unique needs and mission
was highlighted, and existing systems were reviewed. Current major
public health informatics applications, such as surveillance and IIS, were
described. The supporting workflows associated with these systems and
the value of the IT, decision support, and standards that are necessary to
make the systems work were reviewed along with the strengths and
challenges associated with developing an information ecology. This
chapter then reviewed the future strategies underpinning the public health
information infrastructure. Increasing use of EHRs, standards to improve
information exchange, social networking tools, and cloud-based and
mobile computing methods will transform the way that public health
accesses and uses information to improve the health of populations.
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Discussion questions
1. How might you begin to develop a data and information exchange
between acute care, subacute care, and home health se ings that would
support the work of public health? Do such systems already exist?
2. Monitoring population health status is a central public health activity. A
variety of survey systems, such as the CDC's National Health and
Nutrition Examination Survey (NHANES) and National Health
Interview Survey (NHIS), as well as state and national reporting
systems, such as the Behavioral Risk Factor Surveillance System
(BRFSS), Pregnancy Risk Assessment Monitoring System (PRAMS), and
National Electronic Disease Surveillance System (NEDSS), provide
public health practitioners with the ability to assess health trends,
identify and respond to emerging health hazards, and guide
development of interventions and policies that address serious health
conditions such as obesity, smoking, and diabetes. With the proliferation
of EHRs within acute and ambulatory care systems, how much of this
survey activity do you think can be folded in under routine data
collection and exchange activities?
3. The primary goal of public health is to affect population health and
ensure a healthy community. How might you see public health nurses
using web-based tools to reach, manage, and educate populations of
patients residing in targeted communities?
4. Part of the job of the public health informatician is to develop the tools
required to translate between clinical and public health worldviews as
they relate to information system development and data sharing across
the specialties. As a clinical leader, by what means would you advocate
to enable this sharing?
5. Personal health records are technological tools that are being
implemented within the acute care se ing to enable data exchange with
EHRs and to encourage patient activation in healthcare. How might you
foresee the use of patient-entered data from a PHR or patient portal as a
public health surveillance tool?
Case study
You have been hired as an informatician at a state health department. The
health department is developing systems to receive laboratory and clinical
case reports from clinical se ings, such as hospitals and doctor's offices.
Your state has had an immunization registry in operation for several years
and has been successful in ge ing cooperation from healthcare se ings to
send data to the system.
Discussion Questions
1. Why is the system for reporting immunizations and receiving results
at the health department so successful, particularly in comparison to
the struggles you are observing as the health department sets up its
laboratory and case reporting systems?
2. What is the difference between the information required to report the
administration of an immunization and the information required to
report a person with a communicable disease?
3. What standard vocabulary is used to code a vaccine name and how is
this vocabulary different from the LOINC or SNOMED-CT
vocabularies required for laboratory and clinical case reporting?
4. What is the value proposition for a healthcare provider to participate
in an immunization registry?
UNIT 3
Participatory Healthcare
Informatics
12
The Engaged ePatient
Sally Okun; Christine A. Caligtan
Abstract
The term ePatient was coined long before the advent of the internet to describe
patients who take an active role in their health and healthcare by being equipped,
enabled, empowered, and engaged. Today, ePatients connect electronically to a vast
array of digital health information and resources, such as traditional chat rooms,
support sites, health-related social media, patient-to-patient research-based social
networks, mobile devices, and wearable sensors. ePatients understand the value of
engaging in a collaborative partnership with their healthcare providers and view the
integration of participatory healthcare across the U.S. healthcare system as essential.
The ePatient is and will continue to be a pivotal force in accelerating the healthcare
system’s adaptation to the ever-evolving world of technology, information
management, and communication.
The ePatient is and will continue to be a pivotal force in accelerating the
healthcare system’s adaptation to the ever-evolving world of technology,
information management, and communication.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. List at least three “e” terms used to describe ePatients.
2. Explain the driving forces behind the emergence and continuing
evolution of the ePatient movement.
3. Discuss the characteristics of digital healthcare consumers.
4. Describe how the quantified self uses health-related data.
5. Analyze the implications of ePatients for clinical practice.
6. Identify technological innovations likely to be used in routine practice
by clinicians in the future when caring for patients.
KEY TERMS
citizen science 215
Connected Health 207
crowdsourcing 212
Digital Health 207
eHealth 205
ePatient 205
ePatient movement 205
Guided Discovery 211
Health 1.0 207
Health 2.0 207
Health 3.0 207
Medicine 2.0 207
P4 Medicine 215
participatory healthcare 210
participatory medicine 210
patient-generated health data (PGHD) 212
quantified self 209
virtual communities 214
wearables 207
Web 2.0 207
Web 3.0 207
Historical background and drivers of the
epatient evolution
ePatient as a Pioneering Concept
As early as the 1960s clinical researchers1 used emerging technology to test
computer-based patient-driven medical interviews. Slack’s philosophical
view of “patient power” coupled with his belief that computers had a
place in medical practice were controversial at the time. Often asked, “Will
your computer replace the doctor?” Slack’s response was as true then as it
is today: “Any doctor who can be replaced by a computer deserves to be”
(p. S135).2 Empowering patients with innovative tools is about fostering
effective partnerships with their healthcare providers that lead to be er
outcomes. Empowering consumers with innovative health and wellness
tracking tools is about giving individuals the opportunity to lead more
proactive and fulfilling lives.3
The use of the term ePatient predates the availability of online medical
resources. In 1975 another pioneering physician, author, and researcher,
Thomas Ferguson, was interested in the empowered health consumer.
Ferguson coined the term ePatient and characterized ePatients as people
who are equipped, enabled, empowered, and engaged in decisions about
their health and healthcare.4 By the early 1990s, with the rapid emergence
of personal computers and the World Wide Web, Ferguson recognized the
power and potential for consumer use of online health resources. In
Looking Ahead: Online Health & the Search for Sustainable Healthcare,
Ferguson wrote:
The 21st Century will be the Age of the Net-empowered epatient, and …
the health resources of today will evolve into even more robust and
capable medical guidance systems which will allow growing numbers of
epatients to play an increasingly important role in medical care. Online
patients will increasingly manage their own healthcare and will contribute
to the care of others. Medical professionals will increasingly be called upon
to serve as coaches, supporters, and coordinators of self-managed care.5
Ferguson’s work is largely seen as the impetus of the ePatient
movement and his early observations, ideas, and recommendations
continue to resonate. Today an ePatient is characterized as one who uses
technology to actively partake in his or her healthcare and manages the
responsibility for his or her own health and wellness.6 ePatients are
digitally enabled, seeking information, sharing their knowledge, and
connecting with others. An ePatient manages health decisions on a daily
basis and uses the internet and digital devices to supplement his or her
health journey. The collection of data and knowledge from these sources
helps to organize and support ePatients with contextual information and
medical vocabulary necessary to converse with their healthcare providers.
The first evolutionary phase of the connected ePatient movement
occurred as access to health information and health-related services
became increasingly available through electronic means. By late 1999 the
term eHealth emerged in the lexicon as a way to describe electronic
communication and information technology (IT) related to health
information and processes accessible through online means.7
In 2001, eHealth was described as “the use of emerging information and
communication technology, especially the internet, to improve or enable
health and health care” (p. 8).8 Conceptually, the term eHealth was
considered a bridge for both the clinical and the nonclinical sectors capable
of supporting health-related tools for individuals and populations. For this
potential to be fully realized, Eng believed that eHealth initiatives require
integrated information systems that use common data elements and
infrastructure standards that can serve multiple stakeholders, more
commonly known now as interoperability. The implications of
interoperability are more fully discussed in Chapters 5 and 22.
The term eHealth remains a broad concept used to describe internet or
web-based activities that relate to healthcare, yet no consensus about the
definition exists among researchers, policy-makers, clinicians, or patients.9
Pagliaro et al. identified 36 different definitions of eHealth in publications
and internet sources.10 In the final analysis they felt that the definition put
forth by Eng, augmented by Eysenbach’s definition, appropriately
represented eHealth and captured the fluid nature of emergence as a
defining characteristic.11 Eysenbach defined eHealth as:
…an emerging field of medical informatics, referring to the organization
and delivery of health services and information using the internet and
related technologies. In a broader sense, the term characterizes not only a
technical development, but also a new way of working, an attitude, and a
commitment for networked global thinking, to improve healthcare locally,
regionally, and worldwide by using information and communication
technology.11
In addition to viewing eHealth as the delivery of health information to
health professionals and consumers via the internet and
telecommunications, the World Health Organization includes harnessing
the power of the internet and e-commerce to improve public health
services and business practices within healthcare.12
Our Connected World
This transformation must be considered in the context of the emergence of
massive amounts of information on the World Wide Web, connected via
the internet. Traversing the 20th and 21st centuries, the proliferation in the
use of the internet has had an unprecedented impact on access to
information, sharing, and connectedness; moreover, it has been a driving
force in the emergence of the 21st-century consumer.
Just as growth in the number of individuals using online resources is
assured, disparities between internet access “haves” and “have-nots” exist
in large part due to cost, literacy, computer skills, language, and
education. For some, the lack of access is intentional. It is a conscious
decision not to use the internet. Nonetheless, the volume of internet users
is staggering. In 1995 there were an estimated 16 million users. By 1998,
when the search engine Google was launched, there were 147 million
users. In 2001, only a decade after the graphic browser was conceived, 500
million users were online. By 2015 the number of global internet users
surpassed 3 billion (Fig. 12.1).13 A report by Ericsson, a global
communications technology company, suggests that by 2021 there will be
6.3 billion people with smartphone subscriptions. The digital divide will
continue to narrow as technology companies expand free and low-cost
broadband access to those traditionally underserved.14 A partnership led
by Facebook and [Link], is working to bring access to every person
on earth, beginning with millions of people in sub-Saharan Africa via
satellite.15
FIG 12.1 Global digital snapshot. Data from We Are Social's Compendium of
Global Digital Statistics 2015. Copyright 2015 We Are Social.
The emergence of the internet as a valuable tool for health and
healthcare became be er understood at the turn of the century. In The
Future of the Internet in Health Care: Five-Year Forecast, Mi man and Cain
declared, “Health care has discovered the internet and the internet has
discovered health care!” (p. 1).16 Between 1999 and 2001 the Institute of
Medicine (IOM) issued two reports published by the Commi ee on the
Quality of Health Care in America that shed light on significant safety and
quality issues related to health and healthcare in the United States. These
reports continue to influence the emergence of a learning health system
that is more patient-centric. Patients and those close to them are being
included as integral members of the healthcare team, and technology is
highlighted as a critical component for improving safety and quality. The
IOM report, titled Crossing the Quality Chasm: A New Health System for the
21st Century, focused a ention more broadly on the multiple dimensions
of quality and safety concerns in need of fundamental change across the
U.S. healthcare system.17 To narrow the quality chasm, the report offered
six specific areas that represent what healthcare ought to be for all
Americans. Healthcare should be safe, effective, patient centered, timely,
efficient, and equitable. In addition, the report provided “ten simple rules
for the 21st century health care system” that describe what patients should
expect from their healthcare (Box 12.1).
Box 12.1
What Patients Should Expect From Their
Healthcare
1. Beyond patient visits: You will have the care you need when you need it
… whenever you need it. You will find help in many forms, not just in
face-to-face visits. You will find help on the Internet, on the telephone,
from many sources, by many routes, in the form you want it.
2. Individualization: You will be known and respected as an individual.
Your choices and preferences will be sought and honored. The usual
system of care will meet most of your needs. When your needs are
special, the care will adapt to meet you on your own terms.
3. Control: The care system will take control only if and when you freely
give permission.
4. Information: You can know what you wish to know, when you wish to
know it. Your medical record is yours to keep, to read, and to
understand. The rule is: “Nothing about you without you.”
5. Science: You will have care based on the best available scientific
knowledge. The system promises you excellence as its standard. Your
care will not vary illogically from doctor to doctor or from place to
place. The system will promise you all the care that can help you, and
will help you avoid care that cannot help you.
6. Safety: Errors in care will not harm you. You will be safe in the care
system.
7. Transparency: Your care will be confidential, but the care system will
not keep secrets from you. You can know whatever you wish to know
about the care that affects you and your loved ones.
8. Anticipation: Your care will anticipate your needs and will help you find
the help you need. You will experience proactive help, not just reactions,
to help you restore and maintain your health.
9. Value: Your care will not waste your time or money. You will benefit
from constant innovations, which will increase the value of care to you.
10. Cooperation: Those who provide care will cooperate and coordinate
their work fully with each other and with you. The walls between
professions and institutions will crumble, so that your experiences will
become seamless. You will never feel lost.
From National Research Council. Crossing the Quality Chasm: A New Health System for the 21st
Century. Washington, DC: The National Academies Press, Copyright 2001, National Academy of
Sciences.
While the rules in the IOM report align well with the interests of
ePatients, the report’s most important contribution to the ePatient
movement is the a ention paid to using IT to improve the quality and
safety of healthcare. This theme resonates throughout the report with
recommendations that directly support the previously mentioned six aims.
The report highlights the potential benefits of harnessing health-related
applications for the internet that include consumer health, clinical care,
public health, professional education, research, and administrative and
financial transactions. Since the report, a number of health-related
improvements have been initiated in both public and private sectors. The
Office of the National Coordinator (ONC) for health information
technology released a report in 2015 that builds upon the messages in the
IOM reports by providing an interoperability roadmap and long-term
vision for connecting health and care across the United States.18
The recognition of safety and quality flaws in the U.S. healthcare system
led many patients and those close to them to become vigilant advocates.
Access to the internet, coupled with simplified search solutions offered by
companies such as Alphabet Inc. (Google), made looking for health-related
information online more feasible for an increasing number of people. Thus
began the new generation of ePatients who started searching online for
health information to learn more about their symptoms and conditions
and to be er understand the options available to treat and manage them.
An enduring source of rich data about the use of online resources is the
Pew Research Center’s Internet & American Life Project, which began to
monitor basic online activities in 1999 to understand who was using the
internet and what people were doing while online. Susannah Fox, named
Chief Technology Officer for Health and Human Services in 2015,
previously led the Pew Internet & American Life Project, which explored
the impact of the internet on families, communities, work and home, daily
life, education, healthcare, and civic and political life.19 Findings from the
Pew reports have shown that health information remains a popular online
pursuit. In February 2011, the report found that 8 in 10 internet users look
online for health information, making it the third most popular online
activity, following e-mail and using a search engine.20,21 In Health Online
2013, Pew researchers found that the internet is being used as a diagnostic
tool by one third of U.S. adults.22
For those interested in online health-related resources, the internet is
much more than a unidirectional source of information. Web 1.0, as the
early functionality is now known, provided information based on
simplified search parameters; for healthcare resources it was known as
Health 1.0. Since then, Web 2.0 has become available and is more
sophisticated, with social engagement, interaction, and networking
capabilities. Social media platforms such as Facebook, later followed by
others such as Twi er, Instagram, Pinterest, and LinkedIn, demonstrate
the power of the internet to support the formation of spontaneous social,
commercial, and political groups rapidly and in real time.23 For ePatients,
Web 2.0 brought about Health 2.0, allowing previously unavailable
interactive communication with other patients and healthcare resources
across the country and around the world. Online patient communities
range from traditional chat rooms and listservs to more formal social
networking platforms. Patient-to-patient communities such as
PatientsLikeMe, CureTogether, Inspire, and others have emerged as places
where ePatients seek and find communities formed around common
illnesses, treatments, or symptoms. Within these communities, patients
connect with each other for various reasons, including emotional support,
ongoing learning, and advocacy.
Google, Facebook, Amazon, and other online environments learn from
user search behavior and other internet activity to serve up predictive
content, confirming that Web 3.0 has arrived with Health 3.0 rapidly
evolving along with Digital Health, Medicine 2.0, Connected Health, and
mHealth. These terms and concepts represent the changing world of
healthcare and its integration with current technology, making possible
personalized health experiences through the use of predictive search
capabilities and more advanced cognitive computing.24
Health-related resources on the internet are constantly growing and
becoming more innovative and complex. They provide ePatients with
access to incredible resources and data previously unavailable, such as
personal genetic information. To appreciate the power of technology,
consider the Human Genome Project. It took 13 years and nearly $3 billion
to complete the identification and sequencing of genes within human
DNA.25 In contrast, 23andMe, an internet company launched in 2007
offering direct-to-consumer kits, made it possible for anyone to access his
or her personal genetic information quickly, simply, and for less than $500
(the price is now as low as $199).26
Another area of explosive growth has been in mobile technology or
mHealth. Anyone with a smartphone can access thousands of health- and
fitness-related applications. mHealth applications coupled with sensors
and wearables are growing rapidly as technology becomes more
sophisticated and increasingly connected to all aspects of fitness, wellness,
and healthcare delivery. ResearchKit, introduced by Apple in 2015, allows
consumers to participate in healthcare research from the palm of their
hand. Within 24 hours of its launch, over 10,000 iPhone users signed up for
the ResearchKit heart study.27 With recent mobile technological advances,
the collection and display of data are being presented in a more digestible
format which helps inform decision making as well as the ability to share
real-time updates within a social circle. Data visualization and
infographics have become ever more mainstream and are used to enhance
one’s ability to view trends or pa erns in health. The concept of mHealth
is further explored in Chapter 15.
Policy and Legislative Influences
The economics of healthcare influenced the evolution of ePatients and
their use of nontraditional and/or innovative sources for healthcare
information. Patients with insurance have seen their out-of-pocket
expenses, including deductibles and copayments, increase over the last
decade, leading many to look for alternative ways to get answers and
support for healthcare questions. The uninsured and underinsured are
often left trying to manage their own and their family members’ healthcare
needs to avoid incurring expenses associated with various services.
Additionally, with changes in the healthcare reimbursement structure
shifting care from the hospital to home, patients and caregivers are
assuming more responsibility for increasingly complex care needs. The
responsibilities of self-managing health and navigating the healthcare
system motivated many to become ePatients, to find, connect with, and
learn from others who may share similar experiences.
Policy and legislative actions in the United States have been important
drivers in the ePatient movement. In 2009 the American Recovery and
Reinvestment Act was signed into law. A hallmark of this legislation
destined to affect the next phase of the ePatient movement is the
requirement known as Meaningful Use (MU), which sets specific
objectives that eligible professionals and hospitals must achieve to qualify
for incentive programs offered by the Centers for Medicare and Medicaid
Services (CMS) for integrating electronic health records (EHRs) into their
systems. Implementation of MU requirements is a multistage, multiyear
endeavor with expectations that compliance will result in be er clinical
outcomes, improved population health outcomes, increased transparency
and efficiency, empowered individuals, and more robust research data on
health systems. MU requirements are not without controversy, which led
CMS to propose modifications to certain requirements in April 2015. Stage
2 MU requirements for patient engagement were significantly reduced by
making the requirement for patients to use technology for electronic
download, view, and transmit of their medical records from 5% of eligible
providers’ patients to just one patient, prompting much criticism from
ePatients and patient advocates.28
The focus on access to health information fueled the development of
patient portals within EHR systems of large health systems, hospitals,
physician practices, and other eligible healthcare providers. Another
mechanism for ePatient health information access is personal health
records (PHRs). PHR features vary from one system to another, but most
support a menu of transactions including the ability to review test results,
schedule appointments, refill prescriptions, and communicate via
electronic messaging with healthcare providers. Estimates suggest that
approximately 70 million people in the United States have access to PHRs,
yet widespread adoption has been slow, and changes by CMS to the MU
patient engagement requirements may impact prior expectations that the
requirements would improve utilization. Other healthcare reform
measures, including provisions in the Patient Protection and Affordable
Care Act (PPACA) and the Health Care and Education Reconciliation Act
of 2010, which amended the PPACA and became law on March 30, 2010,
significantly affect healthcare coverage and care delivery. In 2015 Health
and Human Services Secretary Sylvia M. Burwell set specific goals and a
timeline for shifting Medicare reimbursements from volume-based care,
commonly known as fee-for-service, to value-based care.29 Patients and
their healthcare providers will bear increasing responsibility for managing
cost and care, leading to the need for more collaboration and engagement
at the actual point of care.
Characteristics of Digital Healthcare Consumers
In a report titled Health e-People: The Online Consumer Experience, Cain,
Sarasohn-Kahn, and Wayne introduced three categories of online
healthcare consumers: those who are well, those who are newly diagnosed
with an illness, and those who are chronically ill and their caregivers.30 The
report suggests that people in each group behave in certain ways on the
internet and that their behavior is a reflection of their health status:
• The well: When the report was wri en, approximately 60% of
consumers looking online for health and healthcare information were
well. The online needs of the well are largely considered episodic and
occasionally driven by the need to seek out specific information
related to prevention and wellness. They tend to move across various
resources both online and offline for information and they typically
place value on convenience over loyalty.
• The newly diagnosed: This group represented only 5% of the total
number of online health consumers in 2009. The newly diagnosed are
driven by a sense of urgency to understand, manage, and mitigate a
recent change in their health status. Their presence and behavior
online depend largely on the nature of the condition and its usual
trajectory. Most newly diagnosed individuals are expected to spend
large amounts of time online in the weeks following the news of their
diagnosis. Those diagnosed with a condition amenable to intervention
and eventual resolution have different needs than those moving from
a state of wellness to a state of chronic illness. For the la er, the need
for online resources is expected to evolve and change to reflect
changes in their health over time.
• The chronically ill: This group represented about 35% of online health
consumers in 2009. Chronically ill patients who use online sites often
align their loyalty to sites with resources, services, and support for
their specific condition. According to the report, 51% of American
adults living with chronic disease go online for health topics related to
disease, medical procedures, medications, or health insurance
information; 1 in 4 adults with a chronic illness have looked online for
someone who shares the same condition.31
Caregivers and loved ones of those living with illness or disability often
become active online. Contemporary ePatients are information seekers and
data gatherers. They take personal responsibility for researching online
and offline resources to improve their health and well-being. The well
ePatient is inclined to peruse a host of digital resources episodically to
prepare for medical appointments, investigate intermi ent family health
questions, or search just out of curiosity. Active ePatients (and their
caregivers), including those newly diagnosed and those with chronic
illnesses, are more invested in gathering important data points by tracking
their health with the use of online self-management tools and biosensors,
such as heart rate monitors, seizure trackers, mood maps, sleep diaries,
and glucose monitors. Digital devices and wearables are becoming
increasingly commonplace for monitoring mobility, medication adherence,
and even for detecting behavioral changes.32 Tracking their health data
digitally in conjunction with online searches empowers ePatients to gain a
sense of participation and ownership of their well-being, treatment
options, and health.
As the evolution of the ePatient continues, more prominent examples of
contemporary ePatients emerge. One emblematic ePatient is Dave
deBronkart, who has dedicated himself to being a patient activist, blogger,
international speaker at health and social media conferences, and health
policy advocate for the ePatient movement.33 His call to action came in
2007 when he received a diagnosis of Stage IV renal cell carcinoma that
had spread to his muscles, bones, and lungs. He was told that his median
survival time was about 24 weeks. With this prognosis, deBronkart was
highly motivated to find an effective treatment and scoured the internet
for viable options. With help from other patients on the Association of
Cancer Online Resources (ACOR) website with a similar diagnosis, he
learned about a promising clinical trial as well as tips on medications to
avoid jeopardizing his trial eligibility. Armed with this information, he
engaged in meaningful discussions with his clinician about his options.
Fortunately, deBronkart had a favorable outcome and the treatment
regimen from the clinical trial led to his successful recovery. One year after
his treatment ended he began publicly sharing his story by blogging and
participating in healthcare conferences and events. deBronkart believes
that patients are the most underused resource within healthcare and
champions the message of “Let Patients Help.” His proactive research and
engagement with his healthcare providers helped to provide a favorable
outcome. However, he is always quick to state that what actually saved
him was phenomenal medical science provided by experts in their field in
an institution well grounded in patient-centered care. In recognition of his
role in patient advocacy and the role of the patient in cooperative science,
the Mayo Clinic Internal Medicine Chief Residents named deBronkart the
2015 Visiting Professor in Internal Medicine.34
Other ePatients are called to activism as a result of their experiences
with the healthcare system. Regina Holliday chose art as the medium to
express her family’s difficult experiences during her husband’s illness and
untimely death.35 Holliday shares her story in a powerful and provocative
mural depicting the journey she and her family traveled through a
fragmented and uncoordinated healthcare system. The journey was
exemplified by her inability to access her husband’s medical records in a
timely way to ensure that he received needed care. The mural is titled 73
cents, the price Holliday was told she would have to pay per page to make
a copy of his medical record. Since completing the mural, Holliday has
continued to bring a voice to the patient and family experience through
art. Since 2010, Holliday has painted more than 372 poignant and thematic
paintings while on-site at healthcare conferences, events, and policy
meetings, using them as an opportunity for public advocacy. She founded
a movement called the Walking Gallery where she and other artists depict
patients’ stories or elements of medical advocacy on the back of jackets or
lab coats for government employees, technology gurus, medical
professionals, social media activists, executives of companies, patients, and
artists. Holliday and 43 other artists have painted 439 wearable images for
the Walking Gallery. As of June 2016, 392 unique Walkers have joined the
Gallery wearing 430 jackets. These jackets are often worn by their advocate
owners at health-related conferences and events. When gathered together
for a Walking Gallery exhibit, the images on each jacket convey powerful
messages to the public about the importance of advocacy.
A new type of health consumer has emerged in the last decade. The
quantified self (or quantified selfer) refers to a person invested in using
tools and data to quantify and monitor daily experiences using personal
metrics.36 A quantified self measures a range of inputs such as food
consumption, environmental factors, emotional and biophysical states,
biometric data, and mental and physical performance. These data,
collected at baseline and over time, can encourage and promote healthy
behaviors and provide signals for early detection of illness or changes
from the baseline state of health. The real-time feedback from the wearable
sensors provides awareness of one’s own physiologic response.37
Semantically, a quantified self may not consider himself or herself to be
an ePatient but rather someone whose goals are to achieve and maintain
good health and who has an innate interest in tracking personal metrics.
This type of health consumer captures health-related data such as blood
pressure, exercise, activity, sleep, and dietary intake using personal
informatics tools for self-monitoring to track their progress toward his or
her goals. This type of tracking has the potential to identify health changes
more quickly and may affect outcomes favorably, especially in
circumstances when a nuanced change leads to an early diagnosis. This
potential is exemplified by the experience of Steven Keating; while a
doctoral student at MIT’s Media Lab, he collected and researched his own
health data and symptoms, which led to the discovery of a brain tumor
and successful timely treatment. Keating, relentless in the pursuit of his
medical information, shares his journey on his website. In a New York
Times article, Keating states, “there is a huge healing power to patients
understanding and seeing the effects of treatments and medications.”38
The aggregation of personal metrics, lifestyle factors, and real-world
experiences has the potential to expand healthcare providers’
understanding of patient responses to wellness and illness, both
behaviorally and physiologically.
Today a perfect, positive storm is brewing as technology, policy,
legislation, patient-centered reform, and patients' interests in personal
health data converge. Observing the evolution of ePatients from their
earliest days to today is akin to watching a movie in slow motion.
However, a shift to fast-forward is rapidly occurring; the impact of an
increasing number of ePatients on health and healthcare will result in
disruptive innovation for healthcare providers and healthcare delivery
systems. More importantly, ePatients will continue to be a driving force in
achieving improvements in the quality and safety of healthcare in the
United States.
Convergence of epatients, clinicians,
patient-centered models of care, and
informatics
Participatory Patient-Centered Healthcare
The maxim of “doctors know best” is a statement of the past. Until the
early 21st century, the old paradigm was a paternalistic model in which
the healthcare provider was the exclusive source of medical knowledge.
Deeply rooted cultural assumptions in this old medical model view the
patient as the uninformed layperson and the medical professional as the
keeper of all health knowledge. In a clinician-controlled environment the
patient is the outsider with li le ability to gather and access data about his
or her condition and is expected to play the “good patient” role. This is
changing with patient-centered care models.
As patient-centered care models rapidly evolve in the United States,
questions emerge about who should direct the care: the patient or the
healthcare provider.39 Patient-centeredness promulgates a model in which
the patient is not only at the center of care but also a full member and
partner of the healthcare team. Patients know best when it comes to
having the most intimate understanding of their personal circumstances,
their preferences, and their bodies. Yet in most healthcare organizations,
including patient-centered medical homes and primary care practice
se ings, provider-directed care remains the norm, perhaps for political,
legal, and reimbursement reasons.40 Scherger suggests that the internet
will test this paradigm of provider-directed care in much the same way
that online banking, travel services, and other previously brokered
services have given way to consumer control.39
The ePatient movement does not support replacing physicians and other
healthcare providers. On the contrary, ePatients understand the value of
collaborative patient-provider partnerships and seek healthcare providers
who appreciate the value of allowing patients to participate. ePatients
appreciate the need for provider-directed care for certain circumstances
such as trauma, acute medical events, and surgical emergencies; however,
the model of patient-centered care exists with the premise that patients are
considered experts in their own care and self-management and must be
allowed to exercise patient-driven controls. Patient-centered care is viewed
as a critical component of achieving the Triple Aim of improving the
experience of care, improving the health of populations, and reducing per
capita costs of healthcare.41 For patient-centered care to succeed, patients
and their clinicians must have respectful partnerships within which
patients and clinicians mutually determine how care will be directed and
managed to meet needs.
An unprecedented opportunity exists to fundamentally change the
experience of healthcare encounters for both patients and their clinicians.
ePatients have the tools and skills to elevate discussions with their
healthcare providers and use limited office visit time engaged in a more
constructive dialog. This can result in greater satisfaction for both
stakeholders. This meaningful collaboration between the ePatient and the
healthcare provider, known as participatory healthcare or participatory
medicine, is defined by the Society for Participatory Medicine as:
…a cooperative model of healthcare that encourages and expects active
involvement by all connected parties, including patients, caregivers, and
healthcare professionals, as integral to the full continuum of care. The
“participatory” concept may also be applied to fitness, nutrition, mental
health, end-of-life care, and all issues broadly related to an individual's
health.42
The Society for Participatory Medicine was founded as a movement in
which networked patients shift from being mere passengers to responsible
drivers of their health. Healthcare providers encourage and value them as
full partners.
Participatory healthcare also requires ePatients and clinicians to use a
variety of data sources to genuinely collaborate on shared goals and
decision making for improved health and outcomes. Iverson, Howard, and
Penney found that gathering information online fosters more patient
engagement in health maintenance and care.43 The movement toward
participatory patient-centered care requires that ePatients, health
professionals, and informatics systems align accordingly. Berwick offered
three maxims that he finds useful when considering a participatory
patient-centered model of care:
• The needs of the patient come first.
• Every patient is the only patient.
• Nothing about me without me.44
The last maxim is often associated with ePatients and calls for openness
and transparency among all involved stakeholders, especially when it
comes to their health data. deBronkart’s notoriety flourished after his
keynote presentation at the 2009 Medicine 2.0 conference titled “Gimme
My Damn Data,” which was picked up by Cable News Network (CNN) in
a series on the empowered patient.45 In response to the CMS decision to
reduce the MU requirement for patient engagement, ePatients, advocates,
leading consumer organizations, healthcare experts, policy-makers, and
technology organizations launched a collaborative data liberation
campaign on July 4, 2015, leading to the formation of “GetMyHealthData,”
an initiative promoting transparency and consumer access to digital health
information.46 In October 2015 the Alliance for Nursing Informatics (ANI)
published a press release stating that it had joined the GetMyHealthData
effort. “Encouraging nurses to get involved in the GetMyHealthData effort
is a natural next step to the multi-year Consumer eHealth agenda of ANI,”
announced Judy Murphy, RN, FACMI, FHIMSS, FAAN, co-chair of ANI.47
While opportunities for health professionals’ growth in participatory
healthcare exist, it is equally important to acknowledge the challenges.
Current care models may not be structured to support patient-
centeredness and even well-intentioned clinicians may find it difficult to
allocate sufficient time and resources to fully engage with ePatients who
come with a well-prepared agenda. However, there is no doubt that
ePatients will continue to push and advocate for their place in the
healthcare system.
Many ePatients want to integrate empirical knowledge into their
understanding of their health conditions. Therefore clinicians should
engage these ePatients in developing a shared hypothesis based on data
and patient-reported experiences to help explain symptoms and other
findings. Developing a shared hypothesis and including the ePatient in
creating a plan to manage care initiates a process known as guided
discovery. Guided discovery includes integrating open-ended questions in
the medical encounter, preidentifying data collection parameters that have
meaning to the ePatient, planning time for analysis of collected
information, completing an evaluation of outcomes, and recognizing that
those results may require experimentation to achieve shared goals.47
Clinicians must also take a proactive role in educating patients to safely
and effectively use internet-based resources including social media sites.
Examples of key points to consider in this education are included on Box
12.2.
Box 12.2
Key Points for Teaching Patients Safe and
Effective Use of Social Media Sites
• Take the time to read the Conditions of Use and Privacy Statement. The
website should be designed in such a way that you can read these
documents before establishing an account.
• Read the About section to determine who has established the site and the
mission or purpose of the site.
• Spend time learning how to navigate the site and set privacy/security
se ing before participating on the site.
• Lurk on the site until you learn the names and characteristics of frequent
participants on the site as well as the personality of the social media
group as a whole.
• If you are unclear about a comment that has been posted, ask questions.
Other people in the group might have some of the same questions.
• Treat people with respect and kindness. If you think something that has
been posted is incorrect, point out that it is different than your previous
knowledge or experience and ask for more information or clarification.
• If you are feeling strong emotion such as angry, excitement and anxiety
it is often helpful, to compose your comments and let them set for a bit
of time before posting. Remember, once it is posted it is permanent.
• Carefully evaluate the information posted by others. Listen/read the
whole conversation. Information may be accurate but not apply to your
situation or case. The first answer to a question is not always the best
answer and group consensus is not always correct.
Sources used include: Joos I, Nelson R, Smith M. Introduction to Computers for Health Professionals.
Burlington, MA: Jones & Bartle . 2014, box 12-1 and Nelson R, Joos I, Wolf DM. Social Media for
Nurses. New York, NY: Springer Publishing Company. 2012, table 1.4.
The New Role of Clinicians and Informaticians in
ePatient Care
Clinicians involved in informatics are uniquely positioned to participate in
system changes that support ePatients’ desire for data openness and
transparency by helping to build data collection models that support
connection, partnership, and guided discovery.48 Patients and healthcare
providers need the right tools at the right time to collect data to support
their need to investigate and hypothesize health issues to create a shared
plan. Clinicians may need to learn new skills and gain new knowledge to
serve as a “guide” for ePatients as they integrate information and data
from multiple sources while navigating their healthcare experience. It is
within this culture of partnership that guided discovery of the ePatient’s
health and well-being can be fully realized.49 Healthcare providers must be
flexible and open to the possibility that patients may be more intimately
adept at the experience of their own illness and that clinicians should not
be expected to have all of the answers. However, ePatients expect their
clinicians to use timely technology, including online and digital sources, to
build their own knowledge and expertise.
ePatients have inherent knowledge of their sense of self and are
encouraging the healthcare field to recognize and support this notion. As
deBronkart has been known to say, “Patients have more skin in the game.”
ePatients look to clinicians not only for their clinical expertise but also for
their willingness to support changing needs during the illness journey.
Health professionals can demonstrate this willingness by understanding
the value of online and digital technology resources to ePatients. Clinicians
have the opportunity to research internet sites and digital devices that are
relevant to their specialty, recommend those that provide value to them
and their patients, and be open to learning about and exploring other
resources and technology solutions favored by their ePatients.
The integration of patient-centered care models enabled by technology
into the U.S. healthcare system will continue, and ePatients will be
essential participants. As with any change, resistance should be expected.
However, initial resistance will not stem the tide that is occurring across
the country to create a partnership model of care that supports safety,
efficiency, and health for all stakeholders.50
Health Informatics and ePatients
Disruptive communication technologies, such as the internet and digital
devices, have drastically altered the way we communicate with one
another. From electronic messaging, texting, and tweeting to updating
social networks, posting pictures, and posting reviews, our experiences
allow us to share knowledge, communicate, and connect in real time with
others around the world. Online businesses are harnessing the power of
communication and connection by researching buyer reviews and
purchasing history data of customers to help drive sales. The idea of using
buyer reviews can also be found within healthcare. One example is the
Hospital Consumer Assessment of Healthcare Providers and Systems
(HCAHPS), the first national, standardized, public report of patients’
perspectives of their experiences with healthcare organizations and
healthcare providers, which is now also in use in ambulatory and
outpatient care se ings.51
The aggregation of data across similar experiences is known as
crowdsourcing. Crowdsourcing is useful in recognizing pa erns within
the population and can also help to expand our knowledge for public
health. The idea of crowdsourcing information and participatory
healthcare is growing; one example is PatientsLikeMe. This research-based
online platform was created for patients to share and learn from real-
world experiences and to produce outcome-based health data for
advancing the current pace of research.52 Imagine a patient who has
recorded data about his or her symptoms over time; the historical data can
lead to productive encounters with healthcare providers, but may also
contribute to emerging knowledge about the experience of living with
certain conditions. Crowdsourced data from real patients in real time
expand and challenge how we view and study health.53
Despite the growing move toward participatory health and collaborative
care, for most healthcare organizations the current health IT infrastructure
does not foster interoperability for patients and healthcare providers so
that they can interact and communicate effectively and efficiently.
Immediate electronic access to one’s health records and electronic
messaging with healthcare providers is becoming more commonplace yet
electronic transfer of information across systems remains a barrier to
accessing information. Health informatics has been touted as one of the
solutions in changing healthcare, which should improve quality,
efficiency, and safety of care and decrease costs, but the delay in
implementing systems is impeding the ability of healthcare to evolve more
rapidly. An additional layer of data architecture is needed to support the
integration of meaningful and relevant patient-generated health data
(PGHD) at the point of care.54 PGHD is defined as health-related data that
is created, recorded, or gathered by patients, family members, and
caregivers to address a health concern.55 A pilot study using PGHD
demonstrated significant improvement in epilepsy self-management and
self-efficacy among veterans using online self-tracking tools in
collaboration with their clinicians.56
Informatics alone cannot build the learning health system as described
in the IOM’s Learning Health System Series.57 The vision of a learning
health system aligns scientific knowledge, biomedical informatics, value-
added incentives, and cultural norms to ensure that continuous
improvement and innovation become natural by-products of the
experience of healthcare. Consumer participation and collaboration are
essential elements of a learning health system.
Transparency and Access to Data
Increasing transparency of medical documentation to patients offers new
opportunities for patient engagement. The OpenNotes project, which
began in 2010, evaluated the impact of sharing clinical encounter notes for
primary care providers and patients online. Participating providers
believed in transparency of medical documentation and the tangible
benefits of sharing notes with patients. Nonparticipating providers
indicated worry over the increased demand on their time and lengthier
visits as well as an inability to record their thoughts candidly about
sensitive issues regarding mental health, obesity, cancer, and substance
abuse. In addition, nonparticipating providers noted that the transparency
of the notes would negatively affect their current practices and have
minimal positive effect on patients. In contrast, patients reported positive
interest in reading clinical notes, and fewer than one in six patients
expressed worry or confusion over reading the notes, regardless of
demographic and health characteristics. Many patients in the study also
indicated that they would consider sharing the notes with friends and
family. Overall, the evidence suggests that giving patients access to their
provider’s notes may improve communication and efficiency of care and
may lead to patients becoming more involved with their health and
healthcare.58 Since the initial study, many sites in the United States are
participating in OpenNotes bringing access to more than 5 million
patients.59
Many ePatient supporters are advocating transparency and challenging
the question of who owns the data. Dave deBronkart has heavily
advocated for transparency of data because of his experiences with
inaccurate information in his health record and his family members’
records that could have led to potentially fatal mistakes. For example, his
mother’s diagnosis of hyperthyroidism was transcribed incorrectly and
treatment for hypothyroidism was prescribed. His wife’s allergy to
penicillin was not recorded and she was almost given the harmful
medication. deBronkart reviewed his own health record and noted
erroneous diagnoses.60 Regina Holliday’s advocacy work, mentioned
earlier, is solidly in favor of access to the health record. She believes that
no patient or family should ever have to struggle, as she did, to gain timely
access to health records. Similar efforts in support of transparency and
open access are occurring in the research realm. Interest has grown over
the past several years and on June 4, 2012, a petition was signed by
thousands of advocates urging the White House to make taxpayer-funded
research available online to everyone. Due to public concerns, the Obama
administration commi ed to giving public access to the results of federally
funded research within one year of publication.61
ePatients a empt to access studies on their chronic illnesses, but closed
access to research papers constrains their efforts. In addition, closed access
prohibits patients who participated in studies from reviewing study
outcomes. Not only are patients often limited in their access to research
results from studies in which they participated, they are often denied
access to their own health data collected as part of the research study. This
practice within the research and publishing world creates a roadblock for
patients and an imbalanced dissemination of knowledge. Progress has
been made on sharing data from clinical trials with the release of an IOM
report in 2015.62 Groups such as Patient Centered Outcomes Research
Institute and PatientsLikeMe have embraced open access as essential for
all of their publications. Open access to research literature gives ePatients
the ability to critically evaluate their best course of action.
Health 3.0 emerges
Over the last decade, the internet has evolved from the static
unidirectional experience of Web 1.0 to the dynamic and interactive
environment of Web 2.0 within which collective intelligence is harnessed.63
With this framework in mind, Van De Belt et al. identified definitions for
the parallel evolution of Health 2.0 and Medicine 2.0, terms that are often
used interchangeably.9 They found 46 unique definitions from 44 articles,
suggesting that the concept is continuing to develop. Seven recurrent
themes indicated that a set of characteristics for Health 2.0 is emerging: (1)
patients/consumers, (2) Web 2.0/technology, (3) professionals/caregivers,
(4) social networking, (5) change of health care, (6) collaboration, and (7)
health information or content.
ePatients participate across various health-related social media spaces:
some blog; some tweet and retweet; some form patient-related pages on
Facebook; some express their experiences through music and art; and
some seek opportunities to communicate their messages at professional
conferences, political gatherings, and citizen forums. ePatients influence
the experiences of other patients on a global scale. As Health 2.0 gives way
to Health 3.0, innovative environments continue to emerge in which
collective intelligence and knowledge of multiple stakeholders is gathered,
exchanged, and shared. The concept of Health 3.0 is built on Web 3.0, also
referred to as the internet of things (IoT). With Web 3.0, a wide variety of
monitors, such as those used to monitor one’s home of health status, can
be connected and managed from the internet, Health 3.0 provides new
opportunities and raises new challenges. A fully connected home could
make it possible for patients with limited cognitive abilities to remain in
their home as opposed to a nursing home. However, while surfing the web
can tell advertisers what websites a user frequently visits, things like
biometric wearables collect and share much more personal data about a
user’s activities and overall health status. As U.S. Secretary of Homeland
Security Michael Chertoff indicated, some caution is in order when it
comes to IoT: “One shouldn’t default to the position that connecting
everything is perfect.”64
However, the viral capability of social media provides ePatients with a
powerful platform from which the experiences of even the most
vulnerable can be collected, appreciated, and shared. Gaps exist in internet
accessibility despite the proliferation of technology across all aspects of
society. This digital divide has both individual and public health
implications since those lacking access are unable to benefit from the
wisdom of collective knowledge to improve health outcomes, whether in
real time or longitudinally. The gap between the internet “haves” and
“have-nots” is beginning to narrow through collaborative efforts of
countries and global technology companies working to bring access to
anyone who wants it. While motivations for this movement may be
commercially driven, engaging the global population in the digital world
provides far-reaching opportunities to impact global health.
Virtual Patient Communities and Research Networks
In Peer-to-Peer Healthcare, Fox found that 18% of internet users were online
to find others who may have similar health concerns.65 Among those users
living with chronic illnesses such as diabetes, heart, or lung conditions,
23% reported going online to look for others with similar experiences. The
report also highlights that 71% of adults seek information, care, or support
from a health professional during an acute moment of need. This
important point reinforces the notion that ePatients want a partnership
with healthcare providers to collaborate and share in decision making.
Fox’s Health Online 2013 report indicates that the general public continues
to use the internet for a variety of health-related needs with 72% of online
users seeking health information in the previous 12 months.22
ePatients seeking health information and support are increasingly
turning to a new generation of innovative tools and devices that include
mHealth applications, comprehensive web-based content, interactive
social networks, and wearable sensors that can seamlessly connect data to
online sites. These digital environments provide the opportunity to
reframe one’s experience from “Why me?” to “Oh, you too? Tell me
more.” The interactions that occur provide support, validation, and a place
to share ideas about how to live as well as possible with illness. This
journey is depicted in Fig. 12.2.
FIG 12.2 The patient and caregiver journey. Copyright PatientsLikeMe.
<[Link] 2012.
One of the most transformative developments for ePatients has been the
emergence of patient-focused virtual communities in which patients
interact, sharing health-related data and learning from each other's
experiences while being unbounded by geographic limitations, social
stigma, or other limiting characteristics. Eysenbach et al. defined virtual
community as follows:
…a group of individuals with similar or common health related interests
and predominately non-professional backgrounds (patients, healthy
consumers, or informal caregivers) who interact and communicate publicly
through a computer communication such as the internet, or through any
other computer based tool (including non-text based systems such as
voice bulletin board systems), allowing social networks to build over a
distance. (p. 1)66
In an online environment ePatients exchange information, compare
notes, learn about treatment options, and engage in discussions that may
seem superfluous and deemed not within the purview of the medical
professional. For example, they can exchange tips on where to purchase
wigs in preparation for chemotherapy, advice on raising children, or
advice on working while managing a chronic illness. Online communities
can also function as a lifeline for those trying to manage the fear and
uncertainty associated with illness. For many, including the uninsured,
underinsured, and those with high-deductible plans, spending time online
to explore ideas with others may be a reasonable first step in deciding
what to do next about a health concern. Patients with rare diseases can
search for specialists, researchers, and newly discovered information for
their rare disease. Schweizer et al. found that among cancer patients,
virtual communities play an important role in helping patients to cope
with their situation.67 Establishing social relationships with other cancer
patients complements and supplements their offline social relationships.
While emotional support is a benefit, evidence also exists that patients
derive physical and quality-of-life benefits as well.68
The lines previously drawn between patients, care delivery, and health-
related research are continually blurring. Studies show that Americans are
increasingly willing to share their health data if it improves their outcomes
or the outcomes of others like them.69 Among veterans using the
MyHealtheVet portal, 79% report interest in sharing access to their
electronic health information with caregivers and non-VA providers.70
ePatients are looking for more than social support from their
interactions with online communities. Nambisan found that patients
participating in online health communities experienced enhanced
perceived empathy when their information seeking was supported by
relevant tools and data displays similar to those used by PatientsLikeMe
(on this site ePatients have access to a variety of tools to share data about
their health conditions, symptoms, treatments, and side effects).71 In a user
survey conducted in 2010, PatientsLikeMe members reported improved
understanding of how their treatments worked, feeling more involved in
decisions regarding their treatments, and be er communication with
members of the healthcare team.72 Researchers identified a “dose effect” of
connectedness among members of the site’s epilepsy community.73
Health-related social networks and patient-powered research sites have
become a rich resource for support, information, empowerment, and
advocacy for ePatients and their caregivers. However, as with all activities
on the internet, participants should review the terms of use and the
privacy and data-sharing policies to ensure that they are well informed.
Reputable sites display links to their privacy policies on every page of the
site (Table 12.1).
Table 12.1
Patient Virtual Communities: User and Privacy Policies
Patient Virtual
User Terms Privacy Policy
Community
Cure Together h p://[Link]/[Link] h p://[Link]/[Link]
Patients Like Me [Link]/about/user_agreement [Link]/about/privacy
[Link]/about/openness
Inspire [Link]/about/terms/ [Link]/about/privacy/
Army of Women [Link]/termsofuse [Link]/privacypolicy
Association of h p://[Link]/pages/termsAndConditions h p://[Link]/pages/privacyPolicy
Cancer Online
Resources (ACOR)
Smart Patients h ps://[Link]/terms h ps://[Link]/privacy
Virtual communities share many of the characteristics of any social
group and these characteristics may evolve and change as the community
grows and matures. Most virtual communities can afford the user some
degree of anonymity since engagement is not typically face to face. This
can be both a benefit and a risk. Patients may feel more comfortable
sharing sensitive information anonymously than they would in person.
Among 1267 polled members of PatientsLikeMe, 41% said that they have
withheld information from their doctors about certain symptoms and 39%
did not share information about lifestyle habits such as exercise, diet, and
alcohol use. Reasons for withholding this information from their doctors
included not wanting to be lectured, feeling too embarrassed, not thinking
the information was important or the doctor's business, forge ing to bring
it up, and fearing that the treatment they wanted would not be provided.
A survey conducted in 2011 by iVillage, an online community for
women, found that women placed more trust in and value on information
obtained from online women’s communities than from other social
networks.74 The respondents believed that sites such as iVillage, CafeMom,
and BabyCenter offered more expertise to understand and meet their
needs.
Virtual communities may also carry risks, especially for novice ePatients
who may feel uncertain or vulnerable in this environment. Many patient
communities incorporate moderators as part of the experience, yet there is
an inconsistent approach to how moderation is done in these communities.
Research is emerging in this area but more is needed to characterize the
effectiveness and quality of moderation in online communities.75
Organizations that create and support online communities should
measure user input to gauge the perceived benefits, risks, and social health
of the community from the patient's perspective.
Online communities can be important sources of patient experience data
that could be harnessed by researchers. Patient-reported outcome
measures (PROMs) are gaining use among academic and clinical
researchers, government and regulatory agencies, policy institutes, and
patients themselves. Information collected within virtual patient
communities offers a novel source of patient-reported outcome (PRO) data
for meaningful measure development. Although of increasing interest,
data generated by patients themselves, either actively reported or
passively gathered from wearable or sensor devices, are not without
challenges including the need to establish data standards and
methodologies for data collection and analysis. The value of patient-
generated health data is gaining favor across all sectors of health and
healthcare, giving ePatients an unprecedented opportunity to impact care,
policy, and payer decision making.58
Conclusion and future directions
21st Century Health and Healthcare
As we look to the future for ePatients, consider the Google generation, a
generation of computer users born after 1993. They have grown up with
immediate access to information and knowledge sources that were
previously unavailable. This generation is also called the Net generation,
the Google generation, digital natives, and millennials. They are very
skilled at navigating internet and digital resources and are accustomed to
sharing data in real time in online environments.76 Insight into this
generation of users is important because they have li le or no recollection
of life without the internet. They are now adults, taking jobs, starting
families, and will increasingly engage in decisions about their health and
the health of their families. These are today’s ePatients and their appetite
for immediacy and responsiveness from online and digital tools will drive
innovation across all consumer interactions including healthcare. Not far
behind is Generation Z, also known as iGen or Digitarians. These future
ePatients only know a world of access powered by the internet, having
been raised with touch-enabled devices and the ability to connect to
anyone globally.77
As these generations age and health technology continues to evolve, the
term ePatients will make way for a more inclusive term, the eHealth
consumer.
The evolution of the web might be summed up this way: Web 1.0 was
akin to a library where you could access loads of information but you
could not contribute anything. Web 2.0 has more of a community feel; it is
a place where groups can gather, where you can exchange information,
and where your contribution can be included and even judged by others
for its value. So what does Web 3.0 enable? Browsers and devices are
already acting more like a personal assistant, such as Apple’s Siri. Search
capabilities now harness user experience behavior to display content of
interest including personally tailored advertising. Web 3.0 uses data from
our online and digital exhaust to put current searches into context to
deliver information that meets our needs and interests in the moment.
What does this mean for health and healthcare? In 2011, Topol described
technological advances in medical devices and other diagnostic tools
emerging in practice.78 Just four years later he said that patients hold the
future of medicine in their hands—literally, in the form of a smartphone.
Topol suggests that the digitalization of medicine has now democratized
it, calling this digitization medicine’s “Gu enberg moment.”79 Research
institutes like the P4 Medicine Institute are working to integrate systems
biology, digital and information technology, clinicians, and patients to
form P4 Medicine, medicine that is predictive, preventive, personalized,
and participatory.80 In April 2014, IBM Watson moved from being a
Jeopardy champion to powering the IBM Watson Health Cloud of
advanced cognitive and analytic technologies for health and healthcare.
As the vision of a learning health system is realized, patients and those
close to them need opportunities to contribute. In May 2012 a summit was
convened in Washington, DC, bringing together representatives from
government, industry, nonprofits, and patients to build consensus on the
core values and principles needed to support a person-centered,
continuous learning health system on a national scale. Regina Holliday,
the artist-in-residence for the 2-day summit, painted Chaordic, depicting
powerful images of multiple stakeholders navigating the fine line between
the chaos and order of our current healthcare environment as they
converge to achieve the vision of a learning health system (Fig. 12.3).81
FIG 12.3 Chaordic. Copyright Regina Holliday, 2012.
Since that time, a ention to including patients as partners across all
domains of health and healthcare has become commonplace. In 2012 an
initiative called Patients Included created a charter to establish aspirations
for patient participation in conferences and now provides a logo that is
proudly displayed for those events that honor the charter’s intentions.82
Since 2013 the multiple centers across the National Institutes of Health
(NIH) have engaged with external stakeholders, including patients, in
workshops and events focused on the role of Citizen Science in
biomedical research. President Obama used his 2015 State of the Union
address to announce a bold initiative called Precision Medicine to recruit 1
million volunteers in a research effort aimed at understanding the
individual differences in people’s genes, environments, and lifestyles in
hopes of developing more personalized and targeted therapies.83 The 21st
Century Cures Act, which passed the House of Representatives in July
2015 and is pending in the Senate, contains provisions that support patient
engagement and participation in drug discovery and development
processes including the use of patient experience data by the U.S. Food
and Drug Administration in the benefit risk assessment of a new drug.84
We are nearing a time when the term ePatient may be irrelevant; a time
when a person-centric health system welcomes equipped, enabled,
empowered, and engaged people in creating health, together as partners in
a peer relationship with their healthcare providers. A time when a
continuously learning health system, supported by an ever-evolving
technological infrastructure, can ensure personalized participatory
medicine, preference-sensitive decision making, and shared accountability
for achieving mutually agreed-upon value-based outcomes.
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Discussion questions
1. Discuss reasons why clinicians may be reluctant to change their current
practice to accommodate the principles of participatory medicine.
2. What ethical concerns do you have about the sharing of health data
online?
3. Considering today’s privacy rules, how can you be expected to maintain
confidentiality when patients are sharing data so freely? How might
privacy rules evolve?
4. Defend or refute the following: Patients should have real-time access to
all information in their health records, including narrative notes.
5. How can we narrow the gap between technology “haves” and “have-
nots”?
6. Develop strategies for working with ePatients and using patient-
generated health data in your personal practice and consider if those
strategies would be acceptable in your work se ing.
7. Debate this statement: Employers who contribute to the cost of
employee health insurance can require employees to monitor certain
health parameters or pay a higher premium to maintain coverage.
8. If you believe that participatory healthcare should become the standard
of care, what policy and legislative changes are needed to make that a
reality?
9. Create a vision for the model of healthcare you want in place by 2020.
What is the single most important characteristic of your vision on which
you are unwilling to compromise?
10. In the interest of public health, shouldn’t all capable patients be
expected to monitor their health using accessible tools? What, if any, are
the unintended consequences of that expectation?
Case study
A few weeks ago you were hired as Director of Patient Education for a
regional medical center located in the Midwest. The medical center
includes three community hospitals ranging from 175 to 321 beds, four
outpatient clinics, and five centers of excellence. The five centers of
excellence are located at two of the hospitals and focus on heart disease,
cancer care, care of the aging, neuromuscular disorders, and women's
health.
In your position you are responsible for coordinating patient education
across the medical center, including all programs and print materials. Your
staff includes three BSN-prepared nurses, one located at each of the
hospitals. As one of your initial steps in this new position, you have
completed an assessment of the current educational offerings and staff
satisfaction with the quality of the current programs. One area of need
stands out: The professional staff report that a growing number of patients
have been joining online social networking sites. One staff member said, “I
think they are all helping each other get online.” These patients are now
raising new and sometimes difficult questions about treatment options.
None of the staff has explored any of the online sites, and they are afraid
to join for fear that they could become involved in some sort of violation of
the Health Insurance Portability and Accountability Act (HIPAA).
Discussion Questions
1. Describe how you would develop a staff education program and
create an outline of key points that you would include.
2. Develop a patient handout that the staff can use to educate patients on
the effective use of online social media materials.
13
Social Media Tools for Practice and Education*
Heather Carter-Templeton
Abstract
To be er understand the concept of social media, this chapter starts with the definition of social media and describes the
various tools included under this concept. Current and potential ways that both healthcare professionals and
patients/consumers can use social media tools are explored. The challenges of social media in healthcare are examined
within the context of privacy, confidentiality, inappropriate behavior, security, regulatory issues, and market pressure.
To address these challenges, the chapter provides a comprehensive overview related to the development of social media
policies in healthcare.
Peer-to-peer healthcare is a way for people to do what they have always done—lend a hand, lend an
ear, lend advice—but at internet speed and at internet scale.
Susannah Fox
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe social media tools and their benefits.
2. Explore the current and potential use of social media in healthcare and healthcare education.
3. Analyze the issues and challenges associated with the use of social media in healthcare and
healthcare education.
4. Provide guidance for writing social media policies.
KEY TERMS
microblogging 222
social media 220
social networks 221
What is social media?
As noted by Kaplan and Haenlein, “Social media is a group of Internet-based applications that build on
the ideological and technological foundations of Web 2.0, and that allow the creation and exchange of
user generated content.”1, p. 61 Anthony Bradley of the Gartner Blog Network identified six core
principles that differentiate social media from other forms of communication and collaboration:
1. Participation
2. Collective
3. Transparency
4. Independence
5. Persistence
6. Emergence2
These characteristics collectively define social media as “an on-line environment established for the
purpose of mass collaboration.”3
For many people in today’s society, the most popular internet-based sites are those that allow the
individual to make and maintain social connections with others. These sites offer user-friendly and easy
ways to keep up with colleagues, family, and/or friends. Many relationships have been maintained or
strengthened as a result of these platforms. Some relationships, including professional relationships,
would not exist without these platforms. While social media sites and tools are easy to use in
establishing and maintain relationships, the overall impact of social media on individuals, groups, and
communities is often overlooked.4
Social media tools are undeniably transforming how groups and individuals acquire and disperse
information, communicate with others, and connect to those with similar interests. It is of no surprise
that consumers and businesses have gravitated toward these powerful tools. The healthcare field has
not been isolated from this phenomenon and has recognized the potential of social media to increase
awareness of healthcare services, disseminate health promotion and preventative education, recruit new
clients, connect patients to others with similar experiences, and increase access to health services. Social
media steps away from traditional print, radio, and one-way internet methods of mass communication
and offers healthcare a new venue for fast, efficient means of sharing information concerning new
services, health promotion programs, and advances in patient care.5 For many, long gone are the days of
waiting for a response from a physician to find the answer to a healthcare question.
The Healthcare Information and Management Systems Society (HIMSS) Social Media Work Group
speculated that in the long term social media will become ubiquitous and be considered part of routine
healthcare operations, in addition to being part of consumers’ everyday lives. The group referred to the
concept of “healthcare + social media = ‘social health’.” 6, p. 3 Several reports examining the future
transformation of healthcare touted the use of social media as a viable method to meet the widespread
needs of patient populations. The Bipartisan Policy Center,7 in particular, asserted social media
platforms can facilitate the promotion of health and wellness.
Social media tools
Social media tools are web-based platforms that facilitate interaction and networking among their
communities. Social media tools offer a form of communication that allows users to create diverse
content for the purposes of sharing with others via online environments. Different types of social media
platforms exist, including networking, media sharing, blogs, wikis, and microblogs. These different
platforms form the foundation for an ever-growing list of applications. Table 13.1 demonstrates the
evolving nature of social media applications using several well-recognized names.
Table 13.1
Development of Social Media Applications and/or Devices
Year Device and/or Application
1978 Computerized bulletin board
1992 First smartphone released
1998 Blogger
2000 Friendstar
2002 MySpace
2003 LinkedIn and Facebook
2005 YouTube
2007 iPhone
2009 Twi er
2010 iPad and Pinterest
2010 Instagram
2011 Snapchat
2014 Learnist
The future Interactions within an augmented virtual reality
Adapted from Nelson R, Joos I, Wolf D. Social Media for Nurses. New York, NY: Springer Publishing Company; 2013.
There are various ways to classify social media tools. One method is a classification1 system based on
social theories (social presence8 and media richness9) and two key social process elements (self-
presentation and self-disclosure). This system is particularly useful for researchers examining the
impact of social media tools. Assumptions that follow from this classification system include the
following:
• The higher the social presence (awareness of the communication partners), the more
communication partners can influence each other’s behavior.2
• In terms of media richness, the more information that is shared, the less likelihood there is of
ambiguity.
• Self-presentation focuses on how someone depicts his or her image.
• Self-disclosure in the social media world involves the amount of personal information, including
feelings and thoughts, that is shared.
Another way to categorize the use of social media tools is to understand that the structure of a social
media site is dependent on its purpose and the exchange of information (Box 13.1).6 A fairly simple
method of organizing social media sites is to classify them by their types of tools. For example, these
tools can commonly be divided into five categories:
Box 13.1
Social Media Structure
• Provider-consumer: Information exchange between a medical provider or institution and patients or
others in the healthcare community. A good example is the Mayo Clinic’s Facebook page.
• Consumer-consumer: The use of social media by patients, families, or caregivers (consumers) to lend
support or gather and share information relating to their diagnoses, treatments, or healthcare
providers. A good example is the PatientsLikeMe community, where patients not only share
information but their healthcare data on various outcomes.
• Companies (life sciences)–consumers: Pharmaceutical and medical device companies’ use of social media
to engage patients and providers, research use and side effects, market products, support or oppose
legislation, and facilitate notification of recalls. An example is AstraZeneca’s use of Facebook and
Twi er.
• Advocacy group–consumer: Engagement between consumers and advocacy organizations such as the
American Heart Association or Autism Speaks.
• Provider-provider: Connection between medical providers for the purposes of clinical information and
experience exchange. Good examples are Sermo for doctors and the American Nurses Association’s
NurseSpace.
• Public health–provider/consumer: Release of public health messages to promote safety and prevention. A
good example is the Centers for Disease Control and Prevention’s campaign for H1N1.
Adapted from Healthcare Information and Management Systems Society (HIMSS) Social Media Work Group. HIMSS white paper: Health
care “friending” social media: what is it, how is it used, and what should I do? HIMSS. <h p://[Link]/rdcms-
himss/files/production/public/HIMSSorg/Content/files/HealthcareFriendingSocialMediav15%284%[Link]>; 2012.
• Social networking (Facebook)
• Blogging (h p://[Link]) and wikis (h p://[Link])
• Microblogging (Twi er, Vine)
• Social bookmarking or pinning (Pinterest) and social sharing news (Digg, reddit)
• Video or image sharing (YouTube, Vimeo, Instagram)
Social Networking
Social networks are online platforms that enable groups and individuals to connect with others who
share similar interests. They transcend time and geographic restrictions, opening lines of
communication and allowing users to share text, photographs, and videos. The notion is that social
networks build on the wisdom of the crowd.10 Social networks have changed the way individuals,
businesses, and organizations experience and interact with the world of healthcare. Examples of health-
related services provided by social networks include information sharing, social support, access to
information on clinical trials, and processes for monitoring health status and data.11
Seemingly an infinite number of health-related social networking sites have been developed by both
for-profit and not-for-profit groups, including healthcare institutions, companies’ professional groups,
voluntary associations, and health consumers. An example of a not-for-profit site is CaringBridge
([Link]). This site allows users to create their own private and personal websites to
facilitate health status information exchange and encourage support between friends and family
members during health crises.
Examples of for-profit sites include PatientsLikeMe, CureTogether, and Inspire. These sites link
patients with each other and facilitate data and information sharing among patients with similar
diagnoses.
General social media sites also facilitate important aspects of health-related networking. A great
example is Facebook, one of the more popular and well-known social networking sites. A wide range of
individuals, businesses, healthcare institutions, companies, special interest groups, and health
organizations have Facebook pages. Although not exclusively designed as a forum for healthcare, these
Facebook pages are often accessed to gather healthcare information12 and to market practices or
institutions to patients.13
Blogging and Wikis
Blogs represent a web-based, chronological journal of an individual author’s thoughts. They allow for
asynchronous conversations and invite readers to comment and join the discussion.14 Blogs contain a
variety of media types beyond simple text, including links to other websites, video, and images.
According to Sparks, O’Seaghdha, Sethi, and Jhaveri (2011), “The popularity of a blog hinges on its
ability to draw together disparate individuals interested in a specialized topic, creating a community of
ideas, interest, and expertise.”15, p. 512 Medical journals, healthcare facilities, nursing organizations,
healthcare provider networks, and educational institutions commonly maintain blogs to relay the latest
information and facilitate discussion.
Wikis are collaborative, web-based tools designed to compile information on a particular topic or
group of topics. They provide a platform for the creation of a flexible document by allowing many
authors to add and edit content. Wikis are often compared to an online encyclopedia. The best known
wiki is Wikipedia. These sites usually provide search functionality and links to other articles. Examples
of healthcare wikis include Wiki Project Med (h ps://[Link]/wiki/Wiki_Project_Med);
Ganfyd ([Link]), developed by medical providers and researchers to generate healthcare-
specific documents; and Clinfowiki ([Link]), focused specifically on clinical informatics.
Microblogging (Twitter)
Microblogging is a form of blogging in which entries are kept brief using character limitations. Twi er,
the primary microblogging site, restricts blog threads known as “tweets” to 140 characters. These posts
are delineated with a hashtag (#) symbol to organize “tweets” of a particular topic. Several examples of
health-related hashtags used on Twi er can be seen at h p://[Link]/healthcare-hashtags/.
Twi er has emerged as an increasingly popular site for public health research and is used in many
studies to track trends and behaviors related to illnesses and conditions.16 It has also proved a useful
tool for instant communication of vital information during crises or disasters.14 Some authors have
suggested that standard hashtags could be used to create a national conversation within and across
disciplines. For example, Resling concluded a 2016 publication with a call for nursing leaders in Canada
to consider the need for a national social media hashtag or series of hashtags that could be utilized to
unify and extend professional messaging for registered nurses (RNs).16a
In 2009 Phil Baumann provided a multipurpose overview of different healthcare uses of Twi er,
which continues to be a useful resource. See “140 Health Care Uses for Twi er” at
h p://[Link]/140-health-care-uses-for-twi er/.
Social Bookmarking
Social bookmarking is a way to organize and store online resources. Unlike saving bookmarks to your
individual computer browser, the bookmarks are tagged on a third-party website such as Delicious,
Connotea, or Digg. Connotea allows users to bookmark websites as well as journals, a great advantage
for researchers. There are three advantages to social bookmarking: “availability, tagging and
collaboration.”17, p. 236 Availability means that users’ bookmarks are accessible from any computer. The
bookmarks are no longer tied to a particular computer; instead, the social bookmarking service allows
users to connect and access all saved bookmarks. Second, tagging allows the creation of established tags
that are meaningful to the user and not just those established by a computer algorithm. Users can share
their tags with others in their network or join other networks to view their tags. In the spirit of social
media, these tools facilitate collaboration within specific or general networks. The downsides of tagging
are “no standardization with taxonomies such as MeSH [medical subject headings] terms, no
hierarchical associations, and mis-tagging due to spelling errors and highly personalized tags.”17, p. 236
Video and Image Sharing Content
Another method for sharing health information is through the video-sharing website YouTube. This
social media channel allows visitors to view and share videos posted by individuals, businesses, and
organizations. Content has been developed by both professional and amateur videographers and can be
“liked” or “disliked.” It can also be accurate or not so accurate. Because YouTube can present visual
instruction for hands-on skills such as changing a tracheotomy dressing or giving an insulin injection,
this site has a unique advantage for providing health education to patients and providers. Readily
available content includes health-promoting exercise instructions, computer-generated depictions of
how a condition such as diabetes affects internal organs, and general educational content on diseases.
For example, during the Ebola epidemic in 2014, the Centers for Disease Control and Prevention (CDC)
posted several videos to YouTube discussing the epidemic and how healthcare providers could protect
themselves as well as others. Along with videos, there are podcasts, asynchronous recordings designed
to provide healthcare information, and current events announcements.
Flickr is a public photo-sharing site that offers a forum for sharing photos and encouraging
conversation and dialog. Medical facilities are actively using these social media tools to interact with
clients, promote facility activities, and open alternate means of communication.
Foursquare, a social media tool designed specifically for mobile applications, allows users to “check
in” at various venues, instantly communicating with friends and at times receiving discounts at
“checked-in” locations (h p://[Link]). Medical facilities that use mobile platforms are creating
the opportunity for visitors to comment on their hospital experience.
Other healthcare sectors are turning to Second Life, a multiuser virtual environment (MUVE) or
virtual world that allows users to create a three-dimensional arena with graphics and sound simulation
for education and socialization purposes.14 The disability community has embraced Second Life and has
created the Virtual Ability Island18; several schools of nursing use this tool for educational purposes.19
Social media statistics
As the use of social media platforms is becoming more widespread in today’s society, social media
statistics are constantly changing with a general upward trend. For example, as of 2015 nearly two-
thirds of American adults (65%) use social networking sites, up from 7% social media usage in 2005.20
This increased use is also seen in healthcare. For example, the number of social media–related articles
indexed in healthcare library databases is increasing. The number of health-related institutions of with
social media policies is also increasing. In addition, many scholarly journals and professional
organizations are using social media to promote and share content, and healthcare organizations are
creating and expanding social media pages. Many healthcare consumers turn to these resources to learn
more about their conditions or to connect with others.
According to a recent report by PricewaterhouseCoopers Health Research Institute, one-third of
healthcare consumers now use social media to find out more about their medical condition and
symptoms and to share thoughts about their doctors, medications, and insurance companies with
others.20a The following social medical–related statistics were also complied by Referral MD:
• Greater than 40% of healthcare consumers are influenced by social media that inform them about
health-related ma ers.
• People aged 18 to 24 are twice more likely than 45- to 54-year-olds to seek social media for
discussions regarding health.
• Thirty-one percent of healthcare organizations have specific guidelines or policies for their staff
pertaining to social media.
• Nineteen percent of smartphone users have at least one app focused on health. The most popular
type of apps are related to diet, exercise, and weight loss.
• Many trust information found through crowdsourcing; 54% of patients are comfortable with their
healthcare provider looking for information about their condition from online groups.
• Thirty-one percent of healthcare professionals use social media tools such as Facebook, Twi er, and
LinkedIn to network.
• Forty-one percent of people surveyed said social media would influence their choice of healthcare
provider and facility.
• Twenty-six percent of hospitals in the United States use some form of social media, with Facebook
being the most popular platform used.
• Sixty percent of doctors believe social media improves the quality of care provided to patients.21
According to the International Telecommunication Union, “the number of active social media users
surpassed the first billion in 2011, many of whom connect to social media using their mobile devices.”22,
p. 5
In the United States, nearly four in five active internet users visit blogs and social networks daily,
spending approximately 23% of their internet time at these sites.23
According to the National Research Corporation’s Ticker survey,11 one in five Americans use social
media to obtain healthcare information. The Pew Research Center, in describing the social life of health
information, revealed that 59% of U.S. adults have used the internet to obtain health information, while
46% of adults use social media.24 Only 15% of those users (or 7% of all adults) have sought health
information from a social media site.24 Eleven percent of all adults have followed a friend’s health
experiences on social network sites and 17% of social network site users have used social networks to
memorialize someone.24 Twenty-four percent of internet users have sought drug reviews online.24
Caregivers and those living with chronic conditions are most likely to seek information from social
network sites.24
Health-related social network use is expanding rapidly. Specific social networks, such as
PatientsLikeMe, MedHelp, and Inspire, present membership and daily usage statistics on their web
pages and demonstrate an impressive number of members. Social media is also being used by hospitals
throughout the United States. Results from a recent descriptive study found that there was variation
among adoption of social media across hospitals. The majority (94.41%, 3351/3371) had a Facebook
page, a Yelp page (99.14%, 3342/3371), and had the ability to check in via Foursquare (99.41%,
3351/3371); about half (50.82%, 1713/3371) had a Twi er account. Hospitals in large, urban areas
classified as private nonprofit and teaching hospitals had higher utilization of these tools.25 A majority
of physicians have social media accounts for personal use,12 including 28% using online professional
physician communities, mainly for educational purposes but also to communicate with colleagues,
socially and professionally. However, use by physicians to communicate with patients is rare.12
Professional workforce sites such as LinkedIn allow healthcare professionals to connect with others in
their field. Doc2doc, Sermo, and Student Doctor Network all offer forums designated specifically for
physician collaboration and networking. Sermo is designed exclusively for physicians and can be used
to hold “closed door” consultations with colleagues and access experts in the field.14 Nurses and other
healthcare specialists maintain their own profession-specific social networking sites to communicate
field-relevant information, such as American Nurses Association’s (ANA’s) Nurse Space and
[Link].
Many major healthcare systems have realized the positive influence of social media and commi ed to
the use of social networking tools to support the delivery of healthcare information, describe their
services, recruit employees, and communicate their mission.4 The U.S. Department of Veterans Affairs
(VA) recognized the power of social media and is aggressively incorporating social media tools into its
agenda. In December 2011 the VA announced Facebook pages for all of its 151 facilities, with more than
352,000 subscribers. While the Facebook sites restrict specific discussion of individual veterans, the staff
members monitoring the site have at times intervened to lend support in mental health crisis
situations.26 The VA has its own YouTube channel, 64 Twi er feeds, a Flickr page for photos, and a
veteran-run blog. The VA’s Directive 6515: Use of Web-Based Collaboration Technologies not only highly
encourages the use of social media but also “endorses the secure use of Web-based collaboration and
social media tools to enhance communication, stakeholder outreach collaboration, and information
exchange; streamline processes; and foster productivity improvements to achieve seamless access to
information.”27, p. 1 The VA believes that the use of social media technologies will support the
organization’s mission effectiveness through the benefits of speed, broad reach, targeted reach,
collaboration, a medium for dialog, and expansion of real-time, sensitive communications.27
The Mayo Clinic has also embraced social media, pioneering a first-of-its-kind social media center.
The Mayo Clinic Center for Social Media “exists to improve health globally by accelerating effective
application of social media tools throughout Mayo Clinic and spurring broader and deeper engagement
in social media by hospitals, medical professionals and patients.”28 The Mayo Clinic Center for Social
Media’s mission to “lead the social media revolution in health care”28 is driven by a philosophy of
improved health through patient empowerment and collaboration among healthcare providers. To
facilitate the growth of social media in healthcare, the Mayo Clinic offers a residency training program
that provides advanced intensive training in the use of social media.
Healthcare insurance companies are also joining the trend of using social media tools to promote
well-being. Blue Cross and Blue Shield (BCBS) maintains a social media site for its members that allows
individual profiles, blogs, discussion threads, and access to experts in nutrition, cooking, and health
coaching. Pharmaceutical companies are using social media tools to provide customers and physicians
with educational materials.12 Input from physicians facilitates a relationship with pharmaceutical
companies to “collaborate for adherence solutions” for improved patient outcomes.12 These sites also
offer customer and patient services, opening channels for medication users to discuss experiences and
needs.12
Benefits of social media
There are several benefits associated with the use of social media. One of the most obvious benefits is
the opportunity to improve provider-to-provider as well as patient-to-provider and provider-to-patient
communication. Social media offers a means of communication between provider and patient that is
more personable and can have the unintended consequences of an enhanced patient experience.29 By
improving communication and facilitating the swift transfer of information, the use of social media may
correlate with a positive influence on patient outcomes.30 These tools go beyond simple one-way
communication, creating an engaging form of conversation between patient and provider.31
Another benefit is in the area of research. A growing number of studies describe potential benefits of
social media. These studies can be divided into three general areas of research in social media: (1)
description of the content on social media sites, (2) the use of social media, and (3) potential use of social
networks for research. The first area examines the content of social media being disseminated through
social networks and microblogging tools such as Twi er. Content analyses and text-mining techniques
are used to assess the nature and quality of the content. Findings from this research include the
following:
• The most common health conditions on social media are diabetes, cancer, pregnancy, mental health,
and neurologic conditions.32
• Social networks are places where information, including personal experiences and personal stories,
can be shared with the intended community.33-36
• The majority of the information is valid, although this can vary from network to network.34,37-39
• Twi er messages produce valuable public health information about the public’s knowledge of
antibiotics,38 H1N1,37,39 and seizures.40 Researchers have validated Twi er as a real-time content,
sentiment, and “public a ention trend-tracking tool.”39, p. e14118
• “Twi er might also be a promising platform for leveraging social support to motivate health
behaviour change”42, p. 1159 and promoting healthy behaviors.41,43
The second area of studies examined how specific patient populations used social media.
PatientsLikeMe44-46 is the most studied network to date. Other studies examined specific patient
populations (oncology,47-50 depression,51 traumatic brain injury,52 and asthma53). Highlighted findings
are as follows:
• Benefits noted by patients included finding others with similar health conditions44-48 and seeking
information related to symptom management and treatments.44-46
• Patients used various techniques to search for other patients’ video stories47 and used them for
encouragement48 and social support.49,51
• Facebook had the largest number of social networks for breast cancer but most were for increasing
public awareness and fundraising.50
The final area examined two major uses of social networks in the research process. First, researchers
are recruiting potential clinical trial subjects from within disease-specific web and social networking
sites that then provide this information to pharmaceutical companies, universities, and research
labs.10,13,54,55 Second, researchers are using social networks to accelerate clinical discoveries10,56,57 and
provide “a low-cost and scalable model of citizen science”58, p. e19256 for data sharing and bidirectional
communication within a disease population. According to Swan, “Self-run clinical trials and structured
self-experimentation are emerging as patients no longer have to wait for formal research findings and
pharmaceutical company-sponsored clinical trials. These efforts may fill the gap for orphan diseases and
other conditions that do not make good business cases in the existing pharmaceutical model.”10, p. 500
Additional benefits of social media include access to information and social support. Facebook,
YouTube, and Twi er are the most common social media sites used by patients to obtain healthcare
information or interact with other patients with similar diseases or health and wellness interests. “Social
media platforms for online dialogue and support among individuals with common conditions, needs or
interests support prevention, wellness, and healthy behaviors.”6, p. 14 Social media sites59 not only foster
social support but also enable patients to manage their own health conditions, typically at no direct cost
to the patient. That is because many of for-profit sites make that profit by selling the data collected from
patient postings as well as through targeted advertising to these patients.4
Two predominant forces are “driving online health conversation: (1) the availability of social tools and
(2) the motivation, especially among people living with chronic conditions, to connect with each
other.”22, p. 3 The most popular social media sites specifically geared toward patients (PatientsLikeMe,
CureTogether, MedHelp, and Inspire) offer venues for dialog and also shift the power of achieving
health and well-being into patients’ own hands. As healthcare evolves from paternalistic to partnership
models,10 these two forces will continue to fuel the growth of social media in healthcare. The
development of social media arenas has created a community of ePatients engaged in their health and
healthcare decisions (h p://[Link]/about-e-patientsnet). Many of these individuals will take part
in quantified self-tracking (online data entry of condition, symptom, treatment, and other biological
information to monitor personal progress) and search for “patients like me.”10
Challenges of social media
The world of social media is not free of challenges and opposition. Social media can enhance the
consumer’s and provider’s healthcare experience but also has the potential to undermine the goals of
healthcare.60 Thus the strengths of social media’s open platform and networking capabilities are also its
greatest weaknesses. The uptake of new technology requires a careful appraisal and informed risk
analysis. Unfortunately, many are not exploring the benefits of social media due to prolonged
discussion and debate often stalled by skepticism and by those who are risk averse.61
While social media connections are facilitated through technology, the technology should not
necessarily be the focal point, but it should serve as the medium used to connect with others. Many may
be apprehensive about using social media platforms to communicate with others, offering reasons such
as:
• It takes too much time to learn
• Participation may be seen as unprofessional by other healthcare providers
• It is too easy to make a mistake and post something that is prohibited by an employer’s social media
policy
• It is too easy to make a mistake and post something that compromises patient confidentiality
Social media has quickly developed into an acceptable form of mass communication.62 However,
managing the stakes associated with social media communication channels requires professionals that
learn to effectively use these tools, work to share quality information, engage other stakeholders, and
respond to feedback from others.
Health professionals should be aware of the dangers associated with social media use prior to
engaging in its activities.60,63 The primary principle influencing the use of social media in healthcare is
the obligation to serve the best needs of the public; however, clinicians are bound by laws, practice
ethics, and professional codes of conduct governing how and when to use social media applications.
The digital environment is not isolated from the real world,64 and professional standards that exist in
one realm should carry over to the other. Moreover, naive and negligent social media practices bring
about security vulnerabilities that can compromise professional integrity and consumer confidence.60
Fortunately private and professional organizations recognizing these issues have provided guidance
regarding appropriate social media practices. Table 13.2 provides several examples. Each of these issues
will be explored in more detail in the sections that follow.
Table 13.2
Health Related Professional Guidelines and Social Media
Professional Document
URL
Association Title
AMA Professionalism <h p://[Link]/ama/pub/dab/[Link]>
in the use of
Social Media
ANA ANA’s <h p://[Link]/MainMenuCategories/ThePracticeofProfessionalNursing/NursingStandards/[Link]>
Principles for
Social
Networking
and the Nurse
AMA; Social Media <Social_Media_and_the_Medical_Profession_FINAL_with_links.pdf>
NZMSA and the
AMSA Medical
Professions: A
Guide to
Online
Professionalism
for Medical
Practitioners
and Medical
Students
Federation Model Policy <h ps://[Link]/Media/Default/PDF/FSMB/Advocacy/[Link]>
of State Guidelines for
Medical the
Boards Appropriate
Use of Social
Media and
Social
Networking in
Medical
Practice
NCSBN White Paper: A <h ps://[Link]/Social_Media.pdf>
Nurse’s Guide
to the Use of
Social Media
NMC Guidance on <h p://[Link]/standards/guidance/social-networking-guidance/>
Using Social
Media
responsibly
NMC Social <h p://[Link]/Nurses-and-midwives/Advice-by-topic/A/Advice/Social-networking-sites/>
Networking
Site Guidance
RCN Use of Digital <h p://[Link]/__data/assets/pdf_file/0008/586988/004_534_web.pdf>
Technology:
Guidance for
Nursing Staff
Working With
Children and
Young People
INRC INRC Social <h p://[Link]/globalassets/docs/prac/[Link]>
Media Use:
Common
Expectations
for Nurses
AMA, American Medical Association; ANA, American Nurses Association; NZMSA, New Zealand Medical Student
Associations; AMSA, Australian Medical Student Association; NCSBN, National Council of State Boards of Nursing; NMC,
Nursing and Midwifery Council; RCN, Royal College of Nursing; INRC, The International Nurse Regulator Collaborative.
Privacy and Confidentiality
The most significant challenge for healthcare providers who use social media is to maintain privacy and
confidentiality. There is an innate relationship between privacy and sharing many aspects of a personal
or professional situation. Digital social media tools have brought these challenges to the forefront. Prior
to social media, with its open access, individuals and organizations had more control over what
information was shared and who had access to that shared information. With online, real-time
capabilities, that control is much more limited. This loss of control requires more a ention and
awareness with regard to personal information that can be quickly and easily shared within online
social environments. Each social media application offers options, often referred to as se ings, related to
privacy. It is not always easy to find and determine how these options actually function. However, it is
important to invest the time and effort necessary to understand these options. The advantages social
media offers for professionals and scholars in terms of networking can be greater than the risks
associated with privacy issues.65
Social media applications tout the ability for users to establish “many-to-many” relationships. As
promising as that may sound, these open forums provide the opportunity for clinicians to inadvertently
divulge consumer information to a vast number of people. A valuable mindset to have is to equate a
social media application to the circumstances inside a hospital elevator;66 any number of people can ride
in an elevator and all can hear the conversations taking place within them. Further, healthcare providers
are “dual citizens” in the social media arena67 because they have professional and private uses for social
media–generated content. This dual role increases the chance that professional boundaries may blur and
may encourage clinicians to inadvertently communicate too openly.68-74
Healthcare providers are accountable to federal laws and professional standards that protect the
privacy of patients’ protected health information (PHI).60,75 The Health Insurance Portability and
Accountability Act (HIPAA) of 1996 defined the appropriate handling of PHI.75 Government agencies
and employees are further restricted by the Privacy Act passed in 1974.76 Both require that a patient
must provide authorization before healthcare professionals and organizations can release any part of
the patient’s record.72,77 PHI refers to individually identifiable information that is related to the delivery
of healthcare78 and does not always indicate obvious identifiers such as name, social security number,
and date of birth.79 Additional information about the privacy and security rules within the HIPAA
legislation is included in Chapter 26.
Even without explicit representation of such individually identifiable information, social media
applications are rich with other details that could identify a particular consumer.80 Social media profiles
displaying a consumer’s hometown, personal interests, and family photographs may be pieced together
to reveal the consumer’s identity. Consequently, healthcare providers may inadvertently reveal certain
key facts that could lead others to recognize a specific patient.79
In addition to federal regulations, healthcare providers are bound by their professional codes of
conduct, which regard privacy and confidentiality as compulsory. For example, the ANA’s Code of
Ethics states that the “nurse has a duty to maintain confidentiality of all patient information.”81, p. 6
Further, according to the ANA’s Principles of Social Networking and the Nurse, “patient privacy is a
fundamental ethical and legal obligation of nurses.”60, p. 4 Physicians are also commi ed to keeping
patient information private. According to the American Medical Association’s (AMA’s) Code of Ethics,82
physicians should not share confidential information without prior consent of the patient. In addition,
the AMA has established a social media policy for physicians.83 These standards apply even when
healthcare providers are not physically in their clinical roles.60
Conscious awareness and diligent adherence to laws and professional standards may not be enough.
Healthcare providers acting in good faith may still unwi ingly expose consumers to privacy and
confidentiality risks. The primary reason lies in the naive trust they may have in the privacy se ings of
the social media application itself.72 Risks often arise because clinicians fail to invoke certain privacy
se ings in their social media accounts.72 Further, social networking sites such as Facebook often push
privacy barriers and wait until consumers complain before tightening privacy restrictions.84 “Friending”
is one example of a less conspicuous means of breaching privacy. A healthcare provider may “friend” a
patient in hopes of keeping in be er contact but fail to realize that the other “friends” on his or her
account may also be able to view the patient’s name and information.70,85 Another critical point to
consider is the consumers’ own account se ings, as they may not share the same level of social media
literacy.13 For instance, a patient may not realize that adding a healthcare provider as a friend may
expose the patient to unwanted scrutiny from other friends. Although this is entirely the patient’s
choice, healthcare providers are responsible for advocating for the best interests of their patients.81,82
Another naive assumption about the use of social media is the belief that consumers are who they
claim to be.86 Healthcare providers unaware of identity impersonation or hacking may unknowingly be
divulging private information to someone other than the intended consumer. Just because consumer
social media pages may have images and some recognizable data do not quantifiably identify them as
accurately representing those individuals. Unless clinicians have a means to authenticate the consumer’s
identity, there is no way to guarantee that any social media contact, no ma er how secure or
confidential, involves the intended individuals. The relative permanence of online activity60 adds an
even greater degree of harm when sharing information with consumers who are not validated.
Inappropriate Behaviors
In addition to the risk of jeopardizing patient privacy and confidentiality, healthcare providers are also
in danger of openly engaging in inappropriate behaviors. The danger arises from a healthcare
provider’s “dual citizenship” in the social arena.64 This dichotomous role can blur the personal and
professional boundaries that exist more clearly in the physical world.70,71,73,74,87 In some cases the
information a healthcare provider shares with his family and friends may be inappropriate for the
general public to see. Consequently, healthcare providers must maintain the same level of
professionalism online as they would in a healthcare se ing.60,68,75
Inappropriate behaviors can include questionable blog and photo postings, unprofessional
commenting, and projecting a itudes unbecoming of respectable healthcare personnel.88 Not only does
such behavior tarnish the clinician’s reputation; it can also result in disciplinary action. For example,
physicians have been reprimanded for misrepresenting their credentials, improper internet prescribing,
and sexual misconduct.89 Moreover, news agencies from various countries around the world have
reported incidences of clinician improprieties, including nursing students posting images of organs
(e.g., displaying a photograph of a placenta), medical students being vulgar or sexually suggestive, and
doctors engaging in unprofessional social “games” online.90-92
Although these behaviors reflect a lack of personal accountability,87 other professional indiscretions
can be even more profound. Healthcare providers may find themselves endorsing drug products or
third-party businesses by joining their online groups or “friending” one of their employees.93 Such
activities, without the appropriate declaration of conflict of interest,73 could give consumers false
impressions.
Another indiscretion involves clinicians actively seeking out patient information online. In particular,
behavioral healthcare providers face professional dilemmas when determining whether to view a
client’s social media site to gain further clinical insight.94 Although intended to facilitate clinical
evaluations, such actions could be viewed as a violation of the patient’s trust.94 Behavioral healthcare
providers are also particularly challenged when gauging the appropriate amount of client contact: too
much contact through social media could encourage client transference and too li le could lead to
patients feeling rejected or abandoned.71 Further, nurses who are excessively passionate about social
media use for consumer advocacy may also be vulnerable to crossing boundaries.95 Patient advocacy is a
professional obligation for nurses;81 however, social media applications enable nurses to overstep their
boundaries. In an effort to connect with patients and win patient approval, some nurses can end up
disclosing too much of their own personal information and come across as flirtatious or self-centered
and misrepresent their profession.95 Healthcare providers can falter in a empts at appropriate online
behavior if they do not keep the patients’ best interests in mind and advocate for patient well-being.68,95
Healthcare providers who use social media must consider who might view their postings and what
impact those postings could have on their individual careers as well as their profession.60,96 They must
always consider social media platforms to be public domain and open to others who are unintended
participants.68 Failure to recognize these truths can have untoward consequences. Organizations and
academic programs have taken punitive steps to address inappropriate behaviors, including expulsion
of students and suspension or termination of employees.87,91,97,98 Licensing boards have held disciplinary
hearings in response to member misconduct.89 Employers have also passed over applicants that have
questionable content on their social media sites. Insurance companies likewise use social media
platforms to validate claims or check on beneficiaries.99,100 Thus inappropriate behaviors could lead to
loss of coverage or cancellation of insurance payments.101
Security
Social media applications reside on the internet, which is characteristically and notoriously
unsecure.102,103 This high-risk environment is one of the principal reasons why healthcare organizations
often restrict employee access to social media sites.87,104,105 Although there are few reports of social
media–related security breaches in healthcare, organizations do not have to look far to comprehend the
risk that social media use can bring. Even with strict security se ings, healthcare information systems
are still susceptible to viruses, spyware, phishing, and other internet threats.102,105 The primary reasons
for these vulnerabilities are the personnel themselves, 106,107 who succumb to social engineering
deceptions and can inadvertently allow the social media site to be a vector for malicious behavior.86,106
Social engineering is the use of tactics to lure or deceive people into doing something they would not
g g p p g g y
normally do. Social media applications have made it easier for dishonest individuals to a ack others by
enabling contact with numerous people at relatively li le or no cost and with virtually complete
anonymity.108 These deceptions can be carried out through the social media site’s electronic mail, which
can contain deleterious software or an infected link on someone’s blog. The social media user’s
interaction with these malicious a acks enables harmful applications to bypass electronic defenses and
enter an organization’s previously secure network.106
Another avenue for perpetrators to infiltrate another computer network is by “malicious friending.”106
This occurs when a person who is accepted as a friend changes his or her profile to include malicious
code or unwanted content.106 Malicious friending can also happen through distal extensions, or friends
of friends. Users who open up their privacy se ings to friends may inadvertently allow extended
friends into their personal sites and subsequently make themselves vulnerable to a ack.108 These
vulnerabilities are considered a type of social engineering that thrives in the social media arena, where
users are quick to assume trust in the social media platform as well as in other users.107,109
Even with sound judgment and scrupulous navigation, social media users may engender security
vulnerabilities by placing too much trust in the social media platform they are using.107 Hackers, or
those who infiltrate websites for malicious purposes, can implant malicious code into the social media
site itself.107 This is often done through advertisements107 or by deceiving users into accessing an
alternate log-in screen.110 There is also free software that allows anyone to access another’s social media
account when both are on an unsecured wireless network.86 Further, sites like Twi er, which enable
broadcasting of microblogs, can also promulgate the spread of malicious activity by disseminating
abbreviated links to websites that appear safe but are in fact gateways that lead the recipient to a
harmful internet location.107,111
The means by which users access social media platforms has also elevated security risks. In particular,
more and more users engage in social media via mobile devices,107,109,112 such as laptops, tablets, and
smartphones. These devices increase social media use and have also made users more vulnerable.113-115
The ease of social media use on these platforms can encourage users to divulge too much personal
information.116 Unwi ing consumers who post their location and activity on their social networking site
may, for instance, actually invite thieves to rob their homes.114
Social media use on a mobile device also opens the risk of additional threats from other third-party
applications called remote access Trojans (RATs)107,114 A RAT is a malware program that opens a
backdoor to the user’s computer, thereby opening up to a third-party administrative control over the
user’s computer. These RATs can appear harmless to the user while allowing third parties to access the
user’s personal information.107,115,117 These apps can then share the information with others, destroy it
outright, or use it to impersonate the content owner.107,117 Moreover, apps often operate in the
background, unnoticed by the user, and can steal passwords, personal account data, and other private
information.102 Finally, storing personal information, such as details of a social media profile, on a
mobile device increases security vulnerabilities if the device is lost or stolen.111,115
Security breaches from any of these vulnerabilities can result in loss of data and varying degrees of
criminal activity.104 Hackers could obtain clinician passwords and gain access to a hospital’s vast
database of PHI, leading to privacy breaches and financial damages. While loss of financial data is
damaging, access to PHI could lead to identity theft and cyberbullying or cyberstalking, and in turn
significant emotional and mental turmoil. Identity theft has been labeled as one of the top five social
networking scams.110 Moreover, identity theft has been reported as one of the most frequent consumer
complaints regarding internet use, second only to nondelivery of goods.118 According to the Federal
Trade Commission (FTC), identity theft is the number one consumer complaint category, and these
grievances are continuing to grow.119
Social media application use can contribute to the threat of identity theft by expanding the user’s
digital footprint, described as lingering electronic information that can be linked back to the user who
provided it.120,121 The bits of information disseminated across the internet can be combined to form a
more detailed profile of the individual.121 Social media users’ naive efforts to become visible to friends
and relatives actually may make them “knowable” to others who may have malicious inclinations.119
Thus the open and trusted sharing of personal information can turn on the user and be employed for
purposes other than what the user intended.122,123
Cyberharassment and cyberstalking are also increasing.118 These terms are synonymous with
cyberbullying but refer to adult behavior, whereas cyberbullying generally refers to underage
harassment.124 Regardless of the terminology, these are all considered social threats and are described as
the stigmatizing, bullying, and threatening of others. This intimidation can pose significant danger to
the recipients and their affiliates or friends.79 Cyberstalking is not limited to threats or intimidation
directed at specific individuals; organizations can be targeted as well.86 Discrimination can be directed
toward an individual’s or organization’s religious affiliation, political views, sexual orientation, or
group association;80 it can even involve an individual’s medical diagnosis or hospitalizations.
Cyberharassment, sometimes called digital abuse, includes online threats or aggression toward
individuals or groups with the objective of intimidating or coercing others who are perceived as being
unable to retaliate.125,126 Social media platforms, which enable anonymous activity, have propagated
these behaviors in the internet environment.126 In addition to practicing these behaviors in relative
anonymity, cyberstalkers may also impersonate another individual, thus causing further harm while
displacing the blame.110 Healthcare providers are not immune to such behavior, as was seen when a
British surgeon’s identity was stolen and used to create a Facebook page that slandered an Olympic
swimmer.127
Regulatory Issues
Many of the challenges and risks discussed here exist because social media sites and the internet as a
whole are not effectively regulated.60,128 The Federal Communications Commission (FCC)129 is the U.S.
government body responsible for regulating communication through various media, including those
employed for internet use. In 2015 the FCC voted to maintain “net neutrality.”130 Net neutrality is the
principle that internet service providers and governments regulating the internet should treat all data
on the internet in the same manner, not discriminating or charging differentially by user, content,
website, platform, application, type of a ached equipment, or mode of communication.
One of the key agencies in healthcare, with legal authority to control who may contribute social media
content, is the U.S. Food and Drug Administration (FDA).131 The FDA regulates the distribution of drugs
and medical devices.131,132 Pharmaceutical companies often engage in social media to promote consumer
interaction and adverse events reporting,132 However, these companies must be cautious and avoid
posting anything that could be interpreted as off-label promotion.133 They must also be careful when
using social media to respond to unsolicited requests for drug information, as this avenue reaches a
broader audience and remains viewable for an indefinite period of time.131 Consequently,
pharmaceutical and device manufacturing companies must respond according to FDA guidance to not
appear to be promoting their products for unapproved purposes.131
Further, as discussed earlier, healthcare provider behavior is governed by laws limiting the kinds of
information to be disclosed and to whom. This is directly related to the appropriate use of consumers’
PHI. In addition to patient content restrictions, healthcare providers must be aware of the medical
information they post and the advice, if any, they provide. This information should be appropriate and
reliable and avoid any copyright infringement.134 Misinformation can be detrimental as well as
dangerous to the individual and organization.60,135 It is also critical that healthcare providers avoid
engaging in behavior that might be regarded as fraudulent or an abuse of their position. Certain social
media information exchanges could be construed as kickbacks or inappropriate in the medical-legal
environment.134,136 If healthcare providers use social media with the intention of providing care, they are
using telehealth, allowing for the provision of care over a distance using telecommunication
technology.137 Accordingly, social media used as a form of telecommunication could be regulated by the
clinician’s state and local agencies overseeing telehealth licensing and scope of practice.138 Additional
information about these regulations can be found in Chapter 8.
In light of the absence of more definitive regulation of social media sites, some have pushed the need
for the federal government to intervene.139 The risk to the public regarding privacy, confidentiality, and
information security would seem to endorse that sentiment. Still, others have suggested that social
media sites engender crowd wisdom and can engage in their own self-regulation.112
Market Pressure
The myriad risks associated with social media use have caused some healthcare providers to avoid
using these applications.140 Yet consumer demand and in turn market pressure for social media
applications in healthcare continue to grow. Healthcare providers who rely on advertising to increase
clientele may have no other choice but to enter the social media arena.140-142 Social media has become a
driving force for corporate marketing as well as consumer ratings.141,143 This is especially true as more
and more social media resources are emerging to provide public opinion on goods and services.144
The fact is that consumers are the primary driving force for using social media in healthcare, and
increasing numbers of consumers seek health information online.145 The resource of choice for many
consumers is a healthcare provider.146 Consequently, consumers may search for and expect to learn
more about their healthcare questions from clinicians using these sites.
As more and more private practice physicians join accountable care organizations (ACOs), marketing
and consumer ratings will become more significant. The push to provide patient-centered care147 in
ACOs will add pressure to those organizations and physicians who are currently reluctant to use social
media as one option to connect with their patients.
Many organizations and individual clinicians have recognized these trends and the value that social
media tools can bring, such as ease of use, information sharing, and timely updates.148,149 From a
business perspective, healthcare institutions find the low cost of social media an economical means to
market their resources,150 educate patients, and engender client loyalty.151 The increase in clientele
gained from social media use5,97 can counter the lack of financial reimbursement,140,152 as well as the time
and effort needed to stay involved in social media sites.135,153 With this pressure, the number of
participating organizations and clinicians is expected to grow, adding to the expanding use of social
media to market healthcare goods and services. Nonparticipating individuals and groups may feel
pressured to opt in, just so that they too may gain market exposure.
Within healthcare organizations, many often work tirelessly to make sure channels of communication
are handled carefully. In most cases, healthcare organizations began to use social media for the
purposes of marketing and public relations. These new and novel avenues of contact and dissemination
offered healthcare organizations contemporary ways to reach those they served and potentially gain
more consumers. Organizations often worked with those designated to maintain their websites and
marketing materials to integrate their brand into the world of social media. Healthcare providers also
began to use social media tools to discover how they might include them in their care and patient
encounters. Social media platforms are becoming more and more intertwined into our daily lives and
activities. Furthermore, many healthcare provider recruiters use social media to gain the a ention of
candidates and potential employees by direct contact or by publicizing a healthy work environment.
Healthcare organizations will continue looking for innovative and relevant ways to use social media for
consumer and provider engagement.62
Social media is clearly valuable in increasing organizations’ visibility. Some organizations may
question whether they can flourish and prosper without these tools. According to Allison, “It’s the new
coffee shop.”154. p 50 The two most likely platforms to connect with your patients are Twi er and
Facebook. Prior to the advent of the internet, healthcare consumers used the advice of their friends and
family when learning about health-related information and resources. That remains the same; however
the amount of friends and contacts we can access easily is greater than before. Patients and healthcare
consumers can now use these connections to broadcast their feelings about their care. In turn, this gives
healthcare providers and organizations the opportunity to come in contact with consumers in real time.
A new source of healthcare-related information is now available in the form of rating sites that offer
information from a patient perspective about quality of care. Consumers are more frequently posting
their opinions online as to whether or not they like a particular service or experience.144 Numerous
websites allow patients to rate their physician or hospital experiences (e.g., [Link],
[Link]). General business websites such as Yelp also allow consumers to rate and post
comments on various hospitals and healthcare service organizations. Consequently, consumers often
seek ratings or rankings from others before making a decision about purchasing goods and services,
including healthcare.146
One of the great risks of social media rating sites is not knowing what rating information, whether
good or bad, is being shared.143 For example, healthcare providers may be surprised to discover their
services are being rated by a site they never heard of and by “patients” they have never seen. While one
might challenge the authenticity of what is found on social media and the internet, this new source
could potentially be useful as a complement to traditional methods of measuring quality of care. Some
suggest future research exploring how suitable social media is in assisting to judge the quality of care
offered by healthcare professionals and organizations.155
With the growing number of sites and consumer interest in them, healthcare organizations and
clinicians may feel compelled to create a social media site to promote their strengths and perhaps
counter any negative ratings.141 Contributing to this urgency is the fact that organization rankings have
been posted on hospital scoring websites such as Healthgrades, Hospital Compare (operated by the U.S.
Department of Health & Human Services), and [Link].
Another compelling reason to enter the social media arena is to dispel misinformation and bridge the
digital divide. Consumers have unprecedented access to health information on the internet but may
encounter inaccurate data.133,145,152,156 Social media enables the creation and propagation of inaccurate
and misleading information.60,96,128,157-159 Largely due to lack of oversight,159 web-based information can
be created by anyone128 and be disseminated far too easily.133 Just about anyone can enter, alter, edit,
and even sabotage social media applications.150 Moreover, authors of social media content do not need
to identify themselves158 or provide any credentials.96 Site association can also perpetuate inaccuracies.
Authors of blog content who are not members of the health profession may associate themselves with
reputable sites in order to seem as though they are in the field.96 Consumers may also be misled by
inaccuracies or opinions that dominate a particular site.153,160 For example, an overabundance of
opposition to child vaccinations on certain sites153,160 could dissuade parents from immunizing their
children, even though vaccines are valuable and could even save a child’s life.161 Information, even when
accurately presented, can be reviewed out of context in the social media arena,162 and subjective
healthcare material can be easily accessed, circumventing any disclaimers or warnings.163
Healthcare providers are in a position to counter inaccuracies by sponsoring a social media site
themselves or guiding consumers to reputable sites.157 By choosing the la er strategy, healthcare
professionals can become apomediaries.156 Apomediation involves standing by to direct consumers to
high-quality information on the internet rather than standing between the consumer and the
information, as has been the usual practice in the past.156 Clinicians may do this in person by
interpreting web-based healthcare information that patients bring to their office visits.160,164 Clinicians
could also perform outreach via social media applications to contact and guide consumers who post
questions or concerns regarding health conditions or services. Caution in these situations is necessary,
as clinicians do not control the content of the referred site and there is a chance that a healthcare
provider could recommend an unreliable source.156
The final incentive to clinician adoption of social media use is to facilitate the bridging of the “digital
divide.” Since the inception of the internet there has been a disparate representation of tech-savvy users,
who have the means and knowledge to use the web, and those who lack either the means or the
wherewithal to navigate.165,166 Social media emerged as a means to bridge this divide because there is
relative uniformity of use of social media across cultural and economic groups.145,166-168 More disabled
consumers can be reached through social media use.60 Consumers in the older age demographic are
about the only ones that have been identified as underrepresented in the social media arena.146,167-169
Nevertheless, clinicians could accommodate older consumers via the usual methods, including in-
person visits, telephone calls, and wri en media, while expanding their impact to others via social
media.
Social media in education
Although the use of social media is widespread and social media tools have the potential to play a
pivotal role in facilitating the sharing of health information and knowledge among healthcare
professionals, limited information exists to explain or demonstrate best practices for educating or
preparing health providers for using this resource. Social media platforms can help facilitate the concept
of crowdsourcing to expand knowledge among expert clinicians.170 To stay current and relevant within
society today, healthcare providers must learn how to employ the use of these technologies while
confronting the obstacles and hurdles associated with the use of social media in healthcare. But to reach
their full potential, providers must be prepared educationally to access evidence-based resources via
social media tools.171
The use of social media to engage and facilitate discussions related to EBP among healthcare
providers as students and professionals holds great potential.172,173 Clinicians immersed in day-to-day
practices can offer each other information about, for example, new diagnostic tests, using social media
formats such as Twi er.174 If healthcare providers can have their clinical questions answered on the fly,
one might anticipate improved patient outcomes, retention, and satisfaction and reduced liability as
potential benefits.
Many healthcare providers, including faculty, remain unaware of the potential Web 2.0 holds for
connecting to other healthcare team members, despite evidence that concludes healthcare professionals
and patients are empowered by information technology.170 Furthermore, healthcare faculty must make
an effort to engage in learning more about these tools in order to prepare a workforce that is ready to
practice in a modern healthcare system. By understanding how social media, Web 2.0 tools, and
applications operate, healthcare providers can effectively use these platforms and tools to improve the
health of individuals and communities they serve. However, much more research is necessary before
best practice models can be established to use these tools to enhance our teaching and learning.
While social media platforms hold vast potential for augmenting professional networks and
supplying valuable evidence-based information to healthcare providers and consumers, healthcare
providers must be well aware of existing policies at the national, state, and organizational levels
pertaining to the use of social media. A careful approach to using social media platforms can result in
professional benefits without the violation of policies or rules regarding patient confidentiality.
Policy
Healthcare organizations that use social media or permit the use of social media typically have policies
that govern the use of such media. Most of the policies related to the use of social media address
personal internet use by employees during work hours. The organization may specifically address what
types of websites may be accessed during work hours or they may even maintain careful control of
websites that may be accessed while in the facility. The policies typically do not address the use of social
media outside of the workplace.175,176
Social media has the potential to enable healthcare providers to foster professional relationships while
facilitating interpersonal communication and consumer education.176 However, healthcare providers
who use social media are subject to increased security vulnerabilities,106,177 blurred professional
boundaries,67,69,73,168,178 and confidentiality breaches.176,177 For these and other reasons, policies are needed
to help guide organizations and clinicians through recommended social media practices.179,180 In
addition to risk avoidance, social media policies can also illuminate professional expectations and
establish definitions for acceptable behavior. The three critical elements that a well-constructed social
media policy could mitigate are information disclosure, professional integrity, and productivity.87
A social media policy should limit information disclosure. It must illuminate the behaviors that
increase the potential for breaches of patient privacy and confidentiality as well as address how such
violations conflict with privacy laws and professional ethical standards.75,80,81 Social media policies
should also engender professional integrity by discouraging clinicians from divulging too much of their
own personal information in addition to discouraging them from creating or disseminating inaccurate
or potentially harmful information.60 Wri en guidelines could also require healthcare providers to
create separate accounts for private and professional use when choosing to use social media for
consumer engagement.181 A social media policy should define acceptable limits for social media use and
consequences for overuse.180,182 It may further delineate the organization’s definition of overuse,
repercussions for loss in productivity, and ramifications if social media indulgence creates an
impression among customers that clinicians are not paying a ention to their work.97
Social media policies must also be congruent with federal, state, and local legislation and regulations.
For example, social media policies must avoid regulating legally protected employee behavior. This
issue is why the National Labor Relations Board (NLRB), an independent federal agency that enforces
the National Labor Relations Act (NLRA), has taken an interest in social media policies that bar
employees from discussing the terms and conditions of their employment on social media. The NLRA
protects the rights of employees to speak about work conditions. This protection extends to certain
work-related discussions carried out via social media platforms. In 2010, the NLRB began receiving
charges related to employer social media policies and the disciplining of employees related to social
media posts. The agency found reasonable cause to believe that some disciplinary actions violated
federal labor law. This resulted in complaints being issued against employers for unlawful conduct.
Additional information about this topic can be found in Chapter 25.
The final consideration regarding social media policy creation is to determine which level of
development would best serve the needs of the public as well as the industry. Health-related public
policies are created at the national or state level and establish authoritative oversight by the executive,
judicial, or legislative branches of government.183 These types of policies tend to protect the interests of
certain groups of people, such as the elderly or underserved, or types of organizations, such as
healthcare plans or employers.183
Organizational-level social media policies can be a primary means of mitigating risks associated with
social media use.184 They can also promote social media engagement by helping healthcare providers
overcome knowledge barriers and issues of mistrust with social media applications.133 Policies can
establish appropriate boundaries between healthcare provider authority and consumer vulnerability,95
foster user accountability,185 and define appropriate consumer engagement.186 Entering the realm of
social media use without strategic planning, including sound policies, could result in unexpected
consequences and security threats.177,186 Healthcare providers have a responsibility to promote patient
health and protect consumers.81,187 Social policies can help healthcare providers positively affect the
quality consumers’ online and real-life social environment.183
Guidelines for Writing Policies
Policy development requires careful planning and implementation. Too lenient a policy would be
ineffective; however, too stringent a policy becomes counterproductive and unenforceable.67 It is also
important to not enter the realm of social media policy too hastily184 and to develop a strategy to make
social media work for the organization.184,188,189 There are no international standards guiding social
media, so it is imperative that policies are carefully created to define appropriate social media
behavior.86 Healthcare organizations and providers should understand the reason they wish to engage
in social media before a empting to create a policy.188 Once this purpose has been clearly defined,
guidelines can be crafted to protect the organization and employees190 and to circumvent draconian
rules that might stymie social media use.184,188
Of equal importance to the content of a social media policy is the process used to create it.182 The first
step in constructing a sound policy is to form a project team. By bringing key stakeholders together, the
organization can be sure that essential elements will be included in the policy.86,148 The project team
should consist of representatives from public relations, marketing, information technology (IT), legal,
administration, representative healthcare and staff members, as well as the community.186,190-192 These
individuals should have a varying range of technological aptitude and experience with social media.182
Invariably, staff member representation should include healthcare providers.60,69 Not only do healthcare
professionals advocate on behalf of patient interests, but they are able to help define and adhere to
professional boundaries.69 Healthcare professionals can also harness their commitment to ethics and
scope of practice when providing recommendations for policy development.60,193
Subsequently, an assessment of the organization environment should be performed.194 The outcomes
of an assessment will enable the team to establish the intent and scope of the policy. It will also help the
project team determine which social media platform to adopt: internally or externally hosted
applications. Internally hosted applications are developed and operated by the organization using
them.86 Although more resource intensive, this type of application enables the organization to control
the security of the site as well as the data generated from it.86 Externally hosted platforms, such as
Twi er and YouTube, have vendors that administer the application but also control the sites’ security
protocols.86 Operating in the social media arena without complete control over site security can be an
added risk for healthcare providers and organizations.
The outcomes of the environmental assessment and platform appraisal enable the project team to
establish its objectives for the policy and to generate its content. Content will need to be concise,
consistent, use simple vernacular,182,184,190 be specific, and include the owner of the policy and
responsibilities of the various departments involved,86 the organization’s a itude regarding social
media, and the organization’s view on acceptable behavior and consequences for misuse.86,180,195 Content
should also include relevant security, regulatory, and safety implications.188
Additionally, the policy should set a framework for appropriate social media etique e.190 As each
application has different features, guidance should be wri en for each application (e.g., blogs, social
networking, or content communities such as YouTube).13 For instance, when posting blogs, employees
may be able to state where they work but should never say that they speak on behalf of the organization
unless they are in an official position to do so.177,190 Also, when engaging in social networking,
healthcare providers should not “friend” a current or former patient.69,73 Further, regarding content
communities, employees may not be allowed to “favorite” objectionable material that could be
discovered by consumers and associated with the organization. Lastly, employees may be expected to
review each application’s privacy policy and to enact specific privacy se ings. Box 13.2 provides an
example of the material covered in a social media policy.
Box 13.2
Sample Outline of a Social Media Policy
Introduction
• Define social media, including what is included under its umbrella (e.g., blogging, social networking,
content sharing).
• State the intent of the policy, including how social media coincides with the organization’s mission
and values.
Purpose
• Define the purpose of the policy.
• Define the scope of the policy and whom it covers.
• Identify the policy’s goals, including promotion of ethical and professional use of the various forms of
social media.
• Link the policy to any other company policies that may have overlapping guidance, such as an
information security policy.
• Link the policy to comply with any applicable regulations and laws, including Health Insurance
Portability and Accountability Act, U.S. Food and Drug Administration regulations, and others.
Responsibility
• Identify the policy owners who created it and will do periodic updates.
• Identify the responsibilities of the organization’s leadership, including their exemplary use of social
media tools.
• Identify the responsibility of the information technology department and information security officer,
including security and system monitoring issues (if any).
• Identify the responsibility of the marketing and public relations departments, including any
monitoring of social media content.
• Identify the responsibility of all employees, including following company policy for employee
conduct as well as the rules of behavior outlined within the policy.
Rules of Behavior (General)
Provide guidelines for acceptable and unacceptable use. Consider the following:
• Outline appropriate and inappropriate tone and content.
• Discuss content management—whether the organization has authority to remove or censor postings
and other activity.
• Discuss company representation—employees may identify with the company but not speak on its
behalf.
• Promote ethical behavior to coincide with professional standards organizations (e.g., American
Nurses Association, American Medical Association).
• Promote legal behavior, such as avoidance of copyright infringement, defamation, conflicts of interest,
and plagiarism.
• Expect privacy and confidentiality of patient and company information.
• Expect everyone to review each social media site’s privacy policy.
• Expect a minimum level of privacy se ings for each social media site used.
• Require that everyone create separate social media accounts for professional and personal activities.
• Describe reasonable usage amounts, including avoidance of excessive use.
• Consider having employees sign the “rules of behavior” and “etique e” guidelines.
• Describe the consequences for violation of policy guidelines.
• Establish an environment of open communication, including reporting policy violations.
References
• Cite all sources for the content of the policy, including other company policies.
• Include any professional organization guidance.
Supplemental Guidelines on Social Media Etique e
• Social networking
• Define it and identify its uses or objectives for use.
• Expect staff to create separate personal and professional accounts (to dissociate their “two lives”).
• Set guidelines for managing vendor contacts and “friending.”
• Provide guidelines for configuring site privacy se ings.
• Set guidelines for managing patient contact and “friending.”
• Set guidelines for managing negative comments.
• Blogging and microblogging
• Define it and identify its uses or objectives for use.
• Address the practice of link shortening.
• Consider providing guidelines for user profile names.
• Address the approval process (if any) for blogging on, or from, the company site.
• Content sharing
• Define it and identify its uses or objectives for use.
• Identify appropriate and inappropriate content.
• Provide guidelines for configuring site privacy se ings.
• Describe the process when inappropriate content is discovered and how it will be retracted.
• Other—Add any other forms of social media within the organization’s purview
• Define it and include its uses or objectives for use.
• Provide guidelines for configuring site privacy se ings.
• Set guidelines for managing etique e according to the functionality of the application.
Adapted from Bahadur G, Inasi J, de Carvalho A. Securing the Clicks: Network Security in the Age of Social Media. OH: McGraw-Hill Osborne
Media; 2011; Barton A, Skiba D. Creating social media policies for education and practice. In: Abbo PA, Hullin C, Ramirez C, Newbold C,
Nagle L, eds. Studies in Informatics: Advancing Global Health Through Informatics. Proceedings of the NI2012. The 11th International Congress of
Nursing Informatics. Bethesda, MD: AMIA 2012:16-20; Centers for Disease Control and Prevention (CDC). CDC social media tools,
guidelines & best practices. CDC. <h p://[Link]/SocialMedia/Tools/guidelines/?s_cid=tw_eh_78>; 2014; and Mayo Clinic. For Mayo
Clinic employees. Version [Link] Mayo Clinic. <h p://[Link]/guidelines/for-mayo-clinic-employees>.
A sound institutional policy can help address social media security needs,190 but its mere creation
should not be the end of the process. Organizations are obligated to educate their employees about the
policy.86,190,196,197,199 Clinicians should understand that a primary objective of social media use is a
positive consumer experience200 and that the policy is designed to guide and protect everyone involved,
from the consumers to the staff.190 As the project team carries out the training, they will need to adjust
their tactics according to the varying degree of social media experience among the staff.190 One
potentially successful method would be to train key individuals in each area of the organization and
establish them as social media experts.190 These individuals could be the resource for their respective
areas, to help monitor for appropriate usage, train staff, and continuously update the ever-evolving
nature of the social media landscape.
Resources for Policy Development
Creating policy does not have to be resource intensive or performed in isolation. Healthcare
organizations may find internal and external resources to assist them with social media policy
development. One resource is the institution’s existing information security policy, which may be
adapted to meet identified needs: it could provide foundational guidance to minimize threats, ensure
privacy, and secure company data, and could be modified to include expected rules of behavior.176,201
Healthcare organizations can also gain useful guidance from other institutions, government bodies, and
professional organizations.97,168,192,198,202 One valuable resource containing examples of existing healthcare
policies was established by Chris Boudreaux and is located at
h p://[Link]/policies. The website contains examples of different policies from
major healthcare providers across the country, including trendse ing organizations, such as the Mayo
Clinic. The Mayo Clinic has established its own medical director203 and created a Center for Social
Media, dedicated to helping its clients connect with clinicians and make healthy choices.28
Conclusion and future directions
If Healthcare + Social media = Social health (today)
Then Social health (today) = Health (future)5, p. 3
As discussed in this chapter, healthcare is discovering the opportunities and challenges offered by
social media. By changing the media of communication, social media is changing the conversation and
in turn the professional relationship between consumers and patients, healthcare providers, and
healthcare institutions. The number and types of social media tools are expanding as the current tools
are meshed and new tools are evolving. The use of social media by all ages and social and cultural
groups is growing rapidly and can be expected to continue.
The use of social media is woven into the tapestry of healthcare; therefore the statement above by
HIMSS Social Media Work Group5 may in fact predict the future. Consumers and patients will lead the
movement toward social health and healthcare professionals, and the healthcare delivery system will
eventually join the social health movement. Federal initiatives such as the Health Information
Technology Pledge (h ps://[Link]/patients-families/pledge-members) encourage healthcare
professionals to educate consumers about being active participants in their healthcare and may increase
the number of healthcare professionals and consumers using social media. Rannie and Wellman204
described the phenomenon of people connected to social media as networked individualism; it is the
new “operating system” because it describes the ways in which people connect, communicate, and
exchange information. The near-term future will likely determine the fate of this new operating system.
There is no doubt that the active role of the patients or consumers in their healthcare will continue to
dramatically change the landscape of the healthcare arena over the next decade. The emergence of
upcoming generations born into a world immersed in social media will result in consumers taking
control of their personal health and will foster a community of both collaboration and independence to
achieve an optimal state of well-being. The growing number of Baby Boomers already immersed in the
social media space may also contribute to the changing healthcare landscape.93 Despite the promise of
social media in healthcare, this area is not without its challenges and risks.
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185 Chretien K.C., Azar J., Kind T. Physicians on Twi er. JAMA. 2011;305(6):566–568.
186 Sco P.R., Jacka J.M. Auditing Social Media: A Governance and Risk Guide. Hoboken, NJ: John Wiley
& Sons; 2011.
187 American Nurses Association. Social Policy Statement. Silver Spring, MD: American Nurses
Association; 2010.
188 Strom D. Who Owns Your Followers? Time to Revise Your Social Media Policy. Readwrite Web; 2011.
h p://[Link]/2011/12/27/time-to-revise-you-social-medi/.
189 Wolfe I. Before You Write that Social Media Policy…Stop, Look & Listen. [Link] 2011.
h p://[Link]/blogs/ira-wolfe/before-you-write-that-social-media-policystop-look-listen-
45660.
190 Barger C. The Social Media Strategist: Build a Successful Program from the Inside Out. Ashland, OH:
McGraw-Hill; 2011.
191 Ohio State Medical Association. Social Networking and the Medical Practice. Ohio State Medical
Association; 2010. h p://[Link]/files/documents/tools-and-resources/running-a-
practice/[Link].
192 Barton A., Skiba D. Creating social media policies for education and practice. In: Abbo P.A.,
Hullin C., Ramirez C., Newbold C., Nagle L., eds. Studies in Informatics: Advancing Global Health
through Informatics. Proceedings of the NI2012. The 11th International Congress of Nursing
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193 Bard R. CEO outlook: embracing social media. Can Nurse; 2012. h ps://canadian-
[Link]/en/articles/issues/2012/january-2012/embracing-social-media.
194 Malone R.E. Assessing the policy environment. Policy Politics Nurs Pract. 2005;6(2):135–143.
195 Guiness A. 7 (More) Must-Haves for Your Social Media Policy. Social Media Policy Templates; 2010.
h p://[Link]/.
196 Mayo Clinic. For Mayo Clinic Employees. Mayo Clinic; 2012.
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197 American Council for Technology–Industry Advisory Council (ACT-IAC), Collaboration &
Transformation (C&T) Shared Interest Group (SIG). Best Practices Study of Social Media Records
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198 Black T. How to Write a Social Media Policy. Inc; 2010. h p://[Link]/guides/2010/05/writing-
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199 Goldman D. Legal Issues (part 3): General thoughts on Developing your Social Media Policy. Mayo
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200 AstraZeneca. White Paper: Social Media in the Pharmaceutical Industry. AstraZeneca; 2011.
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201 Photopoulos C. Managing Catastrophic Loss of Sensitive Data: A Guide for IT and Security
Professionals. Rockland, MA: Syngress Publishing; 2008.
202 Goodchild J. 4 Tips for Writing a Great Social Media Security Policy.
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203 Aase L. Center Names New Medical Director. Mayo Clinic Center for Social Media; 2011.
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204 Rannie L., Wellman B. Networked Individualism: What in the World is That? Pew Internet &
American Life Project; 2012. h p://[Link]/2012/05/24/networked-
individualism-what-in-the-world-is-that-2/.
Discussion questions
1. What are the strengths of using social media in healthcare?
2. What are the challenges of using social media in healthcare?
3. Why are healthcare professionals slow to adopt social media as a tool in healthcare?
4. Is the use of social media in healthcare a fad?
5. In a hospital se ing, what are the key questions that the C-suite (CEO, CFO, CNO, CIO) should ask
about using social media?
6. How does social media affect the relationship between patients and their healthcare providers?
7. Is social media a part of patient-centric care?
8. How can health professional schools prepare future healthcare providers in the area of social media?
9. Describe the meaning of the following statement:
If Healthcare + Social media = Social health (today)
Then Social health (today) = Health (future)7
10. Describe networked individualism and the benefits for one’s healthcare.
Case study
Social Media in Education and Healthcare
Grace Speak is a fourth-year student at Best University. She and her fellow classmates are working hard
in their final courses and preparing for exams. Inspired by the teamwork that the healthcare profession
espouses, Grace gets an idea for a study group. She thinks it will really help share case experiences,
course notes, and study tips. Unfortunately, several members of her peer group live out of town, which
makes it difficult for them to participate fully. Grace is torn, as she does not want to exclude them from
the study group. When she voices her concerns to a classmate, her friend suggests using social media
tools as the primary medium for sharing information.
Discussion Questions
1. What types of social media tools could Grace’s study group use?
2. How would those tools facilitate the objectives of the study group?
3. What are some of the risks associated with using social media for such purposes?
4. What might Grace need to do from the outset when she forms the study group?
*Acknowledgments: We would like to acknowledge and thank Diane J. Skiba, PhD, FACMI, ANEF, FAAN, Professor &
Health Care Informatics Specialty Director, University of Colorado College of Nursing; Elizabeth Dickson, MS, RN, RN
Clinical Applications Coordinator, U.S. Department of Veterans Affairs, Cheyenne, Wyoming; Paul Guillory, MS, RN-BC, Bar
Code Medication Coordinator/Pharmacy Informaticist, Department of Veterans Affairs, Pacific Islands Health Care System,
who wrote this chapter for the first edition of this book. We also wish to thank Heather Carter-Templeton, who revised this
chapter and took on the role of author for this edition of the book.
14
Personal Health Records
Bryan Gibson; Kathleen G. Charters
Abstract
This chapter begins with a definition of the electronic personal health record (PHR)
and a description of the historical trends contributing to the development and
adoption of PHRs. This is followed by a discussion of the history of patient access to
their electronic health records (EHRs) via Blue Bu on. A ributes of an ideal PHR
and its proposed benefits are outlined along with types of PHRs, their pros and cons,
as well as examples of current PHRs. The growing body of evidence supporting the
benefits of PHRs is discussed in terms of the triple aim for healthcare (improving the
patient’s experience of care, improving health, and reducing costs). Issues in further
improving the adoption of PHRs are outlined, and the chapter concludes with a
discussion of the future of PHRs.
If trends in adoption and expansion of the functionality of personal health
records (PHRs) persist, PHRs have the potential to become the platform
for a more efficient, effective, and personalized healthcare system.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe trends and events leading to the development and adoption
of electronic personal health records (PHRs).
2. Describe the history of Blue Bu on.
3. Describe the ideal PHR and its proposed benefits.
4. Explain the different types of PHRs and the pros and cons of each
type.
5. Provide examples of existing PHRs, including their function and
usage.
6. Evaluate current evidence regarding the effectiveness of PHRs as an
approach to improve healthcare.
7. Explore issues affecting the adoption of current PHRs.
8. Discuss the future of PHRs.
KEY TERMS
digital divide 249
networked personal health record 246
stand-alone personal health record 246
tethered personal health record 246
untethered personal health record 246
Definitions of the personal health record
Although no single definition is universally agreed upon, several
organizations have a empted to define the personal health record (PHR).
A joint PHR Task Force of the Medical Library Association and the
National Library of Medicine states the following:
Electronic personal health record [is]: a private, secure application through
which an individual may access, manage and share his or her health
information. The PHR can include information that is entered by the
consumer and/or data from other sources such as pharmacies, labs, and
health care providers. The PHR may or may not include information from
the electronic health record (EHR) that is maintained by the health care
provider and is not synonymous with the EHR. PHR sponsors include
vendors who may or may not charge a fee, health care organizations such
as hospitals, health insurance companies, or employers.1
The Connecting for Health Personal Health Working Group of the
Markle Foundation defined the PHR as
An electronic tool that enables individuals or their authorized
representatives to control personal health information, supports them in
managing their health and ill-being, and enhances their interactions with
health care professionals.2
These definitions emphasize two essential aspects of the PHR: The first
is that the PHR serves as an information aggregator and storage system.
The second is that the PHR is a tool, or suite of tools, that individuals or
their delegates may use to manage their health.
The development of the electronic
personal health record
Individuals have long kept paper records of their healthcare as adjuncts to
their medical records. Common examples include paper records of
immunizations and lists of prescription medications or medical problems
that people may keep in their personal files. A Harris Interactive poll
found that most people thought it was a good idea to keep PHRs; 46% of
those surveyed actually kept records, and 86% of those who did kept
paper records.3 Paper records serve several important functions: they
minimize the need for individuals to remember the details of their medical
history, they are portable, and they are shareable. There is some evidence
that paper records may facilitate health behaviors.4 While paper records
likely remain the most common form of personal health information
storage, the remainder of this chapter will refer to the electronic PHR.
The development and adoption of the PHR in the United States is the
result of several converging historical trends:
• The rise of personal computing devices and the internet.
• The development of electronic health records (EHRs).
• Governmental policies related to health information technology
(health IT).
• Consumer demands for the functions provided by a PHR.
The personal computing revolution began when desktop computers
became affordable in the 1980s and continues today with the increasing
adoption of mobile devices. Concurrent with the increase in adoption of
personal computing devices was the development of the internet. In 2014,
an estimated 84% of Americans had access to the internet,5 thus paving the
way for PHRs and other personal health technologies. With the internet
the adoption of smartphones has exploded: in October 2014 it was
estimated that 64% of U.S. adults owned smartphones; this percentage is
continuing to increase steadily.6 (For detailed information on mHealth, see
Chapter 15.) Fig. 14.1 presents the trends in the percentage of Americans
owning common electronic devices from 2002 to 2014. As will be discussed
later, mobile computing offers tremendous possibilities to expand the
scope and functionality of PHRs.
FIG 14.1 Adult gadget ownership over time (2000–2014). As of
July 2015, 68% of American adults have a smartphone. From
[Link]
While the widespread adoption and use of personal computing devices
and the internet provide the infrastructure that makes PHRs possible,
EHRs serve as the primary source of data populating the PHR. Large-scale
implementation of EHRs began in the early 1990s at several integrated
health systems, such as the Veterans Health Affairs (VHA),7 Intermountain
Healthcare in Utah, and the Regenstrief Institute in Indiana.8
In recent years, the U.S. government implemented policies specifically
intended to increase the adoption of both EHRs and PHRs. In this chapter,
we will only provide a brief overview of these polices and their relation to
PHR adoption. See Chapters 25 and 27 for additional information on these
policies.
The Health Information Portability and Accountability Act (HIPAA) of
1996 requires individuals to be granted access to their health records upon
request. In addition, the law requires individuals to be provided with an
audit trail describing who has accessed their health information and why.9
HIPAA does not require this information to be provided or monitored
electronically; however, since these provisions are most easily addressed
with an electronic record, HIPAA could be seen as a first step in
encouraging the adoption of PHRs.
Subsequent policy had a more direct effect on electronic records
adoption. In April 2004, President George W. Bush set a goal that most
Americans would have their medical information maintained in electronic
records by 2014.10 To facilitate this goal, the Office of the National
Coordinator for Health Information Technology (ONC) was created and
later funded by the Health Information Technology for Economic and
Clinical Health Act (HITECH Act) of 2009. ONC is the “principal Federal
entity charged with coordination of nationwide efforts to implement and
use the most advanced health information technology and the electronic
exchange of health information.”11
In 2009, the American Reinvestment and Recovery Act of 2009
authorized the Centers for Medicare and Medicaid Services (CMS) to
provide financial incentives for adoption and Meaningful Use of EHRs. As
detailed in Chapter 27, the ONC proposed three stages of Meaningful Use,
each characterized by a group of requirements necessary for certification.
In 2010, CMS began to certify healthcare information system products for
compliance with Stage 1 Meaningful Use. Eligible providers and eligible
hospitals who used these products and met other specific criteria were and
still are eligible for financial incentives.12 The incentives are clearly driving
adoption: the prevalence of hospitals in the United States with “basic”
EHRs (as defined by Meaningful Use guidelines) increased from 9.4% in
2008 to 59.4% in 2013.13 Similarly, outpatient clinics are increasingly
adopting EHRs: in 2013, 48% of office-based physicians had a “basic” EHR
system.14
In September 2012, the ONC finalized requirements that eligible
providers who had met Stage 1 requirements would need to meet Stage 2
requirements in 2014 in order to be compliant. Some Stage 2 requirements
directly tie the Meaningful Use of the EHR and PHR together. For
example, Stage 2 states that patients visiting a certified healthcare provider
must be able to access their EHR data electronically and that at least 5% of
patients will actually use this function during a certification period. The
rule also requires that patients discharged from the hospital must be able
to view their information online and download and transmit that
information within 36 hours of discharge from the hospital or, in the
outpatient se ing, within 4 days of the appointment. These requirements
seem to be driving providers to offer their patients PHRs: in 2014 38% of
patients reported being offered online access to the medical records.15
The final and possibly most important trend leading to adoption of
PHRs is individuals’ desire for the functions that PHRs provide. In 1998,
Tang et al. conducted focus groups to explore patients’ information needs
and desires. The researchers found patients wanted to receive
personalized, physician-endorsed health information and summaries of
recent healthcare encounters as well as next steps in care. Participants
thought being be er informed would increase their understanding of their
treatment plan, increase their motivation to comply with the plan, and
improve their satisfaction with office visits.16 A 2005 survey by the Markle
Foundation found that 60% of those surveyed wanted a PHR that they
could use for refilling prescriptions, communicating (e-mailing) with their
doctor, and obtaining results over the internet. In addition, over 70%
supported the use of such a system to allow providers to review their
medical records when needed.17 A 2006 Harris Interactive poll reported
similar findings; in addition, most people wanted the ability to schedule
visits via the internet and wanted to be sent reminders for medical visits.
About half of respondents wanted a system that could transfer self-
monitoring data (such as blood pressures taken at home) to their doctors.18
Recent surveys suggest that interest in PHRs continues to be strong: a
national survey conducted in 2014 found that 57% of respondents who did
not have a PHR would be interested in using one if it provided online
access to their medical records.19
Blue Button for Patient Access to Electronic Health
Records
The idea of patient access to EHRs has been discussed and debated since
the 1990s.20 However, early efforts to make EHRs available to patients
resulted in wide variation in both content and presentation. The idea for
Blue Bu on was developed during a meeting of the Markle Connecting for
Health workgroup in 2010.21 The vision was that by clicking on an image
of a bu on, patients could access their records in either human-readable or
machine-readable format. The symbol for Blue Bu on (Fig. 14.2) and the
slogan “Download My Data” are used to identify electronic access to
health data views, downloads, and transmissions. Blue Bu on includes
clinical, demographic, financial (explanation of benefits or invoices), and
other information related to the health and medical care of patients.22
FIG 14.2 The Blue Button ® Logo. From [Link]
families/blue-button/blue-button-image
Initially pioneered by the CMS, Department of Defense, Department of
Veterans Affairs (VA), and Social Security Administration, Blue Bu on was
soon adopted by private health insurers, hospitals, and healthcare
practices.23,24 In 2011, the Department of Veterans Affairs held a prize
competition called Blue Bu on for All Americans to encourage
widespread use outside federal healthcare programs to benefit veterans
who receive care from non-VA providers.23 The same year, the ONC
launched a pledge program to make it easier for patients to access their
personal health information online and to encourage patients to use that
information to improve their health.24
Blue Bu on challenges were designed to stimulate development of
products by public and private organizations to make health information
more usable and meaningful for patients. In 2012 and 2013, the ONC
sponsored challenges to accelerate awareness of Blue Bu on and
encourage developers to create apps that implement and use this
functionality. The 2012 Blue Bu on Video Challenge asked participants to
create inspiring and entertaining videos that introduce Blue Bu on and
encourage viewers to learn more about it.25 Eighteen videos were
submi ed, and they are now available online.26 The 2012 Blue Bu on Mash
Up Challenge built on this foundation, calling for development of an app
that uses Blue Bu on–downloaded personal health data and combines it
with other data to address the three-part aim of CMS: be er healthcare,
be er health, and lower costs. Videos demonstrating the winning apps are
available online.27
As awareness of Blue Bu on grew, the standards associated with Blue
Bu on were also evolving. The ONC Standards and Interoperability
Framework led to Blue Bu on + for data holders and receivers.28 This
combination of structure, transport mechanism (using a process called the
direct protocol), and automation sets the stage for accelerated
development of an ecosystem of tools and apps based on retrieving
personal health data. Implementing Blue Bu on + Direct met the
requirements of Meaningful Use Stage 2, requiring that patients be given
the capability to view, download, and transmit their health data
electronically.29,30
In 2013 a Blue Bu on Co-Design Challenge based on crowdsourced
ideas was the foundation for apps to be developed using Blue
Bu on + technical standards and to leverage policy drivers, such as
rewarding efforts to engage patients in new ways. Use cases included
combining data from a medical device with other health data; simplifying
care for caregivers managing multiple chronic conditions; one-step
patient-entered data about drugs, pharmacies, and preferred providers;
and enabling a clear view of conditions a patient is at risk for and what
preventive services are needed, as well as tracking preventive steps
patients take on their own. The winning apps provide users with a variety
of patient services and combine health information from multiple
providers through Blue Bu on + .31 GenieMD aggregates data from
multiple providers so patients and their providers have a holistic view of
all of the patient’s medical conditions. ICEBlueBu on provides immediate
access to an In Case of Emergency (ICE) record, including allergies,
medical conditions, and medications, by either nonmedical rescuers or
emergency personnel using QR code scanning. CareTracker simplifies
personal care among patients and their care teams and keeps everyone on
the same page in real time.
The ONC provides an online tool, Blue Bu on Connector, to help
patients find their health data so they can reference, check, share, and use
apps.32 Blue Bu on Connector users can select a source of their health
information (health insurance, hospital or clinic, providers, pharmacy, lab,
or immunization registry) and see what features are available for viewing,
downloading, or securely sending records to an application. Blue Bu on
Connector provides a list of health apps accepting information provided
using nationally recognized standards, including but not limited to Blue
Bu on + standards.33 As of this writing, over 300 organizations pledged to
provide patients with the information and tools they need to be partners in
their own health.34
The question remains whether providing patients access to their health
information makes any difference. Jika et al. conducted a systematic
review of the effect of giving patients health record access and did an
analysis of outcome measures based on eight reviews conducted between
2002 and 2014. They calculated the number of positive outcomes reported
per every outcome measure investigated, finding mixed outcomes across
both patient and providers, with approximately half of the reviews
showing positive changes. They concluded there is:
… a lack of empirical testing that separates the effect of record access
from other existing disease management programs and there is currently
insufficient evidence about the effect of patient accessible electronic health
records on health outcomes for patients.35
Principles of an ideal personal health
record
Aggregated from several publications and reports,36 the following is a list
of principles for an ideal PHR. No current system fully implements all of
these principles; however, some current systems partially address them:
Comprehensive, longitudinal data storage. The PHR should serve as a
persistent longitudinal record of individuals’ health and healthcare over
their life spans. Fully implementing this principle requires data
integration from multiple sources (e.g., EHRs, pharmacies, and patient-
entered data). Developing these kinds of interoperable records is one of
the missions of the ONC and one of the primary reasons for the
Meaningful Use criteria discussed above.
Data ownership, control, and privacy. Individual users (patients) should be
considered the “owners” of data in PHRs. This principle has several
corollaries: users should control access to their PHR, be able to annotate
data created by others (e.g., data from EHRs), be able to create new data
fields, and be able to assign a proxy who can control and use the system
on their behalf. The Markle Foundation’s report titled “Connecting for
Health” focuses on this principle of users’ ownership and control of the
data in PHRs. Table 14.1 provides a summary of the core principles for
PHR design delineated in their report. These core principles reflect the
Federal Trade Commission’s Fair Information Practice Principles.37
Additional information related to these principles is included in Chapter
26.
Table 14.1
Core Principles of Personal Health Record Design from Connecting for Health
1. Openness Consumers should know what information has been collected about them, the
and purpose of its use, who can access and use it, and where it resides. They
transparency should also be informed about how they may obtain access to information
collected about them and how they may control who has access to it.
2. Purpose The purposes for which personal data are collected should be specified at the
specification time of collection, and the subsequent use should be limited to those purposes,
or others that are specified on each occasion of change of purpose.
3. Collection Personal health information should only be collected for specified purposes
limitation and and obtained by lawful and fair means. The collection and storage of personal
data health data should be limited to that information necessary to carry out the
minimization specified purpose. Where possible, consumers should have the knowledge of
or provide consent for collection of their personal health information.
4. Use Personal data should not be disclosed, made available, or otherwise used for
limitation purposes other than those specified.
5. Individual Consumers should be able to control access to their personal information. They
participation should know who is storing what information on them, and how that
and control information is being used. They should also be able to review the way their
information is being used or stored.
6. Data quality All personal data collected should be relevant to the purposes for which they
and integrity are to be used and should be accurate, complete, and up to date.
7. Security Reasonable safeguards should protect personal data against such risks as loss
safeguards or unauthorized access, use, destruction, modification, or disclosure.
and controls
8. Entities in control of personal health information must be held accountable for
Accountability implementing these principles.
and oversight
9. Remedies Remedies must exist to address security breaches or privacy violations.
Portability. The system should be available to the user regardless of
physical location. To this end, several PHRs are available as mobile
phone applications.
Data sharing. The system should allow users to share all or parts of the
PHR with others. The shared data should be provided in an electronic
format that allows the receiver to manipulate the data (making the
sender and receiver’s records interoperable) rather than being available
as read only.
Access. The system should provide a convenient means for users to access
health-related information and services. This information or service may
improve on or augment existing processes. Examples include the
capability for secure messaging between patients and healthcare
providers, the possibility of e-visits (e.g., web-based video or text
consultations between patient and provider), online medication refills,
and administrative functions such as scheduling of appointments.38
Unique and desired services. The system should provide users with unique
services that are otherwise unavailable. Current PHRs provide functions
that improve on existing healthcare processes. However, several
authors39 suggested that PHRs could provide a wider array of functions
not currently available. For example, PHRs could provide decision aids
to assist patients with complex therapeutic decisions, provide
personalized motivational health promotion messages to facilitate
healthy behaviors, and be used to elicit patients’ goals and preferences
and present those back to providers. These kinds of functions are
needed if PHRs are to make a significant impact on users’ behaviors and
health.
Customization. PHRs should allow content customization to address
individual users’ needs. For example, the system might provide a
translation service to help individuals understand clinical notes from
EHRs.40 Such information could be tailored to users’ health literacy and
numeracy. However, the ability to customize content in PHRs has yet to
be implemented.
Proposed Benefits of an Ideal Personal Health Record
An ideal PHR has multiple proposed benefits. For example, by serving as a
single comprehensive record, an ideal PHR could facilitate improved care
coordination between healthcare providers, reduce repetitive tests and
conflicting therapies, and improve patient safety.41 Similarly, a function
allowing users to assign a delegate or proxy to access and control their
records might improve care delivered by informal caregivers (e.g., adults
taking care of elderly parents).42 Finally, a system like a PHR that is
ubiquitously available and provides individuals with customized health
promotion might improve individuals’ self-management of health.36,43
Types of Personal Health Records
PHRs are often grouped into four main types: stand-alone, untethered,
tethered,44 and networked.41,45,46 While the first three types do not provide all
the desired functions of the ideal PHR described above, networked PHRs
have the potential to address these deficits.41
Stand-alone personal health records store health information on an
individual’s computer or a USB device. These systems might be of use in
particular cases (e.g., the capacity for emergency medical providers to
access the person’s USB stored data). These have not been widely adopted,
likely because they require manual data entry by the user and the records
are not interoperable with other systems such as EHRs.44
Untethered personal health records are web-based systems separate
from an EHR. The advantage of these systems over stand-alone PHRs is
that they are accessible anytime and can aggregate data from multiple
sources. The drawback is that they do not link to healthcare providers;
thus users cannot e-mail their doctors, request medication refills, view
their medical records, or schedule appointments. Despite these deficits,
proponents of untethered and stand-alone systems suggest that these
formats offer users maximum control over the content included in their
PHR.47
A tethered personal health record is linked to a single clinic or
healthcare system. Because these systems allow the user to view EHR data
via the PHR, they are sometimes called a patient portal (i.e., the system
provides a portal into the person’s medical information within the EHR).
There are several advantages to these systems: they often provide direct
access to functions such as secure messaging with healthcare providers,
medication refills, and appointment scheduling, and because the PHR is
usually automatically populated with EHR data, they require much less
manual entry of data than untethered PHRs. The main disadvantage is
that the information is linked only to one specific healthcare provider or
system. This creates a problem for individuals with multiple healthcare
providers in different healthcare systems because only the information
from the linked system is represented in the PHR.
A networked PHR is proposed to address the limitations of a tethered
PHR.41 In a networked personal health record patients can integrate data
from multiple sources, from different healthcare providers, health plans,
or laboratories. The data are integrated through use of access services that
conduct user authentication before allowing patient or proxy access to
data. Ideally, users sign in once and gain access to comprehensive,
integrated data. As with EHRs, the development of comprehensive,
integrated PHRs is dependent on the wide implementation of data
representation and data exchange standards that are still needed to create
interoperable records. Fig. 14.3 depicts the differences in information flow
between current processes and a networked PHR.
FIG 14.3 How Meaningful Use changes the healthcare experience
for patients and families. EMR, Electronic medical record; PHR,
personal health record. From Health Research Institute. Putting patients into
Meaningful Use. PricewaterhouseCoopers. <[Link]
industries/publications/[Link]> Page 2.
Examples of existing personal health
records
Selected examples of existing PHRs are presented in this section.
Additional examples of existing PHRs are available via recommended
websites listed on the Evolve website.
One of the first electronic PHRs, the VHA’s MyHealtheVet (MHV), was
first piloted in 1999 and launched nationally in 2003.48 MHV has two levels
of use. The first level allows anyone to create an account online and use
the system as an untethered, web-based PHR. The second level is for
individuals receiving care through the VHA. These users can take full
advantage of MHV’s functionality by completing in-person authentication
at their nearest VHA clinic or hospital. Once individuals are authenticated,
they can use the system as a tethered PHR to exchange secure e-mails with
their healthcare providers, view portions of their EHRs, view upcoming
appointments, and receive wellness reminders.49 As of August 2015, more
than 1.9 million veterans were authenticated users of MHV, or greater than
30% of individuals who use the VHA for healthcare.32 The majority of
system adopters (75%) use the system to order prescription refills, with
more than 70 million refills requested. In January 2010, the VHA began a
rollout of secure messaging within MHV. Since then, secure messaging has
been rapidly adopted. As of August 2015, 81% of authenticated MHV
users have opted in to secure messaging with their healthcare team.50
Kaiser Permanente (KP) is an integrated nonprofit provider of both
health insurance and healthcare in the United States. Between 2004 and
2010, KP implemented a system-wide EHR with a tethered PHR called My
Health Manager.33 The PHR provides secure messaging with healthcare
providers, online appointment scheduling, and prescription refills. In 2013,
4.4 million of Kaiser’s 9.1 million members were using the PHR (48.3% of
all members). The PHR had over 131 million visits, with 34.4 million lab
test results viewed online, 14.7 million secure e-mails sent, 3.6 million
online appointment requests made, and 14.8 million online prescriptions
refilled. A mobile phone PHR app was released by KP in 2012. It reached 1
million downloads in June 2014. Through the app, members can e-mail
physicians, schedule or cancel appointments, get refills for a prescription,
access lab results, and search for nearby KP medical facilities.51
Microsoft launched its web-based PHR platform, HealthVault, in 2007.
The system integrates data from multiple sources: individuals can upload
documents and images, have their records added directly to HealthVault
via fax from their healthcare providers, or pay a service to collect their
records and digitize their medical information. HealthVault serves as an
application platform. When an individual uses a HealthVault application
for the first time, he or she authorizes the application to access a specific
set of data types from their record, and the application exchanges those
data with the platform. One of the strengths of the platform is the ability to
use compatible self-monitoring devices such as pedometers, glucometers,
and blood pressure monitors to automatically capture data. A second
strength of the platform is that app developers can leverage data in
HealthVault when users allow access. As of August 2015, 251 devices can
push data to HealthVault, and 120 apps make various uses of the data
stored on the platform.52 Depending on the number of data sources
connected to the platform, HealthVault can function as an untethered,
tethered, or networked PHR. For example, if all data sources for a specific
patient were HealthVault partners, the patient’s PHR would be a
comprehensive, networked PHR.
Current evidence of benefits of personal
health records
The Institute for Healthcare Improvement (IHI) first developed goals to
improve individuals’ experience of care, quality of care, and costs of care.
These were later adopted by CMS and are referred to as the IHI triple aim
for healthcare.53 Each dimension should be considered when evaluating an
intervention or healthcare process because these aims are interdependent
and can at times be at odds with each other.54 For example, an intervention
that improves the quality of care might also increase costs. Similarly, a
system that reduces costs might also degrade the person’s experience of
care. With this in mind, evidence demonstrating the positive impact of
PHRs across these three dimensions is increasing.55,56
Experience of Care
Evidence regarding the effect of a PHR on individuals’ experience of
healthcare is limited; however, user satisfaction surveys are generally very
positive about the functions included in PHRs. For example, among
individuals accessing their medical records online in 2013 or 2014, greater
than 81% considered the information useful.15 Similarly, most users of a
tethered PHR reported high satisfaction (> 86% were either satisfied or
very satisfied) with functions such as online medication refills, secure
messaging, and the ability to view lab test results.57 Finally, patients from
an academic medical system reported high satisfaction with secure
messaging, as long as response times to their secure messages remained
short.58
The flexibility offered by PHRs may also improve individuals’
experience of care. This is suggested by the results of a survey of PHR
users at the Geisinger Health System. Patients preferred e-mail
communication for some interactions (e.g., requesting prescription
renewals, obtaining general medical information) and preferred in-person
communication for others (e.g., receiving treatment instructions).59
Quality of Care
Since PHRs are relatively new tools, evidence about the effects of PHR use
on the quality of healthcare is limited and data on long-term outcomes are
not yet available. The available evidence comes from two types of studies.
The first are association studies that examined the relation between an
individual’s use of the PHR (usually secure messaging) and intermediate
health outcomes. The second group of studies includes randomized
controlled trials with the PHR as a component of a broader intervention.
In association studies, use of the PHR was related to improved
intermediate health outcomes.60 At KP Northwest, a positive association
was found between patients’ use of secure messaging and the likelihood of
organizations meeting the recommended Healthcare Effectiveness Data
and Information Set (HEDIS) performance measures for diabetes and
blood pressure quality care.61 This effect was significant, even after
comparing users to nonusers, matched on age, gender, and healthcare
provider. Similarly, a cross-sectional analysis of individuals with diabetes
found the use of secure messaging in the MyGroupHealth PHR was
associated with be er glycemic control.62 While the results of these studies
are encouraging, these studies did not control for confounding factors
such as the patient’s self-efficacy, a itudes toward medical care, race,
socioeconomic status, and health literacy.62
Several trials were conducted using a PHR as a component of a larger
intervention. For example, two trials compared the effect of PHR use and
an automated blood pressure cuff on subsequent blood pressure readings.
In the first, the investigators compared three interventions: the PHR alone
(UC); a home blood pressure monitor and the PHR (eBP); or a home blood
pressure monitor, the PHR, and a pharmacist who engaged with the
patient regularly via secure messaging (eBP-Pharm). The outcome of
interest was the percentage of subjects whose blood pressure was
controlled (< 140/90 mm Hg) at a 1-year follow-up. Results were as
follows: 56% of individuals in the eBP-Pharm group, 36% in the eBP
group, and 31% in the UC group had controlled blood pressure at the end
of the trial.63 However, the eBP-Pharm group contains several variables,
making conclusions less definitive about PHR effects. In a similar trial,
Wagner et al. reported on a cluster randomized trial with either a PHR or
none and automated blood pressure cuff or none for 1 year. Of 1686
patients approached, only 453 patients agreed to participate. The authors
found no association between adoption of the PHR and blood pressure
over 1 year. However, in a subgroup analysis, they found that patients
who used the PHR more than twice a month reduced their blood pressure
by 5 mm Hg. They also reported that increased PHR usage was associated
with patients’ perception of the usefulness of the system.64
Similar trials in individuals with diabetes showed that PHR-based care
management modules are useful in affecting physiological outcomes65 and
reducing diabetes-related distress.66 More recently a custom-built,
untethered PHR with personalized messages about potentially
inappropriate medication use had moderately positive effects on older
adults’ medication behaviors.67
While most work on PHRs affecting users’ health focused on individuals
with chronic disease, some studies addressed preventive health behaviors.
For example, Lau et al. compared the effect of a PHR educational module
on flu vaccination rates to a wait-list control among university students
and found that the PHR module increased vaccinations rates and clinic
visit rates.68
Cost/Utilization
Cost-benefit simulation of the effect PHR use and healthcare costs was
estimated as quite positive (assuming > 80% nationwide adoption).69
However, actual data showing changes in healthcare costs are not yet
available.55 Several studies measured the association between PHR use and
healthcare utilization. The assumption behind these studies is that shifting
utilization away from in-person encounters will lead to decreased costs.
Zhou et al. compared 3201 users of KP’s My Health Manager PHR with a
nonuser group, matched for age and disease, and found PHR use was
associated with reduced telephone calls to the clinic and a reduced
number of outpatient visits per year.70 Other investigators have found an
opposite association. Harris et al. reported that increased use of secure
messaging by individuals with diabetes in the My Group Health PHR was
associated with increased outpatient visits.62 Limitations of these two
studies include that they are cross-sectional studies, and no determination
was made as to whether the change in utilization was appropriate or not.
For example, in the Harris study, use of the PHRs secure messaging
function may help individuals realize they need to seek out care more
regularly, and therefore increased utilization may have been appropriate.
In summary, the available evidence suggests that PHRs may improve
patients’ satisfaction with their quality of care, and PHRs also seem to
change individuals’ healthcare utilization pa erns. The effects of this
change on costs remain to be seen. Two facts qualify these statements.
First, virtually all the evidence discussed above comes from studies of
tethered PHRs used by integrated healthcare systems. More evidence from
a more diverse sample is needed. Second, a common finding across these
studies is that regular use of the PHR by patients is necessary to see
improvements; therefore more research on engagement of patients with
the PHR over time is needed.
Current use of personal health records
Several studies found PHR users are more likely to have multiple medical
problems than nonusers.70,71 Even among individuals with the same
disease, individuals with a higher disease burden may use PHRs more
than those who are less ill. For example, Weppner et al. reported that
among older individuals with diabetes, higher morbidity was associated
with increased usage of secure messaging.72 Similarly, a study of PHR use
among individuals with chronic kidney disease found that about half of
participants became frequent users of the systems and that this use
occurred around the same time as clinic visits.73
Data on the frequency of logins to PHRs were reported for several
systems. Among VA patients using MHV, approximately half report using
the PHR monthly and 30% say they use it weekly.74,75 Thirty percent of
respondents in a California healthcare foundation survey about PHRs
reported using PHRs monthly.76 New enrollees logged in most frequently
in the first month, but about half of respondents continued to access the
portal at least monthly. Users most often examined laboratory and
radiology results and sent secure messages to their healthcare providers.
Across se ings the following PHR functions seem to be the most
commonly used (in rough order of decreasing usage): laboratory results
reviews, medication refills, patient provider secure messaging, after-visit
summary review, medical condition review, appointment requests,
immunization review, and allergy review.48,77,78
Barriers to personal health record
adoption
Self-reported PHR adoption as measured by at least one log-in to the
system increased from 3% of the population in 200858 to approximately
20% in 2014.15 As noted above, in some large integrated healthcare
systems, adoption is even higher (i.e., > 30% of VHA patients and > 48% of
KP members).
While this trend is encouraging, several barriers must be dealt with
before PHRs will affect the majority of the population for a long enough
time to influence long-term outcomes. These include awareness of PHRs,
usability, interoperability of current systems, individuals’ concerns over
privacy, and the digital divide. In addition, providers’ promotion of PHRs
and integration of them into the clinical workflows will likely affect
adoption and long-term use.
Awareness
A national survey by the California HealthCare Foundation in 2010 asked,
“How much have you heard about websites where people can get, keep,
and update their health information like test results and prescriptions?”
More than half of respondents answered “not sure/not heard.” A full 76%
of respondents indicated that they had not heard about mobile phone
programs to track their own health information.76 In 2008 Fuji et al.
examined rural physicians’ awareness of PHRs and found that more than
25% of physicians had no awareness of PHR functions and 59% did not
know whether their patients had or used PHRs.79
Wei man et al. conducted interviews and focus groups with
administrators, clinicians, and community members as a component of a
formative evaluation of a PHR. They found that many individuals had
limited awareness of PHRs yet held high expectations of what such a
system should do. Common expectations were that the PHR would allow
searching and linking within the record, that the system would include
tailored communications, and that linkages would exist between self-
reports and clinical data. The researchers commented that these high
expectations created a risk of disappointment when individuals
encountered existing PHRs.80
These studies indicate the most significant barrier to widespread PHR
adoption: the lack of awareness of PHRs.15 To address this problem,
several governmental and nongovernmental organizations recently
launched websites to educate the public about PHRs. (See the appendix for
a representative list.)
Usability
Poor PHR usability may also hinder adoption. For example, in a test of the
usability of the MHV PHR, only 25% of users successfully completed
registration with the system. In 2007, the National Health Service in the
United Kingdom implemented a PHR called HealthSpace and found that
adoption and use was much less than expected. Interviews with users
suggested that users perceived it as neither useful nor easy to use.81
Similarly, older adults with lower eHealth literacy were found to have
significant difficulty in using a PHR to complete commons health
management tasks.82
Schnipper et al. conducted usability testing of a medication
management module embedded within a patient portal. The study
highlighted the need for end user–specific interfaces and functionality in
order to make the user experience easier and more efficient. For patients,
this meant striking a balance between free-text, structured, and coded data
fields to leverage the usefulness of patient-entered data without confusing
or overwhelming patients. For example, drop-down menus and scrolls
bars were found to be less confusing and more efficient than dynamic text
boxes that would react to the word being typed when inpu ing data, such
as medications and allergies.83
Privacy Concerns
A 2010 survey found that 63% of PHR users and 68% of PHR nonusers are
“somewhat or very concerned” about the privacy of their health
information.84 Recent data suggest these concerns remain a serious barrier
to PHR adoption.15
The Digital Divide
Research suggests that a “digital divide” exists in the United States.
Individuals of lower socioeconomic status,85 ethnic minorities,86,87 those
with low eHealth literacy,88 and older individuals are less likely to adopt
PHRs.89 For example, Yamin et al. found that among 75,056 patients in the
Partners Healthcare system, African Americans were half as likely as
Caucasians to adopt a PHR, and individuals of lower income were about a
third less likely to adopt the PHR as individuals of higher income.85
Similarly, limited access to high-speed internet among veterans living in
rural communities was identified as a barrier to adoption of the MHV
PHR.89 Despite this, a survey of Medicaid beneficiaries found most
respondents were very interested in accessing personal health information
online. Moreover, 90% of respondents reported they have access to the
internet, and most use the internet once a week or more.90
Provider Engagement
Several recent studies showed clinician behaviors can markedly improve
adoption of PHRs. For example, Krist et al. found that implementing a
clinic-based promotion of a patient portal increased adoption by 1% per
month.91
In addition, other studies reported that aggressive marketing campaigns
of tethered PHRs were successful in improving adoption of PHRs. In the
first study, a total of 16 techniques were used, including automated
greetings on the practice’s telephone system, posters in waiting areas and
examination rooms, postcard and le er mailings, staff speaking to the
patients in the office or over the telephone, and on-site enrollment with a
computer kiosk. Authors reported nearly a threefold greater likelihood of
PHR adoption among patients of practices employing five or more of these
techniques.85 At the Mayo clinic, North et al. compared the use of a
promotional video to a paper instruction sheet and to a no-a ention
control group to promote PHR adoption and use. In the following 45 days,
individuals’ PHR adoption was 11.7% among individuals who saw the
video, 7.1% among those who received the paper instructions, and 2.5%
among the control group. The superiority of the video intervention
persisted when the authors measured whether users went on to use the
PHR to initiate secure messaging with their healthcare providers.92
Interoperability
As described earlier, PHR data and functions are constrained by the
systems to which the PHR is linked. Current PHRs are integrated with a
limited number of systems and therefore represent only a subset of the
data and services that an ideal PHR should include. It is likely that a
comprehensive, ideal PHR would be more a ractive than current PHRs
and would be adopted at a higher rate.
In principle, all that is required to address the data requirements of an
ideal PHR is for all healthcare data systems in the United States to agree to
use the same data representation and exchange standards. Several data
representation and exchange standards have been developed and
proposed, including Continuity of Care Record (CCR), Clinical Document
Architecture (CDA), and Continuity of Care Document (CCD). For
additional information about standards, see Chapter 22. As an example
standard, CCR was developed by a consortium of medical societies and
adopted by the American Society for Testing and Materials (ASTM).93 By
describing the exact format of the information to be exchanged, this and
other standards provide the possibility for portable and syntactically
interoperable PHRs. Recent laws and policies, such as the promotion of
Nationwide Health Information Exchange by the ONC94 and the
development of accountable care organizations created in the recent
Patient Protection and Affordable Care Act, are intended to promote and
use interoperable records and should facilitate PHR adoption.
Summary of Adoption
While the Federal Communications Commission estimates that 90% of
Americans will have internet access by 202095 and the adoption of mobile
devices appears to be decreasing the digital divide (at least in terms of
ownership),7 adoption and usage of PHRs remains limited. Further work
is needed to increase awareness of PHRs, address patients’ concerns about
privacy, and improve usability and functionality of existing PHRs. Finally,
the interoperability and functionality of PHRs, while steadily improving,
are limited by nationwide adoption of relevant standards and policies.
The future of personal health records
Though early in their evolution, currently available PHRs have positive
effects on patients’ experience of care, healthcare outcomes, and healthcare
use. If the patients’ desire for PHR functions persists and trends in
adoption continue, PHRs have the potential to become the platform for a
more efficient, effective, and personalized healthcare system. To achieve
this promise, improvements in current systems as well an expansion of the
scope and functionality of PHRs are needed.
The available evidence for current PHRs is generally positive. However,
most PHR evaluations have been limited to primary care se ings in a
small number of integrated healthcare systems. Evidence is needed
regarding the adoption, use, and efficacy of current systems in larger and
more diverse groups of healthcare se ings and among users of varying
age, ethnicity, race, socioeconomic level, and disease status. Similarly,
current efforts to promote adoption of PHRs (e.g., marketing campaigns to
increase awareness) and governmental policy changes to promote
adoption need to be evaluated and may need to be refined for specific
subpopulations.
As pointed out at the beginning of this chapter, PHRs serve two main
functions: as data storage systems and as a suite of tools intended to
improve care. Both of these functions need to be expanded in future PHRs.
In terms of data storage, the ultimate goal is to develop PHRs that are
comprehensive, longitudinal records of individuals’ health. To migrate
toward this goal, systems will need to become more interoperable and
networked.41 The barriers to interoperability are not technical but rather
political and economic. Recent governmental policy regarding the
development of accountable care organizations to shift incentives in the
U.S. healthcare system may also drive the promotion and adoption of
PHRs.
In terms of functionality, Krist et al. have argued that current PHRs are
just the beginning and that the functionality of these systems should
evolve to become more personalized and effective over time.39 The first
step in making PHRs more patient-centered is to include services that only
a few tethered PHRs currently include, such as allowing proxies to access
PHRs, granting PHR access to minors, viewing EHR notes, viewing a full
list of diagnoses, patient control over information access, inclusion of a
“break the glass” function that would allow access for emergent service
providers, and clinician response to e-mails in less than 24 hours.96 PHRs
could also be used to collect patient-reported behaviors and outcomes.97
This type of patient-generated data could then be integrated into care. For
example, EHRs are commonly missing information on individuals’
occupational and family medical history.98 These data could be captured
via the PHR. Similarly, mobile systems could be used to capture
observations of daily living, such as measures of dietary behaviors or self-
report of symptoms, and present them back to patients as personalized
real-time feedback.99 Finally, research on PHRs as “persuasive
technologies” (technologies intended to change people’s a itudes and
behaviors)100,101 is in its infancy but holds great promise.
In summary, PHRs are evolving tools with great potential to facilitate
improvement in the health of individuals and the efficiency of healthcare.
While current trends are encouraging and substantial progress has been
made in recent years, significant work remains to be done if PHRs are to
reach their full potential.
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Discussion questions
1. In addition to those trends discussed in the chapter, what societal and
technological trends do you see that might promote increased adoption
and use of PHRs?
2. What specific types of data or functions do you think would draw
people who are not current PHR users to adopt and use the PHR? How
do you think this might vary by user a ributes (e.g., age, disease status,
health literacy)?
3. Examine information on the web about PHRs and current health
policies. What new information did you discover and how will this
information affect the adoption and use of PHRs?
4. In your health organization, what are the main barriers to PHR adoption
and use?
5. What is the nurse’s role in engaging populations to understand
information about their health and understand how to access health
information resources?
6. In thinking about a PHR that patients can use to annotate their EHR data
(e.g., comment on the problem list), what steps do you think patients
will likely take to correct their data? What do you think the advantages
and disadvantages of such a system would be?
7. Examine the PHRs that are available to you: what are their relative
benefits and disadvantages?
Case study
An academic medical center in the western United States recently adopted
a commercial EHR and plans to adopt and integrate a PHR with its EHR.
The hospital CEO drafts a vision statement that states, “By using the latest
technology, University Hospital will improve how our patients experience
healthcare. Instead of patients coming to us for help, we will be there
wherever and whenever they need us, asking, ‘How can we help you?’
This initiative will make healthcare easier to access and more convenient
to use, improve patients’ health, and reduce the rising cost of healthcare in
our area.”
Discussion Questions
1. What is your role in engaging populations to understand information
about their health and how to access health information resources?
2. What steps would patients take to correct their data?
3. What barriers should this facility anticipate in rolling out the PHR,
and what tactics should the organization take to overcome them?
15
mHealth
The Intersection of Mobile Technology
and Health
Sarah J. Iribarren; Rebecca Schnall
Abstract
This chapter analyzes mobile health (mHealth) technologies and their potential to
transform the access, management, and delivery of healthcare services as well as to
restructure patient-provider relationships across the globe. Topics discussed include
the emergence and driving forces leading to vast mHealth activities, examples of the
range of ecosystems where an array of mHealth technologies are used, and benefits
and barriers to its implementation. Potential directions and emerging trends are
described.
Of the world’s seven billion people, six billion have mobile phones.
However, only 4.5 billion have access to toilets or latrines.
United Nations Deputy Secretary-General Jan Eliasson1
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Define mHealth and what makes it unique from other health
information technology applications.
2. Describe driving forces behind the mHealth movement.
3. List mHealth application domains and describe examples of mHealth
uses in healthcare se ings in the United States and in developing
countries.
4. Explore the current state of mHealth research evidence.
5. Discuss benefits and challenges to mHealth implementation.
6. Discuss implications for mHealth research.
7. Describe potential future directions and gaps in mHealth development
and uses.
KEY TERMS
connected health 255
eHealth 255
mHealth 255
mHealth tools 256
mobile applications 257
sensors 257
Introduction
What Is Mobile Health?
Mobile health, commonly referred to as mHealth, m-Health, and more
recently as “connected health,” is described as a catalyst for healthcare
change.2,3 Widespread recognition exists for mHealth technologies’
potential to address and overcome disparities in health services access,
health inequities, shortage of healthcare providers, and high costs for
healthcare.4 mHealth falls under the umbrella of eHealth or the broad use
of information and communication technologies (ICT) to support health
and health-related fields. The World Health Organization’s (WHO’s)
Global Observatory for eHealth (GOe) defines mHealth as “medical and
public health practice supported by mobile devices, such as mobile
phones, patient monitoring devices, personal digital assistants (PDAs),
and other wireless devices.”5 Simply put, it is the use of mobile devices or
wireless technology to achieve health objectives.6 Before discussing
examples from the nascent field of mHealth, this chapter explores what
makes it unique from other health ICT.
mHealth was initially a term used interchangeably with telehealth
(healthcare at a distance), but by the turn of the 21st century, mHealth was
emerging as its own field with distinct characteristics different from
telehealth. In 2000, the movement toward mobile and wireless was defined
as “unwired e-med.”7 Later, Istepanian et al.8 indicated m-Health
“represents the evolution of e-health systems from traditional desktop
‘telemedicine’ platforms to wireless and mobile configurations.” mHealth
is redefining the original definition and concept of telemedicine as
medicine practiced at a distance to include the new mobility and invisible
communication technologies.
With this definition, the term mHealth was recognized as a new field of
study. Within the Federal Health Information Technology (IT) Strategic
Plan 2015–20, produced by the U.S. Office of the National Coordinator for
Health Information Technology (ONC), telehealth and mHealth are noted
as separate technologies and services.9 Unlike telehealth, which often
requires more advanced tools, mHealth uses consumer-grade hardware
and allows for use of the technology with greater mobility. In a review of
technologies and strategies to improve patient care with telemedicine and
telehealth, Kvedar et al.2 stated that mHealth has increased consumer
access to telehealth services and suggests the term “connected health” be
used to encompass the entire family of technologies and services.
Although the delineation between mHealth and telehealth may be more
nuanced within the larger umbrella of eHealth, mHealth tools, such as
mobile phones with video capability, can be used for telehealth to deliver
care at a distance. One example is the use of video conferencing on mobile
devices rather than desktop computers. One thing is clear—the focus of
mHealth is on taking advantage of a ubiquitous tool carried and used by
most people in their daily lives. The rapid proliferation of mobile
technologies and recognition of their inherent potential for improving
health has resulted in major reports and global surveys, dedicated
conferences and journals, and centers of expertise focused on the field of
mHealth.
Mobile Health Tools, Applications, and Examples of
Uses
Labrique et al. developed a taxonomy of 12 common mHealth
applications/domains and recommended mHealth strategies be viewed as
integratable systems fi ing into existing health systems rather than
standalone solutions.10 Table 15.1 lists the 12 common mHealth application
domains, describes the functions of mobile devices used within each
domain, and provides examples of applications in healthcare se ings.
Table 15.1
Examples of Common Mobile Health Application Domains, Functions
Used Within Each Domain, and Examples in Healthcare Settings
Modified from Labrique AB, Vasudevan L, Kochi E, Fabricant R, Mehl G. mHealth
innovations as health system strengthening tools: 12 common applications and a visual
framework. Glob Health Sci Pract. 2013;1(2):160–171. [Link]
13-00031.
GPRS, General packet radio service; IVR, interactive voice response; MMS, mobile
message service (text messaging with photo or video capability); SMS, short message
service.
WAP, Wireless Application Protocol.
a Domain 7 was modified from the original Provider-Provider Communication domain to
Communication to include communication strategies applied with mHealth tools to
increase communication between patients and providers.
mHealth technologies comprise a wide range of tools with various
technical capabilities and functionalities to support health-related
programs. For example, short messaging service (SMS), or texting, is a core
mobile phone function enabling one- and/or two-way communication
commonly employed in mHealth initiatives. Globally over 350 billion text
messages are sent monthly, exemplifying its extensive use.11 Its frequent
use in mHealth programs is due to a number of reasons: (1) it is more
economical than a phone call; (2) SMS is versatile, as it can be sent, stored,
or answered; (3) it is retrieved at the user’s convenience; and (4) SMS is
available on all phone types.12
On a more functionally advanced level, smartphones combine features
of a personal computer operating system with other features useful for
mobile or handheld use. More complex functionalities include general
packet radio service (GPRS), third- and fourth-generation mobile
telecommunications (3G and 4G systems), global positioning systems
(GPS), and Bluetooth technology.5 Additional smartphone tools include
cameras, calendars, mobile applications (apps), multimedia messaging
with pictures or video, gaming, educational tools, mobile internet access,
and wearable devices and sensors. Before describing examples of mHealth
programs, it is helpful to understand the features offered by various
mobile devices. Table 15.2 provides a list of the main
characteristics/features for common mHealth devices.
Table 15.2
Device Type and Characteristics/Features
Device
Characteristics/Features
Type
Basic 2G GSM. Services include: SMS; USSD; calling, alarm clock, calculator, flashlight.
phone
Feature Same as above with added internet-enabled services (usually limited, e.g., downloading music), often
phone with camera (still pictures), internet on EDGE or 2.5G networks (if enabled) and removable memory
cards (some).
Smart Same features as basic and feature phones typically with graphical interfaces and touchscreen capability,
phone built-in Wi-Fi and GPS, 3G + internet access, video camera, ability to install and use apps, Voice Over
Internet Protocol (VoIP) or phone calls over internet rather than cellular service with internet service.
Tablet Same as smartphone with larger screen size and memory, faster processor (enabling playback),
touchscreen with virtual keyboard.
Adapted from World Bank. Information and Communications for Development 2012:
Maximizing Mobile. Washington, DC: World Bank; 2012; and Global Health eLearning
Center. mHealth Basics: Introduction to Mobile Technology for Health. In: Lee CK, Raney
L, L'Engle K, eds. 2014.
2G, Second-generation; GPS, global positioning system; GSM, global systems for mobile
communication; SMS, short message service; USSD, Unstructured Supplementary
Service Data; VoIP, Voice Over Internet Protocol.
Mobile apps are important mHealth tools for smartphone and tablet
mobile devices. In the past few years, the number of health-related apps
based on the two leading platforms, iOS and Android, that are available to
consumers has more than doubled.13 In fact, a 2015 study by the IMS
Institute for Healthcare Informatics identified over 165,000 health-related
apps,14 compared to about 40,000 in their 2013 report.15 Fig. 15.1 provides
the categories of apps available to consumers based on the IMS study. Of
the 26,864 downloaded apps selected for their evaluation, two-thirds
targeted wellness management (e.g., fitness, lifestyle and stress, and diet
and nutrition), and one quarter were for disease treatment and
management, medication reminders and information, women’s health and
pregnancy, and disease specific.14 For the disease-specific apps, 29%
focused on mental health. However, the majority of the apps had simple
functionality, with over half only providing information, thereby limiting
their role in healthcare. About 10% included the capacity to link to a
sensor or a device.14
FIG 15.1 Categories of apps available to consumers. From IMS Institute
for Healthcare Informatics. Patient Adoption of mHealth. Use, Evidence and Remaining
Barriers to Mainstream Acceptance. Copyright 2015 IMS Health Incorporated and its
affiliates.
Client Education and Behavior Change
The mHealth domain of client education and behavior change largely
focuses on the client to improve knowledge, modify a itudes, and support
behavior change.10 Many examples of mHealth interventions exist in this
domain. MomConnect, an initiative in South Africa, is an example of a
program providing pregnant women with tailored information through
text messages about pregnancy, birth, and care of an infant.4 Registrants
also have access to the health system through help desk tools and feedback
services. In England, Florence is an SMS-based intervention for any health
condition, allowing patients to engage in their healthcare and linking
client data directly into clinician software.16
Numerous healthcare-related apps have been designed to promote
behavior change, support self-management of chronic diseases, and offer
healthcare providers easy access to healthcare information at the point of
care.17 Apps are a useful tool for behavior change because of their
popularity, connectivity, and increased sophistication.18 Apps can support
added functionalities beyond, for example, text messaging. They have the
potential for real-time data collection, graphic feedback, interactivity, and
links to social networking. TwineHealth is an example of an app
integrated into healthcare systems that was a finalist in the 2014–15 Health
Acceleration Challenge sponsored by Harvard Business School and
Harvard Medical School. TwinHealth is a cloud-based platform together
with a synchronized patient app that empowers patients in managing their
chronic diseases and establishes personalized plans using a model of
collaboration. In a randomized controlled trial (RCT), the team found
hypertension was significantly reduced in an intervention group using a
model of continuous care with technology support, including coaching.
This was in contrast to the control group of standard face-to-face office
visits. Costs were approximately $75 per patient year for the intervention
group, compared to $250 for the control group.19 Other examples of apps
supporting behavior change targeted diseases such as schizophrenia20 and
depression.21
Sensors and Point-of-Care Diagnostics
Sensors provide links from mobile phones to an external device for
longitudinal data collection or patient monitoring and point-of-care
diagnostics. Fig. 15.2 highlights types and locations of sensors or wearable
technology for collecting physiological information. The data can be
synced to mobile devices for monitoring. For example, AliveCor is a U.S.
Food and Drug Administration (FDA) approved heart monitor that
a aches to the back of an iPhone. It produces a single lead
electrocardiogram that is storable and can be shared with a healthcare
provider.22 Researchers found the device to be feasible, suggesting the
technology could become an important tool for clinical use.22
FIG 15.2 Sensor types and location. From IMS Institute for Healthcare
Informatics. Patient Adoption of mHealth. Use, Evidence and Remaining Barriers to
Mainstream Acceptance. Copyright 2015 IMS Health Incorporated and its affiliates.
Registries and Vital Events Tracking
This domain encompasses the identification, recording, and tracking of
individuals for a specific disease or event. For example, EbolaTXT was
launched in five West African countries to raise awareness about
important Ebola information and provided a convenient way community
members could report potential new cases using SMS.23 Fig. 15.3 provides
a graphical overview of the EbolaTXT program and campaign. The
program was advertised, and participants could opt in by texting a key
word to initiate an interactive educational quiz covering, for example,
important hygiene steps. Over 30,000 unique participants interacted with
the program in Malawi, Ghana, and Mali and Sierra Leone.
FIG 15.3 Graphical overview of EbolaTXT campaign. Used with
permission of TTC Mobile, Copyright © 2016.
Data Collection and Reporting
Mobile devices are replacing paper-based documentation as well as office-
based devices such as computers by allowing data to be directly deposited
into central servers from a mobile device. Potentially this will result in
fewer errors by moving data collection closer to the actual event, using
built-in checks to ensure data accuracy, completion, and quicker program
evaluation. After pilot testing, Uganda rolled out a national data collection
and reporting system using mobile devices to strengthen health reporting.
The District Health Management Information Software System version 2
(DHIS 2) is used for the recording of routine health data by various
healthcare personnel (e.g., records assistants, district health officers, and
other health workers).24 Using this approach, researchers found increased
completeness and timeliness for outpatient reporting.
mPower is an app to help collect patient-reported symptoms related to
Parkinson’s disease for a research study using questionnaires (e.g., tremors
and movement), memory games, phone collected sensor data (e.g.,
continuous location data feeds that provide position without divulging
exact locations), and wearable device data using AppleHealth.25 This app
gives patients an option to work with researchers to understand their
evolving health.
Electronic Health Records
Through the use of mobile-adapted electronic health records (EHRs),
patients’ health records can be accessed or updated in se ings outside
traditional hospitals or clinics. For example, Fazen et al.26 developed an
Android application, AccessMRS, that interfaced with an EHR to support
community health volunteers providing maternal and child health services
in Kenya.
Electronic Decision Support
Algorithms and protocols provide the information source for the
development of electronic decision support tools for healthcare
professionals. mHealth programs using point-of-care decision support
tools and automated algorithms fall into this domain. In Tanzania, an
electronic version of Integrated Management of Childhood Illness protocol
(eIMCI) demonstrated greater adherence to protocols using the mobile
phone–based support app than the usual paper-based approach.27
Decision support on a mobile platform is also available to patients and
consumers. The app SnapDx is a free diagnostic tool downloadable from
the AppStore that does not require the use of Wi-Fi. Symptoms are entered
and the results show a list of diagnoses and the percent probability of a
disease. Another decision support–related app, AllergyCast (Zyrtec),
claims to help identify sources of allergies by triangulating
consumer/patient symptoms, live pollen data, and live weather data (wind
speed and humidity).28
Communication (Provider-Provider, Patient-Provider)
mHealth apps can be used to support direct voice exchange, images, or
sound for immediate remote consultation. A provider-provider example is
ePartogram, an electronic, tablet-based tool used in Kenya to provide
decision support tools along with real-time, expert consultation to prevent
and manage complications of labor.23,29 A patient-provider example,
WelTel, was one of the first large-scale mHealth interventions evaluating
outcome measures for antiretroviral therapy adherence.30 Patients were
sent an e-mail asking how they were doing with their treatment. If they
responded positively, there was no action. If participants responded they
had issues or did not respond, a nurse would directly contact the patient
to identify needs and provide appropriate support. In the study on 538
participants, results indicated those receiving text messages had
significantly improved adherence to antiretroviral therapy and lower rates
of viral suppression compared to those receiving usual care. One example
of a service patients can sign up for to communicate with a healthcare
provider is HealthTap, an app allowing patients to ask their providers
questions directly.31
Provider Work Planning and Scheduling
This domain includes alerts for healthcare visits, adherence to treatment
regimens, or reminders for follow-up for postcare procedures.10 For
example, the Mobile Technology for Community Health (MoTeCH)
initiative in northern Ghana supports work planning and scheduling by
calculating upcoming care schedules for each client and, when care is due,
notifies the client and community health workers.32
Provider Training and Education
Training and education is being provided using a number of mobile
technology features (e.g., video, interactive exercises, quizzes,
informational messages). A number of mobile apps provide access to
continued health and medical education guidelines and protocols,
particularly useful to frontline health workers and providers in remote
areas.
Human Resource Management
mHealth can assist with human resource management by helping
healthcare workers to triage patient needs and focus on patients in need of
extra support during treatment. This is particularly important in se ings
in which a ention from healthcare workers is largely unavailable, costly,
or difficult to access due to geographic distances.
Supply Chain Management
mHealth tools are being used to track and manage medication and other
healthcare-related commodities. For example, cStock is a program
implemented in Malawi to support supply chains for community
management of diseases.23
Financial Transactions and Incentives
Mobile money applications facilitate payment for healthcare services,
provide incentives to providers complying with protocols, and allow users
to transfer money to others.23 In rural Kenya, the feasibility of a mobile
money-transferring platform (mPESA) was evaluated using SMS and
conditional cash transfers for vaccine coverage.33 Of the 72 mothers
enrolled in the study, 90% of their children received their first vaccinations
on time, and 86% received the second vaccination within 4 weeks of their
scheduled dose.
Driving forces of mobile health
mHealth has grown from an emerging field to a mainstream component of
eHealth activities. Some of the driving forces fueling the mHealth
movement include (1) technology (access, reduced cost, and its increasing
functionality), (2) the consumer/patient engagement movement, (3) global
health or connected health (expanding healthcare services to remote and
marginalized populations), and (4) research, policy, and business (both
cost savings and earning potential).5,34
Technology
Near ubiquitous access to mobile devices, along with their range of
functionality and increased capabilities, are some of the driving forces of
the rapid growth of mHealth.
Access
Mobile phone subscribers have grown from less than 1 billion in 2000 to
more than 7 billion in 2015, equating to a penetration rate of 97%
worldwide.35 Indeed, the mobile phone was cited as the most rapidly
adopted technology on the planet.36 For example, many countries in Africa
have leaped to mobile as a first telecommunication service infrastructure,
bypassing landlines. A working paper by the Center for Global
Development published in February 2015 examined trends in the
infrastructure services in Africa and identified mobile phone service as the
most widely available type of infrastructure across Africa.37 Of the 33
countries examined, only 4 had mobile phone service coverage available
for less than 80% of the area, while the remainder had mobile phone
networks available for between 80% and 100%. In contrast, wide
disparities exist for the availability of other services. Electricity was
between 18% to universal availability in only five countries, piped water
ranged from 11% to 89%, and sewer service was available for less than 10%
in five countries, while only seven countries had over 50%.
While mobile phone connectivity is available in the overwhelming
majority of Africa, inconsistent access to electricity often requires that
phones are charged using alternative methods such as a solar energy
source, a car ba ery, or a central charging station.38 In another study,
commissioned by the World Bank, one in five living at the base of the
economic pyramid ($2.50 per day income) in Kenya sacrificed usual
expenses, such as food, in order to reload mobile phone airtime. The most
widely used app in this country was for mobile money transferring.39
While the United States has been a leader in traditional
telecommunications, mobile phones are replacing landline connections.
More than half of Americans aged 18 to 44 (44.1% of all adults) and of
children under 18 (54.1% of all children) lived in wireless-only households
according to a report released in June 2015.40 Furthermore, in the United
States, with the advent of the mobile phone, the gaps in the “digital
divide,” or those who have access to digital technology and those who
don’t, have narrowed.41 As of January 2014, 90% of Americans owned a
cell phone. Ownership was similar across racial and ethnic groups and
community type (urban, suburban, and rural) and only slightly more for
higher-income families (84% for those with household incomes less than
$30,000/year and 98% for those with a household income of $75,000/year or
more). The differences among age groups ranged from 74% for those 65
and older to 98% for ages 18 to 29.
Although smartphones are becoming more accessible globally, the
majority of people worldwide are using basic phones.42 In 2014,
smartphone penetration was 37% globally, 33% in Latin America, and 63%
in the United States.42 Since 2011, China has been the world’s leading
smartphone market. A report by Mobile Futures, a diverse group of
nonprofit organizations, found more mobile devices than personal
computers are bought in China.43
Access to the internet determines the range and capabilities for mobile
devices. Globally, 34% of households in developing countries have access
to the internet in comparison to 80% in developed countries.35 Although
mobile phone ownership in the United States is similar across ethnicities
and community type, there are noted differences in how access to the
internet is obtained. U.S. minorities rely more on their phone for internet
access. In contrast to only 4% of white smartphone owners, 13% of
Hispanics and 12% of blacks must depend on their smartphone for
internet access. That is, they do not have broadband access at home and
have few options for going online other than with their cell phone.44
Range and Capabilities
The range of tools and capabilities of mobile devices has expanded along
with availability. As outlined above, mHealth tools range from basic to
more sophisticated mobile phone features. The functional capacity of
mobile devices has increased exponentially with each smartphone
generation. According to a 2015 report, 5G is in the very near future and
will allow even faster speeds, help enable simultaneous use of different
wireless pathways, and connect “virtually any and every thing.”43
Consumer/Patient Engagement and Empowerment
The impact of the mHealth evolution goes well beyond the introduction of
this technology. The use of mobile devices is transforming peoples’ lives
by changing the way people work and interact. With penetration into
nearly all sectors of society and with these devices almost always turned
on and near their users, smartphones and web-enabled devices are
arguably considered by most people essential to everyday life.
In addition, healthcare models are changing through patient
engagement and empowerment,45 thereby increasing collaborative care,
and changing the roles of both consumers and providers.46 mHealth is
implicated as the basis for the consumer-led, data-driven healthcare
revolution.34 Patient empowerment is being driven by consumers (1)
having increased access to health information and basic medical
knowledge as well as (2) being able to capture their own data.3 mHealth is
a catalyst for moving the locus of control from provider to patient and
toward a more collaborative care approach.47
As described in Chapter 12, provider-determined care is shifting to
participatory healthcare delivery models and changing how health
knowledge and personal data are accessed and shared. Mobile devices
have greatly impacted how communication and information access occurs.
For example, communication by brief mobile messaging (e.g., text
messaging or multimedia messaging through apps) is common and
continues to increase. In fact, mobile messaging traffic is forecasted to be
upwards of 27.7 trillion messages per year by the end of 2016.48
A major contributor to the mHealth evolution is the development,
proliferation, and use of apps and sensors. The 100 billion mobile app
downloads from the Apple store alone speaks loudly to consumer interest
in mobile features.49 Such mHealth tools support consumer/patient
engagement by providing easy access to health information and personal
data and also by enabling them to collect their own health data.34 A 2014
report estimated mHealth-centric wearable devices will account for over
150 million unit shipments by the end of 2020.50 The data collected by
these devices can be used to individually modify behaviors and can also
be shared with healthcare providers, family, or friends. Wireless devices
and apps are making activities such as data collection, analysis, and
sharing simple. With apps, patients can track and share upwards of 60
health indicators (e.g., respiratory rate, body temperature, activity,
nutrition); they can self-diagnose and proactively manage their health and
wellness.
Global Health and Connected Healthcare
Access to healthcare systems in rural, isolated, and resource-limited
se ings is a major driver of global mHealth implementation and research.
The WHO recognized mHealth as a tool for strengthening health systems
and improving health outcomes across the globe, especially in low- and
middle-income countries (LMICs).5 In response, global key stakeholders,
such as governments, national healthcare institutes, and healthcare
professionals, expressed interest or invested in mHealth initiatives.51
Research, Policy, and Business
Research, policy, and the growing business potential are stimulating
mHealth growth.
Research
Two important guides providing principles for mHealth intervention
development, implementation, and evaluation are the Guide for mHealth
Development, Design and Testing52 and the Principles for Digital
Development.53 These guides have been endorsed by major donor
organizations and outline best practices into technology-enabled programs
for sustainability in mHealth projects. A common purpose for both these
guidelines is to build a common strategy to mitigate overlap and waste
and improve collaboration among various healthcare key stakeholders at
local, regional, or national levels.
There are three main phases described in the Guide for mHealth
Development, Design and Testing, with accompanying documents and tools
to guide the iterative process. These phases include (1) concept
development, (2) solution design and testing, and (3) planning for
implementation. The first two phases guide potential mHealth
implementers in identifying the needs and technological literacy of the
target population and in becoming familiar with the context within which
the program will be implemented. The planning-for-implementation phase
highlights iterative steps of incorporating feedback from users and
partners and revising the content and system as needed before scale and
sustainability can be achieved. Examples of this same principle using the
Principles for Digital Development include “reuse and improve” (e.g., use,
modify, and extend existing tools and platforms rather than build new
ones) and “use open standards, open data, open source, and open
innovation.”53
The ONC’s Federal Health IT Strategic Plan 2015–20 on how health IT
can improve health goals includes mHealth technologies and services in
three of the four goals.9 For example, Goal 2 concerns transforming
healthcare delivery and community health using person-centered care and
self-management supported by health IT and specifically mentions
mHealth as a strategy.9 This report recommends improving mHealth
research by using (1) sound intervention development principles, (2)
guidance from established theoretical framework/underpinning, and (3)
rigorous research methodologies (Goal 3C).9 Research on the impact of
mHealth technologies is growing but remains scarce.54 As of July 2016, 256
mHealth trials were registered at h ps://[Link]/ with the term
mHealth in their title or abstract. Funding calls related to mHealth
initiatives have encouraged research. The state of the evidence is described
the sections below.
Policy
After the rapid surge in the number of mobile apps available to the public,
the FDA released guidance on mobile medical apps in 2013.55 The agency
indicated it will oversee a targeted risk-based subset of apps to focus on
patient safety for cure, mitigation, treatment, or prevention of disease.55,56
For example, apps considered high risk and those that act as medical
devices, such as electrocardiogram machines, will require premarket
approval. With other mHealth apps, the FDA will exercise only regulatory
discretion.57 That means apps with functionality to track health
information like blood pressure and transfer the data to healthcare
providers or generate health advice from patient-specific information
might be considered of moderate risk but will not require premarket
oversight.
A 2015 report including mHealth policy was produced in collaboration
across leading organizations (e.g., United Nations, Microsoft, NetHope)
highlights the United Nations Sustainable Development Goals (SDGs) as
the next stage of commitment by world leaders to reduce extreme poverty
in all forms by 2030.58 The report is the SDG ICT Playbook: From Innovation
to Impact. It addresses technological areas such as mHealth to assist the
SDGs achievements.
Business: Economic Potential and Cost Savings
mHealth is a lucrative business. Estimates indicate the mHealth market
will account for nearly $13 billion in 2015 alone.50 Further growth is
anticipated at nearly 40% over the next 6 years despite barriers on
regulation, patient acceptance, and privacy concerns.50 Goldman Sachs
analysts forecast an opportunity in savings from digital healthcare of $305
billion for the United States.59 For healthcare systems, globally and
particularly in low-resource se ings, mHealth has the potential to increase
healthcare quality, decrease costs, and create additional capacity for
healthcare systems.5,60 For example, in Latin America, estimates of
mHealth services in Brazil and Mexico will extend medical a ention to
28.4 million and 15.5 million new patients, respectively, at an estimated
cost reduction of $17.9 billion.61
Service costs, such as traditional provider visits, are projected to
significantly decrease with health digitalization. For example, Armstrong
et al.62 modeled the cost-effectiveness of replacing ambulatory surgical
follow-up visits with mobile app home monitoring. Taking into account
the total of healthcare system, patient, and external borne costs, they found
the total cost difference between mobile app and in-person follow-up care
was the equivalent of $223, with in-person follow-up being more
expensive than mobile app follow-up care. However, research on mHealth
intervention cost-effectiveness or cost-savings remains limited.
Mobile health benefits and challenges
Mobile Health Evolution and Evidence
mHealth has evolved from early clinical decision support at the bedside
using PDAs to the use of personal supercomputers.34,63,64 Over the last
decade, increased research and literature on mobile technologies reflect the
mHealth’s evolution.54 While a number of research studies were
conducted, a review of these studies demonstrate that research is still in
the early stages with limited scope and mixed results.
Labrique et al. describes the first era of mHealth as experimental
proliferation or what was criticized as “pilititis”—that is, a large number
(piles) of pilot studies conducted within a short time frame and not
extending past the pilot phase. This is a natural state of disruptive
technology or innovation introduction.51 Early, proof-of-concept projects
often focus on evaluating technology feasibility and acceptability versus
impact assessment. With the rapid increase in peer-reviewed literature and
larger-scale research projects, we may now be transitioning into a second
phase, an empirical era.54
The evidence base for mHealth continues to grow with an increase in
outcomes research.23 For example, authors of Cochrane Reviews assessed
mobile messaging’s impact on self-management of long-term illness,65
promotion of preventive healthcare,66 adherence to antiretroviral therapy
in patients with HIV infection,67 a endance at healthcare appointments,68
and the effects of apps for asthma outcomes.69 Other systematic reviews
evaluated how mHealth can be used to improve adherence to any
medication regimen70 or usage of antenatal/postnatal care and childhood
immunization.71 High-quality evidence was identified for interventions
using mobile messaging to support smoking cessation66 and to improve
adherence to antiretroviral therapy.67 Some evidence of effectiveness or
studies with positive outcomes were identified for mHealth interventions
to improve adherence to any medication and to improve
antenatal/postnatal care a endance and childhood immunization.70,71
Limited, low-to-moderate quality, or insufficient evidence was found for
mobile messaging to improve self-management of long-term illnesses65 or
rate of appointment a endance,68 and for asthma apps.69 Overall, authors
indicated a need for further high-quality evidence, particularly for
understanding long-term mHealth effects, cost-effectiveness, a broader
variety of se ings, and risks and limitations of such interventions.65,66,68,70,71
Similarly, two systematic reviews conducted by Free et al.72 found
modest improvements in care delivery and mixed results for outcomes
using mHealth technology-based health behavior change or disease
management interventions.73 Among 59 trials of mHealth interventions to
improve disease management and 26 for health behavior change, findings
indicate improved adherence for antiretroviral medication, smoking
cessation, and increased physical activity in diabetics, but not lower body
weight.73
A number of reviews assessed market availability of health-related apps
for specific health topics, their functionalities, and content quality. For
example, reviews were conducted to identify and evaluate apps to support
chronic diseases such as diabetes74 and chronic pain,75,76 as well as for the
prevention, detection, and management of cancer,77 depression,78 and
bipolar disorder,79 and medication self-management.80
Reviews also are available on apps for the prevention and support of
infectious diseases such as healthcare-associated infection prevention,81
HIV,82 and tuberculosis.83 Li le is known about the length of app use.
Although no health outcome was reported, Becker et al84 found 29%
(3406/11,688) of users of an app to support medication adherence used it at
least once a week for at least 4 weeks and 27% (3209/11,688) continued to
use it for at least 84 days.
Benefits
Many actual and potential benefits of mHealth were already discussed
throughout this chapter and have been identified by experts in the field.3
mHealth tools have the potential to support consumers/patients in being
be er informed and more involved in their healthcare. Beyond access to
healthcare knowledge, mobile phones can support patients to participate
proactively in their care and be aware of their health through active self-
monitoring.14 Sensors have the potential to provide real-time measures
with highlights of day-to-day variations, and they may be as ubiquitous as
phones themselves in the future. In summary, actual and potential benefits
include the following:
• Increasing the reach and access to healthcare services (e.g., routine or
emergency) and information (e.g., diagnostic, specialty services).
• Improving efficiencies and lowering healthcare systems expenses (e.g.,
increased data collection accuracy and completeness, rapid collection)
• Empowering individuals or populations for health behavior
modifications and disease prevention
• Greater patient access to medical information to improve health
outcomes
• Greater access to personal data
• Decrease in operational stresses on healthcare organizations
Challenges
The actual and potential value of mHealth is highly agreed upon, but
challenges and barriers still exist.14,47 Chapters 5, 8, and 22 discuss a
number of challenges related to interoperability; these also apply to
mHealth-based interventions. Equally challenging are the issues of human
resources, funding, infrastructure, privacy (which is discussed in greater
detail in Chapter 26), and legal and regulatory issues (discussed further in
Chapter 25 and described from a global perspective in Chapter 34).
Issues for developing and low-income areas include the following:
• Patients frequently changing phones or numbers or phones ge ing
lost or stolen
• Use of pay-as-you go plans, running out of credit, cost of texting
• Inconsistency of a reliable power source to charge devices
• Projects relying on smartphones where access to smartphones remain
too expensive to be sustainable (globally, basic-feature phones are
more common)
• Gender inequities
• Need to accommodate many languages
• Basic literacy, digital literacy, and health literacy
• Scale-up and integration into existing systems
The three biggest mHealth challenges identified by experts in the United
States, according to the Economist Intelligence Report, were:
• Patient misinterpretation of data
• Poor health decisions
• Data privacy risks and legal risks3
Patient Misinterpretation of Data
Concern exists that mHealth consumers may misinterpret their data or
rely on information from apps or devices without consulting a healthcare
professional.57 For instance, 25% of Americans surveyed indicated they
trusted symptom checker apps, websites, or home-based vital sign
monitors as much as they did their healthcare provider, and 26% reported
using these resources instead of going to a healthcare provider.85 Tripp et
al.86 identified pregnancy-related apps and reviewed their purposes and
popularity. They concluded the reduced reliance on healthcare
professionals was concerning due the popularity and availability of
interactive, personalized information from these apps.
Data Privacy Risks
Data security, privacy, confidentiality, and human subjects’ protection are
major concerns for mHealth adoption and expansion.14,47,57 Large amounts
of data are being collected on multiple devices and transferred elsewhere
for central collection and analysis. Confidence in security and privacy of
patient information is a major concern everywhere; the potential exists for
information to be intercepted by third parties.87 Similar to other areas in
informatics, legal questions exist such as to whom the data belongs as well
as licensing issues for treatment across state lines. Legal risks impact the
roles and accountability of data, particularly continuous remote
monitoring. Information handling requirements have increased due to the
vast amounts of data and information generated from mobile devices. As a
result, greater storage capabilities and data integration into large data sets
are needed.34 No protocol exists for the interpretation of the intensity of
data.47 With the massive amounts of data and information, one of the big
questions is who will monitor and be responsible for all the data.46
Legal Risks: Safety, Regulation, and Oversight of
Data
With over 165,000 health-related apps available to consumers/patients and
millions of downloads, li le evidence exists about their effectiveness, risks,
safety, or even if or how long they are used after they are downloaded.14 In
addition, the development and consumer demand for health apps and
sensors are outpacing regulation and policy.57,76 Currently no medical-
specific regulations are available to assure reliability and validity of app
content, and only a small number of apps are FDA approved.57 In fact,
many apps are not current with clinical guidelines, and the functionalities
and quality of apps are limited.79
Given the growing numbers of apps and li le scientific evidence, it is
understandable consumers and healthcare providers are challenged to
become “app literate” or able to identify and recommend efficacious,
credible, and reliable apps.78 Although many apps likely could cause li le
harm, those supporting diagnostic decisions could have serious
repercussions.57 Misinformation is also a concern. For example, Acne App
claimed its mobile app could cure acne by emi ing colored light from a
cell phone. The Federal Trade Commission sued the marketer of this app,
claiming unfair and deceptive practice. The app information was not
verified and information was potentially harmful (as well as not
efficacious) to patients.
To help healthcare providers determine which apps to recommend to
patients, a number of third-party organizations are providing tools to rate,
evaluate, or curate certified apps, such as Happtique, HealthTap,
Wellocracy, and Health AppScript.88 For example, the Health AppScript
uses a proprietary algorithm to rank apps based on six weighted areas14:
1. Licensed healthcare professional input
2. Endorsement by recognized associations (e.g., professional and
hospital associations)
3. Consumer ratings (e.g., download and rating volume, retention)
4. Development quality (e.g., data management privacy and security)
5. Functionality (e.g., data management and control, clinical sensor
compatibility)
6. Clinical outcomes
However, no evidence was found for how the validity of the tool was
established. Readers can also consult the FDA’s website for information on
approved apps.89
Manual methods to evaluate apps are proposed. The Institute for
Healthcare Informatics used seven functionality criteria and four
functional subcategories for app assessment.15 Another tool to classify and
assess the quality of mobile apps uses five measures and is called the
mobile app rating scale (MARS): 90
1. Engagement (e.g., interest, interactivity, customization)
2. Functionality (e.g., performance, ease of use)
3. Aesthetics (e.g., layout, graphics, visual appeal)
4. Information (e.g., quality and quantity of information, credibility,
evidence base)
5. Subjective quality (e.g., if recommended, willingness to pay, star
rating)
MARS was used to review and rate existing apps to support heart
failure symptom monitoring and self-management.91 For reporting
findings of a targeted app evaluation, recommendations are provided by
the Quality and Risk of Bias Checklist for Studies That Review
Smartphone Applications.92
Finding a viable business model to maintain an intervention is another
challenge. Suggestions for remedies include selling mHealth services or
creating subscriptions to premium content and advice for the collected
data.3 For example, the BlueStar app for type-2 diabetes management is
only available by prescription and was the first app to receive approval to
be prescribed for disease therapy and to be eligible for insurance
reimbursement.93 Once be er evidence is available about the effectiveness
of mHealth measures and how to classify them, reimbursements through
insurance companies may be less of an issue.
Leading mHealth Organizations, Key Resources, and
Information Repositories
To address a number of the challenges identified in this chapter, leading
organizations have established repositories and helpful guides for
mHealth development, implementation, and evaluation. Table 15.3
provides a list of several of these resources.
Table 15.3
Leading Mobile Health Organizations, Key Resources, and Databases
NIH, National Institutes of Health; ICT, information and communication technologies,
SDG, sustainable development goals.
Future directions of mobile health and
conclusions
An unprecedented opportunity exists to leverage humanity’s most
pervasive global technology platform into revolutionizing healthcare.
Currently the use of technology is shifting from networks and hardware to
software and services.94 The next generation of mHealth apps using 5G is
likely to revolutionize and transform healthcare, with its projected speeds
100 times faster than today that can support billions of simultaneously
connected devices. This level of connectivity will enable reaction times that
can support the precise control of autonomous vehicles, improve network
reliability, and reduce energy use by a factor of 1000.43
The future points to the connectivity of anything and everything.
Multiple forms of sensors monitoring physiological responses will capture
tremendous amounts of data over extended periods and will likely change
what we know about our bodies. By 2020, over 78.5 million consumers
globally are estimated to use home health technologies and remote
monitoring tools, up from 14.3 million in 2014.95 This revolution of data-
gathering sensors monitoring everything is called the Internet of Things
(IoT) and is mobile, virtual, and instantaneous.96
Wearable technology such as the Apple Watch (an “intelligent health
and fitness companion”), Jawbone, and Smart Scale (monitoring body fat)
is already here and widely used. Smartphones are being fi ed for testing
blood, saliva, and sweat, and breath tests.3 The challenge will be how to
analyze and respond to the growing databases of information. The fields
of big data and personalized medicine will likely integrate to allow be er
understanding of the impacts and capacities of mHealth data.
Major players in the sphere of data and technology integration include
Apple’s HealthKit and GoogleFit, which were both released in 2014. These
are central platforms to aggregate healthcare information, collect fitness
and health data, access personal medical information (diagnoses, lab tests),
develop tools such as apps or integrate ones existing or in use by
healthcare facilities, and allow users to choose what will be shared with
healthcare teams. According to a Reuters poll, 14 of 23 top hospitals in the
United States have rolled out programs using Apple’s HealthKit service.97
In addition, the Apple ResearchKit, an open-source software framework,
will likely transform how individuals or patients become involved to
advance medical research.
mHealth is changing the delivery of healthcare, though its continued
role in the future of global healthcare delivery seems certain. It is uncertain
how mHealth will evolve in response to the challenges outlined above.
mHealth has the potential to empower patients, allowing them to take
control of their health; healthcare may become more personalized and
responsive to individual needs. The ideal would be for integrated systems
to shift from the current reactive, disease treatment focus to a proactive,
disease prevention focus, including problem detection at early stages
outside healthcare structures. A tighter integration of mHealth into health
systems will allow even greater results than today. The future focus on
mHealth and its health impacts is assured in part because the National
Institutes of Health (NIH) included mHealth as one of its main goals in its
NIH-wide 2016–20 strategic plan.98
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Discussion questions
1. Describe the components of an mHealth intervention to support a
patient with a chronic condition.
2. What are the strengths of using mHealth technologies in clinical
practice?
3. What are the barriers to using mHealth technologies in clinical practice?
4. Explain some of the risks involved in using mHealth technology.
5. How can mHealth technologies be used to support patient care?
6. How might mHealth change the patient-provider relationship?
Case study
Henry Brown is a 67-year-old American living in the rural central United
States. He is prescribed multiple medications for hypertension, depression,
diabetes mellitus type 2, and a recent bacterial infection. Henry is not
alone. In fact, estimates suggest at least 70% of the U.S. aging population is
prescribed multiple medications due to the rapid increase in the
prevalence of chronic diseases. This presents a major challenge for our
healthcare system. Most medications require consistent adherence to the
prescribed regimen for them to achieve therapeutic effect. Yet it is known
that adherence rates remain suboptimal across populations and disease
states. Because Henry uses a smartphone, his primary healthcare provider
might recommend a mobile app called the Medication Tracker to help him
manage his complicated medication regimen. Henry’s primary healthcare
provider recognizes apps have the potential to address the specific needs
of patients in a manner that is timely, cost-effective, informative, and
engaging. This app can be configured to deliver automated, personalized
messaging to remind Henry to take his medication; can help Henry
reinforce good self-management behaviors; can provide education on his
chronic diseases; and can provide information about his medications, such
as black box warnings, side effects, and contraindications for use.
Discussion Questions
1. Describe the factors that Henry’s primary healthcare provider should
consider when selecting an app for him.
2. Identify the features most important to facilitate the primary
treatment goals of Henry and his primary provider.
3. Describe how Henry should communicate his activities with the app
to his primary healthcare provider.
4. List some risks for Henry associated with using this app.
UNIT 4
Managing the Life Cycle of a
Health Information System
16
Strategic Planning and Selecting an
Information System
Cynthia M. Mascara; Mical Debrow
Abstract
This chapter provides direction and guidance for the utilization of a systematic
process in the identification and selection of a healthcare information system. The
most critical factor in a selection process is strategic alignment with both the
organization and the information technology department. Understanding the
systems life cycle and performing an assessment of an organization’s requirements
are essential to a successful selection process. The chapter describes the requirements
of both a request for information and a request for proposal. Evaluation criteria for
system selection are also explored. Appraisal of vendors and their capabilities to
meet current and future needs are outlined.
The pace of change in healthcare is anticipated to only accelerate, and
both the organization and the vendor must be able to adapt quickly.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Use an institution’s vision and strategic plan as a guide in selecting a
new or upgraded healthcare information system.
2. Organize and implement a system selection process using the initial
phases of the systems life cycle.
3. Prepare a request for information (RFI) and a request for proposal
(RFP).
KEY TERMS
request for information (RFI) 278
request for proposal (RFP) 278
requirements definition 274
strategic alignment 271
strategic vision 271
systems life cycle (SLC) 273
vendor 279
Introduction
This chapter provides an overview of the system selection process within a
healthcare environment. Box 16.1 lists steps that are usually part of the
process. However, it is important to realize that the specific steps used for
each purchase of a healthcare information system will vary depending on
the size and mission of the institution, the significance of the purchase to
the institution, the governance model of the institution, and a number of
external factors. In addition, a systematic process should be used when
selecting a new system; however, the process is not linear but rather
somewhat reiterative as new information and insights develop during the
process.
Box 16.1
Steps in the System Selection Process
Identify the Project as a Formal Organizational Priority
• Have the organization executives endorse the project as a priority, define
its initial scope, and provide start-up resources.
Identify Responsible Groups/Individuals
• Establish the interdisciplinary selection commi ee, outline scope of
responsibilities, and provide release time for individuals.
• Establish reporting relationships for the selection commi ee.
Perform Initial Internal and External Data Collection
• Review the mission and goals of the institution and how this project
relates to them.
• Review resources, both internet-based and available literature, on real
installations of the new project. If available, work with a formal project
manager to formulate project steps.
• A end trade shows and major conferences related to the project.
• Obtain related guidelines/regulations.
• Develop initial system specifications.
• Develop a list of vendors that offer the planned new system.
• Review computerized, manual, and/or paper processes and forms in use.
• Identify information systems that could interface with the project.
• Identify all current projects that might interface or conflict with the
project.
• Develop lists of institutions/contacts with project experience.
Develop Goals, Benefits, and Scope of Project
• Prepare a statement outlining the goals, benefits, and scope of the
project.
• Develop feasibility statement and refine system specifications.
• Send RFI to potential vendors (optional).
• Review the responses to the RFI (optional).
• Create a list of potential vendors for RFP distribution.
Develop and Distribute RFP
• Conduct preliminary site visits for specification development.
• Define and prioritize system requirements—“must have” and “nice to
have.”
• Create an RFP, including a standardized response format and weighted
evaluation criteria (best value across clinical, technical, vendor, pricing).
• Develop and include criteria and mechanisms for vendor responses and
commi ee evaluation.
• Finalize the list of potential vendors.
• Finalize and distribute RFP to potential vendors.
Analyze Vendor Proposals and Make
Recommendation(s)
• Evaluate responses to RFP across at least these factors: clinical
functionality, technical capability/feasibility, financial aspects, project
timeline, and vendor a ributes, including projected company stability.
• Have vendors conduct demonstrations using scenarios the commi ee
devises. Use formal evaluation criteria to rate them.
• Conduct site visits and use formal evaluation criteria to rate the vendors.
• Combine findings and develop decision recommendations.
Conduct Contract Negotiations
• Include the RFP as part of the contract, including vendor responses to
issues or questions.
• Review and iterate the agreement (see Chapter 18).
• Sign the agreement and begin the installation process.
RFI, Requests for information; RFP, request for proposal.
When the decision has been made to identify and select a new or first
healthcare information system, an initial search will quickly identify that
although some vendors have exited the health information technology (IT)
(or health information systems [IS]) market, more than 200 companies
remain marketing health IT. This large number of choices must be
narrowed to a reasonable number of systems that can meet the
organization’s unique needs by considering factors such as the size, type,
complexity, and unique cultural aspects of the organization. Although the
natural inclination of an organization is to reach out to well-known
companies or those used in the local community in selecting a system, a
systematic process involving a thorough review of available information
systems is recommended. However, selecting a new system or upgrading
a current system is doomed to failure if that process is not based on a
careful analysis of the institution’s current status and desired future. This
chapter provides the framework for that process.
Strategic vision and alignment
A strategic vision is the desired future state. Strategic alignment involves
matching two or more organizational strategies to ensure that they
synergistically support the organization’s goals and vision. Before
beginning the system selection process for any new or updated system, the
institution must develop and implement a strategic vision and plan. In
addition, the information technology (IT) department must develop its
own strategic vision and plan in alignment with and guided by the
organization’s strategic vision and plan. It is essential that these plans
consider the multiple internal and external stakeholders, including users
of the patient’s healthcare information such as physicians, nurses, ancillary
healthcare staff, payers, regulatory groups and, finally, the patient.
The strategic vision and plan for an organization provides a long-term
road map for the organization and is critical in light of economic,
regulatory, and market pressures. Strategic planning in healthcare is used
to determine the desired future of the organization. It involves a variety of
organizational processes, including, for example, external and internal
scans. The strategic plan sets the goals, objectives, assignments, and
measures based on the community’s needs and provides the direction for
the organization when planning how it will achieve its clinical and
financial goals and objectives. The plan will provide guidance in selecting
the information systems that most closely align with the desired future of
the organization, stakeholder buy-in, engagement, productivity, and
efficiency. The strategic vision and plan should also create a sense of
urgency that begins with the vision of the organization. Strategic plans
typically do not address issues or problems but rather chart the direction
of the organization.
The IT plan should align with the organization’s mission, vision, and
overall strategic plan. Strategic planning for both the organization and the
IT department is not a linear process; rather, it is iterative in nature and
requires consideration of multiple variables, including future goals and
directions.
Key factors in identifying and selecting information systems are the
business plans for the organization and the IT department. It makes li le
sense to consider $20 million systems when the business plan states a
maximum of $10 million. However, cost is not the only consideration.
System selection teams must review key objectives of the organization and
the IT department to ensure that the objectives of the selection team are in
alignment with the institution and the IT department before proceeding
with selection of potential information systems. Once objectives are
aligned, the team is ready to begin the process of identifying and selecting
the systems that will most closely align with the economic, operational,
and clinical objectives of the organization. The stakeholders in each of
those three areas must be heard, considered, and educated about what
systems can and cannot do to support the objectives of different
stakeholders within the organization. No system in isolation supports the
practices of medicine or nursing, improves financial reporting of
outcomes, and changes the operation of the organization. Rather, systems
support the decision makers and stimulate process changes in these areas
in order to realize institutional objectives. A thorough review and
understanding of the clinical objectives as well as the financial and
operational objectives of the organization and the IT department are
essential, as these should guide the ongoing evaluation and system
selection process.
Once the alignment of objectives has been completed, the IT department
should review and update the inventory of existing systems. All of the
current systems in place in the organization should be identified,
including independent departmental systems as well as large integrated
systems and those buried in areas outside IT. A review of the inventory
allows the organization to identify overlapping functionality as well as
gaps among systems. It is not unusual for multiple systems that
accomplish the same task or goal to be in place. This happens when
individual departments have implemented systems they need without
addressing the organization’s overall plan. Within the objectives of the IT
department, clinical, financial, and operational goals of the organization
are considered in identifying which systems are to be replaced and why.1
Answering a series of questions provides a straightforward approach for
the institution to determine which systems may be replaced or updated:
1. Need for the system. What are the functions that the system
addresses, and how frequently do those functions occur? In
addition, are there some tasks or functions that are not addressed
by the system? Is current staff using the system? Have work
processes been developed to accomplish tasks or functions that the
system does not address or that the staff find difficult to accomplish
using the system?
2. Development process. Which information systems are in development
and what is the nature of the development team and its
methodology? New is not always be er, but neither is what is
familiar and comfortable. Are the requirements of the stakeholders
being met, including management, financial, clinical, and
operational stakeholders as well as the largest group of
stakeholders, patients and their families?
3. Basic structure. What parts or functions can be observed? Are these
items working to meet today’s requirements or tomorrow’s desired
function? Does the current system work as designed and to meet
future needs?
4. Functionality. What are the system response times, accuracy,
reliability, and ease of use for end users? What are the plans to
continue development of the system to meet new and ongoing
requirements? How are the new and ongoing requirements
determined?
5. Impact. How does the system affect providers, patients, processes,
and the organization’s users in nonpatient care areas? Does the
system support data collection and reporting?
6. Integration. How does this system interface with other systems in
the institution from a technical perspective as well as from a
workflow perspective?
The following key areas are important in detailing and documenting
this institutional analysis:
1. Mission-critical requirements
2. Regulatory and accreditation requirements
3. Financial and increased net revenue requirements
4. End user demands and functionality requirements that are “must
have”
5. End user demands and functionality requirements that are “nice to
have”
This assessment of the institution’s current status and needs will form
the basis for future documentation and specifications. The systems
analysis is an internal document and is best presented in comparative
format (such as a spreadsheet) that is easy for technical and nontechnical
readers to evaluate. An additional approach is to document the strengths
and weaknesses of each system. Using the data and information from this
assessment, the institution should carefully document system
requirements from both an institutional and a department perspective.
These requirements will then be used to develop key criteria to use during
the system identification and selection process.2
Systems life cycle
Knowledge about the life cycle of an information system will help in
understanding the importance of a carefully designed system selection
process in obtaining overall success in meeting an organization’s needs.
The systems life cycle (SLC) is a framework for understanding the process
of developing or configuring, implementing, and using an information
system. This process is described in a series of sequential logical steps or
phases, listed as follows. These phases are based on the Staggers and
Nelson SLC model discussed in Chapter 2 and depicted in Fig. 2.8:
1. Analyze
2. Plan
3. Develop or purchase
4. Test
5. Implement or go-live
6. Maintain and evolve
7. Evaluate
8. Return to analyze
System selection, the focus of this chapter, involves the first three phases
of the SLC model: analyze, plan, and develop or purchase. The remaining
phases of the SLC model are discussed in Chapter 19.
Analysis and Requirements Definition
The project planning and analysis phases often occur concomitantly in a
recursive process. In this section, for the purposes of discussion, analysis is
presented first, although others may decide that the planning step is first.
The decision to purchase and implement a new information system
usually begins with the realization that the systems currently in place do
not meet the needs of the organization and its users. At this point the
selection team should identify specifically which type of information
system needs to be replaced or added by the organization by completing
the analysis described in the previous section. However, this initial
understanding of needs does not provide enough information to begin a
formal search process, as one cannot determine if a system meets the
organization’s needs without a thorough evaluation and understanding of
those needs or requirements.
Requirements definition is the process of determining the specific
needs that the organization has for an information system and the specific
functionality that is desired. This analysis is built upon the institutional
inventory and analysis discussed in the previous section. However, at this
point in the system selection process the analysis is focused on the specific
system being selected, and the specifications are much more detailed.
Therefore a detailed plan for data gathering is essential to effectively
determine system requirements. Components of the requirements
definition plan include the following:
1. Review and, if necessary, update the inventory of current information systems
and functionality. The focus at this point is on those systems that will
interface with or be directly affected by the new system. This evaluation
should include a list of the components and functions of each system,
listing the tasks that can be performed as well as any supporting
information to be er describe the functionality. An understanding of the
general data flow between systems is also important in determining
system requirements.
2. Inventory paper documents and forms. It is also important to obtain
samples of all paper forms currently in use as well as reports from current
information systems. Including paper forms in the inventory as
opportunities for additional automation may drive the development of
additional requirements for a new information system. Importantly, the
paper process should not be replicated; forms are used to understand
requirements, especially for subspecialties and linkages between
departments. In addition, the selection commi ee will benefit from
reviewing forms and templates that are commonly part of the system
selection process. Examples of these types of documents can be seen in Box
16.2. The preferred sources for these documents are ones that the
institution has used in the past with previous system selection commi ees,
however; examples of these types of forms can be obtained from
professional organizations such as Healthcare Information and
Management Systems Society (HIMSS) or downloaded from the internet.
While each selection commi ee will need to design their own forms, the
opportunity to review several examples can be very insightful.
Box 16.2
Documents and Forms Commonly Used in
Systems Selection
• RFI and/or RFP template
• RFI and/or RFP cover le er
• Proposal cover le er
• Disqualification or rejection le er
• Nonbinding le er of intent
• Scoring or decision matrix
RFI, Requests for information; RFP, request for proposal.
3. Interview and observe staff. The selection team should plan to interview
hospital staff in various departments and roles regarding their work. One
goal of the interviews is a determination of which functions are currently
supported by an information system as well as functions and
documentation that are not yet supported by an information system.
Interview questions should also be used to gain an understanding of the
decisions that staff will need to make as they perform their job functions
and to determine which data are needed for these decisions. Management
and frontline staff can provide valuable information about the work that is
actually performed and how data are collected and used, while
observations of the staff at work may uncover additional requirements and
provide an increased understanding of the use of data. Members of the
selection team should include interview questions for key stakeholders
and frontline staff to elicit their opinions and experience with the current
information system. The SWOT strategic analysis tool is useful in guiding
these questions. SWOT is an acronym that represents the identification of
strengths, weaknesses, opportunities, and threats.3 Box 16.3 contains
several sample interview questions to consider. Additional insights can be
obtained if the users can demonstrate their answers on the current system
as well as describe their experiences.
Box 16.3
Sample Interview Questions
Strengths
• Which features and functions of the current system do you find useful?
• How does the current system support you in providing safe patient
care?
• Is the current system easy to navigate and use? If so, which features
support this?
Weaknesses
• Which features of the current system do you dislike, and why?
• Is the system difficult to use? If so, why?
Opportunities
• Are there any features or functionality that you feel are missing from the
current system?
Threats
• Are there any shortcomings or issues with the current system that may
create a risk to patients that you are caring for?
4. Collect samples of system and manual reports. The selection team should
collect samples of reports that are provided by existing information
systems as well as reports that are generated manually. In addition,
frontline staff, management, and hospital administration should provide
information about their specific data needs, including other desired
reports that are not currently available. Consideration should be given to
data and reports that would support the hospital in determining how well
they are meeting regulatory and accreditation requirements defined by
organizations such as The Joint Commission (TJC) and Centers for
Medicare & Medicaid Services (CMS).
5. Develop process and dataflow maps. Developing process and dataflow
maps for each function or role will also clearly document the data needs of
various groups of users.4 Process maps illustrate an organization’s
workflow, which is a series of steps representing work activities and
resources that follow a path to produce desired outcomes or outputs.5 A
thorough analysis of the workflow of future users of the new information
system will help identify system requirements that may not have been
identified during the interview process. Dataflow diagrams are often used
to document this type of information. See Figs. 16.1 and 16.2 for examples
of how this type of information may be documented.
FIG 16.1 Information flow in MS and CF clinics. CF, Cystic fibrosis; MD,
medical doctor; MRI, magnetic resonance imaging; MS, multiple sclerosis;
OGTT, oral glucose tolerance test; PFT, pulmonary function test; RN,
registered nurse. Modified from Unertl KM, Weinger MB, Johnson KB, Lorenzi NM.
Describing and modeling workflow and information flow in chronic disease care. J Am Med
Inform Assoc. 2009;16:830. With permission from BMJ Publishing Group Ltd.
FIG 16.2 Information flow in chronic disease care. Admin, Administration;
appt, appointment; EMR, electronic medical record; ER, emergency room.
From Unertl KM, Weinger MB, Johnson KB, Lorenzi NM. Describing and modeling workflow
and information flow in chronic disease care. J Am Med Inform Assoc. 2009;16:832. With
permission from BMJ Publishing Group Ltd.
6. Identify hospital standards and policies and regulatory and accreditation
requirements. Hospital standards of care and policies as well as evidence-
based practice must be supported by the information system that is
selected. In addition, regulations established by state and federal
governments and requirements of accreditation groups such as TJC must
be considered. An example of legislation that has had a great impact on
clinical information system functionality is the Health Information
Technology for Economic and Clinical Health (HITECH) Act, signed in
2009. The goal of this legislation is to promote the adoption and
Meaningful Use of health IT. Specific information about the HITECH Act
and Meaningful Use can be found at [Link]/policy-researchers-
implementers/health-it-legislation-and-regulations and in Chapter 27. The
selection team should identify precise and clear system requirements
related to how the information system might support the organization in
meeting these standards. One strategy may be to narrow down the field of
potential vendors by starting with the Certified HIT Product List (CHPL),
which provides a list of electronic health records (EHRs) and EHR
modules that have been tested and certified by the Office of the National
Coordinator for Health Information Technology (ONC).6
Following these various methods of information collection regarding
system requirements, the selection team should develop a comprehensive
list of requirements that it will evaluate as each potential information
system is reviewed. This thorough list of requirements will guide the
selection team as it develops the request for information (RFI) and the
request for proposal (RFP). When developing the list, an effective strategy
is to list the objectives related to each requirement without specific
decisions or details about how the software will meet this objective. By
listing requirements as objectives instead of specific descriptions of how
these objectives are to be met, the team will not limit potential vendor
solutions before it has had a chance to evaluate them.
Objectives can be logically grouped into several categories that will
facilitate organization of the requirements list:
1. Patient care objectives. Determine the types of patient data that should be
entered as well as any specific patient care areas that may require special
processes, such as the emergency department, critical care units, or labor
and delivery areas. Examples of patient care objectives are listed in Box
16.4.
Box 16.4
Example Requirements for a Hospital
Information System: Patient Care Objectives
1. Patient care documentation (assessments and notes) by clinical users
• Nursing
• Physician
• Social work and case managers
• Nutrition
• Wound care
• Respiratory therapy
• Pharmacy
• Occupational therapy and physical therapy
• Other ancillary users
2. Orders management
• Order entry, including order sets by stakeholder groups
• Order selection menu based on physician clinician specialty
3. Care plan and problem list
4. Patient data displays
• Summary view of patient data
• View longitudinal data across visits
5. Clinical decision support and alerts
6. Medication reconciliation
7. Patient discharge processes
• Instructions and prescriptions
• Continuity of care document, summary of care
8. Requirements for special care areas
• Medical and surgical units
• Critical care units
• Step-down units
• Ambulatory services
• Psychiatry
• Rehabilitation
• Long-term care
• Labor and delivery
• Oncology
2. Usability. Usability is the extent to which a product can be used by
specific users in specific contexts to achieve specific goals with
effectiveness, efficiency, and satisfaction.7 The information system that is
selected should be easy to use and intuitive. A variety of methods for
testing usability are described in detail in Chapter 21. Improved usability
improves safety and reduces user frustration as well as the time needed for
educating users to effectively and efficiently use the system. For example,
the user should be able to easily find a patient in the system and then
proceed to view or enter patient data. Efficiency considerations should not
be limited to bedside users only. System reports providing summarized
patient data for management and administration can also greatly improve
efficiency. See Box 16.5 for examples of efficiency objectives.
Box 16.5
Example Requirements for a Hospital
Information System: Efficiency Objectives
Data Collection
• Ease of data entry by end users
• Does the orders management system support customization for different
categories of users?
• How long does it take for an end user (pharmacy, nurses, physicians) to
enter a complex medication order?
• Does the system support difficult orders such as total parenteral
nutrition, chemotherapy, and future orders?
Integration
• Is integration or interface with other systems supported, allowing
bidirectional communication of data and information?
• Does the system support point-of-care data collection device integration,
such as vital sign monitors?
Data Retrieval
• Ease of data retrieval by end users
• Is the process for viewing results easy to use while providing flexibility
for the end user to choose what is needed?
Reports
• Are reports available to supply data needed to users at various levels,
including the frontline staff, management, and administration?
• Is the creation of customized reports possible, and does the skill set
needed for this exist within the organization?
3. IT department objectives. The IT department will also be able to identify
key requirements for a new information system. These may be related to
the degree of customization allowed as well as the ease of customization.
These factors will affect the IT resources needed to implement and
maintain the system. Information regarding hardware and third-party
software requirements should also be included in the IT objectives, as this
will affect both the initial cost of implementation and the cost of
maintenance. Another key objective is the ability of the information system
to support data security and protection of patient confidentiality. The
importance of this factor is highlighted as an objective of Meaningful Use
certification as outlined by the HITECH Act.
4. Organization objectives. The organization will have additional objectives
for the information system. Some of these may be related to how the
organization can meet regulatory and payer requirements such as those of
the American Recovery and Reinvestment Act (ARRA) and the Patient
Protection and Affordable Care Act (PPACA).
Project Planning
Effective project planning requires the use of formal project planning tools,
processes, and principles. Because of the importance of solid project
planning, project management has emerged as a formal specialty within
and outside health and is the focus of Chapter 17 in this book. During the
project planning phase, the high-level project goals are identified and
established. The goals for the system should be in alignment with the
strategic vision of the organization. Any change or improvement in an
information system should directly support the ability of the organization
to meets its goals. Goals may be directly related to the information system,
such as ease of data entry and data retrieval. Systems that support accurate
and easy data access support improved decisions during care. In addition,
systems that allow easy and accurate data entry support improved patient
care and can be designed to provide information about patient outcomes.8
When selecting an information system, it is also important to consider
whether the system functionality is appropriate for the type of patients
cared for by the facility, including inpatients, outpatients, and patients of
the emergency department and specialty areas such as psychiatry. Goals
may also be related to the ability of the system to facilitate the achievement
of regulatory goals such as compliance with CMS measures and successful
Meaningful Use a estation. Financial goals might include the budget
guidelines for purchase, implementation, and ongoing maintenance
related to the information system. Finally, the selection team must
understand the goals related to system implementation, including the ease
of implementation, the degree to which the software can be customized to
meet specific needs, and the resources required to implement and
maintain the system.
Another important aspect of project planning is the creation of the
information system selection team and development of their roles and
responsibilities. System selection is best accomplished by a
multidisciplinary team representing the departments and roles that will be
affected by the system to be purchased by the organization. This team
should include representation from nursing; physicians; ancillary
departments such as pharmacy, occupational and physical therapy,
respiratory therapy, nutrition, social work and case management, infection
control, and quality and risk management; IT technical specialists; and
hospital administration. Clinical representatives must be involved in every
step of the system selection process. Their input is key to the identification
of requirements and system selection, as technology can support clinicians
in providing be er patient care. However, some of the department
representatives on the team may not have previous experience with the
system selection process. The system selection process will be more
effective if the initial meetings of the team include a clear statement of the
scope of the project and an orientation to the system selection process. The
IT department must also be included in the system selection team. Ideally
there are clinical and IT representatives who have had previous experience
with the system selection process. The organization should carefully
consider the goals of this group as well as the leadership. Requirements of
users as well as the IT staff who will be supporting the system are
important to consider. For more information about informatics governance
and its role in the system selection process, see Chapter 28.
Develop or Purchase
Once analysis and planning are completed, the institution must decide if it
will (1) develop a new system, (2) reconfigure or upgrade the current
system, or (3) select a new system. For the purposes of discussion, this
chapter is presented with the assumption that a decision has been made to
select a new system. Reconfiguring or upgrading a current system is
discussed in Chapter 19.
Developing, Obtaining, and Evaluating Requests for
Information and Requests for Proposals
Once the selection team has been established and oriented to the system
selection process, its first job is to develop a request for information (RFI).
The RFI will determine who should be encouraged to submit a request for
proposal (RFP). Understanding the essentials of RFIs and RFPs facilitates
decision making and selection processes. Basically, the RFI is an
information step in vendor evaluation. The organization prepares a list of
system goals and high-level requirements and asks vendors to respond to
them with specific information such as projected costs. Larger institutions
often have a template with sections, such as a description of the institution
already provided. Common sections often found in an RFI can be seen in
Box 16.6.
Box 16.6
Sections of a Request for Information
Purpose of Request
A brief statement describing the type of information system that the
institution is planning to select. For example, is it searching for an
electronic health record for use in physician offices or a classification and
staffing system for use in the outpatient clinics?
Background
The description of the institution, including mission size and number and
type of patients treated.
Qualifications
Any specific qualifications required by the vendor. For example, does it
need to have been in business for 5 or more years?
Information Requested
A list of specific elements that should be answered. For example:
• Size, history, and financial status of the company
• Basic system architecture and software configuration
• Number of installations and selected names of customers
Time and Type of Response
This section includes the due date for the response, where the response
should be sent, and who the vendor should contact if the vendor has any
questions. The vendor should be discouraged from contacting anyone else
at the institution.
The response to an RFI describes the vendor’s experience and product
and how it communicates with clients. Any vendor that cannot meet the
RFI expectations or omits requested information may not remain on the
evaluation list. An RFI is requested from potential vendors to determine
which of their products and services are potentially available in the
marketplace to meet the institution’s needs. The response also lets
organizations know the capability of the vendor in terms of strengths and
offerings. For example, if the vendor has consistently installed in small
community hospitals and the institution is a large academic medical
center, this may not be a vendor worth further investigation.
RFIs are commonly used on major procurements, such as hospital
information systems, but they are not an invitation to bid, so some vendors
will not respond, even if they have systems that meet requirements. An
RFI is not binding on either party and may or may not lead to an RFP. An
RFI should inform the vendor of the organization’s goals and how they
will be achieved. An RFI should be specific enough to foster clear
collection and evaluation of responses that enable a comparison of vendors
to determine from whom more detailed responses (e.g., including price,
quality of delivery, guarantees, and other considerations) to an RFP should
be requested. This is not an insignificant step, as the organization will be
investing large dollar amounts and commi ing resources to a new
information system.
For financial considerations (actual bids for a health IT product),
organizations should submit an RFP. Common sections of a RFP are
provided in Box 16.7. An RFP is an invitation for vendors to submit back
to an organization a formal proposal that clearly spells out what system
(including functionality and capability) can be delivered and at what price.
The RFP gives the vendor a very clear and detailed understanding of what
the organization is looking for in a system and starts the negotiation
process based on price and quality of delivery. An RFP requires much
more effort and is done at the stage where the organization clarifies its
expectations and receives assurances from the vendor that it can deliver
the system on the organization’s timetable and terms. The RFP is a more
complete and formal step, with the vendor response often translating
directly into the formal contract.
Box 16.7
Major Components of a Request for Proposal
• Overview of the institution and its mission
• Project overview—purpose, goals, rationale for the project
• Project overview—teams, locations, services/specialties, proposed
schedule
• System specifications—e.g., functional, technical, interfaces, data
integration, current installed systems related to the new project or
projected Agile development for specific areas
• Services requested (what is needed from the vendor)—e.g., training,
installation, maintenance and support, equipment, required uptime,
response to issues
• Vendor requirements and information—e.g., number of installed sites,
qualifications of vendor team personnel, projected company stability
• Projected pricing and payment provisions (high level)
• RFP evaluation criteria
• Submission guidelines (a standardized format for responses)
• Any exclusions—e.g., timelines for responses, company size, or lack of
monolithic system capabilities
The RFP is the organization’s way of soliciting competitive bids to
supply a specific information system. An RFP should include detailed
information about the organization as well as questions that elicit
differences among competing vendors. An RFP should solicit cost quotes
for installation and implementation and security standards, as well as
delivery time (and estimated completion time) and resource requirements.
Resource requirements should be spelled out for both the organization and
the vendor in the response. The best RFP also seeks information on total
cost of ownership (TCO) over the expected lifetime of the system. The RFP
should require information such as corporate information on the vendor as
well as its history with this kind of system. Customer references that can
and should be validated must be part of the response from the vendor.
Prior to issuing an RFP, an organization should establish certain items:
1. The organization’s needs as outlined in the organizational and IT
vision and strategic plan, and the specific needs.
2. The organization’s evaluation criteria. These should include vendor
experience, vendor staff strength, market and industry
understanding, and differential advantages such as usability or
available functionality and cost.
When responses are received, they should be evaluated in total—not just
on cost or any other single criteria. Following that, the organization should
interview the vendors that have live, working systems and distinguish
between available functions and future capability or functionality.
Healthcare systems or hospitals will be using this information system for
years, even decades, to come. Organizations want to ensure that available
functionality is real today and will continue to grow with the needs of the
health system or hospital.9
As much as everyone dislikes deadlines, organizations need to set a time
limit for responses to both RFIs and RFPs; 6 to 8 weeks should be the
outside limit of the timeline, although very complex organizations such as
the Department of Defense may allow 60 to 90 days. Also, allow a
sufficient time for the organization to evaluate responses adequately;
healthcare today moves at a very fast pace, but ensure that the
organization has carefully measured the responses and interviewed those
who can deliver.
Evaluating Vendors
There are some basic characteristics to look for when finding an
information system vendor. A fundamental element is the fit between the
organization and the vendor. For example, is the organization small and
more informal? Is the vendor large and bureaucratic? Does the
organization make change rapidly? Can the vendor do the same? Does the
vendor come across as professional? Also, a vendor should be expected to
have a great deal of experience in the same type of facility or organization
that is seeking an information system.10 Information system support (24/7)
and the help desk, as well as education and training, are key areas to
examine when deciding on the vendor for a product. New or replacement
systems without proper installation and implementation can be doomed
from the start. For additional information on vendors, check the data
available from the major IT research groups: Forrester, Gartner, HIMSS
Analytics, and KLAS. These major research firms provide clear,
unambiguous analysis of vendors and systems. Table 16.1 gives additional
information about these research groups.
Table 16.1
Major Healthcare Information Technology Research Firms in the
United States
Firm and Location Overview
Forrester Research, Inc.
Forrester is a global research and advisory group. Forrester serves clients as they face
Cambridge, Mass. increasingly complex business and technology decisions on a daily basis. To help them
[Link] understand, strategize, and act on opportunities brought about by change, Forrester
provides proprietary research, consumer and business data, custom consulting, events
and online communities, and peer-to-peer executive programs. Forrester guides leaders
in IT, marketing, and strategy and the technology industry through independent, fact-
based insight, ensuring their business success today and tomorrow.
Gartner, Inc. Gartner is an IT research and advisory company. Gartner delivers the technology-related
Stamford, Conn. insight necessary for its clients to make the right decisions every day. From CIOs and
[Link] senior IT leaders in corporations and government agencies, to business leaders in high-
tech and telecom enterprises and professional services firms, to technology investors,
Gartner is a partner to clients in 12,000 distinct organizations. Through the resources of
Gartner Research, Gartner Executive Programs, Gartner Consulting, and Gartner Events,
it works with every client to research, analyze, and interpret the business of IT within the
context of its individual role. Gartner is headquartered in Stamford, Conn., and has 5000
associates, including 1280 research analysts and consultants, and clients in 85 countries.
KLAS Research KLAS conducts over 1900 healthcare provider interviews per month, working with over
Orem, Utah 4500 hospitals and over 3000 doctor's offices and clinics. KLAS is independently owned
[Link] and operated. KLAS has ratings on over 250 healthcare technology vendors and over 900
products and services. KLAS publishes approximately 40 performance and perception
reports per year. KLAS is headquartered in Orem, Utah, with independent researchers
working throughout North America. The name KLAS is an acronym comprising a le er
from each of the founders’ names.
Adapted from Forrester Research Inc. at [Link], Gartner Inc. at
[Link], and KLAS Enterprises LLC at [Link].
CIO, Chief information officer; IT, information technology.
Information is adapted from the appropriate company’s website.
Additionally, valuable information is available from the HIMSS at
[Link]. A detailed analysis of vendor research should include
visiting the vendor’s website. Also, a number of internet blogs have
comments, both positive and negative, about vendors. An example is
HIStalk at h p://[Link]. Organizations should also validate
information with peers in other hospitals and health systems.
Selecting the System
Now that the selection team has defined objectives and requirements for
the new system, developed an RFI and RFP, and completed research about
various vendors, the team must have a plan for how it will select an
information system. The team must take steps to develop specific system
evaluation criteria and a process for recording its individual and group
decisions. This should be done before actually reviewing the RFI and RFP
responses so that each team member can begin to evaluate and score the
various information systems as soon as information is obtained. One
effective approach is to develop a scoring system, where all of the system
requirements are listed and each requirement is given a numeric score or
weighted numeric score based on the degree to which it meets each
objective. By using numeric ratings, organizations are able to obtain an
overall score for each vendor’s system. It may help to classify the
requirements as “must have” or “nice to have,” because this information
will be useful as findings are evaluated. As team members complete the
scoring document for systems, it is essential that they be open-minded and
broadly explore all options presented by various vendors. The software
that vendors present may meet the requirements but in a manner that is
different from what was anticipated.
During the evaluation process, it is important to evaluate potential
software products very rigorously since the amount of time and money
invested in purchasing and implementing an information system is quite
large. The impact of a new health information system on an organization’s
users cannot be minimized, so the task of evaluating and selecting a
system should be given adequate a ention and resources. Vendors
responding to an RFP will provide presentations and demonstrations
aimed at showing how the system can meet or exceed the requirements. In
the past, organizations have found it helpful to script scenarios for the
vendors to follow during the demonstrations. In this way, the organization
can tailor the scenarios to its own patient populations and highlight the
patient flow across modules. For example, a script may be developed
following a patient from outpatient to the operating room, post–anesthesia
recovery, intensive care, and surgical unit, then back to outpatient.
During this process, clinicians, IT, and hospital leaders should
remember to focus on deployed, working systems only, as these are what
will be delivered once the system is purchased. Vendors will spend some
time explaining what their plans are for future development, but it is
important for all to know what can actually be configured and
implemented when receiving the software. Plans for future development
by the vendor can be considered. However, there is no guarantee when
new functions will be available or how they will actually work if
delivered.
After initial presentations by various vendors, the selection team will
have good ideas about the top contenders for the organization. Once the
group has narrowed down the list to a handful of vendors, it should
arrange for site visits to actual customers using the information systems.
Working with the vendor in planning the site visit can be helpful, but there
are important reasons to not give a vendor complete control in selecting
the site or planning the details of the visit. Often, a vendor will select a site
that is most successful and innovative. It may be more advantageous for
the selection team to find a site themselves that is more representative of
their institutional goals and objectives. The selection team should also
determine if the site selected for the visit will receive direct or indirect
remuneration from the vendor for providing a site visit.
The site visit team should be interdisciplinary and use specific
evaluation criteria to guide the visit. This will allow the team to see how
this organization has configured the system to work at its site. The biggest
advantage of a site visit is the opportunity to talk with people at various
levels to obtain their opinions and information about their experiences
with the system. In planning for the visit, ask for sessions or opportunities
where all can talk with various clinical users of the system, such as nurses,
physicians, and ancillary users. IT staff will also want to talk with IT
representatives to get their opinions and perspective. Some of these frank
discussions will be most effective if the vendor representative is not
present, allowing the staff at the hospital site to be more open and honest.
After the visit, there are often additional questions. The selection team
should obtain the names and contact information for individuals they may
want to contact after the site visit with follow-up questions.
As the group evaluates various information systems, keep in mind the
TCO. This is a financial estimate of the cost of implementing and
maintaining the information system over the life of the project, also known
as life-cycle costing.11 This estimate should include all hardware, software,
and resource costs associated with all phases of the project, including
design, implementation, testing, and ongoing support over the entire life
span of the system. Typical life cycles are about 11 years but can run much
longer. During the evaluation phase make sure that the group obtains this
type of information from the vendor. Include discussions about the
frequency of software updates and upgrades and the IT resources needed
to test and implement these changes. Ask how specific change requests
from one organization are prioritized and what the average time lapse is
from request to delivery. Include discussions about the frequency and
duration of planned downtimes to accomplish updates.
Once the information systems have been reviewed and the vendors
offering these systems have been evaluated, the selection task force makes
a recommendation. If possible, the recommendation should include two or
three potential options with a ranking and rationale statement for each
option. The rationale should include the pros and cons of each option.
Usually the decision on which product to recommend is made at the next-
to-last meeting of the task force. The meeting should start with a general
summary of the findings for each vendor and its product. Plenty of time
should be given for discussion. If there are any major disagreements on
which product to select, it is helpful if key administrative personnel such
as the chief information officer (CIO) and the vice-president for the
department most affected by the new system join the discussion.
At the final meeting of the task force, members should agree on the
items to be placed in the contract including the scope of the
implementation. This might include plans such as implementation in a
pilot unit or units only versus the entire hospital. The final job of the IT
staff for this product selection task force is to summarize the process and
findings in a report for senior management. The final report includes the
recommended products and vendors as well as the rationale for each
recommendation. The report should also include any recommendations
for the contract and implementation process.
Preparing for Contract Negotiations
For major purchases, contract negotiations are usually performed by a
negotiating team. The composition of this team will vary depending of the
organization, the specific anticipated purchase, and the governance model
of the organization. In many organizations, especially large ones, the
negotiations will occur at the executive level. These may be a team
consisting of the contracts lawyer, the CFO, and/or the CIO, although in
other organizations, the composition may be at a lower organizational
level and include a project leader and key technical IT representation. In
any case, the chair and members of the selection commi ee should be
available for questions from the negotiating term once the formal
negotiations begin. The vendor should be informed about the specific
personnel performing contract development and negotiations and adhere
to any communication restrictions.
Contracts or licensing agreements are described in detail in Chapter 18;
however, the selection team should play a key role in planning for these
negotiations and supporting the negotiating team during the process. The
final report of the selection commi ee should include specific
recommendations for items to be placed in the contract. Examples of such
items are specific training programs and training supplies to be offered by
the vendor or the stipulation that the hospital or clinic will be a test site for
new functionality that is very important to the hospital or clinic.
During the negotiation process, the negotiating team may also call on
the selection commi ee to review sections of the contract that could be
misinterpreted. Examples include the following:
• The vendor should be asked to provide a definition of all vendor-
specific terms and concepts referred to in the contract. These
definitions can be reviewed by the selection team to ensure these
definitions are consistent with the institutions understanding of these
terms or concepts.12
• The contract should include a detailed explanation of line items in the
pricing schedule. The selection term can review these explanations
describing the line items, especially those items that might be
misinterpreted and raise questions or concerns.
• The contract should include clear definitions of data ownership,
especially when discussing aggregate data. Again the selection terms
can help determine if these definitions are consistent with other
institutional projects and goals.
• The contract should include the experience level of vendor staff who
will provide project assistance for implementation, training, and
support.5 Again the selection commi ee can assist in reviewing these
qualifications, especially vendor staff who are not providing technical
type support.
Establishing a Working Relationship with the Vendor
From the day the RFI is mailed, the institution will begin managing its
vendor relationship. The tone and nature of these relationships can be
expected to change through the life cycle. However, an effective open and
professional relationship can be key to success throughout the total
project. Managing a vendor relationship requires skilled and careful
leadership and a level of personal finesse. Vendor managers are usually
experts in their own subject ma er area. In many cases, they also have
project management and business skills. But not every vendor manager
has leadership expertise. Therefore communicating with the vendor is as
important as communicating with an organization’s stakeholders.
Establishing communication channels and information flow between local
clinicians, IT, and leaders and the vendor can lead to increased efficiency,
reduced costs, and be er service. The vendor will play a key role in local
success. Building mutually strong relationships with a chosen vendor is
critical and can ultimately strengthen overall performance. Vendor
management is more than ge ing a lower price or be er service. Properly
managed vendor relationships can give the vendor and institution a
significant competitive advantage. A successful vendor relationship shares
local priorities and mutually agrees upon factors such as the following:
• Definition of a quality implementation
• Metrics for successful adoption of the system
• Elements of the vendor’s quality assurance program, including
measurable outcome metrics—not just response times and limits to
unplanned downtime and upgrades but the real outcome to end users
A good vendor must understand and share priorities, but the
organization must first communicate those priorities. If a vendor cannot
help with stated priorities, a good vendor will disclose this limitation or
weakness up front. Thus it is absolutely essential that the chosen vendor
becomes a partner in the implementation, optimization, and ongoing use
and upgrades of the organization’s information system. There is a concrete
need to drive contract terms and obligations, but in the end, no contract
will adequately cover all long-term goals and expectations. A solid, true
collaborative partnership with a vendor will provide for such needs. When
some things go bad, as they most assuredly will at some point, the
organization will be be er served to have a partner at the table, not just a
vendor. Early on, demand proof of concept. If an organization is seeking
value, then the group needs to see it firsthand. A good vendor will prove it
can be done.
The International Organization for Standardization (ISO) has developed
a set of minimum standards, practices, terminologies, and requirements
that, when adopted, demonstrates a vendor’s products and services have
achieved a minimum level of quality. ISO certification demonstrates a
vendor’s commitment to quality and service. These standards are outlined
on the ISO website ([Link]). It is important to note the ISO does not
perform certification but does provide the standards for certification.
Actual ISO certification must be performed by an outside certification
body. In reviewing the ISO standards, note that clinical practice varies
around the world, and students will need to adapt minimum standards to
their country’s requirements.
Conclusion and future directions
When selecting an information system, clinicians, IT, and leaders need to
understand the vendor’s plan for responding to changes in the market and
regulatory environments. The pace of change in healthcare is anticipated
to only accelerate, and both the organization and the vendor must be able
to adapt quickly. The group may wish to review the selected vendor’s
history with response to changes such as these, including the timeliness of
software changes and compliance. In the future, the vendor model may
erode from full-service or monolithic health IT products such as EHR to
commodity or component providers. For example, organizations may
choose their pharmacy applications from one vendor and clinical
documentation from another. The interoperability requirements being
promulgated today would then allow organizations to compile functions
using off-site cloud computing versus installing huge systems on-site.
However, with this more futuristic notion, the phases and concepts listed
in this chapter are still needed.
References
1 Si ig D., Hazelhurst B.L., Palen T., Hsu J., Jimison H., Hornbrook
M.C. A clinical information system research landscape. Permanente
J. 2002;2(6):1–6.
2 How to Implement EHRs; 2014. h ps://[Link]/providers-
professionals/ehr-implementation-steps/step-3-select-or-upgrade-
certified-ehr/.
3 Helms M.M., Moore R., Ahmadi M. Information technology (IT)
and the healthcare industry: a SWOT analysis. Int J Healthc Inform
Syst Informat. 2008;3(1):75–92. doi:10.4018/jhisi.2008010105.
4 Staccini P.M., Joubert M., Quaranta J.F., Fieschi M. Towards
elicitation of users requirements for hospital information system:
from a care process modeling technique to a web based
collaborative tool. Proc AMIA Symp. 2002;732–736.
5 Damelio R. Basics of Process Mapping. 2nd ed. Boca Raton, FL: CRC
Press; 2011.
6 How do I select a vendor?; 2013. h ps://[Link]/providers-
professionals/faqs/how-do-i-select-vendor/.
7 International Organization of Standards (ISO); 2008.
h p://[Link]/tools/r_international.htm.
8 Nurse leaders discuss the nurse’s role in driving technology
decisions. Am Nurse Today. 2010;1(5):16-19.
h p://[Link]/[Link]?
id=6142&fid=6116/.
9 Adler K.G. How to select an electronic health record system. Fam
Pract Manag. 2005;12(2):55–62.
10 Gor is L.G. Selecting healthcare information systems provided by
third-party vendors: a mind map beyond the manuals. Inform
Health Soc Care. 2010;35(1):1–9.
11 Cellucci F. What is the true TCO for information technology
projects? ConnectivITy; 2011.
h p://[Link]/blog/bid/54338/What-Is-The-True-TCO-
For-Information-Technology-Projects/.
12 Craig J.B. Life cycle of a health care information system. In:
Englebardt S., Nelson R., eds. Health Care Informatics: An
Interdisciplinary Approach. St. Louis: Mosby; 2002:181–208.
Discussion questions
1. How do strategic vision and alignment affect decisions made in your
organization?
2. What is the role of healthcare providers in the identification and
selection of a healthcare information system?
3. The selection team should be an interdisciplinary team, but how should
the chair of the commi ee be selected?
4. What is the impact of a well-defined and complete RFI and RFP process
on identification and selection of a healthcare information system?
5. What are the key roles and functions in identification of system
requirements?
6. Why are vendor relationships with management essential? Brainstorm
ideas for maintaining good site–vendor relationships.
Case study
You have been chosen to participate in the selection team for a new clinical
information system to be purchased and implemented at the community
hospital where you are a staff nurse. The selection team has been asked to
develop an initial list of requirements that they would like to use for the
evaluation of potential systems in relation to documentation of
assessments for interprofessional use, including nursing, physicians, and
some other departments such as physical therapy and occupational
therapy. The selection team has decided to group the requirements that
they identify into the following categories:
• Patient care objectives
• Usability
• IT department objectives
• Organization objectives
Your task for this case study is to use the key considerations listed below
to develop a list of system requirements for electronic documentation in a
clinical information system, grouping the requirements into the four
categories listed above. The key considerations include information that
the selection team has gathered in anticipation of developing system
requirements.
Key Considerations for System Selection
Findings from Inventory of Current Systems and
Functionality
• Electronic laboratory and radiology report results are produced by
ancillary information systems.
• The intensive care units (ICUs) have an ICU information system where
some documentation is done electronically, including vital signs,
intake and output, and some interfaced data from monitoring
systems.
Findings from Inventory of Paper Documents and
Forms
• Nursing notes and care planning currently are documented only in the
paper chart on medical/surgical units.
• Physician progress notes and orders currently are documented only in
the paper chart.
• There are numerous paper forms and various versions of forms in use
with no consistency across the organization.
• Paper order sets are in use. Some order sets are physician specific, with
multiple versions for the same diagnosis or procedure. None appear
to be evidence based.
Findings from Staff Interviews and Observations
Direct observation studies were conducted in the ICU, medical/surgical
units, and pediatric unit. Observations and interviews also were
conducted in various other clinical departments including Physical
Therapy (PT), Occupational Therapy (OT), and wound care. The study
revealed that there are similarities in the types and needs of data collection
in all of these areas. Key findings included the following:
• Need to be able to document using structured data such as predefined
drop-down boxes.
• Need to be able to enter free-text comments.
• Entry of an electronic assessment must include the user’s electronic
signature and the current date and time.
g
• All entries must have the capability to be edited, and changes to the
document must be tracked by the system.
SWOT Analysis
A SWOT analysis of the current documentation was conducted with the
following findings:
• Strengths. Structured electronic data in the ICU facilitates accurate and
timely data collection.
• Weaknesses. Lack of standardization may result in inconsistent patient
care.
• Opportunities. An electronic order management and documentation
system could support evidence-based practice methodology.
• Threats. Paper documentation is difficult to read and could result in
patient safety issues.
17
Project Management Principles for
Health Informatics
Michele Mills
Abstract
Because of the increased demand for effectiveness and efficiency in healthcare
delivery, leaders at all levels are forced to determine the best way to use available
resources, whether these are human, physical, or monetary. Project management, a
systematic approach to planning and guiding project processes from start to finish, is
a proven way to improve outcomes that can directly and positively impact costs
through the efficient and effective use of limited resources for health information
technology (IT). Fundamental project management practices allow organizations to
reach strategic goals within a planned timeline within cost parameters. A strong
project management discipline includes high degrees of communication,
organization, interpersonal leadership, cross-functional team coordination and
negotiations, problem solving, a entiveness to detail, technical and business domain
knowledge, and the ability to methodically guide the project processes through
organizational governance parameters using these formal steps:
• Initiation or preplanning
• Formal planning with the creation of a project plan
• Implementation and execution of that project plan with measurement of
progress and performance
• Project closure through delivery of value through project objectives
As costs continue to increase and more government regulations are
mandated, healthcare professionals need to approach strategic initiatives
and projects in a proven, methodical way by using formal project
management principles.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Distinguish between the terms project, program, and portfolio in a
healthcare se ing.
2. Describe the need for formal project management in contemporary
organizations.
3. Understand general project management processes and procedures
and knowledge areas.
4. Describe the skills required for successful project management
discipline.
Key Terms
portfolio management 285
program management 285
project management 285
Introduction
Dr. Armstrong started a small ear, nose, and throat (ENT) clinical practice
that was recently acquired by a large local hospital network. Each morning
he meets with his clinic nurses and staff to review a list of patients treated
the day before to ensure information in their files is complete and correct.
Up to now, he has not been able to fully expand his office capabilities to
include a full electronic health record system. Instead, he and his office
staff spend time reviewing paper patient forms. He was just informed that
hospital administration found his clinic to be losing revenue because they
are not accurately capturing all the patient data required for efficient
billing. He understands the importance of optimization for the patient
experience and efficiency of cost, which a streamlined electronic patient
documentation process would likely provide. He and the hospital would
like a health IT solution within 3 months. He has proposed they select a
few key patient paper forms they could convert into electronic forms that
would integrate into the hospital system.
Later that week, Dr. Armstrong had conversations with hospital
administration and the information technology department about making
his forms electronic. He found a larger hospital initiative already
underway for an enterprise document management system that would
integrate departmental documentation into the larger hospital electronic
health record (EHR) system. That initiative had an expected timeline of 18
months. Under his current timeline constraints, Dr. Armstrong negotiated
a small capital budget to get a temporary electronic solution in place for a
few of his critical ENT patient forms until the larger solution was
available. The biggest question on his mind at this point was, “How in the
world am I going to get this all done in 3 months?!”
In a complex organization like a hospital, where many clinics and
physicians have competing priorities and demands, healthcare providers
are often responsible for ensuring that tools, processes, infrastructure, and
capabilities are in place to meet the demand for excellent patient care. A
structured process called project management is an essential technique for
clinicians and informaticians to know. Project management is defined by
the Project Management Institute (PMI) as “a temporary endeavor
undertaken to create a unique product, service, or result. The temporary
nature of projects indicates a definite beginning and end. The end is
reached when the project’s objectives have been achieved or when the
project is terminated because its objectives will not or cannot be met, or
when the need for the project no longer exists.”1
Project management is indispensable in health IT, as it is a structured
approach to help ensure effective implementations of healthcare
initiatives. A strong project management process includes initiation or
preplanning, formal planning, creation and implementation of a project
plan, and measurement of progress and performance.2 A health IT project
might focus on the implementation of a single application or initiative
within a short timeline, such as providing a temporary electronic
documentation solution for Dr. Armstrong’s clinic.
Program management, on the other hand, involves larger
implementations, like a large-scale hospital document management
application or an organization-wide EHR system. With program
management, there are multiple, aligned projects affecting many teams or
departments that are coordinated and managed in concert.
Portfolio management is even more complex and involves the creation
of common programs and projects that are not necessarily related but are
important to combine and view as a whole. One example would be a
clinical portfolio where all projects and programs that directly affect
patient care are managed or aligned in a common category. Other
portfolios might be a financial or a technology infrastructure portfolio.
Effective management of portfolios is essential for a healthcare
organization to adequately prioritize and approve new project requests
and to work strategically on projects throughout the years. Portfolio
management provides an essential foundation for decisions and
discussions in governance commi ees as projects are prioritized and
funded.3
The need for project management in
healthcare organizations
Project management can improve the quality of health IT project
outcomes, provide accountability of expenses, and reduce inefficiencies
through structured change control processes. The Project Management
Institute (PMI), an association created to improve organizational success
and mature the profession of project management, has conducted a
number of studies related to the impact of project management. These
studies reveal that nearly 80% of all projects fail to meet their objectives if
they do not have some type of structured project methodology.4
Applying appropriate processes, methodologies, and tools within a
hospital se ing can have multidimensional benefits by reducing variability
across processes, providing standardization across projects, and increasing
the overall project success rate. This is important in any industry but even
more critical in a healthcare environment where multiple stakeholders,
departments, clinics, and providers functioning under a single hospital
umbrella must coordinate between competing priorities, budgets, capital
expenses, and large enterprise initiatives. Many healthcare projects across
departments can overlap or even clash. This is because departments are
frequently regarded as separate entities or “silos” where clinical projects
and initiatives are often carried out independently at the discretion of a
leader and at times without aligning project goals with the larger
organizational objectives. In the case of Dr. Armstrong, without a
coordinated and structured project management approach at the hospital,
his ENT clinic might implement a software solution for his particular
electronic patient forms that may be incompatible with the hospital
document management system. This could result in rework for
interoperability/integration and a waste of valuable resources in the longer
term, although it may provide a short-term solution for his area.
Projects implemented by healthcare practitioners themselves are often
done with the best intent, but practitioners are seldom trained in formal
project management methodologies. They may lack the skill set and
knowledge base to properly mitigate project risks, define the scope of the
project, develop realistic schedules, or manage resource issues throughout
a given project timeline. Without these requisite skills, organizations may
have projects with inconsistent outcomes, including cost overruns, time
delays, and/or poor quality deliverables. At the macro level of hospital
administration, this can often create conflicts where differences in project
implementations from department to department result in an inability to
estimate annual costs and departmental performance. Without a
standardized approach, it is difficult to gather and measure organizational
performance metrics, prepare performance reports, forecast financial data,
and understand financial impacts and human capital costs of
organizational initiatives. Standardized and consistent project
management is needed throughout the organization at all levels to
optimize process and project outcomes across all entities. The most
effective organizations have formal strategic plans showing what they can
and will do, so there is a clear understanding of what is expected across
organizational departments and levels. Project management best practices
can help create transparency and visibility within the organization and
helps eliminate many of these issues.5
Good use of project management techniques can help align key areas
and ensure skills and tools are consistently applied to health IT. This is
important because healthcare must generate revenue while in a
competitive landscape, control costs, operate within government
regulations, and not compromise quality, patient care, or satisfaction.
Project management can help ensure delivery of initiatives and projects on
time and within budget and provide well-defined value requirements that
positively affect the organization’s financial performance, productivity,
and delivery of patient services. It can also enhance patient satisfaction
either directly or indirectly.5
Project management serves as an effective way to bring all of these
concepts together to more efficiently appropriate resources in support of
an organization’s goals (Fig. 17.1). Fig. 17.1 shows project management
areas surrounded by typical stakeholders. A PMI “Pulse of the Profession”
study showed that projects within high-performing organizations are able
to meet planned goals two-and-a-half times more frequently than those in
low-performing organizations.3 Additionally, high-performing
organizations waste about 13 times less money than low performers. The
need for strong project management skills and a solid understanding of
the process has never been more important in healthcare.6
FIG 17.1 Coordination areas of project management. Adapted from
Bhide, D. Patient care—a project management perspective.
<[Link] 2011.
Project, program, and portfolio
management
As defined earlier project, program and portfolio management are three
levels of focus in formal project management. The following section
explores each level and their interrelationships.
Project Management
A project refers to an undertaking that is time bound and delivers a
particular product or service. It is a temporary undertaking ending after a
set of goals are achieved, involving the application of knowledge, ideas,
and skills to execute a plan of action.2 More specifically, a project consists
of goals, activities, a timeline, projected risks, and mitigation plans. Each
project has an appointed manager who leads the effort. An example of a
project is the purchase of a perinatal clinical system that needs to be
integrated with the current EHR.
To comply with project management best practices, project processes,
documentation, and procedures must follow a methodical approach
through a series of defined phases that each have a specific set of
deliverables and steps that must be completed before the next phase
should begin. These project phases include initiation, planning, execution,
and closure. Monitoring and control formally takes place during the
planning and executing phases when most activities are moving at a fast
pace. Monitoring and controlling and are not necessary during two phases
—initiating and closing—because the work has not been defined
(initiating) or it is completed (closing). See Fig. 17.2 for a graphic depiction
of these concepts.
FIG 17.2 Project management phases. Copyright Michele Mills, 2015.
Project Process Groups
The PMI provides various process groups (or steps) and knowledge areas
critical to the success of a project or program.3 These process groups and
associated activities form the primary foundation for the life cycle of a
project (Table 17.1):
Table 17.1
Project Management Process Groups (Steps)
• Initiating activities are generally the most important activities and yet
often the most rushed or undervalued. The initiation phase of a project
requires a project manager (PM) to gather initial information and
resource estimates so that project viability can be assessed. This includes
activities like submission of a formal project proposal or business case
for approval from leadership teams, prioritization of competing projects
at the program or portfolio governance levels, and approvals for capital
funding and operational budget from hospital administration. Initial
project scope and timelines should be established so leaders can balance
the impact on resources and existing workloads. Projects should have
organization visibility so larger risks and impacts on architecture and
existing initiatives can be mitigated across efforts. This can help mitigate
unnecessary spending and ensure solid alignment organization strategic
goals and objectives. Once projects are approved, funded, and
resourced, formal project planning can begin.
• Planning activities lay the foundation for the project life cycle and are
used to track future project performance. Planning is where projects are
formally defined by project teams and subject ma er experts who
decompose project deliverables into workable tasks as part of the overall
project plan. The plan will assist project leaders with time management,
cost estimation, quality, change, risk, and issues throughout the life of a
project. Often this step is where healthcare project advocates struggle,
because there is a constant need to deliver “quicker, be er, faster” and
rush to implement a product or solution. Key risks may not be fully
planned for or even considered, and tasks greatly affecting the scope or
timeline may not be identified early enough to mitigate them. Steps may
be left out completely. Defining the project through planning helps team
members achieve defined goals and objectives and serves as a basis for
good communication and evaluation for managing project staff and
external vendors about timelines and budgets. Skipping this step or
even inadequately completing this step typically hinders progress
throughout the life of a project and affects the long-term results
stakeholders seek. Once a formal project plan has been completed,
resourced, and scheduled, the project is ready for execution.
• Executing activities often take the most time and resources to complete.
The execution phase ultimately defines the success of a project. This is
where the build of project deliverables and customer testing and
approval occurs. Use of solid management processes, including effective
monitoring and control of all elements of a project—time, cost, quality,
change, management of risk, issues, procurement, customer acceptance,
and communications—can help ensure success at the execution phase.7
PMs monitor challenges encountered during development, and risks
should be mitigated through well-thought-out risk plans. Risk
management should include requisite changes to project scope. Any
issues should be well controlled to keep the project on schedule and
avoid project derailment. Once goals are met, project closure can begin.
Project management theory often assumes a “best-case scenario” view.
All project types can be managed based on these best case
methodologies, but healthcare tends to have more uncontrollable
variables. For example, compare healthcare with manufacturing, which
is an industry with embedded processes. In manufacturing, every
process step builds on the next in sequential order. Healthcare projects
rarely follow precise processes because of variables that are out of a
PM’s control (e.g., regulatory change), so project management
methodologies in a healthcare environment must take these kinds of
unexpected events into account. Successful project management in
healthcare is absolutely a ainable, but it requires a strong
understanding of the culture and limitations to “perfect” project
management.
• Closing activities include release management, project delivery,
documentation of lessons learned, and formal handoffs to operational
and maintenance teams.2 These steps are critical to define and complete
in a healthcare se ing because some of the same people (resources) who
worked on a project are often the ones who maintain that project’s
outcomes. Equally important is the fact that a project, by definition, has
a beginning and an end. Therefore a clear delineation of the end of every
project is needed to understand when maintenance and operational
phases begin. Also, PMs should conduct a postimplementation review
to gather and share lessons learned and define next steps. Typical
deliverables in this phase include documentation for support and
specific communications to inform stakeholders the project has ended.
For instance, Dr. Armstrong’s initiative to capture accurate and
complete billing data through electronic patient forms for his ENT clinic is
an example of a project in healthcare. His project should have a formal PM
and a clear definition of project goals, objectives, and deliverables. Paper
forms included in the project scope should be discussed, selected, and
approved. Required data elements need to be identified, and resources
need to be allocated to the project. A well-defined plan for execution
should be formulated, so a solid understanding of the work required is
communicated to the project team. This will enable them to meet the
aggressive 3-month timeline. Monitoring project progress and controlling
changes to scope is critical to ensure accurate patient data is captured on
the new electronic forms and issues and risks are resolved to keep the
project within budget and timeline constraints. A formal closing process
can then effectively deliver a production-ready system for his clinic
without affecting patient care, cost, or quality of service.
Key Knowledge Components
PMI knowledge areas or components of formal project management align
directly with the project management process groups, activities, and steps
and are vital to successful delivery. These include project integration,
scope management, time and cost management, quality management,
human resource management, communication management, risk
management, and procurement management2:
• Project integration includes the development of a project charter. A
project charter or management plan outlines the direction and
management of overall project execution, monitoring and control
processes for scope, schedule and resource management, performance of
change control procedures, and project closure and release management
steps. This area focuses on how project issues will be managed, tracks
changes to the original plan, and coordinates replanning, if necessary.
• Scope management focuses on work of the project and clarifies
boundaries and areas to include or exclude. Scope management involves
collecting project requirements (desired functions) and defines the scope
in more detail. This includes creating a work breakdown structure,
scope verification, and validation process with stakeholders and key
project sponsors and outlines scope change control. Without a well-
defined scope document, there is no way to know if a project is in or out
of scope at any particular phase.
• Time management includes estimations of task effort (by complexity),
determines the project schedule, and records actual completion dates.
This knowledge area includes monitoring and control of schedule and
resources, ensuring project teams are empowered to be productive, and
reporting accurate time spent on activities (effort) throughout the
project. This is closely aligned with cost management, especially for
estimating resources required for tasks and task durations, as these
directly align with project costs.
• Cost management involves the cost of resources such as materials,
equipment, facilities, labor, and other related services. Determining cost
estimates, budget, and financial controls all fall into this category.
• Quality management includes creating deliverables that meet an
acceptable quality level and the quality of the project management
process itself, focusing on quality assurance and quality control. Quality
assurance consists of auditing and comparing initial quality
requirements against quality control measurements. Quality control
involves monitoring results of quality activities, which include project
deliverables and project management results. An example of this would
be tracking a project budget or schedule during the project life cycle.
• Human resource management is the management of people and
includes aspects like team acquisition, team development, and processes
for project resource issue resolution. PMs work closely with RMs to
ensure they are in sync throughout a project.
• Communication management includes meeting management, risk
actions and assessments, project plans, project reviews, stakeholder
identification, and project information distribution. Stakeholder
communication should be frequent and include project status, issues,
risks, and successes to adequately manage expectations.
• Risk management includes both project threats and opportunities.
These are plausible scenarios that may or may not impact the scope,
timeline, or resources of a project, given a set of circumstances. Both
have uncertainty so must be managed to avoid delays or project failure.
The focus is on planned risk management, identification of risks,
performance of qualitative and quantitative risk analysis, and
monitoring and control of risks. Risk identification is most effective if
done during the planning phase and should include outcomes and
possible solutions to threats if the given scenario materializes.
• Procurement management includes acquiring products or services from
outside the project team. This includes working with vendors,
contractors, and service groups.
Benefits of Improved Project Performance
Organizations realize increased efficiency in service delivery and
enhanced customer satisfaction when following formal project
management process areas and using key knowledge components. In
healthcare, project management can provide benefits listed in Box 17.1.5
Finally, fundamental project management practices allow organizations to
reach strategic goals within a planned timeline within cost parameters.2
Box 17.1
Project Management Benefits
1. Provide a guide for project teams to follow. This helps the team as a whole
stay on task and avoid issues that could delay the project or overrun the
budget.
2. Impact patient outcomes. Projects can affect patient safety outcomes. Those
with quality deliverables may include improved patient safety (e.g.,
computerized physician order entry alerts for medication interactions).
3. Potentially enhance patient satisfaction. Projects that are delivered on time
and under budget and those including quality measures could impact
patient satisfaction.
4. Provide be er team performance on future projects. With positive project
outcomes, project teams will likely be inspired to perform more
effectively on future projects. Likewise, with negative project outcomes,
teams can learn from a project “postmortem” or as a “lessons learned”
exercise and not repeat the same mistakes twice.
5. Improve the organizational standing and competitive edge. With continued
successful project outcomes, an opportunity exists for more positive
standing in the organization and community with a stronger
competitive edge. Superior performance is marketable.12
6. Improve organizational efficiency and effectiveness. Project management can
allow for more flexibility in how work is prioritized by portfolio
commi ees. Teams are able to work efficiently and effectively.
7. Anticipate risks. Project management techniques help organizations plan
for risks. Managers can see risks in future projects before they become
problematic.
8. Increase project quality. Techniques can result in achieving quality project
outcomes more consistently.
CPOE, Computerized physician order entry.
Program Management
A program refers to a group of related projects managed together.
Program management is the art of cohesive coordination of various
interrelated projects such as those for an EHR (imaging, documentation,
barcode medication administration, etc.). The logic behind program
management is that it is less complicated, less costly, and more
operationally efficient to control similar projects together than separately.
Resource sharing can then occur, as projects might be able to be managed
by the same person or with shared resources, leading to significant
efficiencies, financial savings, and coordination across projects. Program
management ensures goals, project steps, and resource needs are in sync.8
Ultimately, projects in a program are more likely to achieve the agreed-
upon set of objectives when managed together rather than separately. An
example would be an enterprise-wide document management system
where multiple departments and clinics have competing requirements and
workflows that must be managed under the umbrella of a single software
installation that requires well-managed coordination, phased
implementation, or various subprojects to run in parallel (Fig 17.3).
FIG. 17.3 Sample healthcare program. Copyright Michele Mills, 2015.
Portfolio Management
Portfolio management centralizes the management of processes,
methodologies, and technologies used by PMs, program managers, and
project management offices (PMOs). This allows collective management of
the entire suite of current and proposed projects, such as all projects
supporting patient care (pharmacy, laboratory, EHRs, imaging, etc.). The
purpose of portfolio management is to determine an optimal resource mix
for project implementation and scheduling that is most effective in
achieving an organization’s operational and financial goals. In healthcare,
these goals include patient care, quality, and cost goals.
A portfolio includes projects that are combined together as a logical
group, but they are not necessarily linked directly together as in program
management.3 This might include aligning projects, programs, and
operations with strategic objectives and investing resources in the right
work to deliver the expected value.4 All projects within the portfolio do,
however, have similar strategic goals or initiatives. Like program
management, portfolio management allows for be er prioritization and
optimization of projects as well as creating the opportunity for efficiencies
(Fig. 17.4).9 According to research, many organizations find mature
portfolio management provides invaluable tools to sync projects and
programs with strategic business goals. For organizations describing
themselves as highly effective at portfolio management, 62% met or
exceeded expected return on investment (ROI) targets. Among this group,
89% said senior managers had an understanding of what portfolio
management meant and how it is used. This helped mitigate individual
departments expending monies and labor on single department initiatives.
It also assisted in collaborative decision making for organization priorities.
Organizations rated highly effective at portfolio management were twice
as likely to adopt portfolio management to help them innovate within
their sectors. Over half of minimally effective organizations did not take
portfolio management as seriously,5 resulting in less favorable outcomes.
FIG. 17.4 Sample healthcare portfolio management structure.
Copyright Michele Mills, 2015.
Portfolio management can remove a portion of organizational politics
and deliver clarity across project goals and processes. With structured
evaluation of projects and selection, there is more visibility to
organizational politics and political maneuvering. Projects are either viable
or not, based on the more objective criteria put in place for each portfolio.
This does not mean politics will be completely eliminated, but they are
made visible, not hidden, with project management processes. Portfolio
management is also likely to result in greater organizational stability and
realization of projected benefits. For those reasons, it is not surprising that,
according to the PMI research, leaders of highly effective organizations are
three times more likely to understand portfolio management principles
than minimally effective ones.3
Despite the benefits, initiating a portfolio management process can be
difficult because portfolio managers must sometimes convince leaders
these processes are best for their business. Strong leadership skills are
essential for portfolio management. Without it, particularly in large
healthcare organizations, projects across entities are disconnected,
invisible project lists exist, and hidden agendas are common.6
Benefits of Portfolio Management
In the past, estimating and managing resources, using formal project
management, and fostering alignment with strategic goals was said to be
important, but it was not recognized as a critical aspect of organizational
success. Project management provides a way to do this, bringing great
value to organizations.
Portfolio management is a way to improve implementation of myriad
organizational initiatives. In a healthcare environment, portfolio
management can mitigate uncoordinated, decentralized efforts. This
allows for an efficient sharing of resources, where feasible, and a be er
appraisal of what needs to be accomplished. Additionally, it provides an
avenue for measuring ROI at the highest organizational level.4
While portfolio management requires organizational discipline and
maturity, it is well worth the effort. It helps clarify organization-wide
priorities and project and resource expectations upfront. Staff will
appreciate the stability of being able to predict their efforts day to day, and
they will likely work more effectively on approved tasks throughout the
year. Organizations reap benefits by working strategically, targeting
investments, gaining advantage against competitors, reducing or avoiding
costs, and having the ability to comply more effectively and quickly with
government regulations as well as effecting risk reduction through
mitigation or elimination.
Portfolio Governance
Portfolio governance plays a significant role in a healthcare organization
and its strategy. It is difficult to be successful if no clear plan is available
on existing and proposed projects or about how resources are allocated.
No ma er how an organization’s portfolio governance is structured,
articulating it clearly provides guidance to the organization.
In most organizations with formal governance process, separate
portfolio governance commi ees determine priorities and funding. They
also decide if, when, and how any reprioritizations occur within the
respective portfolios, based on resource availability. Projects and programs
are categorized as a portfolio of investments and are meant to deliver
maximum value. Cost is a factor, because it is important to stay in
business, but money alone will not bring long-term success. To accomplish
a strong ROI from each project or program, outcomes need to be
measurable, weighted, and reviewed by a governance commi ee. Projects
and programs of li le value can be eliminated during prioritization or
yearly reprioritization in portfolio governance meetings. It is most effective
for any industry, but particularly healthcare, to prioritize at the beginning
of the year (fiscal or calendar) and not continuously reprioritize
throughout the year unless urgent issues occur. This allows staff to focus
on planned efforts, rather than deal with the chaos of shifting priorities
every day, week, or month. All portfolios should roll up to an
organization’s executive level commi ee for prioritization of projects and
programs for the entire organization.7 Once that is completed, individual
portfolio prioritization can be done more effectively (see Fig. 17.4).
Strong portfolio governance commi ees manage ongoing and projected
initiatives to determine if a set of projects can or should be implemented.
Alignment of this decision-making process, new project selection for
capital investments, and strategic planning is critical. The 2014 PMI Pulse
of the Profession: Portfolio Management states that "alignment of projects to
organizational strategy most likely contributes to the surprising result that
nearly one half of strategic initiatives (44%) are reported as unsuccessful.”2
Thus each commi ee needs a good understanding of resource
management, project risks, and financial management, as these are key to
the success of any project management governance model.9 Utilizing
project management practices will strengthen deployment of organization
resources so they are working on the “right projects at the right time.”4
Inherent risk exists in any project or program implemented in a
healthcare environment. Integrating cost, schedules, contingencies, and
risk response plans in a group with portfolios allows commi ees to review
projects and programs holistically to mitigate issues before projects are
funded or implemented. This enables organizations to have more visibility
and less uncertainty about upcoming efforts.9
Roles and responsibilities: project,
program, and portfolio managers
Project, program, and portfolio managers need to have a variety of skills in
order to bring people, tools, and processes together in successfully
delivering project objectives and value. Each of these roles requires strong
leadership. Leaders are typically visionaries, collaborators, commi ed to
organizational goals, excellent communicators, good problem solvers, and
results oriented. They are accountable team players and can see the “big
picture” of a project or program holistically. Project and program
managers must be able to effectively communicate the project or program
purpose, direction, and desired results to the project team and
stakeholders so they can motivate people to deliver their best effort.10
The most effective leaders are collaborative in nature and include their
project team(s) in the project strategy, risk assessment, planning, and
decision making. Leaders must have strong, visible, and consistent
commitment to their project, positively impacting the outcome. Without
that, a team will likely not have confidence in their activities, or they may
not understand expectations for a successful outcome. Leaders must be
able to identify and react quickly to urgent issues. They work with the end
goal in mind to help guide them through the project management process
journey, basing their decisions and actions on outcomes they want to
achieve. A solid project management discipline includes PMs who possess
skills with high degrees of communication, organization, interpersonal
leadership, cross-functional team coordination, negotiation, problem
solving, a entiveness to detail, and knowledge about technical and
business domains. Specific responsibilities and activities for each
managerial level are outlined in the following sections.
Project Manager
PM roles and responsibilities span the beginning to the end of a project.
PMs are responsible for controlling any project changes that occur,
ensuring progress is monitored continuously and that performance is
measured periodically. PM activities include a major focus on project
planning, budget allocations, and resource allocations. They bring
structure to a healthcare environment to ensure projects and programs are
delivered on time and on budget and within the set scope and
requirements.7
Project planning is a significant role of PMs. They manage project
overall planning and project deliverables. Their key role is to bring people
and processes together to keep a project moving at an optimal pace and to
ensure project deliverables are completed accurately and efficiently within
the project deadline. Moving too quickly and rushing a project under
pressure can often lead to missed details, so PMs have a responsibility to
help stakeholders and staff manage the pace of delivery.
PMs monitor and continuously assess the project as well as record and
manage issues throughout the course of the project execution. Issues are
sometimes urgent and may impact scheduled implementation deadlines. If
a team member working on a project reports that a current task or
deliverable is not feasible because of a given environmental or hardware
issue discovered in the process, this can delay or stop the project. These
obviously need to be resolved immediately to avoid a negative impact on a
project.
A PM is obliged to control the project scope so it does not diverge from
what has been planned. Sometimes stakeholders who are highly engaged
in the project may want more than can realistically be achieved within a
given timeline and can add additional, unplanned requirements during
the execution phase. This increase of original scope, or “scope creep,”
should be avoided or managed to avoid delays to project schedules. Most
IT projects and programs tend to grow in scale and complexity as they
progress, especially as more people get involved. One reason for this is
that as more stakeholders see details of the project, they think of additional
ideas. This is not always a negative situation, but adding more functions
during scope creep still needs to be managed and/or mitigated. The most
important aspect of scope creep is the creation of a scope document.
Without such a document, how can you really assess your “scope creep”?
It is essential to have a full understanding of what is in and out of scope so
projects can be effectively managed.
An example of how scope creep can impact a project or program
negatively is the delivery of an EHR in a large hospital. Hospital ABC
planned to link 10,000 physicians with 200 hospitals around the world.
The organization felt this project was an imperative for its future
competitiveness and the project was worth the effort and cost to
implement it. However, the organization had an immature internal project
management process. Organizational leaders scheduled project
implementation with the vendor without any requirements or input from
the PM who would be managing the program for budget and timeline.
The PM was given a gross project outcome—18 months and a budget of
$25 million—but additional project functions were not defined as part of
the implementation. As a result, the program ended 5 years later with a
budget that doubled from the original estimate. The major lesson learned
for the organization was that the lack of documentation of requirements
from the beginning created project failure for the budgeting aspect. Not
having that initial information about the project created a situation where
the PM was not adequately prepared or able to manage scope creep.
To manage a project’s potential scope creep, a PM should begin with a
strong scope document. Project scope documentation should include
information about project time, cost, and resources. It provides an
overview of what the project team is expecting to achieve and how the
work will be accomplished. It can be used to clarify what stakeholders can
expect and what the parameters are for any changes that may be requested
(scope creep).
This situation is not unusual in low-maturity organizations,
unfortunately. Without documentation to help manage scope creep,
leaders are forced to repeatedly push out go-live dates to accommodate
critically needed changes. There is no way to show stakeholders what was
originally agreed to. How can they effectively determine which changes
are appropriate? For an IT PM, this type of situation can be a career killer.
Managing scope creep well can help ensure project success and a PM’s
long career in healthcare project management.
At each performance measurement stage, the PM must update the
sponsor and other stakeholders and solicit their help when necessary.
Budget allocations for projects and programs are typically estimated to
make certain the allocated funds are adequate for the effort to be
successful. This is an area where a strong PM with excellent leadership
skills can excel. In particular, successful PMs will be able to indicate what
the requirements are and make them realistic. PMs provide vital
information to leaders so the la er can make decisions based on solid data.
Resource allocation is another significant role for a PM. PMs need to
understand the depth of resource requirements throughout a project or
program. Thus a proper analysis of requirements is essential to determine
the amount of resources needed at each stage. A PM may be responsible
for hiring staff or consultants for a project or provide enough detail to
directors or resource managers (RMs) who do the hiring. The PM is
ultimately responsible for providing the most comprehensive information
possible for adequate resources to be secured.
To avoid conflicts with resource allocation, PMs and RMs should
determine at the beginning of a project or program what the parameters
will be. The following are a few basic questions PMs can ask before
activities begin:
1. Who is responsible for allocation of team members’ time for the
project or program?
2. What role will the RM play on the project, if any?
3. How will the RM and PM coordinate the work? What is the
frequency of this coordination?
Some organizations have managers serve a dual role of both RM and
PM simultaneously. This is not a recommended way to manage projects or
programs because of the conflicting needs and goals of each role.
Operationally, RMs must ensure their operational area continues to run in
parallel with whatever projects or programs are in progress. Likewise,
PMs must fulfill their duties to make certain nothing gets off track. When
an RM is expected to do both, project management suffers. RMs can have
an understandable bias toward their own teams, which can impact health
IT project outcomes negatively.
Program Manager
Program managers are tasked with similar roles and responsibilities as
PMs. They guide organization leaders and multiple projects, so their
efforts need to be especially well coordinated. Like a PM, they are
responsible for planning, executing, and delivering a program or collection
of related projects within the defined program scope and schedule.
Monitoring progress of individual projects, they coordinate activities
across the group of projects in their program, which adds a level of
complexity.
A program like the implementation of an EHR requires someone like a
program manager to oversee the entire overarching implementation of the
system among many clinics and departmental areas. Each area has
requirements that may be managed as individual projects with their own
individual, respective PMs. Projects and team members within a program
cooperate to allow resources to be streamlined and synchronized to meet
overall program objectives. Some elements of project management, like
reporting to stakeholders, are typically more frequent in a program to
prevent overlooking a small but critical element. Program managers’ skills
are typically at a higher level of strategic leadership, cross-functional team
coordination, organizational resource negotiation, and communication
due to the increased complexity of their responsibilities.
Portfolio Manager
A portfolio manager is responsible for centralized management of
portfolio processes, methods, and structures to ensure successful flow of
projects within a portfolio. The portfolio manager provides information
about projects, programs, and resources within a portfolio to governance
commi ees who will evaluate new requests based on strategic alignment.
In a healthcare se ing, portfolio management involves organizing projects
to focus, for example, on patients, quality outcomes, and financial goals.
Portfolio managers can help commi ees determine which projects should
be given priority in terms of resource allocation, availability, realistic
completion timelines, and project overlap because they should be aware of
stakeholder demand and have high-level insight to requirements and
deadlines of the projects within the portfolio.
Portfolio managers play a key role in ensuring project and program
risks are known to commi ees and controlled to avoid poor project
selection or delays. The ultimate success of a portfolio is dependent on the
performance of individual projects. Portfolio managers should perform a
value assessment for each completed project to provide information to
leadership about long-term value. This requires comparing initial
definitions of benefits against actual results.
Project management tools
Some PMs use productivity software like Microsoft Word and Excel to
perform project management functions. Microsoft Office has various free
templates in Excel, Word, and PowerPoint of use for program evaluation
review technique (PERT) and Gan charts that outline project tasks and
their interrelationships, as explained in the following section. These are
low-cost options for a department or organization that is small to medium
sized or those working on small projects limited to a low number of users
and activities. Aspects to track are project scope determination, timelines,
budget, resource assignment, and project documentation. There are also
many project management software tools on the market that provide the
same functionality but are built into the system.
PERT charts are used to schedule, organize, and coordinate tasks in a
project. Using the foundation of an “activity list” (Fig. 17.5), these charts
provide a graphical view of a project as a network diagram consisting of
numbered “nodes” (Fig. 17.6). These nodes can be either circles or
rectangles that represent events or milestones. They are linked by labeled
vectors or directional lines that represent tasks. The direction of an arrow
on a line indicates a task sequence. These are dependent or serial tasks.
Tasks between nodes that are not dependent on the completion of one
node to start the other node and can be undertaken simultaneously are
called parallel or concurrent tasks.
FIG. 17.5 PERT activities list. Copyright Michele Mills, 2015.
FIG. 17.6 PERT chart (activities in days).
Gantt Charts
A Gan chart is a graphical view of the duration of tasks and activities
shown as a progression in a timeline. A simplified view of the schedule
and milestones is provided in Fig. 17.7. After that, managers would add
task relationships and predecessors of each and put them into a graphical
template (Figs. 17.8 and 17.9).
FIG. 17.7 Key tasks and durations in a Gantt chart. Copyright Michele
Mills, 2015.
FIG. 17.8 Task relationships and predecessors in a Gantt chart.
Copyright Michele Mills, 2015.
FIG. 17.9 Simplified Gantt chart. Copyright Michele Mills, 2015.
PERT charts are preferred by some PMs, rather than Gan charts,
because they clearly show task dependencies. They can, however, be more
difficult to interpret, particularly in a complex project. PMs often use both
tools to ensure they can interpret all the details effectively.
More scalable tools can be found in the market, but which one to select
is dependent on the organization’s strategy. Does the PM need to report
only basic information (e.g., how much time project team members are
spending on each task)? Does the PM need to go further and link project
time to cost? Does the organization require the PM to be able to provide
information about a large volume of projects and nonproject work? As
with any software purchase, it is important to fully understand what is
required before purchasing a product. Selection of a project tool is the
ultimate project for an organization looking to reduce costs, meet
mandated government regulations, and focus on strategic initiatives more
methodically. More complicated medium- to large-sized organizations
would be well served if they select a more formalized tool.
Project and portfolio management
software selection
For complex or medium to large organizations, purchasing a formal
project management tool can be justified. Depending on an organization’s
needs, a wide variety of options exist. In Gartner’s Project and Portfolio
Management (PPM) Magic Quadrant report, information is provided
about various project management software (Fig. 17.10).11 Gartner’s review
included both on-site and cloud-hosted options. Their report emphasizes
that the current demand for IT PPM software will continue to gain traction
due to increased speed and types of organizational change. Today PMs are
more focused on digitalization and having cloud-based options. Most tools
will have what an organization needs to be successful, but they must be
prepared to do some work to get what they need.9
FIG. 17.10 Gartner Magic Quadrant 2015. Copyright 2016 Gartner,
Inc. and/or its Affiliates. All rights reserved.
“Selling” a complex PPM system and discipline to your own
organization can be difficult. Having a senior-level executive sponsor is
critical. To do this, the PM should resist the temptation to speak about PM
theoretical concepts. Leaders will focus on how new software will help the
organization’s bo om line. What kind of data does the PM have to show
them? How are projects being compromised today, and how can an
effective tool help correct the problems? PMs can answer questions either
by providing leaders with information about a specific project or by a
process that demonstrates value. PMs could use, for example, two projects
to show a comparison—one managed using project management software
and one without. Measuring projects before and after they started will
allow empirical data to emerge. In healthcare IT, it would be useful for
PMs to show links with improvement(s) to monetary, patient care, or
quality data. Once PMs have a senior leader in their corner, they should be
well on their way to finding the right tool for the organization.
Conclusions and future directions
High-performing organizations use project management processes to
maximize project success and organizational value. Through consistent
use of project management practices, healthcare organizations can deliver
value through high-quality projects that are more cost effective to
implement. The result can be be er patient care, higher quality, and
financial and human resources leading to higher profit margins. Though
profit maximization is not always the primary aim of healthcare
organizations, it is needed for sustainability. Integration of project
management in healthcare is a significant step toward achieving overall
cost-effective, quality healthcare delivery for patients by aligning all levels
of the organization with strategic objectives.
Currently, healthcare organizations are only beginning to adopt formal
project management techniques, tools, and process groups. As healthcare
organizations mature in their processes, more will adopt these systematic,
formal techniques to ensure more favorable project outcomes.
The future of project management in health IT is a positive one. As more
and more organizations work to cut costs, they are seeing advantages in
the use of project management principles, processes, and tools. The cost of
purchasing an effective, scalable project management system pales in
comparison to the cost of unnecessary waste. Expansion beyond basic
project management into the more complex areas of program and portfolio
management will either mature or begin over the next 3 to 5 years. There
will be a be er understanding of the importance of effective prioritization
techniques to gain competitive advantage, focusing efforts on appropriate
projects and programs with substantial ROIs of financial gain, cost
effectiveness, and be er patient outcomes and satisfaction. These all have
the purpose of meeting overall organization objectives, rather than only
the individual, personal desires of a stakeholder. The project management
of the future will allow more visibility, input, and buy-in from all
organization entities.
References
1 Project Management Institute, Inc. A Guide to the Project
Management Book of Knowledge: PMBOK. 5th ed. Newtown Square,
PA: PMI Publications; 2013.417.
2 Project Management Institute, Inc. Project Management Institute
Pulse of the Profession® in-depth report: Portfolio Management. Project
Management Institute; 2014. h p://[Link].
3 Project Management Institute, Inc. The Standard for Portfolio
Management. Newtown Square, PA: PMI Publications; 2006.
4 Mulcahy R. Top Reasons Projects Fail. 1999. h p://[Link].
5 Bhide D. Patient Care—A Project Management Perspective.
h p://[Link]. 2011.
6 Rajegopal S. Portfolio Management: How to Innovate and Invest in
Successful Projects. Basingstoke: Palgrave Macmillan; 2012.
7 Harrison F.L., Lock D. Advanced Project Management: A Structured
Approach. 4th ed. Aldershot: Gower; 2004.
8 Thiry M. Program Management. Burlington: Gower; 2010.
9 Reiss G. Project Management Demystified: Today’s Tools and
Techniques. London, UK: E&FN SPON; 1995.
10 Ma hews D., Cooke-Davies T. HSI: Portfolio Management Optimizes
Your Strategic Position. h p://[Link]. 2013.
11 Stang D., Handler R., Jones T. Gartner Magic Quadrant. Magic
Quadrant for IT Project and Portfolio Management Software
Applications, Worldwide. Gartner, Inc.; 2015.
12 Berkun S. Making Things Happen: Mastering Project Management.
Revised ed. Sebastopo: O'Reilly Media; 2008.
Discussion questions
1. Discuss why some healthcare organizations continue to underutilize
formal project management practices.
2. What effects will a fully implemented project management methodology
have on an organization? How might it impact the budget?
3. What are additional benefits for healthcare organizations that utilize
project management?
4. How can project management enhance healthcare quality or patient
care?
5. Project management can help mitigate unrealistic or even made-up
deadlines imposed by managers or leaders. Explain the relevance of this
benefit in healthcare.
6. Discuss how healthcare project management can be optimized to be
different from other industries.
7. Hospitals are separated in many individual and specialized departments
that respond differently to project management. Discuss different
aspects of an ideal healthcare organization that could be enhanced
through project management.
8. Discuss the various challenges limiting actualization of project
management in a healthcare environment. How can these challenges be
resolved?
9. How can project management help reduce negativity about healthcare
organizations that patients might hear about in the news media?
10. What are the advantages portfolio management in a healthcare
environment?
Case study
A PM’s ability to achieve a successful outcome can be impacted by the lack
of standardization of project management processes. This case study is
designed to help you understand the importance of the standardization of
project management practices and identify ways you can influence the use
of standard processes to determine what the potential problems and
solutions might be.
You are a program manager who has been asked to implement a new
electronic health record (EHR) to help meet new regulatory guidelines.
You are enthusiastic about your role but have concerns about the lack of
project management processes in your organization. You fully understand
the ramifications of failure with the implementation, and so you are
looking for ways to mitigate issues with a large number of departments
involved.
You know that an EHR needs to be focused on patient care, quality, and
business and clinical workflows. A multidisciplinary implementation team
needs to be assembled and must include clinicians and IT and operational
staff. Training for staff at all levels is required. IT will need to be engaged
to customize templates and workflows.
The organization is unsure what value having one EHR will provide, so
communication about benefits of such a system is important. You have a
good relationship with external organizations who have implemented
their own EHRs. You are planning a meeting with some of them to see
what you can glean from what they learned, during implementation.
You need to effectively define the scope of work your project teams are
expected to deliver. You are constrained by availability of clinical
resources and related funding. You are told that both of these are not
flexible, and your sponsor emphasizes the political nature of the situation.
She asks for your input on how to best deal with these constraints from a
project management perspective.
Discussion Questions
1. What do you propose to your stakeholder as possible solutions to the
resource constraint issue? What might be project risks if resources are
constrained?
2. How would you implement project management processes in your
project even if they are not yet systemwide?
3. What would your first steps be to implement project management in
this EHR initiative?
4. If there is resistance to the use of project management techniques, how
might you influence stakeholders on adopting these processes?
5. Discuss why some healthcare organizations continue to underutilize
formal project management practices.
6. What effects will a fully implemented project management
methodology likely have on an organization? How might this impact
the budget?
7. Hospitals are separated into many specialized departments that
respond differently to project management. Discuss different aspects
of an ideal healthcare organization that could be enhanced through
project management.
18
Contract Negotiations and
Software Licensing*
Jon C. Christiansen
Abstract
Healthcare organizations (HCOs) need a negotiating team with the expertise
and knowledge to properly assess and negotiate software license agreements
with vendors. This team will need to represent different interests, including
user, technical, finance, and legal interests of the HCO. The agreements
provided by software vendors tend to be very one-sided and do not
adequately protect HCOs or address all HCO needs. “Legalese,” the legal
terms and language of contracts, is not harmless and in many respects affects
technical, business, and financial issues, including business continuity, data
protection, return on investment, and other value propositions. HCOs should
not underestimate their leverage to negotiate for be er terms in their software
license agreement with vendors. This chapter describes a process for health
information technology (IT) contract negotiation and provides a description of
contract terms, related issues, and negotiation compromises.
Never underestimate the leverage that a healthcare organization has
to contractually protect itself.
OBJECTIVES
At the completion of this chapter, the reader will be prepared
to:
1. Understand the implications of contract provisions commonly
included in an agreement (contract) for software licensed to a
healthcare organization (HCO).
2. Learn how to participate in the process of negotiating an
agreement for software by understanding key elements,
compromises, and additional essentials to incorporate into the
agreement.
3. Understand who should be involved in the negotiation process
and roles these persons play.
KEY TERMS
cloud licensing 300
derivative works 300
limitations and exclusions of liability 313
open source software 300
service level agreement (SLA) 305
software as a service (SaaS) 300
software escrow 305
software license agreements 298
software warranty 305
Introduction
Healthcare organizations (HCOs) depend on computer software for
the delivery of healthcare services to patients and for most, if not all,
of their business operations. It is unimaginable today that an HCO
could function without the use of software for a wide variety of
applications and purposes, including clinical care, billing, security,
compliance, research, and operations. Software vendors who
provide the software are diverse in size, expertise, resources, ability,
and the solutions they offer, but one practice they have in common is
their insistence on software license agreements (also referred to as
contracts) as a prerequisite to using their software. The term
“vendor” refers to the licensor, service provider, or other company
that licenses or provides the software to the HCO. The term HCO is
used generically in this chapter to mean not only the HCO itself but
also, when the context allows, the HCO’s leadership or the
designated representatives on a team doing the contract
negotiations.
A negotiating team for a software agreement may be at the
executive level or comprised of other designated team members who
first work with the vendor on the terms and conditions of the
agreement. Then, the agreement is signed by an executive such as
the chief executive officer (CEO), chief financial officer (CFO), or the
chief information officer (CIO) who is authorized to sign purchases
or contracts and make financial commitments. A negotiating team’s
typical composition is listed in Box 18.1.
Box 18.1
Contract Negotiating Team Composition
• The CFO. This person or designed representative represents the
financial interests of the HCO.
• An a orney. This a orney should generally understand relevant
healthcare technology, intellectual property rights, and contract
law. Experience in software license agreements is essential for
proper representation.
p p p
• The CIO or designated representative. This team member
understands the relevant technology, including the information
systems of the HCO and the licensed software.
• Key users. One or more key stakeholders represent the software
users and know what functionality and features are needed or
expected by those users. These stakeholders may include a chief
medical informatics officer or chief nursing informatics officer for
a clinical system and/or clinical executive such as the chief medical
or nursing executive.
• Contract administrators. If the HCO has contract administrators,
then one of them may also be on the negotiating team.
• Compliance officer. This officer is needed to make sure that the
agreement adequately and properly addresses HIPAA, Stark, anti-
kickback, and other regulatory issues and does not include any
provisions that could be construed as violating applicable law or
patient privacy.
• Security expert. Software licenses and related services and data
storage often trigger security concerns. A member of the HCO’s
security team should be involved not only to identify security
risks in the agreement but to make sure that the agreement
proactively address security risks as needed in a manner
consistent with the HCO’s security policies and practices.
CFO, Chief financial officer; CIO, chief information officer; HCO,
healthcare organization.
Although this chapter does not address Stark, anti-kickback,
Health Information Portability and Accountability Act (HIPAA), and
other regulatory issues, those issues must always be carefully
considered and accounted for by the HCO. Details about legal issues
may be found in Chapter 25, HIPAA is discussed in Chapter 26, and
regulatory issues such as Health Information Technology for
Economic Clinical Health (HITECH) and Meaningful Use are in
Chapter 27.
This chapter focuses on commercial software license agreements
rather than open source software licenses. It is wri en primarily to
address traditional “on-premises” software licenses, but much of
what is said about “on-premises” licenses also applies to cloud-
based services. The chapter does include a discussion of cloud-based
services (e.g., software as a service [SaaS] licenses) and is wri en
from the perspective of informing healthcare professionals and
informaticians who are expected to take a leadership role in
understanding the implications of these types of agreements. It is not
wri en for a orneys but rather for others responsible for
understanding and approving software license agreements and
ensuring that the HCO complies with those agreements. By
necessity, the chapter is not completely comprehensive (i.e., any
given software license agreement is likely to include additional
provisions not mentioned here and may not include some provisions
that are mentioned). However, the chapter does provide a
description of the topics and contractual provisions deemed the
most relevant to the intended reader.
When purchasing a license for software that is “mission critical” or
highly important, the HCO should be sure to understand what it is
agreeing to and should make sure that the agreement makes sense in
the context of the “real world” in which the HCO will use the
software. Software license agreements can be relatively simple, but
more often they are lengthy and complex and even confusing. They
include provisions that address significant business and technical
issues. They may also include provisions that are referred to as
“legalese” or “boilerplate.” These legalese or boilerplate provisions
should never be dismissed or overlooked as “routine” or “harmless.”
These provisions, if enforced, can create some very unpleasant
surprises with business, technical, financial, and/or patient care
consequences.
In dealing with these types of agreements, there are three key
points to always remember (Box 18.2).
Box 18.2
Key Points About Agreements
• A vendor’s form of agreement is not wri en to protect the HCO
(i.e., the agreement is almost always very one-sided and wri en to
protect the vendor).
• The HCO leadership should take the time and make the effort to
clearly understand what the agreement says and what that means
to the institution.
• The HCO leadership should negotiate these agreements to ensure
the agreement meets the HCO’s needs. Of course, the HCO
leadership may not always have sufficient leverage to require the
vendor to make the desired changes or to even negotiate the
agreement, but in the author’s experience, HCOs are more likely
to underestimate their leverage than to overestimate it. Vendors
need and want sales and can be reasonable. In the end, they want
customers who are willing to sign up for software and services.
HCO, Healthcare organization.
Overview of licensing agreements
Intellectual Property Concepts Relevant to
Software
Software is a “work of authorship” under the copyright laws. There
is always a copyright to any software that is original (i.e., not copied
from someone else). Copyrights only protect “expression” and not
ideas, methods, facts, concepts, inventions, or systems. Writing
computer software is analogous to writing a book. Both are
expressions protected by copyright, but the concepts and ideas in
them are not. Therefore copyrights can protect software against
copying and even against derivative works based on the software (a
derivative work copies or includes at least some of the original
expression). Infringement of a copyright requires that the original
work be copied. Independent creation, even independent creation
that was inspired by ideas and concepts in the original work, is not
copyright infringement.
It is important to understand that copyright and patent are two
different concepts. Copyright is a form of protection provided to the
authors of "original” works. A patent protects the “invention” of an
inventor. Sometimes, software includes or represents a patentable
invention or the use of the software may be or involve a patentable
method. If patented, the invention or method is protected by the
patent, and to that extent the software is protected by the patent.
Patent protection applies to inventions.1 Therefore, patent protection
is potentially much broader than copyright protection but is more
difficult and expensive to obtain. A software vendor might have one
or more patents applicable to its software. It is also possible that
another person owns a patent that is infringed by the HCO’s use of
the software. A patent can be “innocently” infringed. Being unaware
of the patent does not excuse infringement and is not a defense, but
can be a mitigating factor when it comes to damages payable to the
owner of the patent. If software is licensed to an HCO and if the
vendor (licensor) owns a patent applicable to the software, then
there is no infringement of the vendor’s patent by the HCO because
of the license. But the license is no defense if another person owns a
patent that is infringed.
Trade secrets are a third form of intellectual property applicable to
software. A trade secret is information that is not generally known to
others and not readily ascertainable by others.2 Trade secrets are
protected against misappropriation (e.g., taking by improper
means). Software can include trade secrets. The source code to
commercial software is often held by the owner of the software as a
trade secret. Open source software is not a trade secret, as the
software and its source code are typically made available to the
public and therefore are generally known to the public. Typically,
when commercial software is distributed, it is the object code or
executable code version of the software that is distributed and the
source code is withheld from distribution. In such cases, the source
code may be a trade secret.
Why Are Contracts Used for Software Licensing?
Vendors will insist on using a binding contract, such as a software
license agreement, when licensing commercial software to an HCO.
License agreements provide the vendor with contractual protection
of its software in addition to intellectual property protection. They
create binding obligations such as payment obligations and
restrictions on use as well as limitations of liability and disclaimers
that protect the vendor. However, a license agreement can also
protect HCOs by including obligations and warranties binding on
the vendor that give the HCO assurance as to the software and its
functionality, performance, and compatibility, as well as other
protections (e.g., indemnification against claims that the software
infringes another person’s intellectual property).
The Concept of Licensing Versus Sale
Software is “licensed,” not sold, when distributed to customers. If
the software itself were sold, this would give ownership to the
customer, which is unacceptable to a vendor wanting to license the
software to others. A license is, in effect, permission to use the
software. A license to use software is sold, but the software itself is
not sold. If the software were sold, it presumably means that the
copyrights and other intellectual property in and to the software
were also sold. Then the vendor would no longer have any rights to
license the software to others without the permission of the new
owner.
The media (e.g., DVDs) on which the software resides and is
distributed to an HCO (1) may be owned by the HCO as a purchaser,
or (2) may be leased or loaned to the HCO (i.e., the vendor owns the
media). Ownership of the media is not an issue when software is
downloaded by the HCO via the internet from the vendor or is
remotely accessed and used by the HCO via the internet as in a
software as a service (SaaS) agreement. Software as a service (SaaS)
is a software distribution model where applications are hosted by a
vendor and made available to customers over a network, typically
the internet.
“On-Premises” Licensing Versus Licensing
Through the “Cloud”
Traditionally, software licenses have been “on-premises” licenses,
meaning that the software (usually the executable code but not the
source code) is installed and runs on a computer or network located
at the facility of the licensee (e.g., the HCO). (See Table 18.1 for
definitions of the terms source code, executable code, and
interpretive code.) Cloud licensing takes a different approach. The
software resides and runs on the vendor’s server(s), and the licensee
(e.g., the HCO) remotely accesses and uses the software through the
internet (e.g., via a web browser).
Table 18.1
Definition of Terms
Term Definition
Source code Software wri en in a programming language such as C++. The source code is
understandable to the human programmer.
Executable code Source code compiled into a format understandable by computers (machine
(machine code or object code).
code)
Interpretive code Source code wri en in a specific language that is “interpreted” on the fly when
the software is run to produce code that the computer can execute.
An example of cloud licensing is SaaS licensing. “True” SaaS can
be characterized by a single instance of the software running on the
vendor’s server(s) that is accessed and used by multiple licensees
(i.e., “multitenant”). This maximizes some of the benefits of a SaaS
solution (e.g., the cost of hosting, running, maintaining, and
supporting a single instance of the same version of the software
reduces costs when those costs can be shared by multiple licensees).
The term SaaS can also apply to solutions that are not single instance
or multitenant, although some persons may not consider such
solutions as “true SaaS.”
Other cloud services and licenses (and terms that are used to
identify them) include hosting, managed services, on-demand
services, and application service provider (ASP) services. Some
agreements are structured as a hybrid between or combination of an
“on-premises” license and a “cloud” license. For example, some
vendors will license the software through an “on-premises” license
but then offer hosting services through a services agreement (e.g., a
hosting or managed services agreement). In such cases, the HCO is
licensed to use the software under the license but engages the
vendor through a services agreement to host and run the software
for the HCO on the vendor’s servers. If the services agreement were
to terminate, it remains possible for the HCO to run and use the
software on its own computers or network under the terms of the
“on-premises” license agreement.
The Vendor’s Contract: Healthcare Organizations,
Beware!
Typically, the vendor has a standard template for a license
agreement. However, it is often possible to negotiate the terms of
any software license, as the vendor’s version should be viewed by
the HCO as only a starting point. The vendor’s form of agreement is
mostly designed to protect the vendor as opposed to protecting the
HCO. The agreement usually includes legalese that can mislead,
surprise an HCO, or in some cases offend basic concepts of fairness.
It often fails to include many protections and assurances important
to the HCO. Health providers and informaticians involved in
contract negotiations should not be distracted by the “friendliness”
of a vendor or with the developing informatics–vendor relationship,
but rather they should focus on gaining a clear and objective
understanding of what is in the agreement. HCOs should not
hesitate to negotiate aggressively for the needs of the healthcare
institution. Vendors can be persuaded to change their agreements,
but they will not do so if no demand or request for change is clearly
made. HCOs should not underestimate their leverage. While HCOs
should negotiate firmly and aggressively for the need of the
institution, a collegial, professional manner is always the most
effective way to reach an acceptable agreement. The HCO and its
representatives should have and maintain an amicable and
professional relationship with the vendor at all times, and contract
negotiations are no exception.
The Mechanics and Process of Contract
Negotiation for a Software License
Although situations will vary, the progression of a negotiated
agreement is likely to include a process similar to the one outlined in
Box 18.3. As is illustrated, the process involves numerous “back and
forth” steps.
Box 18.3
Typical Negotiating Process for an
Agreement
1. Vendor’s standard form of agreement—Draft #1.
2. HCO reviews Draft #1.
3. Telephone conference or meeting with the vendor to discuss Draft
#1.
4. Vendor prepares Draft #2.
5. HCO reviews Draft #2.
6. HCO prepares Draft #3.
7. Vendor reviews Draft #3.
8. Telephone conference or meeting with the vendor.
9. Vendor prepares Draft #4.
10. Repeat as necessary to reach final agreement.
HCO, Healthcare organization.
The reason for having the vendor prepare a second draft is that
this allows the agreement to move closer to what the HCO needs
and wants in an agreement before the HCO starts to change the
agreement. Assuming that the vendor accommodates some of the
changes requested by the HCO in the first teleconference or meeting,
there will be fewer changes that the HCO needs to make in its final
draft (i.e., third draft). In the process, there should be shared control
of the agreement document, by taking turns in preparing response
drafts that are redlined to show changes to the prior draft. Two
major tips for version control are listed in Box 18.4.
Box 18.4
Tips on How to Control the Versions of a
Draft Contract
Tip #1: If a vendor insists that it must control all drafting and refuses
to provide an editable draft that is not locked or protected, simply
inform the vendor (especially its salespeople) that this will greatly
delay the negotiating process, as the HCO must then “type up” (or
convert from a locked PDF) the entire agreement from the
uneditable draft provided by the vendor to create an editable draft
so that changes can be “tracked” and then sent to the vendor in an
editable form. Given the complexity and length of license
agreements, this is not a trivial issue, as the HCO’s representatives
responsible for the agreement and negotiating process will incur
much more review time if they cannot rely on “document
comparison” and “tracking” functionality in word processing
software that can be used on editable documents. Also, manual
typing, text readers, and other conversions can introduce errors. In
any event, a careful reading of the final version of the agreement is
critical before it is signed. This will ensure no provisions in the
contract were changed during the numerous steps without the
HCO knowing the changes.
Tip #2: Whenever there is a teleconference or meeting to negotiate
the agreement, it is always advantageous to the HCO if the then-
most-recent draft on the negotiating table (other than the first
draft) is a draft provided by the HCO, even if that means reducing
the frequency of the calls or meetings to negotiate.
HCO, Healthcare organization.
Before the Agreement Is Signed: Due Diligence
Even the best agreement is not a substitute for due diligence (see
also Chapter 16 on system selection processes). The HCO should
check with other users and even visit their sites. Although somewhat
uncomfortable for both the vendor and the HCO, the HCO can ask
who has recently discontinued use of the vendor’s software and
why. References provided by the vendor are not likely to include
customers with bad experiences or complaints that the HCO might
need to know about. Sometimes vendors are asked to provide
financial statements so that the financial stability of the vendor can
be assessed. Suddenly losing support and maintenance services (not
to mention hosting or SaaS services) from a vendor in bankruptcy or
buyouts can be a huge problem.
Always conduct due diligence on alternative vendors to get the
best value. This also strengthens negotiating leverage with the first
vendor and puts the HCO in position, should the need arise, to
terminate negotiations with the first vendor and more rapidly move
to negotiations with a second. The HCO needs to know its
requirements and must clearly communicate those requirements to
the vendor. Document the responses from the vendor to these
requirements, including those presented during demonstrations of
the software. Outside consultants/experts engaged by the HCO may
be useful to it in the due diligence and negotiating process.
Use the Request for Proposal Process
Request for proposal (RFP) or request for information (RFI) or
similar mechanisms are worth the effort, time, and expense if the
software is mission critical or of high importance or high cost to the
HCO. The RFP process, outlined in Chapter 16, sets forth the HCO’s
requirements and expectations for the software, including its
functionality, performance, compatibility, etc. Do not overlook data,
data migration, and data warehousing issues, if relevant. The RFP
should also be used to ask relevant questions of prospective vendors,
including costs. The more comprehensive the RFP, then the more
comprehensive the response should be from the vendor. This will
reduce the likelihood of misunderstandings and surprises later.
Traditionally, an RFP is used with multiple vendors and is the basis
for a bidding, comparison, and selection process, but even if there is
only one vendor in the running, the RFP process is extremely
valuable and very important in successfully negotiating a good
license agreement.
The vendor’s response to the RFP should be made a part of the
license agreement. For example, the license agreement can reference
the vendor’s response and state that the vendor stands behind its
response (i.e., that the response is accurate and that any promise or
assurance in the response will be met by the vendor). Because of the
nature of “Entire Agreement” clauses (see the next section), the
response will be of no effect if not incorporated into the license
agreement.
If the vendor objects to the inclusion of its response to the RFP in
the license agreement, then the HCO should insist that the HCO
relied on the vendor’s response in the selection of the vendor. If the
vendor still objects, the HCO should offer to allow the vendor to
correct or clarify its response, and then the corrected or clarified
response should be added to the agreement. If the corrections reveal
some unpleasant surprises, it is be er for the HCO to know before
rather than after signing the agreement.
Although it is not common to do so, the RFP should be used to
address the tough contract issues (including legal issues) that
inevitably arise in contract negotiations (e.g., limitations of liability,
termination, and scope of use). Negotiating these is much more
difficult after the vendor knows that it has been selected, so now is
the time. This approach can reduce the amount of time spent
negotiating the agreement and can lead to a be er result for the
HCO.
The “Entire Agreement” Clause: Know What This
Means!
An “Entire Agreement” clause also known to a orneys as an
integration clause might read as follows:
Entire Agreement. This Agreement is the entire agreement between
the parties with regard to the subject matter of this Agreement and
supersedes and incorporates all prior or contemporaneous
representations, understandings or agreements, and may not be
modified or amended except by an agreement in writing signed by
the parties hereto.
What does this mean? Since no competent a orney for the vendor
will allow you to negotiate this out of the agreement, the HCO must
put everything it is relying on in the agreement. Exhibits,
addendums, appendices, and documents that are incorporated by
reference into the agreement can be used for this purpose.
Statements made by salespersons, demonstrations, marketing
materials, and other peripheral statements and documents do not
count unless they are incorporated into the agreement. The
agreement should identify what the HCO is paying for (Box 18.5).
Box 18.5
Elements in an Agreement Typically Paid
for by HCOs
• Licensed software/databases
• Hardware
• Third-party software
• Technical and end user documentation
• Customizations
• Interfaces
• Implementation services
• Support
• Maintenance
• Other services (e.g., data migration)
HCO, Healthcare organization.
Major steps or stages in the
performance of a license agreement
Although there is significant variation, a mission-critical license
agreement might include the steps and stages listed in Box 18.6.
Box 18.6
Steps in the Performance of a Mission
Critical License Agreement
• Create specifications (before or after signing of the agreement).
• Develop customized components and interfaces, if needed.
• Deliver the defined software and documentation (the
“deliverables”).
• Install and implement the software.
• Train HCO’s personnel.
• Conduct acceptance testing of the software and then accept the
software if it passes the testing.
• Determine when the warranty period begins.
• Determine when the maintenance and support phases begin.
• Conduct future phases and projects, if applicable.
HCO, Healthcare organization.
Specific components of the licensing
agreement
Major components of a licensing agreement are located in Box 18.7.
Specifics are discussed in the following sections.
Box 18.7
Main Components of a Licensing
Agreement
• Definition of terms
• Time schedule
• Scope of the license
• Scope of use
• Derivation works
• Software and SaaS escrow
• Specifications
• Software warranties
• Service level agreements
• Acceptance
• Maintenance and support, other services (e.g., implementation
support)
• Revenue recognition and payments
• Dispute resolution
• Termination
• Limitations and exclusions of liability
• Special clauses—confidentiality, intellectual property infringement
SaaS, Software as a service.
Definitions of Terms
The agreement should include definitions of all vendor-specific
terms and concepts, as mentioned in Chapter 16. The system
selection team, negotiating team, or designated representatives
should review these to ensure they are consistent with the HCOs use
of the terms and for clarity.
Time Schedule
The license agreement should include a time schedule to keep the
vendor on time (e.g., a project timeline for purchasing hardware,
installing initial software, customizing the software, building
interfaces, training, testing, acceptance, and go-live events). The
contract should contain a good estimate of the initial project from
start to go-live and acceptance testing. For example, a community
hospital may project an 18-month timeline that is broken into
discrete events. The time schedule should address most major stages,
objectives, or milestones of the project, not just delivery of the
software. The time schedule can be tied in whole or in part to an
implementation plan (project plan). (For more information about
project management, see Chapter 17.) Generally, vendors resist
contractual time commitments, but usually an HCO can get some
meaningful time commitments or at least good faith estimates. Even
if the estimates are nonbinding, they create expectations and
increase the probability that the project will be completed within an
expected time frame. Furthermore, payment milestones or monetary
incentives can be tied to milestones, even if the dates associated with
the milestones are nonbinding estimates. For example, the vendor
would not be in breach of the agreement for failing to meet an
estimated time schedule date for a given milestone, but if that
milestone is also a payment milestone, then payment may be
delayed until the milestone is met.
Assuming that the vendor is commi ed to a time schedule, the
agreement should indicate the consequences of a failure to meet the
schedule. Such consequences may include liquidated damages,
credits, discounts, or delay in payments. For example, if a go-live
date is missed by more than a week, the contract may specify that
the license fee might be reduced by a specified amount. In response,
some vendors may seek financial incentives for early or timely
performance of the schedule. In our previous example, a vendor
might receive a bonus payment for an early go-live date. Assuming
the vendor accepts the concept of a binding time schedule, the HCO
should expect the vendor to insist on exceptions for delay or non-
performance caused by the HCO, another supplier, or a force majeure
(disruptions caused by causes beyond the control of the vendor such
as natural disasters or other unforeseeable circumstances beyond the
control of a group). The vendor may also insist on building a margin
for error into the time schedule.
Scope of the License
Who Are the Users?
Fundamentally, the license is permission from the vendor for the
HCO to use the software. The license agreement needs to define who
may use and access the software. Obviously, this includes the HCO
and its employees, but a broader scope may be needed. Do others
(nonemployees) need to use or access the software? Often, the
answer is yes! Affiliated corporations, companies, and organizations
(e.g., a subsidiary or sister corporation) may need to be included as
users of the software. Other examples are (1) independent physicians
having admi ing privileges at the HCO’s hospitals; (2) independent
healthcare providers and clinics (e.g., to share medical records or
perform billing); (3) patients or their family members who will see
screen displays or output generated by the software; (4) consultants,
other independent contractors (e.g., programmers), and volunteers;
and (5) in some cases affiliated foundations or staff and students
from affiliated institutions of higher learning. For example, the
emergency department may contract with an outside billing agency.
This outside agency needs to be mentioned as a user. Otherwise,
billing and reimbursements will be negatively affected. The HCO
needs to anticipate who the users will be and then make sure that
the license agreement allows for those users.
Rights
The basic rights to software under a license are permissions to
• Use the software
• Copy the software as needed for licensed use
• Generate and use the output of the software (e.g., screen
displays and reports)
Sometimes, but not often, other rights are included in a software
license:
• Disclose the software or its output or screen displays to others
• Distribute the software to others—special cases
• Modify the software and create derivative works based on it
Restrictions and License Metrics
The scope of the license will often be subject to “internal use” or
“permi ed use” restrictions. The language may vary, but the HCO
should be comfortable that these types of restrictions do not prohibit
the intended use of the software. For example, a simple restriction
that the software may only be used for internal purposes might
prohibit a use of the software that benefits or involves others outside
of the HCO. The scope of a software license is often defined or
limited by various license metrics, such as those listed in Box 18.8.
Box 18.8
Typical License Metrics in a Software
License
• Number of “named” users (either by specific name or by category
such as physician, nurse or pharmacist)
• Number of “concurrent” users
• Number of computers, servers, or workstations
• Number of processors or other measure of processing power
• Number of users or seats
• Number of procedures, images, reports, etc.
• Specific site or facilities
• Entire enterprise, etc.
HCOs should anticipate that applicable license metrics might be
exceeded at some time in the future and to provide for the same
discounted pricing originally negotiated to cover the excess. An
annual “true up” of the license is a good approach. In other words,
the agreement should allow for a review of the situation annually
and for the payment of additional license fees if needed to cover the
excess. With this approach, the HCO will not be in breach of the
agreement for exceeding a license metric provided that the HCO
does a “true up” at the end of each year.
Scope of Use
Number of Copies
The license might include limits on the number of copies of the
software. An extreme example might be the following clause: Vendor
grants to HCO a license to use one copy of the software and to have and
maintain one back-up copy of the software. This is a problem because
multiple copies of the software can be found in the areas listed in
Box 18.9.
Box 18.9
Where Copies of Software Might Exist
• The master copy provided by the vendor
• Updates of the software
• Memory (e.g., RAM)
• Storage devices (e.g., hard drives)
• Backups (and other archive and disaster recovery storage)
• Nonproduction (non-live) environments used for testing, training,
development, etc.
An HCO will certainly exceed a one copy limit just by virtue of the
fact that software held in the computer’s memory (e.g., random
access memory, or RAM) is legally considered under the copyright
laws as a copy of the software and that there will be a copy of the
software on the hard drive. Any limitation on the number of copies
should reflect the reality of the technology and the use.
Environments and Instances
Sometimes a license is limited to certain number and types of
environments and instances. If so, and at the very least, the HCO
will need to be licensed to use the software in a “production
environment” or to use one “production instance” of the software.
The HCO’s technical advisors should review this wording carefully
to be sure that it is adequate in the context of expected use. Often the
HCO will want the right to use the software in more than one
production environment or in other environments, such as testing,
training, development, and recovery environments. The same is true
if this concept is expressed in terms of “instances” or some other
technical terminology.
Derivative Works
Normally, a software license will prohibit the HCO from modifying
the software or creating derivative works based on the software. But
if the HCO needs to maintain, customize, or enhance the software,
then the HCO will need to expand the license to include permission
to modify and create derivative works. In such case and at a
minimum, the agreement needs to require the vendor to provide the
materials listed in Box 18.10 to the HCO.
Box 18.10
Materials to Be Provided to the Healthcare
Organization If Derivative Work Rights Are
Granted
• Source code and comments (if not already delivered as part of the
software)
• Development environment (to the extent not commercially
available)
• Programming documentation (e.g., compilation and build
instructions)
• Updates to the foregoing to keep current with the software used by
the HCO
• Anything needed by developers to understand the source code
HCO, Healthcare organization.
The HCO will also need programmers, employees, or contractors
with the necessary abilities to use the source code to maintain,
customize, and enhance the software. More may be needed,
depending on the particulars of the software and environments in
which it is developed and used. Also, third-party software may be
needed.
Software and Software as a Service Escrows
For mission-critical or highly important software, an escrow may be
included with the license agreement for business continuity
purposes. For instance, if the vendor goes out of business or
otherwise ceases to provide maintenance of the software (e.g., to fix
programming errors or to update the software), the HCO may be left
in an untenable position. A software escrow is a means to provide
protection of the HCO if such event arises. For a software escrow, a
neutral third-party escrow company holds the source code,
programming documentation, and other items needed for
maintenance and modification of the software. The escrow
agreement includes release conditions and release procedures and
legalese addressing intellectual property and bankruptcy law issues.
A release condition is typically the bankruptcy or insolvency of the
vendor, the vendor’s breach of maintenance or other obligations, the
discontinuation of maintenance and support by the vendor, the
vendor going out of business, or in any other manner the vendor
discontinuing support and maintenance of the software. The
occurrence of a release condition entitles the HCO to receive the
escrowed materials from the escrow company.
A SaaS escrow is an escrow for a SaaS or other cloud-based
software solution. It is similar to the typical software escrow
described previously, but also includes having the escrow company
maintain a mirror or very similar solution on its own server in a
condition that can be brought live and online for the HCO’s use in
the event that a release condition occurs or the HCO’s access to the
software is terminated by the vendor. The frequency of data updates
to the escrow’s server is just one of many details to be addressed in
the escrow agreement. How “hot,” “warm,” or “cold” the escrowed
solution (at the escrow company’s data center) is affects cost and
how quickly the escrowed solution can be brought live for the HCO.
Specifications
The HCO should not shortchange the required specifications, as
these define the software that the HCO expects to receive.
Specifications may apply to warranties, acceptance, payment
milestones, and maintenance obligations of the vendor. The initial
draft of the license agreement from the vendor will likely include
few or no specifications. The HCO should negotiate for meaningful
specifications and preferably create and negotiate them prior to the
signing of the agreement. Sometimes, the specifications need to be
created after signing. If so, then stage 1 of the agreement can focus
on the creation of the specifications. If parties agree on the
specifications (which is almost always the case), then they proceed to
subsequent stages of the agreement. If they do not agree, then the
agreement is terminated.
Many types of specifications can be included in the agreement,
such as those in Box 18.11. If the agreement includes custom
development and if the development is “agile,” then few if any
specifications may exist. Agile software development3 has its
advantages that may outweigh the protections that we try to achieve
for the HCO in an agreement.
Box 18.11
Types of Specifications in Agreements
• Features and functionality
• Reports, forms, screen displays, output, input
• Compatibility with hardware, operating system, third-party
software, etc.
• Communications and networking
• Minimum system requirements
• System software (e.g., operating system)
• Other third-party software
• Hardware and peripheral devices
• Communications, networking, interfaces, etc.
• Performance (e.g., response time; and latency in the case of a SaaS
solution)
• Interfaces, etc.
SaaS, software as a service.
Software Warranties
Sometimes the vendor offers no warranty (i.e., software is provided
“as is” without any guarantee). The HCO should refuse to accept
such an agreement. A good software warranty addresses most or all
of the components in Box 18.12. The vendor is likely to have in its
draft of the license agreement disclaimers or protections listed in Box
18.13.
Box 18.12
Components of a Software Warranty
A good software warranty addresses most or all of the following:
• Programming errors (a “No Error” warranty is not realistic)
• Compliance with specifications
• Compliance with documentation
• Performance problems
• Output or input problems or errors
• Interface, network, or communications problems
• Compatibility
• Minimum system configuration
Other warranties may address:
• No self-help code or termination triggers
• No viruses or harmful code
• Compliance of the software with applicable laws and government
regulations (e.g., HIPAA)
• Meaningful Use certification
• Vendor owns software or has right to license
• No conflict with other contracts or rights of others
• Non-infringement of intellectual property
• Compliance with privacy, security, and IT policies
Box 18.13
License Agreement Disclaimers or
Protections
• No warranties clause or “as is” approach (you get only what you
get)
• A clause requiring the HCO to agree that there are no warranties
that are not expressly included in agreement
• A clause disclaiming all implied warranties, including the
following implied warranties:
• Merchantability
• Fitness for a particular purpose
• Non-infringement
HCO, Healthcare organization.
There may be other disclaimers or limitations. For example, a
clause may state that the software is not intended or licensed for
high-risk uses or applications. The HCO should seek clarification
that those high-risk uses or applications do not apply to healthcare
or the specific purposes the HCO intends for its use of the software.
Service Level Agreements
When the license agreement is a SaaS agreement, a service level
agreement (SLA) is often included as part of, or in addition to, the
SaaS agreement. The SLA is intended to define certain service levels
and the consequences of a failure to meet those levels. Typically, the
service levels are not commitments of the vendor. The vendor is not
in breach of contract for failure to meet those levels but is only
obligated to provide the specified remedy (e.g., credits as explained
later on if the levels are not achieved).
Uptime
The most common service levels address uptime versus downtime
(i.e., availability of the software to the HCO), response time,
resolution time, latency, and performance. When calculating uptime
(or downtime), scheduled downtime for maintenance and updates is
commonly not considered downtime. Also, health professionals and
informaticians need to understand that 100% uptime is typically not
feasible. For each increment toward 100% uptime, expenses can
increase dramatically and be unaffordable. However, redundant
systems can be designed and implemented to support critical areas.
Leaders will want to weigh the areas supported by the software
(mission critical, patient safety) with their tolerance for downtime.
Some may need 100% (intensive care, operating rooms), while
business offices could have less stringent requirements.
Obviously, scheduled maintenance should not include emergency
fixes. Adjustments are also made for downtime caused by the HCO
(e.g., connectivity issues or failure to meet the vendor’s
requirements). Force majeure events (i.e., disruptions beyond the
control of the vendor such as natural disasters like floods, war, or
lightning strikes) are also often excluded from uptime calculations.
The HCO should ensure that the vendor is obligated to maintain
disaster recovery solutions sufficient to overcome many force
majeure events (see Chapter 20 on downtime and disaster recovery).
Because of these adjustments to uptime calculations, an uptime
service level of 99.999% is not likely to reflect true uptime and
availability of the software. The appropriate uptime percentage
should be based on a number of factors, including the criticality of
the software and impact that downtime would have on the HCO. An
uptime of 99.999% is generally considered the gold standard, but
lesser uptimes may be appropriate and less costly (i.e., the HCO
would likely have to pay more for the gold standard). Even if an
uptime percentage of near 100% is achieved, there can still be other
issues, such as network bo lenecks, poor latency, and other
performance problems.
There can be disagreement about what “uptime” means. Does it
simply mean that the HCO is able to access the software? What if
some critical functionality of the software is producing errors or is
not functioning but 90% of the functionality is available? The
agreement should be clear. A very favorable clause for the HCO would
define “uptime” as the time during which the software, including all of its
functionality and without material error, is available for access and use by
the HCO.
Performance
In the context of a SaaS agreement, users will not tolerate a painfully
slow performing solution, and the SLA should be drafted to address
this. Sometimes this type of performance is described as response
time (i.e., the time for the computer running the software to respond
to the user’s input of a command). These performance issues can be
very complex and difficult to precisely define in an SLA, and slow
performance is not necessarily the fault of the vendor or the
software. A simpler solution, but often unacceptable to the vendor, is
to use general wording to define a service level in terms of
reasonableness (e.g., response time will not be unreasonable).
Response Time and Resolution Time
A different type of response time is the time it takes for the vendor to
respond to a notice of a problem. It is easy to draft this type of
response time in an SLA. Resolution time is much more difficult.
Without knowing what the problem is, the vendor will be hesitant to
commit to a resolution time or even to guarantee that the problem
will be resolved. Nonetheless, the HCO should a empt to build
these concepts into the SLA or into warranties elsewhere in the
agreement. One compromise is to have good response times coupled
with an assurance by the HCO that diagnosis or troubleshooting of
the problem will begin within the response time period and that
efforts to resolve the problem will be diligently pursued to
completion as soon as reasonably possible. This should also include
a promise to provide a workaround solution, if practicable, while the
permanent resolution is being worked on. This compromise may be
be er expressed as a warranty or contractual promise outside of the
SLA and in some other part of the agreement instead.
Problem Severity
An SLA commonly defines the problem in terms of different
categories of severity. Simplistically, categories will range from
critical to nothing more than a minor fix or a change request. The
HCO should carefully review the actual wording used by the vendor
to define severity categories, because a lesser category may result in
a long and unacceptable resolution time. For example, the resolution
time for a low-severity category might be nothing more than a
promise by the vendor to include a fix in the next release of the
software without any assurance as to if and when the next release
will take place. The HCO should insist that a patient safety issue is
critical and should be addressed within a few hours.
The agreement may spell out response times and severity levels in
simple terms or very complex details. The HCO should note that a
“response” is not a solution. A response time of 30 minutes may only
mean that the vendor’s support personnel will acknowledge receipt
of a support ticket. The agreement should at least require diligence
in diagnosing and troubleshooting the problem and then solving it.
Temporary workaround solutions should be provided, if practicable,
by the vendor while the HCO is waiting for a permanent fix.
Vendors vary on their contractual commitments to fix a problem.
The range of commitments include those listed in Box 18.14.
Box 18.14
The Range of Vendor Commitments to Fix
Problems
• Absolute commitment that errors will be fixed!
• Best efforts to fix
• Commercially reasonable efforts to fix
• “You get what you get”—which may be a late fix or no fix
Remedies
The usual remedy for a failure to meet an SLA level is a credit to be
applied against future payments to the vendor. For uptime, the
credit may be defined as a percentage of the SaaS fee for the time
period measured based on the level of uptime achieved for that same
period. As the level of uptime decreases, the credit increases.
Remedies other than credits can be used in an SLA, but vendors are
typically reluctant to use anything other than credits. The HCO
should make sure that the SLA allows for use of the credit to pay for
any obligation to the vendor, not just as a credit against future
payments of a SaaS fee. For example, the HCO should be allowed to
apply credits toward additional services (e.g., training, consulting,
custom development, data migration, and additional software
products). It should also allow for the HCO to collect cash for the
credit if the credit still exists at the time the agreement terminates.
Vendors usually include a clause in SLAs to the effect that the
credit or other remedy is the sole and exclusive remedy for a failure
to meet an SLA level. The HCO should be leery about this. For
example, this should never apply to a breach by the vendor of an
obligation to provide maintenance of the software. As a more
extreme example, if the credit for uptime is capped at 25% of the
SaaS fee, then literally the SLA would still require the HCO to pay
the remaining 75% of the SaaS fee even if uptime were 0%. Of course
that would be outrageous, but the literal wording of many SLAs
actually mean this. As ultimate protection, the HCO should insist on
the right to terminate the SaaS agreement if the SLA levels are
significantly or continuously not met. This termination right is in
addition to other remedies.
Acceptance of the Software
After implementation, the HCO should have the right to test and
then accept (or reject) the software. Acceptance should be based on
conformance of the software to the acceptance criteria. Acceptance
criteria can include those listed in Box 18.15.
Box 18.15
Typical Acceptance Criteria in an
Agreement
• Relevant provisions in the agreement (such as functionality or
software performance once installed)
• Warranties
• Response to RFP or RFI issues
• Specifications exhibit
• Free of known errors
• End user documentation and other documentation
• Specifications published by the vendor
RFP, Request for proposal; RFI, request for information.
If a problem (i.e., nonconformance with any acceptance criterion)
is discovered through the testing, then the HCO should reject the
software and the vendor should be required to fix the problem and
redeliver the software for retesting. If and when no problem is
discovered, then the HCO should accept the software. The process
may be repeated as necessary.
In some situations, it may be important to first do pre-live
(preproduction) testing of the software before it is used and tested in
a “live” (“production”) environment. With this approach, the HCO
does not risk using the software in a live environment (on live data
and at the risk of patients’ well-being) until after it is accepted
through pre-live testing. But testing based on live data in a live
environment is still important because live testing can reveal
problems not discovered in a pre-live environment. In effect, the
testing and acceptance (or rejection) process is repeated for the live
environment.
Sometimes vendors want separate acceptance testing of software
components, applications, and interfaces. If done separately, this
might not reveal problems that arise when the whole system (all
components, applications, and interfaces) is used and should not be
acceptable to the HCO. A possible compromise is to have a
preliminary acceptance of each component, application, or interface,
followed later by final acceptance testing of the complete system.
For a multisite solution, testing of the software at one site may not
reveal all problems when the software goes live for all sites,
especially if there is transmission or sharing of data between sites or
other interactions between sites. Final testing and acceptance for all
sites is advisable.
Software acceptance should be one of the payment milestones on
which a portion of the license fee is conditioned. But vendors may
resist this for revenue recognition reasons.
Remedies for Rejection
The HCO’s right to reject the software if acceptance criteria are not
met should be expressly stated in agreement. The vendor should be
obligated to fix problems and redeliver for a repeat of acceptance
testing. The entire software should be retested, not just the corrected
portion of the software because correcting one problem may lead to
a new one.
Often a difficult issue to negotiate with the vendor is the concept
of an absolute obligation to fix versus an effort to use “best efforts”
or “commercially reasonable efforts” to try to fix. This is just one
more issue to negotiate. There may be time limits on the time to
complete a fix or to provide a workaround solution. What happens if
acceptance testing still fails after repeated a empts to correct the
problem? How many tries and how long will the vendor have to
correct problems? This needs to be negotiated and addressed in the
agreement.
In the event of ultimate failure, vendors will usually say that the
HCO will get a refund of the license fee but only for the software
components or applications that fail. There is no refund for other
software components and applications that pass and are accepted
and no refund for services (e.g., installation, implementation,
training). This should be unacceptable to the HCO. For example, if
some of the accepted software components require an unaccepted
component, then the HCO should be able to reject everything. (As a
reminder, for more detail on downtime and disaster recovery, see
Chapter 20.)
The HCO should have the option to elect one of the following
remedies in Box 18.16 if the software ultimately fails to pass
acceptance testing.
Box 18.16
Possible Remedies If Software Fails
Acceptance Testing
1. Final rejection of the software by the HCO
• Software is de-installed and erased or destroyed or, if this is a
SaaS solution, access to the software is terminated.
• The HCO receives a complete refund.
• Of what? Some or all of the license fees, hardware payments,
third-party software fees, fees for customization,
implementation and development, other fees, etc.?
• This would need to be negotiated.
2. Acceptance of the software “as is” with compensation for the
nonconformance with the acceptance criteria.
• Compensation can be a partial refund, credit, some free services,
or additional software licenses.
• This acceptance should not excuse the vendor’s obligation to
maintain the software.
3. Some other solution that the vendor and HCO agree to.
HCO, Healthcare organization; SaaS, software as a service.
Maintenance and Support
Maintenance and support by the vendor of the software are essential
in most license agreements. An HCO should not rely on continued
use of software that is not adequately maintained and supported by
the vendor. Maintenance and support include some or all of the
components listed in Box 18.17.
Box 18.17
Maintenance and Support Components in
an Agreement
Maintenance components include the following:
• Fix programming errors
• Fix failure to conform to documentation
• Fix failure to comply with specifications
• Fix performance problems (e.g., response time, latency issues)
• Fix anything that’s a breach of warranty after warranty period
• Keep software current with laws, regulations, etc.
• Provide workaround solutions
• Provide updates, upgrades, new versions, and future releases.
Support includes some or all of the following:
• Telephone calls and access to help desk
• E-mail support
• Answering questions but not training
• Website support
• Access to other support resources
• Consultation
• Diagnosis and troubleshooting of software problems
• Solve software problems
• Site visits if necessary
HCOs may employ various tactics to reduce maintenance and
support costs, which involve high costs to the organization. The
HCO may create its own help desk to discount or reduce fees
payable for support. Through the HCO’s help desk, support
personnel provide frontline or first-tier support to HCO users of the
software. Then the vendor’s support personnel provide backup or
second tier support to the HCO’s support personnel as needed, not
to other HCO users.
The agreement should clearly indicate the support hours of the
vendor. Will support only be available during business hours (in
which time zone?) or is 24/7 support needed? This depends on the
nature of the software and the HCO’s reliance on it. The HCO or its
a orney should not automatically demand 24/7 support, because it is
likely going to cost much more. If 24/7 support is needed, then it
should be included.
Maintenance Fees
Fees for maintenance and support are typically 12% to 24% and
more typically 15% to 22% of the license fee per year. If the license
agreement is a SaaS agreement, the maintenance and support is
typically included in the annual or other recurring SaaS fees.
The HCO should seek to cap increases on these fees. The cap may
be based on a percentage or CPI (a specified customer price index) or
other limit. The HCO should also consider negotiating for multiyear
fixed prices to facilitate budget planning and to preserve discounts.
A significant issue is how long the vendor will commit to provide
support and maintenance. This should be at least 5 years and
preferably for a longer period sufficient to cover the expected return
on the investment. HCOs should not be locked into the same
number of years. They should be able to terminate support and
maintenance after any year, because a reason for discontinuing use
of the software may arise. No one wants to explain why the HCO is
paying for support and maintenance of software no longer being
used. Although this approach is not reciprocal, many provisions
exist in a license agreement that are not reciprocal. Moreover,
vendors should not sell licenses if they cannot assure long-term
support.
Payment for support and maintenance should also entitle the
HCO to updates and new releases of the software. The fine print in
the agreement may make exceptions to this obligation or charge
extra fees in some cases. Scrutiny of the agreement is needed.
The agreement should indicate how far back versions of the
software will be supported and maintained. For example, an
agreement may indicate that only the most current version of the
software will be supported and maintained, but the HCO may want
to continue to use prior versions. Upgrading to a new version may
be costly, time consuming, and inconvenient. Security issues may
arise when a new version is implemented. At some point, upgrading
becomes necessary, as the HCO cannot reasonably expect the vendor
to continue to support and maintain versions that are long outdated.
Compromises on this issue often include support and maintenance
for one or two of the most recent prior versions or giving the HCO a
period of time to upgrade. After that is resolved, another good idea
is to require the vendor to support and maintain old versions if the
HCO is willing to pay a premium, a “just in case” precaution.
If the overall software solution includes third-party software, then
support of the third-party software may not be covered by the
support and maintenance obligations in the agreement and may
instead depend on the support and maintenance provided by the
third party. Make sure this is understood prior to signing the
agreement and is adequately addressed.
Other Services
The license agreement should include other vendor services that the
HCO needs or may want (e.g., those listed in Box 18.18).
Box 18.18
Other Services to Include in a License
Agreement
• Installation and implementation
• Training
• Data conversion
• Interfaces
• Development, customizations
System Implementation or Installation Support
Agreements often include services in support of system
implementation, as listed in Box 18.19.
Box 18.19
Services to Include for Implementation
Efforts
• Implementation approaches, such as “big bang” or incremental
• Vendor personnel and their qualifications
• Initial training for HCO functional and technical teams with
specified approaches such as “train the trainer”
• Vendor “go-live” implementation support team as adjuncts to site
super-users
• Consultation services (e.g., experts to act as implementation teams
or experts who assess a site’s implementation plans)
HCO, Healthcare organization.
A significant issue can be “hours vs. results” when purchasing
additional services. Is the HCO just buying “hours and effort” or
“results”? For example, paying by the hour or day is no assurance as
to how many hours or days it may take to complete a project or task.
Or is the HCO buying results and basing payment on results (e.g.,
paying a fixed fee for completion of a project or task)? These are
different approaches, each with pros and cons. If the HCO insists on
a fixed-fee approach, the quote from the vendor is likely to build in a
healthy margin for error, possibly resulting in a higher cost to the
HCO. This approach gives certainty in budgeting and a greater
chance that the results will be obtained without cost overruns. If the
“buying hours and efforts” approach is used, the HCO should also
include in the agreement the number of hours that the vendor
estimates in good faith is needed for completion. The estimate can
help the HCO negotiate if the vendor exceeds the estimated hours
and asks for more.
The HCO should include in the agreement an open-ended
obligation for the vendor to provide other or additional services at
the option of the HCO, if they are needed by the HCO, as not
everything can be anticipated at the time the agreement is signed.
Needs may occur for additional assistance on installation,
implementation, and data conversion; for more training; for more
customization and interfaces; or for more consultation. Although
additional fees (plus expenses) will have to be paid, it is worth
having the option, if needed.
Outsourcing to Data Centers for Hosting and
Software Management Services
If the software license is an “on-premises” license, the HCO should
include the right to have a third-party data center host the software
for the HCO and even to provide software management and other
data center services. A typical license agreement includes restrictions
that prohibit transferring or disclosing the software to any third
party, and these restrictions would prohibit the HCO’s use of third-
party data centers to host the software for the HCO. Here is a sample
clause that gives the HCO the right to use a third-party data center
and other vendors for other purposes:
HCO may outsource to other vendors any of HCO’s needs or
requirements for information technology equipment, resources, or
services, including, without limitation, hosting, co-location,
application management, and data center services. If and to the
extent that any such outsourcing is applicable to any of the licensed
software licensed to HCO under this Agreement, then this
Agreement and the licenses granted to HCO will be reasonably
expanded, if and as necessary, to allow such outsourcing, including,
without limitation, the right for the licensed software to be run on
servers, computers or processors of such vendors, or at their data
centers for HCO. Any such vendor must agree in writing that it will
not store, run, or use the licensed software for any purpose other
than services for HCO and to protect the licensed software from any
unauthorized copying, use, or access by others.
Revenue Recognition and Payments
From the vendor’s perspective, revenue recognition issues drive or
affect many key provisions in the agreement. These issues may arise
from:
• Conditions on payment
• Delivery of software not existing at the time the agreement is
signed
• Payment milestones (e.g., acceptance)
• Possible refunds or other elements
Do not be caught by surprise—this is a huge issue to many
vendors, especially those that are public companies. The HCO
should expect pressure to commit or finalize the agreement by the
end of the quarter or end of the year, but the negotiating team
should work together to avoid being affected by this pressure! There
is always the next quarter or next year, and the urgency felt by the
vendor will return. Often discounts are conditioned by the vendor
on a signing of the agreement by a certain deadline, with the
expectation that the HCO will concede on points of negotiation to
meet the deadline. This is pressure on the vendor, not the HCO.
Payments
Is the HCO ge ing the best price? Generally, an HCO should not
have to pay list price for a software license, and any discounts
should have a long-term life for future purchases. Sometimes HCOs
and other customers ask for “most favored nations” pricing and
terms, but this is extremely hard to get from an established vendor
for good reasons from its perspective.
When negotiating the agreement, look for opportunities to lock in
prices or discounts on optional software, expansions, or future
projects. The HCO has the most leverage before signing the agreement, not
after. The HCO should negotiate for a payment schedule that ties
some payments to milestones and acceptance. This is a good way to
motivate a vendor to stay on schedule. The agreement will often
provide that the HCO pay for the vendor’s expenses and other
charges, especially with respect to some services. This should not
apply to support and maintenance services. For other services,
expenses should be reasonable, capped, and documented.
The HCO should consider credits, refunds, or other financial
consequences for delays, breaches, or other failures by the vendor. If
custom development or lengthy and complicated implementations
and rollouts are involved, this can be important. For legal reasons,
these credits, refunds, and other financial consequences should not
be characterized as “penalties,” even though non-a orneys tend to
do so. In some cases, it may be appropriate to characterize them as
“liquidated damages.” When faced with the prospect of credits,
refunds, or other financial consequences, a vendor may respond by
asking for incentives (e.g., additional payment) if time schedules or
other performances are overachieved by the vendor. The HCO
should be prepared for this response by the vendor and probably
should reject it.
The HCO should make sure that everything is covered. The
vendor should provide line-by-line pricing for the system selection
and/or the negotiating team to review. This is the “no unpleasant
surprises” approach to payment obligations. Open-ended
obligations to pay for services (e.g., implementation) may lead to
unexpected budget overruns.
Overview of Termination
If things go wrong, the termination provisions may be the most
important part of the license agreement. The agreement may be
terminated simply because its term expires or because both parties
agree to an early termination. Sometimes the agreement includes a
clause giving the HCO the right to terminate for convenience or
dissatisfaction or something other than a breach of the agreement by
the vendor. For example, a failure of the vendor to meet a
nonbinding time schedule or an SLA performance level might not be
a breach of the agreement but could be expressed in the agreement
as triggering a right on the part of the HCO to terminate the
agreement. It would be a mistake for the HCO to give a similar right
to the vendor. Other termination rights may include termination for
bankruptcy, insolvency, or breach.
It should be noted that a license agreement usually includes a
survival clause that indicates that certain provisions of the
agreement will continue in effect after termination of the agreement.
Confidentiality provisions are one such example. Although rarely
the case in a vendor’s form of agreement, the license itself can
survive, but other provisions, such as maintenance and support, will
terminate.
Termination for Breach
Nearly every license agreement includes a clause giving each party
the right to terminate the agreement in the event that the other party
breaches the agreement. Sometimes, one-sided license agreements
only give the vendor this right, but in such cases, it is typically easy
for the HCO to successfully negotiate for reciprocity.
From the perspective of the HCO, termination, even if for a breach
by the HCO, can be much more dangerous and unreasonable than
meets the casual eye. If the software is mission critical, it is not
practical or realistic to expect the HCO to suddenly stop using the
software being relied upon. For example, if the electronic health
record of the HCO is reliant on the software, the HCO could not
possibly stop use of it without terrible consequences to patients and
operations. With a typical “termination for breach” clause, that is
exactly what the HCO is agreeing to. Without a license, continued
use of the software would be an infringement of the copyright and
other intellectual property of the vendor. Typically, provisions are
included that obligate the HCO to stop using the software upon
termination.
An agreement includes many provisions that can potentially be
breached by the HCO. For example, confidentiality provisions could
be inadvertently or carelessly breached. Other restrictions, such as a
prohibition against benchmark testing, may be breached without
realizing that the agreement includes this prohibition. Exceeding the
scope of the license is also a breach and can be done unintentionally.
What if there is a dispute about the timing or amount of a payment?
The vendor would likely claim a breach and threaten termination if
the HCO does not concede and pay the disputed amount. Examining
the agreement will reveal many provisions that might be breached.
In the case of an “on-premises” license, the HCO might out of
necessity, for the sake of patients, ignore a notice of termination by
the vendor and continue to use the software running on the HCO’s
computers, even though the HCO would be without support and
maintenance. The vendor would then be forced to seek an injunction
from a court to order the HCO to stop use. Hopefully, a court would
not issue such an order if patient safety were jeopardized, but it may
be hard to explain to the court why the HCO agreed that it would
stop use upon termination for breach and now refuses to do so. The
situation is riskier in the case of a SaaS license because all the SaaS
vendor needs to do is terminate access by the HCO to the software
running on servers at the vendor’s data center. Hopefully, the
vendor would not do this, but it is unwise for the HCO to agree to
this provision. In any event, the vendor is likely to use the threat of
termination to extract concessions to its advantage.
At the very least, the HCO should insist that the agreement
include provisions that require (1) the breach be “material” in order
to justify termination and (2) the vendor give the HCO notice of the
breach and a 30-day opportunity to cure the breach before
termination. If the breach is timely cured, then no right exists for the
vendor to terminate. Sometimes more than 30 days is needed to
complete a cure, so the HCO should request a clause that allows for
an extension of the 30 days if the cure begins within the 30-day
period and is diligently pursued to completion.
Is the Breach Curable?
A troubling issue is whether or not a given breach is curable. For
example, is a breach of confidentiality curable once a disclosure of
confidential information has been made? If the breach is not curable,
then no cure is available in a timely manner and the right to
terminate will be triggered. Some vendors specifically state in their
agreements that the right to cure does not apply to noncurable
breaches. Also, it is often not clear as to what it takes to cure a
breach. The HCO should seek to include a provision to the effect that
the breach will be deemed cured if the HCO discontinues the breach
and takes reasonable steps to prevent a repeat of the breach.
Sometimes the HCO may dispute that an alleged breach has
occurred. For example, the vendor may claim that the HCO has
failed to make a maintenance fee payment in full and is in breach.
The HCO may believe that the maintenance fee is less than what the
vendor claims (e.g., there might be a dispute about a cap on
maintenance fee increases). The vendor may then send a notice of
breach and threaten termination of the license, a draconian
consequence for the HCO and unfairly disproportionate to the
amount in dispute. The HCO, faced with this “termination
blackmail,” may need to concede on the payment. It cannot risk that
a court might conclude that the vendor’s interpretation of the
agreement is correct or that the vendor may stop support and
maintenance or, in the case of a SaaS license, “flip a switch” and
terminate the HCO’s access to and use of the software running on
the vendor’s servers. Even if termination by the vendor is wrong, the
vendor may have li le or no monetary liability because of limitation
and exclusion of liability provisions in the agreement. Limitation
and exclusion of liability provisions are discussed later in the
chapter.
The ultimate protection for an HCO is to include in the agreement
a provision to the effect that the license will survive termination of
the agreement even if there is a breach of the agreement. This does
not excuse the breach, as the HCO remains liable for damages
caused by the breach. The vendor can still obtain injunctive relief to
stop the breach, but it is very difficult to get vendors to agree to this.
Their a orneys are often adamant that termination of the license is
essential for protection of the vendor’s software and intellectual
property. This concern is somewhat overstated because (1) the HCO
is only seeking the right to continue to use the software within the
scope of a license that the HCO has already paid for, and (2) the
vendor can always obtain injunctive relief against any use,
disclosure, distribution, or copying beyond the scope of that license.
Assuming that the HCO cannot get the ultimate protection
described previously, the following clause or a variation is
reasonable despite the vendor’s dislike for it. It will as often as not be
accepted by the vendor:
In view of the “mission critical” nature of the Licensed Software to
HCO and HCO’s reliance on it and of the responsibility of HCO to
protect the safety, health, and wellbeing of patients, Vendor may not
suspend or terminate the License [or any services or rights of HCO
under this Agreement or any access to or use of the Licensed
Software by HCO or its users] unless this Agreement is terminated in
accordance with this Section. The vendor may terminate this
Agreement only upon a material breach of this Agreement by HCO
that is not cured by HCO within 30 days after receiving written notice
from the vendor of such breach. The notice must specifically identify
the provisions of this Agreement that are breached and must state
the actions that the vendor believes are necessary for HCO to cure
the breach and must give notice of the vendor’s intention to
terminate the Agreement if the breach is not cured. If more than 30
days are needed to cure the breach, then HCO will be allowed such
additional time as is reasonably required for the cure, provided that
HCO gives notice of the need and begins the cure within the 30-day
period and that HCO is thereafter diligent in pursuing the cure to
completion. If the breach is not curable, then for the purposes of this
Section, the breach will be deemed cured if HCO takes reasonable
steps to prevent a repeat of the breach. HCO remains liable for
damages caused by its breach and nothing in this Section excuses
monetary liability for those damages, but damages are subject to the
agreed upon limitations of liability. If HCO disputes in good faith that
a material breach has occurred, then the issue must first be decided
through the dispute resolution provisions and, if necessary, litigation
in accordance with governing law and forum provisions of this
Agreement. If a court holds that a material breach occurred, then
HCO shall have an opportunity to cure the breach as described
above (or to address an incurable breach as described above) in
order to preserve its license and rights and to avoid termination of
the Agreement by the vendor. The 30-day cure period will begin
when HCO receives notice of the final decision of the court in writing
and such 30-day cure period is subject to extension as described
above. Nothing herein permits HCO to use, distribute, or copy the
Licensed Software outside the scope of the License and rights
granted to HCO. Nothing prohibits or delays Vendor from obtaining
an injunction to stop HCO from using, distributing, or copying the
Licensed Software outside of such license and rights or from
otherwise infringing or misappropriating any intellectual property or
confidentiality information of Vendor.
Do not think that the nightmare of termination cannot happen. It
does and can happen, although rarely. Even if a vendor is very
unlikely to abuse termination rights in the agreement if the HCO
acts in good faith and is repentant, the HCO is still exposed to the
“termination blackmail” threat when the HCO disputes the existence
of a breach or disputes what the remedy should be for the breach.
As a final comment on the issue of termination, the importance of
this issue is proportional to the significance of the HCO’s reliance on
the software and the ease of transitioning to a substitute solution in
the event of termination. Many situations exist where the HCO can,
with relative safety, ignore the issue because the risk or downside of
termination is so low that negotiating with the vendor is not
justified. If the software is mission critical to the HCO, then the risk
can be summed up as follows: (1) the probability of a serious
termination issue occurring is very low, but (2) in the unlikely event
that it does occur, the consequences can be very serious. In a worst-
case scenario, it may be difficult for the HCO’s representatives
responsible for approving the agreement to explain to management
why the HCO agreed to allow the vendor to terminate or threaten to
terminate the use of mission critical software.
Transition and Transition Period
As an additional protection in the event of termination, the HCO
may want to add a clause entitling it to transition rights and a
transition period. A clause of this nature might read as follows:
In the event that the Agreement is terminated for any reason or
expires and if the safety, health, or wellbeing of any patients or
healthcare or business operations of the HCO are jeopardized or
compromised by such termination or expiration, then the HCO will be
entitled to a reasonable transition period to transition to computer
programs, products, services, and solutions from another vendor that
are a substitute for the Licensed Software, Services, and Solution of
this Agreement. During this transition period, HCO may continue to
use and exercise the License and rights with respect to the Licensed
Software, Services, and Solution pursuant to this Agreement and
subject to this Agreement. In effect, the transition period is an
extension of the term of this Agreement and delays termination or
expiration until the end of the transition period. The transition period
must be sufficient in duration to allow for an orderly transition to
substitute computer programs, products, services, and solutions, but
HCO may not extend the transition period beyond one year. HCO will
give notice to Vendor after the transition period ends.
Sometimes, especially for a SaaS license, the transition clause will
require the vendor to provide transition services at the vendor’s
current standard fees plus expenses.
Exclusive Remedy Clauses
License agreements frequently include exclusive remedy clauses that
state that the HCO’s sole and exclusive remedy for a breach is
limited to one specific remedy and not others. For example, a section
may state that if the services are not performed in accordance with
the warranties, then the exclusive remedy is that the services will be
re-performed. What if the re-performed services continue to be in
noncompliance? Even if performed properly later, there is no
compensation to the HCO for the delay. The agreement may even
include a provision stating the exclusive remedy still applies even if
the remedy “fails of its essential purpose.” The provision then leaves
the HCO without a meaningful remedy.
No other damages or remedies can be recovered if the exclusive
remedy clause is enforced! Usually an exclusive remedy clause is
applied to warranties, but they can be applied to any obligation in
the agreement. Sometimes vendors are overly aggressive and broad
in the language of an exclusive remedy clause and incorrectly (or
unfairly or illogically) apply it to any breach of the agreement! For
example, an exclusive remedy may mention having a vendor re-
perform an activity as the sole remedy for any breach of the
agreement. However, this action would be illogical for a security or
confidentiality breach by a vendor. The exclusive remedy should
make sense in the context of the specific breach to which it applies
and should only apply to specific breach of contract claims, not to
other claims such as negligence or damage to property.
Limitations and Exclusions of Liability
A license agreement will almost always include clauses on
limitations and exclusions of liability. These clauses are not
harmless “legalese.” The HCO should understand these clauses from
a business point of view and not expect to be able to totally negotiate
these clauses out of the agreement, but details may be negotiable.
Limitation of Liability
A limitation of liability clause limits the HCO’s liability to an
amount or cap that cannot be exceeded. For example, “In no event
shall Vendor’s aggregate liability exceed an amount equal to the
license fee paid to Vendor under this Agreement.” For the HCO, it
may be be er to increase the cap to all amounts paid under the
Agreement (e.g., to further include amounts paid for support,
maintenance, training, implementation, and other services). If the
agreement is a SaaS agreement, then the cap may be an amount
equal to 1 year of the SaaS fee or some other very limited amount
much less than the total fees under the agreement. The consequence
of an HCO agreeing that the vendor’s liability is limited means that
the HCO cannot recover damages from the vendor in excess of the
cap, even if the HCO can prove a higher amount of damages.
Exclusion of Liability
An exclusion of liability clause totally excludes certain types of
damages from recovery. For example, “In no event shall Vendor be
liable for any consequential, indirect, special, punitive, or incidental
damages, or for any loss of business, opportunity, profits, revenue,
data, or programs.” The consequence of the HCO agreeing to this
means that the HCO recovers nothing for these types of damages,
even if the HCO can prove that it suffered the damages. Only direct
damages remain recoverable, subject to the limitation of liability cap
described previously.
Reciprocity and Exceptions
The HCO should insist these clauses are reciprocal so they benefit
the HCO, not just the vendor. When these clauses are made
reciprocal, the vendor will often insist on exceptions for
infringement of its intellectual property, breach of confidentiality,
indemnification, and possibly some other clauses. The HCO should
negotiate for other exceptions, such as breach of a business associate
agreement or data security agreement, intentional breaches, willful
misconduct, and wrongful suspension or termination. For example,
if the vendor wrongfully suspends or terminates a SaaS license and
access to the software, the HCO would have li le or no monetary
recourse against the vendor because the limitation and exclusion of
liabilities would prevent recovery of the most significant damages,
including loss of revenue and disruption of business. This would be
a terrible surprise to the HCO. Having these exceptions in the
agreement will make a SaaS vendor leery about being too quick to
suspend or terminate services for fear of being exposed to unlimited
liability for doing so wrongfully.
Insurance
The vendor should agree to maintain adequate liability insurance,
including cyber-liability insurance governing data privacy, security
breaches, and business continuity. The HCO may need recourse
against the insurance for negligence and other covered fault of the
vendor, or the HCO may need to be additionally protected. The
HCO should carefully consider whether it should be named as an
additional insured party in the vendor’s insurance policy, because
existing insurance policies may not cover claims against another
insured (e.g., the HCO). The limitations and exclusions of liability
should not limit or exclude any losses and liabilities covered by the
vendor’s insurance policies. The HCO insurance advisor or risk
management officer should work with the HCO’s negotiating team
in deciding on adequate insurance requirements expected of the
vendor.
Dispute Resolution
Some license agreements require a dispute resolution process before
litigation or arbitration. For example, a requirement may exist for a
meeting to discuss and a empt to resolve the dispute. If that meeting
is unsuccessful, the dispute must be escalated to a higher level of
management of both parties for discussion and resolution. Only if
this process has been followed without success may a party proceed
with litigation or arbitration. This is generally a good approach for
HCOs, especially if the dispute resolution process is a prerequisite to
termination or suspension of a license or the agreement.
Special Clauses
Confidentiality
The license agreement typically includes confidentiality protections
for the parties and their confidential information. The HCO’s
confidential information may include RFPs, plans, financial
information, and anything that can be learned by the vendor’s access
to any networks or computer systems of the HCO. The party
receiving the other party’s confidential information should agree not
only to keep the information confidential but also to not use it for
any purpose other than performing obligations or exercising rights
under the agreement. The HCO should expect to see some or all of
the following exceptions in Box 18.20 to the confidentially
provisions.
Box 18.20
Exceptions to Confidentiality Provisions
• Information that is or becomes (through no fault of the receiving
party) publicly known or generally known in the industry or
profession of either party
• Information known to the receiving party prior to first disclosure
by the other party
• Information that is lawfully disclosed on a nonconfidential basis
by third parties to the receiving party
• Information that is independently created by or for the receiving
party
The HCO should make sure that these exceptions do not apply to
protected health information or other personally identifiable
information, or to any obligation under a business associate
agreement or data security agreement. The confidentially provisions
should not prohibit a disclosure required by law, regulation, or court
or government order, but a protective order or similar protection
should be sought.
An important issue is the duration of the confidentiality
obligations. The confidentiality obligations may expire after a certain
number of years after the date of the agreement or after the date of
first disclosure. Or they may never expire unless and until one of the
previously given exceptions applies.
The vendor will include provisions that specifically protect the
software and documentation against disclosure or transfer to others.
It is not always clear if and to what extent protections apply to
screen displays and output (e.g., reports). Because of the broad and
restrictive nature of confidentiality provisions, the HCO may want to
include an exception for incidental disclosures:
Nothing in this Confidentiality Section or any other confidentiality
provisions of this Agreement prohibits any disclosure that reasonably
or inherently occurs as part of the licensed use of the Licensed
Software or the servicing by contractors of hardware or systems for
the HCO. By way of non-limiting examples, screen displays,
interfaces and reports generated by the Licensed Software may be
visible to visitors to HCO’s facilities and reports and other output
generated by the Licensed Software may be given to others in the
ordinary course of business.
The HCO may want to go beyond the protections of a business
associate agreement when it comes to patient data. The agreement
should include provisions that protect patient data even if the data
are de-identified and aggregated. Some vendors are eager to extract
and use patient-related data and other data of the HCO for
commercial or analytic purposes. This should be prohibited by more
than just a business associate agreement, and careful a ention
should be given to any permission or license relating to data. If the
vendor, especially a SaaS vendor, is to hold or store any of the
HCO’s data, then data security provisions will be needed in addition
to the confidentiality provisions of the agreement.
Intellectual Property Infringement
The license agreement should include a warranty of non-
infringement and a clause indemnifying (providing compensation
for a particular loss) the HCO and its users of the software against
claims that the software or its licensed use infringes or
misappropriates any patent, copyright, trade secret, or other
intellectual property. Often the vendor will not offer a warranty of
non-infringement, saying instead that it only offers an
indemnification clause that can be complex and include exceptions
that need to be carefully considered. The clause might indemnify
against monetary judgments payable to the owner of the intellectual
property, but often not against the HCO’s own losses or damages if
it must suddenly cease use of the software because of an
infringement claim. The HCO will want the broader indemnification
protection.
Indemnification by the Healthcare Organization
and Disclaimers by the Vendor of Responsibility
The vendor may seek to have the HCO indemnify the vendor against
claims by others arising from the HCO’s use of or reliance on the
software or its use, results, and output. It is not uncommon to see
vendors disclaim responsibility for the results and output of the
software and to require HCOs to examine and verify those results
and output, such as accuracy of medication calculations. How
practical is it for the HCO to verify? Some will say, “Isn’t this the
purpose of the software?” The best approach is to delete these types
of provisions, especially indemnification by the HCO, and simply
make each party responsible for its own fault in the event of any
claims by a third party.
Restrictive Covenants and Feedback Clauses
The HCO should take careful note of restrictive covenants and
feedback clauses and should only agree to them if they are
reasonable and understood by the HCO. Restrictive covenants
include noncompetition clauses and other restrictions on doing
business or conducting certain activities with others and clauses that
prohibit the hiring or solicitation of the other party’s personnel.
Feedback clauses may require the HCO to assign ownership of
feedback and its intellectual property to the vendor. Feedback is
typically defined as suggestions, ideas, recommendations,
improvements, and enhancements relating to the software or a
service of the vendor. This can become a serious problem if the HCO
wants to use or commercialize the feedback independent of the
vendor or to share the feedback with other vendors. At most, a
feedback clause should only grant to the vendor a nonexclusive
license to use the feedback in the vendor’s software and services. The
license should be granted on an “as is” basis without any warranty.
Any feedback clause requires careful consideration and possible
exceptions (e.g., for copyrights and patents).
Governing Law and Forum Clauses
These clauses indicate which jurisdiction’s (e.g., state’s) law will
govern the agreement. The forum clause indicates the jurisdiction
and venue for any litigation between the parties (i.e., where a
lawsuit will take place). It may seem odd, but a court in one state
may apply the law of another state to the agreement and dispute.
With respect to jurisdiction and venue, one compromise is to say that
a party may only bring an action in the state (or more specific venue)
of the other party. This may discourage litigation.
Right to Assign the Agreement and License
License agreements generally prohibit an assignment (of license and
other rights and delegation or transfer of duties and obligations) or
transfer of the agreement to a third party. Given the possibility that
the HCO may merge with or be acquired by another entity someday,
it is a good idea to at least allow the HCO to assign or transfer the
agreement in the event that the HCO or its assets or business is
acquired by sale, merger, or otherwise. A change of HCO control
should not be deemed as a prohibited assignment or transfer.
Use of the Healthcare Organization’s Name,
Marks, and Logos
The license agreement should prohibit the vendor from using the
HCO’s name, trademark, service mark, or logo in any marketing,
sales, or promotional materials; on a website; or in any other public
communication without the wri en consent of the HCO in each case,
including the right of prior review. Use of the HCO’s name in a list
of customers or a press release may be permi ed by the agreement
without that consent. Vendors should not be allowed to use these
materials to imply any HCO affiliation, endorsement, or sponsorship
of the vendor or its software, product, or service. Similar restrictions
should be considered for the name of any officer, researcher,
developer, clinical informatician, physician, or other healthcare
professional employed by the HCO.
Data Usage and Data Ownership
The agreement should specify data ownership, especially for
aggregated data generated through use of the vendor’s software. The
HCO will want to consider carefully how population health data will
be managed, define who owns those resulting data, and include
these aspects in the agreement.
Conclusions and future directions
License agreements are an essential part of an HCO’s software
procurement process. An understanding of those agreements and a
willingness to negotiate for reasonable terms and conditions can
reduce risk, save money, and protect the HCO against unpleasant
surprises. An agreement, no ma er how favorable to the HCO, is
never an acceptable substitute for due diligence prior to the signing
of the agreement or for a careful and systematic vendor selection
process. After the agreement is signed, the HCO should have a
process for ensuring and monitoring compliance with the agreement
and for utilizing the protections and advantages successfully
negotiated into the agreement. Although it may seem obvious, the
HCO should have an organized archive of agreements and an index
and summary of the important agreements that can be consulted
when needed. Finally, never underestimate the leverage that an
HCO may have to contractually protect itself. The future of license
agreements will only grow more complex as technology and data
become more distributed over time. As data are merged from
different sources, data ownership and security breaches will
continue to be issues in the future.
References
1 Section 101 of the U.S. Patent Laws (35 U.S.C. 101), 2016.
2 Uniform Trade Secrets Act Definition.
h ps://[Link]/wex/trade_secret. Accessed
July 20, 2016.
3 Agile Software Development Processes, 2016.
h ps://[Link]/wiki/Agile_software_development.
Discussion questions
1. Thinking about your own organization, outline the composition of
a team to assist with a generating a licensing agreement to
integrate all imaging services in your facility across ultrasound,
radiology, and cardiology. Give the rationale for each team
member.
2. Discuss what steps organizations might take for due diligence.
How might these protect the organization beyond having a good
contract in place?
3. In this chapter, the author recommends numerous sections to a
licensing agreement. Which ones surprised you?
4. Your electronic health record (EHR) vendor was sold to another
company. What provisions in the agreement will be the ones you
will look for to ensure patient care is not compromised as a
transition occurs?
Case study
Best Bet Hospital is a tertiary care medical center with 500 acute care
beds, 35 ambulatory clinics, a Level-1 emergency department, a 75-
bed skilled nursing facility, and telehealth services for both stroke
and dermatology services. The leadership decided to change its EHR
after a 10-year life cycle and shift to a SaaS agreement. You are the
long-term care representative on the selection commi ee. Due to
your expertise in health care, leadership has asked you to assist with
the licensing agreement for this purchase.
Discussion Questions
1. Give an overview of the particular needs (functional aspects) of
long-term care that should be included in a licensing agreement.
2. Glancing over the sections in this chapter, create an outline of
the most important areas to consider in the licensing agreement.
3. Best Bet wants to reduce maintenance and support costs. What
are some ways this might be accomplished? What areas should
be included in the licensing agreement to support these?
* The author of this chapter is a founder and managing a orney of TechLaw
Ventures, PLLC, a law firm that focuses on transactions and disputes relating to
technology and innovation. He has three decades of experience in representing
licensors and licensees of software and information technology assets, including
large healthcare organizations. He is also a founder and owner of EscrowTech
International, Inc., a software and SaaS escrow company. The views expressed in
this chapter reflect the bias, knowledge, and experience of the author, especially
with respect to the types of software escrows discussed in this chapter.
19
Implementing and Upgrading an
Information System
Christine D. Meyer
Abstract
This chapter analyzes the processes for implementing a health information system
with a specific emphasis on an electronic health record (EHR). The decision to
implement a new health information system or to upgrade a current system is based
on several factors, including (1) providing safe and up-to-date patient care, (2)
meeting federal mandates such as Meaningful Use (MU) and Medicare Access and
CHIP Reauthorization Act of 2015 (MACRA) requirements, and (3) leveraging
advanced levels of clinical decision support. Implementing EHRs entails
multilayered decisions at each stage of the implementation. Major decisions include
vendor and system selection, determining go-live options, redesigning workflows
and processes, and developing procedures and policies. The timeline and scope of
the project is primarily dictated by expenses, staff, resources, and the drop-dead date
for go-live. Success depends on a well-thought-out and detailed project plan with
regular review and updating of the critical milestones, unwavering support from the
organization’s leadership, input from users during the design and build phases,
thorough testing, end user education, mitigation of identified risk factors, and control
of scope creep. The implementation of an EHR is never finished. Medication orders,
nonmedication orders, and documentation screens or fields will continuously need to
be added, modified, or inactivated; patches will be installed and tweaks to workflows
and functionality will be ongoing.
No matter whether the health information system is new or an upgrade, the
ultimate goal in implementations is to provide the highest level of care at
the lowest cost with the least risk.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Discuss regulatory and nonregulatory reasons for implementing or
upgrading an electronic information system.
2. Compare the advantages and disadvantages of “best of breed” and
integrated system approaches in selecting healthcare information
system architecture.
3. Explain each step in developing an implementation plan for a
healthcare information system.
4. Develop strategies for the successful management of each step in the
implementation of a healthcare information system.
5. Analyze the benefits of an electronic information system with an
integrated clinical decision support system.
6. Explain the implications of unintended consequences or e-iatrogenesis
as they relate to implementing an electronic health record (EHR).
KEY TERMS
best of breed 323
big bang 330
e-iatrogenesis 321
phased go-live 330
scope creep 322
Tall Man le ering 321
workarounds 325
Introduction
This chapter focuses on the implementation of healthcare information
systems. Of course, many different types of applications are used within a
healthcare information system. The general principles for implementing
different applications are the same; however, to demonstrate these general
principles, this chapter will focus mainly on the implementation of an
EHR. In 2004, President George W. Bush promoted the idea of a fully
functional electronic medical record (EMR) for Americans within 10 years.1
This proposal officially initiated the massive changes that we continue to
witness in health informatics. Healthcare information systems are widely
used today in many diverse se ings. Small hospitals, ambulatory clinics,
and small physician practices generally implement a simple and
streamlined system with limited features and are tailored for a quicker
implementation and easier long-term maintenance. Large medical centers,
multifacility enterprises, and multiphysician practices with more complex
needs typically opt to install a more robust system that allows for
customizations. However, there are still hospitals and physician practices
without an EHR or that have an outdated system that cannot
accommodate recent regulatory mandates. An outdated system may be
one reason to implement or upgrade a health information technology
(health IT) solution, but there are others.
Reasons to implement or upgrade a
healthcare information system
There are several reasons why a health organization (hospital
organization, physician office, or clinic) may decide that a major change is
needed. A careful review of the reasons for the change will start the
process of deciding whether to install a new information system or
upgrade the current system. One of the primary reasons for making such a
major change is changing government regulations.
Changing Government Regulations
The American Recovery and Reinvestment Act
The American Recovery and Reinvestment Act (ARRA), enacted in 2009,
spawned the Health Information Technology for Economic and Clinical
Health (HITECH) Act. One of its primary goals was that each person in the
United States would have a certified digital medical record by 2014,
including the electronic exchange of health information across healthcare
institutions to improve quality of healthcare. As discussed in detail in
Chapter 27, the HITECH Act created a $27 billion federally funded
incentive program providing Medicare and Medicaid payments over 5 to
10 years to three groups: (1) eligible providers (EP), (2) eligible hospitals
(EH), and (3) Critical Access Hospitals (CAH). CAH are defined as rural
hospitals certified to receive cost-based reimbursement from Medicare.
Within the HITECH Act, there are two EHR incentive programs: the
Medicare EHR Incentive Program administered by the Centers for
Medicare and Medicaid Services (CMS) and the Medicaid EHR Incentive
Program, which is governed by individual states and territories.
It is important to note that these government incentive programs were
not established to cover the total cost of implementing an EHR system but
to encourage or “incentivize” healthcare organizations and healthcare
providers to use an EHR in a meaningful way, called Meaningful Use
(MU), and to foster faster rates of adoption across the nation.2 Other terms
often used for this incentive program are “stimulus funds,” “stimulus
package,” or simply “ARRA funds.”3
CMS established the criteria for MU, which included minimal
thresholds for select objectives. There are three stages in the EHR Incentive
Program. Stage 1, which began in 2011, emphasized capturing patient data
that was expected to be shared with other healthcare professionals and the
patient. Stage 2 began in 2014 and focused on advanced clinical practices
and providing patient portals where patients could access their medical
records. Stage 3, slated to begin in 2017, accentuates data interoperability
and patient outcomes while increasing the thresholds for the objectives
and clinical measures.4 Additional requirements include the submission of
detailed and timely reports demonstrating MU adoption to CMS and the
appropriate state offices.
To meet MU requirements, an EHR should be a “certified complete
EHR” or have individual modules that are “certified EHR modules.” This
means that they are certified by the Office of the National Coordinator for
Health Information Technology (ONC). Complete EHR certification means
that the system has the functionality, required data elements, and logic to
support ambulatory, emergency room, outpatient, and inpatient MU
requirements. EHR module certification means that the ancillary
application meets one or more requirements. Most hospitals and physician
offices purchase a commercial system that is deemed certified, meaning
that the vendor incorporated these essential capabilities. A list of certified
products can be found at h p://[Link]/ehrcert?q=chpl.
The Certification Commission for Health Information Technology
(CCHIT) tested and certified new software applications beginning in 2006.
However, in 2015 it ceased testing and certifying EHRs for financial
reasons and changed its role to advising healthcare providers on how to
comply with the government’s regulations and providing guidance to
health IT developers on how to meet the government’s requirements for a
certified EHR. The CCHIT works with the Health Information and
Management Systems Society (HIMSS) to advance programs and policies
that strongly promote interoperability and to advocate using IT between
patients and providers as another tool to transform healthcare.5
The newly defined recertification program is structured so that the ONC
now serves to manage or oversee the program, which involves several
agencies or organizations that are responsible for the actual testing and
certification of the products.6 The flowchart shown in Fig. 19.1 illustrates
the organization and flow for testing and certifying new EHR products.
FIG 19.1 The certification process at a glance. Source: US DHHS Office
of the National Coordinator. ONC. About the ONC Health IT Certification Program.
<[Link]
program>; September 20, 2016.
However, the MU criteria do not require purchasing a commercial,
certified product. A few hospitals and eligible providers have developed
their own “homegrown” EHRs that may or may not include commercial
components. CMS welcomes organizations to certify their systems using
the EHR Alternative Certification for Healthcare Providers (EACH)
program. The EACH program is a three-step program to certify
homegrown systems or existing EHR technology not already covered by a
vendor certification. The program provides a mechanism to obtain
certification by demonstrating that the system meets the U.S. Department
of Health & Human Services (HHS) MU requirements.7 For example, the
Regenstrief Medical Record System (RMRS) in Indiana is an EMR system
that began in 1972 and expanded to several additional major hospitals.8
Other medical centers that successfully opted for this alternative include
Geisinger Health System, Marshfield Clinic Health System, Landmark
Hospitals (Chartpad), and Brigham and Women’s Hospital.9,10
U.S. hospitals were initially slow to adopt an EHR system. However, the
impact of HITECH can be clearly demonstrated. A 2011 survey conducted
by the American Hospital Association found that the percentage of U.S.
hospitals that had adopted EHRs doubled from 16% to 35% between 2009
and 2011. However, in 2014 the ONC reported that 76% of hospitals
implemented at least a basic EHR system, and almost 97% of those
implemented a certified EHR technology.11
The Transition from ICD-9-CM to ICD-10-CM Codes
and from HIPAA Version 4010 to HIPAA Version 5010
In 2015 the CMS issued a mandatory transition from the International
Classification of Diseases (ICD)-9-CM codes to ICD-10-CM codes. The
requirement has also served as a major impetus for providers and
healthcare facilities to upgrade their current EHR or to implement a new
one. ICD-10-CM codes are used to classify all inpatient and outpatient
diagnoses, report medical care and cause of deaths, process payments,
calculate trends, and perform statistical analyses. Early versions of
healthcare information systems could not adopt the new ICD-10-CM codes
because they were configured to accept three to five numeric-only
characters. The ICD-10-CM codes have three to seven characters in which
the first and third characters are always alpha characters, the second
character is always numeric, and characters four through seven are either
alpha or numeric.12 The ICD-9-CM system had 13,000 codes to define
diagnoses and procedures. In contrast, the ICD-10-CM version contains
over 68,000 diagnostics codes, which allows for a more detailed definition
and be er reporting for reimbursement and biosurveillance. Another
difference between the two systems is that ICD-10-CM does not include
procedure classifications, so there is a separate ICD-10-PCS (procedure
coding system) with over 71,000 procedure codes that are used by
hospitals for inpatient procedures (Table 19.1).13 During the migration to
ICD-10, the Centers for Disease Control and Prevention (CDC) suspended
new additions or modifications to the ICD-10-CM and the ICD-10-PCS
codes. However, in 2016 the CDC added nearly 1900 new diagnosis codes
to the ICD-10-CM codes and 2651 new inpatient procedure codes to the
ICD-10-PCS starting in fiscal year 2017.13 A complete list of all ICD-10
codes is available at [Link]. and [Link].
Table 19.1
Comparison of ICD-9-CM and ICD-10-CM Codes
Characteristic ICD-9-CM ICD-10-CM
Field length 3-5 characters 3-7 characters
Available codes Approximately 13,000 codes Approximately 68,000 diagnostic codes
Code composition Digit 1 = alpha or numeric Digit 1 = alpha
(i.e., Numeric, Digits 2-5 = numeric Digits 2-3 = numeric
alpha) Digits 4-7 = alpha or numeric
Character position Characters 1-3 = category Characters 1-3 = category
within code Characters 4-5 = anatomic site, etiology, Characters 4-6 = anatomic site, etiology, severity, or
manifestationa clinical detailb
Character 7 = extension
Available space for Limited Flexible
new codes
Overall detail Ambiguous Very specific
embedded within
codes
Laterality Does not identify right versus left Often identifies right versus left
Sample code 438.11, late effect of cerebrovascular I69.320, speech and language deficits following
disease, speech and language deficits, cerebral infarction, aphasia following cerebral
aphasia infarction
From ICD-10 State Medicaid Readiness Medicaid ICD10 Implementation [Link].
<[Link]
Systems/ICD-Coding/Downloads/[Link]>; 2016.
ICD, International Classification of Diseases.
a Not always the case for ICD-9-CM.
b Not always the case for ICD-10.
The United States has lagged behind other countries in the
implementation of ICD-10 codes. When the conversion occurred in the
United States, 138 other countries were already using ICD-10 codes to
track mortality, and 99 countries were using these codes to track morbidity
(Table 19.2).12
Table 19.2
Examples of Countries That Use ICD-10 Codes
Year Adopted Country
1994 to 1997 Scandinavian countries (Denmark, Finland, Iceland, Norway, Sweden)
1995 United Kingdom
1997 France
1998 Australia
1999 Belgium
2000 Germany
2001 Canada
2015 United States (original compliance date—October 1, 2013)
Adapted from Brooks P. ICD-10 Overview. <[Link]
Contracting/ContractorLearningResources/downloads/ICD-
10_Overview_Presentation.pdf>; 2010 (slide 15).
In addition to the ICD-10 conversion, in 2012 all health plans, healthcare
providers, and clearinghouses that conduct business electronically were
required to convert the Health Insurance Portability and Accountability
Act (HIPAA) standard for electronic transactions from Version 4010 to
Version 5010. Version 5010 was important because it accommodated the
move to ICD-10-CM and ICD-10-PCS code sets. While the conversion to
ICD-10 and HIPAA Version 5010 were major challenges, what is important
for the informatician to understand is that these types of requirement
changes can be expected to occur on a regular basis as legislation and
technology continue to change.
Best Practices: Incorporating Evidence-Based
Content and Clinical Decision Support Systems
With each new release, information systems become more complex and
robust, enabling them to incorporate evidence-based content (called
evidenced-based practice [EBP]) and to use clinical decision support (CDS)
features in the system. Detailed information on EBP and CDS is included
in Chapter 3 and Chapter 10; however, one of the most frequently quoted
definitions for EBP is one proposed by Sacke et al.: EBP is “the
conscientious, explicit, and judicious use of current best evidence in
making decisions about the care of individual patients. The practice of
evidence based medicine means integrating individual clinical expertise
with the best available external clinical evidence from systematic
research.”14, p. 71 EBP involves making decisions for clinical care based on
the most current recommended treatments for specific diagnoses. These
recommendations are derived from an ongoing review and analysis of
high-caliber, peer-reviewed scientific studies in the literature. While
entering orders from an EBP order set, the practitioner may override any
of the recommended diagnostic or treatment options based on the
individual needs of the patient. Some healthcare providers strongly object
to a preconfigured EBP order set, referring to it as “cookbook medicine,”
and resist incorporating it into practice. Berner offers an analogy of CDS
including EBP similar to the nursing process of the traditional “five rights”
for medication administration: “The clinical delivery system should
provide the Right information to the Right person in the Right format
through the Right channel at the Right time.”15, p. 7
A major challenge to EBP is remaining current due to the continuous
discovery of new knowledge and the resulting changes to recommended
best practices guidelines that are embedded in EHRs. Commercial
products can assist organizations in updating protocols by providing
current EBP clinical solutions, such as order sets and care plans. Most
major EHRs have been upgraded with common CDS features that help
meet some of the specific MU mandates, such as alerts for critical lab
results or a history of methicillin-resistant Staphylococcus aureus (MRSA) on
new admissions, pregnancy warnings on select medications and
diagnostic tests, drug allergies, drug–drug interactions, drug–diagnosis
warnings, dosage range limits, the capture of specific data such as
smoking status and advance directives, and immunization reminders.
The advantages of using a system that incorporates evidence-based
content and CDS include the following:
• Defines standardized, appropriate care and reduces variability of care
for common diagnoses.
• Defines local or facility-owned orderables (elements that can be
ordered using computerized provider order entry [CPOE] available at
that facility.
• Triggers alerts and other CDS features based on locally built logic
(rules). For instance, an alert may be triggered if (1) blood products
are ordered on patients who request no blood products be
administered, (2) pregnancy category teratogenic medications are
ordered on patients of childbearing age with an unknown pregnancy
status, or (3) the potassium level is below a preset level on patients
receiving digitalis medications.
• Collects detailed metrics for specific reports required to meet MU
criteria. These reports address a variety of MU requirements such as
patient education, smoking status assessment, native language,
discharge instructions, deep vein thrombosis prophylaxis in select
patient populations, and the use of thrombolytic and antithrombotic
medications in stroke patients.
• Enables a more timely update of treatment plans based on best
practices. The study Translating Research into Practice (TRIP),
conducted by researchers sponsored by the Agency for Healthcare
Research and Quality (AHRQ) in 1999, concluded that it took an
average of 10 to 20 years to incorporate new clinical findings into
general clinical practice.16 This time lag between the discovery of new
treatment options and the use of this new knowledge at the point of
care is sometimes called the “lethal lag” or “fatal lag.” CDS and EBP
are likely to accelerate the incorporation of new findings into clinical
practice.
Patient Safety and Improved Quality of Care
Before MU rules were initiated, most healthcare leadership and
professionals cited patient safety as the primary reason for implementing
an EHR; however, with the rapid adoption of EHRs it may appear to some
healthcare professionals that the sole reason for implementing an EHR is
to qualify for the incentive package. In response to this concern, leadership
needs to communicate to staff that the primary deciding factors for
implementing or upgrading an EHR include patient safety, improved
quality of patient care, and efficiency. ARRA is not the reason for the
implementation or upgrade but rather is the match that has ignited the
process. Reinforcing this message on a regular basis through all the stages
of the implementation cycle helps counteract resistance to using the
system.
For example, EHRs help decrease medication errors, especially if closed-
loop bedside barcoding medication administration is an integral piece of
the system. Quality of care and outcomes improve when decision support
mechanisms, standardized order sets, and care plans based on best
practices are incorporated in the EHR. Besides being aware of all the
positive functionalities and advantages of the EHR, staff also need to be
well informed on what the EHR cannot do.
Major implementations can elicit strong pushbacks from hospital staff
for a variety of reasons. A primary reason is that a major implementation
often involves changes in well-established workflows and processes,
resulting in a temporary decrease in productivity, particularly in the early
stages when clinicians are still learning the system. In addition, while the
new system may offer significant advantages to the institution (e.g., a
decrease in medication errors, reduced time between order entry and
delivery of services, or a dramatic decrease in telephone calls from nursing
and pharmacy to physicians about illegible or questionable orders),
individual practitioners may focus on the disadvantages that personally
affect them, such as an increase in time to enter admission orders or
immediate post-op orders.
In a paper world, some healthcare providers created their own personal
order sets for their practice and titled them using their name, such as Dr.
Smith’s Routine Admission Orders for Surgery. Once records become
electronic, personalized order sets are discouraged. Each specialty should
collaborate to create a single order set for each of its common procedures,
diagnoses, surgeries, and admissions, incorporating EBP. This approach
minimizes wide variances in care and avoids an IT maintenance nightmare
to keep individual physicians’ order sets up to date. One of the most
important success factors in the implementation of an electronic health
system is to involve as many users as possible in the design and planning
of that system and discuss the inevitable changes to workflows, processes,
policies, and procedures.17
The number of unnecessary verbal or telephone orders has long been a
major patient safety issue, even though certifying organizations voice
strong warnings against using them for simple convenience. The Joint
Commission (TJC) has a standard requiring that all verbal and telephone
orders be recorded and “read back” to the ordering healthcare provider.18
This scenario exemplifies another source of clinician frustration because
the clinician must remain on the telephone while the person recording the
verbal order retrieves the electronic record, enters it into the system, goes
through all prompts, and reads the order back to the ordering practitioner.
One study examined the number of verbal and telephone orders pre-
CPOE and post-CPOE and reported a 12% reduction in the number of
verbal orders and a 34% decrease in unsigned verbal orders after
implementation.19
Using the EHR to perform a task for which it is not designed or using a
poorly designed system may produce poor results or outcomes. Published
studies report a variety of unintended consequences for EHRs. Ash et al.
identified nine types of unintended consequences and corresponding
interventions to minimize each of these risks.20 A few of the unintended
consequences are associated with human error, such as selecting the
wrong patient or the wrong medication from a list. They refer to this type
of error as a juxtaposition error. Recommended strategies to decrease
unintended consequences are very similar to the best practices for a
successful implementation discussed later in this chapter.21 Weiner et al.
coined a new term, e-iatrogenesis, to describe the most critical of the new
type of errors seen in EHRs.22 Other types of errors include users who fail
to validate or read the list of all orders entered during a session before
final acceptance or who accept the defaults for select orders without
review.
The EHR may use Tall Man le ering (i.e., the use of mixed-case
le ering) for look-alike names of medications recommended by the
Institute for Safe Medication Practices (ISMP). Studies indicate that using
mixed-case le ering in similar drug names helps decrease medication
errors during order entry, medication dispensing, and medication
administration by highlighting the differences in the drug names. A few
examples of medication names using Tall Man le ering are NiFEDipine
versus niCARdipine, DOBUTamine versus DOPamine, and CISplatin
versus CARBOplatin.23
Another safety benefit associated with the implementation of an EHR is
that it can enforce the use of CMS-approved abbreviations. In addition,
EHRs can incorporate real-time updates or revisions to the order item
master (a master list of orderable items) and electronic order sets. For
example, Darvon and Darvocet were recalled in 2010 because of serious
cardiac arrhythmias. Institutions with EHRs were able to quickly remove
these medications from the pharmacy formulary, automatically
inactivating Darvon and Darvon equivalents on all electronic order sets.
HIPAA legislation that was originally drafted in 1996 mandated unique
national patient identifiers to ensure patient safety and promote
interoperability. However, privacy advocates voiced strong opposition,
and Congress passed laws preventing the development of unique national
patient identifiers. HIMSS has recently reintroduced a strong argument for
a National Patient Identifier (NPI) and Patient Matching strategy using
demographic a ributes that are considered relatively stable and unlikely
to change. Many proponents believe that we cannot achieve true
interoperability until it is in place.24 Examples of a ributes include first
name, middle name, last name, maiden name, date of birth, gender,
driver's license number, street address, city, state, ZIP code, and phone
number.26 Both proponents and opponents can cite scenarios in which data
a ributes may prove unstable and the algorithms that are used do not
address enough data elements. An ONC report found that patient
matching accuracy oftentimes depended on whether it was matching
patients internally or externally across organizations. The error rate varied
widely from 10% in IT sophisticated organizations to an alarming 40% to
50% rate when matching across enterprises.25 Keith Fraidenburg, vice-
president of the Education and Communications College of Healthcare
Information Management Executives, who strongly supports an NPI,
believes that an NPI (which must be encrypted) should not be the sole
source of patient authentication. He wants to see a multidimensional
strategy using NPI with retinal or thumb scans.
New implementation versus an upgrade
Once the decision has been made that a major change is needed in the
current information system, the next question is whether to upgrade or
implement a new system. Answering the question “Do we need to make a
change?” leads to the follow-up question, “What specific changes are
needed?” The institution or healthcare provider should begin by
determining what level or degree of change is needed to achieve their
goals, including meeting MU requirements. If there already is a well-
established homegrown system, it is often wiser to upgrade. Making this
decision can be supported by using the EHR Alternative Certification for
Healthcare Providers (EACH) process to consider the level of scope
needed.
Many competing factors must be evaluated in deciding whether to
implement a new system or upgrade the current system. In Chapter 16,
which explains the process for selecting a health information system, the
assumption is made that the institution is planning to purchase a new
system. However, a formal implementation process is used whether an
institution selects a new system or upgrades a current system. Once that
decision is made, the institution will move forward to the implementation
phase of the systems life cycle.
Sufficient Resources
The three major resources that will have the most impact on whether to
implement a new system or to upgrade an existing one are staff, budget,
and physical or environmental constraints. Having a sufficient number of
available and knowledgeable staff with the specific skill sets needed for
each step in the process is imperative to the success of the project. The
needed skill sets relate to the following:
• Installing and testing new hardware, software, and wireless networks
• Designing, building, and modifying applications
• Testing new applications and interfaces
• Providing staff education and support
• Maintaining hardware, software, and wireless networks
The project manager will usually create a grid of all resource assignments
for easy tracking and reference. Regardless of the type of project,
informatics projects are expensive and often incur unexpected costs for
items such as adding computer memory, upgrading wireless systems, and
developing new interfaces. Funds must be allocated for staff, servers,
hardware such as new computers, scanners, printers, wiring, antennas,
training rooms, software, and post-live vendor support. Physical
requirements may include creating additional space in the clinical units,
patient rooms, dictation areas, doctor lounges, etc.
Risk Factors
A good project plan identifies all probable and possible risk factors that
may interfere with achieving a successful project completed on time, with
sufficient quality, and within budget. A risk management plan lists
corresponding reasonable strategies to mitigate the identified risks. Some
risk factors can be anticipated with plans to minimize their effect, such as
an upcoming accreditation inspection, the possibility of a strike by
workers, new construction, and remodeling. Unexpected risk factors may
be a loss of key project players, a publicized sentinel event, or a natural
disaster in the area.
Scope Creep
Scope creep is one of the most frequent causes of project delays. Scope
creep is defined as changes in the scope of the project during the
implementation that frequently necessitates other changes resulting in
additional expenses, resources, and time. Scope creep occurs when
requirements are altered after the initial project is defined and those added
requirements are substantial enough to affect the project timeline. Well-
defined objectives for the parameters of the project and strong project
management can help minimize scope creep. However, even with the best
planning, some informatics projects must be expanded for valid yet
unanticipated reasons. There are several reasons for scope creep.
Sometimes users do not understand the product until they interact with it.
They then realize that the system will not meet their needs, creating an
impetus to incorporate changes in the product and project plan. Likewise,
the extent of workflow changes may not be apparent until the EHR is
piloted. Sometimes projects that begin as an upgrade shift to the
implementation of a totally new system due to changes in leadership and
management, new regulations, and new enhancements or options that are
now viewed as critical.
Best of Breed Versus an Integrated Health System
There are two approaches to implementing an EHR: (1) best of breed and
(2) monolithic or fully integrated EHR. The best of breed approach
involves reviewing several vendors for their “best” module or application,
such as an admission, discharge, and transfer (ADT) system or emergency
department module. Then multiple modules are purchased from different
vendors to create a full suite of functions. Purchase decisions are based on
each module’s or application’s most desired or robust features and
connectivity capabilities. This approach typically provides the customer
with tools to customize the application according to local, specialized
needs. Vendors typically incorporate enhancement requests more quickly
in a hot fix (fast fix), through software patches (fixes), or in the next
version. Both of these advantages can be important to large medical or
research-intensive university centers. The disadvantages of this approach
are the need for multiple complex interfaces to integrate all of the
products, the need for highly skilled and specialized IT staff to support the
different interfaces, and the existence of various hardware platforms and
operating systems that may be on different versions of software and
therefore complicate integration. Lastly, each module may have a different
user interface, meaning that each application looks and acts differently to
the end users. All of these factors make the best-of-breed approach more
expensive and resource intensive, but this approach is frequently selected
by large medical, university, and research medical centers.
A monolithic or fully integrated health information system is an EHR
system that includes a suite of modules to support care. It is typically
easier to install and easier to support and usually has a similar-looking
user interface across modules, which helps users learn the EHR more
quickly. Because all applications share a common database, the
information exchange among the modules is quicker. The initial
installation is frequently faster and less expensive because a scaled-down
IT department is required at the local site. Smaller medical facilities and
those not wanting large IT departments tend to favor this approach. The
downside is that the system may not have specific features that the health
facility needs, and vendors often have applications that are excellent for
some areas and less optimal for others. In addition, the customer cannot
easily customize the system without assistance from the vendor, which
may involve a work order and additional cost. System changes can incur
long delays from large vendors as they prioritize changes across many
clients. For example, orders for total parenteral nutrition (TPN) are
generally customized to the patient’s needs and are difficult to construct
for CPOE. Thus TPN orders may remain on paper and be faxed to the
pharmacy department. Of course, having both paper and electronic orders
creates a fragmented health record, potential safety issues, and issues with
workflow. These types of exceptions are becoming less common as more
and more institutions develop fully functional EHRs.
Opportunities for Improvement
The decision to implement a new system or to upgrade an existing one
provides an opportunity to increase patient safety and quality of care,
enhance communication, increase EBP, and create more efficient
workflows and processes. A new system allows the organization to
thoroughly evaluate, correct, and clean up a current database to address
common issues such as misspellings, order names that do not comply with
established naming conventions, and the addition of helpful aliases for
orders. In most scenarios, multiple analysts will build the EHR system,
especially in a multifacility enterprise. The IT team, which includes
members with technical and clinical expertise, must emphasize that all
analysts use the same style, such as a specified naming convention and
uniform data assays (or elements), so that all orders or charting screens
have a consistent look and feel. Defining a naming convention includes
decisions about details such as building applications using all capitals or
mixed case and commas versus dashes, colon, or a space, and an
understanding to not use specific special characters, such as semicolons,
ampersands, or backward slashes, in order names that may be
misinterpreted as a part of a Health Level Seven (HL7) message.
Sometimes order names were originally built in an ancillary system such
as a laboratory or radiology system and abbreviated with archaic or
cryptic acronyms that are understood only by that department but are not
meaningful to the clinician. These department-specific systems were likely
stand-alone applications that did not interface with other applications.
Once they are integrated, older department-specific orders need to be
reviewed and renamed to be more user-friendly for clinicians. When
different builders are constructing new orders and not adhering to a
naming convention over the life span of the CPOE application, the
orderables cannot be found easily by clinicians. For example, radiology
may have orders that start with a modality like “CT Head w Cont.” Other
computed tomography (CT) orders may start with the body part, as in
“Head CT w/o Cont.” Some orders may spell out “with” or abbreviate it
using “w” or “w/.” This lack of standardization can result in alphabetized
lists that clinicians do not understand, long search times by clinicians, and
sending incorrect orders to radiology. This issue is very important in
CPOE applications because orders will not line up alphabetically when a
clinician searches for “CT HEAD” if dashes, colons, or spaces are used
inconsistently.
A common mistake in the implementation of a new EHR is replacing a
legacy system but designing the new system with old workflows and
processes. Organizations should resist building a new system to imitate
the current system or current workflows; rather, they should evaluate the
system and transform to more updated evidence-based efficient processes.
If this is ignored, a risk exists that the new EHR will merely automate and
magnify broken processes that exist in the current organization and
system.
Another improvement that often accompanies a new implementation or
an upgrade is the introduction of more advanced decision support features
not available in the older system. Features not available in older EHRs
typically are duplicate order checking; codified (coded) allergies; allergy
checking against medication and diet orders; drug–drug, drug–food, and
drug–diagnosis interactions; dose checking; weight-based medication
dosages; suggested drug level monitoring; automatic discontinuation of
controlled substances; and the display of critical lab values during order
entry before orders are placed. Older pharmacy systems performed these
checks after order entry, requiring the pharmacist to contact the ordering
healthcare provider when alerts were displayed, thereby delaying the first
medication dose to the patient. More recent EHRs employ logic, allowing
the institution to create rule-based logic for specific scenarios or variables,
such as patient gender, age, weight, diagnosis, patient location, active
order list, and other miscellaneous a ributes. The following are examples
of rule-based logic:
• Patient allergies and the patient’s height and weight must be entered
in the system before orders on a patient are entered but can be
overridden in emergencies.
• An alert is triggered when a provider orders a blood product be
administered to a patient who is a Jehovah’s Witness.
• An alert is triggered when a clinician orders a radiology test that
requires contrast on a patient with a documented allergy to iodine.
Implementation and the systems life
cycle
Phases of the Systems Life Cycle
Successful implementations follow the systems life cycle model introduced
in Chapter 2. To summarize, the main phases of the systems life cycle are
as follows:
• Analyze. The existing environment and systems are evaluated. Major
problems and deficiencies are identified using informal or formal
methods. A needs assessment is developed. Gaps are noted and
current capabilities and limitations are outlined. Initial user and
system requirements are formulated.
• Plan. The proposed system is comprehensively planned. Planning
includes strategic levels, such as whether the system will be
developed internally, purchased and tailored, or designed and
developed jointly with a vendor.
• Develop or purchase. At this stage, either the system is purchased or the
new system development begins. New components and programs are
obtained and installed. For vendor-supported solutions, extensive
tailoring occurs.
• Test. At this stage, extensive testing occurs just before Stage 5, and
“go” or “no go” decisions are made about deadlines. Toward the end
of this phase, marketing and communication efforts are accelerated to
make users aware of the impending change.
• Implement or go-live. The system is implemented using a selected
method best suited to the organization and its tolerance for risk. User
training is completed.
• Maintain and evolve. Once the system has been formally acknowledged
as passing user acceptance testing, typically at 90 or 120 days after go-
live, it enters a maintenance phase.
• Evaluate. Activities in each phase are assessed for their quality and
effectiveness.
Project Planning
The process of project planning occurs throughout the systems life cycle.
Two key points in the life cycle when planning becomes more intense are
(1) the planning required for system selection and (2) the planning
required for system implementation. Chapter 16 discusses planning
related to system selection. Chapter 17 provides an overview of project
management principles and processes that underlie the planning process
as these apply to clinical systems. In this chapter, the discussion focuses on
the process of project planning as it relates to system implementation.
Defining Success
One of the first planning steps includes defining the project and its success
factors. Before an implementation can be called a success, the term success
must be defined using measurable terms or goals. An example might be
reducing medication errors by 15% by installing medication and barcoding
applications. Any required baseline metrics should be determined and
measured before implementation if post go-live comparisons are required
(Box 19.1). Other examples are pre and post statistics for the number of
pharmacy callbacks to physicians; the volume of nonformulary
medications; and the time between order entry and first medication dose,
especially for critical medications such as tissue plasminogen activator
(tPA); the time between “stat” order entry and order completion; the
percentage of suspected acute myocardial infarction patients who receive
aspirin within 24 hours before or after arrival at the emergency
department; the number of duplicate laboratory or radiology orders; and
the number of verbal or telephone orders with a documented read-back.27
Box 19.1
Factors for a Successful Electronic Health
Record Implementation
• Project team defines a clear scope of the project.
• Senior leadership, clinical leaders, and EHR champions provide
enthusiastic and unwavering support for the project.
• Employ a health IT professional to lead the project, and be sure to have
adequate resources.
• Solicit input from representatives from each discipline at every stage of
the initiative.
• Have default clinical information and responses to order prompts on
orders and fill in as much as safely possible on order sets.
• Consider mandatory use of CPOE.
• Educate users, particularly physicians, on the trade-off of initial reduced
productivity and time to perform ordinary tasks such as order entry
with long-term positive gains of reduced callbacks, reduced time
between order entry and first dose medications and “stat” orders, and
“everywhere” access to the chart. If clinicians understand and are
educated on why the change was made, they tend to be accepting of the
change.
• Examine and develop collaborative detailed plans for the anticipated
changes in current workflows early in the project, with a sign-off from
each user group.
• Provide one-on-one education to physicians and a dedicated physician
liaison.
• TEST, TEST, TEST the system from every user’s perspective.
• TRAIN, TRAIN, TRAIN: Provide ample education to IT staff and end
users.
• Use the “train the trainer” approach for maximum mileage.
• Use superusers for go-live and post go-live support.
• Provide abundant support during go-live and 7 to 10 days following go-
live.
• Anticipate user resistance and plan for it.
• Possess an understanding that there is no finish line for EHR
maintenance.
• Have a strong resolve, knowing that the project will be difficult.
CPOE, Computerized provider order entry; EHR, electronic health
record; IT, information technology.
Whether undertaking a new implementation or an upgrade,
organizations will want to adhere to solid project management principles,
such as the use of a project plan. It is essential that the implementation
team creates a comprehensive and detailed project plan that includes all of
the critical milestones, assumptions, and tasks, with target dates and
assigned resources. Resources may include IT staff, medical and nursing
staff, representatives from each department, and superusers. Superusers
are selected staff who receive extra training and help provide additional
support during the go-live process. The project plan can be created using
Microsoft Office Excel, but most facilities use more sophisticated
applications specifically designed for project planning, such as Microsoft
Office Project. Fig. 19.2 provides an overview of areas within such a plan.
FIG 19.2 Sample computerized provider order entry (CPOE)
timeline.
Facilities should develop a go-live theme, such as giving the
implementation project an official name and a slogan, reference the project
name each time the implementation is discussed, and start early with a
slogan and use it continuously throughout the project for activities such as
project marketing with pamphlets, posters, flyers, and announcements.
Some organizations will also select a color scheme and use it for all
publicity, communications, updates, banners, posters, table tents, and T-
shirts or bu ons that support staff may wear during the go-live. Large
facilities will have a marketing plan for the project, especially closer to go-
live.
Executive Management Support
A crucial initial planning step involves eliciting the support of
organization executives. One of the key factors for a successful
implementation or upgrade is public a estation and repeated unwavering
support for the project by the executive team. This kind of support is
needed from the project’s kickoff day to after go-live. Leaders need to
communicate this message to the organization at every possible
opportunity and on a regular basis.28,29 This commitment is especially
critical when a powerful stakeholder, such as a key physician, repeatedly
escalates EHR issues to the executive suite with requests that could
undermine the project. Regarding issues with CPOE, some healthcare
organizations mandate that physicians enter orders into CPOE modules
with a few well-defined exceptions. Organizations that have more success
with mandatory CPOE are those in which physicians are employees of the
hospital and those in which the physicians and physician leaders were
involved in the project from the beginning. Other tactics used to deal with
CPOE resistance include policies that instruct nurses and unit secretaries
to inform physicians that they are not allowed to enter orders on a
physician’s behalf. However, if the physician submits a complaint against
a staff member as a result, executive management must support this policy
when challenged.
Engage Stakeholders
Another important factor in planning is to solicit input from
representatives in every discipline from the beginning and continue to
inform them of the progress of the project.30 Savvy implementers will
ensure that voices from each group are heard. One of the most effective
methods for engaging stakeholders is to involve them in the analysis of
current workflow processes and the redesign of those processes.
Redesigned Workflows
As mentioned earlier, a new system will change the current workflows,
processes, procedures, and policies. Redesigned workflows require
preparation so that professional practice processes match the available
EHR functions. This early work is imperative to preclude modified
workflows or negative workarounds (a method used to circumvent a
problem without solving it). Revisions to the policies and procedures as
well as new policies need to be adopted for new workflows. All current
workflows and processes need to be assessed in successful
implementations. The best approach to obtaining this information is to
schedule separate meetings with representatives from each department,
being certain to include unit or department secretaries, who frequently
know the unofficial workarounds, and actual end users. While department
or unit managers can easily provide the organization’s approved
workflows and processes, they may not be aware of the unofficial
workarounds used by the staff. In short, the goals of scheduled meetings
with each department are to identify all current official and unofficial
workflows and processes and to plan the future workflows and processes
using the EHR’s new functionalities so that users can anticipate how their
jobs will change. At these separate meetings, the areas of overlap or
instances where workflow moves from one department to another should
be noted, but decisions about how to manage the interfaces and overlap
should be made in joint session with all affected departments represented.
These can be critical and sometimes difficult points in planning a
redesigned workflow. Redesigned workflows and planned changes must
be included and thoroughly reviewed in all end user training classes.
Student reactions to this information in these classes can be an important
alert concerning workflow processes that need additional discussion
and/or design.
Building or Tailoring the Product
Once the current workflow is understood and redesigned, teams work to
build or tailor the EHR to match the new workflow. Typically, clinical
analysts work with vendor analysts to tailor a product for the current
environment. Actual end-users are often involved in the process. At a
minimum, once a module is initially tailored, analysts have end users
assess the module in an iterative fashion. The following tips can be useful
in this design process:
• Design and build the system to keep the number of clicks and amount
of scrolling to an absolute minimum. Employees, such as physicians
and others whose income can depend on their ability to manage more
patients in less time, in particular will calculate the time it takes to
perform common tasks. Excess clicking can be a huge user dissatisfier
and can discourage users. To avoid excessive clicks, implementation
analysts often use what is commonly referred to as the 80/20 rule. The
term 80/20 refers to a mathematical formula proposed by an Italian
economist in 1906 that states that 80% of our results or outcomes are
derived from 20% of our efforts or causes.31 An example of applying
the 80/20 rule in health informatics is to assign default responses
when a specific response is selected 80% of the time. For instance,
builders will prefill as many of the fields as possible in order entry,
with prompts such as “Routine” for the priority and “Once” for the
frequency for all laboratory and radiology orders to facilitate faster
order entry. The underlying rule is to minimize all keystrokes and
excessive scrolling whenever possible. Default se ings can be
especially useful in saving time, but they also need to be evaluated
carefully to ensure that they do not increase safety issues.
• Do not ask clinicians to respond to prompts that they cannot answer.
For example, most radiology systems have a mandatory prompt for
“Method of Transportation.” Physicians most likely do not know if
the patient requires a gurney or a wheelchair and will typically select
the first option to place the order. Some organizations now use a
default of “Wheelchair” or a term such as “Call Unit” for the “Method
of Transportation.” Avoid the overuse of alerts in order to minimize
alert fatigue. Alert fatigue occurs when a user becomes desensitized to
pop-ups or alerts if too many are triggered during an average session.
Set the level of sensitivity so that only critical medical alerts fire and
those with marginal clinical significance are suppressed.
• Maintain a consistent look and feel to the screens so the same
information is always found in the same place on the screen and
color-coding is consistent on every screen. Ideally this consistency
should extend across vendors and institutional departments.
Testing
Implementing or upgrading an electronic health system involves extensive
testing. The different types of testing must be carefully planned and
conducted throughout the project. These include hardware, software, and
functional testing. Functional testing is used to determine whether the
system functions as designed and works effectively with the newly
structured work processes. All testing should be done first within a
module. Once all modules are functioning correctly, integrated testing
across modules is performed using patient flow scenarios. Table 19.3
outlines several different types of testing that are often part of the testing
protocol.
Table 19.3
Different Types of Testing During an Implementation and Post Go-
Live
ADT, Admission, discharge, and transfer; ARRA, American Recovery and Reinvestment
Act; CAH, Critical Access Hospitals; CMS, Centers for Medicare and Medicaid Services;
CPOE, computerized provider order entry; EHR, electronic health record; I&O, intake and
output; IT, information technology; RN, registered nurse; VTE, venous thromboembolism.
A test plan is often created in a spreadsheet format. The plan should
include fields for the name of the test, date of the test, name of the tester,
log-in used for the test, role of the tester (e.g., medical doctor [MD], nurse
practitioner [NP], registered nurse [RN], respiratory therapist [RT], unit
secretary [US]), test objective, and test instructions. An example of such a
test plan is shown in Fig. 19.3.
p g
FIG 19.3 Sample test plan. ADT, admission, discharge, and
transfer; HIS, healthcare information system; Pt, patient. Copyright
McKesson Corporation.
The testing process requires that a testing environment be created
within the organization’s electronic system. Box 19.2 lists the different
environments that are usually created in order to install and maintain a
healthcare information system. These environments can be conceptualized
as copies of the live environment. Testing is best done in an environment
as close to reality as possible. Using the test environment to execute test
plans, the implementation team will develop detailed test plans for each
staff group such as healthcare providers (physicians, physician assistants,
and advanced practice registered nurses), staff nurses, pharmacists, unit
secretaries, and ancillary personnel for each application. Test plans
evaluate information and data flow throughout the application, including,
for example, messages, allergies, orders, test and other diagnostic results,
automatic and manually demanded reports, and archiving of the patient’s
record post discharge. If this is an upgrade implementation, medical
facilities often have ready-made test plans that they use with each upgrade
but modify to accommodate changed or new functionalities, improved
features, and fixes to previous defects. An upgrade test plan differs from a
new implementation test plan in that the upgrade test plan typically has a
short list of test items or orders for each department versus a new
implementation that involves testing every item in the order item
dictionary, as well as every prompt and combination of prompt responses
on each order. Testing includes all devices such as computers, printers,
handheld devices, barcode scanners, etc.
Box 19.2
Healthcare Information System Online
Environments
• Live or production environment refers to the healthcare information
system application’s actual use with patient and hospital data. Testing
and teaching should not be done using this environment since changes
are very likely to affect patient care.
• Build environment refers to a copy of a healthcare information system
application that is used to configure and customize an application.
Building usually occurs at the module level. Once a module is designed,
it is moved to the test environment.
• Test environment refers to a copy of the healthcare information system
application that is used to test the application. It should be a complete
copy of the most recent version of the actual application. The test
version of the software should not be an empty shell but should reflect
the actual type and amount of data one would expect to see in the live
environment.
• Teaching environment refers to a copy of the healthcare information
system application that is used for teaching users. Like the test version
of the software, this version should not be an empty shell but should
reflect the actual type and amount of data one would expect to see in the
live environment.
• Teaching/testing environment refers to the combined use of a healthcare
information system application for both testing and teaching activities.
This does require careful scheduling since testing should not occur at
the same time that a class is using the environment for teaching.
However, the advantages are that this approach saves resources, and
using the test environment for teaching provides additional testing for
the application.
Preparing for go-live
Preparing for go-live involves deciding on the go-live approach;
developing the go-live plan, support, and schedule; and preparing the end
users.
Big Bang or Incremental Go-Lives
There are two approaches to a go-live: big bang or incremental (also called
a phased or a staged approach). The big bang approach occurs when all
applications or modules are implemented at once. This approach is
favored by vendors and facilities conducting large upgrades. With a
phased go-live approach, both paper and electronic environments exist at
the same time within the healthcare institution; however, the existence of
both paper and electronic environments forces the clinician to use different
workflows in patient units that have implemented the system than in units
that have not, potentially creating safety concerns. The advantages of the
big bang approach are that it is usually less expensive and implementation
time is shorter, allowing staff to return to a new normal and see early
improvements in the project metrics more quickly. The negatives
associated with the big bang approach are the significant reductions in
productivity seen immediately at go-live and for a short time afterwards
due to users’ unfamiliarity with the new system and a large influx of
requests to tweak the system (Box 19.3).
Box 19.3
Advantages and Disadvantages of the Big Bang
Approach
The incremental approach is usually selected when a facility has limited
resources that cannot support a house-wide implementation or when the
facility has a low tolerance for or ability to respond to institutional
changes. There are a variety of ways to employ this method. Some facilities
may decide to go-live with specific staff groups such as nurses, unit
secretaries, and ancillary staff, including laboratory, pharmacy, radiology,
respiratory therapy, physical therapy, occupational therapy, speech
therapy, and dietary, followed by physicians and other clinicians a short
time later. Others may choose to go-live with select clinical departments or
product lines (e.g., patient flow within a specialty such as surgery).
Reasons for selecting the first units to go-live may be based on their
perceived support and enthusiasm for the project or their low number of
admissions, transfers, and discharges. Advantages of the incremental
approach are that it allows time to make changes to the build or the
workflows and does not decrease productivity house wide while creating
constant change for end users. The early adopters or the new users of the
initial departments normally will share their experiences, perceptions, and
satisfaction with others. However, this communication can either support
or speak against the project. The disadvantages include the potential for
errors due to multiple systems and the possibility that the project can be
protracted and workflow disruptions will occur over a longer period,
although on a smaller scale. Another factor to consider with the
incremental approach is the availability of support for each successive
unit. Most vendors typically like to transition from their implementation
or services team to the support team 2 to 4 weeks after initial go-live.
Continued support can be expensive for organizations. This also means
that the organization will be calling vendor employees who may not be
familiar with the build, workflows, and customizations when issues arise
with each new mini go-live. Repetitive go-lives also tax the IT department
and the superusers and delay the deployment of fixes and physician
requests from the initial go-live departments. Sometimes the rollout is
more prolonged than originally planned or it may even stall indefinitely
due to user dissatisfaction. The early go-live users who do not see quick
resolution of easily fixed issues will complain because the support staff is
too busy with the next go-live unit (Box 19.4).
Box 19.4
Advantages and Disadvantages of the
Incremental Approach
Detailed Go-Live Plan
A detailed go-live plan includes each planned activity as a line item
assigned to a specific individual or team with a completion date for each
task. The go-live plan should include critical tasks that are scheduled to be
completed a few days to a few weeks before the go-live date. Some project
managers may break down the immediate days before go-live to the
number of hours before go-live, marking tasks that must precede other
tasks. Some of these may include cross-checking the patient census
between the new and old systems, backloading a specific number of days
of diagnostic tests results and medications into the new EHR, and
confirming that all active and future orders on all patients are in the new
HER.
Education and Training
A common mistake in an implementation or upgrade is not planning
sufficient time to thoroughly train end users or failure to allot a sufficient
budget to conduct training.32 Education of all end users is a mini project
and is best assigned to a person or facility education department that can
coordinate or oversee all of its components. In fact, training is complex
enough that software support in the form of a learning management
system (LMS) is often used. An LMS includes planning and tracking the
end users trained and the results of any competency tests. A training plan
must address the development of teaching plans, training manuals, and
job aids that provide instructions on common tasks and can be used
during training and on the job. Different types of training must be
developed for the different groups of end users, including physicians,
students and/or outside faculty, nurses, pharmacists, unit secretaries, and
ancillary personnel such as respiratory therapy, rehabilitative services,
clergy, quality control, etc. For example, physicians will need instruction
on using CPOE, viewing test results, viewing charting, and performing
medication reconciliation, while nurses will need education related to
order review, order entry, nursing documentation, and medication
administration.
Policy and procedures for dealing with the consequences for not
a ending and/or passing the training should be developed as part of the
training plan. For example, should providers with order-entry privileges
be suspended if they have not demonstrated that they are competent to
use the system for order entry? If yes, how should this policy be
implemented if there are patients who are dependent on this provider for
the management of their care?
Questions to consider in planning education hours are the number of
users to be educated, education methodology including online or
traditional classroom, the timing and length of the classes for each user
group, the number of training rooms and training devices available, the
training schedule, and trainers for each group. The content of the course
should reflect the scope and standards for practice with role-specific
processes, decisions, tasks, workflow and policy changes, and supportive
EHR functions for each group of users. During training, common user
errors or system quirks should be highlighted to help users avoid them.
MU-related tasks such as assessing smoking status, advance directives,
and immunization status should also be addressed so that users
understand the importance of completing those data fields. Privacy and
security policies, including not sharing one’s log-in and password and
accessing only those medical records the user needs to review, should be
emphasized in every class. The consequences for violating privacy and
security policies and practices should also be clearly stated.
Trainers
Depending on the organization’s structure, the trainers might be in-house
staff, vendor educators, temporary consultants, superusers or power users,
or a mix of these. Organizations need to identify how professional
students such as nursing or medical students will be educated on the new
EHR. Some have regularly scheduled classes where students can register
to a end while others take a “train the trainer” approach using the
school’s educators to provide the education. If the organization is using a
big bang approach, it will often need to bring in temporary trainers in
order to get all users trained and then revert to in-house educators or
superusers following go-live for new hires, system upgrades, and
remediation training. The advantages of using in-house educators are that
they are familiar with the organization’s policies and usually have a
background in adult education. Vendor educators and consultants
frequently know the application very well but are not familiar with the
organization’s future workflows and policies. Superusers who can spend
time with students who are having difficulties are valuable as assistants in
the classroom. Training is an ongoing process that will continue after go-
live to orient new hires and to address new responsibilities or changes in
staff roles that consequently cause changing workflows.
Training Methodology
Most organizations use a combination of different training methods. One
of the most popular methods is an instructor-led class in a classroom that
contains all of the equipment needed to demonstrate essential
functionalities, including printers, barcode scanners, identification bands,
medication labels, etc. The advantages of instructor-led training are the
ability for end users to ask questions, quick clarification of complex
concepts, and easy identification of users who may need additional help.
The primary disadvantages are the expense and resources needed to have
multiple instructor-led classes. In addition, the number of students per
session is limited, and no-shows are common among nurses and
physicians since training competes with patient care needs. Another
common training method includes a blended approach in which end users
complete an “anytime/anywhere” online module about EHR basics and
then a end a brief instructor-led session. These are also used as mini-
refreshers or primers during upgrades.33 A major drawback to using a
variety of approaches is the constant need to update all of the training
materials with the introduction of new functionalities. No ma er the
approach, the use of competency tests to assess proficiency is
recommended.
With a CPOE implementation, most organizations create a new position
for CPOE liaisons who are dedicated to clinician training 24 hours a day, 7
days a week. Physicians may be unable or unwilling to a end scheduled
classes and prefer just-in-time or one-on-one education.34 Some
organizations employ physician liaisons who are dedicated exclusively to
assisting physicians. Even though this is a labor-intensive strategy,
physicians quickly become adept at their new workflows, report greater
user satisfaction, and have a greater likelihood of using and being satisfied
with the new system.
Length of Class and Class Schedule
Depending on the EHR functions needed, class time will vary. For
example, CPOE classes for unit secretaries in an organization where
prescribers will be expected to use CPOE may be 2 to 3 hours, whereas the
same classes for healthcare providers may require 6 to 8 hours. Once the
total number of users and the number of hours for each learning module
are determined, a training schedule is developed, often using the LMS
mentioned earlier. With a house-wide go-live, training will need to be
provided around the clock. If users must a end class during their off-duty
time, organizations will have to consider paying overtime. Alternately, if
user education is incorporated into the 40-hour workweek, replacement
staff may be required. End users should not be expected to a end class
immediately after a shift when they are most likely tired and may not be
able to leave their department when planned. Education should be
conducted as close to the go-live date as possible to facilitate retention of
the new knowledge and skills, with a goal of no more than 4 weeks pre-
live. It is recommended that users have access to a device that points to the
train environment to practice and become more familiar with the system.
Some hospitals dedicate one device on each clinical unit that is in a remote
location like the break room, while others reserve a readily accessible
classroom with several devices. Once a significant majority of employees
has completed the training, the institution is ready for go-live.
Go-live
During the initial weeks of the go-live, organizations must plan to provide
close support (“elbow-to-elbow” support) for end users. Many institutions
will provide 24/7 support for a week or two and a few may offer it for
several weeks. Assigning superusers wearing easily identifiable apparel to
roam departments offering assistance to users is an excellent tactic that is
well received by the end users. Issues, questions, and misunderstandings
should be reported to the project team, which then catalogs, prioritizes,
and tracks them for resolution and future reference. Additional tips
include the following:
• Avoid a go-live date that falls on a weekend, a Monday or Friday, or
close to a major holiday when vendor support personnel may be less
available. Two exceptions to this guideline are the implementation of a
new financial system, which must start at midnight on the first day of
the month for billing purposes, and a big bang implementation, which is
typically scheduled to start on a weekend to minimally affect surgery
and procedure services.
• Set up an organized and well-equipped command center for the go-live
that includes the following:
• A highly publicized hotline number for assistance; incoming calls
need to roll over to a bank of well-staffed phones.
• A system for reporting, cataloging, assigning criticality, and assigning
skilled resources to identified issues and problems.
• A hotline number is one communication method, but urgent issues
need to be addressed and, if necessary, escalated immediately to the
vendor or IT department for resolution. Stock the command center
with supplies such as whiteboards, poster boards, phones with
outside access, preprinted “Issue Reporting” forms, printers, office
supplies, meals, snacks, and water. Devices must be loaded with new
software and integrated with upstream ADT and downstream
(laboratory, radiology, pharmacy, dietary, electrocardiography, etc.)
systems for immediate troubleshooting.
• Devise several different mechanisms to obtain and give user feedback in
a timely manner.
• Include clearly identified people associated with the command center
and project. For example, roaming superusers could wear an identifying
T-shirt, vest, or large easy-to-read badge in the project “color.”
Other go-live tactics include the following:
• Give small gifts to units (donuts or bakery items, boxes of candy,
popcorn tins, balloons for desks).
• Use posters or banners in main lobbies, atriums, and waiting rooms.
• Provide a well-publicized process for end users to communicate with the
implementation team and change-control commi ee (which collects and
prioritizes system changes).
• Provide a generic e-mail address for users to ask questions, request a
change or new item, or make suggestions, with prompt feedback to
users’ questions and requests.
• Create a suggestion box that allows anonymous input and has scheduled
collections.
• Place notebooks in staff lounges with scheduled pickups and returns.
• Send e-mails to all users that include FAQs and “Tips and Tricks.”
Post-live maintenance
A vendor-supported implementation is officially over when the system
formally transitions from the vendor’s services team to its support
division. With in-house development, the project leader announces when
the go-live is over. Maintenance is an ongoing process that involves a
variety of tasks such as applications updates, patches for identified defects,
and a continuous revision of the system in response to users’ requests.
This includes revising documentation screens, adding new content,
creating new orders such as new medications, and deactivating obsolete
content such as outdated interventions and medications that are no longer
in the hospital formulary. While outdated content is deactivated from user
access, a record of the content must be maintained. For example, if a drug
is removed from the formulary, a record of when this drug was in the
formulary must be maintained. The change control commi ee receives
input for new content, such as newly defined order sets, as well as
requests for revisions to current order sets so that they align with updated
best practices. Users may discover system flaws that were not detected
during testing, and these need to be submi ed to the change control
commi ee and vendor. In addition, the IT departments should conduct
regularly scheduled rounds to the clinical units to solicit input from the
users.
As mentioned earlier, major reasons to implement EHRs are patient
safety, improved patient care, and clinical outcomes. One of the final tasks
in the implementation plan is to evaluate whether and how the system
made a difference according to the metrics identified and collected during
the preimplementation phase. This collection of data is typically
performed approximately 3 to 6 months after the go-live to allow users to
become more proficient with the EHR. Implementing a new EHR or
upgrading an older version is a process without a definitive end point.
After installation, an EHR will require software upgrades, new hardware,
ongoing training of staff, and education of IT staff.32
Conclusion and future directions
Meeting MU criteria as well as future criteria developed to support the
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and the
Merit-Based Incentive Payment System (MIPS) will continue to spur
growth of EHRs. In the future, increasing numbers of patients will interact
with their healthcare providers via electronic means to set up
appointments, send questions, request prescription refills, and retrieve
their health record, including test results. There will be rapid movement
away from stand-alone outpatient EHR systems toward integrated
systems. Mobile devices such as smartphones and iPads will play a larger
role in patient–clinician relationships and nurse–patient–family
relationships in the home. Health-related apps that allow for home
monitoring of vital signs, blood glucose levels, electrocardiography
monitoring, and fetal monitoring will become commonplace.
In the future, the United States may develop a registry to track EHR-
related safety issues. The registry could be used to monitor safety and
adverse issues and initiate timely notifications to medical providers and
patients.35 In a similar vein, the Institute of Medicine advocates the
creation of a new federal agency or National EHR Safety Board under the
auspices of HHS to oversee EHR safety. Presently there is no formal
national or global process through which organizations or individual users
can report possible EHR-related safety issues. The IOM also recommends
that the federal agency have the authority to (1) require IT vendors to
register their products and communicate negative events associated with
their applications, (2) establish mandatory IT safety criteria, and (3)
publish an annual report on identified safety issues and strategies in an
effort to minimize or eliminate them.36–38 No ma er whether the EHR is
new or an upgrade, the ultimate goal in implementations now and in the
future is to provide the highest level of care at the lowest cost with the
least risk.
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2009;78:S69–S76. doi:10.1016/j.ijminf2008.07.15.
21 Ash J.A., Stavri Z., Kuperman G.J. A consensus statement on
considerations for a successful CPOE implementation. J Am Med
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22 Weiner J.P., Kfuri T., Chan K., Fowles J.B. e-Iatrogenesis: the most
critical unintended consequence of CPOE and other HIT. J Am Med
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23 Institute for Safe Medication Practices (ISMP). FDA and ISMP Lists
of Look-alike Drug Names with Recommended Tall Man Le ers.
h p://[Link]/tools/tallmanle [Link]. 2011.
24 Ri D. Opinion: It’s Time for a National Patient Identifier; 2013.
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ItemNumber=21464.
25 Office of the National Coordinator for Health Information
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h ps://[Link]/sites/default/files/patient_identification_
matching_final_report.pdf. 2014.
26 Terry K. National Patient Identifier Struggles for Life. CIO; 2015.
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identifi[Link].
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h ps://[Link]/sites/default/files/docs/page/percentage-
[Link]. 2009.
28 Ash J.A., Fournier L., Zoë Stavri P., Dykstra R. Principles for a
successful computerized physician order entry implementation.
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Discussion questions
1. Discuss the reasons why some institutions experience significantly more
satisfaction or dissatisfaction during an implementation than do others.
2. What are some of the approaches that can be used to coordinate care
during an incremental go-live as patients are transferred from units that
have gone live to units still waiting to go live?
3. When developing new workflow processes using a systems approach,
the work of patient care or specific tasks often shift from one department
to another. While the new workflow can make the care provided to
patients more efficient and effective for the institution as a whole,
certain departments may experience more rather than less work. What
are some approaches that can help users accept the new workflow?
4. Workarounds develop when employees find a quicker and/or easier way
to complete a task. However, workarounds can create new and
dangerous situations. Given the motivation for developing a
workaround and the danger these can create, what are some of the
guidelines or principles that should be used in managing workarounds?
5. Should insurers offer incentives to patients to select healthcare providers
who are using EHRs to engage patients in managing their own care?
6. Review the EMR Adoption Model (EMRAM), an eight-step scale
developed by the HIMSS to monitor hospitals’ and health systems’ EHR
progress toward a paperless or near paperless system, at
h p://[Link]/emram. What are the characteristics of
the organizations who have successfully achieved Stage 7 status?
7. What are the advantages and disadvantages of a Healthcare Information
Technology Standards Panel (HITSP)–certified health IT system versus a
homegrown IT system that meets certification standards?
8. Should employees who have repeatedly failed to a end go-live classes
be subjected to discipline measures?
9. Identify creative strategies to encourage physicians and other clinicians
to participate in the implementation of a new health IT system.
10. Discuss ramifications and causes regarding interoperability issues
among electronic health systems and applications.
Case study
Middleville Hospital, located in a small rural town, is a 58-bed acute care
facility with both inpatient and outpatient services. The hospital consists of
more than 600 employees and more than 300 volunteers. It is a
community-owned, not-for-profit hospital dedicated to providing
compassionate, accessible healthcare close to home. The facility primarily
serves one major county and nine surrounding counties. The hospital has a
homegrown EHR system, but its functionality just barely meets
Meaningful Use Stage 2 criteria. The hospital’s primary goal is to
implement a certified EHR, but the leaders are weighing the benefits of
two options: recruiting a skilled professional to rebuild the current system
or purchasing a commercial system. There is pressure to make a decision
as soon as possible.
What are the musts, constraints, and barriers?
• The new system must be fully implemented and operational no later
than June 2017.
• The EHR must be able to meet MU Stage 3 criteria.
• The hospital has a very small IT department and a modest budget.
• The new EHR requires larger servers, new devices, central monitors,
printers, and tablets.
• The wireless infrastructure must be upgraded to eliminate known
dead spots in areas of the facility.
• The hospital wants to more effectively take advantage of select
features such as clinical decision support and incorporate best
practices or evidence-based medicine.
Discussion Questions
1. Based on what you read in this chapter and the case study, compile an
initial list of functional requirements (functions needed) for the new
EHR.
2. Create a brief evaluation plan by developing five or six criteria for
evaluating vendors’ products.
Case Study Follow-Up
The hospital made a list of all pros and cons of rebuilding a homegrown
system or buying a commercial product. Realizing that regulations
governing healthcare and reimbursement will only become more
complicated, the hospital decided to go with a vendor-supplied EHR.
Ultimately, it decided to purchase a fully integrated electronic health
system that shares a common database to eliminate the issues often seen
with interfaces.
Fourteen months later, the EHR went live house-wide for all staff,
including housekeeping and pastoral services. The implementation
included the functionality to meet MU and the installation of new servers
and hardware in addition to an upgrade of the wireless network. All staff
can even view a large monitor showing occupied, clean, and dirty beds
that is updated by housekeeping.
The new EHR benefits are many. Initially the physicians grumbled
about having to do “secretaries’ work” in CPOE, but they gradually came
to realize the benefits for their patients. Pharmacy reports a 55% decrease
in nonformulary medications and a 73% reduction in physician callbacks.
The time between a “stat” medication order and administration of the
medication and the time between a “stat” lab test order and posting of the
lab results have also decreased significantly. Due to the introduction of
order sets based on best practices and evidence-based medicine, the
hospital has seen a dramatic decrease in its 30-day readmission rates for
heart a ack, heart failure, and pneumonia patients compared to the U.S.
national average and now has the lowest rates in the county.
Discussion Questions
1. Brainstorm two additional factors you would evaluate for this
installation.
20
Downtime and Disaster Recovery for
Health Information Systems
Nancy C. Brazelton; Ann M. Lyons
Abstract
Healthcare entities are complex operations that are increasingly dependent on
computerization. This chapter identifies tactics related to planning for and responding
to computer downtime events and disasters. Focus areas include the clinical impact, the
information technology (IT) impact, business continuity, and communications. A model
for assessing the level of downtime response is provided.
The primary objectives for downtime and disaster planning are to protect the
organization and the patients served by minimizing operational disruptions.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Explain downtime risk assessment.
2. Analyze considerations for a health system inventory.
3. Describe an assessment tool for evaluating a downtime event.
4. Summarize the clinician’s role in system downtime planning.
5. Summarize information technology’s role in system downtime planning.
6. Establish key components of a business continuity plan for an
organization.
7. Formulate communication strategies for downtime in an organization.
KEY TERMS
application 338
bolt-on system 341
business continuity 348
clinical application 340
cold site 345
configuration management database (CMDB) 341
data center 338
disaster recovery 348
downtime 337
electronic data interchange (EDI) 340
electronic health record (EHR) 341
enterprise resource planning (ERP) 340
high availability 351
hot site 345
human-made disaster 338
incident response team (IRT) 347
information systems 337
natural disaster 338
picture archiving and communication system (PACS) 338
revenue cycle 349
service level agreement (SLA) 345
Introduction
Healthcare entities, no ma er how small or large, are extremely complex
businesses that are increasingly dependent on computerization in their quest
to provide exceptional healthcare. The employees of these healthcare
organizations move through a unique labyrinth of systems, machines,
workflows, regulatory requirements, business rules, and tools to provide the
best care for patients and their families and to keep the business intact.
Healthcare organizations select from a variety of vendors, adopt information
systems at different rates, and implement systems in the order that works
best for them.
Given the importance of information systems within any healthcare
entity, institutions and their employees must be prepared for the many
variations of downtime, including those caused by human errors, software
and hardware failures, severed power cables, software viruses that invade
the firewall, and disruptions caused by Mother Nature. The bulk of literature
around the topic of downtime is in white papers, blogs, and industry group
publications found via internet searches. The very few research articles
discuss current trends and strategies.1,2 The impetus to publish is often
spurred by a downtime event experienced by the authors, who encourage
readers to get plans in place.3–5 Anderson reports a study conducted by AC
Group that determined that each hour of downtime can cost $488 per
physician per hour.6 In their time and motion study, the authors determined
that a physician spends 2.15 minutes during recovery for each minute the
system was unavailable. A report estimates the average cost of a downtime is
$8000 per minute.7 The costs are staggering when translated to a large
healthcare enterprise. Given the cost and the risk to patient care, the
priorities for every healthcare institution are working to prevent downtime
and recovering quickly if an incident occurs.
This chapter focuses on practical, tactical ways to put plans in place for
managing health system downtime and disaster recovery. Tips and tools for
downtime risk assessments, downtime and disaster response planning,
clinical and information technology (IT) system recovery, and business
continuity are provided. The chapter also provides information on
developing a communication strategy and ideas for keeping patients safe
and the business functioning, because downtime does happen.
Downtime risk assessment
Planning for downtime can and should occur from project inception through
system support, and maintenance and must include all existing systems and
infrastructure. The complexity and criticality of the organization will
determine how extensive an exercise this must be. Potential types of
downtime and their impacts on the systems should be anticipated, and
mitigation plans must be put in place.
Downtimes can be classified by the root cause and the degree of impact. A
general network related incident or outage is different from a power outage
or a planned software upgrade. A single noncritical software application
may be unavailable, which will have a much lower impact than a total
outage of the admission, discharge, and transfer (ADT) system. It is
important to also consider the users or processes that are impacted.
Determining the root cause of a downtime is not always straightforward.
The first step is to determine what is and what is not functioning; however,
this first determination may not be the final answer. For example, a network
downtime may be diagnosed easily by asking the following questions: Can
you access the internet and the intranet? How about the computer next to
you? What about the computer on the unit downstairs? If the answer to these
questions is “no,” suspect an entire network downtime. However, networks
in many healthcare enterprises are now segmented for security purposes and
include a series of switches, firewalls with coded rules, as well as the actual
fiber network, cable pulls, and other components. This makes diagnosis of
the specific network problem or the location of the problem more complex,
potentially increasing the length of the network downtime. Also, external
factors may exist, such as telecommunication fiber vendors that may be
having problems as well as the millions of miles of fiber infrastructures
vulnerable to physical damage, commonly referred to as “backhoe outage.”
Thus the first step in preventing or managing a downtime is to determine
what might cause a downtime and then to perform a risk assessment of the
impact for each potential downtime. This step can be iterative with step three
discussed below, which is compiling an inventory of existing applications
and systems. Classifying all potential downtimes and pu ing them into
mutually exclusive categories can be difficult. It is usually best to start by
identifying the most common technology source of downtimes and
document these. A systematic approach starting with infrastructure is more
likely to ensure a comprehensive list. Begin by dividing the infrastructure
into IT infrastructure and physical infrastructure.
IT infrastructure includes the network and application delivery systems,
such as those listed in Box 20.1. Examples of physical structures include
those listed in Box 20.2. Some overlap exists between the IT infrastructure
and the physical infrastructure, and partial versus complete downtimes must
be considered. Box 20.3 includes examples of both IT infrastructure and
physical infrastructure. The order of the elements does not reflect their
priority. Networks include both hardware and software components and
therefore need to be examined from both aspects.
Box 20.1
Sample Elements of Information Technology
Infrastructure
• Electronic health record software
• Clinical and ancillary system software (e.g., physiologic monitoring,
endoscopy, registry databases)
• Picture archiving and communication system (PACS)
• Laboratory applications
• Cardiology applications
• Radiology applications
• Anesthesia systems
• Surgical processing systems
• Revenue cycle software
• Interfaces or the interface engine
• Enterprise data warehouse
Box 20.2
Examples of Information Technology Physical
Structure
• Hardware related to the chillers that keep the data center cool
• Storage (physical hardware that stores the electronic health record, e-mail,
and other third-party systems)
• Electrical power
• Network switches and hubs
• Biomedical devices
• Any component of the buildings themselves
Box 20.3
Information Technology and Physical
Infrastructure
IT, Information technology; UPS, uninterruptible power supply.
The second step is to identify the most common potential causes of a
downtime in the facility, areas of vulnerability, and the most likely scenarios
of natural disasters or human-made disasters in the geographic area. Is the
facility or data center on an old or outdated power grid? Is the building only
rated to withstand a 6.5 magnitude earthquake in an area where experts
predict one much stronger? Is the facility’s generator located in an area that
is vulnerable to flooding? Common disasters are noted in Table 20.1; these
lists are notmutually exclusive but instead provide a starting point for
planning at a specific organization.
Table 20.1
Downtime Vulnerabilities and Common Human-Made and Natural
Disasters
Most Significant Downtime Vulnerabilities Human-Made Disasters Natural Disasters
Buildings or data center not to current code or vulnerable to Biologic: Intentional Biologic
natural or human-made disasters
Cyber a ack Cyber a ack Dam failure
Lack of recovery site Explosion: Intentional (bomb) Drought
Lack of disaster planning or business continuityplanning Explosion: Unintentional Earthquake
(natural gas line rupture)
Lack of backups or inability to recover from backups Fire Fires, wildfires,14
smoke
Lack of high availability or failover for critical systems or Hazmat incident Flood
applications Heatwave
Lack of downtime planning Nuclear incident Hurricane
Outdated or aging physical infrastructure Pandemic Landslide,
mudslide, debris
flow
Outdated or aging technology (i.e., not on current or supported Terrorist a ack Pandemic
level of code or servers that are no longer supported)
Power grid and supply Workforce violence, shootings, Snowstorm,
loss of life of key personnel blizzard
System resources at or near capacity (disk space, database, Space weather,
storage, etc.) geomagnetic
storm
Tornado
Tsunami
The third step is to complete an inventory of all systems and document
them. All systems in use at the organization should be inventoried, because
each is important to some aspect of the business. A sample inventory is
located in Table 20.2.
Table 20.2
System Inventory Considerations
Type of
Examples
System
Core clinical Electronic medical record (EMR), electronic health record (EHR), emergency department,
applications computerized provider order entry (CPOE), clinical documentation, medication administration
record (MAR), surgical services, and anesthesia information system
Ancillary Pharmacy, radiology and imaging, laboratory, arterial blood gas, cardiology, endoscopy, respiratory,
service and neurology, nutrition care, dictation, health information management, biomedical devices (physiologic
procedure monitors, vital sign machines, intravenous pumps, ventilators, pneumatic tube systems, etc.)
area
information
services
Online Drug information references; patient education; policies and procedures; disease, diagnosis, and
reference interventional protocol databases; formulas or health-related calculators
databases
Revenue cycle Admission, discharge, and transfer; enterprise scheduling; preauthorization; facility and technical
billing; health information (HIM), document management (scanning), coding; professional and
physician billing; claim scrubbers; print vendors; address verification; electronic data interchange
(EDI) transactions; benefit checking
Business, E-mail, office software, cash collections, credit card transactions, banking, business intelligence,
finance, and reports and reporting, supply chain and enterprise resource planning (ERP), budgeting, human
personnel resources, payroll, staff scheduling, keyless entry, facilities and engineering, telephone systems and
wiring, telephone operators, paging systems, wireless communication devices
Miscellaneous Printers, Bluetooth devices (scanners, label printers), reports, data warehouse, barcode scanning,
print vendor, internet-based public web pages, intranet and related internal web sites, wikis, clinical
health information exchanges, retail outlets (retail pharmacies, gift shops, food service)
Note: This is not a complete list.
An inventory list can be surprisingly difficult to compile and may involve
doing walk-throughs of departments and units to observe systems and
devices that end users are actually using in their day-to-day workflow. This
is especially critical if the institution has a hybrid system (i.e., a system using
multiple vendors for specific functionality). For instance, the ancillary
systems within a hospital often have a limited amount of data requirements
but highly specific ones. For example, the pharmacy may have homegrown
applications perhaps to assist in adjudicating pharmaceutical costs in
addition to major modules in an electronic health record (EHR). These
unique systems are added on to the main EHR because of the need for
specific functionality or perhaps because the ancillary application was built
and implemented prior to the EHR. Table 20.3 lists areas that may have
special considerations within an acute care se ing. In addition, readers
should remember to bear in mind the outpatient and ambulatory se ings
that may have unique requirements as well as specialty populations such as
pediatrics8 or geriatrics.
Table 20.3
Special Considerations by Area for Acute Care Setting
Area Specialty Requirements
Anesthesia Ventilators, anesthetic gases, frequent vital signs
Automated charge Can be from many systems
capture
Cardiac catheterization Hemodynamic monitors, image capture, documentation for registries
lab
Emergency department Tracking patients in the waiting room and through the department
Endoscopy Image capture and specific discreet documentation for registries or billing
Health information Coding, release of information, maintenance of the legal medical record, legal cases,
insurance queries, scanning solutions
Physicians, advanced CPOE, clinical decision support systems, diagnostic test results, dictation
practice clinicians
Newborn intensive care Bedside monitoring and extracorporeal membrane oxygenation devices, ventilators,
intravenous pumps
Nursing Care planning, CPOE, Bar Code Medication Administration or electronic medication
administration record, telemetry, patient communication systems with nurses, clinical
decision support reminders, nursing databases (e.g., patient education resources)
Nutrition care Assessments, nutrition care system, consultation notes, CPOE
Obstetrics Fetal monitoring, mother and baby monitoring and documentation during the labor period,
preterm wave forms, information from mother's record that needs to be available on
newborn's record for continuity of care
Outpatient procedure Point of care systems, registration and scheduling, medication-dispensing machines (i.e.,
areas Pyxis and Omnicell)
Pharmacy Medication dispensing machines (Pyxis and Omnicell), robots, inpatient versus retail
pharmacy ordering systems, intravenous pumps that contain drug-specific information
(Alaris, etc.), pharmacy ordering system often interfaces with the medication supplier
Physical, occupational, Therapy systems have specific patient education content
and speech therapies
Physiologic monitoring Often supported by biomedical engineering and has vendor-specific content
Radiology, imaging, Image and procedure capture, multiple modalities, questionnaires
and picture archiving
and communication
system
Respiratory therapy Contains respiratory measures like ventilator se ings, ventilator weaning parameters,
respiratory treatments and measurements
CPOE, Computerized provider order entry.
To locate applications, consider functional operations, type of personnel,
data and information being processed or consumed, how and where vital
records are housed, and policies and procedures that guide the business or
practice.9 This compilation will involve persistently reaching out to all
members of the IT team or others who host applications or provide some
component of infrastructure for input. The more specific and complete the
inventory, the more useful and helpful it will be in the event of an actual
planned or unplanned downtime. Due to the difficulty of ge ing a very
complete inventory, it is best to start with the most critical applications and
work on less critical ones later. Minimally, the inventory should include the
items listed in Box 20.4.
Box 20.4
Inventory Items
• Vendor name
• If developed in-house, where is the source code and other
documentation?
• Date of contract and its current location
• Application or module name
• Date of original go-live
• Current version
• Date of upgrade
• Categorization (site defined): major/minor, Tier I/II/III, other
• Host model (where the application or service is located): in-house or
remote
• If remote, supported by whom?
• Interfaces, both inbound and outbound
• Third-party bolt-on systems
• Other key dependencies
• Primary use
• Primary users and number of users
• Business owners
• Information technology contacts
• Notes and comments
Other data useful for general system support and downtime planning
should be carefully documented as well. These items may be part of the
application inventory, or they may be housed in a separate document,
including those listed in Box 20.5.
Box 20.5
Elements for General Systems Support
• A checklist for the IT team to follow when a planned or unplanned
downtime occurs
• Checklists and role definition cards for the clinicians, caregivers, and
registration staff
• Known system vulnerabilities
• Documentation of frequent error messages
• Pa erns of error messages indicating known problems or pending system
failure
• Knowledge objects used in supporting or maintaining system
• Contact information with phone numbers for vendors and the teams
supporting the application
• Service level agreements with key users of the application
• Preferred user communication plan for planned and unplanned
downtimes
• Plan to deploy nonclinical staff to support clinicians or perform duties
assigned by the command center
• Unit- or department-based workflow diagrams
• Unit or department blueprints that document all electronic devices
connected to the wired or wireless network
• Agreed-upon time for planned changes and maintenance work, also
known as a change window
• Policies, procedures, rules, or standards from information technology or
the broader organization applying to the particular application
System dependencies, configuration diagrams, and interface data should
also be documented and stored in a place that is easily accessible and backed
up on a routine basis as the final step. Best practices for maintaining this
inventory and documentation from an Information Technology
Infrastructure Library (ITIL) perspective is a configuration management
database (CMDB) that has configuration items unique to the organization.
However, many tools or combinations of tools are available for this purpose,
such as shared drives and folders, spreadsheets, databases, vendor-supplied
tools, wiki sites, collaboration software, document management systems
repositories, or even simple paper notebooks.
With the appropriate data collected, IT should work very closely with the
organization’s emergency preparedness and disaster planning groups in
planning for disasters. Having some component of IT downtime as a part of
disaster drills is a very effective way for IT and staff to practice disaster
response and hone plans. The federal government has published many
helpful articles and websites to assist in institutional and personal planning
and in case of an actual [Link] include the Federal Emergency
Management Agency (FEMA) website at [Link] and several others,
including the National Incident Management System (NIMS), Public Health
Emergency and the U.S. Department of Health and Human Services, and an
educational curriculum developed the Veterans Health Administration
(VHA).10–13
Downtime And Response Planning
Once the system documentation is developed and the risks are understood,
the healthcare institution is ready to define the different types of potential
downtimes. These can be depicted on a continuum indicating the degree of
significance for each potential downtime. The significance of the different
downtimes will depend on the level of complexity and the installed base of
the institution. For example, if the organization has results review
implemented and a single results feed is down, the response will be very
different than if the organizations has a mature EHR and the network is
unavailable. Context makes a difference. For instance, is this a physician’s
office with a single provider and a very experienced staff or a huge
integrated delivery network (IDN) spread across multiple states or
geographic regions?
Consider both planned and unplanned downtimes. If a downtime is
scheduled, there should be ample time to plan; however, if the downtime is
unexpected, no contingency plans may be in place. A worst-case scenario of
an unplanned downtime is a total loss of the network occurring midweek at
the start of the business day when the hospital and clinic schedules are full,
all operating rooms are in use, and the emergency department is busy and
expecting two traumas (one via flight service) on a snowy winter day when
20% of staff is late due to road conditions.
Table 20.4 identifies a number of elements that will influence the impact of
an individual downtime. The list in Table 20.4 is not intended to be followed
linearly. Different scenarios or error messages will lead down different
paths, just as different symptoms might lead to different diagnoses in patient
care. In direct patient care, readers would take different actions if a patient’s
temperature increased by a half-degree Celsius and the heart rate increased
by 10 beats per minute over the last 45 minutes, as opposed to if a patient
had a sudden decrease in heart rate to 30 beats per minute. Some events
allow for a measured response, whereas others require immediate a ention.
The same process occurs when managing EHRs or other systems. Being able
to quickly translate error messages and recognize pa erns are keys to
reducing the length of the downtime and restoring clinician and staff
workflow.
Table 20.4
Impact Considerations
A ribute Continuum
Expected or actual duration ≤ 1 h to > 4 h; should also plan for catastrophic events in which network or
systems may take weeks to months to rebuild
Time of day The slowest night of the week to about the busiest day of the week (think OR
scheduling pa ern)
Number of users affected and scope Single user or department to the entire facility; partial to full; single system or
of outage infrastructure component to complete loss of application, network, or building
IT infrastructure Intact to completely damaged and replacement parts need to be ordered
Impact on workflow Users are able to carry on activities with minimal disruption to complete
change in workflow reverting to paper/manual systems
Complexity of IT installs and Single system with review-only functionality to an organization that is > 90%
criticality of applications electronic and paperless with multiple systems for all business and healthcare
requirements
Planned or unplanned Downtime scheduled during agreed-upon service level agreement and system
comes back up as promised to an unexpected system-wide downtime with no
estimated time to recovery
Complexity of health system or Single office to multistate integrated delivery network; office that still keeps
complexity and criticality of unit or paper records to a fully electronic ICU with patients on multiple assistive
department affected devices
Communication methods and Communicate in person or via two-way radios or satellite phones until
mechanisms communications systems are back online (analog phones, VOIP phones,
paging, cellphones, internet, intranet, faxing)
Redundancy of infrastructure and No redundant systems or infrastructure to fully redundant, highly available
the ability to recover system in a co-located data center
Maturity of downtime plans, No plans or supplies to mature and tested policy, procedure, and plans with
policies, and procedures and stocked supplies and staff aware of them
availability of backup supplies
ICU, Intensive care unit; IT, information technology; VOIP, Voice Over Internet Protocol.
Once the organization has clear definitions for downtimes and has
methods of assessing the significance of potential events,4 the emergency
preparedness and disaster planning team can develop the response,
communication, and recovery plans. A comprehensive and accurate
assessment will provide a reliable starting point for the team responding to
the downtime, thereby decreasing chaos and saving critical time at the start
of an event. The downtime plan will include different levels of interventions
for various events. For example, a downtime event with a simple application
may be managed with a decision tool. An example of a simple decision tree
is shown in Fig. 20.1. However, this same approach may become too
cumbersome when dealing with multiple systems. In these cases, an
organization may use a “level” system such as the one shown in Table 20.5.
FIG 20.1 Simple downtime decision tree.
Table 20.5
Downtime Levels
Definition Response Examples
Level Part of a system down or unavailable but IT team and targeted users only are involved per standard SLA.
1 minimal impact and no loss of content or data Service desk agent communicates with user.
integrity. Expected time to recovery less than
1 hour.
Level Complete system unavailable, data may be IT team and targeted users are involved per standard SLA.
2 unavailable, and data will have to be entered Unit-based downtime plans invoked. May require additional
into the system to maintain integrity. communication to stakeholders and plans for reentry of data.
Expected time to recovery up to 4 hours.
Level Multiple systems unavailable, big impact on IT incident response team involved along with multiple teams.
3 workflow, and content may be unavailable Downtime plans invoked. Broad communication to the
and will have to be entered into the system to organization. Notification to key stakeholders and
maintain integrity. Expected time to recovery administration. Plan for reentry of data.
greater than 4 hours.
Level All systems and network unavailable but root IT incident response team involved, along with multiple teams.
4 cause is known and recovery is possible. Downtime plans invoked. Broad communication to the
Users must complete downtime plans. organization. Notification to key stakeholders and
Estimated time to recovery greater than 4 administration. Plan for reentry of data. May involve
hours. emergency response team and opening of command center.
Level All systems and network unavailable. Major All hands on deck and event directed per emergency response
5 catastrophic event and facility structure may team or administration. May require communication to the
be compromised. Systems and infrastructure wider community.
need to be rebuilt. System-wide emergency
plans and response invoked.
IT, Information technology; SLA, service level agreement.
With a downtime event involving multiple systems, the use of a tool to
quickly assess the significance of the downtime event will help the IT team
and users determine which of the predefined responses should be invoked.
One example of such a tool is the Downtime Determinator depicted in Fig.
20.2, a tool developed by the authors. The x-axis is the length of downtime
(or time to recovery) and the y-axis is the impact and risk. Each of the seven
risk a ributes is plo ed on the Downtime Determinator tool in one of the
four quadrants, and a pa ern or cluster of numbers will start to emerge. The
pa ern of numbers becomes the basis for evaluating the event.
FIG 20.2 Downtime Determinator Model.
Using the risk a ributes described previously, quadrant responses would
be defined by the organization and might be similar to the earlier examples
provided with the levels. For example, when the majority of numbers cluster
in the lower left quadrant, this should invoke a quadrant 1 response;
numbers clustered in the upper right quadrant should invoke a quadrant 4
response. The lower left quadrant represents the least critical events, and the
upper right quadrant represents the most critical events. The Downtime
Determinator displays the numbers 2/3 and 3/2 in the upper left and lower
right quadrants, respectively. Each organization will need to assign
quadrants 2 and 3 based on its assessment of each individual downtime
event, after considering the impact and risk versus time. There may be times
when the length of the downtime is so long that the event warrants a
quadrant 3 (more intense) response. There may be other times when the
event is so massive that even though the downtime is scheduled for 30
minutes, the impact to the organization is so great that it warrants a
quadrant 3 response.
The Downtime Determinator is similar to the “level” system mentioned
earlier, as both have four categories. However, the Downtime Determinator
allows for more specificity and nuances in responses because each of the
a ributes can be considered separately and responded to in relation to other
a ributes. When using a tool such as the Downtime Determinator, each
organization would customize the tool by defining each a ribute and
delineating time along the x-axis that is significant to the organization. Four
scenarios are outlined below using the Downtime Determinator, ranging
from least to most impact:
• Scenario 1: Level I trauma center and teaching hospital. Planned EHR
downtime from 02:00 to 05:00 on a Wednesday night. IT infrastructure
and communications intact (Fig. 20.3).
FIG 20.3 Downtime determinator Quadrant 1 example.
• Scenario 2: Community hospital. Unplanned downtime of the hospital
billing system at 15:30 on a Monday. Multiple staff unable to do work,
but patient care is not affected. Recovery expected in 3 hours. System
requires replacement of a hard drive; the hard drive is available locally,
and it should be delivered to the data center by the vendor shortly.
Communications intact (Fig. 20.4).
FIG 20.4 Downtime determinator Quadrant 2 example.
• Scenario 3: Acute care hospital with multiple intensive care units (ICUs)
with a physiologic monitoring system interfaced to the EHR via bedside
medical device integration (BMDI). The vendor-specific server is
damaged due to a water spill in the communication closet, and the
BMDI unexpectedly quits working at 08:00 on a Saturday morning. The
vendor indicates a 2-week lag until a replacement server will be
available (Fig. 20.5).
FIG 20.5 Downtime determinator Quadrant 3 example.
• Scenario 4: An F-16 military airplane crashes into the data center of an
academic medical center at 19:00 on a Friday night during training
exercises. The data center is destroyed physically, a large fuel spill
covers the area, and there is complete IT system downtime. The hospital
and campus are otherwise intact. The academic medical center has a hot
site that can host approximately 30% of critical systems and a cold site
that has capacity to host the remainder of the systems. The critical hot
site applications can be available in 24 hours, but the remaining 70% of
applications to be built in the cold site will take 30 days for complete
recovery (Fig. 20.6).
FIG 20.6 Downtime determinator Quadrant 4 example.
As seen with these scenarios, the clustering of numbers helps guide the
response of the organization in managing the event or disaster. A quadrant 1
event (scenario 1) should be a routine event that is managed with standard
processes, communications, and service level agreements (SLAs) that are
already in place. With a quadrant 4 major disaster (scenario 4), the response
y p q j p
should be massive and system- and organization-wide. Such a disaster
would have a significant impact on the ability of the organization to carry on
the business of healthcare. Taking time to plan and put realistic processes
into place before the event will determine whether the organization will
continue to care for patients safely and have the business remain intact.
Clinical Impact and Planning: Acute Care Focus
With the increased use of technology at the point of care and in the clinical
environment, healthcare organizations must now precisely determine their
response when technology is unavailable. How do clinicians find historical
data, including recent vital signs, the first of three troponin results, the
history and physical prior to surgery, and the last time the PRN (as needed)
pain medication was given, with the patient’s response to it? How do
healthcare providers document new events, medications, orders, and
treatments? How does the pharmacy dispense a medication and keep track
it? How do ancillary systems such as radiology and pharmacy receive
handwri en orders? Do the computerized supply cabinets have
programming that permits overriding the system and, if so, how are charges
captured after the fact? These are a few of the potential problems that may
arise at institutions in the event of EHR unavailability. Each addition to the
technology in use can produce unintended consequences and in turn affect
the initial assessment and resulting plan. A 4-year analysis of the unintended
consequences of computerized provider order entry (CPOE) identified nine
types of unintended consequences.15 A list of these unintended consequences
is included in Box 20.6.
Box 20.6
Unintended Consequences of the Impact of
Computerized Provider Order Entry
• More/new work issues
• Workflow issues with mismatch of order entry and related activities
• Never-ending demands
• Paper persistence
• Communication issues with changes in communication pa erns
• Emotions
• New types of errors introduced by use of a computer
• Changes in the power structure
• Overdependence on technology
Modified from Ash JS, Si ig DF, Poon EG, Guappone K, Campbell E, Dykstra RH. The extent and
importance of unintended consequences related to computerized provider order entry. J Am Med
Inform Assoc. 2007;14(4):415-423.
Logically, the more electronic components in the organization, the more
complex troubleshooting becomes. The elements that need to be considered
include inpatient and outpatient venues, networks, intranets, printers,
databases, interfaces, storage hardware, published applications, and layering
software used to manage the myriad devices in an institution. Failure at any
of these points may result in some sort of downtime for clinicians. Reducing
the risk of a downtime can be accomplished by using the approaches
outlined in the following sections.
Redundant Systems
Redundant systems, also known as backup systems, provide clinicians the
ability to access some if not all patient data during an electronic downtime. If
clinicians can recover just enough information to carry on with patient care
from the point at which the downtime begins, care can proceed safely.16
Therefore a subset of critical data must always be available, even during
downtime. Each individual organization should define the required subset of
data according to applications and services. Suggestions are basic
demographics, orders, medication administration records (MARs), most
recent vitals, laboratory values, imaging reports, and physician and provider
progress notes.
Vendors are increasingly responding to the need for improved downtime
solutions. As an example, a vendor might install one or more stand-alone
machines in each patient care area, depending on the average patient census
and geographic layout of the unit. Each machine might be designed to store
a subset of historical patient data for up to 30 days. During a downtime, staff
access these machines to retrieve patient-related data. Obviously, once the
downtime begins, these systems will no longer be updated, and new patient
data that are generated must be maintained manually. These data must be
entered back into the EHR by keying them into the system or scanning them
in after the system is up again. Because healthcare providers may need
printed data during the downtime event, each machine should be directly
connected by cable to a printer so it is not dependent on the down network
connection for printing services. Another benefit of these machines is that
they can be portable. In the event of a hospital evacuation, these machines
can be removed from the premises and data from these machines can be
used until a recovery plan is in place.
However, this particular redundant downtime solution has limitations.
One concept that is difficult for clinical and IT staff to understand is that once
the network becomes unavailable, these downtime machines are no longer
updated with patient information. This requires the healthcare providers to
check the new manually recorded data as well as the historical data
maintained in the temporary system when providing care. Another
limitation is that the data may be organized differently than in the EHR, and
as a result, information may be displayed or printed in a different format.
This can cause confusion and even errors in patient care. Also, data entry for
the downtime may not be complete, resulting in a fragmented or incomplete
record.
The downtime solution using temporary machines must meet Health
Insurance Portability and Accountability Act (HIPAA) requirements for
security, privacy, and confidentiality. As a result, these machines require an
extra layer of encryption to prevent information theft in the event that the
machine is removed from the hospital. However, these encryption systems
typically are add-ons that slow down the response time of patient care
applications running on the machines.
Other terms used to describe redundant systems are shadow, mirror, or
read-only systems. The downtime system described previously is a shadow or
mirror system that is only able to be read by clinicians. Clinicians cannot add
any patient data to this type of system. Some shadow or mirror systems
duplicate the EHR. In the event that the primary system crashes, the
secondary system automatically, and hopefully seamlessly, transitions the
clinician to the secondary system. The clinician continues to document
orders, medications, or care. Generally, these systems reside on separate
hardware that “mirrors” the configuration of the primary system. These
systems are generally more robust than the redundant downtime solution
described previously, encompassing a similar look and feel and often read
and write capability. These systems are beneficial because clinicians use their
current log-in and password to access the system, the look and feel of the
system are almost identical to the EHR, and printing can be available.
Redundant systems often resemble the configuration of the existing EHR,
requiring a substantial financial investment with the vendor. The financial
investment can be an obstacle; therefore a business case should be made with
and for the clinicians on behalf of patients. The more mature the EHR, the
more dependent the clinicians are on the system to get information to
provide patient care. Investing in a backup system of this caliber is arguably
a necessity after institutions have reached a certain level of EHR maturity,
and organizations should assess this requirement frequently.
In addition to the previously discussed solutions, homegrown, web-based
solutions are available for use by clinicians prior to a planned downtime. For
example, a web-based solution may be configured so that clinicians can print
an MAR or all current patient orders. These have proven helpful during
planned upgrades because they provide clinicians with enough information
to weather the upgrade as well as provide a place to begin manual
documentation of patient care during the downtime.
Downtime policies and procedures
Approved downtime policies and procedures are needed to guide the
clinical team. These policies should be prescriptive, include roles and
responsibilities, and define workarounds or manual procedures that allow
for the continuity of critical functions. They should include specific
instructions about required data entry to the legal and permanent EHR
record at the conclusion of the downtime. Examples of downtime policies are
available in the literature and on the internet.16–19
A best practice is for patient units to have up-to-date, physical
“downtime” boxes.21 Each box contains documentation forms specific to the
patient care area, instructions for paper form completion, and a plan for
managing the paper documents on the unit. For example, ICUs may revert to
traditional six-panel paper flow sheets. Other patient care areas have
screenshots of the electronic “patient admission” form or other forms
directly from the EHR. When no preprinted forms are available, blank or
lined pieces of paper are used and work as long as healthcare providers are
aware of documentation requirements. Each downtime box should be
stocked to last at least 24 hours and have instructions for restocking the
forms. Each patient care area is expected to maintain and customize the
contents of its “downtime” box.20 Informaticians can partner closely with
clinicians to create downtime policies and procedures to ensure that clinical
requirements are matched with available IT solutions.
Information technology impact and
planning
The IT impact and downtime risk can be reduced by following a systematic
process when changes are applied to the “production” or “live” system. One
approach is to organize a service management program to organize a risk
assessment and downtime planning document. Service management is a
discipline for managing IT systems that focuses on the customer and the
business and its operations, as opposed to simply being technology-centric.
The service life cycle includes service strategy, service design, service
transition, service operation, and continual service improvement.21
Interestingly, this life cycle is similar to both the system development life
cycle used to implement computer systems22 and the nursing process.23
Various process-based systems exist to assist the IT team in instituting a
service management program, including ITIL,21,24 Six Sigma, and total
quality management (TQM). These systems require the use of standardized
terminology, problem identification and management, change control
measures, and communication pa erns. The benefits of using these systems
are agreed-upon, realistic service levels; predictable and consistent processes;
metrics; and alignment with business needs.
Implementing a service management program requires financial and time
commitments from the organization, the IT executives, and all members of
the IT team, but is well worth the investment. Commitments are needed
from the IT staff to fill roles on commi ees such as the change advisory
board, incident response team (IRT), and IT service management. The
benefits of a service management program include having a framework with
clear rules and processes to structure IT activities so fewer unplanned events
occur. One of the disadvantages of a service management program is that the
program will invariably increase the time to implement new code or new
functionality. This additional time might turn into an advantage, as waiting
may reduce knee-jerk reactions from users. It also gives the IT team more
time to test the new functionality and discover any dependencies. Waiting
also benefits clinicians because they can negotiate a standard change time
and reduce unnecessary downtimes.
Disaster planning
Organizations are obligated to maintain contingency and disaster plans in
order to be compliant with the HIPAA security rule of 1996, the U.S.
Department of Health and Human Services, and accreditation bodies. A
separate set of IT policies should exist to supplement the organization’s
overall disaster plan and include security and privacy components. Senior
leadership of the IT department, the security and privacy office, the
emergency preparedness group, and senior leadership from the broader
organization should review and approve the plans.9 These plans should be
frequently reviewed, tested, and revised as needed. Staff need to be updated
on a consistent basis so they are prepared to implement contingency and
disasters plan with minimum effort. Considerations for the IT components of
an IT disaster plan are listed in Table 20.6.
Table 20.6
Information Technology Contingency and Disaster Recovery Plan
Considerations
Data from Hoong LL, Marthandan G. Factors influencing the success of the disaster
recovery planning process: a conceptual paper. Research and Innovation in Information
Systems (ICRIIS), 2011 International Conference. 2011;1-6:23-24.
doi:10.1109/ICRIIS.2011.6125683; Federal Emergency Management Agency (FEMA). IT
disaster recovery plan. <[Link] 2012.
IT, Information technology; SPOF, single point of failure.
Once contingency and disaster plans are implemented and at the point
when the institution is converting back to its standard systems, the
organization needs to be prepared to test the clinical system rapidly to
ensure that all aspects of the system are functioning as planned. Therefore
having up-to-date test plans for all clinical systems is an integral part of
turning around a downtime quickly once hardware and database issues have
been resolved. Software upgrades can and do occur frequently. If the test
plans are not current, the testing process may not be reliable. In addition,
without systematic preplanned processes in place, it is difficult to enlist the
help of non-IT people. Keeping test plans up to date ensures that people
external to the recovery team can assist with testing and ge ing the system
online sooner.
Disaster Recovery
Preparedness and planning are the keys to disaster recovery following either
a simple incident or a catastrophic event. In fact, the process of planning can
be as beneficial to an organization as the final wri en plan. Recovery should
include all components identified as crucial: network, servers, connectivity,
data, telecommunications, hardware, software, desktops, security, wireless,
and any other specific items.
The goal of disaster recovery is to recover the business fully and
completely. Depending on the severity of the event or disaster, it may be
necessary to do an incremental recovery. Key administrative leaders, with
input from the staff, should be involved in the decisions about the sequence
of recovery of systems or applications. All employees in an organization will
likely have changed workflows during the disaster, and it is important that
they understand their roles during the disaster or downtime and during the
recovery period. The steps to actual recovery will be different for each event
and for each organization. Because of this complexity and the time involved
to develop a comprehensive disaster recovery plan, an organization may
choose to hire outside consultants instead of using internal resources.25,26
Business Continuity
Business continuity management is a complementary process to disaster
recovery. Business continuity has a larger scope than recovering only IT
systems. It also includes determining which administrative and healthcare
services must be available using a defined timeline and identifying which
systems can be excluded from initial recovery. Business continuity
management outlines the functions, processes, and systems needed to allow
the core business of providing health services to continue.
A tier system works well for this purpose, and each organization will have
unique requirements. For example, Tier I applications would be identified as
critical and are recovered first. The organization defines the expected time to
recovery based on the requirement for service and available resources. As a
general rule, the faster the recovery must occur, the more expensive the
recovery process will be. The cost should also be evaluated in comparison
with the cost of the downtime. For a Tier I application to be recovered in 24
hours or less, it is likely that a hot site would be required with hardware
standing by. Tier II applications would come next and may be identified as
needing to be available within 72 hours. Finally, Tier III and Tier IV may be
identified as requiring recovery within 1 week and 1 month, respectively. For
healthcare, business continuity includes providing care of both patients and
the revenue cycle. Defining business continuity should be a formal process
that includes the following:
• A business impact analysis that takes into consideration the institution’s
business needs and the needs of the community for healthcare services
• Definition of recovery strategies
• Development of a formal plan
• Exercises to test the plan
As with other elements discussed previously, this process will need
resources (both human and financial) from the organization’s senior
leadership.27,28
Part of business continuity includes the downtime boxes mentioned earlier
in this chapter. Every business unit needs to have a downtime box that
includes items such as registration forms, charge sheets, fax forms, and other
commonly used forms for that business area. Consider keeping paper
instructions about how to fill out and use paper forms in a downtime box.
This is important because some of the newer clinicians have never wri en
paper orders or documented a clinical assessment on paper. In addition, it is
a good idea to have these documents stored on a portable media device to be
kept in the downtime box. In the event of a disaster, these forms can be
stored on a second portable device and kept in a secure location.
Organizations should make specific assignments to ensure that these are
kept up to date and staff review the downtime box procedures periodically.
Communication
Communication is an integral part of any downtime. Five components of
communication plans are needed to determine the following:
• Who needs to know the details?
• What details are needed?
• What media or modes of communication will be used?
• Who will communicate what information?
• What systems or workflow processes are affected?
Of course, the more complex the downtime is, the more people need to be
notified and the more information needs to be communicated. For example,
if the bedside monitoring device is not transmi ing data to the EHR, only the
ICU staff need to be notified. If the EHR database becomes corrupt, then all
clinicians who use the system will need to be notified, as well as all IT teams
and possibly hospital administration and the risk management department.
Fahrenholz et al.18 compiled a downtime communication template useful
to readers. Their questions are as follows:
• What system will be down?
• When will the downtime begin?
• How long will the system be unavailable?
• Why will the system be down?
• What changes are being made to the system?
• Who will be affected and what can the end user expect?
• What procedures should be followed during the downtime?
These guidelines can be adapted for any facility’s use during both planned
and unexpected downtimes.
If the facility uses a tool for IT service management such as ITIL, the
procedures discussed here will be used. If people in the facility do not use
one of these systems, they should use other sources29,30 to develop policies
and procedures to ensure that communication is managed properly.
Communication occurs most predictably and reliably when the
responsibility belongs to one consistent team or group of people. A service
management or equivalent team works well to manage the communications.
Whoever is designated as the primary communication team must work very
closely with the IRT and the help desk. Communications are coordinated,
and the help desk is kept informed of the event and of the information it
should supply to end users as inquiries are made about the event. The help
desk is critical to communication, as in most cases, staff experiencing
technical problems will contact the help desk first. Plus, in most healthcare
institutions, the help desk staff are on-site and have on-call agents available
24 hours a day. Training the help desk staff to manage these communications
allows the infrastructure and application teams to work on resolving the
problems. Some tools that might be used in addition to managing the trouble
ticket queue are continuous or intermi ent conference calls, individual and
group paging for the IT department, individual and group instant
messaging, webcasts, updated web pages, group e-mail updates, recorded
phone messages, and coordination with hospital operators. Multiple means
of communication need to be considered when planning for an event. The
technical problems causing the downtime or the disaster event may also
eliminate certain communication modes. For example, if the network is
down, an e-mail cannot be sent with information about managing the event
to the clinical units and Voice Over Internet Protocol (VOIP) phones will not
work.
The hospital telecommunications operators can manage many aspects of
the communication plan, including individual and group pagers, cellphones,
tablets, and other communication devices for clinicians and the operational
areas. Sending information to these communication devices may help
manage information distribution during sudden or extended downtimes. A
best practice in the age of internet-based phone systems is to have some
analog phones available in key hospital areas because they function during
network and electrical downtimes. These phones can be identified by using a
different color of phone, such as red. Hospital telecommunications operators
can also use the overhead paging system in the hospital to distribute
information. The point is to be sure to include these hospital operators in the
downtime communication plans.
In the event of a major disaster, satellite radios and phones can be used.
Satellite phones and radios are network independent but require electricity
to recharge their ba eries. The local emergency management office in the
organization will have more information about these capabilities.
Responsibilities
The IT staff is responsible for communicating the necessary information to
the help desk agents. In addition, some electronic systems contain
notification alert capability. For example, planned downtimes can be
communicated using the notification system in the facility’s EHR. Obviously
this method would not be available during an EHR downtime, but it can be
used to announce a planned downtime or when any of the ancillary systems
are offline.
IT leaders are responsible for communicating with the organization’s
senior leadership and the public relations department so they can manage
media relations with the community. Social media applications can also be
used to manage information with the media and to distribute information to
staff in the event of a downtime (assuming that staff members have
subscribed to the service and the service can provide the appropriate level of
security and privacy).
Other mechanisms may be in place, depending on the institution and the
se ing. For example, if the institution is affiliated with a university, a
“campus alert” system may be available. Using this system, notifications can
be sent via e-mail, cellphone, work phone, home phone, or a combination of
these. This communication strategy can be very helpful during disaster drills
as well as unexpected events. Numerous ways exist to communicate with
hospital employees and leadership, IT staff, news media, and the public.
Finding the right combination for the facility’s budget and staff and
formalizing the ownership of specific communication will facilitate the
workflow transitions during EHR downtimes at the facility.
Conclusion and future directions
This chapter identifies tactics for health system downtime planning and
disaster recovery. It challenges clinicians and informaticians to assess, plan
for, respond to, recover from, communicate about, continue business during,
and prevent downtimes and disasters when possible. The primary objective
for downtime and disaster planning is to protect the organization and the
patients who are served by that organization by minimizing disruption to
the operations. This includes minimizing economic loss; ensuring
organizational stability; protecting critical assets of the organization;
ensuring safety for personnel, patients, and other customers; reducing
variability in decision making during a disaster; and hopefully minimizing
legal liability.5 In healthcare and health IT, the single most important reason
to carry out the activities described in the chapter carefully and methodically
is the ability to provide uninterrupted, exceptional service and safe care to all
patients.
In the future, the potential impact of downtimes and disasters will
continue to grow as healthcare entities become more dependent on
technology and as individual healthcare institutions continue to become part
of a larger network. This should drive administrators to invest additional
human and material resources in assessing and planning to minimize the
impact of potential threats. Advances in technology can be expected to offer
be er solutions than currently exist. These solutions may be less costly as
new and improved technology eventually reduces the potential for
downtimes. Additional research is very much needed to help clinicians and
health systems understand the experience of downtime workflow
interruptions, the patient safety implications, and the operational impacts. In
addition, research should be initiated to drive a standard approach to
downtime planning for health systems, disaster recovery, and business
continuity efforts. Many focus areas might be addressed along the
continuum of disaster planning to business continuity, where research could
have a very positive impact for the health system and its clients.
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22 Whi en J., Bentley L. System Analysis and Design Methods. 7th ed.
McGraw-Hill Higher Education: New York, NY; 2007.
23 American Nurses Association. The Nursing Process. Nursing World;
2012. h p://[Link]/EspeciallyForYou/What-is-
Nursing/Tools-You-Need/[Link].
24 Hoerbst A., Hackl W.O., Blomer R., Ammenwerth E. The status of IT
service management in health care: ITIL in selected European
countries. BMC Med Inform Decis Mak. 2011;11:76.
25 Hoong L.L., Marthandan G. Factors influencing the success of the disaster
recovery planning process: a conceptual paper. In: Research and
Innovation in Information Systems (ICRIIS), 2011 International
Conference; 2011:23–24. doi:10.1109/ICRIIS.2011.6125683.
26 Federal Emergency Management Agency (FEMA). IT Disaster Recovery
Plan. h p://[Link]/business/implementation/IT. 2012.
27 Federal Emergency Management Agency (FEMA). Business Continuity
Plan. h p://[Link]/business/implementation/continuity. 2012.
28 Nickole e C. Business Continuity Planning Description and Framework.
Comprehensive Consulting Solutions, Inc; 2001. h p://[Link]-
[Link]/BCP_whitepaper.pdf.
29 Healthcare and Public Health Sector. Working without technology: how
hospitals and healthcare organizations can manage communication failure.
n.d.
h p://[Link]/Preparedness/planning/cip/Documents/workin
gwithou [Link]. Accessed June 13, 2016.
30 (x)ma ers. Proactive Communications During Major Incidents. Best
Practices Beyond Incident Resolution (whitepaper).
h p://[Link] [Link]/resource/proactive-communications-
during-major-incidents/. 2015.
Discussion Questions
1. Explain the importance of an organization-specific downtime risk
assessment.
2. Describe the pros and cons of different assessment tools for evaluating
downtime events and discuss scenarios in which they might be used to
their best advantage.
3. Compare and contrast the roles of the informatician, the clinician, and IT
personnel in system downtime planning.
4. Describe key components of a business continuity plan and (a) how they
might differ for different types of organizations and (b) how they might
differ depending on EHR maturity level.
5. Contrast different communication methods for system downtime events
and summarize the pros and cons of each.
Case Study
At your Level 2 trauma center, an unplanned EHR downtime occurs at 17:00
on a Tuesday. After 1 hour of troubleshooting and working with the
vendor’s help desk, the IT team a empts a system reboot, which is
unsuccessful. The vendor is in a different time zone, so specialists have to be
called in from home to respond to this incident. The initial assessment is that
the downtime is due to database corruption and the system will have to be
recovered from backup systems. Unfortunately, the system is not configured
with high availability techniques, nor is it redundant. The IT department
estimates that it will take 8 hours to recover the system, for a total downtime
of 10 hours.
Discussion Questions
1. Plot each component on the Downtime Determinator for both part 1 and
part 2 of the scenario as it unfolded, and document your IT response,
end user response, and communication plans.
2. Make changes to the assessment and plans to account for changes to the
scenario.
UNIT 5
User Experience, Standards,
Safety, and Analytics in Health
Informatics
21
Improving the User Experience for
Health Information Technology
Nancy Staggers
Abstract
The usability of health information technology (IT) products is a worldwide concern.
U.S. federal agencies are responding to this challenge by developing regulations and
reports to guide improved user experiences (UXs) for health IT products. Health
professionals and informaticians require a suite of skills to understand concepts
about the UX and to conduct usability tests. This chapter provides the knowledge
and skills to meet those needs. First, the chapter outlines the need for a ention to the
UX. Terms are defined, the concepts of usability goals are presented, and user-
centered design precepts are discussed. Potential benefits for improved UX are
outlined. Available human-computer interaction (HCI) frameworks are listed; one
framework is explained in detail, and selected methods particular to UX evaluations
are explained. Then types of usability tests are discussed and linked to the systems
life cycle. Examples of actual usability studies in health se ings are provided. These
techniques will allow readers to design and conduct usability tests to determine the
effectiveness and efficiency of and satisfaction with health IT products.
Usability has a strong, often direct relationship with clinical productivity,
error rates, user fatigue, and user satisfaction1
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Compare and contrast the terms user experience, human factors,
ergonomics, human-computer interaction, usability, and design thinking.
2. Discuss the potential benefits of incorporating usability into
organizational processes.
3. Describe the goals of usability and user-centered design.
4. Identify the major components to consider in human-computer
interaction and usability studies.
5. Analyze methods for conducting usability studies and relate them to a
specific purpose of a usability study.
6. Outline components of four different usability tests related to their
position in the systems life cycle.
7. Explain the basic steps in conducting a usability test on a healthcare IT
product.
Key Terms
contextual inquiry 362
design thinking 355
discount usability methods 359
ergonomics 353
focused ethnographies 361
heuristic evaluations 359
human factors 353
human-computer interaction (HCI) 354
joint cognitive systems 357
sociotechnical system 352
task analysis 361
think-aloud protocol 361
usability 354
user interface 356
user-centered design 354
Introduction to improving the user
experience
Readers can easily describe their frustrations with today’s poorly designed
health information technology (IT) products. Solutions to these health IT
issues involve the systematic study of the user experience (UX) that
incorporates a wide variety of available resources. This section of the
chapter outlines users’ current experiences with health IT. After terms are
defined, potential benefits are discussed for improved UX to health IT
product users and health organizations.
The Current User Experience With Health Information
Technology Products
UX issues with health IT products are a worldwide concern. The
expansion of mobile health (mHealth) and electronic health records
(EHRs) in particular has resulted in complex interactions among multiple
users, IT products, and environments, all with varying characteristics.
These complex interactions, known as a sociotechnical system, coupled
with complex health systems, are magnified as users interact with health
IT.
Convincing evidence exists that UX issues in health IT can result in
patient safety problem and errors.1–3 In the United States, The Joint
Commission (TJC) issued an alert in mid-2015 concerning sentinel events
related to health IT. TJC evaluated 3375 previous adverse event reports,
identifying 120 health IT-related sentinel events.4 One third of these
stemmed from factors related to the human-computer interface, while 24%
stemmed from workflow and communication issues. Lack of
interoperability and difficulties in extracting relevant data from vast
quantities of information can result in omissions and errors in care
continuity mechanisms such as handoffs.5,6 Moreover, providers have
difficulty finding critical information and developing the “big picture” of
the patient.7,8 In the federal sector, an ambulatory EHR application serving
more than nine million patients failed to support providers during patient
encounters, did not allow them to obtain situation awareness of the patient
(the “big picture” of the patient), promoted workarounds for the existing
nonintegrated systems, and greatly increased frustrations because of
required structured documentation.9 Last, potential patient safety issues
occurred with two different Electronic Medication Administration Records
(eMARs) because nurses could not easily view patients’ medications to
determine those missed and those due.10,11
Physicians are currently very vocal about their dissatisfaction and
productivity issues with EHRs. Their perceptions about EHR usability
were increasingly negative between 2010 and 2013, according to a national
survey.12 In a le er signed by 30 physician organizations in 2015, the
American Medical Association (AMA) issued a call for solutions to poorly
designed EHRs.13
Other healthcare professions are similarly affected but less outspoken.
However, a recent call to action was issued to improve nurses’ UXs,
especially for EHRs.14 Nurses are particularly affected by excessive
documentation requirements. For example, admission assessments in
acute care can take from 30 to 60 minutes and involve 532 clicks,
structured documentation does not reflect the nuances of care (a pick list
cannot capture how a patient feels about dying, for example), and nurses
indicated that EHRs are a hindrance to care because they take time away
from patients.8 These issues could be ameliorated by incorporating known
UX principles and processes to improve the UX with health IT.
Definitions of terms and their
relationships
Despite discussion in the literature for more than 30 years, precise
definitions for UX terms are a source of debate and overlapping concepts.
The relationship of terms is depicted in Fig. 21.1. As demonstrated in the
figure, UX is the most inclusive of these terms, with human factors,
ergonomics, human-computer interaction (HCI), and usability embedded
within it. Usability and ergonomics overlap and intersect human factors
and HCI. These terms overlap in conceptual definitions and also because
the physical a ributes of ergonomics may be combined with software,
which is more the purview of usability and HCI.
FIG 21.1 Terms and Their Relationships. Adapted and expanded from
Staggers N. Human factors: imperative concepts for information systems in critical care.
AACN Clin Issues. 2003;14(3):310-319; quiz 397-318.
User Experience
The term user experience encompasses all aspects of users’ interactions.15
The International Organization for Standardization (ISO) 9241-11 defines
the term as “a person’s perceptions and responses that result from the use
or anticipated use of a product, system or service.”16,17 Schaffer indicates
that UX is concerned with a range of experiences, from walking into a
bank to designs that fit into complex ecosystems with many users
interacting.18 To achieve a high-quality UX, a seamless merging must occur
from the talents of multiple disciplines, such as engineering, graphic and
industrial design, interface design, psychology, and domain experts in the
discipline at hand.19,20 ISO 9241-11 is being revised at the time of this
writing. Readers are encouraged to search ISO for new revisions beginning
in mid to late 2017.
Human Factors
According to the Human Factors and Ergonomics Society (HFES), human
factors is “the scientific discipline concerned with the understanding of
interactions among humans and other elements of a system, and the
profession that applies theory, principles, data and methods to design in
order to optimize human well-being and overall system performance.”17
Simple examples include a design for opening a door efficiently, how to
turn on the lighting for one area of a room from a bank of light switches,
and how to safely and efficiently operate the controls to drive a car. In
healthcare, human factors might concern the design of a new operating
room to be er support workflow, teamwork, and patient flow, or
identifying obstacles to intensive care nurses in their task performance.21
See Donald Norman’s classic book about the design of everyday objects
such as lighting and even teapots.22
Ergonomics
The term ergonomics is used interchangeably with human factors by the
HFES in Europe, but in the United States and other countries, its focus is
on human performance with physical characteristics of tools, systems, and
machines.23 For example, ergonomics issues might address the design of a
power drill to fit a human hand or the design of chairs to promote comfort
and safety. In healthcare, ergonomics can be the number, types, and
locations of computer workstations or the physical design of a mobile
device to support care. Ergonomics also deals with the design of a surgical
instrument to fit the human hand to perform desired functions effectively
and efficiently.
Human-Computer Interaction
Human-computer interaction (HCI) is the study of how people design,
implement, and evaluate interactive computer systems in the context of
users’ tasks and work.24 As with human factors, HCI draws on the
disciplines of psychology and cognitive science, computer science,
sociology, and information science and on the discipline of the user at
hand. HCI can be addressed throughout the systems life cycle to include
the design, development, purchase, implementation, and evaluation of
applications. HCI topics can include the following:
• The design and use of devices such as an intravenous pump or a
touchpad on a computer
• User satisfaction with computerized provider order entry (CPOE)
• Patient usage rates of mHealth apps or personal health records
• Users’ perceptions of eMARs
• The standardization (or not) and meaning of icons on a patient portal
• Principles of effective screen design, including mobile application
design
• Analysis of the capabilities and limitations of users and matching
these to mHealth designs
Usability
The term usability is often used interchangeably with HCI when the
product is a computer, but usability also concerns products beyond
computers. Usability is also more focused on interactions within a specific
context or environment for a specific product. Formally, the ISO defines
usability as the extent to which a product can be used by specific users in a
specific context to achieve specific goals with effectiveness, efficiency, and
satisfaction.16 A product with good usability allows users in a particular
context to achieve their goals when interacting with a product.24 Usability
is, however, fundamentally concerned with human performance, and in
the case of healthcare, interactions that promote safety rather than only
subjective data. Usability can include the following dimensions:
• Speed and errors in interactions with a health IT product
• Ease of learning and remembering interactions after time has elapsed
• User satisfaction or perceptions about the interactions with health IT
• Efficiency and accuracy of interactions
• Designs to promote error-free or error-forgiving products
• Seamless fit of an information system to the tasks and goals of users
The goals of usability
The overall goals of usability are established by the ISO. Fig. 21.2 depicts
the ISO usability goals19:
FIG 21.2 Usability goals. From HIMSS Usability Task Force. Promoting Usability
in Health Organizations: Initial Steps and Progress Toward a Healthcare Usability Maturity
Model. Chicago, IL: Healthcare Information and Management Systems Society; 2011.
Reprinted with permission from HIMSS.
• Effectiveness is the accuracy and completeness with which specified
users achieve specified goals in particular environments, including
worker and consumer or patient safety.
• Efficiency includes the resources expended in relation to the accuracy
and completeness of goals achieved.
• Satisfaction is the level of comfort and acceptability that users and
other people associate with the product or work system and deals
with users’ perceptions.19
Dimensions of usability correlate to potential benefits of UX depicted in
Fig. 21.3, and (as discussed in detail in the next section) include
improvements for individuals or groups of individuals in the following
areas: productivity and efficiency, effectiveness in product use, safety, and
cognitive support (an aspect of effectiveness).
FIG 21.3 The value of usability to health organizations. From HIMSS
Usability Task Force. Promoting Usability in Health Organizations: Initial Steps and
Progress Toward a Healthcare Usability Maturity Model. Chicago, IL. Copyright ©
Healthcare Information and Management Systems Society; 2011.
User-centered design
UX experts employ a process of user-centered design composed of the
following three axioms:
• An early and central focus on users in the design and development of
products
• Iterative design
• Systematic measures of the interactions between users and
products23,24
These principles were derived nearly 30 years ago by Gould and Lewis
and are more salient than ever because contemporary environments are
filled with an array of complex tools. An early and central focus on users
means understanding users in depth—that is, their characteristics,
environment, and tasks.24 Direct contact with actual users is needed early
and often throughout a design or redesign process. Iterative design means
having rounds of design and having key users evaluate product
prototypes to determine their effectiveness and efficiency in the care
process and health decisions. One design is never adequate, and typically
at least three rounds are necessary. Once a design is available, even on
paper or in PowerPoint, designers or informaticians work with users to
determine any issues by having them systematically interact with and
respond to the design. Specific methods to accomplish this are explained
in subsequent sections. The important point is that major usability issues
are identified and corrected early in the process. Design and evaluation
then occur in a cycle until major usability issues are corrected. This
dynamic, iterative process, which includes the three axioms listed above, is
known as user-centered design. Importantly, structured and systematic
observations, including identified measures, are necessary. Usability goals
and axioms apply not only to developing products but also to the
selection, purchase, customization, and redesign of products.
This kind of design allows us to integrate health data, information, and
knowledge into health IT products. For example, a well-designed eMAR
would filter medication routes to match the particular medication,
eliminating inappropriate options (e.g., being able to chart an antacid as an
intravenous medication or administer a tablet in the left arm). Although
this sounds like common sense, current designs in major EHRs often do
not accommodate this kind of filtering.
Design Thinking
Many UX professionals embrace a creative process called “Design
Thinking.” The process is complementary to User-Centered Design (UCD)
discussed previously because it focuses on understanding problems from
a user’s perspective but the process concentrates on innovative solutions.
Design thinking began in earnest in 1987 with Peter Rowe’s book titled
Design Thinking. Stanford University expanded this work for business,
calling it a process for creative solutions. Essentially design thinking is a
formal process of addressing ill-defined problems through creative design,
using an iterative process of creating and testing multiple designs, as in
UCD, to evaluate their fit as an appropriate solution.25
Potential Benefits of Improving the User Experience
A white paper from the Healthcare Information Management and Systems
Society (HIMSS) describes how to incorporate UX or usability in health
organizations.19 This publicly available white paper includes a section on
the benefits of usability to healthcare summarized here.
Usability can add value to organizations across a range of areas.
Usability ROI material is available from (1) non-healthcare projects such as
Bias and Mayhew26 and Nielsen,27 (2) the User Experience Professionals
Association website, and (3) Dey Alexander Consulting.28 To the author’s
knowledge, no research is yet available about large-scale ROI or cost
savings for UX efforts in healthcare projects. Thus material is cited from
non-healthcare applications. However, findings from non-healthcare IT
projects are very likely to extend to healthcare because of the often
dramatic changes that usability can create. Fig. 21.3 outlines potential
areas of value when UX is improved in health organizations.
Increased Individual Effectiveness
Usability can positively affect at least three areas of particular interest in
health IT:
1. Increased user productivity and efficiency
2. Decreased user errors and increased safety
3. Improved cognitive support
Increased User Productivity and Efficiency
One of the most prevalent complaints about health IT in general and EHRs
specifically is that the technology impedes users’ productivity. For
example, outpatient visits were reduced from four to three per hour after
an ambulatory EHR was fielded.29 A cognitive work analysis of the same
system in a laboratory se ing showed a large number of average steps to
complete common tasks, a high average execution time, and a large
percentage of required mental operators.30
Employing usability processes helps improve productivity and
efficiency. The Nielsen Norman Group estimated that “productivity gains
from redesigning an intranet to improve usability are eight times larger
than costs for a company with 1,000 employees; 20 times larger for a
company with 10,000 employees; and 50 times larger for a company with
100,000 employees.”27, p. 5 Website redesign statistics for the 42 cases
collected by Nielsen Norman yielded an average increase in user
productivity of 161%. After testing intranets for low and high usability,
these authors projected a savings of 48 hours per employee if intranets
were redesigned for high usability. Souza et al. cited usability research
showing that two-thirds of buyers failed in shopping a empts on well-
known sites.31 Thus poor usability on intranets can mean poor employee
productivity.
Decreased User Errors and Increased Safety
One of the major reasons why health IT is installed is to reduce errors in
healthcare.32 While clearly some classes of errors such as medication errors
can be reduced with health IT, technology can create unintended
consequences and new errors due to poor usability.33,34 For example,
Kushniruk et al. were able to identify how certain types of usability
problems were related to errors as physicians entered prescriptions into
handheld devices.35
Nielsen and Levy collected case studies and found a decrease in user
error rates in 46 redesign projects measuring user error.36 Another study
showed a 25% decrease in user errors after screen redesign.37 Users found
needed information only 42% of the time on 15 large commercial websites,
even when they were directed to the correct home page; 62% gave up
looking for desired items on websites.27 Redesigns could prevent errors in
these types of interactions; thus incorporating usability can potentially
decrease errors in health IT products.
Improved Cognitive Support
Stead and Lin concluded that the premier EHRs in the United States in
2009 did not provide the required cognitive support for clinicians (i.e.,
tools for thinking about and solving health problems).7 This is still true
today. Cognitive support may include designs to provide an overview or
summary of the patient, information “at a glance,” intuitive designs, and
tailored support for clinicians in specific contexts. An example of how
usability can provide cognitive support is the work on novel physiologic
monitoring designs. Researchers employed UCD and usability testing
techniques to create novel designs integrating physiologic data in a
graphic object.38–40 The new design provided integrated, “at a glance”
pictorial data to show changes to clinicians. These graphic objects are now
being incorporated in vendors’ products as an adjunct to numeric data
displays. Another example is the design and testing of new displays for
ICU nurses after researchers performed a comprehensive study of their
tasks and cognitive requirements.41
Increased Organizational Efficiencies
Well-designed user interfaces and systems translate into organizational
efficiencies, including the following:
• Decreased maintenance costs
• Decreased customer and individual training and support costs
• Decreased development time and costs
Decreased Maintenance Costs
Eighty percent of software life cycle costs occur in the maintenance phase
and are related to unmet user requirements and similar usability
problems.42 Usability experts estimated that by correcting usability
problems early in the design phase of a project, two different U.S. airline
projects reduced the cost of those fixes by 60% and 90%.43 At IBM,
researchers concluded that it is more economical to consider users’ needs
early in the design cycle than to solve them later.44
Decreased Customer and Individual Training and Support Costs
A study by Microsoft showed that time for support calls “dropped
dramatically” after a redesign of the print merge function in Word.43
Business analysts found that a well-designed user interface had an
internal rate of return of 32%, realized through a 35% reduction in
training, a 30% reduction in supervisory time, and improved
productivity.37 Logically, a well-designed user interface would require
fewer resources to support, less time and effort in training, and decreased
time on support calls. Souza also cited a web redesign at [Link] that
resulted in a 20% reduction in support calls.31
Decreased Development Time and Costs
According to Marcus, the rule of thumb in many usability-aware
organizations is that the cost-benefit ratio for usability is $1:$10:$100.45
Once a system is in development, correcting a problem costs 10 times as
much as fixing the same problem during design. If the system has been
released, it costs 100 times as much relative to fixing the problem in
design. This estimate is frequently quoted, and while it may be overly
optimistic, its main point is clear: It is far more expensive in time, costs,
and effort to correct issues later in the development life cycle than to
complete an informed design at the beginning of a project.
Best practices in usability engineering could alleviate major reasons for
inaccurate cost estimates by managers in these areas: frequent requests for
changes by users, overlooked tasks, users’ lack of understanding of their
own tasks, and insufficient communication and understanding between
users and analysts.43 By including usability techniques, two companies
reduced time spent on development, one by 40%43 and another by 33% to
50%.46 An ROI analysis by Karat indicated a $10 return on each dollar
invested in usability.47 According to Landauer, when usability is factored
in at the beginning of a project, efficiency improvements can be greater
than 700%.48 On a national level Landauer estimated in 1995 that the
inadequate use of usability engineering methods in software development
projects cost the U.S. economy about $30 billion per year in lost
productivity. Of course, the cost would be even more substantial now.
Incorporating usability into health IT provides significant value to all
such projects; therefore it is essential that healthcare team members,
informaticians, and IT staff understand and apply usability principles and
processes in their work. This chapter provides readers with an
understanding of the knowledge and skills to conduct usability tests.
Human-computer interaction frameworks
for health informatics
Frameworks provide guidance for understanding essential components
that improve the UX. They are helpful in completing UCD processes,
usability tests, IT adoption evaluations, and usability research. This section
of the chapter provides an overview of existing frameworks and describes
in detail the Health Human–Computer Interaction Framework (HHCI).
Human Factors and Human–Computer Interaction
Frameworks
Various HCI frameworks and models with different foci are available49–58:
• Fit Between Individuals, Task, and Technology (FITT), with the
elements connected by interactions and influences49
• User, Function, Representation, and Task Analyses (UFuRT, or TURF).
System knowledge is distributed across multiple users who have
differences in expertise and cognitive characteristics. It includes a task
analysis portion to describe steps in tasks and interactions.58 More
recently, this framework was renamed TURF.59
• A framework for employing usability methods to redesign a fielded
system54
• A framework for technology-induced error51
• A combined health IT adoption and HCI model52
• Joint cognitive systems53
• Systems Engineering Initiative for Patient Safety (SEIPS) 2.0, which
incorporates human factors concepts of configuration, engagement,
and adaptation, a model at a higher level of abstraction for systems60
The last two models bear more discussion. Hollnagel and Woods coined
the term cognitive systems engineering, acknowledging that sociotechnical
systems, or complex technologies embedded within social systems, are
increasingly prevalent yet have frequent system failures.53 The authors
devised a cyclic model called contextual control model, or CoCom, with
the following elements: event, modifies, constructs, determines, acts, and
produces. Users and context are major components of the model.
Importantly, joint cognitive systems imply that information is shared or
distributed among humans and technology. This framework is useful for
examining teamwork in healthcare, such as those for patient care.
SEIPS 2.0 is a model centered on work systems. Work performance
results in a sociotechnical system with people as one component. People
(or a person) are central to work systems, and support for the design of
work is necessary. Support includes the design of work structures and
processes using human factors science. Often work systems include
technology, but SEIPS may also be used to examine work without
technology.60
An analysis of the existing frameworks found each helpful but
inadequate for health usability studies. Missing elements across
frameworks included (1) interactions among disparate users, including
patients, although SEIPS acknowledges groups of people and CoCom and
TURF mention information distribution, (2) characteristics and actions of
products and users, (3) a focus on context, and (4) a developmental
timeline. Context is critical in particular because it defines the kinds of
users, tasks, and work design.58,59 A developmental time element is also
necessary because it accounts for users changing (maturing) in their
interactions over time.52,55 Therefore a new framework was created.
The Health Human–Computer Interaction Framework
The HHCI Framework is described here. The current framework builds on
early work by Staggers and Parks describing nurse-computer interaction.61
It was expanded to include groups of healthcare providers and
interactions with patients.55 The framework is adapted further here to
acknowledge that IT may be only one example of an available health IT
product (e.g., others might be physiologic monitors or intravenous
pumps).
The elements of the framework are outlined in Fig. 21.4. Information
(e.g., patient care, administrative, or educational information) is the
exchange mechanism. Interactions occur in a system of mutual influences
where elements (e.g., individuals, health IT) act and respond based on
specific characteristics. Context is paramount with all interactions
embedded within a context. This means that any outcomes of interactions
are distinct, as they are defined by a context. The developmental timeline
indicates that interactions change over time. Thus the outcomes of
interactions are different based on when an interaction occurs in time.
FIG 21.4 Health human–computer interaction framework. Copyright
Nancy Staggers. Reprinted with permission.
Humans or products can initiate interactions. The information is
processed through either the product or the humans, according to
characteristics. The recipient then reacts to the information; for example, a
healthcare provider could read and respond to an e-mail from a patient, or
a product might process interactions after the Enter key is pressed.
Iterative cycles continue as humans behave and products act according to
defined characteristics. Goals and planning are implicit within the tasks
displayed in the framework.
Essential Components for Improving the User
Experience
The important point in this section is that using a framework or model can
greatly assist readers to think comprehensively about UX for health IT and
the conduct of usability studies. Readers may choose a framework to
match the need at hand. Methods can then be applied as appropriate,
while ensuring that critical elements are under consideration. This idea is
expanded in later sections to illustrate how the framework assists usability
testing. In summary, product interactions are a complex part of a
sociotechnical system. Critical elements to consider are as follows:
• Users and their characteristics
• Interactions
• Tasks (goals of tasks)
• Information
• Products and their characteristics
• Context
• Interactions mature over time (developmental timeline)
Selecting methods to improve the user
experience
UX methods can be at a more strategic level or project-based. For instance,
strategic UX methods were outlined by the American Medical Informatics
Association (AMIA) in 10 recommendations to improve patient safety and
quality of care by improving the usability of EHRs (Box 21.1).62
Box 21.1
American Medical Informatics Association
Recommendations for Improving Electronic
Health Records Usability
• Accelerate a research agenda for usability a human factors in health IT.
• Prioritize standard use cases.
• Develop a core set of measures for adverse events related to health IT
use.
• Research and promote best practice for safe implementations of EHRs.
• Create new policies.
• Include usability concerns as a part of the standardization and
interoperability across EHRs.
• Establish an adverse event reporting system for health IT and
voluntary health IT event reporting.
• Develop and disseminate an education campaign on the safe and
effective use of EHRs.
• Develop industry guidelines.
• Develop a common user interface style guide for select EHR
functionalities.
• Perform actual usability assessment on patient-safety sensitive EHR
functionalities.
• Create clinical end-user recommendations.
• Adopt best practices for EHR system implementations and ongoing
management.
• Monitor how IT systems are used and report IT-related adverse
events.
AMIA, American Medical Informatics Association; EHR, electronic
health records; IT, information technology.
To effect these recommendations and also apply concepts to health IT in
local projects, readers will want to know some specific methods for
analyzing UX in health IT systems. Techniques to improve the UX can be
informal or formal, simple or complex, and employ a few individuals or a
wide range of users. Readers or researchers can design small projects or
sophisticated studies by combining usability precepts with usability-
specific or traditional research designs and methods such as quantitative,
qualitative, or mixed methods. The type of usability study is dependent on
the purpose of the project; when the assessment is targeted within the
systems life cycle; the desired outcome of the project; and available
resources, including time, people, and money. However, any study can
use the elements from the HHCI framework as a guide (Box 21.2).
Box 21.2
User Experience Methods and Techniques
An excellent resource for UX methods and techniques is the [Link]
website. This resource includes content such as the basics about usability,
project management, and visual design. For our purposes here, the most
relevant content is the section on “how to and tools.”
Usability projects can be done at any point in the systems life cycle from
initial work (to identify usability issues; clarify requirements; and assess
initial designs, technical prototypes, or simple computerized applications)
to iterative development of solutions, product selection, product
customization, or evaluation of a system after installation.63 The important
point is that UX experts recommend usability tests early and often.
UX, User experience.
UX methods were developed over decades and are robust. This section
of the chapter concentrates on unique, proven UX methods to choose and
apply. These include discount usability methods and other UX methods
described later.
Discount Usability Methods
Nielsen developed techniques he called discount usability methods to
reduce the number of required users in usability projects and to use early
design prototypes. Meant for UX experts, this method has proven useful
for others involved in designing projects.64,65 A discount usability method
offers economies of time, effort, and cost and can be completed at any
point in the systems life cycle. The most common technique is heuristic
evaluation.
Heuristic Evaluation
The definition of a heuristic is a “rule of thumb” or guideline. Heuristic
evaluations (HEs) compare products against accepted usability guidelines
to reveal issues. Nielsen recommends that three to five experts complete
independent evaluations and then combine issues into a master list after
discussion and consolidation. HE violations of guidelines are made and
severity scores are then assigned to the identified issues.65 Importantly,
dual domain experts (experts in both UX and the field to which the
application is geared) can find 81% to 90% of existing usability problems
and increased numbers of major issues with the application.66 HE is a
commonly employed technique, and readers can complete an HE after
only a modest amount of training.
A number of usability heuristics are available to evaluate applications:
• Nielsen’s 10 heuristics67
• Zhang et al.’s 14 heuristics68
• Dix et al.’s 10 heuristics23
• Shneiderman’s 8 golden rules69
• HIMSS’s 9 usability principles1
Zhang et al.’s guidelines have been used extensively in health applications
and devices. These authors combined Nielsen’s and Shneiderman’s
heuristics and applied them to a project evaluating two infusion pumps,
finding 192 and 121 heuristic violations, respectively, categorized into 89
and 52 usability problems. Using this technique, they concluded that the
pump with the higher violations might contribute to more medical errors
than the other one.68 Zhang et al.’s 14 adapted heuristics and definitions
are outlined in Table 21.1. Once readers develop a basic understanding of
the meaning of each heuristic, they can evaluate a health IT product
against the heuristics as in the following examples.
Table 21.1
Zhang Heuristics and Nielsen Severity Rating Scheme
Heuristic
Definition
Category
Consistency Consistency across all aspects of the product: methods of navigation, messages and actions,
and standards meaning of bu ons, and terms and icons. Congruence with known screen design principles for
color and screen layout. Consistency with ISO (International Organization for Standardization)
usability guidelines.
Visibility of Users understand what the system is doing and what they can do with the product from the
system state system messages, information, and displays.
Match between The technology matches the way users think and do work, uses appropriate information flow, has
system and typical options that users need, and includes expected actions by the system.
world
Minimalist No superfluous information. System and screen design targeted to primary information users’
needs. Use of progressive disclosure to display details of a category of information only when
needed. The exception can be designs for expert users where screen density is preferred.
Minimize Minimizing the amount of information and tasks users have to memorize to adequately use the
memory load technology. Product makes use of sample formats for data input, such as a calendar for date
format.
Informative The technology provides prompt and useful feedback about users’ interactions and actions (e.g.,
feedback feedback that orders were placed).
Flexibility and The ability to tailor and customize to suit individuals’ needs. Includes novice and expert
efficiency capabilities (e.g., string searches).
Good error Tell users what error occurred and how users can recover from the error. Not abstract or general
messages such as “Forbidden!” Need to be precise and polite and not blame the user.
Prevent errors Catastrophic errors must be prevented (e.g., mixing pediatric medication order dosing between
kilograms and pounds or delivering a radiation dose with the device left wide open instead of
being tailored to tumor size).
Clear closure Users should know when a task is completed and all information is accepted. Displays should
include progress toward 100% completion versus using a series of bars.
Reversible Whenever possible, actions and interactions should be able to be undone within legal limits in
actions electronic health records. If actions cannot be reversed, there is a consistent procedure for
documenting the correction of any misinformation in the system.
Use the users’ The technology uses language and terms the targeted users can comprehend and expect. Health
language terms are used appropriately.
Users in Users initiate actions versus having the perception that the technology is in control. Avoid
control surprising actions, ending up in unexpected places, and loud sounds with errors.
Help and Provide help for users within the context the actions occur (context sensitive). Embed help
documentation functions throughout the application.
Severity Scale Definition
Rating
Element
0—No No need to correct the issue.
usability
problem
1—Cosmetic Correct the issue only if extra time and fiscal resources allow. Lowest priority.
problem
2—Minor Annoying issue with minor impact. Low priority to fix.
problem
3—Major Issue with major impact to use or training or both. Important to fix. Considerations are the
usability numbers and kinds of users affected by a persistent problem.
problem
4—Usability Severe issue that must be corrected before product release, especially those related to patient
catastrophe safety.
Data from Zhang J, Johnson TR, Patel VL, Paige DL, Kubose T. Using usability heuristics
to evaluate patient safety of medical devices. J Biomed Inform. 2003;36(1,2):23-30;
Nielsen, J. Severity ratings for usability problems.
[Link] 1993.
Examples of a Heuristic Evaluation Project
Guo et al. used Zhang’s heuristics to evaluate a vendor’s eMAR installed at
a tertiary care center.11 The authors received training on the eMAR,
defined typical tasks that nurses complete using the product, and also
modified Zhang’s heuristics to include concepts about patient safety. The
authors independently completed the defined tasks and compared their
interactions to the heuristics, synthesized results, and found 233 violations
for 60 usability problems. Problems included having to manually update
the screen by clicking an “as of” bu on to refresh the screen and ensure
that the most current medication orders were being viewed. Nurses had
great difficulty in determining medications given “at a glance.” These
results have implications across all three usability goals of effectiveness,
efficiency, and satisfaction, and also raise potential patient safety issues.
Researchers evaluated the Veterans’ Administration’s eMAR using a
similar process to the one listed above; however, they also validated UX
findings with the site barcode medication administration nurse
coordinators.10 Findings included 90 usability problems and 440 heuristic
evaluation violations. Fifteen issues were rated as catastrophic, with
nurses particularly impaired in situation awareness or having the ability to
develop a “big picture” of what was happening with patients and their
medications. An example was medication preparation for a group of
patients. The application allowed nurses to access only one patient’s
medication list at a time even though they cared for groups of patients, so
they developed workarounds such as using paper 4 × 6 index cards to
organize medications for times throughout a shift. HE provided insights
about how this application needed to be improved to support nurses’
cognitive processes and medication activities.
Traditional Usability Methods
A large suite of methods is available to conduct UX examinations of health
products and processes. Three of these methods—think-aloud protocol,
task analysis, and contextual inquiry/focused ethnographies—are
presented here.
Think-Aloud Protocol
Think-aloud protocol involves a small number of actual application users
(vs. experts). Even as few as five users can offer rich data about UX issues.
Users talk aloud while they interact with a product and observers record
their experienced usability problems. As users voice what they are trying
to do, they indicate where interactions are confusing and provide other
thoughts about the product. This allows a detailed examination of the
specified tasks, in particular to uncover major effectiveness issues. This
method may be used in the design, redesign, development, or evaluation
of applications at any time in the systems life cycle. Think-aloud methods
are often used in conjunction with other techniques.
With this technique, researchers first determine a specific set of tasks for
users to complete, such as tasks to operate an infusion pump or use an
mHealth app. Defining tasks ahead of time provides structure and
consistency across participants and guides users through the procedure.
Participants are asked to complete the tasks and talk aloud during the
session. Methods to capture the session can include observing and taking
notes, audio- or video-recording using software such as Morae or even a
smartphone, and handwri en diaries or issue logs.23 The resulting material
is then analyzed by grouping issues or using a schema such as HE
categories to label findings. The analysis portion of this method can be
time consuming, depending on the complexity of the product, the number
of users tested, and the number of tasks. However, the information gained
by using this method is robust and helpful in pinpointing areas needing
redesign.
Task Analysis
Task analysis is a generic term for a set of more than 100 techniques that
range from a focus on cognitive tasks and processes (called cognitive task
analysis) to observable user interactions with an application (e.g., a
systematic mapping of team interactions during a patient code). Task
analyses are systematic methods used to understand what users are doing
or required to do with a health IT product. They focus on tasks and
behavioral actions of the users interacting with products. These methods
provide a process for learning about and documenting how ordinary users
complete actions in a specific context.33,70,71 Task analyses are helpful to
identify task completeness, the correct or incorrect sequencing of tasks
(especially their fit to cognitive tasks), accuracy of actions, error recovery,
and task allocation between humans and products. Task analysis is
typically used early in the systems life cycle to determine user
requirements for design or to determine redesign when rich data are
needed. This technique may be used to analyze areas for redesign. One
type of analysis, cognitive task analysis, is particularly useful for
understanding users’ goals while interacting with products.72 A task
analysis can be used, for example, to determine who is a ending to
patients’ preventive health alerts in a clinic because alerts are seen by a
variety of healthcare providers.
Sample methods of task analysis include the following:
• Interviews
• Observations
• Shadowing users at their actual work sites
• Observing users doing tasks
• Conducting ethnographic studies or interviews71
A critique of cognitive task techniques is available for readers who want
to find the right method for their project.73 References on the specifics of
performing task analyses are available.70–72
Sample output from a task analysis is listed in Table 21.2. After
observations and interviews, evaluators record user actions (e.g., a flow
chart with task descriptions). Evaluators might video-record users as they
interact with an mHealth application, asking users to perform specific
tasks and use a think-aloud protocol to uncover tasks (especially cognitive
tasks) and requirements.
Table 21.2
Sample Output From Task Analyses
Type of Task Analysis
Description
Output
Profiles of users or Short narrative, visual descriptions, and/or summaries about the characteristics of
personas users
Workflow diagrams A flow diagram of tasks or cognitive processes performed by users
Task sequences or Lists of tasks order by sequence or arranged to show interrelationships
hierarchies
Task scenarios Detailed descriptions of events or incidents, including how users handle situations
Usability issues A list and classification of usability problems with a product
Affinity diagrams Bo om-up groupings of facts and issues about users, tasks, and environments to
generate design ideas
Video and audiotape Clips that illustrate particular observations about users and tasks in a context
highlights
Adapted from Staggers N. Human-computer interaction. In: Englebardt S, Nelson R, eds.
Information Technology in Health Care: An Interdisciplinary Approach. Philadelphia, PA:
Harcourt Health Science Company; 2001:321-345.
Example of a Task Analysis
Researchers video-recorded nurses as they interacted with an existing
eMAR in an inpatient application.74 They also observed nurses’ medication
management tasks in the actual se ing in a variety of acute care units. The
researchers created a task flow diagram of medication tasks that included
cognitive tasks and delineated deficiencies with the current application. By
using task analysis to define requirements, the researchers could then
develop a novel and more effective eMAR.
Contextual Inquiry or Focused Ethnographies
Ethnography methods are borrowed from anthropology and sociology,
where fieldwork and analyses of people in cultural and social se ings are
completed. Focused ethnographies and contextual inquiry involve
interacting with users in their actual sites or “field se ings.” They
concentrate on individuals’ points of view and their experiences and
interactions in social se ings, rather than on just the actions of those
individuals.75,76 However, researchers are observers rather than a part of
the society. During observations, detailed descriptions are generated with
an emphasis on social relationships, interactions with IT, and their impact
on work. Ethnographies have become important in understanding the UX
and describing the impact of complex products.
Example of a Focused Ethnography or Contextual
Inquiry
Ash et al. used this method to research the impact of CPOE on users in
acute care facilities in the United States34,77,78 They completed interviews,
focus groups, and observations and outlined unintended consequences for
CPOE: new and more work, workflow issues, unusual system demands,
disruptions in routine communications, extreme user emotions, and
overdependence on the technology. Their studies are considered seminal
works in informatics.
Formal user testing
“Usability measurements are to user interface design what physical exams
are to patient care.”79
User tests may be done at any point in the systems life cycle, but they
are often completed as summative tests—that is, after a product is nearly
or completely developed and/or fielded. At that point, more objective
methods are employed. A critical aspect of conducting a usability test is
measuring human performance and having a larger sample of users. To
assist readers, a taxonomy of usability measures is presented in Table 21.3.
This table is adapted from Sweeney et al. and from Staggers and expanded
here.55,80,81 The taxonomy includes measures from three perspectives: users,
experts, and organizations. Researchers recommend at least 15 users for
summative testing.82 The important points are that usability is measurable
and that a suite of measures is available. In addition to the objective
measures in the table, questionnaires are available to measure users’
perceptions of or satisfaction with their product interactions.
Table 21.3
Sample Usability Measures
Usability Focus Usability Measures
User behaviors (performance) Task times (speed, reaction times)
Percentage of tasks completed
Number, kinds of errors
Percentage of tasks completed accurately
Time, frequency spent on any one option
Number of hits and/or amount of time spent on a website
Training time
Eye tracking
Facial expressions
Breadth and depth of application usage in actual se ings
Quality of completed tasks (e.g., quality of decisions)
Users’ comments (think-aloud) as they interact with technology
System setup or installation time, complexity of setup
Model of tasks and user behaviors
Description of problems when interacting with an application
User behaviors (cognitive) Description of or systems fit with cognitive information processing
Retention of application knowledge over time
Comprehension of system
Fit with workflow
User behaviors (perceptions) Usability ratings of products
Perceptions about any aspect of technology (speed, effectiveness)
Comments during interviews
Questionnaires and rating responses (workload, satisfaction)
User behaviors (physiologic) Heart rate
EEG
Galvanic skin response
Brain-evoked potentials
User behaviors (perceptions Perceptions about anxiety, stress
about physiologic reactions)
User behaviors (motivation) Willingness to use system
Enthusiasm
Expert evaluations Model predictions for task performance times, learning, ease of understanding
(performance) Observations of users as they use applications in a se ing to determine fit with
work
Expert evaluations Level of adherence to guidelines, design criteria, usability principles (heuristic
(conformance to guidelines) evaluation)
Expert evaluations (perception) Ratings of technology, informal or formal comments
Context (organization) Economic costs (increased FTEs for the help desk for a new application)
Number of support staff, time needed to support product
Number of training staff, time needed to support product
Costs (for support, training, loss of productivity)
Observations about the fit with work design and workflow in departments,
organizations, networks of institutions
Combined Videotaping and audiotaping users as they interact with an application and
capturing keystrokes. Can capture any combination of the above.
Adapted from Staggers N. Human-computer interaction. In: Englebardt S, Nelson R, eds.
Information Technology in Health Care: An Interdisciplinary Approach. Philadelphia, PA:
Harcourt Health Science Company; 2001:321-345; Staggers N. Improving the usability of
health informatics applications. In: Hebda T, Czar P, eds. Handbook of Informatics for
Nurses and Health Professionals. Upper Saddle River, NJ: Pearson Education; 2012:170-
193.
EEG, Electroencephalography; FTE, full-time equivalent.
Usability Questionnaires
At least four questionnaires are available to measure user interaction or
user interface satisfaction:
• System Usability Scale (SUS)83,84
• Questionnaire for User Interaction Satisfaction (QUIS)85
• Purdue Usability Testing Questionnaire86
• Software Usability Measurement Inventory (SUMI)87
The SUS is considered an industry standard among UX professionals
and has been used widely on a variety of products outside of and internal
to healthcare.83,84 The SUS is a publicly available, 10-item scale developed
in 1986 by John Brooke at Digital Equipment Corporation.83
Developed in the late 1990s, QUIS addresses users’ overall perceptions
of a product, including overall reaction, terminology, screen layout,
learning, system capabilities, and other subscales such as multimedia
applications.85 QUIS subscales can be mixed and matched to fit the
application at hand. Participants can complete the QUIS in about 5 to 10
minutes. Reliability and validity assessments are available for this tool.
The Purdue Usability Testing Questionnaire has 100 open-ended
questions about how features adhere to accepted guidelines. Students
would need to be familiar with design guidelines before using this
questionnaire.86 However, reliability and validity assessments of the
questionnaire are not reported.
Less information is available about the SUMI, including its assessed
reliability and validity. The instrument has three components: an overall
assessment, a usability profile, and an item consensus analysis.87 The
usability profile examines areas such as efficiency, helpfulness, control,
and learnability. The consensus component addresses adherence to well-
known design alternatives such as categorical ordering of data in a simple
search task.
Selecting a type of usability test
A key decision before beginning a UX assessment is determining the type
of study to conduct in a specific case. This section expands on work by
Rubin and Chisnell and uses the system’s life cycle to organize the types of
tests available.24
Determining User Needs and Requirements
At the beginning of the systems life cycle, during initial design or redesign
process, informaticians determine user needs and requirements from the
following:
• Users’ characteristics
• Tasks (including cognitive tasks)
• Work design
• Interactions among workers and tasks and products
• Requirements about the specific environments and particular needs
related to the context of interactions
Studies can be conducted with limited resources if the scope of the
investigation is focused. As the complexity increases, resource
consumption increases concomitantly. Assessments early in the systems
life cycle seek to answer the following questions:
• Who are the users and what are their characteristics?
• What are basic activities and tasks in this context?
• How do users cognitively process information?
• What information processing can be supported by products?
• What special considerations should be made for users in this
environment?
• What a ributes need to be in place for an initial design?
Observations using think-aloud protocol and task analysis can be used
to determine users’ needs and requirements and answer the questions
listed previously.
Example of a Requirements Determination Usability
Study
Researchers completed a series of studies focused on nurses’ acute care
handoffs or change of shift reports to determine the current state of the
activity and to develop requirements to support handoff tasks.5,88,89
Handoffs are highly complex and cognitively intensive periods where
nurses going off shift synthesize information about patients and
communicate it to nurses coming on shift. Methods that would generate
rich details about the process, such as observation, field notes, and
interviews, were selected. The HHCI framework guided the thinking
about requirements analysis for different aspects of the handoff process.
For example, researchers considered nurses (expertise levels, regular vs.
travel nurses), types of units (critical care, emergency department,
medical, and surgical), and types of product support in place (EHRs,
CPOE, eMAR). Handoff tasks can be completed in a variety of ways,
including audio recordings, face-to-face interactions, and bedside reports.
The researchers completed a focused ethnography across available medical
and surgical units in different facilities. They observed change of shift
reports, audiotaped nurses, photographed nurses’ tools, and took field
notes about nurses’ interactions with the existing EHRs in the facilities.
From the findings, the researchers were able to derive detailed information
about requirements for computerized support for change of shift
activities.89
Formative Tests
Formative tests are conducted earlier in the systems life cycle after
requirements are determined. These tests are conducted on preliminary
designs/redesigns when fewer resources have been commi ed to
programming the product. Methods are often more informal and involve
extensive interactions between the evaluator and user. Results often
produce rich data (e.g., from think-alouds). The objective of a very early
formative test is to assess the effectiveness of emerging design concepts by
asking the following:
• Is the basic functionality of value to users?
• Is basic navigation and information flow intuitive?
• Is fundamental content missing?
• How much computer experience does a user need to use this module?
24
The usability focus is on the effectiveness goal. Users are asked to
perform common tasks with the prototype or step through paper mockups
of the application using the think-aloud method. At this assessment,
researchers strive to understand why users are behaving as they do with
the application rather than how quickly they perform.5 To assess
effectiveness, the researcher is interested in finding cognitive disconnects
with basic functions, missing information or steps, and assessing how
easily users understand the task at hand.
Nielsen recommends having at least five users perform think-aloud
protocols as an observer watches them and records any issues. This
number of users can detect as much as 60% to 80% of design errors.64,90
Later research confirmed that as few as five to eight users are sufficient for
most early usability tests.91,92
Examples of Formative Tests
A public health researcher wanted to develop an application to display
reportable patient conditions across jurisdictions. After researching
available applications and completing requirements, she developed a
prototype using PowerPoint to meet initial requirements and to assess
usability for the following sample tasks: (1) find out whether chlamydia is
a reportable condition in Utah, Colorado, or Washington; (2) determine the
time frame for reporting the condition; and (3) ascertain whether a
specimen must be submi ed and the location for the submission. She
selected key public health, clinical, and laboratory users as participants in
the test. These users were asked to think aloud as they completed common
tasks. The researcher took notes to record the data related to their
responses. Using these data, several iterations of the prototype were
designed to improve the UX in completing the tasks.93
A second example of a formative test is one conducted midway through
the development of a product application.24 After the organization and
general design were determined, this type of test assessed lower-level
operations of the application, stressing the efficiency goals of the product
(vs. effectiveness in the above example) and how well the task is presented
to users. The researcher assessed a subsequent version of the public health
application described previously. She asked the same key users to use the
same tasks, but now participants commented on operations, icons, and the
arrangement of the radio bu ons.
Questions during this test might include the following:
• How quickly and accurately can users perform selected tasks?
• Are the terms in the system consistent across modules?
• Are operations displayed in a manner that allows quick detection of
critical information?
Users performed common tasks with a product that was partially
developed. Usability measures (see Table 21.3) such as performance time
and errors are often selected. Users can perform tasks silently or
researchers can use think-aloud methods to elicit issues. Again, designers
use the results to craft a redesigned prototype to correct issues.
Validation Test
A validation test is completed later in the systems life cycle using a more
mature product. This type of test assesses how this particular product
compares to a predetermined standard, benchmark, or performance
measure. A second purpose might be to assess how all modules in a
technology application work as an integrated whole. For instance, a
validation test can be useful in a system selection process to decide how a
new vendor supports critical tasks such as medication barcoding or
medication reconciliation. Questions for a validation test might include the
following:
• Can 80% of users retrieve the correct complete blood count (CBC) test
results within 10 seconds of interacting with the system?
• How many heuristic violations are identified for this product?
• Can users complete admission orders for a trauma patient with no
errors?
This type of test is more structured, so it precludes interactions between
testers and users. Performance measures mentioned earlier are employed
as users interact to complete the benchmark testing. The methods are
carefully structured.
Example of a Validation Test
A nurse researcher wanted to ensure that a new mobile device for rural
care in Tanzania mirrored the established algorithms on paper. The goal
was to assess whether the algorithms used with the mobile device were
100% accurate. She enlisted key users and informaticians to interact with
each pathway in the device. Deviations from the established algorithms
were documented and corrected.94
Comparison Test
Readers can conduct comparison tests at any point in the systems life
cycle, but they are more commonly done to compare an existing design
with a redesign or to compare two different design solutions for the same
application. The major objective of this usability test is to determine which
application, design, or product is more effective, efficient, and satisfying.24
The study design can range from an informal side-by-side comparison
with structured tasks or use of a classic experimental study design. Results
are more dramatic if the designs are substantially different.
Examples of a Comparison Study
The purpose of this study was to determine whether a new user interface
for orders management was different than an older interface in terms of
performance times, errors, and user satisfaction.74 The tasks and
interactions were planned to minimize the amount of time that nurses
would be away from patient care. The informaticians used an HCI
framework to guide elements in the study. Users interacted on identical
computers to test both interfaces. Tasks were “real-world” orders and
identical for the two designs. The environment was a computer training
room away from patient care units and distractions. The developmental
trajectory was considered in this study to ensure that results were not
affected by practice time. Therefore 40 tasks for each interface allowed
nurses to become practiced at each user interface. (The threshold of task
numbers was determined in pilot work.) Tasks, keystrokes, and errors
were captured automatically by the computer. The QUIS was
administered after each interface to assess user satisfaction. Each nurse
interacted with both interfaces, but the order in which they were presented
was randomized. The results showed the new interface was significantly
faster, had fewer errors, and produced high user satisfaction.
In a second study, a nurse researcher wanted to compare the traditional
design of physiologic monitors and other products to a new design that
integrated data across physiologic parameters, medication management,
and communication.95,96 His target population was intensive care unit
(ICU) nurses. The tasks were designed so that the study could be
completed in about 20 to 30 minutes in each of two sessions. Paper
prototypes were used to assess effectiveness, efficiency, and satisfaction
before resources were expended to code bidirectional interfaces to the
devices. Tasks were defined, and nurses interacted with the prototypes.
Findings were that the new, integrated monitor view resulted in faster task
times, higher detection of potential medication interactions, lower
perceived mental workload, and higher satisfaction.
Identifying Usability Issues With Fielded Health IT
Products
As organizations begin to understand the importance of the UX, leaders
may be unsure where to begin identifying usability issues in their current
environments. The following list includes symptoms of potential strategic
usability issues and provides a framework for determining where initial
energy and resources could be focused19:
• Products or applications requiring long training times
• Support calls categorized by product or application
• Adverse events related to product interactions
• Lists of requested system change requests typically tracked in a
database of system change requests across users and products
• User group requests for updates or changes
• Users’ descriptions of their most vexing applications and interactions
• Users’ identified delays or errors when they interact with complex
applications, especially any requiring information synthesis such as
eMARs, clinical summaries, and handoffs
Once a usability problem is suspected, researchers or students begin
assessing the issue more systematically using the techniques described
previously.
Steps for Conducting User Experience Tests
At some point in their careers, readers will likely want to conduct a
usability project. Step-by-step guides are available.1,24,97 The texts by
Crandell, Klein, and Hoffman;72 Rubin and Chisnell;24 and Tullis and
Albert98 can act as specific guides. HIMSS1 and the National Institute of
Standards and Technology (NIST)97 have published guides for conducting
usability tests on EHRs. For instance, the NIST suggests using both HE
and summative testing to evaluate products, especially EHRs.
The basic steps for conducting usability tests can be summarized as
follows:
1. Define a clear purpose. The specific purpose guides testers to determine
the type of study, methods, and users required. For example, if the
purpose relates to assessment of a redesign of a CPOE module for an
intraoperative surgical team, an exploratory test may be indicated.
2. Assess constraints. Testers are always mindful of study constraints: time;
resources; availability of the software to be evaluated; and availability of
other equipment such as video cameras, testing labs, or users, especially if
the users are specialists. These constraints may drive the type of usability
test. For example, if the tester’s goal is to evaluate an application to
support anesthesiologists, these time-constrained physicians may not be
willing to spend more than 15 to 20 minutes participating in a usability
test. Tasks, methods, and products are defined to work within this
constraint.
3. Use an HCI framework to define pertinent components. Use a framework to
assess each component against the planned study. Who are the key users?
What are typical tasks? What information needs to be exchanged? What
product characteristics and which actions are needed? What is the se ing
or context? Will it be a naturalistic se ing to determine exactly how an
application will be used or a laboratory se ing to control interruptions?
What is a representative time in the developmental trajectory? How much
practice time needs to be considered, especially if the design is new? Be
sure to examine the la er component carefully to ensure a valid
comparison between users’ interactions with a new product and a current
one by including practice time in the study.
4. Match methods to the purpose, constraints, and framework assessment.
Methods that produce rich results such as a think-aloud protocol will
match a purpose of understanding key user requirements, while a more
structured method will allow a comparison of new and old designs. Long
training and practice times for complex devices may constrain the number
of tasks testers can offer. Other basic methodological steps are as follows:
• Select representative end users.
• Select a usability test appropriate to the purpose and point in the
systems life cycle.
• Define and validate tasks.
• Measure key elements and control for others (e.g., measure performance
time but control interruptions unless the effect of interruptions is the
focus).
• Define the context to be used.
• Consider training and practice for new products.
• Pilot test methods before running the main study to smooth out
procedures and bugs.
Once the methods are defined, all of these pieces can be put into action
and the evaluation can be conducted.
Conclusion and future directions
UX issues have clear impacts on health IT users. In the United States,
agencies are engaging in activities to improve the UX for health IT
products (e.g., NIST, the Office of the National Coordinator for Health
Information Technology, and AMIA). The Food and Drug Administration
has required usability testing on medical devices for over 20 years, but
other health IT vendors and health organizations are only beginning to
employ the principles and processes for improving UX. The most
immediate future direction concerns UX education and understanding
action steps to be taken. Organizations need to increase their knowledge
and skills related to improving the UX. One way is to use the material
outlined by the HIMSS Usability Task Force in 2011 on a Health Usability
Maturity Model.19 The material can guide organizations in assessing their
current level of UX, employing methods to market usability to the
organization, and increasing the UX to reach a strategic level.
Future UX directions are both strategic and tactical. Strategic directions
might include the development of a national clearinghouse or organization
to track UX issues and solutions. In particular, tracking for issues related
to patient safety and health IT use is needed. AMIA usability
recommendations should be implemented to include an expanded
research agenda for health IT and UX. UX issues should also have a
“home” within respective professional organizations (e.g., nurses might
collaborate with HIMSS or the American Nurses Association on a
repository for UX solutions). Tactically, the future might include the use of
automated methods to ensure that designs conform to known standards,
especially basic screen designs. Best practices in UX and implementations
should be employed. The future must include a focus on health IT
products that support the way users think and work in health se ings.
This chapter described current issues with technology, definitions, or
terms and the potential benefits of improving the UX in health
organizations. Axioms of usability were defined: an early and central focus
on users in the design and development of systems, iterative design of
applications, and systematic usability measures. Across HCI frameworks,
these major elements exist: users, products, contexts, tasks, information,
interactions, and a developmental trajectory. Common usability methods
and tests were discussed, and examples were provided. Readers are now
prepared to conduct discount usability tests and several types of
formative, summative, validation, and comparison usability tests. Readers
have examples of performance and benchmark measures and four steps
outlining the planning and conducting of usability tests.
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Discussion questions
1. Discuss critical user experience issues in your own organization.
Describe one example in more detail.
2. Outline how to apply the heuristic evaluation technique to analyze
where the major violations exist for a selected health IT product.
3. Search the internet for current policies on the user experience in health
IT by searching the Centers for Medicare and Medicaid (CMS), the
Office of the National Coordinator for Health Information Technology,
and the National Institute of Standards and Technology websites.
Analyze how one of these current policies will affect your organization.
4. Outline a usability test for one module of your current EHR. Include the
elements discussed in the chapter in your proposed usability test.
Describe why you chose the methods you did.
5. Your organization is planning to purchase new physiologic monitors for
the adult ICUs. You are the clinical/informatics person assigned to this
project. Describe how you would include usability in the purchase
process. Outline participants, methods, and tasks to be tested.
Case study
A tertiary care center in the western United States has an installed base of
EHRs supported by Cerner Corporation for inpatient areas and by Epic for
outpatient areas. Other technology includes a suite of about 300 different
applications supported by the IT department. The current environment,
while including robust capabilities such as computerized provider order
entry, is “siloed” with information. Healthcare providers complain that
they have difficulty obtaining the “big picture” of the patient across
systems and they have to remember information located in disparate
systems. They are burdened with integrating information themselves. Not
only is this time consuming; it is potentially prone to error. Providers have
developed numerous workarounds to the different systems in ambulatory
and inpatient areas, including “shadow” files for patients they see
frequently. Nurses complain that they have to “jump around” the
inpatient system to find information they need for activities such as patient
handoffs.
The organization responds by developing a vision for the future that
centered on the concept of knowledge management (KM). This concept is
defined as the systematic process of identifying, capturing, and
transferring information and knowledge that people can use to create,
compete (with other organizations), and improve. A crucial aspect of KM
is improving the user experience. As the leaders in the organization begin
to address KM and improve the user experience, they are employing the
same tactics described in this chapter.
Discussion Questions
1. Assume that you are the leader for UX for your discipline in your
organization. Where would you start to improve the user experience?
2. Pharmacists supporting the ICUs are asking for your help to improve
their situation (their user experience) because they are forced to use
nonintegrated systems. What methods would you use to examine this
issue?
3. The institution is in the process of purchasing new physiologic
monitors for their step-down unit. Describe how usability should be
incorporated as part of the purchasing process. Design a brief
usability test to support the purchasing process.
22
Informatics-Related Standards and
Standards-Se ing Organizations
Tae Youn Kim; Susan A. Matney
Abstract
The current health information technology (health IT) environment is rapidly
changing worldwide. There is increasing evidence that the adoption of health IT will
ensure the use of best practices and improve quality of care in a cost-efficient
manner. However, shaping a cost-effective, quality healthcare system based on best
practices is only possible if interoperability within and between all aspects of the
healthcare delivery system has been achieved. Achieving interoperability requires a
system-wide consensus concerning the standards for the operating of that system.
This chapter begins with an explanation of standards and the standard development
process in health informatics, including the relationship between standards and
interoperability as these concepts relate to health informatics. The chapter then
focuses on standardized terminologies, which are one of the fundamental
components of standards and in turn interoperability. These terminologies facilitate
coherent communication as well as the collection and aggregation of healthcare data
across se ings. The advantages of adopting standard terminologies in practice
include (1) an enhanced user interface in electronic health records (EHRs), (2)
effective data retrieval and exchange, (3) improved monitoring of quality of care, and
(4) discovered knowledge through clinical research. The role of standardized
terminologies in the process of exchanging healthcare data across systems is also
discussed. The chapter concludes with a discussion of topics for future research and
development, including data summarization and mining, knowledge management
and decision support, linkage of professional vocabulary and consumer vocabulary,
and clinical translational and comparative effectiveness research.
The use of standardized clinical terminology can allow patient data to be
available across the full spectrum of healthcare settings.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Use basic terms and resources available to health professionals
regarding data standardization, health information exchange, and
interoperability.
2. Examine selected standard-se ing organizations and their foci.
3. Explain the difference between a standardized reference terminology
and an interface terminology.
4. Apply adopted evaluation criteria in assessing the quality of different
standard terminologies.
5. Compare and contrast the similarities and differences among
standardized healthcare terminologies relevant to patient care.
6. Examine how the adoption of standardized terminologies can assist in
the implementation of Meaningful Use criteria of electronic health
records (EHRs).
7. Describe the importance of data exchange across se ings and the role
of standardized terminologies in the development process of data
exchange.
8. Discuss the areas of future research and development in relation to
data standardization and exchange from a nursing perspective.
KEY TERMS
classification 373
data exchange 383
data standards 383
interface terminology 373
interoperability 383
ontology 373
reference terminology 373
standardized terminology 373
standards development organizations (SDO) 371
standards-se ing organizations (SSO) 371
terminology cross-mapping 383
terminology harmonization 383
Introduction
The Institute of Medicine (IOM) identified health IT as critical to closing
the quality chasm and shaping a be er healthcare delivery system in the
21st century.1 Achieving this goal of closing the quality chasm and shaping
a be er healthcare delivery system, however, is only possible if
interoperability within and between all aspects of the healthcare delivery
system has been achieved. Interoperability is defined as the extent to
which healthcare systems and devices can exchange data and users can
interpret that shared data.2 Standards are imperative for the achievement
of interoperability. A standard is defined as an established specification,
guideline, or characteristic that describes the measurement, material,
product, processes, and/or services required for a specific purpose.3
Standards can be as basic as the distance between the prongs on a plug for
a household appliance or as complex as the standards of practice for the
treatment of a major health problem.
The simple household plug provides an excellent example of the
relationship between standards and interoperability. There are very few
rooms within any home in North America that do not have a wall outlet.
Plugged into those outlets are an unbelievable variety of electrical devices
produced by companies across the world. Yet all of these devices have the
same size plug, thereby meeting the specific standards required to connect
to the electrical grid for all of North America. Achieving this level of
standardization involves both a process for establishing and maintaining
the standards and an organizational infrastructure for implementing that
process. For example, in the case of the electrical grid for North America,
the North American Electric Reliability Corporation (NERC) develops and
enforces reliability standards.4
In health informatics, a number of such organizations exist, referred to
as either standards development organizations (SDO) or standards-
se ing organizations (SSO).a In turn, there are a significant number of
standards developed by these organizations. The SSOs and the standards
themselves evolve from three primary sources: (1) standards related to the
technology used in health informatics, (2) standards related to healthcare
in general, and (3) standards specific to health informatics. In most cases,
these standards have evolved when the need for a specific standard has
been identified and refined. For example, the Digital Imaging and
Communications in Medicine (DICOM) standard was developed in 1985
when the National Electrical Manufacturers Association identified the
need for a nonproprietary data interchange protocol, digital image format,
and file structure for biomedical images and image-related information. As
this example demonstrates, groups identifying the need for standards are
usually focused on a specific need. As a result of the diverse needs and
fragmentation of the standard development process, a number of SDOs
have focused on consensus building and coordination in healthcare
standards. For example, the American National Standards Institute (ANSI)
has emerged as “the ‘accreditor and coordinator of the U.S. private sector
voluntary standardization system ensuring that its guiding principles—
consensus, due process, and openness—are followed by the entities
accredited by this organization.”5
Not all standards are established by an accredited SSO. Standards are
established primarily through one of two different processes:
1. Dominant vendors. With this process, the standard becomes the de
facto established standard due to market dominance of the vendor.
Examples of this process for establishing standards are
demonstrated by both the Microsoft and Apple operating systems.
Today several companies unrelated to either Microsoft or Apple
have designed their applications to run on top of one or both of
these operating systems. While there are other computer operating
systems, the vast majority of applications for personal computing
use one or both of these operating systems.
2. Official SSO. These organizations are founded with the mission of
developing or coordinating specific standards. They use a formal
process that stresses the building of consensus through open
communication. Standards established by an official SSO are
referred to as de jure standards. Table 22.1 includes several examples
of SSOs of importance in health informatics.
Table 22.1
Select Standards-Setting Organizations Impacting Health Information Technology
A great deal of work needs to be done on standards, as there are many
existing standards to choose from in healthcare. Given this reality, learning
about and understanding standards related to health informatics cannot be
done by studying lists of standards. Such an approach would be the
equivalent of reading a textbook on diagnostic tests, such as a lab manual,
with no background or understanding of the disorders being diagnosed.
Likewise, developing an understanding of standards in health informatics
is best done by learning individual standards in the context of their
specific purpose. In the rest of this chapter, the focus is on standard
languages and their purpose in communicating health related data,
especially across EHRs.
Standardized healthcare terminologies
relevant to patient care
The use of health IT, including EHRs, has become a component of a
funded national agenda in the United States, as it is considered a tool to
support patient-centered care and improve quality and safety of
treatments during the last decade.6 Of the various health IT products,
EHRs are lauded as a means to collect longitudinal data, provide best
evidence for practice, support efficient care delivery, and promote
electronic access by authorized users for quality care, research, and policy
development.7 To make EHRs optimally beneficial, however, data
standardization and data exchange are needed as fundamental
components, in that they facilitate clear, concise communication as well as
the collection and aggregation of healthcare data across se ings.
The Centers for Medicare and Medicaid Services (CMS) established an
incentive program for the use of a certified EHR system to meet the
standards and criteria of Meaningful Use.8,9 EHRs should, for example,
support e-prescribing, maintaining patient problems and medication lists,
and care management, and demonstrate interoperability according to the
Health Information Technology for Economic and Clinical Health
(HITECH) Act.9 Standards that facilitate data capture and data sharing
play a key role in achieving Meaningful Use of healthcare data. This
chapter first examines current healthcare data standardization and
exchange efforts. Applications of standardized health terminologies are
further discussed, along with future directions. Additional information
concerning Meaningful Use and HITECH Act regulations is available in
Chapter 27.
Healthcare data standardization
Definitions
Patient records contain words, terms, and concepts that are used in a
variety of ways. A word is a unit of language, while a term is a linguistic
label used to represent a particular concept.10 A concept is defined as a
construct representing the unique meaning for one or multiple terms. For
example, sudden pain in lower back is composed of five words, and the term
sudden pain is identical to the term acute onset pain, consisting of three
words. In this case, both terms can be denoted with the concept acute pain.
Also, the concept pressure ulcer can be represented with diverse terms such
as bedsore, decubitus, pressure sore, decubitus ulcer, and pressure ulcer. These
examples indicate that various expressions (including abbreviations) used
with identical meanings can be characterized using a representative
concept in patient records.
When a list of words or phrases is organized alphabetically, such a
collection is called a vocabulary. In contrast, a collection of representative
concepts in a specified domain of interest is defined as a terminology, which
is often organized in a hierarchical or tree structure according to semantic
relationships among concepts. Continuing our example, the concept acute
pain is a type of pain and presents a narrower meaning than the parent
concept pain in a terminology.
Identifying a representative concept for terms with the same meaning is
particularly important when communicating healthcare data. Natural
language, with its diverse expressions of terms with equivalent meanings,
cannot be used to share information within or across systems in a
consistent way. Incongruent descriptions of patient care contribute to poor
quality care and hinder the Meaningful Use of EHRs. Accordingly, a
number of healthcare terminologies have been developed by different
disciplines and specialties. When a terminology meets specific
requirements established by an SDO, it is referred to as a standardized
terminology. A reference terminology serves as a resource to represent
domain knowledge of interest and thus facilitate data collection,
processing, and aggregation. Such a terminology, however, may not be
sufficient to design and structure documentation forms used by healthcare
providers in daily practice.11 Task-oriented terms with abundant
synonyms can assist documentation by enhancing expressivity and
usability of standard concepts. An interface terminology is a collection of
task-oriented terms considered to support data entry and display in
EHRs.11
A terminology is often called a classification when concepts or
expressions are organized according to their conceptual similarities rather
than semantic (meaning) resemblances. For example, a set of concepts
related to the human body could be arranged by physiologic function or
body structure. For instance, chest pain and growing pain are semantically
close in that both are considered a type of pain. Therefore both terms can
be categorized as a finding of the sensory nervous system. However, they
could also be classified by the location of pain (i.e., body structure); chest
pain can be categorized as a finding of trunk structure and growing pain can
be categorized as a finding of limb structure.
A concept refers to a class in ontology, where the meaning of a concept
is formally specified using properties and its relationships with other
concepts through inheritance.12 While a terminology often presents only a
broad–narrow relationship between two adjacent concepts, an ontology
contains multiple subsumptions or subclass relationships of a concept
based on its formal definition. A reasoner or classification software can be
used to assist in this process by automatically determining logical
placements of asserted concepts and creating an inferred hierarchy.13 An
example of how ontology is structured is demonstrated by the BioPortal
sponsored by the National Center for Biomedical Ontology, including
more than 500 terminologies, classifications, and ontologies maintained by
various organizations and individuals.14 Fig. 22.1 presents a hierarchical
organization of sample concepts (or classes) related to human organ
systems and a graphic view of the hierarchy in BioPortal.14
FIG 22.1 An example ontology. From the Foundational Model of Anatomy in
BioPortal. [Link]
Evaluation of the Quality of Terminology
Healthcare terminologies have a long history of research and
development. Currently, the Unified Medical Language System (UMLS®)
Metathesaurus® contains more than 190 source terminologies,
classifications, and ontologies used in the healthcare domain.15 Regardless
of the structure of a source terminology, the UMLS consolidates all source
concepts in a unified framework so that it is possible to examine lexical
and semantic relations within and across source terminologies.16 The
UMLS Metathesaurus is distributed by the National Library of Medicine
(NLM) every 6 months and includes more than 3.2 million concepts and 13
million unique concept names, available for browsing through UMLS
Terminology Services.15 Any source concepts with semantically equivalent
meanings are assigned to the same concept unique identifier in the UMLS
Metathesaurus.16 Fig. 22.2 displays a search result for the keyword
“comfort alteration” in the UMLS browser. An online resource, “NLM
Resource for Standards and Interoperability,” developed by the NLM
provides introductions to the terminologies used by nursing and a tutorial
on how to find a map between two different terminologies.17
FIG 22.2 The Unified Medical Language System Metathesaurus
browser. ([Link]
Given the complexity of the healthcare delivery system in the 21st
century, the health IT industry demands a comprehensive solution to
promote data standardization and exchange. One terminology is unlikely
to meet the needs of the wide range of disciplines within healthcare, yet
adopting quality terminologies is crucial for Meaningful Use of EHRs.
Assessing the quality of a terminology is not a simple task, as each
terminology evolves according to its terminology life cycle linked to
structural and development processes.18-21
A terminology life cycle contains three major phases: change requests,
terminology editing, and terminology publication.21 A terminology change
request is a formal mechanism for users to submit requests for any changes
or additions with respect to a given terminology.20,22,23 Terminology editing
begins with the activation of a new concept, revision of an existing
concept, or inactivation of a concept, and follows formal concept change
and version management guidelines. When terminology editing is
completed with subsequent documentation, a series of tasks is performed
throughout the terminology publication phase to release a new version of
terminology for public use. Any products (such as terminologies, cross-
maps, translations, subsets, and educational materials) generated through
the terminology life cycle should be easily accessible, usable, and
interoperable in EHRs.21
Requirements for maintaining healthcare terminology quality address
the terminology structure, content, mapping, and process management in
alignment with the terminology life cycle.21,24-30 The International
Organization for Standardization (ISO) has developed international
terminology standards. Specifically, ISO/TS 17117:2002, Health Informatics
—Controlled Health Terminology—Structure and High-Level Indicators,
describes technical specifications for high level evaluation of a controlled
health terminology. According to the specifications, the purpose, scope,
and content coverage of a terminology should be explicitly stated for a
specified domain of use. Each concept should be clearly defined with a
unique identifier; hence there should be no redundancy, ambiguity, or
vagueness.31
Further, ISO/TS 18104:2014, Categorical Structures for Representation of
Nursing Diagnoses and Nursing Actions in Terminological Systems,
provides a framework to promote terminology development and
mapping, data analytics, and interoperability of nursing diagnoses and
actions across healthcare se ings.32 This standard defines categories of
healthcare entities for nursing diagnoses, including clinical course, clinical
findings, degree, focus, judgment, potential, site, anatomical structure,
subject of information, and timing.32,33 For example, the nursing diagnosis
severe pain meets this standard, as it consists of the finding concept pain
and the degree concept severe. The ISO standard also requires that a
nursing intervention be composed of at least two categories of healthcare
entities, including action, means, route, subject of record, and target.32 For
example, the nursing intervention patient education about pain management
comprises a nurse’s education (action) on pain management (target).
Building on these standards, the American Nurses Association (ANA)
recognizes 10 healthcare terminologies appropriate for use in nursing.34,35
Of these, seven are designed specifically for nursing and the other three
are considered multidisciplinary terminologies (Table 22.2). The ANA also
recognized two minimum datasets: (1) the Nursing Minimum Data Set
(NMDS) as a framework for collecting nursing care data, and (2) the
Nursing Management Minimum Data Set (NMMDS) as a framework for
collecting nursing service data elements. That is, the NMDS requires
patient demographics, nursing process data (i.e., assessments, diagnoses,
interventions, and outcomes), and service elements (e.g., agency and
admission and discharge dates) to assess the quality of care.36 The
NMMDS focuses on collecting variables associated with nursing
environment, nurse resources, and financial resources to support
administrative analysis and decision making of nurse executives.37-39
Table 22.2
An Overview of Standardized Terminologies Relevant to Nursing
Practice
HL7, Health Level Seven; RELMA, Regenstrief LOINC Mapping Assistant.
a All terminologies and classifications are accessible through the Unified Medical
Language System (UMLS) released every 6 months by the National Library of Medicine
(NLM). Available at [Link]
b All of the web browsers listed are publicly available at no cost. Also, personal digital
assistant (PDA) versions of terminology browsers may be available as knowledge
resources.
Multidisciplinary Terminologies
Terminologies are essential to communicate and document patient care
data in alignment with the care process. Various types of data are critical
to clinical care, such as lab results, medications, medical diagnoses and
procedures, and billing information. Accordingly, multidisciplinary
terminologies as described in this section are essential.
Logical Observation Identifiers Names and Codes
Logical Observation Identifiers Names and Codes (LOINC), established in
1994 by the Regenstrief Institute, is a standardized coding system for
laboratory and clinical measurements (observations).40 Each LOINC
observation is created using six axes: (1) the name of the observation (or
analyte); (2) property (e.g., substance concentration, mass, volume); (3)
timing of the measurement; (4) the type of system or sample (e.g., serum,
urine, patient, family); (5) scale (e.g., qualitative, quantitative); and (6) the
method used to make the observation (optional).41
All LOINC names are case sensitive. Table 22.3 presents an example of
blood glucose tests coded using the LOINC system. Actual values of
observations need to be documented using numeric values or other
standardized terms. LOINC contains more than 80,000 terms (as of 2016)
and is widely adopted for ordering and exchanging laboratory and clinical
observations in the communication protocol called Health Level Seven
International (HL7).41 The laboratory portion of the LOINC database
contains the usual laboratory categories, such as chemistry, hematology,
and microbiology. The domain and scope of clinical LOINC are extremely
broad. Some of the sections include terms for vital signs, obstetric
measurements, clinical assessment scales, outcomes from standardized
nursing terminologies, and research instruments.42 LOINC is also used for
document and section names.43 Nursing content is one of the scientific
domains with a special focus on clinical LOINC.44 Nursing assessments
can be structured in LOINC as a “Panel.” For example, the Skin
Assessment Panel (LOINC ID 72284-3) contains “Skin Color,” “Skin
Temperature,” “Skin Turgor,” and “Skin Moisture.” Nursing assessment
development is an ongoing project for the Nursing Clinical LOINC
Subcommi ee.
Table 22.3
Coding Structure and Application of LOINC
LOINC, Logical Observation Identifiers Names and Codes.
a Details on the abbreviations can be found in McDonald C, Huff S, Mercer K, Hernandez
J, Vreeman DJ, eds. Logical Observation Identifiers Names and Codes (LOINC) Users’
Guide. Indianapolis, IN: Regenstrief Institute, Inc.; 2016.
[Link]
Systematized Nomenclature of Medicine—Clinical
Terms
Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT)
is the most comprehensive clinical terminology and has become an
international standard for coding healthcare data.45,46 The International
Health Terminology Standards Development Organisation (IHTSDO) has
developed a set of principles to guide SNOMED CT development and
quality improvement. SNOMED CT is continually updated to meet users’
needs. The governments of member countries fund IHTSDO; therefore
healthcare institutions in IHTSDO member countries are able to use
SNOMED CT without additional costs. For example, there are no fees for
use in the United States, whose national release center is responsible for
managing concept requests and distributing and supporting IHTSDO
products. The NLM, which also maintains and distributes the UMLS, is the
U.S. member of the IHTSDO.
SNOMED CT contains preferred terms and the related synonyms
(including Spanish translations of preferred terms) organized in a
hierarchical tree structure with top-level concepts, such as body structure,
clinical finding (e.g., diseases, disorders, drug actions), event, observable
entity, procedure (e.g., treatment or therapy, surgical procedure,
laboratory procedure), specimen, and substance.47 Concepts lower in the
hierarchy are more specific in meaning than those higher in the hierarchy,
creating multiple levels of granularity. Defining a ribute relationships
using description logics further details the meaning of a concept by
relating all necessary and sufficient conditions.
In general, clinical questions for assessment and measureable outcomes
(e.g., pain level) can be coded using concepts placed under observable
entity. Most nursing diagnoses and outcomes can be found under clinical
finding and event, while nursing interventions and actions are found under
procedure. An example of SNOMED CT coding of the clinical question
“ability to manage medication?” with the answer “unable to manage
medication” is presented in Fig 22.3. This set of questions and answers
coded using standardized terminologies is ready for data exchange using
messaging standards such as HL7.
FIG 22.3 The structure and application of SNOMED CT. Retrieved
from the IHTSDO SNOMED CT browser. [Link]
Classifications Used for Reimbursement
The International Classification of Diseases (ICD), copyrighted by the
World Health Organization (WHO), is used to report mortality and
morbidity data worldwide and to compare statistics across se ings,
regions, or countries over time.48 Further, ICD is used for billing,
reimbursement, and allocation of health service resources for
approximately 70% of the world’s health expenditures.48 The current
version of ICD-10 (10th edition) was endorsed by the WHO in 1990 and
implemented in the United States as of October 1, 2015.49 Additional
information concerning the structure and function of ICD-10 is included in
Chapter 19. With the advancement of information technology and EHRs,
ICD-11 has been developed and is currently in a revision process, with an
anticipated release in 2018. ICD-11 provides more detailed information
(such as definitions, signs, and symptoms) on disease in a structured way.
Depending on the focus of specialty areas, additional classifications can
be used for ordering, billing, and reimbursement of medical procedures
and diagnostic services. ICD Clinical Modification (ICD-CM) is a coding
system developed to encode medical diagnoses and procedures (such as
surgical, diagnostic, and therapeutic procedures) performed in U.S.
hospital se ings.50 ICD-10-CM, a modified version of ICD-10, is updated
annually by the National Center for Health Statistics (NCHS) and CMS.
The Current Procedural Terminology (CPT) classification system is used
extensively in the United States, as CMS mandates its use for reporting
outpatient hospital surgical procedures as part of the Omnibus Budget
Reconciliation Act.51 Diagnosis Related Groups (DRG) is a patient
classification scheme designed to cluster similar cases using ICD and CPT
codes as well as patient characteristics for reimbursement purposes
according to the inpatient prospective payment system (IPPS).52
Other healthcare providers may use a different coding system for
ordering, billing, and reimbursement for care delivered. For example, the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-
IV), developed by the American Psychiatric Association, has been widely
used by clinicians to code mental and behavioral health–related
conditions. All DSM-IV diagnostic codes have been integrated into ICD-9-
CM.53 Due to differences between the two coding systems, however, cross-
map between DSM-IV and ICD-10-CM is under development. Another
example is the ABC Coding Solutions, which provides more than 4500
codes for integrative healthcare services and products.54 In other words,
the ABC coding system covers clinical services related to nursing,
behavioral health, alternative medicine, ethnic and minority care,
midwifery, and spiritual care. An ABC code consists of five characters
representing types of services, remedies, supplies, and practitioners.54
RxNorm
RxNorm is a normalized drug-naming system derived from 14 drug
terminologies containing drug names, ingredient, strength, and dose
form.55 Example source terminologies within RxNorm include
Micromedex RED BOOK, Food and Drug Administration (FDA) National
Drug Code Directory, SNOMED CT, and the Veterans Health
Administration National Drug File. Due to different naming systems used
in each terminology, the NLM produces normalized generic and brand
names of prescription drugs and over-the-counter drugs available in the
United States.55 The NLM uses the UMLS framework to maintain and
distribute RxNorm, allowing consistent communication among various
hospital and pharmacy systems. RxNorm preserves original drug names
as synonyms and semantic relationships among drugs. It also serves as a
knowledge resource to advance e-prescribing systems with decision
support functionality, as RxNorm contains pharmacologic knowledge
such as drug interactions.56
World Health Organization Family of International
Classifications
The WHO formed a Family of International Classifications (WHO-FIC),
containing a suite of WHO-endorsed classifications, including three
reference classifications, five derived classifications, and five related
classifications.57 ICD and International Classification of Functioning,
Disability and Health (ICF) are core reference classification systems in
WHO-FIC.57 While the ICD system provides a set of diagnosis codes to
encode causes of death and health conditions, ICF (formerly known as the
International Classification of Impairments, Disabilities, and Handicaps) is
a classification system that focuses on functional status as a consequence of
disease or health conditions.58 Although ICF has been used mainly in
physical therapy and rehabilitation professions, previous studies
demonstrated the usefulness of ICF in documenting nursing practice in
acute care hospitals and early postacute rehabilitation se ings.59-62
Knowing that these core classifications lack in covering other specialty
areas, the WHO recognizes an additional 10 classifications or
terminologies in WHO-FIC.63 For example, ICD-10 Classification of Mental
and Behavioral Disorders and ICF Version for Children and Youth are
derived from the core classification systems (i.e., ICD and ICF).
International Classification of Primary Care and International
Classification for Nursing Practice (ICNP®) are considered related
classifications in WHO-FIC.
Nursing Terminologies
As shown in Table 22.2, the ANA recognized seven nursing terminologies
or classifications supporting nursing practice as they conform to the
terminology development standards.64 All of the ANA-approved nursing
terminologies have been integrated into the UMLS Metathesaurus and
widely adopted nationally and internationally. This section briefly
introduces the nursing terminologies and describes their purpose, scope,
content coverage, and structure.
Clinical Care Classification
The Clinical Care Classification (CCC) has been used for more than 20
years in nursing across the care continuum since its development as the
Home Health Care Classification System in 1991.65 CCC is a classification
system of nursing diagnoses and interventions organized under 21 care
components to support documentation of the nursing process.66 In this
classification, a nursing care component is a navigation or high-level
abstract concept, clustering the nursing practice with similar pa erns.
These care components are further aggregated into four healthcare
pa erns of patient care: functional, health behavioral, physiological, and
psychological.
CCC Version 2.5 includes 176 nursing diagnoses (60 major categories
and 116 subcategories), from which 528 nursing outcomes can be derived
using three modifiers: (1) improved, (2) stabilized, and (3) deteriorated.67
As such, 201 nursing interventions (77 major categories and 124
subcategories) can be expanded to as many as 804 nursing actions by
combining four action types: (1) monitor/assess/evaluate/observe, (2)
perform/direct care/provide/assist, (3) teach/educate/instruct/supervise,
and (4) manage/refer/contact/notify. This compositional ability of CCC
allows users to express nursing care in any care se ing while maintaining
a simple classification structure (Table 22.4). Each nursing diagnosis,
intervention, and outcome is assigned to a code with alphanumeric
characters.
Table 22.4
Structure and Application of CCC In Relation to the Nursing Process
for Pressure Ulcer
CCC, Clinical Care Classification.
International Classification for Nursing Practice
The ICNP is a nursing terminology designed to represent nursing
diagnoses, outcomes, and interventions capturing the delivery of nursing
care across se ings.68 The ICNP is an entity of the International Council of
Nurses (ICN) eHealth Programme that was launched to transform nursing
through the use of health information and communication technology.69
The ICN is a federation of more than 130 national nurses associations that
represent millions of nurses worldwide. Since 1989, the ICNP has evolved
from a collection of nursing-related concepts to a logic-based nursing
terminology system maintained in an ontology development
environment.68 The ICNP has been developed using a sophisticated
language (i.e., Web Ontology Language, or OWL) to ensure the
sustainability of the ever-expanding terminology and maintain the quality
of the terminology.70
In conformance with ISO standards (ISO/TS 18104:2014), nursing
diagnosis, outcome, and intervention statements are precoordinated with
primitive concepts such as focus, judgment, and action concepts. Each
precoordinated concept is assigned a unique identifier, and it is possible
for practitioners to postcoordinate primitive concepts to meet their needs.70
For example, as shown in Box 22.1, the nursing diagnosis acute pain is a
precoordinated concept with an assigned code (10000454), but acute
abdomen pain does not exist in ICNP, meaning that the concept could be
postcoordinated with two concepts: acute pain (10000454) in abdomen
p p p
(10000023). All ICNP primitive and precoordinated concepts are organized
in a hierarchical tree structure. The 2015 release included 805 nursing
diagnoses/outcomes and 1019 intervention statements. A new version of
ICNP is released every 2 years in conjunction with the ICN conference.
Due to the size and complexity of ICNP, subsets are created to promote
the utility of ICNP in practice.71 That is, ICNP catalogs or subsets with
select nursing diagnoses and interventions have been developed and
distributed in collaboration with national nurses associations, health
ministries and governments, and expert nurses worldwide.72–75
Box 22.1
Structure and Application of ICNP
ICNP, International Classification for Nursing Practice.
aThis example shows the placement of the nursing diagnosis Acute pain in the ICNP
asserted hierarchy.
NANDA International Nursing Diagnoses
The North American Nursing Diagnosis Association (NANDA) dates back
to 1970, and its terminology was the first to be recognized by the ANA.76
The membership organization was renamed NANDA International
(NANDA-I) to reflect worldwide use of the terminology and established
network teams in Latin America, Europe, Asia, and Africa.77 In NANDA-I,
a nursing diagnosis is defined as “a clinical judgment about actual or
potential individual, family, or community experiences/responses to
health problems/life processes.”77, p. 134 The purpose of NANDA-I is to
ensure consistent, accurate documentation of nurses by clinical reasoning
judgments and drive nursing interventions and outcome evaluations. As
shown in Table 22.5, a three-level structure was adopted to place diagnoses
according to conceptual similarities.77 That is, a nursing diagnosis (Level 3)
g p g g ( )
is located in a class (Level 2) according to its definition, defining
characteristics and related factors, or risk factors. A class is further
clustered into a domain (Level 1). The NANDA-I 2015–2017 release
includes 235 nursing diagnoses organized in 47 classes and 13 domains,
along with the evidence to support knowledge-based diagnostic decisions.
Table 22.5
Structure and Application of NANDA-I With Knowledge Content to
Reference
NANDA-I, North American Nursing Diagnosis Association International.
Nursing Interventions Classification
The Nursing Interventions Classification (NIC) is a funded research-based
standardized classification of interventions describing nursing activities
performed directly or indirectly. An intervention is defined as “any
treatment, based upon clinical judgment and knowledge that a nurse
performs to enhance patient/client outcomes.”78, p. 2 This means that
choosing a nursing intervention is based on the characteristics of nursing
diagnosis and expected patient outcomes. The NIC is designed to support
the communication and documentation of nurses and other healthcare
providers with the exception of physicians.78 The current release (2013)
includes more than 550 interventions clustered into 30 classes and 7
domains. Each intervention concept includes a definition, a code, and a list
of detailed activities ranging from 10 to 30 statements. An intervention
concept may appear in more than one class, resulting in approximately
13,000 narrative activity statements.78
Nursing Outcomes Classification
The Nursing Outcomes Classification (NOC) is also a funded research-
based standardized classification of patient and caregiver outcomes that
p g
can be used in the course of care delivery for any specialty and se ing.78,79
An outcome is “a measurable individual, family, or community state,
behavior or perception that is measured along a continuum and is
responsive to nursing interventions.”79, p. 35 The current release (2013)
includes 490 outcomes clustered into 32 classes and 7 domains. Each
outcome concept consists of a definition, a list of indicators, and five-point
Likert-type scales. The scales, ranging from 1 to 5, are used to measure the
existing level, patients’ preferred level, and subsequent evaluation
longitudinally to determine change scores in patients. The Center for
Nursing Classification and Clinical Effectiveness (CNC) at the University
of Iowa College of Nursing has an ongoing collaboration and alliance with
NANDA-I to establish linkages among the three nursing classification
systems—NANDA-I, NIC, and NOC—for use in EHRs.79 An example
linkage of the three classifications is presented in Table 22.6.
Table 22.6
Structure and Linkage of NANDA-I, NIC, AND NOC
NANDA-I, North American Nursing Diagnosis Association International; NIC, Nursing
Interventions Classification; NOC, Nursing Outcomes Classification.
Omaha System
The Omaha System is a standardized classification designed to document
nursing practice across the continuum of care. (Details about home health
and the Omaha System are provided in Chapter 9.) Work on the Omaha
System began in the 1970s and was further expanded with the release of
the 2005 version. The Omaha System is structured with three schemes—
Problem Classification, Intervention, and the Problem Rating Scale for
Outcomes.80 The Problem Classification Scheme (i.e., assessment) consists
of four components: domains, problem statements, modifiers, and signs
and symptoms (Table 22.7). Forty-two problem statements are neutral
until two modifiers are a ached to the problems. One set of modifiers is
related to potentiality (i.e., actual and potential) and health promotion; the
other set of modifiers is related to health problems (i.e., individual, family,
and community). A problem is considered actual if signs and symptoms
associated with the problem are selected from a predefined list. All
problems are grouped into one of four domains: environmental,
psychosocial, physiological, or health-related behaviors. The Intervention
Scheme (i.e., care plans and services) consists of 75 target interventions
and 4 action categories: (1) teaching/guidance/counseling, (2)
treatments/procedures, (3) case management, and (4) surveillance. Patient
problems are evaluated throughout the course of care using a Likert-style
measurement scale ranging from 1 to 5 in the areas of client knowledge,
behavior, and status.
Table 22.7
Structure and Application of Omaha System
Perioperative Nursing Data Set
The Perioperative Nursing Data Set (PNDS) is a standardized classification
system designed specifically to support the perioperative nursing process
in documenting patient experience from preadmission to discharge.81 The
PNDS (2011) is composed of 74 nursing diagnoses adopted from NANDA-
I, 153 nursing interventions, and 38 nurse-sensitive patient outcomes. All
nursing interventions consist of three different types of actions:
assessment, implementation, and evaluation. These statements are
clustered into one of four domains: safety, physiologic responses,
behavioral responses (of family and individual), and health system (which
is not directly related to nursing process).81,82 Using the Perioperative
Patient Focused Model, the PNDS provides a systematic approach for
identifying the contributions of perioperative nursing care by reporting
and benchmarking. Table 22.8 shows example statements selected from the
PNDS in relation to the nursing process.
Table 22.8
Structure and Application of PNDS in Relation to the Nursing Process
NANDA-I, North American Nursing Diagnosis Association International; PNDS,
Perioperative Nursing Data Set.
Data exchange efforts
Health terminologies keep evolving to incorporate changes in clinical
practice, health policy, and advances in science. It is unlikely that in the
future any one standard language will be able to support all clinical
practices within the different disciplines functioning within the healthcare
system. A key concern is how to communicate and exchange data collected
through the various clinical practices across se ings while preserving
terminology-related standards. HL7 standards have been established to
regulate data exchange and integration using standardized terminologies
and other terminology harmonization efforts.
HL7 Standards
Since 1987, HL7 has served as a standards-developing organization to
promote data retrieval, exchange, and integration across different health
information systems.83 HL7 provides a comprehensive framework and the
standards necessary to foster interoperability (or exchange) of healthcare
data. This chapter focuses on the two standards most commonly used in
clinical practice: Clinical Document Architecture (CDA) and Fast Health
Interoperability Resources (FHIR).
CDA is used to represent clinical documents using eXtensible Mark-up
Language (XML) and standard terminologies in defined reusable pa erns
called templates.84 CDA markup standards specify the structure of clinical
documents and semantic relations among the subcomponents of clinical
documents.84 CDA is used to exchange documents such as patient
assessments, discharge summaries, imaging reports, and quality reports
between healthcare providers.85 The Consolidated Clinical Document
Architecture (C-CDA) Release 1.1 is an implementation guide required by
Meaningful Use stage 2 for the exchange of patient information within the
following measures: transitions of care, data portability, patient
engagement, view, download and transmit to a third party, and clinical
summary.86-88
FHIR is designed to enable the exchange of clinical, healthcare-related
administrative, public health, and research data.89 FHIR is intended to be
useable worldwide in various contexts, including in-patient, skilled
nursing, and long-term care. Resources are the most important parts of the
FHIR specification to understand because they simulate paper “forms” by
replicating different types of clinical and administrative information that
can be captured and shared. The FHIR specification defines a generic
“form template” for type of clinical information such as demographics,
health conditions, and procedures.89 The FHIR data repositories contain
completed “forms” (resource instances) that describe patient-related
information as well as administrative information such as practitioners,
organizations, and locations. Each resource defines a small amount of
specific data. A single resource does not provide much information, but a
compilation of resources taken together constructs a useful clinical record.
Information systems map actions that a user takes (e.g., record vital signs,
add a nursing diagnosis) to operations on the relevant resources.
While the C-CDA and FHIR specify structural components, HL7
messaging standards address rules to communicate detailed information
about patient care. Regardless of coding rules employed in individual
departments or organizations, messaging specifications prevent any
misclassification of data communicated between senders and receivers of
clinical data.83 The messaging standards thus ensure consistent
descriptions of patient care among disparate systems. Standardized
terminologies reviewed earlier in this chapter are the basic elements of the
messaging standards.
Terminology Harmonization
Interoperability is defined as “the ability of health information systems to
work together within and across organizational boundaries in order to
advance the effective delivery of healthcare for individuals and
communities.”90, p. 75 The U.S. Department of Health and Human Services
(HHS) recommends the implementation of a health IT infrastructure to
enhance interoperability of healthcare data.91 The Healthcare Information
Technology Standards Panel (HITSP), founded in 2005 through a contract
with the HHS, has contributed to enabling interoperability among EHRs
through the development of technical specifications.92
Standards harmonization is an effort to consolidate and enhance the
coverage of domain knowledge of interest. Terminology harmonization is
regarded as one way to support interoperability, considering variations in
terminology adoption in practice. Cross-mapping healthcare terminologies
is essential to preserve the meaning of exchanged information and
facilitate integration of clinical data in a disparate information system so
that the comprehensive picture of healthcare delivery can be understood.
As described previously, numerous health and nursing terminologies
exist, resulting in various harmonization activities within and across
disciplines. The scope of these harmonization activities ranges from a
simple survey designed to understand the characteristics of terminologies
adopted in clinical practice to harmonization agreements between two
standards organizations. Harmonization of the multidisciplinary
terminologies includes maps between SNOMED CT and ICD-10,
SNOMED CT and ICD-10-CM, and LOINC and HL7 vocabulary. These
cross-maps are publicly available through the NLM. A draft cross-map of
LOINC Version 2.15 and CPT Version 2005 is available in the UMLS.93
Since LOINC and SNOMED CT are widely adopted and considered
data standards nationally and internationally, nursing has participated
actively in harmonization efforts through terminology cross-mapping and
integration of nursing terminologies into SNOMED CT and LOINC. The
ANA further recommends using SNOMED CT and LOINC for a C-CDA
exchange with another se ing for problems and care plans.94 The
recommendation promotes standard terminologies and also suggests that
all care se ings create a plan for mapping ANA-recognized nursing
terminology to national standards such as SNOMED CT or LOINC.
Both the CCC and Omaha System outcomes are mapped into LOINC.17
All ANA-recognized nursing terminologies are mapped to SNOMED CT
to some extent.77,95–97 This means that nursing diagnoses, interventions,
and outcomes have been modeled in SNOMED CT and assigned to a
unique identifier according to the SNOMED CT development guidelines.
Equivalency tables between ICNP and SNOMED CT are distributed
through ICN and IHTSDO. Table 22.9 presents examples of nursing
concepts mapped to SNOMED CT and shows a potential opportunity for
collaboration in harmonizing all of the nursing terminologies and
SNOMED CT. In addition, ICNP has been mapped to CCC, ICF, and other
local terminologies to enhance data capture and sharing and to develop
national nursing datasets.98-102 Harmonization agreement between ICN and
SabaCare resulted in cross-maps between CCC and ICNP, presenting
different yet complementary solutions to advance standardization of
nursing process data across specialties and se ings (Table 22.10).
Table 22.9
Mapping Nursing Concepts to SNOMED CT
Source
Example Concepts in Source Terminology Target Terminology: SNOMED CT (Type)
Terminology
CCC K25.5 Infection risk 78648007 At risk for infection (finding)
K30.0.1 Teach infection control 385820004 Teach infection control (procedure)
ICNP 10021941 Lack Of Knowledge Of Medication 129866007 Deficient knowledge of medication
Regime regimen (finding)
NANDA-I 00004 Risk for infection 78648007 At risk for infection (finding)
NIC 6540 Infection control 77248004 Infection control procedure (procedure)
NOC 1807 Knowledge: Infection control 405111006 Knowledge: Infection control
(observable entity)
Omaha System 71 Infection precautions (Qualifier: 77248004 Infection control procedure (procedure)
Treatment/procedure)
PNDS A.350 Assesses susceptibility for infection 370782005 Assessment of susceptibility for
infection (procedure)
O.280 Patient is free from signs and 397680002 Absence of signs and symptoms of
symptoms of infection infection (situation)
CCC, Clinical Care Classification; ICNP, International Classification for Nursing Practice;
NANDA-I, North American Nursing Diagnosis Association International; NIC, Nursing
Interventions Classification; NOC, Nursing Outcomes Classification; PNDS, Perioperative
Nursing Data Set; SNOMED CT, Systematized Nomenclature of Medicine—Clinical
Terms.
Table 22.10
Mapping CCC Concepts to ICNP
CCC, Clinical Care Classification; ICNP, International Classification for Nursing Practice.
Application of standardized
terminologies
There are multiple ways of communicating and recording patient care data
in EHRs. Many clinical records (e.g., physical assessments) are
documented using prestructured clinical templates with discrete data
elements and predefined value sets. Yet massive volumes of narrative text
data (e.g., clinical notes from various disciplines, progress notes, discharge
notes) are also documented in free-text forms in EHRs. Developing quality
terminologies and classifications to cover domain-specific content is of
critical importance for system design, data retrieval and exchange, quality
improvement, and clinical research.103-111
Choosing one among the various terminologies is not immediately
straightforward. Although informatics and professional organizations
endorse various terminologies, they do not recommend single taxonomies
for use. Informaticians will need to evaluate their organizational,
professional, and contextual needs to determine the most appropriate
terminologies to deploy. In many cases with EHRs, vendors have
embedded local terminologies and used particular communication
standards (e.g., HL7), so any decisions about terminologies will need to be
evaluated at the system selection stage or just be accepted as part of the
purchasing package. For other applications, informaticians will want to
consider the context (e.g., home health) and evaluate existing
terminologies for that se ing. At this point in the time, the onus is still on
the purchaser to evaluate terminologies for the extent of use,
completeness, and appropriateness to the module at hand.
Designing User Interfaces Using Terminologies
The comprehensiveness and completeness of a standardized health
terminology vary depending on the domain of interest and the facility.
When designing prestructured clinical templates for clinical
documentation, interface terminologies can be used to facilitate data entry
and storage of clinical data at the point of care. An interface terminology is
considered a solution to enhance the user interface in EHRs because of its
ability to cover clinicians’ preferred terms with rich synonyms and
conceptual relations among the terms.11 An interface terminology either
can be derived from standardized reference terminologies and
classifications reviewed in this chapter or can be developed locally to
support the documentation practice. However, if not careful, local systems
might result in numerous duplicate and ambiguous concepts without
development guidelines.11 Accordingly, a systematic approach should be
undertaken to map any local interface terminology to standardized
reference terminologies. Otherwise, clinical data cannot be communicated
as intended.
Supporting Data Retrieval and Exchange
Storing clinical data using standardized terminologies means that data are
encoded using concept unique identifiers or alphanumeric codes to
prevent any inconsistencies created by typing errors. Prestructured clinical
templates can be a vehicle to help users pick and choose from a predefined
value set and encode accurately selected values. Retrieving these coded
data is much easier than free-text data that are documented using natural
language that contains numerous variations in expressions for the same
concept or meaning.
While coded data can be easily retrieved and transferred to other
facilities using messaging standards (such as HL7), exchanging free-text
data requires multiple steps for processing.112 For instance, assume that no
structured form exists to document a skin and wound assessment but only
narrative text. To identify a patient who developed a pressure ulcer during
hospitalization in the narrative statements, natural language processing of
clinical notes would be required. This requires computing resources and
human verification of the machine-aided findings (i.e., patients with a
pressure ulcer). Many natural language processing tools used in the
healthcare domain adopt standardized terminologies to map terms
extracted from clinical notes or scientific articles. For example, MetaMap,
developed and distributed by the NLM, uses UMLS Metathesaurus to
extract certain expressions in a standardized way.113
Monitoring the Quality of Care
Clinical databases hold massive amounts of structured and unstructured
data along with date and time stamps. Once clinical data are coded in a
standardized way, it is possible to monitor the quality of care by joining
multiple data sources, including administrative databases. Clinicians and
administrators can examine gaps between current practice and best
practice, trends in patient outcomes associated with changes in the
organization’s policy, practice pa erns, and nurse staffing ratios. This type
of investigation can be summarized and shared for ongoing quality
monitoring and benchmarking.114 Example quality-monitoring activities
include identification of the following:
• Medication errors associated with reconciliation, prescription, and
administration
• Degree of clinicians’ adherence to best evidence and guidelines
supported through reminders and alerts
• Healthcare resource use (e.g., length of stay, 30-day readmission rate
of select population)
Using a standardized terminology facilitates the aggregation of patient
care data based on predefined conceptual and semantic relationships of
the coded data. An administrator may want an overview of staffing to
support various types of patient populations. The highest-level construct
of each terminology (e.g., functional, physiologic, or psychosocial) could
be used to aggregate diagnoses and interventions implemented by unit.45
Next, the administrator could examine the types of patient problems most
prevalent in each unit by sorting according to the next level of hierarchical
structure of the given terminology. Practitioners can also benefit from data
summarization and presentation produced at both high and granular
levels to understand their level of individualized care for accreditation
processes or to guide local clinical education to address the major
problems, risks, and needs for health promotion for the patient
population.
To ensure patient safety and reduce healthcare costs, CMS developed
various initiatives to collect quality measures such as smoking cessation
and hospital-acquired pressure ulcer development.9 CMS is collaborating
with public agencies and private organizations to support the use of such
quality measures, including, for example, the National Quality Forum, The
Joint Commission on Accreditation of Healthcare Organizations, the
National Commi ee for Quality Assurance, the Agency for Healthcare
Research and Quality, and the American Medical Association.115 Reporting
these quality measures requires the adoption of standardized terminology.
Discovering Knowledge Through Research
Clinical researchers can benefit from EHRs with the functionality and
capacity to access complete coded data across the care continuum. Current
barriers, including that data are coded with multiple terminologies, could
be removed as more standardized terminologies are harmonized to
support data exchange and reuse. Ideally healthcare terminologies can
complement each other to enhance the coverage of domain knowledge and
thus promote Meaningful Use of clinical data. Coded data enable
comparative effectiveness research and healthcare transformation using
standardized data retrieved from multiple EHRs.116
Huge volumes of clinical and administrative data reside in large
repositories, providing additional opportunities for clinical research, as
discussed in Chapter 23. When paper-based records are used for clinical
research, the number of reviewed charts is restricted because of the major
resource requirements and the time-intensive chart abstraction process. In
contrast, clinical research using current EHRs can involve thousands or
even millions of patient records, offering the potential to identify new
relationships among the data. Standardized terminologies in EHRs
facilitate this kind of research. Even so, using current EHRs for research
creates additional challenges and costs for data queries, processing, and
analysis to handle the many inconsistent descriptions of patient care and
large volumes of missing data.
Conclusion and future directions
Since the release of the IOM report on the U.S. quality chasm in 2001,
health IT has been seen as a promising solution for improving patient
safety, delivering patient-centered care, and reducing healthcare costs.1
However, a fundamental requirement for health IT is information
exchange across systems. The use of standardized terminologies facilitates
information exchange and is one of the requirements for Meaningful Use
and healthcare interoperability.
Health practitioners recognize the benefits of using standardized
terminologies and are actively participating in the development of both
discipline-specific terminologies and multidisciplinary terminologies. As
patient engagement with electronic records increases, the health
practitioner needs to be involved in the development of consumer health
vocabulary as well. With standardized clinical terminology, patient data
will be available across the full spectrum of healthcare se ings. Also, these
data are and will be shared with individual patients, requiring additional
efforts to translate professional vocabulary to consumer vocabulary.
Patient-centered records maintained jointly by consumer and health
professionals will provide opportunities to enhance public health
surveillance by enabling a clinician’s ability to track a patient’s health
maintenance, follow-up activity, engagement, and progress. The health
professions should continue to participate in current and future endeavors
to ensure that the domain concepts are represented in the approved
manner within health IT.
Data standardization and exchange efforts were reviewed at various
levels. Historically, coding requirements were associated with billing and
reimbursement. Clinically focused coding efforts have advanced with the
expansion of electronic health information. With the advancement of
health IT and health sciences, data standardization and exchange are key
elements for improving the nation’s healthcare. Many benefits of using
data standards have yet to be realized, but progress is evident. While
terminology developers will continue to put their efforts into further
enhancements, terminology users also need to evaluate the quality of
terminologies and provide feedback to terminology developers.
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96 College of American Pathologists (CAP). SNOMED CT® Mappings
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97 Kim T.Y., Hardiker N., Coenen A. Inter-terminology mapping of
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Discussion questions
1. A cost-effective, quality healthcare system requires interoperability,
which in turn requires standards. However, “healthcare standards
developed by specific vendors often do not rise to dominance because
there are no truly dominant vendors in the industry, nor are there
industry action groups powerful enough to achieve voluntary
convergence.”5 Given this reality, how can healthcare providers and
health informatics specialist support the development of standards?
2. You are the only informatician at your small community hospital and
have been asked to choose terminologies within your EHR for
interdisciplinary care planning. What terminologies would you use and
why?
3. Discuss the benefits of using standardized terminologies within your
EHR.
4. Discuss the major local, national, and international obstacles to
implementing standardized terminologies within EHRs.
5. As a researcher, you have been assigned to obtain data from two
different facilities. Both facilities have mapped their data to
standardized terminologies within their data warehouses. Discuss how
this will benefit your research. Alternatively, what if the data in both
facilities were not coded using standards? What obstacles would need to
be overcome?
Case study
A small community hospital in the Midwest has used a homegrown
information system for years. The system began in the early 1970s with a
financial module. Over time, additional modules were added. A limited
number of departments selected a commercial system, and interfaces were
used to integrate these into the overall functionality of the hospital
information system. Except for physicians, most in-house clinical or care-
related documentation is online. However, about 15% to 20% of this
documentation is done by free text and is not effectively searchable. In
addition, the screens, including the drop-down and default values, were
built using terms selected by the in-house development team in
consultation with clinical staff; thus there is no data dictionary or specific
standard language. In the last few years the hospital has purchased two
outpatient clinics (obstetrics and mental health) and a number of local
doctor practices. The clinics and doctors’ offices are now being converted
to the hospital administrative systems as described in Chapter 7. A few of
the clinical applications that are tied directly to the administrative systems
such as order entry and results reporting are also being installed.
A major change is being planned. A new chief information officer (CIO)
was hired last year, and she has appointed a chief medical information
officer (CMIO) and a chief nursing information officer (CNIO). No other
significant staff changes were made. With her team in place, one of the
CIO’s first activities was to complete an inventory of all applications. As
part of this process, each application and the system as a whole were
assessed for the ability to meet Meaningful Use criteria. Based on this
analysis, the CMS modified Stage 2 criteria are currently met; however,
meeting Stage 3 criteria will require a significant investment in hardware,
software, and additional staff. Rather than continue to build, a decision has
been made to switch to a commercial vendor. The hospital is now in the
process of selecting a commercial system. Because of your background as a
member of the clinical staff with informatics education, you have been
appointed to the selection commi ee. It is also anticipated that you will
serve on the implementation commi ee.
Discussion Questions
1. What role, if any, should standard language play in the selection
process?
2. What key standard languages and coding systems should be
incorporated in the new system?
3. Can the work done in building the screens and developing the terms
that are used for documentation of care in the old system be used in
the new system, or will this delay customizing the new system
applications?
4. It is expected that clinical staff will participate in site visits and vendor
displays. What, if any, preparation related to standard languages
should be given before these activities?
5. How should clinical staff who will be using the new system be
prepared for the introduction of new or different terms in the clinical
documentation system?
a The terms standards development organizations (SDO) or standards-se ing organizations
(SSO) are used interchangeably in the literature and this chapter.
23
Data Science and Analytics in
Healthcare
Mollie R. Cummins; Louis Luangkesorn; Nancy Staggers
Abstract
Availability of extremely large repositories of healthcare data and new analytic tools
have revolutionized efficient access to comprehensive data across large numbers of
patients. Advances in tools and methods for analyzing large stores of data enable
detection of subtle pa erns in these data, even with missing or less than optimal data
quality. This chapter introduces approaches to data science, analytics, and
knowledge building from health data, including details on a process known as
knowledge discovery and data mining (KDDM). Data science or “big data” concepts
are introduced, and the fundamentals of data analytics are discussed. The chapter
explores the application of data analytic processes in healthcare and describes
organizational needs for data science such as personnel and data governance. The
chapter concludes with recent advances and challenges in the field and a discussion
of future directions in data science, data analytics, and KDDM.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Analyze the meanings of various terms and concepts related to big
data.
2. Define the goals, objectives, and uses of big data, healthcare analytics,
including knowledge discovery and data mining (KDDM).
3. Describe three categories of analytics.
4. Interpret characteristics of big data.
5. Discuss the key elements of model development.
6. Outline the steps in Knowledge, Discovery and Data Mining (KDDM)
as well as current challenges to the process.
7. Describe three categories of analytics platforms.
8. Identify the roles and activities of the informatics specialist related to
data management and use in healthcare environments.
KEY TERMS
big data 392
classification matrix 399
data analytics 392
data governance 404
data mining 398
data science 392
exploratory data analysis 394
knowledge discovery and data mining (KDDM) 394
machine learning 395
natural language processing (NLP) 397
predictive analytics 394
prescriptive analytics 394
Introduction
Leaders must foster a shared learning culture for improving healthcare.
This includes extending improvement efforts beyond individual units or
healthcare organizations to create more generalizable knowledge
development. Sound, rigorous methods are needed by leaders, analysts,
researchers, informaticians, and health professionals to (1) create
knowledge for learning organizations and (2) address practical questions
about risks, benefits, and costs of interventions as they occur in actual
clinical practice. A powerful tool for accomplishing this is the use of data
science to answer questions such as:
• Are treatments used in daily practice associated with intended
outcomes?
• Can adverse events be predicted in time to prevent or ameliorate
them?
• Which data elements are key to predicting patient behaviors for
population health management?
• How can evidence-based practice be used in providing individualized
patient care?
• What planning for individualized patient care and which potential
interventions are most likely provide the greatest value?
• What groups of individuals are at risk for certain conditions?
• How can available resources be best used to deliver care to patient
population?
• Which available tools and methods best meet the needs of an
organization or individual who is analyzing large datasets?
Data science in healthcare
U.S. healthcare expenditures exceed one-sixth of the U.S. gross domestic
product.1 Health information technology (IT) can help leverage those
monies by reducing costs and improving outcomes. However, routine use
of IT, in and of itself, does not automatically lead to these benefits. Rather,
these benefits are tied to specific uses of health IT within and across
healthcare organizations, including the use of data science to improve
care.
Data science, also called data analytics or “big data,” offers a systematic
approach to answering interesting questions across large datasets. Simply
put, big data is a colloquial term for extremely large datasets that are
analyzed using computerized techniques to reveal pa erns, trends, and
associations.2 New and specific analysis techniques allow managing and
processing across a combination of data types. These are analyses that are
not possible with conventional research and database analysis methods.
The volume and size of big datasets are often in the range of terabytes
and typically above one petabyte. One petabyte can be explained using the
following analogy: If an average MP3 song on a mobile device lasts 4
minutes, then a petabyte of songs would play continuously for 2000 years.
Likewise, a petabyte has enough space to store the DNA of the entire
population of the United States, including one clone of each person.3
The amount of data being generated today is enormous. Over 2.5
quintillion terabytes of data were generated each day in 2012. The data
generated in two days is now estimated to be as much as was created from
the dawn of civilization through 2003.4 Kaiser Permanente estimated it had
already generated 26.5-44 petabytes from its electronic health records
(EHRs) alone by 2013.5 As organizations continue to install EHRs,
integrate patient-generated data, and move toward precision medicine
(with its inherent requirement of integrating genomic, environmental,
health, and other data), datasets will continue to grow exponentially.
Data science involves the analysis within and across types and
categories of data. Examples of these categories are listed in Table 23.1.6
Table 23.1
Data Categories and Examples of Big Data6
Data Category Examples of Collected Data
Web and social media Facebook, LinkedIn, Twi er, health enterprise websites, mHealth apps
Machine to machine Uploads and readings from sensors and other devices
Big transaction Claims data and billing records
Biometric Vital signs, medical imaging, fingerprints, genetics, retinal scans, handwriting
Human generated Electronic health records, e-mail, paper documents
Data from Institute for Health Technology Transformation. Transforming Health Care
Through Big Data: Strategies for Leveraging Big Data in the Health Care Industry.
Institute for Health Technology Transformation. [Link]
[Link]/iHT2_BigData_2013.pdf;
2013.
Big data in healthcare are a mixture of structured (e.g., laboratory
values) and unstructured information (e.g., clinical notes). Using analytical
techniques, data science has the potential to provide powerful insights
across and within patients, institutions, regions, and nations. For example,
clinical records can be linked to repositories of genetic or familial data.7–9
These data constitute an incredible resource that is currently underused
for scientific research in healthcare.
Analyses can be conducted to support the decision-making process at
the population or individual patient level. For example, the United States
Veterans Health Administration (VHA) has a repository storing
nationwide EHR data. Analyses using this repository enabled the VHA to
recognize the dangers (such as cardiovascular events) of Vioxx, a
nonsteroidal antiinflammatory drug, among its patients. The VHA then
initiated a policy to restrict Vioxx use well before the drug was finally
removed from the market.10 Other questions useful to analyze the
population health management across millions of patients might include:
• Which treatments are associated with be er outcomes for patients
with kidney disease or specific carcinomas?
• How does obesity affect the need for joint replacement surgery at
younger ages and at what costs?
• How do patients’ physiologic parameters compare for newer and
previous cardiac medications?
Unlike traditional reports, these analyses require information across
multiple sources such as patients’ problem lists, histories, medications,
and lab and imaging results, as well as claims data.11
Data science analyses for individual patients can allow for more
personalized care (precision medicine). For instance, a patient with
diabetes might have metabolic rates, biochemical reactions, and responses
to insulin that could be analyzed against norms to pinpoint specific,
individualized medication delivery doses and times, along with tailored
nutritional guidance.11 In another example, Tamoxifen is 70% to 80%
effective for the population of patients with breast cancer. However, at the
individual level, Tamoxifen is 100% effective in 70% to 80% of patients but
100% ineffective for 20% to 30%. Thus individualized data are required to
determine what treatment is effective for a particular patient. A final
example is the IBM Watson project that combines information from the
entire corpus of published medical journals along with individuals’ health
records from healthcare organizations to suggest treatment pathways
tailored to the individual, a method of personalized medicine.12 Similar
individualized questions could be completed for genetic test results.13 The
same data used for personalized medicine can also then be analyzed to
identify population health trends, enabling a healthcare organization to
monitor emerging health trends and issues among its patient population.
Other obvious data science applications are quality improvement
initiatives and learning systems projects. In fact, the potential for
knowledge development is seemingly unlimited. Sample data science
projects are listed in Box 23.1.
Box 23.1
Sample Data Science Projects
• Neonatal infections. Real-time analyses of neonates’ physiologic data
predicted nosocomial infections 24 hours before clinical symptoms were
evident. These kinds of early detection may be applied to any ICU
se ing and lead to improved patient outcomes.14
• National influenza rates. Google Flu Trends in late 2013 showed the rate
of influenza across the United States as “intense.” Two weeks later, in
early 2014, the Centers for Disease Control (CDC) confirmed the rating.
The reason Google data surfaced earlier is because Google mined its
data for terms that would likely be related to influenza, while the CDC
relied on reports from physician visits.15
• Big Data to Knowledge Program. The Big Data to Knowledge (BD2K)
Center for Causal Discovery, part of the BD2K program, is developing
and making available a set of open-source tools for modeling and
discovering knowledge from large health and biomedical datasets.
Initial work is integrating real data from lung disease, cancer driver
mutations, and functions and connections of the human brain.16
Information about the BD2K program is available at
h p://[Link]/bd2k.
• Alzheimer’s Disease Neuroimaging Initiative. This multicenter,
collaborative effort is gathering clinical and imaging data for a large
cohort of patients.17 Researchers have already developed dementia risk
stratification based on these data.18
Characteristics of big data
Five data characteristics are important in understanding big data in
healthcare, as seen in Box 23.2.
Box 23.2
The Five Vs of Big Data
• Volume
• Velocity
• Variety
• Veracity
• Value
The first three characteristics are important to data in any field.19 Volume
refers to the sheer quantity of data generated and analyzed. In practical
terms, data are often stored in distributed locations, so techniques for
working with distributed data storage, such as cloud computing or
clusters, need to be employed. Velocity refers to the speed at which data are
generated and change over time. The important implication here is that the
environment generating the data changes rapidly, and any analysis must
be completed quickly enough to support decisions relevant to that data.
Otherwise, decisions may not be useful or timely.
Variety means that the data come from many different sources
simultaneously and in many different formats, as seen in Table 23.1. These
include varied forms of storing or sharing data, different types of media
(e.g., such as visual, audio, text, molecular), different rules surrounding
data (e.g., security for data protected under HIPAA), and different sources
(e.g., census data, billing, public health, EHRs, and social media). For
example, payment data provided by the Centers for Medicare and
Medicaid Services, hospital patient data, and hospital billing data are all
from different sources and have different rules for use, as well as different
levels of data validity and reliability.
Veracity and value are two issues that need to be addressed to make data
useful to a healthcare organization. Veracity refers to the accuracy and
completeness (the “truth”) of the data or its opposite, the messiness of the
data. The quality of individual data elements can vary greatly, especially
when they are from various sources. Data processing must then include
normalizing data so varied elements related to a single subject are
g g j
identified and matched. That allows the processing of data to proceed so
unstructured data such as voice or freely chosen text can be analyzed in
ways similar to structured data.
Value recognizes that the purposes of collecting, processing, and
analyzing data are to fill a need. For example, an acute care staffing mix
that emphasizes more highly educated nurses can result in fewer patient
complications; however, there is a point beyond which increased labor
costs do not produce fewer complications (or produce value). Considering
value, a key component of any data project is the question the data are
expected to answer and how a healthcare organization will respond to the
results of the analysis.
A data scientist or analyst needs to be able to manage data with mindful
consideration of the five Vs of big data (see Box 23.2). An analyst or
analytic team member should have computer programming skills to
manage the data and have expertise to recognize how to test for the
veracity of the data, perform correct analyses, and present the results in a
meaningful format to provide value to the organization.
Data science for clinical and translational
research
Big data can be used for decision making and/or research. The gold
standard research design for answering questions about the efficacy of
treatments is an experimental design, often referred to as a randomized
controlled trial (RCT). An RCT requires random assignment of patients to
treatment conditions as well as other design features, such as tightly
controlled inclusion criteria to ensure, as much as possible, that the only
difference between the experimental and control groups is the treatment
(or placebo) that each group receives. The strength of the RCT is the
degree of confidence in causal inferences. In other words, how confident
can one be that the therapeutic intervention caused the clinical effects (or
lack of effects), as opposed to some other variable? Drawbacks of the RCT
include the time and expense required to conduct a comparison of a small
number of treatment options and the limited generalizability of the results
to patients, se ings, intervention procedures, and measures that differ
from the specific conditions in the study condition. Further, RCTs have
li le value in generating unique hypotheses and possibilities.
Benefits of data science
Data science benefits come from using data across a wide range of
resources that are beyond the ability of an individual person to aggregate
and synthesize. Data analytics is a powerful tool with the ability to inform
healthcare delivery decisions based on complex information. Various
forms of data analytics and tools are used to systematically analyze
healthcare operations across healthcare areas, including financial,
operational, and clinical data. They can be used to coordinate care and/or
business decisions over time and venues. For instance, analysts can
examine the process of care and generate insights on how to improve
those processes.
General benefits of data science include the advancement of science and
improvements in healthcare, treatments, and the economics of
healthcare.20 Clearly, the projects described earlier show how advances in
science, healthcare, and treatments can be made. Other benefits cross
typical healthcare areas (e.g., healthcare costs and treatments). Newer cost
models like value-based payment are based on the effectiveness of medical
treatments for individuals or groups of patients in contrast to the
traditional model of fee for service (i.e., volume of treatment). Fee for
service can result in the administration of treatments that may not be
effective for a particular individual.21 Through data science and analytics,
particularly methods of knowledge discovery and data mining (KDDM),
knowledge models can be developed to identify optimal treatments for
individuals and groups of patients according to their characteristics, such
as diabetic diet and exercise regimens for inner-city, underserved patients.
Components of computerized clinical decision support (CDS) systems
with these knowledge models become routinely available as part of the
clinicians’ toolset and can allow care to be delivered at a lower cost.5 Thus
adding data science to the healthcare provider’s toolset can offer a more
cost-effective and less time-consuming approach to building knowledge.
However, insights from data are not realized automatically through
installation of an analytics IT infrastructure and/or an EHR system. To
derive the benefits of analytics, a healthcare organization needs to (1)
identify the required analytic capabilities at all levels of the organization,
(2) ensure that the system has the required capabilities, and (3)
commission appropriately educated personnel to plan and implement the
analytic process from data to deployment, thereby ensuring ultimate
translation.10
No ma er whether data analytics are used for research or decision
making, the approaches to analyses are similar. In the next section, these
sample approaches are outlined.
Approaches to analyses
Data analytics can be approached in three general ways: exploratory,
predictive, and prescriptive.21
Exploratory Data Analysis
Exploratory data analysis (EDA) prepares and analyzes retrospective data
to identify pa erns or trends. The process of EDA includes the use of
descriptive statistics (including summaries and data visualizations) and
statistical analysis. The goal of EDA is to understand the state of a system,
such as the distribution of inpatient stays among current patients in a
hospital or the outcome of all patients’ diagnoses or treatments over the
past year. Information and knowledge gained by revealing pa erns and
trends through EDA can be used to support more effective administrative
or clinical decision making. EDA can also be used to generate hypotheses
that can be answered by analyzing available system data (e.g., the
frequency of lab tests and their costs over the past year). The information
discovered through the use of EDA produces data reports or information
dashboards using spreadsheets or web-based applications to view and
interpret specific information to aid decision makers.
Predictive Analytics
Predictive analytics is the development of analytic models that predict
future trends based on retrospective or real-time data. KDDM methods
including machine and statistical learning methods are commonly used in
predictive analytics. Other methods can include:
• Regression. Predicting an outcome or a new observation (e.g.,
predicting which patients can be expected to experience a fall).
• Classification. Predicting the category for a new outcome (e.g.,
predicting which patients will respond to a specific medication or
treatment protocol).
• Clustering. Grouping observations into similar groups (e.g., seeing that
women who smoke have a higher rate of premature infants).
• Association rules. Determining a new characteristic based on known
characteristics of an observation (e.g., noting that people in a lower
socioeconomic group have a higher rate of health literacy problems).9
Prescriptive Analytics
Prescriptive analytics refers to the use of models to evaluate and
determine new ways of operating in a health system. These work through
modeling the system and potential alternatives, both assessing the value of
the business objective and tracking constraints. Methods used in
prescriptive analytics include queuing models, mathematical
programming methods for optimization, and simulation. These methods
have the advantage of being able to predict system output under a range
of system configurations, allowing decision makers to choose the best of
potential alternatives.
Knowledge discovery and data mining
KDDM is a process of data analytics where machine learning (ML) and
statistical methods are applied to identify pa erns in large sets of data. It
entails the use of specialized software tools that facilitate the (1) extraction,
(2) sampling, (3) large-scale cleaning, and (4) preprocessing of data.
Frequently, KDDM is used to infer missing information based on available
data and to develop models that predict future events. Methods of KDDM
are preferred because these methods are effective for analyzing very large
repositories of clinical data and for analyzing complex, nonlinear
relationships. The level of analysis far exceeds the types of descriptive
summaries typically presented by dashboard applications, such as a
clinical summary for a patient. Instead, KDDM is used to build tools that
support clinical decision making, generate hypotheses for scientific
evaluation, and identify links between genotype and phenotype. KDDM
can also be used to “patch” weaknesses in clinical data that pose a barrier
to research. For example, if poor data quality is a barrier to automatic
identification of patients with type II diabetes from diagnostic codes, an
ML approach could be used to more completely and accurately identify
the patients on the basis of text documents and laboratory and medication
data.
Models developed for use with routinely collected clinical data have
several advantages:
1. KDDM models access and leverage the valuable information
contained in large repositories of clinical data.
2. Models can be developed from very large sample sizes or entire
populations.
3. Models based on routinely collected data can be implemented in
computerized systems to support decision making for individual
patients.
4. Models induced directly from data using ML methods often
perform be er than models manually developed by human experts.
For example, Walton et al. developed a model that forecasts an
impending respiratory syncytial virus (RSV) outbreak.22 RSV is a virus that
causes bronchiolitis in children, and severe cases warrant hospitalization.
RSV outbreaks cause dramatic increases in the census at pediatric
hospitals, so advance warning of an impending RSV outbreak would allow
pediatric hospitals to plan staffing and supplies. Some evidence indicates
that weather is related to outbreaks of RSV, and RSV outbreaks are known
to follow a biennial pa ern, information that may be useful for predicting
outbreaks in advance. Given these circumstances, the authors built a
model using historical data that predicts RSV outbreaks up to 3 weeks in
advance. In addition to planning for events such as RSV, these types of
models can be especially effective in designing CDS systems.
The design of individual CDS systems based on KDDM methods varies
and can be as simple as an alert that warns about potential drug-drug
interaction.23 Every CDS system is based on some underlying algorithm or
set of rules that are applied to existing or entered patient data. These rules
must be specified in machine-readable code that is compatible with patient
data stored in an EHR or other applications. Historically, clinical practice
guidelines have not been expressed as a set of adequately explicit rules
and could not be executed by a machine. See, for example, Lyng and
Pederson and Isern and Moreno for a detailed discussion of this issue.24,25
While a human being can reason on the basis of conditions such as
“moderate improvement” or “diminished level of consciousness,” a
machine has difficulty working with “fuzzy data.” The term fuzzy data
refers to data that are vague and lack a precise meaning. The interpretation
or meaning of fuzzy data can vary greatly in different se ings. CDS
models must consist of rules, conditions, and dependencies described in
terms of machine-interpretable relationships and specific data values.
Moreover, the algorithms and rules must be executable over the data as
they are coded in the information system. For example, gender may be
included in a set of rules. If the rule is based on a gender variable coded
with the values male, female, or unknown, it will not work in a system
where gender is coded as 0, 1, 2, 3, or null, where 0 = male, 1 = female,
2 = transgender, 3 = unknown, and null = missing. While relatively simple
changes could adapt the rule set for use in a system with different coding
of gender, other variables pose a greater challenge. Some necessary
variables may not exist as coded data in an information system or may be
represented in a variety of ways that cannot be resolved as easily as gender
can be.
A substantial effort is underway to develop computer-interpretable
guidelines—guidelines that are expressed as an adequately explicit set of
rules—with some success.26 KDDM is also advantageous in this situation
because it develops only machine-executable algorithms or rules, based on
native data. Native data are data that have been coded for a specific
system. Therefore using KDDM to develop a set of rules will result in rules
that can be applied to the data within that system. Moreover, in situations
where there is insufficient evidence to fully specify rules, the rules can be
induced from a large sample of real-life examples using KDDM.
Retrieving a Dataset for Analysis
The process of KDDM depicted in Fig. 23.1 encompasses multiple steps
and actions. Although KDDM projects increasingly use streams or feeds of
data, data are more commonly extracted from a data warehouse. Data
warehouses are complex, retrospective collections of data that originate
from a variety of different sources. KDDM projects almost never use all of
the data. Instead, analysts use queries to select a subset of relevant data. To
accomplish this, analysts must collaborate closely with data warehouse
personnel to develop effective queries, queries that select the clinical data
relevant to the specific KDDM project with a sufficient but not
overwhelming sample size.
FIG 23.1 Steps of the KDDM process. KDDM, Knowledge
discovery and data mining.
To request the appropriate data, investigators and clinicians first need to
understand how the concepts of interest are represented (coded) in the
data. Clinical concepts are typically represented in EHRs in a way that
supports healthcare delivery but not necessarily research or broader
analytics. For example, pain might be qualitatively described in a patient’s
note and EHR as “mild” or “be er.” This may meet the immediate need
for documentation and care, but it does not allow the analyst or researcher
to measure differences in pain over time and across patients, as does
measurement using a pain scale. Another example is one where coded
data is available. In many healthcare organizations, laboratory tests and
many other types of data relevant to healthcare are coded according to the
standard Logical Observation Identifier Names and Codes (LOINC)
terminology.27 To ensure that the extracted dataset contains urinalysis
data, for instance, it would be necessary to first determine how and where
a urinalysis is coded. In the case of VHA data, this may entail
identification of the LOINC codes used to represent urinalysis results. For
concepts with greater coding variability, such as mental health diagnoses,
multiple codes may be relevant and applicable. Some data may not be
structured and may be captured only in text documents such as discharge
summaries. Information extraction from these documents can be
accomplished and represents an active area of research and development
with increasingly available commercial solutions.28
Queries wri en in a specialized programming language such as
structured query language (SQL) are used to retrieve data from a data
warehouse according to a researcher’s specifications. Currently,
investigators and healthcare organization IT personnel collaborate to
develop effective queries. The code used to execute the query is saved as a
file and can be reused in the future or repeatedly reused on a scheduled
basis. In some cases, healthcare organizations opt to support ongoing
investigator data needs by creating separate repositories of aggregated,
processed clinical data that relate to a particular clinical domain. In the
VHA, investigators in infectious disease have developed procedures to
aggregate a specialized set of nationwide patient data related to
methicillin-resistant Staphylococcus aureus (MRSA).29 These specialized
repositories of data can be more readily analyzed on an ongoing basis to
support quality improvement, health services research, and clinical
research.
The amount of data retrieved from clinical data warehouses can be
enormous, especially when data originate from multiple sites.
Investigators will want to define a sampling plan that limits the number of
selected records, according to the needs of the study or project. For
KDDM, it may not be possible to import the data fully into analytic
software as a single flat file. Fortunately, many statistical and ML software
packages can be used to analyze data contained within an SQL database.
For example, SAS Enterprise Miner can be used to analyze data within an
SQL database using open database connectivity (ODBC).30 Clinicians or
investigators who are new to KDDM should collaborate with statistical
and informatics personnel to plan an optimal approach.
Preprocessing Clinical Data
To illustrate preprocessing, this section uses EHR data as an example. The
process can be extrapolated to other datasets. EHRs include both coded
(structured) data and unstructured text data that must be cleaned and
processed prior to analysis. EHRs collect and store data according to a
coding system consisting of one or more terminologies. While standard
terminologies exist, many systems make use of a local terminology, a
distinct set of variables, and a distinct coding system for those variables
that are not necessarily shared across systems. Different sites, clinics, or
hospitals within a healthcare organization could use different
terminologies, coding data in different ways. Within a single site, changes
in information systems and terminologies over time can also result in
variations in data coding. When data are aggregated across time and
across sites, the variations in terminology result in a dataset that
represents similar concepts in multiple ways. For example, one large
healthcare organization recognized that within its clinical data, the
relatively simple concepts of “yes” and “no” were represented using 30
unique coding schemes.31 Unlike data collected using a prospective
approach, clinical data often require extensive cleaning and preprocessing.
Thus preprocessing constitutes the majority of effort in the clinical KDDM
process shown in Fig. 23.1. See Box 23.3 for information concerning tools
that can be used in this process.
Box 23.3
Tools for Processing Clinical Data
The U.S. National Library of Medicine maintains a repository of the many
available informatics tools, called the Online Registry of Biomedical
Informatics Tools (ORBIT) Project, at h p://[Link]. However,
given the complexities of processing clinical data with these tools,
investigators should consider collaboration or consultation with an
informatics specialist versed in the use of these techniques.
Preprocessing Text Data
In clinical records, the richest and most descriptive data are often
unstructured, captured only in the text notes entered by clinicians. Text
data can be analyzed in a large number of clinical records using a
specialized approach known as natural language processing (NLP) or,
more specifically, information extraction.32 Methods of information
extraction identify pieces of meaningful information in sequences of text,
pieces of information that represent concepts and can be coded as such for
further analysis. Machine interpretation of text wri en in the form of
natural language is not straightforward because natural language is rife
with spelling errors, acronyms, and abbreviations, among other issues.33
Consequently, information extraction is usually a computationally
expensive, multistep process in which text data are passed through a
pipeline of sequential NLP procedures. These procedures deal with
common NLP challenges such as word disambiguation and negation and
may involve the use of ML methods. However, each pipeline may differ
according to the NLP task at hand.33 Unstructured Information
Management Architecture (UIMA) (h p://[Link]) is one example
of an NLP pipeline framework. Information extraction for clinical text is an
active area of research and development. Information extraction tools are
maturing and increasingly available. However, more advanced
applications of semantic NLP typically require custom software and/or
collaboration with NLP specialists.
Preprocessing Coded (Structured) Data
In a set of consistently coded clinical data, the data should be analyzed
using descriptive statistics and visualization with respect to the following:
• Distribution. Normally distributed data are most amenable to
modeling. If the data distribution is not normally distributed, the data
can be transformed using a function of the original data or analyzed
using nonparametric statistical methods.
• Frequency. The frequency of specific values for categorical variables
may reveal a need for additional preprocessing. It is not uncommon
for identical concepts to be represented using multiple outcome
values. Also, some values are so rare that their exclusion from analysis
should be considered as outliers.
• Missing data. Missing data can be meaningful. For example, a missing
hemoglobin A1c (HgA1c) laboratory test may indicate that a patient
does not have diabetes. In that case, a binary variable indicating
whether or not HgA1c values are truly missing can be added to the
dataset. In other circumstances, the values are simply missing at
random. If values are missing at random, they can be replaced using a
number of statistical imputation approaches.
• Sparsity. Sparse data are data for which binary values are mostly zero.
Categorical variables with a large number of possible values
contribute to sparsity. For example, a field called “primary diagnosis”
has a set of possible values equal to the number of diagnoses found in
the International Classification of Diseases (ICD)-10 coding system.
Upon 1 of n encoding, the number of possible values becomes the
number of new columns added to the dataset. Some diagnoses will be
more common than others. For uncommon diagnoses, the value of
“primary diagnosis” will almost always equal zero. The value of “1”
will be found in only a small percentage of records.
• Outliers. Outliers, data points that fall far outside the distribution of
data, should be considered for elimination or further analysis prior to
modeling.
• Identifiers. Codes or other values that uniquely identify patients should
be excluded from the modeling process.
• Erroneous data. Absurd, impossible data values are routinely found in
clinical data. These can be treated as randomly missing values and
replaced.
Descriptive analysis is facilitated by many software packages. Weka, a
freely available data mining software package, is an example.34 In this
software, when a variable from the dataset is selected, basic descriptive
statistics and a graph of the frequency distribution are displayed. A variety
of filters can then be applied to address issues with the data.
The considerations in preprocessing the data at this stage are numerous
and beyond the scope of this chapter. Preprocessing is always best
accomplished through a joint effort by the analyst and one or more
domain experts, such as clinicians who are familiar with the concepts the
data represent. The domain experts can lend valuable insight to the
analyst, who must develop an optimal representation of each variable.
Review of the data at this point may reveal conceptual gaps, the absence of
data, or the lack of quality data that represent important concepts. For
example, age and functional status (e.g., activities of daily living) might be
important data to include in a project related to predicting patient falls in
the hospital. By mapping concepts to variables, or vice versa, teams can
communicate about gaps and weaknesses in the data as well as potential
solutions.
Sampling and Partitioning
Once the data have been fully cleaned and preprocessed, they must be
sampled and partitioned. Sampling is the step in which a smaller subset of
the data is chosen for analysis. Sampling is important because excessive
amounts of data slow computer processing time during analysis. Sampling
for classification tasks is typically random or stratified on class
membership.
Partitioning refers to the assignment of individual records or rows in a
dataset for a specific purpose: model development (training, incremental
testing of models during development) or model validation (data held out
from the development process for the purpose of unbiased performance
estimation). There are multiple approaches to sampling and partitioning,
and the suitability of the approach depends on the nature of the project
and the quantity of available data. If very large amounts of data are
available, large sets can be sampled for model development and
validation. If more limited amounts of data are available, it will be
necessary to optimize the use of that data through resampling approaches.
Two common resampling approaches are termed bootstrapping and cross-
validation.35 Bootstrapping involves repeatedly calculating the mean from
multiple samples to increase the data available for training.
Within the model development dataset, cross-validation can be used to
maximize the amount of data used for both training and testing. In cross-
validation, the data are partitioned into n folds. Then, in a series of n
experiments, n – 1 folds are used to train models, and the remaining fold,
which is unique in each experiment, is used for testing. In that way, each
record is available for both training and testing, but there is no duplication
of records in the testing dataset. Cross-validation is commonly performed
with either 10 or 100 folds. In very small datasets, leave-one-out cross-
validation can be implemented, wherein the number of folds equals the
number of records. This maximizes the amount of data available for
training within each of the n experiments.
Data Mining
Data mining is the step in the knowledge discovery process where
pa erns are enumerated over a set of data.36 The methods used to
accomplish this are varied and include both ML and statistical approaches.
Examples of these approaches are outlined in the following sections.
Statistical Approaches
Statistical approaches fit a model to the data. Bayesian networks, a class of
models based on Bayes theorem, constitute one popular approach.
Bayesian models are robust, tolerate missing data, and can be computed
quickly over a set of data. The simplest implementation, Naive Bayes, has
been shown to perform well despite its assumption of independence
between input variables. Another important approach is logistic or linear
regression, which represents the observed relationship between input
variables and a classification or a dependent variable.
Machine Learning
ML methods are computer algorithms that learn to perform a task on the
basis of examples. In data mining, the task is typically prediction or
regression (predict a real number) or classification (predict class
membership). ML algorithms vary in the way they learn to perform tasks.
Many algorithms begin with an initial working theory of how a set of
input data predict an output (a.k.a. target), a future event, or an unknown
value. The algorithm then makes incremental adjustments to the working
theory, based on examples of both the input and the target. The examples
are contained in a set of training data. A complete discussion of ML and
specific ML algorithms is beyond the scope of this chapter. However, key
methods and characteristics are summarized in Table 23.2. All of the
methods listed in this table are commonly implemented in general-
purpose data mining software.
Table 23.2
Examples of Data Mining Methods
Method Description
Decision trees Recursive partitioning of data based on an information criterion (entropy, information gain, etc.)
Common algorithms: C4.5, CART
Easily interpreted
Require pruning based on coverage to avoid overfit
More difficult to calibrate to new populations and se ings
Decision rules Classification rules in the form of if-then-else rule sets
Easily interpreted
Require pruning based on coverage to avoid overfit
Closely related to decision trees; decision trees can be easily converted to decision rules
Artificial neural Networks of processing units
networks Output a probability of class membership
Computationally expensive
Effective for modeling complex, nonlinear solutions
Not easily interpreted
Support vector Linear functions implemented in a transformed feature space
machines Computationally efficient
Effective for modeling complex, nonlinear solutions
Not easily interpreted
Random forests “Ensemble” method that combines the output of multiple decision trees
Scalable (computationally feasible even with very large amounts of data)
Not easily interpreted
Bayesian Probabilistic models based on Bayes theorem
networks Models are easily calibrated for use with new se ings and populations
Models may assume conditional independence among variables
Not as scalable as other methods; may not work well with very large amounts of data due to the
way in which Bayesian networks are computed
CART, classification and regression trees.
Multiple variant algorithms can be used to implement each approach,
and specialized method-specific software is available to support more
flexible configurations. ML algorithms also can be implemented in a
variety of programming languages. Data mining software allows users to
implement versions of these algorithms via point-and-click graphic user
interfaces. However, these algorithms can also be wri en and executed
using analytical environments such as R, MATLAB, or Python. It is
important that users understand how to apply each unique method
properly in order to produce optimal models and avoid spurious results.
Evaluating Data Mining Models
The most critical step in evaluation, the partitioning of data, occurs early in
KDDM (Fig. 23.2). Performance estimates are calculated by comparing a
model’s predictions to actual values on a set of data for which the actual
values are known. If this comparison is made using the training data—that
is, the same data used to parameterize the model—the performance
estimates will be optimistically biased. It is critical that a sizable sample of
the original data is set aside and not used in any way to train or calibrate
models. This held-out sample of data is often termed the validation set or
testing set. Used solely for performance estimation, the held-out data will
yield unbiased estimates.
FIG 23.2 The relationship of data partitioning to both model
development and evaluation.
Performance measures are based on a comparison of the predicted and
actual values in a set of held-out testing data. In classification, this
comparison yields a classification matrix that can be used to derive
performance measures, similar to the performance measures used in
evaluating clinical diagnostic tests, such as true-positive rate, false-positive
rate, true-negative rate, false-negative rate, sensitivity, specificity, and
likelihood ratios (Fig. 23.3). The specific performance measures should be
selected with respect to the goals of the KDDM project. For example, if a
model is developed as a screening tool, sensitivity may be of particular
interest. If a model is developed for a CDS tool, alert fatigue is an
important consideration, and so the false-positive rate may be of particular
interest.
FIG 23.3 The process of calculating performance estimates from a
comparison of predicted and actual values for a classification model
of MRSA status on admission. MRSA, Methicillin-resistant
Staphylococcus aureus; ROC, receiver operating characteristic.
To evaluate and compare overall model performance, the receiver
operating characteristic (ROC) curve and the area under the ROC curve
are important measures of performance. The ROC curve, depicted in Fig.
23.4, is obtained by plo ing the false-positive fraction and true-positive
fraction, based on cumulative comparison of predicted and actual values
at increasing values of probability. The resulting curve shows the trade-off
between sensitivity and specificity exhibited by a classifier at any given
threshold. The area under the ROC curve is the probability that a
randomly chosen positive case will be selected as more likely to be positive
than a randomly selected negative case.37 As such, it serves as an overall
y g
measure of model performance. An area under the ROC curve (Az = 0.5) is
equivalent to random chance. Be er performance is indicated by higher
values of Az. Interpretation of the area under the ROC curve, especially in
relation to other models or classifiers, requires the calculation of
confidence intervals.
FIG 23.4 Smoothed ROC curve. ROC, receiver operating
characteristic.
For models that predict a real number (e.g., glucose level), performance
measures are simply based on the difference between the predicted value
and the true value in a set of held-out testing data for which the true
values are known. From these differences various measurements of error
can be calculated, such as mean squared error and root mean squared
error. Measurement of correlation is also important (e.g., r2), as is
visualization of predicted and actual values.
Model Deployment
Deployment refers to the actual use of analytic models or tools. In this
step, analysts determine how the models or tools are optimally delivered
to a decision maker—that is, they translate the models or tools to the
problem at hand. In the simplest sense, deployment could consist of
merely reporting analyses. Another model involves routine prospective
use of analytic models to offer predictions or decision support based upon
real-time data. The la er entails either configuring the system such as an
EHR or adding a module that functions to provide analyses within the live
information system. Examples of analytic models functioning with live
data outside healthcare are the live recommendations offered by Netflix or
[Link] as well as credit card fraud detection alerts.
A key aspect of deployment is the ability of an analyst to adapt models
to changes in the nature of the data and to calibrate models for different
se ings and patient populations. Sometimes, the analyst and the developer
are the same. In other cases, the developer works in response to analyst
needs and feedback. Often, analysts will request changes to the model to
address a specific need or issue. These types of changes are best developed
and tested in conjunction with a source code version of the model. Once
the changes are well tested in the source code environment, these changes
can be examined for potential inclusion into the main model functioning in
a live system. The concept of “make one to throw it away” is well known
in software development,20,38 but in analytics it is common to have many
iterations to allow institutional knowledge to grow as initial, rough results
are shared with decision makers.
Another method of deployment is the direct delivery of results to a
decision maker without explicit analyst intervention. One way to
accomplish this is through delivery of spreadsheets such as Microsoft
Excel, with graphical user interfaces (GUIs) that can be operated by the
decision maker to select the data and generate predeveloped summaries
and charts. For example, a display may show registered nurse (RN)
staffing pa erns and projected infection rates occurring within the next
few days. The user may drill down into the data looking at education level
of the staff or into the type or location of specific infections.
A third deployment method is the intranet delivery of reports, where
decision makers access a site that allows them to tailor a report request or
details. Their requested details are run on a remote server and delivered
through an internet browser, including generated tables, charts, and
explanations on how they should be interpreted.
A fourth method is automated report generation. Programming can be
embedded into statistical software such as Sweave39 or knitr,40 platforms
such as IPython41 and Jupyter,42 notebooks, or other reproducible research
tools.43 These can be used to specify the subject of the analysis, directed to
run the analysis in the hosted data analysis software and produce a report
in Adobe PDF or word processor formats with tables, charts, and other
results embedded. A descriptive narrative can be included so that the
analysis can be reproduced with the same or new datasets as needed. For
instance, one neurological practice uses a combination of R and Sweave to
analyze the data and deliver a customized, comprehensive report
immediately after the completion of a series of neuropsychological tests.44
Sweave is a tool that uses the R code for data analyses within a document,
thereby creating dynamic reports that can be updated automatically if data
or analyses change. Another example is shown in Fig. 23.5, which displays
intensive care unit (ICU) and step-down unit usage over time.45 The
explanatory text indicates that the step-down unit is often at capacity,
while the ICU is rarely so.
FIG. 23.5 A sample report showing ICU usage. ICU, Intensive care
unit.
Modern software development methodologies such as the spiral
development model incorporate multiple rounds of feedback. Once
deployed, this model is in continual use in a live environment with
constant feedback within its cycle. That is, as decision makers’ stated
requirements change and as the organization builds experience using this
approach, new information is incorporated into the analysis used in
making decisions. This process can improve business and data
understanding, which changes the way that analysis products are used, as
well as decision makers’ future requirements.
The spiral model approach is demonstrated in a project undertaken by
one of the authors (llk).46 The analysis was conducted using data from a
health screening clinic. The author wanted to determine optimal clinic
design to increase the efficiency of patient processing in the clinic. The first
step was to understand the structure of the clinic, the activities of the
workers, and the procedures used as clients arrived and were processed
through their clinic visit. While developing this understanding, we found
that the data about clinic times were rounded to the nearest whole minute,
so in the data preparation and analysis phase, we used methods to deal
with this kind of altered time data. Several forms of models were applied
to determine parameters for a simulation to model the current system.
This model was shared with employees in charge of the clinic, which both
confirmed our understanding of the clinic workflow process and
generated questions that improved our understanding of the clinic and
pertinent data. The resulting simulation was then used to explore different
clinic configurations, run analyses, and ultimately identify the best clinic
design and management of resources for optimal patient processing in the
clinic.
Organizational Considerations for Data Science
Organizations can mature over time in their use of data science and
analytics. A model showing this progression is in Fig. 23.6. Organizations
begin with retrospective analysis (exploratory data analyses discussed
earlier in the chapter) and gradually move up the scale of difficulty and
value toward prescriptive analytics. As organizations gain maturity,
several elements are important in this growth: data science personnel,
tools and platforms, data standardization, and data governance.
FIG. 23.6 Gartner Analytics Maturity Model. Reprinted with permission of
Gartner, Inc.
Data Science Personnel
An analytics group needs to be established and grown over time.
Analytics has a superficial overlap with traditional data analysis and/or
software engineering, but requirements for modern analytics cannot be
satisfied by a traditional data analyst or a pure programmer. Traditional
data analysts are normally asked to perform descriptive analysis or to run
standard summary or review procedures on standard datasets (e.g., to
produce a chart for a report or to produce summary statistics using
statistical software). An analytics group, on the other hand, is generally
asked to be creative in developing analytics procedures across a range of
datasets to meet the specific needs of decision makers and to present the
results in ways that enhance decision makers’ understanding of problems
as they make decisions.
An example of this kind of project would be predicting the impact of
adding another operating room to the current suite of rooms. Analytics
could show decision makers data such as number of projected new cases
to be added, the downtime in all rooms, the number and kinds of new staff
required, the case mix, and projected revenue or loss. Similarly, software
engineers and programmers may be asked to develop software products,
and their workflow bears a resemblance to an analytics workflow, but
software engineers do not require the same level of business domain
understanding as an analytics professional.
Recommended Skills for a Data Science/Health Analytics
Professional
To be of the most benefit to a healthcare system, a health analytics
professional, a newer specialty in healthcare, is required to be bilingual in
the skills of computer information systems and in healthcare operations.47
Drew Conway describes the requirements of analytics professionals as a
three-part Venn diagram (Fig. 23.7).48 The three areas of knowledge
required by analytics professionals are mathematics and statistics,
computer hacking (programming), and subject ma er expertise.
FIG. 23.7 Data scientist skills. Copyright 2015 Drew Conway Data
Consulting, LLC.
Computer hacking skills are required because of the way the data used
in analytics is electronically stored and because of potential errors in the
collection and recording of data. Without the ability to manipulate
electronic data, including various types of numerical and text data, and to
think algorithmically, this data is essentially closed off. This means that the
analytics professional needs a fair proficiency in programming data,
although a formal degree in programming may not be necessary. In
addition, the analytics professional needs enough understanding of IT
infrastructure to discuss issues with computer and IT engineers who
manage the IT infrastructure and databases.
To develop true insight from data, the analytics professional requires
mathematical and statistical understanding. Although the computational
work of mathematical and statistical methods may be done through
computer packages, an understanding of mathematical and statistical
concepts is necessary to identify what is valid for a given situation, how to
interpret the results, and how to determine if the results are of practical
significance.
The need for subject ma er expertise is the biggest divergence from
most quantitative professionals. This expertise is required for examining
the healthcare business process to identify important values, translate the
business requirements to mathematical and statistical models, and
interpret the results in terms that make sense in the business se ing. Drew
Conway indicated this separates data science from academic fields such as
ML, which are typically developed separately from the subject ma er of
potential applications.49
One issue is the difficulty in finding someone with the combination of
all these skills. Each of the three knowledge areas could be a career in its
own right, so finding a person who embodies strength in all three of these
knowledge areas is often compared to looking for a mythical unicorn.50 But
what is often truly needed is a team of people who each have a minimum
level of skills and understanding in all aspects and as a team collectively
have strength and depth in every aspect of the analytics role.
Tools and Platforms
A second decision the organization needs to make in conjunction with the
analytics group is the choice of computer platform. While many of the
platforms are made to interact well with others, forming synergy across
different types of capabilities, a basic understanding of choices is helpful.
A common platform for analytics is spreadsheet software such as MS
Excel and business intelligence platforms such as Actuate BIRT and
Pentaho. These are known for being able to connect or import data from
databases and perform basic summaries and charting. As they are
ubiquitous as part of software office suites or through intranet interfaces,
these are often used for descriptive analytics or as a delivery platform for
more sophisticated methods, which can create databases as output then
can use spreadsheets or business intelligence platforms as means to deliver
the results. Table 23.3 illustrates categories of analytics tools and provides
examples.
Table 23.3
Examples of Analytics Tools
Class Examples
Spreadsheets and business intelligence tools MS Excel, LibreOffice, Actuate BIRT, Pentaho
Statistical analysis programs SAS, SPSS, Stata, Weka, KNIME, Rapidminer
Programming language R, Python, Matlab, Scala, Julia
Another class of analytics platforms is stand-alone analytical programs.
These can be driven through GUI menus or custom batch programming
languages. These include many traditional statistical platforms such as
SAS, SPSS, and Minitab, as well as graphical ML platforms such as
Rapidminer,51 KNIME,52 or Weka.53 These packages are specialized for
statistics and data analysis and include ways of connecting to common
databases. Often they include graphical model building capabilities to
specify the data processing and analytical workflow. These graphical and
menu-based workflows can significantly ease the initial development of
models for use in analysis.
A third platform class is based on programming languages with special
facilities for data analysis. Two characteristics are common to these
languages:
1. Data frame data structure that stores information about entities and
features that are based on a functional programming paradigm (as
opposed to the more common object-oriented programming
paradigm). These languages include R,54 Python,55 and Scala.56 One
advantage of the programming language–based platforms is that
they are often extensible, meaning that capabilities not originally
considered by the initial developer can be created and added to the
platform.
2. Applications wri en using these languages can be connected to
other applications. For example, the big data platforms of Apache
Hadoop can embed the ML capabilities of Apache Spark,57 which
can be scripted (programmed) using Java, R, Python, or Scala.
Similarly, the cloud data platform MS Azure58 can include the
Azure ML extension, which can be scripted using Python or R.
Obviously, applicable computer programming knowledge and
skills in addition to a mathematical and statistical background are
needed to master these.
In the end, the choice of platform is dependent on the type of expected
deployment for analytical products and the people available to the
analytics group.
Data Standardization
Data quality affects the feasibility of secondary analysis and is critical to
data science and analytics. Data quality can be enhanced through
standardized data and the use of terminologies, as discussed in Chapter
22. The lack of data standardization and interoperability challenges are an
ongoing issue in healthcare locally and nationally. Healthcare
organizations need to make decisions about the extent of data
standardization they will employ and enforce locally. This directly affects
their data repository/data warehouse construction and usage. Nationally,
recent initiatives such as PCORnet and federal policy changes such as the
Medicare and Medicaid Meaningful Use incentive programs are
improving the standardization and interoperability of clinical data.59,60
Data Governance
Organizations need to make myriad decisions around managing and
obtaining value from data, such as minimizing cost and complexity,
managing risk, and ensuring adherence to regulations and legal
requirements. As organizations mature in their data science analyses, they
need formal mechanisms, called data governance, to oversee these analytic
processes. Data governance means decision making and authority over
data-related ma ers. The concept can have many nuances such as
organizational structures for managing data, rules and policies, data
decision rights, methods for accountability, and methods enforcement for
data-related processes.61
Thus organizations need a structure for enterprise-wide data
management.62 This is a first step in transforming an organization’s
adoption of data science.
Data governance typically addresses these types of vendor-agnostic
topics:
• Tools
• Techniques
• Models
• Best practices
Readers are referred to an excellent resource, the Data Governance
Institute (DGI), at: h p://[Link] to learn more about
this topic. The DGI provides a data governance framework seen in Fig.
23.8 that includes 10 components every data governance program should
employ.61
FIG. 23.8 Data governance framework. Reprinted with permission of The
Data Governance Institute.
Conclusions and future directions
Data science, data analytics, and methods of KDDM are processes that can
be used to glean important insights and develop useful, data-driven
output and models from collected healthcare data. With each patient and
each healthcare event, data describing numerous aspects of care
accumulate. Large warehouses of clinical data are now commonplace, and
as time passes, the data will become increasingly longitudinal in nature.
This future direction presents an enormous opportunity, as large
repositories of clinical data can be used to gain insight into the relationship
between the characteristics of patient, diagnoses, interventions, outcomes,
and other elements such as costs and operational processes. Data can also
be used to identify prospective patient cohorts for scientific research. They
can be used to assist healthcare providers with clinical decisions and avoid
medical error. However, the sheer size and complexity of the data
necessitate specialized approaches to data management and analysis. The
methods of KDDM enable us to analyze the data efficiently and effectively
and develop clinical knowledge models for decision support.
Accountable care organizations and shared risk reimbursement models
require that organizations fundamentally understand the cost and
outcomes of providing care, and this capability depends on data science.
As more healthcare systems install EHRs and other health IT, data
acquisition will become easier and less costly; data elements needed for
analyses can be hard-coded in health IT in structured, exportable formats
while also being used for clinical documentation of care. This concept has
been implemented already in health systems in Israel and in various
studies in the United States.63 However, health IT transitions present
challenges. While health IT can facilitate data acquisition, systems are not
always data analytic or research-friendly. Many important clinical
concepts are stored only in narrative text format, such as clinical notes,
and cannot be easily analyzed. Textual data must be abstracted manually
or via NLP, both labor-intensive and costly approaches. Systems for
rapidly fulfilling data requests for aggregated retrospective data are not
commonly well developed, and so data requests can be costly and
consume an enormous amount of time. Subsequently, the extracted data
requires validation and extensive cleaning.
Using data science and data analytics, informaticians and health
professionals can leverage the vast amounts of data generated in the
course of providing healthcare in order to improve healthcare. Leaders are
now focusing on building and leveraging predictive analytics. Data science
and KDDM can yield systematic cost, process, and outcomes information
that complement the largely anecdotal and informal knowledge base
underlying clinical practice. These tools are essential in contemporary
healthcare organizations and necessary to optimize patient and
organizational outcomes.
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Discussion questions
1. Write a statement outlining the three top big data or data analytics
questions you would want to consider in your work se ing.
2. Compare and contrast the types and methods that are available for EDA,
predictive, and prescriptive analytics. Give examples of each.
3. Why is it necessary to process coded and text data before using data
mining methods?
4. When discussing KDDM, what is the meaning of the following adage:
“Garbage in, garbage out”?
5. Fig. 23.7 includes 10 components every data governance program should
employ. For each component, provide one implication of that
component within a healthcare se ing.
Case study
You are a new hire in a regional office that oversees 35 long-term care
facilities. One of your goals is to build a regional knowledge development
program. You have support from your supervisor in developing this new
program. Your supervisor went to a recent conference and now
understands the potential of using data across facilities for improved
decision making. But your supervisor does not understand how to even
begin such a program and is looking to you to provide some guidance.
Using the information in this chapter, answer the following questions:
1. Thinking about the Gartner model that outlines how analytics mature in
organizations, what would be your initial goals for a knowledge
development program? Discuss initial characteristics of output for a
beginning program.
2. One of your first steps would be to assess the health IT capabilities in
each of your facilities and at the regional level. Think about what you
would want to know about each of these. Consider available local
functions, interoperability (information transfer) of systems, repositories
at the local or regional level, and support personnel.
3. Thinking about the skills needed for data science analysts, outline an
initial team of people you would need to begin the program.
4. Discuss marketing efforts for this program targeted to the executive staff
of the long-term care facilities. Create a list of the kinds of questions that
might be answered by using data science.
24
Patient Safety and Quality
Initiatives in Health Informatics
Patricia C. Dykes; Kumiko O. Schnock
Abstract
The focus of this chapter is patient safety and quality of care in health informatics.
The chapter begins by defining these concepts and by discussing key regulatory
initiatives for improving the quality and safety of healthcare in the United States. The
Framework for Patient Safety and Quality Research Design (PSQRD) is then
introduced as a means to classify and evaluate adverse patient safety and quality
events. The application of the PSQRD Framework is demonstrated with a focus on
medication safety, chronic illness screening and management, and nursing sensitive
quality outcomes. The chapter ends with a discussion of success factors, lessons
learned, and future directions that will assist with using the PSQRD Framework as a
guide for both practice and research.
Due to the complexity of the errors in healthcare, multifaceted strategies
including health information technology tools are needed to realize
improvement in clinical processes and patient outcomes when striving to
improve quality and safety.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Define patient safety and quality of care from a health informatics
prospective.
2. Describe the role of health information technology (IT) in advancing
the quality and safety of healthcare in the United States.
3. Analyze three national initiatives driving adoption and use of health
IT to improve safety and quality of care in the United States.
4. Explore two national initiatives related to promoting quality data
standards in the United States.
5. Discuss the three components of the Framework for Patient Safety and
Quality Research.
6. Describe how the Framework for Patient Safety and Quality Research
can be used to evaluate quality and patient safety interventions.
KEY TERMS
adverse event 411
American Recovery and Reinvestment Act 409
Bar Code Medication Administration, (BCMA) 414
Electronic Medication Administration Record (eMAR) 414
health information technology (health IT) 409
patient safety 409
pay for performance 416
quality of care 409
workarounds 414
Introduction
In this chapter, the use of health IT to improve quality of care and patient
safety is examined. The concepts quality of care and patient safety are
defined, and selected key regulatory initiatives that are driving a focus on
quality of care and patient safety in the United States are discussed. The
Framework for Patient Safety and Quality Research Design1 is then
introduced and used to classify adverse patient safety and quality events,
discuss key success factors and lessons learned, and then make
recommendations for implementation and future research.
For more than a decade, a series of Institute of Medicine (IOM)a reports
on the quality of healthcare have led to widespread recognition that errors
occur far too often and that the quality of patient care is variable across the
U.S. healthcare system.2–7 Evidence generated from several different
studies8–10 now demonstrate that health information technology (health
IT) can be used to improve communication and reduce errors.8,9
Widespread adoption of health IT is a recommended strategy to facilitate
effective, high-quality, and safe patient care.10
The passage of the American Recovery and Reinvestment Act (ARRA)
of 2009 was expected to improve the quality of care by promoting the
adoption of electronic health records (EHRs) and by supporting
Meaningful Use of EHRs11 to achieve widespread improvement in the
ability to detect and reduce clinical errors.12 Examples of specific ARRA
requirements directed at improving the quality of care are included in Box
24.1.
Box 24.1
Examples of Specific ARRA Requirements for
Improving the Quality of Care
Meaningful Use Requirement Rationale
Use of a certified EHR Ensures that EHRs in practice have the capability of achieving
the goals of Meaningful Use (e.g., they are not simply used as
“word processers”)
Facilitation of care coordination and quality by Ensures that the correct data is available to support evidenced-
participating in the exchange of electronic based care at each encounter across the healthcare continuum
health information
Submission of data for quality reporting To improve the quality of care in the United States, consistent
data are needed to support measurement and quality
improvement
Early data indicate that Meaningful Use was effective in promoting use
of certified EHRs. As of 2014, 83% of ambulatory providers have adopted
an EHR, and as of 2015, 95% of hospitals demonstrated Meaningful Use of
certified health EHRs.13 However, improved care coordination, routine
exchange of electronic health information, and automated submission of
quality data have not been universally achieved and will likely be the
focus of future health IT related legislation.14,15 For example, the Medicare
Access and CHIP Reauthorization Act of 2015 (MACRA), which is
discussed in additional detail in Chapter 27, includes several provisions
related to patient safety.16,17
Definitions
Inconsistent use of language and variations in definitions are barriers to
understanding the concepts of quality care and patient safety, as well as to
benchmarking beyond the organizational level.18 The definitions of quality
of care and patient safety put forth by the IOM and the World Health
Organization (WHO) World Alliance for Patient Safety provide a solid
foundation for the consistent use of these terms.
Quality of Care
In its 1990 report titled Medicare: A Strategy for Quality Assurance, the IOM
defined quality of care as “the degree to which health services for
individuals and populations increase the likelihood of desired health
outcomes and are consistent with current professional knowledge.”4, p. 21 In
2001, in its report titled Crossing the Quality Chasm, the IOM proposed six
aims as a means to narrow the quality chasm that exists in the U.S.
healthcare system.2 It proposed that healthcare should be:
• Safe. Prevents injury or other adverse outcomes
• Effective. Ensures that evidence-based interventions are used, with
patients always receiving the treatments most likely to be beneficial
• Patient-centered. Ensures that patient preferences, needs, and values are
front and center in the process of clinical decision making
• Timely. Delivered when needed and without harmful delays
• Efficient. Prevents the waste of valuable human and material resources
• Equitable. Provided to all individuals without regard for ethnic, racial,
socioeconomic, or other personal characteristics
The WHO World Alliance for Patient Safety adopted the IOM definition
of quality of care in its International Classification for Patient Safety (ICPS)
released in 2009.18
Patient Safety
The IOM defines patient safety as “freedom from accidental injury due to
medical care, or medical errors,” where error is defined as “the failure of a
planned action to be completed as intended or the use of a wrong plan to
achieve an aim.”3, p. 4
The ICPS defines safety as “the reduction of risk and unnecessary harm
to an acceptable minimum” and patient safety as “the reduction of risk of
unnecessary harm associated with healthcare to an acceptable
minimum.”18, p. 21 The ICPS defines error as “failure to carry out a planned
action as intended or application of an incorrect plan” and healthcare-
associated harm as “harm arising from or associated with plans or actions
taken during the provision of healthcare, rather than an underlying
disease or injury.”18, pp. 19, 21
These definitions highlight the multifaceted nature of quality and safety
and the notion that failures of both omission (e.g., failure to provide
evidence-based care) and commission (e.g., providing care incorrectly) can
compromise the quality and safety of healthcare.
National initiatives driving adoption and
use of health it
A key lesson learned from the IOM’s Quality Chasm Series is that
achievement of higher quality and safer care in the United States requires
systemic redesign of established clinical processes and that health IT is
needed to support and maintain the transition to best practices.1–3,5,19,20
Several initiatives on the national level have maintained a steady focus on
quality and patient safety. Recent U.S. policy is aligning incentives with
the goal of adoption and widespread use of health IT to ensure a
healthcare system characterized by uniform high quality and safe patient
care.21
In 2011, the Office of the National Coordinator for Health Information
Technology (ONC) published a report titled Federal Health Information
Technology Strategic Plan: 2011–2015.22 This report defined the ONC’s plan
for working with the private and public sectors to achieve the nation’s
health IT agenda. Specific examples of accreditation and policy efforts
designed to achieve the six quality aims defined by the IOM through a
focus on redesign of clinical processes and adoption and Meaningful Use
of health IT are included in Table 24.1.
Table 24.1
Accreditation and Policy Initiatives Focusing on Improving Quality of
Care and Patient Safety Through Health Information Technology
(Health IT)
CMS, Centers for Medicare and Medicaid Services; CPOE, computerized provider order
entry; EHR, electronic health record; eMAR, Electronic Medication Administration Record;
EMR, electronic medical record; LDL, low-density lipoprotein.
As of 2015, the majority of providers and hospitals adopted EHRs;12
however, not all Meaningful Use aims were achieved, largely due to lack
of interoperability.13,14 Without interoperability, the larger vision of
achieving a learning healthcare system is in peril. In response, the ONC
has released its first version of its shared nationwide interoperability
roadmap, Connecting Health and Care for the Nation, which lays out a plan to
achieve interoperable of health IT and to support a functional learning
health system by 2024.23
The ONC also released an updated Federal Health Information Technology
Strategic Plan: 2015–2020,14 highlighting both the achievements of
Meaningful Use (e.g., widespread adoption of health IT) and those areas
where the U.S. IT infrastructure is lacking (e.g., interoperability, patient-
centeredness). In this report, the ONC calls on public, private, consumer,
and industry stakeholders to align to achieve the federal health IT vision of
high-quality care, lower costs, a healthy population, and engaged people.14
In discussing safety-related initiatives, the Federal Health Information
Technology Strategic Plan: 2015–2020 links to the Health Information
Technology Patient Safety Action and Surveillance Plan: June 2013.24 This plan
addresses health IT through two objectives: (1) to use health IT to make
care safer and (2) to improve the safety of health IT. In September 2014,
ONC issued an update on the progress achieved by implementing the
plan. “The report explains that we now have a be er understanding of the
types of safety events related to health IT and, more importantly, the
interventions available to prevent unintended consequences of the use of
health IT tools.”25 Information about this plan and continuing progress can
be found at h p://[Link]/policy-researchers-
implementers/health-it-and-patient-safety.
Key areas of focus for ongoing accreditation and policy efforts include
improving the quality of care and preventing adverse events. An adverse
event is any undesirable experience associated with the use of a medical
product in a patient. Evidence suggests that the United States may be
making progress in the quest for higher quality and safer care, but there is
much room for improvement. Cohen et al. (2015)26 examined national
trends in surgical outcomes from 2006 to 2013. They reported long-term
improvement in surgical outcomes for hospitals participating in the
American College of Surgery National Surgical Quality Improvement
Program. Improved outcomes included mortality, morbidity, and surgical
site infections.27 Downey et al. evaluated national trends in patient safety
indicators (PSI) such as postoperative pulmonary embolism, deep vein
thrombosis, and pressure ulcers. They found significant PSI trends for the
decade 1998 to 2007. PSIs with the greatest levels of improvement during
that period included birth trauma injury to neonates, postoperative
physiologic and metabolic derangements, and iatrogenic pneumothorax.
The PSIs with the greatest increase in incidence included pressure ulcers,
postoperative sepsis, and infections due to improper medical care.
Downey et al. noted that health IT holds potential for decreasing PSIs
through standard reporting requirements and by supporting evidence-
based practices through decision support and the use of order sets.27
National efforts related to quality data
standards
As mentioned in the previous section, the Meaningful Use initiative aimed
to improve the quality of care in the United States through routine
exchange of electronic health information for care delivery and quality
reporting purposes. However, much work is needed to build the
informatics infrastructure required to support the interoperability of
systems and routine data exchange.13,14,23 An important component of the
informatics infrastructure is establishing and adopting standards at
multiple levels to support semantic interoperability. Semantic
interoperability means that data are exchanged without a loss of context or
meaning and therefore can be reused without special effort on part of the
user.23 Semantic interoperability is only possible when all organizations
adopt the same standards for quality measurement and reporting and use
those standards in their electronic systems. The ultimate goal is to capture
data for quality reporting in the context of existing documentation
workflows. This requires that standard clinical content is adopted and
used in electronic systems, standard taxonomies or vocabularies are used
to encode that content, and messaging standards are used to transfer
information from one healthcare organization to another.
To automatically track the quality of care, standard quality measures are
needed to ensure that all organizations are using consistent metrics for
benchmarking and that organizations are using the same types of data to
populate the quality metrics. For data to be collected as a by-product of
documentation, the standard quality metrics must define standard value
sets (allowed values), taxonomies (standard terminologies), concept codes
(codes assigned by the terminology developer), a ributes (characteristics
that provide context), and data structures, and these same standards must
also be used to encode the content in the electronic record.
The ongoing work that maps (links) specific quality concepts to
recommended terminologies for Center for Medicare and Medicaid
Services (CMS) quality measures is published on the electronic Clinical
Quality Improvement (eCQI) website. The eCQI website is coordinated by
the CMS and ONC to provide the most up-to-date measures, tools, and
resources for applying existing standards to specify measures
electronically.28
Defined standards to support Meaningful Use are included in Table 24.2.
As mentioned previously, representation of the complete data element set
(e.g., the entire question-answer pair) by standardized terminologies and
codes within an EHR system is required for full automation of quality
reporting. Adoption and use of the same standards by all organizations
are required for quality reporting and benchmarking beyond the
organizational level. Many of these standards were included in the Stage 2
Meaningful Use initiative that aimed to provide incentives for their use in
EHR systems and subsequently to provide the informatics infrastructure
needed across the United States to collect and report quality data as a by-
product of documentation. Stage 3 Meaningful Use proposes to focus on
outcomes and is scheduled to begin in 2017.29 However, recent policy
changes to MACRA may affect the start date.
Table 24.2
A Sample of Categories and Types of Data Elements Common to
High-Priority Measures and Adopted Terminologies*
Adapted with permission from American Medical Informatics Association and based on
Dykes PC, Caligtan C, Novack A, et al. Development of automated quality reporting:
aligning local efforts with national standards. AMIA Annu Symp Proc. 2010; 2010:187-
191.
CPT, Current Procedural Terminology; ICD, International Classification of Diseases;
LOINC, Logical Observation Identifier Names and Codes; SNOMED, Systematized
Nomenclature of Medicine.
*For a complete list of data elements and codes, see the 2016 Interoperability Standards
Advisor at [Link]
Evaluating quality and patient safety
The foundation for the approach used to evaluate quality and patient
safety in healthcare organizations in the United States is based on the work
of Avedis Donabedian. Donabedian developed a framework for measuring
quality based on organizational structure, processes, and their linkages to
patient outcomes.30 Donabedian’s model provides the underpinnings for
the framework used to assess patient safety and quality research design
(PSQRD). Box 24.2 provides definitions of the primary concepts of the
Donabedian model in terms of healthcare. Fig. 24.1 demonstrated the links
and interactions between the concepts.17
Box 24.2
Definitions of the Primary Concepts for the
Donabedian Model in Terms of Healthcare
FIG. 24.1 A framework for patient safety and quality research
design. EHR, Electronic health record. Modified from Brown C, Hofer T, Johal
A, et al. An epistemology of patient safety research: a framework for study design and
interpretation. Part 1. Conceptualising and developing interventions. Qual Saf Health Care.
2008;17[3]:160.
Conceptual Framework for Patient Safety and Quality
The framework for PSQRD builds on Donabedian’s structure-process-
outcome model to support evaluation of an intervention from the
preimplementation testing phase through implementation and
evaluation.17 In the case of a health IT intervention, the expanded
framework supports understanding where the health IT intervention is
most likely to have an effect, within the organizational causal chain of
quality and safety events (see Fig. 24.1). The PSQRD framework provides a
means to categorize interventions according to areas of the causal chain
targeted (e.g., the structure, the management or clinical processes, and the
patient outcomes or throughput targeted by the intervention or that drive
adoption and use of the intervention in clinical practice).
The PSQRD framework is pertinent for evaluating the effect of health IT
interventions on quality and patient safety, as it provides a means to be er
explain why a health IT intervention was successful (or not). There are
many reasons why health IT interventions are not adopted in practice.31,32
Health IT tools not widely adopted and used will have a limited effect on
patient outcomes. In the sections that follow, we use the PSQRD
framework to first evaluate health IT interventions designed to improve
quality and patient safety. We then use it to make recommendations for
improving the implementation and evaluation of health IT interventions
aimed at enhancing quality and patient safety.
Within the PSQRD framework, quality and safety issues are not
mutually exclusive entities but exist on a “vector of egregiousness” (Fig.
24.2). Quality is at one end of the vector, representing frequent events with
lower levels of immediacy. Causality and patient safety are at the opposite
end of the vector, encompassing more immediate events with high levels
of causality. Errors or events that do not fall on or close to the vector are
included within the quality–safety continuum and classified as having
components of both. The PSQRD framework defines causality as “the
confidence with which a bad outcome, if it occurs, can be a ributed to an
error” and defines immediacy as “immediate or rapid.”17, pp. 158-159 For
example, there is good evidence on the population level that screening
mammography decreases breast cancer mortality in women.33,34 When an
unscreened woman develops end-stage breast cancer, the adverse outcome
was preventable. However, the causal link is low, and the time over which
breast cancer occurs is typically not immediate or rapid.
FIG. 24.2 The quality–safety continuum. Modified from Brown C, Hofer T,
Johal A, et al. An epistemology of patient safety research: a framework for study design
and interpretation. Part 1. Conceptualising and developing interventions. Qual Saf Health
Care. 2008;17[3]:159.
Using this model as a framework, a hospital-acquired infection from
poor hand-washing practices has a high degree of causality and a low to
moderate degree of immediacy. For example, there is a lot of evidence that
poor hand-washing causes infections, though there is typically a time
delay between exposure and onset of the infection. Patient falls and
pressure ulcers are located midway up the vector of egregiousness, with
lack of tailored interventions to mitigate risk, placing patients at risk for
injury with moderate degrees of causality and immediacy. Serious
medication errors are higher on the vector, as they may occur due to
inadequate adherence to the “five rights” for medication safety (right
patient, right time, right drug, right dose, and right route). Medication
errors are the most common adverse event (an unintended and
unfavorable effect of medical care or treatment) in hospital se ings and are
largely preventable through use of health IT systems with decision
support at the bedside (i.e., closed loop barcoding, medication
administration, and smart pumps).35 Medication errors are high on the
vector of egregiousness toward safety because these types of errors are
preventable through adherence to the “five rights” and, when they occur,
have the potential to cause immediate and significant patient harm.
Medication Safety
Health IT systems hold promise for improving the quality and safety of
care, particularly in the area of medication safety. To date, computerized
provider order entry (CPOE) and clinical decision support (CDS) systems
have been used successfully in clinical practice to reduce errors during the
process of ordering medications.7,8 In addition, Bar Code Medication
Administration (BCMA) and Electronic Medication Administration
Record (eMAR) systems have been adopted in a number of hospitals to
improve patient safety and streamline clinical workflow, focusing in
particular on improving administration processes at the point of care.36-38
These systems leverage barcoding applications, with barcode labels placed
on patient wristbands and on medications. The systems can ensure
adherence to the “five rights” to reduce medication errors and to
document administration of drugs in real time. BCMA and eMAR systems
are effective when implemented and used properly.39–41 For example, after
BCMA system implementation, the scanning compliance rate is often
suboptimal for scanning both drugs and patient IDs.42,43 One study found
that compliance with scanning medications was only 55.3%.42 Another
study revealed that nurses may bypass scanning processes and create
workarounds to reduce workloads or prevent delay of medication
administration.41 Workarounds are defined as any use of an operating
system outside its designed protocol.41 This problem occurs most often in
the system implementation stage and may create potential new paths to
medical errors or other negative effects, such as inefficiency.40,44
Another important medication safety system that functions at the point
of care is a smart infusion pump. Smart infusion pumps (also known as
“smart pumps” or computerized patient infusion devices) include features
designed to reduce administration errors and represent transformational
clinical tools with the potential to greatly decrease the rate of IV
medication errors in hospitals.45 This technology provides medication
error reduction capabilities via a preprogrammed drug library with dose
limit alerts and audio/visual feedback to users regarding entries
programmed beyond predetermined dose, concentration, and duration
thresholds. Smart pumps have been widely used in the United States and
other regions, and the adoption rate in the United States has doubled from
2005 to 2012.45 The growing adoption rate corresponds with the
implementation of other technologies for quality and safety improvement,
such as EHRs, CPOE, and BCMA.39 One review paper found that smart
pumps could reduce programming error rates, but other types of errors
may persist after implementing smart pumps (e.g., wrong drug errors,
administration timing errors, and wrong patient errors).46 A combination
of smart pumps along with other clinical systems can prevent these errors,
and interoperability between currently implemented clinical systems and
smart pumps is key to making meaningful improvements in IV medication
safety. A lack of smart pump integration with other clinical systems in
practice may limit the benefit of smart pumps.
The IOM reports, The Joint Commission Standards, and the National
Patient Safety Goals (NPSG) represent structural incentives for use of
health IT to improve medication safety.9,20 The Joint Commission is an
international nonprofit organization that provides motivation through
accreditation for healthcare organizations to excel in providing safe and
effective care of the highest quality and value. The NPSG and The Joint
Commission Standards relevant to medication administrations (Table 24.3)
are requirements for institutions in the United States and other countries
that seek The Joint Commission accreditation.
Table 24.3
The Joint Commission Standards and National Patient Safety Goals
Data from The Joint Commission. National Patient Safety Goals. Effective January 1,
2015. <[Link]
* Medication containers include syringes, medicine cups, and basins.
Published studies suggest that successful implementation of BCMA and
eMAR systems that improve patient safety depends on several factors,
including the following:36–38
1. A positive workplace culture (leadership, teamwork, and clinician
ownership)
2. Training and support
3. Acceptance of the major impact of work practices by all team staff
4. A usable system with adequate decision support
Systems implemented using these principles can meet TJC Standards
and NPSG and are likely to improve patient safety.
Chronic Illness Screening and Management
Health IT has demonstrated potential in improving the quality of care with
regard to chronic illness screening and management.47–54 As noted in Fig.
24.2, health IT interventions that target chronic illness screening and
management fall on the quality end of the vector of egregiousness, with
lower levels of causality and immediacy.
Examples of structural incentives for use of health IT to improve clinical
processes include clinical decision support based on practice guidelines
such as the U.S. Preventive Services Task Force (USPSTF)
recommendations on screening for breast cancer55 and depression,56 pay-
for-performance measures,57 and CMS core measures.58 Analysis of these
types of external programs on process improvement and patients’
outcomes suggests that the long-term effect is limited and that tailoring
quality improvement programs (e.g., the management and clinical
processes) based on organization-specific situations is recommended.57
One strategy that is successful in improving quality outcomes is the use
of health IT interventions that target patients to improve access to
treatment,49 adherence with medication, diet and exercise regimens,59,60
adherence to recommended screening guidelines,47 and engagement in
symptom management.52 Engagement of patients using health IT is a
successful strategy for improving adherence with screening and best
practices management of chronic illness and improved quality
outcomes.61,62
Nursing Sensitive Quality Outcomes: Patient Falls
and Pressure Ulcers
Health IT interventions are also effective for improving quality of care and
patient safety related to fall and pressure ulcer prevention.59,63–67 The
patient characteristics and factors related to risks for falls and pressure
ulcers are multifaceted. For example, the patient’s risks increase when skin
surveillance is inadequate or when fall prevention interventions are not
ordered and taught to the patient and family. As noted previously and in
Fig. 24.2, patient falls and pressure ulcers are located midway on the
vector of egregiousness between quality and safety, with moderate levels
of causality (failure to consistently implement tailored interventions) and
immediacy (time to patient fall or development of pressure ulcer). An
important structural component present for hospitals in the United States
was the Deficit Reduction Act of 2006, through which CMS identified a list
of preventable, hospital-acquired conditions for which hospitals would no
longer receive additional payment.10 The regulations regarding
nonpayment for hospital-acquired conditions included both patient falls
and pressure ulcers.10 The regulations provided an external directive (e.g.,
structure) that created a sense of urgency within organizations to eliminate
preventable patient falls and pressure ulcers.
Management processes, including an administrative focus on fall and
pressure ulcer prevention, are key factors in improving quality of care. At
the organizational level, interventions such as training, the use of health IT
systems for decision support, and involvement of peer champions in
identifying and implementing interventions that are both feasible and
effective provide an environment conducive to fall and pressure ulcer
prevention.64,67 The use of clinical experts to improve the knowledge base
of nurses and other healthcare providers59 and the use of a peer champion
model59,64,67–69 support fidelity of both management processes (e.g.,
communication, importance of behavior change, advocacy for fall and
pressure ulcer prevention initiatives) and clinical processes (e.g., end user
training, support, modeling the intervention set on patient care units).
When implementing complex practice changes, as required for fall and
pressure ulcer prevention, health IT is often a single component of a
multifaceted performance improvement intervention, and leadership
support for the practice change is essential. Health IT interventions are
most effective when both clinical and management processes are
addressed and where organizational leadership demonstrates strong
support for improvement strategies.59,64,67
Success factors and lessons learned
The effects of health IT interventions aimed at improving quality and
patient safety using the PSQRD framework have been evaluated to
identify key success factors and to provide a foundation for making
recommendations for health IT implementation and future research. The
PSQRD framework is useful for exploring the relationships between the
organization’s structural forces (e.g., se ing a ributes, exogenous factors)
that support organizational change, including adoption and use of health
IT as a tool to improve clinical processes and patient outcomes. External
accreditation or regulatory requirements provide structural incentives for
the changes in clinical processes that are supported by health IT
interventions. The PSQRD framework expands the process component of
the Donabedian model to include both management and clinical processes.
The expanded process components underscore the relationship between
managerial interventions, improved clinical processes, and patient
outcomes. Management interventions are effective in maximizing
stakeholder support for a project. An example of a management
intervention is the appointment of a task force to address poor adherence
with best practice guidelines. The task force is charged by management
with identifying and overcoming barriers to best practice. These types of
interventions improve overall adherence to practice changes and improve
fidelity with health IT interventions. In addition, the PSQRD framework
includes a focus on intervening variables that improve staff commitment
to process changes such as incentive payments and morale.68 Additional
examples of management strategies to improve fidelity with the
intervention include the use of peer champion support networks59,70,71 and
end user education.67,68,71
The PSQRD framework provides a means to plan for and evaluate
health IT interventions designed to improve quality and patient safety.
Characteristics of successful health IT implementation projects are
provided in Box 24.3. The PSQRD framework is a useful guide for
development of a comprehensive implementation and evaluation plan that
addresses these success factors and provides an effective strategy for
evaluating the effect of health IT on quality of care and patient safety
outcomes.
Box 24.3
Characteristics of Successful Health IT
Implementation Projects Supporting Quality
and Safety
Factor Description
Leadership support Leaders support adoption and use of health IT to improve patient care and facilitate
practice changes.
Comprehensive health IT A ention to both management and clinical processes to promote fidelity with the
implementation and intervention.
adoption strategy
Health IT as a “tool” Health IT applications considered a tool or a single component of a multifaceted
intervention to improve the underlying clinical processes and, ultimately, patient
outcomes.
Patient engagement Patients engaged in clinical process changes to deliver evidenced-based care, to
improve safe practices, and to improve patient outcomes. Health IT is one tool to
support process changes.
End user involvement End users involved in iterative development and implementation of health IT
interventions to improve quality and safety.
Peer champion support The use of peer support to facilitate adoption and proper use of health IT
applications within clinical workflows.
The PSQRD framework is recommended as a guide for implementation
and evaluation of health IT interventions. The PSQRD framework
provides a means to introduce health IT interventions in a systematic way,
and it serves as a reminder to incorporate measures of success across the
causal chain. This approach supports implementation, performance
improvement, and research projects with an appreciation for the effects
and the limitations of health IT and other intervention components.
Adoption of the PSQRD framework for both research and
organizational implementations will provide a means to plan for
successful implementation and to collect data on the structural and
process factors that may affect adoption and use of health IT interventions
and ultimately patient outcomes. This type of measurement is appropriate
for both research-based and operational implementations of health IT.
Even well-designed health IT interventions require a comprehensive
plan that includes a focus on structure, management and clinical
processes, and intervening variables to address fidelity with the
intervention. Failure to address these factors may prevent adoption and
use of health IT tools and serve as a barrier to patient safety and quality in
clinical practice. For example, Schnipper et al. describe a Smartforms
application, a clinical documentation tool designed to facilitate real-time,
documentation-based decision support to capture structured, coded data
in the context of documentation.72 A randomized controlled trial
demonstrated a limited impact of the Smartforms on patient outcomes,
because only 5.6% of eligible healthcare providers used the application.69
Investigators summarized their lessons learned, stating that in addition to
well-designed health IT tools, improvements in chronic disease
management require a comprehensive approach that includes the
following:
• Financial incentives (structure)
• Multifaceted quality improvement efforts (management processes
including interventions to promote fidelity with the intervention)
• Reorganization of patient care activities (clinical processes) across care
team members69
This is one example where the PSQRD framework used during project
planning could have highlighted strategies to promote adoption and use
of the health IT intervention and potentially led to a more significant
outcome. While many frameworks exist, this chapter introduced one
framework that has been successfully used; however, others are available
and deserve consideration. A process of thoughtful consideration of each
se ing and its characteristics is needed to identify what frameworks,
models, and techniques should be considered to improve the quality and
safety of patient care.
Conclusion and future directions
Medical errors and poor quality care continue to occur far too often in
healthcare organizations. The evidence presented in this chapter
demonstrates that the United States is making progress toward addressing
suboptimal care through recognition of the problem (i.e., IOM reports), an
emphasis on quality reporting, and Meaningful Use of EHRs. Health IT
innovations continue to be associated with improved patient safety and
quality related to chronic illness care and the prevention of patient falls,
pressure ulcers, and medication errors.
Further improvements require that healthcare organizations use a
comprehensive and thoughtful approach to health IT evaluation. The
PSQRD framework takes into consideration the supporting structures and
processes (management and clinical) that drive healthcare outcomes. This
approach can facilitate adoption and Meaningful Use of health IT tools
that will systematically drive patient safety and quality in clinical practice
and inform effective research.
Because of the complexity of the errors in healthcare, multifaceted
strategies, including evaluation frameworks and innovative health IT
tools, are needed to realize additional improvement in clinical processes
and patient outcomes by improving the quality and safety of healthcare.36-
3853,54,59,63,64,69,70
Prerequisites for health IT systems that will improve quality
and patient safety include strong clinical leadership and a solid
informatics infrastructure. Clinical leadership characterized by technical
skill, experience with managing IT projects, and a vision for the value of
technology for improving patient care are associated with successful IT
adoption.73 Such a ributes are needed to lead the clinical team from
planning to implementation, where the optimal benefits of health IT can be
realized. A solid informatics infrastructure across healthcare
organizations, where standards are adopted and used by all, is vital to the
improvement of safety and quality. In addition to standardized measures
and benchmarks, standard clinical content used in electronic systems,
standard taxonomies or vocabularies to encode that content, and
messaging standards to transfer information from one healthcare
organization to another are the foundational requirements for improved
quality and safety of care.
The Meaningful Use initiative as well as newer legislation continues to
develop standards that will create an informatics infrastructure to support
quality and patient safety across the United States.74 However, standards
are often the minimum required, and much more than the minimum is
necessary to advance best practices in each se ing. Standards are a place to
ensure quality and safety at a very basic level, but patients often define
(and expect) quality at a much higher level. Moving forward, all healthcare
organizations and institutions must strive to meet and exceed patient
expectations of quality and safety through the adoption and use of health
IT.
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48 Cebul R.D., Love T.E., Jain A.K., Hebert C.J. Electronic health
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49 Knaevelsrud C., Maercker A. Long-term effects of an internet-based
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50 Kwok R., Dinh M., Dinh D., Chu M. Improving adherence to
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51 Park M.J., Kim H.S. Evaluation of mobile phone and Internet
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52 Ruland C.M., Andersen T., Jeneson A., et al. Effects of an internet
support system to assist cancer patients in reducing symptom
distress: a randomized controlled trial. Cancer Nurs. 2013;36(1):6–
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54 Saposnik G., Teasell R., Mamdani M., et al. Effectiveness of virtual
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2010;41(7):1477–1484.
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for-performance in hospitals: lessons for quality improvement.
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58 Chassin M., Loeb J., Schmal S., Wachter R. Accountability
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59 Carson D., Emmons K., Falone W., Preston A.M. Development of
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60 Park M.J., Kim H.S. Evaluation of mobile phone and Internet
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61 Shade S.B., Steward W.T., Koester K.A., Chakravarty D., Myers J.J.
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75 The Leapfrog Group; 2015. h p://[Link]/home.
Discussion questions
1. The U.S. Department of Health and Human Services Agency for
Healthcare Research and Quality has identified seven Portfolios of
Research. The full list can be viewed at
h p://[Link]/cpi/portfolios/[Link]. Two of the Portfolios of
Research that are of key importance to this chapter are (1) Health
Information Technology and (2) Patient Safety. Describe how these two
Portfolios of Research relate to the ONC’s Health Information Technology
Patient Safety Action and Surveillance Plan: June 2013 (Washington, DC:
Office of the National Coordinator for Health Information Technology,
2013).
2. What is the utility of Donabedian’s structure-process-outcome model as
the basis for evaluating quality of care and patient safety associated with
a health IT application? Describe two limitations. Discuss how the
framework for patient safety and research design can be used to
overcome these limitations.
3. Use the framework for patient safety and quality research design to
create a comprehensive plan to support successful implementation of
Bar Code Medication Administration.
4. The Office of the National Coordinator (ONC) is taking actions on health
IT and patient safety as described in their Health IT Patient Safety Action
and Surveillance Plan by improving the safe use of health IT, learning more
about the impact of health IT on patient safety, and leading to create a
culture of shared responsibility among all users of health IT. A
description of this initiative is located at
h ps://[Link]/policy-researchers-implementers/health-it-
and-safety. Describe the implications of this initiative from an
interprofessional prospective for either your current work se ing or that
of the case study presented later.
Case study
Western Heights Hospital (WHH) is a 1125-bed, 5-hospital academic
healthcare system servicing central and western Massachuse s. WHH is
the only designated Level I Trauma Center for adults and children in the
area and is home to New England’s first hospital-based air ambulance and
the region’s only Level III Neonatal Intensive Care Center. WHH launched
a 5-year strategic plan with a fundamental goal of a system-wide move
from a predominately paper environment to an electronic one. Phase I
included implementation of an EHR system consisting of order entry for
all laboratory, radiology, and patient care orders. Additionally, clinical
documentation was implemented, including admission assessments and
all nursing flow sheets. The nursing informatics counsel, a 25-member
group of nurses representing all disciplines, developed the clinical content.
The clinical content was custom built using both free text and structured
data entry fields within the application.
Three months after go-live, hospital leadership is reporting that it is
unable to report on various state and federally mandated quality
measures. These measures track healthcare quality based on national
standards, are compared to nationally accepted benchmarks, and are used
to plan ways to improve quality. Leadership has communicated that the
reports generated by the system are incomplete and are pu ing the
hospital at financial risk due to lower reimbursement rates.
Clinicians are eager and excited to continue to develop content in the
application. However, the project’s program manager is proposing a
stabilization and optimization approach and does not want to go forward
with content development until the issue of reporting has been assessed
and addressed.
Discussion Questions
1. Assuming that you are the clinical content manager and lead all
reporting efforts, what approach would you take to address the
reporting problem?
2. Preadmission testing data are currently collected on paper. The chief
of surgery has identified an opportunity to have these data collected
in the new EHR system by the preadmission testing area in the
outpatient se ing. Many of the collected data elements are shared
with the current admission assessment. Describe how this effort can
be approached. What methods can be used to implement the process?
3. Using the PSQRD methodology, identify an area of quality
improvement in the hospital se ing, develop a process plan, and
identify the expected outcomes.
a Effective July 1, 2015, the National Academy of Science, Engineering, and Medicine
voted to change the name of the Institute of Medicine to the National Academy of
Medicine. In March 2016, the National Academy of Sciences announced that the division
of the National Academies of Sciences, Engineering, and Medicine (the Academies) that
focuses on health and medicine was renamed the Health and Medicine Division (HMD)
in place of the name Institute of Medicine (IOM). In this textbook, you may see any of
these three names used, depending on the date of the publication or report.
UNIT 6
Governance Structures, Legal,
and Regulatory Issues in Health
Informatics
25
Legal Issues, Federal Regulations,
and Accreditation
Jonathan M. Ishee; Shannon Majoras; Robin L. Canowi
Abstract
This chapter provides (1) a brief synopsis of the legal system of the U.S. government
as a basis for understanding how healthcare and specifically informatics is regulated;
(2) an overview of selected laws and regulations impacting health informatics; (3) an
overview of the accreditation process for healthcare entities, focusing specifically on
health information systems management; and (4) insight on emerging uses of
technology in the healthcare arena, with the potential for new or increased
regulations.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe the U.S. governmental processes and structure for regulating
health information technology (health IT).
2. Explain the difference between laws, regulations, and sub-regulatory
guidance.
3. Discuss the intersection of federal fraud and abuse regulations as they
relate to electronic health records (EHRs) and health IT.
4. Discuss the impact of informatics-related regulations on payment
reform.
5. Outline accreditation measures and agencies in the United States.
KEY TERMS
accreditation 422
Anti-Kickback statute 426
donation safe harbor 427
False Claims Act 427
liability 425
mHealth 431
privacy 423
Stark law 426
wearable devices 432
Introduction
The U.S. healthcare system functions within the context of the legal system
of the U.S. government. Healthcare, and in turn health informatics, is
heavily regulated by federal and state governments. Therefore
understanding health informatics-related legal issues, federal regulations,
and accreditation begins with an understanding of the basic structure of
the legal system in the United States.
The federal government consists of the three branches of government:
legislative, executive, and judicial. Each plays a role in health IT laws and
regulations. Bills (proposed laws) are passed by the U.S. legislature and
become law. Administrative agencies within the executive branch
implement these laws by establishing regulations or rules. Disagreements
about how those laws and regulations should be interpreted are se led by
the courts, the judicial branch. These judicial interpretations become
precedent and are binding on future actions. Through these processes each
of the three branches of the U.S. government has significant impact on the
day-to-day operations within the American healthcare system and health
IT. In addition to laws and regulations, many healthcare systems must also
meet accreditation requirements to be eligible for participation in
healthcare programs administered by the government. While there are a
variety of accrediting agencies in healthcare, the two primary agencies that
accredit hospitals and other healthcare-related institutions are The Joint
Commission (TJC) and Det Norske Veritas (DNV) Healthcare.
Legal system
Federalism and the Constitution
The government of the United States functions as a federal system. There
is a distribution of power between the federal government and the state
and municipal governments. The U.S. Constitution, the supreme law of the
land, defines the basic composition of the three branches of government
and sets forth the powers of each branch. It also provides the state
governments with governing authority. State governments have their own
rule-making authority and do not need to have federal approval before
passing a state law. However, any laws or regulations that states pass
must comply with the Constitution and be within the scope of power
granted to them by the Constitution. Ultimately, the states and municipal
governments are subject to both the federal government and the
Constitution, despite having some autonomy.
Within the Constitution, there are two types of grants of powers, express
or implied. Express, or enumerated powers, are powers explicitly granted
to Congress. Examples of express powers include the powers to regulate
interstate commerce, to create requirements for states or individuals who
receive federal funding, or to levy taxes. Implied powers do not define the
exact scope of the authority granted. An example of an implied power is
the necessary and proper clause, which gives Congress the power to enact
any laws “necessary and proper” to execute its responsibilities under the
Constitution. Both express and implied powers have been used by
Congress to implement laws that ultimately impact informatics and health
IT, including Health Information Portability and Accountability Act
(HIPAA), Meaningful Use requirements for EHRs, and the Patient
Protection and Affordable Care Act (PPACA).
Powers expressly delegated to the federal government may not be
exercised by the state governments.1 Any law a state passes that
encroaches upon the federal government’s scope of authority would be
preempted by the federal law, and the state law would be invalid. For
example, a state could not pass a law to establish its own system to patent
new health IT. The federal government alone has the power to issue
patents and trademarks, so the state law would be overturned.
There are also powers that are given both to the federal government and
to the state governments. These are called concurrent powers. For instance,
both the federal government and the state government have the ability to
regulate the privacy of personal health information in EHRs. When both
the federal and the state governments have the authority to regulate a
particular industry, the question of which law controls in the event that
state and federal laws conflict becomes more complex. Typically, a federal
law will control and preempt a conflicting state law absent special
circumstances. An example of when federal law would not preempt state
law occurs when a state enacts a health privacy law that provides more
privacy protections than HIPAA, such as California’s Confidentiality of
Medical Information Act.2
The state and federal governments also occasionally collaborate so that
laws passed in various states do not create a hostile environment for
health IT nationwide where different states have conflicting regulations
that make the use of health IT across states impractical. Two current
examples of collaboration are the Health Information Exchange (HIE)
Consensus Project and the Health Information Security and Privacy
Collaboration.3 Both of these projects seek to minimize the differences in
laws and regulations between the states that govern HIE and health IT
privacy and security. Regulations with different requirements in every
state for the same subject ma er can be burdensome to comply with for an
entity that operates nationwide. It should be noted that while
collaborations may produce model laws (a proposed series of laws
pertaining to a specific subject), it is still up to individual state legislatures
to pass legislation implementing the model law.
State governments have significant regulatory power related to
healthcare and health informatics. Sometimes this power has been
expressly granted to the states by the federal government through
legislation, as is the case with Medicaid.4 In other cases, the state derives
their power to regulate the healthcare industry through the Tenth
Amendment (that of reserved powers) and the state police power to
establish laws to protect the health and safety of the public. For example,
state governments may pass stricter regulations for health IT security and
privacy than what the federal government mandates through HIPAA.
Federal Healthcare Regulatory Framework
The healthcare regulatory system, on a federal level, is shaped like a
pyramid (Fig. 25.1). At the base, on the broadest level, are laws passed by
Congress. On the next level are regulations, or rules, which are
promulgated by administrative agencies.5 Finally, at the top of the
pyramid are advisory opinions and subregulatory guidance documents
issued by administrative agencies.
FIG 25.1 The healthcare regulatory system at the federal level.
Laws
Laws passed through Congress are often wri en in broad terms and
establish only general objectives that must be met. For an overview of the
process of passing a law through Congress, see Table 25.1. Congress does
not typically provide the specific means to implement the law. As part of
the legislative process, Congress may choose to delegate authority to
implement those laws to the executive branch. This delegation may carry
with it the power to pass separate, legally binding regulations, or rules, to
facilitate compliance with the laws.
Table 25.1
The Legislative Process
For example, Congress may pass a law that states that healthcare entities
need to establish a quality control system. The law that Congress passes
may not provide the specifications that such a system must meet or
determine a specific timeline to implement such a system, but the law does
mandate participation in the quality control program. Congress, in order
to fully execute the law, turns to administrative agencies. For the executive
branch of the government to assist with what would ordinarily be a
legislative duty, Congress must first grant the administrative agency a
specific authority to create regulations. Once an agency has been granted
authority to pass regulations under a particular law, it can begin the rule-
making process.6
Regulations and Rule Making
The burden of creating regulations to carry out legislation often falls to the
executive branch and the administrative agencies because they are more
experienced than Congress in working within a particular industry or
regulatory system. There are several agencies that play significant roles in
regulating health IT. Table 25.2 provides several examples.
Table 25.2
Administrative Agencies
Agency Purpose
Food and Drug Regulates and approves new drugs and medical devices. Issues regulations about drug
Administration interactions, safe storage and handling of drugs, and counterfeiting of drugs or devices.
(FDA) Responsible for producing a new report proposing a new risk-based regulatory framework for
health IT.
Centers for Issues regulations for Medicaid and Medicare, including information about appropriate
Medicaid and billing and coding. Issues the Conditions of Participation, which govern the accreditation
Medicare Services standards. Responsible for some enforcement of Stark and Anti-Kickback laws.
Office of the Responsible for establishing programs and regulations to improve safety, quality of care, and
National efficiency through health IT. Establishes standards and certification criteria for EHRs.
Coordinator for
Health
Information
Office of Civil Enforces HIPAA and HITECH compliance.
Rights
Department of Enforces False Claims Act and Anti-Kickback statutes.
Justice
Federal Trade Regulates development of new health IT devices. Responsible for enforcement of competition
Commission in the healthcare market.
National Labor Issues regulations that can govern the interaction of healthcare and social media.
Relations Board
EHRs, electronic health records; FDA, Food and Drug Administration; HITECH, Health
Information Technology for Economic and Clinical Health.
The rule-making process starts with the drafting of a proposed rule. The
agency is required to submit that proposed rule for publication and a
comment period. This comment period is open to anyone who might have
an interest in the proposed rule. A key responsibility of health
informaticians either working through their professional organizations
and/or as individuals is to take advantage of this opportunity to
participate in the rule-making process. Comments are generally made
through a government website. The agency reads the comments and either
publishes a final rule or issues another proposed rule if significant changes
will be made to the initial rule. A final rule is typically published with
responses to comments submi ed during the proposed rule’s comment
period. Through its response to the comments, the agency provides some
insight into how it will be enforcing the rule or what result is expected
from a particular regulation. This commentary is not binding authority,
but it does provide valuable information for entities looking to fulfill their
obligations under newly promulgated rules. Once a final rule is passed
and published, it becomes a regulation, which is legally binding.
Guidance and Advisory Opinions
In addition to rule making, agencies also provide advisory opinions and
guidance documents on regulations they enforce. Advisory opinions are
responses to a wri en request by a regulated party for an interpretation of
whether its action is in compliance with a particular regulation. These
advisory opinions are only legally binding on the particular entity that has
asked for the opinion and involve a very narrow issue. Agencies publish
advisory opinions to provide assistance and information on the
application of a regulation to particular facts. These advisory opinions are
another way to understand the agency’s rationale behind enforcement.
Guidance documents are official agency publications designed to help
subjects understand and comply with specific regulations. Guidance
documents are often significant and can appear similar to rule making in
their scope. Typically, guidance is issued to clarify potentially ambiguous
sections of a rule or to explain how an agency intends to enforce a rule.
Guidance documents are much narrower in scope than rules, and there
may be several guidance documents that relate to different subsections, or
even words, of a single rule.
Guidance documents may be issued by the administrative agency
without a specific authorization from Congress because they are not
legally binding. This means that guidance documents may be issued at
any time by the administrative agency without having to comply with the
formal requirements of the rule-making process. Despite their seemingly
informal nature, guidance documents can sometimes have just as much
impact on an industry as a rule because, in practice, agencies tend to treat
the two similarly.
Enforcement
The final step of the healthcare regulatory process is enforcement. There
are two possible mechanisms for regulatory enforcement. The first is
through the administrative agencies that promulgate the regulations. The
second mechanism is through the court system.
Administrative Enforcement
Administrative enforcement can be initiated in several ways. Oftentimes
enforcement mechanisms will be built into the law or regulation. The
Health Information Technology for Economic and Clinical Health
(HITECH) Act, passed in 2009, called for the Office for Civil Rights to
implement an audit program to evaluate compliance with HIPAA
standards. Compliance issues that are identified during the audit program
may then trigger an initiation of a formal investigation. Similarly, the
Physician Self-Referral (Stark) law now contains a mechanism for
healthcare entities to self-disclose possible violations of the law once the
entity discovers a potential compliance issue. Another way an enforcement
action may be initiated is through a complaint from an individual.
Once an enforcement action has been initiated, an administrative agency
investigates the allegations of noncompliance. The administrative agency
investigating the complaint may be the same agency that issued the
regulation, or it may be a separate agency that is generally tasked with
enforcement, like the Department of Justice, the Office of the Inspector
General, or the Office for Civil Rights. The agencies have the authority to
enact a wide range of penalties, from monetary penalties to exclusion from
participating in federal programs to a demand for corrective action.
Several examples of penalties for HIPAA-related violations can be seen in
Chapter 26.
Typically, an agency will negotiate and try to reach a se lement with a
potentially noncompliant entity before initiating a formal proceeding. If
the entity reaches a se lement agreement with the agency, there will be no
finding of liability against the entity. However, se lement agreements
may still result in monetary penalties or expulsion from federal programs.
If a se lement agreement cannot be reached, then a formal proceeding
will be initiated. Once a formal proceeding is initiated, the entity has a
right to have a hearing in front of an administrative law judge if monetary
penalties are involved. An administrative law judge is a decision maker
who is independent from the agency and has authority under the agency’s
procedural rules to issue a binding decision. An administrative proceeding
in front of an administrative law judge is typically less formal and less
strict procedurally than a comparable proceeding in front of a federally
appointed judge. The exact nature of the proceedings will be governed by
the agency’s rules. Once a final decision is issued, a formal appeal of the
decision is permi ed. Generally, before the appeal may go before a federal
court, it must be appealed through the agency, usually in front of a review
board.
Court System
An enforcement proceeding may also be initiated in the federal court
system, either at the beginning of the process or as an appeal of an
administrative decision. If the allegations involve a criminal indictment,
then the proceedings must be started in the federal court system. The
federal court system is composed of three levels of courts. A case is
initially brought in a district court. If a case is appealed, it is appealed to
the circuit court that oversees the district court. It is possible to petition for
an appeal from the circuit court to the Supreme Court through a writ of
certiorari, but the Supreme Court hears very few appeals during a year
because it has the sole discretion whether to grant any particular appeal.
A court proceeding is more formal than an administrative proceeding.
In addition, a court proceeding and an administrative proceeding may
follow different procedural rules. Another important difference between a
court and an administrative hearing is the length of time it takes to reach a
decision. Bringing an action in a federal court generally takes much longer
to resolve than would be the case in an administrative proceeding.
A court and an administrative proceeding are functionally equivalent.
The federal court judge and the administrative law judge have the same
remedies available in the event that the entity is found guilty of
noncompliance. The administrative law judge and the federal court judge
issue binding decisions, although there is an additional route to appeal if
the decision is issued in an administrative proceeding as opposed to a
federal court proceeding.
Fraud and abuse and billing issues
related to electronic health record use
Although the federal government has incentivized the use of EHRs, there
are pitfalls for the unwary user. EHRs can make some clinical
documentation easier for users, but use of an EHR can lead to fraud and
abuse claims by the federal government that may include hefty fines and
jail time if violations are proven. Chief among the potential pitfalls are
EHR purchase transactions. EHR systems are expensive. Hospitals and
health systems are usually able to cover these expenses within their
budget, but it is often financially difficult for independent practitioners
including medical group practices to purchase these systems. The systems
purchased by these practitioners need to be interoperable with other
healthcare entities such as hospitals, long-term care, laboratories, and
other healthcare institutions. It may seem logical for these practitioners to
approach hospitals, laboratories, and other large corporations to ask them
to help fund these purchases. However, legal and regulatory hurdles must
be understood and purchasers need to be wary before moving forward
with these types of transactions.
In the area of fraud and abuse, there are three laws that should be
considered before providers purchase EHR systems—the Stark law, the
federal Anti-Kickback statute, and the federal False Claims Act (FCA). It is
important to have a general understanding of what these laws prohibit,
and to examine transactions related to and within the EHR while keeping
these laws in mind.
Stark Law
The Stark law, passed in 1992, is named after its sponsor, U.S.
Congressman Peter Stark. It is a combination of statutes and regulations
that were promulgated in three phases.7 The Stark law governs physician
self-referral for Medicare and Medicaid patients.8 This law generally
prohibits a physician from referring patients for certain designated health
services (DHS) to entities with whom the physician has a financial
relationship. DHS includes following services (other than those provided
as emergency physician services furnished outside of the United States):
• Clinical laboratory services
• Physical therapy services
• Occupational therapy services
• Outpatient speech-language pathology services
• Radiology and certain other imaging services
• Radiation therapy services and supplies
• Durable medical equipment and supplies
• Parenteral and enteral nutrients, equipment, and supplies
• Prosthetics, orthotics, and prosthetic devices and supplies
• Home health services
• Outpatient prescription drugs
• Inpatient and outpatient hospital services.9
The Stark law’s central tenet is that there is a conflict of interest created
when referring physicians or their families can benefit from the referral. It
is believed that allowing self-referrals encourages over-utilization of
services, increasing healthcare costs. Therefore healthcare providers must
be careful when they enter into business relationships with family
members, or with companies where the physician has a financial interest.
There are two types of financial relationships that trigger the Stark law.
The first is when there is physician or family “ownership or investment
interest” in the entity furnishing the DHS.10 The second type of
arrangement is a compensation arrangement with the physician or the
physician’s immediate family.11 This relationship can be either direct or
indirect. The only way to avoid the requirements of Stark is to fall under
an exception or a “safe harbor.” The penalties for not complying with the
Stark law are discussed in more detail later, but may include civil
monetary penalties, denial of payment, or exclusion from the federal
healthcare program.
Federal Anti-Kickback Statute
The federal Anti-Kickback statute is a criminal statute that prohibits the
exchange or offer to exchange anything of value in an effort to induce
referral of a federal healthcare program beneficiary.12 Because this is a
criminal statute, the government must prove its case beyond a reasonable
doubt. A typical situation where a violation of the Anti-Kickback statute
might occur is when physicians lease space within their office to another
provider who is in a position to refer business to the landlord physician.
Another situation often arising in the Anti-Kickback context is when
physicians receive remuneration from a drug company when they are in a
position to prescribe a drug manufactured by that company. In the EHR
context, the Anti-Kickback statute could be triggered when a hospital or
other healthcare provider offers to purchase or to help fund an EHR for a
provider who refers patients to the hospital or other healthcare provider
for testing, surgery, lab work, or other clinical services.
The statute requires a knowing and willful offer of payment, solicitation,
or receipt of any remuneration to induce someone to refer patients or to
purchase, order, or recommend any item of service that may be paid for
under a federal healthcare program.13 The PPACA added a provision
clarifying the intent requirement of the Anti-Kickback statute. Under the
PPACA, actual knowledge of an Anti-Kickback statute violation or the
specific intent to commit a violation of the Anti-Kickback statute is not
necessary for conviction under the statute.14
Remuneration and inducement generally involve exchanges that are
direct or indirect, overt or covert, or cash or in kind. The threshold for
triggering the Anti-Kickback statute is low. “If one purpose of the
payment was to induce future referrals, the Medicare statute has been
violated.”15
The penalties for violating the Anti-Kickback statute apply to those on
both sides of the transaction. A single violation can result in a fine of up to
$25,000 and up to 5 years imprisonment. Additionally, a violation can
result in mandatory exclusion from the federal healthcare program. The
government may also assess civil monetary penalties, which could result
in treble damages plus an additional $50,000 for each violation.16
Safe Harbors
The Office of Inspector General and the U.S. Department of Health and
Human Services (HHS) have been given the authority to adopt safe
harbors that protect against criminal and civil prosecution for Stark and
Anti-Kickback violations in certain situations. To qualify for safe harbor
protection, the arrangement must cover all parameters of the safe harbor
as wri en. There are common criteria that must be met to meet safe harbor
requirements under the Anti-Kickback statute. These generally include the
following:
• Wri en and signed agreements are in effect for more than 1 year.
• Agreement specifies all services, products, and space to be provided.
• Agreement specifies part-time intervals and/or charges.
• Payment is set in advance, is fair market value, and does not take into
account the volume or value of referrals.
• Agreement terms do not exceed commercially reasonable terms.
• Agreement does not involve counseling or promotion of illegal
activity.
Health and Human Services Donation Safe Harbor
In 2006, a donation safe harbor exception was created, allowing certain
referral recipients to donate an EHR system to referral sources. This safe
harbor was originally scheduled to end in 2014 but was revised and
extended until 2021.16 It was designed to facilitate physician adoption of
EHR technology, as many physician practices were unable to purchase
and support the technology due to its high cost.
Under this exception, a donor may donate EHR technology and services
to persons in a position to refer to the donor. The donor may only pay up
to 85% of the cost to purchase and implement the technology. This allows
hospitals and other large healthcare entities to transfer or assist with the
purchase of EHRs for physicians and other practices that refer patients to
them at a large discount without violating Stark or the Anti-Kickback
statute. Under the latest iteration of the safe harbor, laboratory providers
are not allowed to donate EHR technology. In order to qualify for the safe
harbor, the EHR must meet current EHR certification criteria as of the date
of the donation. This means the EHR must be certified by a certifying body
authorized by the National Coordinator for Health IT. This certification
process is further explained in Chapter 19. Table 25.3 includes the basic
safe harbor requirements.
Table 25.3
Electronic Health Record Donation Safe Harbor
EHR, electronic health record; MA, Medicare Advantage.
False Claims Act
The False Claims Act (FCA) imposes civil liability on any person who
submits a claim to the federal government that he or she knows or should
know to be false, and imposes certain monetary penalties for violations of
the act. The FCA essentially prohibits fraudulent or false claims submi ed
to the government for payment and also fraudulent or false claims that
would decrease an amount owed to the government. Monetary penalties
are imposed by the FCA, including a penalty of three times the amount of
the claim submi ed to the government for payment plus $11,000 per
claim.17 In the healthcare arena, the FCA creates an issue with EHRs
because each clinical encounter generates a bill. If that bill is not accurate
and is sent to a governmental payor (such as Medicare, Medicaid, or the
military’s health insurance program [Tricare]) for payment, it is
considered a false claim. This can present an added challenge with coding
systems being changed, such as the recent move from International
Classification of Diseases (ICD)-9 to ICD-10. Each individual bill would be
a separate violation of the FCA, and the fines and penalties can add up
very quickly. No intent to defraud the government is required to violate
the law. Although the statute uses the word “knowingly,” it does not
require that a person submi ing a claim have actual knowledge that the
claim he is submi ing is false. Acting in reckless disregard, or in deliberate
ignorance of the truth or falsity of the information, can also lead to liability
under the statute.18
The PPACA expanded the scope of the FCA. Medicare and Medicaid
providers may discover that they have received payment on a mistaken
claim that they submi ed to Medicare or Medicaid. The claim may have
been improperly coded, or there was a clerical error, resulting in an
overpayment to the provider. Under the PPACA, a provider receiving a
Medicare overpayment has 60 days to report and return the money before
facing civil charges once the overpayment has been identified, or
reasonably should have been identified.19 If providers retain overpayments
past the 60-day deadline, this creates an “obligation” under the FCA, and
the provider faces liability under the FCA as well. Each individual
overpayment is a separate false claim and triggers the penalties and fines
discussed previously. When an overpayment situation occurs, it is very
important to act quickly to return the money to the government to avoid
the FCA fines and penalties.
Private citizens may also bring suits to enforce the FCA. These suits are
called Qui Tam suits, and the person who brings them is referred to as the
Qui Tam relator. These Qui Tam relators can potentially recover a portion of
any judgment or se lement. The U.S. Department of Justice reviews all
cases brought by Qui Tam relators and determines whether the
government should join in the lawsuit. When the government joins, the
amount that is recoverable by the Qui Tam relator is diminished but is still
significant.
In addition to civil penalties,20 the federal government can also
prosecute and fine those engaging in healthcare fraud from a criminal
perspective. An example of this is the general Healthcare Fraud statute.
This statute provides that any person who knowingly and willfully
executes, or a empts to execute, a scheme or artifice to (1) defraud any
healthcare benefit program, or (2) obtain, by means of false or fraudulent
pretenses, representations, or promises, any of the money or property
owned by, or under the custody or control of, any healthcare benefit
program in connection with the delivery of or payment for healthcare
benefits, items, or services shall be fined under this title or imprisoned not
more than 10 years, or both.21 It is important to note that this criminal
statute applies to any healthcare payor, public or private, and is not just
limited to federal healthcare programs. Additionally, there is a criminal
FCA statue that can be used against healthcare providers, but unlike the
general healthcare fraud discussed previously, the criminal FCA only
applies to a claim for payment from the federal government.22
Wire/Mail Fraud
Mail fraud and wire fraud are additional issues that need to be considered
during claims submission by providers. Mail fraud includes healthcare
fraud that occurs through use of the U.S. mail system or common delivery
services such as FedEx or UPS. Mail fraud can occur when paper claims
with improper coding are sent to patients or their insurers. If these paper-
based claims for payment contain fraudulent information, charges of
criminal mail fraud can be brought against the provider.23
Improper computerized claims submission can lead to charges of wire
fraud. The statute addressing wire fraud provides criminal penalties for
devising a scheme to defraud or “for obtaining money or property by
means of fraudulent or false pretenses.”24 Wire fraud involves interstate
use of wire, radio, or TV communication to commit fraud, and would
clearly encompass computerized claim submission. Each claim submi ed
would create a separate count of wire fraud. Both mail and wire fraud are
punishable by fines of up to $1000 and up to 5 years imprisonment per
violation. For example, assume a physician upcoded 50 claims and
submi ed those claims electronically to Medicare via the EHR billing
module. In addition to the civil penalties any physicians would face
through the FCA, they may face criminal charges for 50 counts of wire
fraud and one or more counts of Medicare fraud.
Fraud and Abuse and the Electronic Health Record
Each entry in an EHR helps determine what a healthcare provider will bill
to an insurer or to Medicare or Medicaid. When these entries are
inaccurate, fraudulent billing may occur. Each time a fraudulent claim is
submi ed to a government payor, there is a separate claim of fraud the
government can make. Therefore it is very important that those who use
EHRs are educated regarding steps they can take to ensure that fraud does
not occur.
Healthcare fraud can include such things as billing for services not
rendered, billing for services that were unnecessary, or unbundling
services that are generally billed as one Current Procedural Terminology
(CPT) code in order to increase revenue. Over-documentation is the
practice of inserting false or irrelevant documentation to create the
appearance of support for billing at a higher level of service. Some EHRs
autopopulate fields when using templates that may be inaccurate if not
appropriately edited. For example, if a provider pulls up an order set for a
particular diagnosis and several of the orders are prechecked, including
some procedures that have already been performed, this may lead to
additional testing that is not necessary.
Most EHRs allow providers to create macros and templates for
documentation. These macros and templates should be edited each time
they are used to accurately reflect what occurred at each visit. Providers
often do not take the time to edits these templates. For example,
pediatricians may have a template they use for an adolescent well-child
visit. The template may say that a mental health screening was done when
it was not done at a particular visit. The physician then bills for the mental
health screening, resulting in fraudulent billing. Features in the EHR
resulting in over-documentation to meet reimbursement requirements can
cause problems for providers when the services were not medically
necessary or were not delivered.
One of the biggest fraud and abuse issues the government is targeting
within the EHRs is the use of copy and paste functionality. When used
appropriately, copy and paste can be a valuable tool. However, it can also
result in creating a flawed medical record that could result in poor patient
care. Consider a situation where the phrase “family history of breast
cancer” is copied and pasted into a medical record as “history of breast
cancer.” This history is then reviewed by providers on each additional
visit, which could lead to unnecessary care and testing that would not
otherwise be needed by this patient.
The Centers for Medicare and Medicaid Services (CMS) published a
toolkit that advises providers about ways they can ensure EHR fraud and
abuse detection. Some of their key recommendations are as follows:25
• Providers should purchase systems that incorporate anti-fraud
features.
• Software should have operational audit logs that always remain
operational.
• Systems should have the ability to show who modified a record and
when.
• Providers utilizing EHRs should have robust compliance programs
that include standards of conduct that ensure that employees act in an
appropriate and lawful manner.
• Employees should be trained regarding risks associated with EHRs.
The training should emphasize the importance of accurate record-
keeping and the potential criminal and disciplinary issues that can
arise if there are issues with the integrity of the health record.
• Providers should audit their EMRs or EHRs to ensure that audit logs
are functioning appropriately and users are appropriately utilizing
the system. Fraud detection software is available to perform pa ern
matching that would identify text that is cloned or copied from other
sections. Unusually high usage of these features should be addressed
with employees. If issues are identified, an appropriate investigation
should occur.
A 2013 report issued by the Department of HHS Office of Inspector
General found that most hospitals with EHR technology had audit
functions in place, but not all were using them to the full extent.26 This
report noted that although most hospitals were analyzing audit log data,
their efforts were aimed at HIPAA privacy issues, and not on the
prevention of fraud and abuse.
It is important for those who are utilizing EHRs to recognize and
understand the risks they face related to fraudulent billing. Audit controls
should be in place to help providers ensure that the records they are
creating are accurate.
State Law
In addition to federal law, each state has its own laws regarding fraud and
abuse in the healthcare system. When providers are billing their states
through Medicaid, they must also be cognizant of their local laws related
to fraud and abuse, and how those laws might impose civil or criminal
penalties on unwary healthcare providers.
Accreditation
CMS has designated TJC and DNV as third-party agencies able to accredit
hospitals for participation in Medicare and Medicaid programs.27,28 TJC
and DNV each have separate accreditation programs, but both
accreditation programs use the Medicare Conditions of Participation as
baseline requirements in order for hospitals to achieve accreditation.29 TJC
uses a survey and audit program called TJC Standards that it developed
specifically for the healthcare industry. It provides more detailed, care-
based requirements that a hospital must satisfy.30 Additionally, TJC
provides guidance documents on the implementation of its care
requirements and publishes alerts and recommendations for coping with
new issues that may impact the quality of patient care in the future.31
DNV uses the National Integrated Accreditation for Healthcare
Association Organization program, which evaluates hospitals based on
compliance with the Medicare Conditions of Participation and the
International Organization of Standard’s (ISO) 9001 Quality Management
Program, an internationally recognized quality control program that is
used across many industries.32 DNV does not set specific care-based
requirements, instead requiring only the satisfaction of the Medicare
Conditions of Participation. It then uses the ISO 9001 program to evaluate
other quality metrics.
While both TJC and DNV offer accreditation programs, only TJC
provides a specific health information management chapter.33 DNV
addresses health IT only through the broader Medicare Conditions of
Participation. The remainder of this section will take a closer look at TJC
standards and its specific recommendations for health information
management.
The Joint Commission Health Information
Management Standards
TJC has developed a specific chapter of its accreditation standards dealing
with information management. The goal of TJC’s information
management standards is to ensure that healthcare providers have a well-
planned information management system that assists practitioners with
the provision of safe and high quality care. There are four primary
categories of responsibilities a hospital will have to address in order to
ensure full performance of the TJC Standards for information
management:
1. Planning for management of information,
2. Using health information,
3. Using knowledge-based information, and
4. Monitoring the data and health information process.
Included within those broader categories are provisions for protecting
the privacy of health information and managing the capture, storage, and
retrieval of health data.
Each larger category is divided into separate elements of performance
that TJC uses to evaluate hospitals’ compliance when it performs
accreditation surveys. The elements of performance are specific actions
that a hospital must take to satisfy the overall standard. For example,
within the planning for management of information category, elements of
performance include the organization identifying the information needed
to provide quality, safe care; the organization identifying how data and
information will flow through the organization; the organization using
that identified information to develop a process to manage information;
and staff and practitioners participating in the assessment, integration, and
use of information management systems in the delivery of care. In other
examples, elements of performance related to patient privacy and security
of patient information track the HIPAA standards, requiring specific
privacy and security policies and procedures to be in place. For a
summary of TJC’s standards relating to information management, see
Table 25.4.
Table 25.4
The Joint Commission Information Management Accreditation
Standards
From The Joint Commission. Information Management. 2016 Comprehensive
Accreditation Manual for Ambulatory Care (CAMAC). Accessed August 1, 2016.
During an accreditation survey, TJC surveyors evaluate the hospitals on
each element of performance to determine whether the overall standard is
met. Every element of performance is given a scoring category, and the
elements of performance are ranked based on the threat to patient safety
and quality of care.34 Whether or not a hospital fails to meet the standard
for accreditation, based on its failure to meet an element of performance,
depends on the particular nature of an incomplete element of
performance.
Sentinel Event Alerts
The TJC also issues Sentinel Event Alerts, describing potential hazards to
the quality of care and patient safety. TJC will identify actions that may
serve to minimize the risk associated with those hazards. Since 2008 TJC
has issued two major Sentinel Event Alerts related to health IT.
The earlier of the two, Sentinel Event Alert 42, was issued in December
2008.35 In Alert 42, TJC identified the two primary factors that led to
preventable adverse events related to, or caused by, health IT. The first
factor was the human–machine interface and the second was the overall
organization and design of the health IT system. Contributing to these
factors was a general failure to perform adequate due diligence before
investing in and implementing health IT—including failing to involve
practitioners in the discussion on the best uses of and the care-related
needs for health IT, an overreliance on vendor advice regarding health IT,
and an inability to integrate feedback from providers into the end user
experience. TJC advised hospitals to take more time to receive input from
providers before investing into any health IT, to continuously monitor the
use of the health IT, and to implement adequate training programs prior to
initiating the use of any new IT programs.
Sentinel Event Alert 54 was issued in March 2015.36 This alert built upon
the conclusions of Alert 42. Again TJC found that the use of health IT had
inherent risks for preventable adverse events after they analyzed over 3375
adverse events reports. TJC identified eight areas of weakness that
contribute to adverse events within health IT. The three largest areas of
weakness came from (1) the human-computer interface (a full one-third of
health IT–related events), (2) workflow and communication issues relating
to health IT support, and (3) design issues related to clinical content and
decision support. To understand more about health IT design, usability,
and interaction outcomes, readers are referred to Chapter 21. To help
resolve these issues, TJC recommended action through three pathways.
The first pathway is an increased culture of safety. A safety-minded
culture includes active internal reporting and identification of possible
health IT hazards. In addition to internal reporting, hospitals should not
hesitate to make reports to external organizations, such as patient safety
organizations, to reduce the aggregate risk throughout the healthcare
system. The focus in reporting should be identifying risks rather than
apportioning blame to individuals involved in any adverse events.
Hospitals should also conduct an analysis of any adverse event to
determine if health IT had been involved in the adverse event. Any
analysis or identification of an adverse event or risk of an adverse event
should be communicated globally, including with vendors, so that the
overall hazard related to health IT is decreased.
The second pathway is process improvement. This involves
implementing strategies to make the health IT programs themselves safer
and free from malfunction, as well as using the health IT programs to
monitor patient safety. TJC recommends using the SAFER (Safety
Assurance Factors for EHR Resilience) guides, an EHR checklist produced
by the ONC to address the safety of the installed IT programs. The SAFER
checklist includes items such as backing up hardware systems, conducting
extensive testing of systems before implementation, and using
standardized codes across all platforms. TJC also recommends ensuring
that providers and other health IT users have adequate training on the use
of IT programs and that IT programs are structured to be user-friendly
and to minimize the effect of human error.
The third and final pathway is through hospital and facility leadership.
The leadership of the hospital should encourage the culture of safety and
responsibility related to potential adverse events caused or contributed to
by health IT. The identification and reporting of adverse events should be
done in a manner to encourage reporting and not assign blame.
Additionally, leadership should be proactive in engaging health IT users
to provide feedback and recommendations for improvements to IT
interfaces and hazard identification. Furthermore, leadership should be
proactive about evaluating IT programs for safety risks and inefficiencies.
If leadership believes a change to IT programs is in the best interest of
patient safety and quality of care, any modifications or improvements to
the system should be implemented only after appropriate due diligence
and training of all end users.
The intersection of new technology and
regulation
The explosion of mobile health (mHealth) technology and consumer-
driven health applications has taxed an outdated regulatory framework
that was never designed for these new types of technologies. This section
presents a discussion of the current regulatory framework and recent
efforts to update this framework, given the impact of exploding innovate
technology in healthcare. Currently, no one agency is tasked with
regulating health IT or applications. Regulatory authority is spread over
agencies such as the Food and Drug Administration (FDA), Federal Trade
Commission (FTC), state medical boards, Federal Communications
Commission (FCC), CMS, and the Office of the National Coordinator
(ONC) for health IT.
Medical Devices
The FDA has authority over the Food Drug and Cosmetic Act (FDCA). As
the title of the FDCA suggests, the FDA generally has regulatory authority
over foods, drugs, cosmetics, herbal supplements, and medical devices
(including certain health IT and embedded medical device software). The
FDA is also tasked with assuring the safety and effectiveness of medical
devices. Specifically, Section 201(h) of the Act defines a “Device” as
… an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component part,
or accessory which is: recognized in the official National Formulary, or the
United States Pharmacopoeia, or any supplement to them, intended for
use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary intended purposes
through chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement of
any of its primary intended purposes.37
Table 25.5 illustrates the various classes of medical devices and FDA
oversight.
Table 25.5
Food and Drug Administration Classes of Medical Devices
FDA, Food and Drug Administration.
Initially it appears the FDCA regulates any type of health IT since the
majority, if not all, of health IT is intended to be used “in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man.”38 However, FDA has taken a risk-based
approach and not exercised its authority over certain health information
technologies such as EHRs, even if such EHRs have computer decision
support (CDS) or computerized physician order entry (CPOE)
functionality.
Congress passed the Food and Drug Administration Safety and
Innovation Act (FDASIA) in 2012 in recognition of the need for federal
agencies to work together to come up with a new regulatory framework
related to emerging health IT.39 Specifically, Section 618 of the FDASIA
required that the FDA in consultation with ONC and FCC create “a report
that contains a proposed strategy and recommendations on an
appropriate, risk-based regulatory framework pertaining to health IT,
including mobile medical applications, that promotes innovation, protects
patient safety, and avoids regulatory duplication.”38 In issuing its final
report, the agencies divided health IT into three categories: (1)
administrative health IT functions, (2) health management health IT
functions, and (3) medical device health IT functions, with corresponding
recommendations on each.40
The report suggests no additional FDA oversight on technology
primarily engaged in administrative health IT functions, and no increased
oversight activities for technology classified as a medical device serving a
health management health IT function outside of the FDA’s current focus
“on medical device health IT functionality, such as computer aided
detection software, remote display or notification of real-time alarms from
bedside monitors, and robotic surgical planning and control.”40 The report
recommended se ing up a Health IT Safety Center in which federal
agencies could convene stakeholders to discuss patient safety issues and
the other topics described in Fig. 25.2. Since the report does not
recommend that the FDA regulate any new technologies that are not
currently the focus of FDA regulation, the practical results of the
recommendation is that new consumer-focused mHealth technologies
discussed later are in effect unregulated from a patient safety standpoint.
FIG 25.2 FDASIA recommendation for health IT safety center. From
Food and Drug Administration Safety and Innovation Act, Pub. Law 112-144.
mHealth Wearable Devices and Telehealth
The development and use of mHealth applications and wearable devices
has exploded with the advent of smartphones and broadband cellular
technology. Patients can now open an application on their phone and be
immediately connected to a physician for treatment, or ask the mHealth
app a question about a health issue and be immediately given an answer,
including a course of treatment. Some insurers now provide premium
discounts to individuals who use wearable devices and agree to share the
information collected with the insurer. While these applications provide
convenience to patients, they also raise potential regulatory and liability
issues.
As discussed previously, regulators seem to have taken a hands-off
approach when it comes to mHealth applications and wearable devices.
This perception was reinforced in January 2015 when the FDA issued draft
guidance titled “General Wellness: Policy for Low Risk Devices.”41 This
guidance reaffirmed the idea that the FDA generally will not regulate
wearable devices used for general wellness under the FDCA. The FDA
uses a two-part test in determining whether a wearable device is a low-risk
general wellness product and not subject to regulation: (1) the project
makes only general wellness claims, and (2) the product does not present
inherent risks to a user’s safety. Under the first part of the test, the FDA
examines whether the device is designed and intended to maintain healthy
lifestyles or promote healthy activities and does not make any reference to
diseases or conditions unless it is well understood that healthy lifestyle
choices may help reduce the risk of or help living with a certain disease or
condition (such as making a claim that a wearable device will cure or
mitigate diabetes). If a device uses an intervention or technology that
requires device controls such as implants or raises novel questions of
biocompatibility, the second part of the two-part test may trigger FDA
scrutiny. Many mHealth applications have the functionality of connecting
a patient in real time to a physician who may be physically located in a
different state and may not be licensed in the same state of the patient.
Some states like California require all physicians who provide telehealth
services to California residents hold an active, unrestricted California
Medical License or face the potential charge of the unauthorized practice
of medicine.42 Other jurisdictions such as the District of Columbia have
more flexibility for physicians licensed out-of-state to provide telehealth
services to District of Columbia residents.43 Finally, some jurisdictions
such as Texas allow for a limited scope telehealth license for specialist
consults44 but require some type of preexisting relationship between the
physician and patient before a remote telehealth visit can occur.45 For more
traditional telehealth applications, interstate licensure issues continue to
be a challenge to the broader use of this form of health IT. For a more
detailed discussion of telehealth challenges, see Chapter 8.
Privacy and Ownership of Data Collected by mHealth
and Wearable Devices
The privacy of health data that is collected by mHealth applications and
wearable devices is also an issue of intense debate. Since these applications
are not covered entities under HIPAA, there is no healthcare specific
federal prohibition on the collection, use, and disclosure of personal health
information that is collected by the app. Recently, the FTC has recognized
the need for more transparency regarding how information collected by
mobile applications is used by application developers and has published
some subregulatory guidance on this issue, but such guidance does not
have the force of law.46 This does not mean that there are no regulations
related to the privacy of data collected by these types of applications and
devices. Some state privacy laws expand the prohibition of the collection
and use of personally identifiable information related to health
information, but most states do not have these types of protections.47
Another unresolved issue involves the ownership of data collected by
mHealth applications and wearable devices in the era of big data and the
data analytics. The data collected by these devices are valuable to both the
developer of the device or application and to third parties such as
researchers or pharmaceutical companies.48 This has led many developers
to monetize the sale of aggregated data to third party researchers as part of
the developer’s business plan. Patients should read the terms and
conditions that accompany a particular device before use to determine
whether the device manufacturer will share users’ personal information
with third parties.
Liability Issues
Finally, only mHealth applications that are regulated by the FDA are those
considered medical devices, such as electrocardiograms or physiologic
monitoring. The majority of the more than 165,000 available health apps
are generally not considered medical devices, and they are not regulated
by the FDA (or any other federal agency) from a patient safety perspective.
This can be problematic when there is incorrect or grossly false data in the
application and a patient relies on this information in lieu of seeking
professional medical advice and suffers an injury. Adding to this problem
is that many of the developers of mHealth applications are located in
foreign countries, with varying legal systems making it difficult for an
injured patient to recover damages from a developer.
Furthermore, the data collected by mHealth applications and wearable
devices are becoming more and more combined with patient data stored
in EHRs, which can lead to reliance on the accuracy of this data by
providers when creating a treatment plan or treating a chronic disease.49 If
a provider relies on this information and such reliance results in harm to
the patient, should the developer be held accountable, in addition to the
provider? Also, if a developer is held liable, should the developer now be
able to argue that it should have the benefit of the monetary caps many
states have enacted related to medical malpractice tort reform?
Alternatively, if this type of information is available to a provider but is
not reviewed, is the provider liable? These issues all play into whether or
not the standard of care owed a patient should take technology into
account. For a more detailed discussion about these issues and current
research, see Chapter 15 on mHealth.
Social Media and Informatics
Another hot bu on issue in healthcare and informatics is the role of social
media in balancing the rights of employees and free speech against the
privacy rights of patients. More recently the National Labor Relations
Board (NLRB) made this balancing act more difficult by publishing model
social media polices for employers that might, if enforced, effectively
prohibit employers from implementing social media policies that protect
patient privacy.
Historically, one way employers would protect patient privacy on social
media was to create and enforce employment policies that prohibited
employees from posting patient information on social media. These types
of policies were enacted after a spate of high-profile incidents in which
employees posted patient information to social media. Here are some
examples:
• A 2012 Chicago Daily Herald article detailed incidents such as a
physician who on his blog called a patient “lazy” and “ignorant” because
the patient had made several visits to the emergency room after failing to
monitor her sugar levels.50
• In yet another case, a medical student filmed a doctor inserting a chest
tube into a patient, whose face was clearly visible, and posted the footage
on YouTube.50
• An incident in which a temporary employee assigned to the Providence
Holy Cross Medical Center in Los Angeles posted a photo of a patient’s
medical record (clearly showing the patient’s name), accompanied by the
comment, “funny but this patient came in to cure her VD and get birth
control.”51
Section 7 of the National Labor Relations Act (NLRA) protects the right
of employees to “engage in … concerted activities for the purpose of …
mutual aid or protection” and gives the NLRB authority to investigate
such behavior even if the employee filing a claim is not a union member or
the employer is located in a right-to-work state.52 On May 30, 2012, NLRB’s
Acting General Counsel published a memo that disapproved of a social
media policy that prohibited employees “from posting information … that
could be deemed material non-public information or any information that
is considered confidential or proprietary.”53 Similarly, the NLRB found
unlawful a social media policy that prohibited an employee from sharing
“confidential information with another team member unless they have a
need to know the information to do their job.” These memos (if they were
to be enforced) would effectively prohibit healthcare employers from
implementing prudent social media policies that prohibit employees from
engaging in activities that might expose the employer to violations of
HIPAA or state privacy laws. After widespread condemnation by
healthcare providers, the NLRB may revise these memos and guidance
documents, but this has not been finalized.
Conclusion and future directions
The healthcare system in the United States is highly regulated, and these
regulations have a significant impact on the practice of health informatics.
As a result, for their own safety, health professionals, health
informaticians, the providers they serve, and the patients who depend on
the healthcare system must understand and utilize the regulatory
framework associated with health IT and informatics. This is especially
important as the use of the technology becomes more widespread in the
delivery of healthcare and the implementation of new consumer-focused
technologies. Additionally, health informaticians must become proactive
as the law and regulators struggle to catch up with health technology–
related innovations as well as providers’ and patients’ reliance on these
new technologies.
References
1 McCulloch v. Maryland, 17 U.S. 316 (1819). JUSTIA: U.S. Supreme
Court. h ps://[Link]/cases/federal/us/17/316/. 2016.
2 California Civil Code §§ 56 et seq.
3 Office of the National Coordinator for Health Information
Technology. Policymaking, regulation, & strategy. Federal-State Health
Care Coordination. h ps://[Link]/policy-researchers-
implementers/federal-state-health-care-coordination/. Accessed
December 7, 2015.
4 42 U.S.C. §§ 1396 et seq. h p://[Link]/fdsys/pkg/USCODE-
2010-title42/pdf/USCODE-2010-title42-chap7-subchapXIX-
[Link]. Accessed July 5, 2016.
5 Administrative Procedure Act, Pub. L. 79-404, 60 Stat. 237; 1946.
h p://[Link]/sal/60/stats/[Link].
6 5 U.S.C. §§ 551 et seq. h p://[Link]/federal-
register/laws/administrative-procedure/. Accessed July 5, 2016.
7 National Mining Association v. Jackson, 816 [Link]. 2d 37 (D.D.C.
2011). JUSTIA: U.S. Law; 2016.
h p://[Link]/cases/federal/district-courts/district-of-
columbia/dcdce/1:2010cv01220/143120/167/.
8 Section 1877 of the Social Security Act.
h ps://[Link]/OP_Home/ssact/title18/[Link]. Accessed
July 5, 2016.
9 42 U.S.C. § 1395nn. A list of CPT codes associated with Designated
Health Services can be found at
h ps://[Link]/medicare/fraud-and-
abuse/physicianselfreferral/list_of_codes.html.
10 42 U.S.C. § 1395nn(a)(2)(A).
11 42 U.S.C. § 1395nn(a)(2)(B).
12 42 U.S.C. § 1320a-7b.
13 42 U.S.C. § 1320a-7b(a).
14 Section 6402(f)(2) of the Patient Protection and Affordable Care Act, Pub.
L. No. 111-148, 124 Stat 119 (2010).
15 U.S. v. Greber, 760 F.2d 68, 69 (3rd Cir. 1985), cert. denied, 474 U.S.
988 (1985).
16 78 Fed. Reg. 79202 (December 27, 2013).
17 31 U.S.C. § 3729(a)(1).
18 31 U.S.C. § 3729(b)(1).
19 42 U.S.C. § 1320a-7 k(d)(1).
20 42 U.S.C. § 1320a-7a.
21 18 U.S.C. § 1347.
22 18 U.S.C. § 287.
23 18 U.S.C. § 1341.
24 18 U.S.C. § 1343.
25 Centers for Medicare and. Detecting and responding to fraud, waste and
abuse associated with the use of electronic health records (July 2015).
h ps://[Link]/Medicare-Medicaid-Coordination/Fraud-
Prevention/Medicaid-Integrity-Education/Downloads/ehr-detect-
[Link]. 2015.
26 U.S. Department of Health and Human Services. Office of Inspector
General (December, 2013). Not all recommended fraud safeguards have
been implemented in hospital EHR technology. 2013.
h p://[Link]/oei/reports/[Link].
27 Centers for Medicare & Medicaid Services. Continued approval of
the Joint Commission’s (TJC) hospital accreditation program. 79
Federal Register 36524. June 26, 2014.
28 Centers for Medicare & Medicaid Services. Continued approval of
Det Norske Veritas Healthcare’s (DNVHC) Hospital Accreditation
Program. 77 Federal Register 51537. September 26, 2012.
29 Kenney L. American Society for Healthcare Engineering. Hospital
accrediting organizations offer different approaches to the survey process.
h p://[Link]/resources/ashenews/2013/hosp_ao_article_13
[Link]#.Vjd2-t_lupo. Accessed November 2, 2015.
30 The Joint Commission. Facts About Joint Commission Standards.
h p://[Link]/facts_about_joint_commission_ac
creditation_standards/. 2016.
31 The Joint Commission. Benefits of Joint Commission Accreditation.
h p://[Link]/about_us/accreditation_fact_shee
[Link]. 2015.
32 DNV GL Healthcare. DNV GL’s pioneering NIAHO program integrates
ISO 9001 with the Medicare conditions of participation.
h p://[Link]/accreditations/hospital-accreditation.
Accessed November 2, 2015.
33 The Joint Commission. The Joint Commission standards edition:
information management. h p://[Link]/tjc/im/[Link].
2014.
34 The Joint Commission. Facts about scoring and certification decision.
h p://[Link]/facts_about_scoring_and_certific
ation_decision/. 2015.
35 The Joint Commission. Sentinel Event Alert 42: Safely Implementing
Health Information and Converging Technologies.
h p://[Link]/sentinel_event_alert_issue_42_saf
ely_implementing_health_information_and_converging_technolog
ies/. 2008.
36 The Joint Commission. Sentinel Event Alert 54: Safe Use of Health
Information Technology.
h p://[Link]/assets/1/18/SEA_54.pdf. 2015.
37 21 U.S.C. § 201(h).
38 Food and Drug Administration Safety and Innovation Act, Pub. Law
112-144.
39 Section 618 of the Food and Drug Administration Safety and Innovation
Act, Pub. Law 112-144.
40 FDASIA Health IT Report. Proposed strategy and recommendations for
a risk-based framework.
h p://[Link]/AboutFDA/CentersOffices/OfficeofMedicalPr
oductsandTobacco/CDRH/CDRHReports/[Link]. 2014.
41 Food and Drug Administration. General Wellness: Policy for Low Risk
Devices. Draft Guidance for Industry.
h p://[Link]/MedicalDevices/DeviceRegulationandGuidan
ce/GuidanceDocuments/[Link].
42 Sections 2220-2319 of the California Business and Professions Code.
h p://[Link]/cgi-bin/displaycode?
section=bpc&group=02001-03000&file=2220-2319. Accessed July 5,
2016.
43 District of Columbia Statute § 3-1205.02.
h p://[Link]/sites/default/files/dc/sites/doh/publication/a ach
ments/Medicine_Health_Occupations_Revision_Act_%28HORA%
[Link]. July 5, 2016.
44 22 TAC § 172.12.
45 22 TAC §§ 174.1-174.12.
46 Federal Trade Commission. Location, location, location.
h ps://[Link]/news-events/blogs/business-
blog/2015/02/location-location-location?utm_source=govdelivery.
2015.
47 Tex. Health and Safety Code § 181.100 et seq.
48 Business Insider. Senator warns Fitbit is a ‘Privacy Nightmare’ and
could be ‘Tracking’ your movements. 2014.
h p://[Link]/senator-warns-fitbit-is-a-privacy-
nightmare-2014-8#ixzz3A5M2nn17.
49 Mobile & Device Integration.
h p://[Link]/Solutions/Workplace:Health/Wellness_Sol
utions_and_Services/Mobile_and_Device:Integration/.
50 Being Facebook Friends and Doctors May Cross Line. Chicago Daily
Herald. Published at 2012 WLNR 14380254; July 9, 2012.
51 Patient Info on Facebook Traced to Temp Staff. Same-Day Surgery.
Published at 2012 WLNR 7485830; May 1, 2012.
52 29 U.S.C. §§ 151-169.
53 The National Labor Relations Board. The NLRB and social media fact
sheet. h ps://[Link]/news-outreach/fact-sheets/nlrb-and-
social-media. July 5, 2016.
Discussion questions
1. How does the U.S. regulatory framework work to ensure patient safety?
2. Describe two express powers and one implied power given to the
federal government in the Constitution that has implications for health-
related technology.
3. Name two federal agencies and describe their role in the regulatory
oversight of health IT.
4. What are the different types of healthcare fraud and abuse statutes?
5. What are three major issues with mHealth applications and wearable
devices?
6. How are patient privacy rights impacted by labor and employment
regulations?
Case study
A 50-member multispecialty medical practice has decided to implement a
new EHR system. The practice chooses the new EHR system based on both
clinical functionality and the practice management and billing
functionality that is demonstrated specifically because the EHR sales
representative repeatedly states that the new EHR can reduce patient visit
times (thus increasing the number of patients a provider can see in a day)
and increase reimbursement to the practice by helping the practice
“correctly code” to the highest E/M (evaluation and management) code
available. While the healthcare providers and practice administrator are
impressed with the new EHR, the new system will cost $2,000,000 for the
EHR software and $250,000 for the associated hardware, plus yearly
maintenance fees of $125,000. These costs exceed the practice’s budget.
One day, while meeting with the vice president of a community hospital,
the practice administrator mentions this issue and how the practice will
have to delay purchasing an EHR due to the budget constraints. The VP
states that the hospital will be happy to cover 85% costs for the new EHR
system if the practice agrees to (1) consider their hospital first before
sending a patient to any other potential competitors including not just ER
or inpatient admission but outpatient diagnostic services and hospital-
owned specialty practices, (2) include the hospital’s logo on patient
education materials printed from the system, (3) use the hospital’s
template for designing data entry pages for practitioners, and (4) use the
hospital’s template for the patient portal in the design of their patient
portal.
Discussion Questions
1. Explain the basic requirements for a hospital to help finance the
purchase of an EHR system by a provider.
2. Discuss whether the proposed course of action would be permissible
under current fraud and abuse regulations.
3. If the structure of the proposed donation is not permi ed under
current fraud and abuse regulations, explain what steps the parties
would need to take to make the transaction compliant.
4. Explain common issues related to use of EHR and healthcare fraud.
5. Discuss how the proposed new EHR could potentially facilitate
healthcare fraud.
26
Privacy and Security
David L. Gibbs; Nancy Staggers; Ramona Nelson; Angel Hoffman
Abstract
This chapter begins by explaining how the concepts of privacy and security apply to
electronic health information. International, national, and state security and privacy-
related practices, guidelines, and principles are then outlined. Current regulatory
processes are discussed. The chapter concludes with an examination of security
concepts and procedures necessary to ensure the safety and integrity of electronic
health data.
Neither patients nor healthcare providers will fully accept electronic
healthcare systems unless they trust that private patient data are accurate
and held in confidence through effective policies and procedures and
secure information systems.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe and explain the following informatics concepts: privacy,
security, confidentiality, integrity, availability, covered entity, and
business associate.
2. Analyze current federal and state laws and regulations and their
implications for privacy and security practices and procedures.
3. Use appropriate resources in establishing and implementing both
privacy- and security-related policies and procedures.
4. Apply common procedures for securing sensitive health information.
KEY TERMS
availability 437
business associate 440
confidentiality 437
covered entity 440
informed consent 451
integrity 437
privacy 437
protected health information (PHI) 436
risk 450
risk assessment (risk analysis) 450
safeguard 440
security 437
threat 450
transparency 438
vulnerability 450
Introduction
A primary responsibility of healthcare providers and their business
associates is to ensure that the health data for which they are responsible is
held in the strictest confidence. However, the reality is that the risks to
confidentiality are significant for electronic health data. The importance of
protecting and safeguarding protected health information (PHI) has
grown exponentially as health-related device use has expanded for mobile
devices, electronic health records (EHRs), sensors, biomedical devices,
telehealth, personal health records, personal health devices, and health
information exchanges (HIEs). Increased usage brings increased risk for
data breaches. The increase in the number of users, types of use, and
volumes of health IT-based data is directly proportional to the increased
opportunities for privacy and confidentiality breaches. Patients as well as
healthcare providers typically support concepts related to the use of data
for research purposes, electronic health data storage, and communication.
However, concerns regarding data security persist.1
As the volume of privacy breaches increased in recent years, health
information privacy and information security became a top priority for
contemporary healthcare organizations. Over 720 health information
breaches occurred in 2015, with the top 7 affecting 193 million records. At
this writing, the largest was Anthem (health insurance), with a breach of
78.8 million patient records.2 To put this number in perspective it may be
helpful to realize that the population of California, the largest in the
United States, was 38.8 million in 2014.3 The Office for Civil Rights (OCR)
lists over 130 breaches (at greater than 500 people per breach) for
electronic health data during 2015.4 In two of these events, hacking
incidences at a medical center in California and a health plan in New York
resulted in a breach of 4.5 million and 10 million individuals’ records,
respectively. Readers can access the list of the most recent breach reports
at h ps://[Link]/ocr/breach/breach_report.jsf.4
Definitions and concepts
Privacy is the right of individuals to control access to their person (body
privacy) or information about themselves (information privacy).5 In
informatics, the concern is focused primarily on privacy of information.
Designing systems to ensure the security of information privacy is one of
the most difficult challenges for institutions and individuals living in our
digital age.6 Health records can contain information on any or all aspects
of an individual’s life and as a result may contain highly sensitive
information (e.g., sexually transmi ed diseases, behavioral health
information, or financial information). Health data and information must
be kept private if such data are to be considered trusted information and a
primary resource for building new knowledge. Also, the information must
be protected from access and misuse by unauthorized persons. Moreover,
specific policies and procedures must be implemented to prevent
disclosures or breaches that encroach on the privacy of the data’s primary
owner—the patient.7
The difference between privacy, confidentiality, and security can be
confusing. Terms central to these concepts are defined in Table 26.1.
Privacy concerns who has access to information, a patient’s right to keep
information private, and what constitutes inappropriate or unauthorized
access. Confidentiality relates to protecting and safeguarding health
information from inappropriate access, use, and disclosure. In short,
privacy is about the person, while confidentiality is about the information.
Privacy speaks to the rights of patients, as they have a right to their
privacy. Confidentiality speaks to the responsibility of healthcare
providers because they are responsible for keeping patients’ information
private. Security relates to the administrative, technical, and physical
safeguards implemented to prevent privacy and confidentiality breaches
and also to ensure integrity and availability of information.
Table 26.1
Distinctions Among Terms
Terms Definitions
Accountability The requirement for actions of an entity to be traced uniquely to that entity.64
Authenticity Able to be verified and trusted; confidence in the validity of a transmission, a message, or
message originator.64
Availability Data or information is accessible and useable on demand by an authorized person.39
Confidentiality Data or information is not made available or disclosed to unauthorized persons or processes.39
Integrity Data or information have not been altered or destroyed in an unauthorized manner.39
Privacy Restricting access to subscriber or relying party information in accordance with federal law and
agency policy.64
Safeguard Protective measures prescribed to meet the security requirements (i.e., confidentiality, integrity,
and availability) specified for an information system. Safeguards may include security features,
management constraints, personnel security, and security of physical structures, areas, and
devices. Synonymous with security controls and countermeasures.40
Security Protecting information and information systems from unauthorized access, use, disclosure,
disruption, modification, or destruction in order to provide confidentiality, integrity, and
availability.39
Legal and historical context
Today’s focus on health information security is built on a long history of
concern with the privacy of information obtained during a caregiver–
patient encounter. Even in the fourth century, the Hippocratic oath
addressed the privacy of communications between patients and their
healthcare providers.5,8 In 1860, Florence Nightingale’s Notes on Nursing
addressed various uses of health information, including the importance of
its proper acquisition for the benefit of the patient first and foremost, a
concern that exists today.9 Privacy and confidentiality continue today as
global concerns. After all, the information that individuals share with their
caregivers as part of that trusted relationship may not have been shared
with their families or even close friends.10
Fair Information Practice Principles
Fair information practices (FIPs), also referred to as fair information
practice principles (FIPPs), are a set of internationally recognized practices
for addressing privacy of information. The principles are the result of joint
work by U.S., Canadian, and European government agencies over time
and are available in reports, guidelines, and legal codes that ensure that
information practices are fair and provide adequate privacy protection to
individuals.11,12 Although these statements can vary according to the
source, typical FIPs are included in Table 26.2.
Table 26.2
Fair Information Practice Principles
Principle Description
Transparency Organizations should be transparent and notify individuals regarding collection, use,
dissemination, and maintenance of personally identifiable information (PII).
Individual Organizations should involve the individual in the process of using PII and, to the extent
participation practicable, seek individual consent for the collection, use, dissemination, and maintenance of PII.
Organizations should also provide mechanisms for appropriate access, correction, and redress
regarding use of PII.
Purpose Organizations should specifically articulate the authority that permits the collection of PII and
specification specifically articulate the purposes for which PII is intended to be used.
Data Organizations should only collect PII that is directly relevant and necessary to accomplish the
minimization specified purpose(s) and only retain PII for as long as is necessary to fulfill the specified
purpose(s).
Use limitation Organizations should use PII solely for the purposes specific in the notice. Sharing PII should be
for a purpose compatible with the purpose for which the PII was collected.
Data quality Organizations should, to the extent practicable, ensure that PII is accurate, relevant, timely, and
and integrity complete.
Security Organizations should protect PII in all media through appropriate security safeguards against
risks such as loss, unauthorized access or use, destruction, modification, or unintended or
inappropriate disclosure.
Accountability Organizations should be accountable for complying with these principles, providing training to
and auditing all employees and contractors who use PII and auditing the actual use of PII to demonstrate
compliance with these principles and all applicable privacy protection requirements.
Source: Fair Information Practice Principles. National strategy for trusted identities in
cyberspace. Appendix A. National Institute for Standards and Technology.
<[Link]
Since the 1970s, many government agencies addressed the impact of
computerization of health records. Some industrialized countries codified
FIPs into a privacy law at the federal level, although this has not yet
occurred in the United States. Instead, in the United States, FIPs are the
basis of many individual laws at federal and state levels. The value of the
FIPs is that they provide a framework for privacy laws and also can form
the foundation for an organization’s or an industry’s privacy policy. For
example, although the Health Insurance Portability and Accountability
Act of 1996 (HIPAA) does not formally codify FIPs in the legislation, it
implements all FIPs in some way.13
Code of Ethics for Health Informatics Professionals
When we discuss ethics in healthcare, biomedical ethics come to mind;
however, a discussion on ethics in healthcare should involve business
ethics as well. Business ethics are how we conduct ourselves, our
organizational culture, and leadership. In informatics, sample business
ethics are codified by the International Medical Informatics Association
(IMIA).
International Medical Informatics Association
The IMIA published a Code of Ethics for Health Informatics Professionals
that is closely related to the FIPs.14 This code has two major sections. The
first addresses fundamental ethical principles: autonomy, equality and
justice, beneficence, nonmalfeasance, impossibility, and integrity as
applied to informatics (Table 26.3). The second section concerns the rules
of ethical conduct for health informatics professionals. As this code
demonstrates, FIPs are now an integral aspect of ethical practices in health
informatics.
Table 26.3
General Principles of Informatics Ethics Included in the IMIA Code of
Ethics for Health Informatics Professionals
Principle Description
1. Information All persons have a fundamental right to privacy and hence control over the collection, storage,
—privacy and access, use, communication, manipulation, and disposition of data about themselves.
disposition
2. Openness The collection, storage, access, use, communication, manipulation, and disposition of personal
data must be disclosed in an appropriate and timely fashion to the subject of those data.
3. Security Data that have been legitimately collected about a person should be protected by all reasonable
and appropriate measures against loss, degradation, unauthorized destruction, access, use,
manipulation, modification, or communication.
4. Access The subject of an electronic record has the right of access to that record and the right to correct the
record with respect to its accurateness, completeness, and relevance.
5. Legitimate The fundamental right of control over the collection, storage, access, use, manipulation,
infringement communication, and disposition of personal data is conditioned only by the legitimate,
appropriate, and relevant data needs of a free, responsible, and democratic society, and by the
equal and competing rights of other persons.
6. Least Any infringement of the privacy rights of the individual person, and of the individual’s right to
intrusive control over person-relative data as mandated under Principle 1, may only occur in the least
alternative intrusive fashion and with a minimum of interference with the rights of the affected person.
7. Any infringement of the privacy rights of the individual person, and of the right to control over
Accountability person-relative data, must be justified to the affected person in good time and in an appropriate
fashion.
From International Medical Informatics Association (IMIA). IMIA Code of Ethics for health
information professionals. IMIA. <[Link]
IMIA, International Medical Informatics Association.
Principles, laws, and regulations guiding
practice
Over the centuries, health professionals used a combination of ethical
codes, including a set of guidelines or guiding principles, and applicable
laws and regulations to maintain patient confidentiality. The introduction
of computers into healthcare offered new challenges and opportunities for
securing health-related data and maintaining patient confidentiality.
The U.S. federal government recognized the need for legislation to
protect privacy in an electronic environment with the passage of the
Privacy Act in 1974. This act protects certain personal information held by
federal agencies in computerized databases.15 It includes three important
factors. First, privacy of health data is considered within the larger context
of privacy in general. The Privacy Act is not specific to the protection of
health data but provides for protection of health-related data in federal
agencies with health-related databases such as the Veterans Health
Administration (VHA), Military Health System (MHS), and Medicare.
Second, this legislation reflected the code of FIPs described previously.
Third, the Privacy Act included specific legislation about cross-referencing
data in multiple federal and state databases because combining databases
could create information that clearly identifies individuals. Later in this
chapter, we will review how this has changed in more recent years, as
HIEs were created within and among states and regions in the U.S. Health
and informatics professionals play a key role in understanding these
complexities and developing policies and procedures to protect patient
privacy within and across health-related databases.
The use of federal legislation to protect health data began in narrowly
defined areas. For example, in 1975, the Department of Health, Education,
and Welfare published rules and regulations governing the confidentiality
of patient records containing information related to alcohol and drug use.16
HIPAA was the first federal U.S. legislation to broadly address the privacy
and security of health data.17 This act set a standard in the United States
for protecting an individual’s health information, although other countries
already had such laws. HIPAA began in 1996 with subsequent revisions
and effective dates: HIPAA Privacy Rule in 2003, Electronic Data
Interchange in 2003, and the Security Rule in 2005. Additional privacy-
related legislation was included in the HITECH Act in 2009 and in the
HIPAA Omnibus Rule, which went into effect in early 2013. Critical
aspects of PHI and HIPAA are discussed next.
National Privacy and Security Framework for Health
Information Laws and Regulations
When consumers think of HIPAA, they often think that it covers all of
their privacy rights. However, HIPAA only addresses those rights as they
relate to PHI. PHI is individually identifiable health information
transferred in any medium (e.g., demographics, health and mental
conditions, and their treatments as well as payment information).18 The
following section outlines international efforts and then focuses on U.S.
laws and regulations related only to PHI under HIPAA.
International Laws
On an international level, many countries instituted privacy laws prior to
HIPAA. While there are differences between countries in how privacy is
conceived and in the value placed on privacy of health data, privacy of
health data is increasingly being recognized as an international value.19
Becoming familiar with these laws is critical for conducting international
business to avoid violations. Whether conducting domestic business in the
United States or conducting international business, readers need to know
what is addressed in each law and then conduct business accordingly to
mitigate risks of privacy breaches.
The European Union (EU) has historically been more protective of
personal information than the United States. One of the earliest and most
recognized agreements and legislation supporting the transfer of health
data across their borders was created by the EU in 1995. It passed a
comprehensive data privacy law titled the “EU Directive on the Protection
of Individuals with Regard to the Processing of Personal Data and on the
Free Movement of such Data.”20 The EU selected a “directive” approach
that required each EU member state to enact its own law based on the fair
principles outlined in the directive. As each EU member state developed
and implemented its legislation, it implemented the 1995 rules differently,
resulting in divergences in enforcement and a number of related problems.
1. In late 2015, the EU’s General Data Protection Regulation (GDPR)
was enacted to provide consumers with more input about how their
digital information is collected and managed, strengthening the
privacy rights of Europeans. The changes take effect in early 2017
across the 28 members of the EU. One of the unique concepts in the
GDPR is the “right to be forgo en,” which provides individuals in a
region the right to ask companies to remove data about them. The
law also requires companies to inform national regulators within
three days of any reported data breach. This goes beyond what is
required by U.S. authorities currently. Another GDPR issue is in
regard to children under 16 years old. The rule requires young
children to obtain parental consent before using popular internet
services such as social media applications.21
2. In a similar vein, the EU and the United States agreed to a
framework for data sharing in early 2016. This new framework will
protect the more stringent rights of EU citizens when their data are
sent to the United States. It includes safeguards and opportunities
for redress should personal data be compromised.22 These
regulations are important for readers to know, especially if they are
employed by companies with international sites.
A number of other countries, in addition to those in the EU, have
developed international agreements and legislation related to privacy of
personal data. What does not exist at this point is a single set of standards,
rules, or legislation that could be used in designing information systems
storing health-related data, although both EU and Canada show evidence
of being progressive in that direction. Other countries have adopted
privacy standards (e.g., Philippines in 2011, Vietnam in 2008, and South
Africa in 2002).23 Readers may find a list of these countries at
h p://[Link]/files/Uploads/Documents/Data%20Breach%20d
ocuments/[Link].
Informaticians should approach each international situation on an
individual basis. Both the Electronic Frontier Foundation (EFF)
(h ps://www.eff.org/issues/international-privacy-standards) and the
Electronic Privacy Information Center (h ps://[Link]/privacy/intl/)
maintain websites listing privacy-related international accords and
agreements. Neither list is comprehensive but can be used as a starting
point in exploring international privacy agreements pertinent to the
privacy of health-related data.
U.S. Federal Law
U.S. federal efforts to protect and safeguard PHI are based on various
federal and state laws and regulations. A list of related laws and
regulations is provided in Box 26.1. The primary U.S. federal legislation
dealing with privacy is HIPAA.18 HIPAA has multiple sections and
subparts related to maintaining the confidentiality of health information,
whether in paper or electronic format, and addressing privacy, security,
and electronic data interchange standards. Here the discussion of HIPAA
is limited to its importance in designing and implementing health
information systems.
Box 26.1
Healthcare-Related Privacy and Security Laws
and Regulations a
• Health Insurance Portability and Accountability Act (HIPAA) in 1996
and subsequent rules on privacy and security (2000)
• CMS Security Standard
• Confidentiality of Alcohol and Drug Abuse Patient Records
• The Privacy Act of 1974
• Family Educational Rights and Privacy Act (FERPA)
• Gramm-Leach-Bliley Act
CMS, Centers for Medicare and Medicaid Services.
From Brown GD, Patrick TB, Pasupathy K. Health Informatics: A Systems Perspective. Chicago, IL:
Health Administration Press; 2012.
a Additional information on other laws and regulations is located at
h ps://[Link]/sites/default/files/privacy-security/federal-privacy-laws-
table2-26-10-fi[Link]
The History of HIPAA
In 1996, HIPAA was enacted by Congress.17 Subsequently, several
associated rules emerged: the Privacy Rule, Security Rule, Transactions
and Code Sets, National Provider Identifier (NPI), Enforcement Rule, and
Breach Notification Rule to increase safeguards. Of note, HIPAA applies to
“covered entities” (healthcare providers, health plans, and healthcare
clearinghouses) and their “business associates.” Much debate and legal
definitions exists about the term “business associate” as it relates to
HIPAA, and a complete definition is lengthy. An example of the subtle
implications with the use of this term can be seen in Box 26.2. For this
chapter, we will use the term in its generic sense to mean an organization
supporting the work of a covered entity having access to its PHI. For
example, an external billing service (the business associate) may process
specialized insurance requests for an emergency department in a medical
center (the covered entity). Through this association, the billing company
is considered a covered entity because the firm has access to PHI. All
entities are responsible for protecting and safeguarding PHI. This section
discusses pertinent and more recent HIPAA-related rules or laws.
Box 26.2
Covered Entity or Business Associate
Is a software vendor a business associate or a covered entity?
Answer: The mere selling or providing of software to a covered entity
does not give rise to a business associate relationship if the vendor does
not have access to the protected health information of the covered entity.
If the vendor does need access to the protected health information of the
covered entity in order to provide its service, the vendor would be a
business associate of the covered entity. For example, a software company
that hosts the software containing patient information on its own server or
accesses patient information when troubleshooting the software function
is a business associate of a covered entity. In these examples, a covered
entity would be required to enter into a business associate agreement
before allowing the software company access to protected health
information. However, when an employee of a contractor, like a software
or information technology vendor, has his or her primary duty station on-
site at a covered entity, the covered entity may choose to treat the
employee of the vendor as a member of the covered entity’s workforce,
rather than as a business associate. See the definition of “workforce” at 45
CFR 160.103.
Source: Office for Civil Rights (OCR) (2002) HHS Home > HIPAA > For Professionals > FAQ > 256—
Is a software vendor a business associate of a covered entity? Located at
h p://[Link]/hipaa/for-professionals/faq/256/is-software-vendor-business-
associate/[Link]
HITECH Act
The 2009 HITECH Act included requirements for privacy breaches by
covered entities and/or business associates.24 Breaches are defined as an
impermissible use or disclosure of PHI.25 Specific new requirements were
outlined in 2009 for notifying individuals, the media, and the HHS.24 Any
individuals affected by a breach must be notified about the details of the
breach within a specific time frame. When a breach affects more than 500
residents of a state or jurisdiction, the covered entity or business associate
is required to provide notice to prominent media in addition to notifying
the affected individuals. For breaches affecting 500 or more individuals,
the secretary of the HHS also must be notified. A summary of provisions
expanded by the HITECH Act are in Box 26.3.
Box 26.3
Provisions of HIPAA Expanded by the HITECH
Act
• Application of privacy provisions and penalties to business associates of
covered entities
• Application of security provisions and penalties to business associates of
covered entities; annual guidance on security provisions
• Notification in the case of breach
• Education on health information privacy
• Limitations on certain contacts as part of healthcare operations
• Breach notification requirement for vendors of personal health records
and other non-HIPAA covered entities
• Expanded use of business associate contracts
• Application of wrongful disclosures criminal penalties
• Required audits
HIPAA, Health Insurance Portability and Accountability Act; HITECH
Act, Health Information Technology for Economic and Clinical Health
Act.
HIPAA Omnibus Final Rule of 2013
In January 2013, the Department of Health and Human Services (HHS)
announced the HIPAA Omnibus Final Rule, based on statutory changes
under the HITECH Act and the Genetic Information Nondiscrimination
Act of 2008 (GINA).26 Major provisions are summarized in Box 26.4.
Modifications include a number of provisions to expand and strengthen
the privacy and security protections for health information first established
under HIPAA.26 Specifically, this final rule adds patients’ privacy
protections, provides individuals new rights to their health information,
and strengthens the government’s ability to enforce the law. Current
provisions are outlined in Box 26.5.
Box 26.4
Overview of the 2013 HIPAA Omnibus Final
Rule
Final HIPAA Rule Overview. The omnibus final rule strengthens and
expands patient rights as well as enforcement and is composed of the
following four components:
1. HIPAA Privacy, Security, and Enforcement Rules and HITECH Act.
The final rule modifies the Privacy, Security, and Enforcement Rules.
These modifications include the following:
• Changes regarding business associates
• Limitations on the use and disclosure of PHI for marketing and
fundraising
• Prohibition on the sale of PHI without authorization
• Expanded rights to receive electronic copies of health information and
to restrict disclosures to a health plan concerning treatment paid out
of pocket in full
• Requirement to modify and redistribute notice of privacy practices
• Modified individual authorization and other requirements to facilitate
research, disclose child immunization proof to schools, and access
decedent information by family members/others
2. Enforcement Rule. Final rule adopts changes to the HIPAA
Enforcement Rule to incorporate the increased and tiered civil money
penalty structure provided by the HITECH Act.
3. Breach Notification Rule. Final rule adopts the Breach Notification for
Unsecured PHI created under the HITECH Act and replaces the Breach
Notification Rule’s “harm” threshold with a more objective standard.
4. HIPAA Privacy Rule as It Relates to Genetic Information. Final rule
modifies the HIPAA Privacy Rule as required by the Genetic
Information Nondiscrimination Act (GINA) to increase privacy
protections for genetic information by prohibiting most health plans
from using or disclosing genetic information for underwriting purposes.
From eHealth Initiative. New HIPAA Rules and Implications for the Industry. (PDF document).
January 29, 2016.
h p://fi[Link]/sharedchcpolicies/Policies_Forms/HIPAA/HIPAARulesWebinar%
[Link].
Box 26.5
HIPAA Regulations: Individuals’ Rights to
Access Their Personal Health Information
With limited exceptions, HIPAA provides individuals with a legal,
enforceable right to see and receive copies of the information in their
medical and other health records maintained by their healthcare
providers and health plans, as well as to direct the covered entity to
transmit a copy to a designated person or entity of the individual’s choice.
Key Terms
• Covered Entity. Includes (1) healthcare providers such as hospitals,
physicians, clinics, psychologists, dentists, nursing homes, and
pharmacies if they transmit any information in an electronic format; (2)
insurance companies, HMOs, and government plans that pay for
healthcare; and (3) healthcare clearinghouses that process nonstandard
health information they receive from another entity into a standard
format or vice versa.
• Designated Record Sets. The group of records maintained by the
covered entity and/or business associate used to make decisions about
the diagnosis, management, and treatment of the patient. This includes
medical records, billing records, enrollment, payment, claims
adjudication, and any other records used to make decisions about the
patient.
• Personal Representative. A person with authority under state law to
make healthcare decisions for the individual.
What Patient Rights Are Included?
• The right to receive copies of all information in the medical records,
including clinical laboratory test results, medical images such as X-rays,
wellness and disease management program files and clinical case notes,
all billing and payment records, and insurance information.
• The right to request a change to any information the individual believes
is wrong as well as to add information the individual believes is missing
or incomplete. If the covered entity believes the information is correct or
complete, the individual has the right to have the disagreement noted in
their file within 60 days.
• The right to receive test results directly from clinical laboratory that is a
covered entity. The designated record set includes not only the
laboratory test reports but also the underlying information generated as
part of the test, as well as other information concerning tests a
laboratory runs on an individual. Patients may still obtain their results
from their physician’s office, but are not required to use that option.
• A personal representative also has the right to access PHI in a designated
record set as well as the right to direct the covered entity to transmit a
copy of the PHI to a designated person or entity of the individual’s
choice.
Exceptions
• PHI that is not part of a designated record set because the information is
not used to make decisions about individuals. This includes records that
are used for business decisions more generally rather than to make
decisions about individuals such as quality assessment data.
• Psychotherapy notes, which are the personal notes of a mental
healthcare provider documenting or analyzing the contents of a
counseling session that are maintained separate from the rest of the
patient’s medical record.
• PHI is in a designated record set that is part of a research study that
includes treatment that is still in progress, provided the individual
agreed to the temporary suspension of access when consenting to
participate in the research.
Source
U.S. Department of Health and Human Services: Office of Civil Rights.
(2016). Individuals’ Right under HIPAA to Access their Health Information 45
CFR § 164.524. Retrieved 11.01.16, from HIPAA for Professionals: Privacy:
Guidance: h p://[Link]/hipaa/for-
professionals/privacy/guidance/access/[Link]
U.S. Department of Health and Human Services: Office of Civil Rights.
(n.d.). Your Health Information privacy Rights. Retrieved 08.01.16, from U.S.
DHHS Office of Civil Rights:
h p://[Link]/sites/default/files/ocr/privacy/hipaa/understanding/c
onsumers/consumer_rights.pdf
Under the rule, business associates who receive PHI (e.g., contractors,
subcontractors, and other third parties) are also liable for noncompliance
based on the level of negligence up to a maximum penalty of $1.5 million.
The rule clarifies when breaches of unsecured health information must be
reported to the Department of Health and Human Services. Individual
rights were also expanded. Importantly, patients can ask for a copy of their
electronic medical record in an electronic form, and if they choose to pay
cash for services provided, the patient can instruct the healthcare provider
not to share information about their treatment with their health plan. The
challenge lies in the processes healthcare providers have in place to honor
this request.
This rule describes new limits on how information is used and disclosed
for marketing and fundraising purposes.26 It prohibits the sale of an
individual’s health information without their permission. A covered entity
must request and obtain wri en authorization from an individual to use or
disclose his or her PHI for marketing purposes. Specific exceptions exist
when the provider receives no compensation for the communication,
when the communication is face to face, or if the communication involves
a drug or biologic the patient is currently being prescribed and the
payment is limited to reasonable reimbursement of the costs of the
communication (at no profit).
ONC Tool for Integrating Privacy and Security into
Health Practices
Individuals and healthcare providers are not willing to share complete and
accurate health-related data unless they can trust that the data have been
secured in a protected environment. As noted in Chapters 6 and 25, HIEs
combine information from multiple databases, introducing new
information from other practitioners or organizations and integrated
elements such as medications, treatments, and therapies into a more
comprehensive patient plan of care. This may, of course, include PHI. This
is another area where informatics professionals play a key role in
understanding these types of issues and complexities to develop policies
and procedures to safeguard and protect PHI both internally and
externally to an organization.
In April 2015, the Office of the National Coordinator for Health
Information Technology (ONC) released a document titled, “Guide to
Privacy and Security of Electronic Health Information,” version 2.0.27 The
purpose of this tool is to assist providers and organizations, especially
smaller organizations and practices, in understanding how to integrate
federal health information privacy, security, and breach notification
requirements into their practices. The tool answers practical questions
such as, “Do I have to inform patients how I disclose their health
information?” It summarizes patients’ rights to their information and
provides sample questions to ask of vendors, such as, “Does software
installation include ePHI encryption, auditing and unique, individual
identifications with strong passwords?”27 Readers may view the full guide
at h ps://[Link]/sites/default/files/pdf/privacy/privacy-and-
[Link].
While HIPAA protects PHI from misuse, the law also enables disclosing
or sharing information when needed for patient care. To help clarify when
PHI may be disclosed without obtaining an individual’s authorization,
ONC and the OCR developed easy-to-read fact sheets, released in
February 2016:
• Permi ed Uses and Disclosures: Exchange for Health Care Operations is
available from
h ps://[Link]/sites/default/files/exchange_health_care_ops
.pdf.
• Permi ed Uses and Disclosures: Exchange for Treatment is available from
h ps://[Link]/sites/default/files/exchange_treatment.pdf.
In addition to federal laws, health plans, healthcare clearinghouses, and
healthcare providers must follow state laws and regulations. State laws are
further complicated when health services and institutions cross state lines,
such as with telehealth services.
Federal-State Collaboration
The Health Information Security and Privacy Collaboration (HISPC) was
established in 2006. In 2008, HISPC moved into its third and final phase,
with 42 states and territories addressing the privacy and security
challenges presented by electronic HIE through multistate collaboration.28
Phase 3 projects included the following:
• Studying intrastate and interstate consent policies
• Developing tools to help harmonize state privacy laws
• Developing tools and strategies to educate and engage consumers
• Developing a toolkit to educate healthcare providers
• Recommending basic security policy requirements
• Developing interorganizational agreements26
Each project was designed to develop common, replicable multistate
solutions for reducing variation in and harmonizing privacy and security
practices, policies, and laws. A number of products and reports have been
produced as a result of these efforts and can be accessed at
h p://[Link]/policy-researchers-implementers/health-
information-security-privacy-collaboration-hispc. Each covered entity is
required to interpret and apply these rules, as applicable to their
organization and the state in which they reside.
HIPAA and Secondary Uses of Electronic Health Data
In addition to being used in the provision of healthcare, PHI can be used
for a number of other activities. This is referred to as the secondary use of
health data, and it presents its own special set of privacy and security
issues. The three most common secondary uses of personal health
information are public health monitoring or surveillance, research, and
marketing.
Public Health Monitoring or Surveillance and HIEs
Public health agencies, which frequently must work within states and
across state lines, are required to follow applicable federal and specific
state laws and regulations. In addition to HISPC, discussed previously, the
Public Health Data Standards Consortium (PHDSC) provides information,
education, and tools for protecting the privacy of personal health data.29
PHDSC is a national, nonprofit, membership-based organization of
federal, state, and local health agencies; professional associations;
academia; public and private sector organizations; international members;
and individuals. Its mission focuses on promoting health IT standards to
empower health communities to improve individual and community
health. The PHDSC Privacy, Security, and Data Exchange Commi ee
addresses individual and organizational privacy and security standards
related to maintaining and sharing health information in electronic form
for public sector health programs and health services research purposes.
The goals include the following:
• To represent and educate broad public sector health and health
services research interests on privacy and security issues
• To focus on priorities related to privacy, security, and data
standardization
• To balance the need for individual privacy, confidentiality, and
security with the need for use of data for public health and research
activities
For additional information regarding PHDSC, go to [Link].
PHDSC conducted a survey on privacy-related variations, solutions, and
implementation plans directly involving or affecting public health
practice. Two reports were issued. The first report summarizes the
variations in privacy and security policies, practices, and state laws
affecting the interoperability of public HIEs. The second report focuses on
the analysis of solutions and implementation plans proposed by states and
aimed at addressing barriers to public HIEs. Both reports are available
from PHDSC at [Link].
With the information in these reports, PHDSC developed a Privacy
Toolkit for Public Health Professionals (PRISM). PRISM consists of a series
of tables that outline different types and purposes of information use and
disclosure and the general legal requirements relevant to each type of use
or disclosure. The tables describe the baseline privacy requirements for
disclosure of health information using HIPAA, other federal laws affecting
health privacy, and common state privacy laws and related requirements.
The PRISM tables can be accessed at
h p://[Link]/privacy_security/[Link].
De-identification of Data
The 2013 HIPAA Omnibus Rule provided clarification regarding the use of
patient information for marketing purposes. Health data used for
marketing (and some research) are almost always de-identified; that is,
PHI is removed so that remaining information neither identifies nor
provides a reasonable basis to identify an individual. HIPAA includes no
restrictions on the use or disclosure of de-identified health information.29
However, there are regulations concerning the specific procedures that can
be used to de-identify protected data.30 These two procedures, the safe
harbor method and the expert determination method, are outlined in Fig.
26.1.
FIG 26.1 Two methods to achieve de-identification in accordance
with the Health Insurance Portability and Accountability Act’s
(HIPAA’s) Privacy Rule. Copyright U.S. Department of Health and Human Services
[HHS] Office for Civil Rights. Guidance regarding methods for de-identification of protected
health information in accordance with the Health Insurance Portability and Accountability
Act [HIPAA] Privacy Rule. HHS. <[Link]
professionals/privacy/special-topics/de-identification/> Accessed January 13, 2016.
The next section discusses why information security is critical to today’s
organizations and individuals and provides an overview of critical
security procedures.
The importance of information security
While privacy and confidentiality are important, they are not the only
issues that arise when dealing with health data. The HIPAA Security Rule
requires safeguards be in place to ensure the confidentiality, integrity, and
availability of PHI.31 This triad is frequently mentioned together and often
labeled CIA by cybersecurity professionals. Definitions for these and
related terms may be found in Table 26.1.
As health data increasingly move from paper to electronic storage and
transmission, they can become more vulnerable to unauthorized
disclosure and modification, either accidentally or intentionally. Health
professionals should be familiar with various safeguards, also known as
controls or countermeasures, to protect the CIA of data. Likewise,
ensuring health information confidentiality and security is facing new
challenges as technology is introduced. One of the promises of EHRs is
improved accessibility, especially through simultaneous access by
multiple authorized persons and distributed across geographic locations.
While electronic information systems do deliver this benefit, they also
introduce new obstacles to availability such as system downtime, network
outages, authentication, and access control. Just as modern healthcare is
dependent on electrical cabling to bring power to medical devices, it also is
dependent on networks (wired or wireless) to carry data. Safeguards are
required to address availability of patient data. (See Chapter 20 for
detailed information on downtime and disaster recovery.)
The HITECH Act, Meaningful Use, and subsequent efforts by
government agencies to accelerate electronic exchange of health
information make it virtually impossible for eligible providers to avoid
having an internet connection. HITECH requirements such as exchanging
patient data, submi ing claims electronically, generating electronic
records for patients’ requests, and e-prescribing make an internet
connection an absolute necessity. The existence of such a connection
requires that these providers devise methods to safeguard data being
shared via the internet. Effective cybersecurity practices are needed to
protect the confidentiality, integrity, and availability of EHR systems,
regardless of how they are delivered, whether installed in a small provider
office or accessed over the internet by large organizations.27
Three areas emphasize the importance of health information security
today: (1) the public trust, (2) legal requirements and fines, and (3)
increasing security threats to healthcare data.
The Public Trust
A balance is needed for patients’ requirements for privacy and society’s
need for improved efficiency and reduced costs.32 With increased
connectivity comes the sharing of highly sensitive data as well as social
and political pressure to avoid inappropriate sharing. Healthcare
institutions and providers earn patients’ trust by guaranteeing the privacy
and security of their health information. Patients entrust their most
intimate information to healthcare providers, and they do not expect their
health information or their identities to be exposed publicly.33 Thus
breaches of privacy and security undermine patients’ confidence in their
healthcare institutions and providers. On the other hand, adequate
security measures can bolster the public trust and perhaps boost EHR
adoption rates.34 The following paragraphs identify efforts to establish and
maintain public trust in EHR systems by applying formal risk
management frameworks (RMFs).
To help healthcare organizations address the complex array of
standards and regulations related to privacy and security, the Common
Security Framework (CSF) was developed by the Health Information Trust
Alliance (HITRUST). The framework provides a proven approach to risk
management and regulatory compliance. Through the HITRUST CSF
Assurance Program, healthcare organizations may perform internal
assessments of their privacy and security practices or contract with a third-
party assessor to achieve CSF certification.35
HITRUST was founded in 2007, and the CSF v.1 was released in 2009,
with certification based on 35 security controls. The 2014 CSF v6
framework consisted of 135 control specifications organized into 13
categories. Box 26.6 lists the HITRUST CSF control categories. In 2015,
version 7 was released with the framework expanded to incorporate cross-
references related to privacy in addition to security. The additional privacy
standards include the HIPAA Privacy Rule and NIST SP 800-53 R4
Security and Privacy Controls for Federal Information Systems and
Organizations, among several others.36
Box 26.6
HITRUST CSF Control Categories
• Information Security Management Program
• Access Control
• Human Resources Security
• Risk Management
• Security Policy
• Organization of Information Security
• Compliance
• Asset Management
• Physical and Environmental Security
• Communications and Operations Management
• Information Systems Acquisition, Development and Maintenance
• Information Security Incident Management
• Business Continuity Management
HITRUST Common Security Framework v6 brochure.
h ps://[Link]/content/uploads/2014/02/HITRUST-CSF-
[Link]
Some health plans require their business associates to become HITRUST
certified. HITRUST certification is also occurring at the state government
level. For example, the Texas Health Services Authority partnered with
HITRUST to establish standards for sharing PHI and maintaining
compliance with federal and state law.37
The U.S. federal government recognizes the importance of cybersecurity
and has taken steps to help organizations across all industries, including
healthcare, to understand and manage cybersecurity risks. The National
Institute of Standards and Technology (NIST) is one agency heavily
involved with cybersecurity. The NIST Computer Security Resource
Center (CSRC) publishes a series of special publications (SPs) on computer
security available at h p://[Link]/publications/[Link]. These
are documents of interest to the security community and include current
topics such as security measures for cloud computing and mobile devices.
The collection is known as the SP 800 series because the documents, like
SP 800-53 mentioned previously, are identified with a number beginning
with the prefix 800. For example, NIST publishes SP 800-66, “An
Introductory Resource Guide for Implementing HIPAA Security Rule.”
Other relevant NIST documents are outside the SP 800 series. One example
is the Cybersecurity Framework created by the NIST in 2014.38
The Cybersecurity Framework consists of three parts that work together
to manage cybersecurity risk. The first part, Framework Core, includes
activities, desired outcomes, and references common across multiple
industries. Best practices, industry standards, and guidelines are
organized and presented. These are organized into five functions: Identify,
Protect, Detect, Respond, and Recover. Each function is further organized
into subcategories and aligned with Informative References. Box 26.7 shows
the Cybersecurity Framework functions and categories.38 Box 26.8
provides information about the HIPAA Security Rule Crosswalk to the
NIST Cybersecurity Framework.
Box 26.7
NIST Cybersecurity Framework Functions and
Categories
NIST Cybersecurity Framework v1.0,
[Link]
Accessed February 8, 2016.
Box 26.8
Security Rule Crosswalk to Cybersecurity
Framework
In February 2016, the Office of Civil Rights (OCR) released a crosswalk
developed with the National Institute of Standards and Technology
(NIST) and the Office of the National Coordinator for Health IT (ONC),
providing a helpful mapping of the HIPAA Security Rule and the
Cybersecurity Framework, along with other commonly used security
frameworks.
The crosswalk is available at h p://[Link]/hipaa/for-
professionals/security/nist-security-hipaa-crosswalk.
The second part is the Framework Implementation Tiers characterizing an
organization’s risk management practices as Partial (Tier 1), Risk
Informed, Repeatable, or Adaptive (Tier 4). The framework recognizes
varying target profiles and bases success on an organization achieving its
cybersecurity goals versus progression to a higher tier.38
The third part is the Framework Profile, which represents the
organization’s business needs and priorities. The profile enables the
organization to establish a roadmap to address cybersecurity risk in
alignment with the organization’s goals, regulatory requirements, and best
practices. Comparing the current profile to the target profiles reveals gaps
to be addressed.38
The previously provided frameworks are significantly influenced by the
NIST RMF, as is the HIPAA Security Rule. The NIST RMF provides a
structured, disciplined, extensible, and repeatable process built around
continuous monitoring. NIST SP 800-66, “An Introductory Resource Guide
for Implementing the HIPAA Security Rule,” includes specific mapping of
RMF phases to HIPAA Security Rule requirements.39 The NIST RMF was
initiated in 2005 and has been expanded to describe over 230 specific
security controls organized into 17 families. Fig. 26.2 illustrates how the
security controls are applied throughout the RMF Security Life Cycle.40
Selected security controls will be highlighted later in this chapter.
FIG 26.2 NIST Risk Management Framework. From NIST Special
Publication 800-53 Revision 4 Security and Privacy Controls for Federal Information
Systems and Organizations. Joint task force transformation initiative; April 2013. Found at
<[Link] [p. 8].
More federal guidance is forthcoming. The Cybersecurity Act of 2015
included nine pages dedicated to healthcare-related security. Included in
the language is the requirement for a task force to be formed with
representatives from HHS, Homeland Security, and NIST. The task force is
to examine the actions and safeguards used in other industries for
application to healthcare cybersecurity. It is also tasked with analyzing
EHR and interoperability issues.41
Another requirement of the Cybersecurity Act of 2015 is that agencies
continue to improve preparedness by educating stakeholders and sharing
cyber threat indicators and defensive measures between government and
other entities. Also included is the Cybersecurity Information Sharing Act
that establishes the personal data to be removed before data are shared
and the notification rules for individuals whose information is shared.41
Legal Requirements and Fines
Legal requirements and potential fines make information security even
more critical to organizations. In 2011, the largest fine was $4.3 million for
an organization that refused to release health records to several patients
and then did not cooperate with the government’s investigation of the
ma er.34 Today penalties and other costs related to security breaches have
far exceeded the 2011 example. In fact, 2015 was considered to be a record
year for privacy breaches. According to the Identity Theft Resource Center,
the number of total breaches in 2015 was 781, about the same as in 2014,
while the number of records compromised almost doubled from 85 million
to 169 million. Of those numbers, 35.5% of the breaches and 66.7% of the
records compromised were for healthcare organizations.42 Financial
penalties affected organizations in the form of fines; organizations are also
faced with the costs of notifying affected customers as well as civil
litigation.43
As can be seen in Table 26.4, security breaches are costly to
organizations. The average cost of a health record breach in 2010 was $301
per compromised record.44 In 2015, that figure grew to $363 per record.45
Healthcare data breaches have become the most costly type of breach to
remediate and are over twice the average cost across all industries.
Considering that a single breach can include thousands or millions of
records, even one breach is expensive. The average cost of a breach at a
healthcare organization is estimated at over $2 million, while a breach at a
business associate averages over $1 million.46 The largest healthcare breach
to date, Anthem, could exceed $1 billion in costs.47 Therefore multiple
organizations have either purchased or are exploring the purchase of cyber
insurance.
Table 26.4
Examples of HIPAA Violations and Related Fines
Increasing Security Threats to Healthcare Data
The security threats to healthcare data are increasing for a variety of
reasons, including the expanding volume of healthcare data being stored,
proliferation of EHRs interconnected by HIEs, the internet of things (IoT),
and increasing a ractiveness of health data to hackers.
Recent health practices increase the risk of a security breach, including
increased electronic health data access and transmission due to the use of
mobile devices and expanded health data sharing within and across health
organizations. Mobile devices are a ractive to healthcare providers
because they support increased health data access and increased
individual productivity. However, these devices also increase
opportunities for interception of health data and, in turn, data loss.
Health data are being increasingly shared. EHR information is no longer
tied to one institution, and traditional stakeholders are transitioning to
having patients inpu ing information in their own records.48 HIE, by
design, is meant to enable data sharing within a region and between
regions. Population-based research is growing and, with it, the need for
increased security for “big data.”1 Authors are now publishing material
about how to share health data nationally and internationally.49 Sharing
and transmission of health data is also increasing on local networks. Each
of these has security implications and opportunities for breaches.
The IoT is the term used to refer to the collective set of sensors and
mobile devices connected to the internet and exchanging data. The IoT is
improving the healthcare experience for patients and providers while also
increasing the risks to privacy and security. For example, patients may be
discharged to home sooner by using technology that permits remote
monitoring by nurses and physicians.50 Inside hospitals, IoT technology
such as radio frequency identification (RFID) and real-time location
services (RTLS) enables the location of movable items, including people, to
be tracked. While these wireless, remote technologies provide tremendous
value, they also bring new security vulnerabilities.
In 2015, external criminal a acks became the leading cause of healthcare
data breaches.46 One reason is that stolen medical identity may now be
worth 10 to 20 times the value of a stolen credit card number.51 Criminals
may use a stolen medical identity to obtain expensive health services or
equipment that they can sell on the black market. It may take months or
years for victims to learn that their medical identity has been
compromised. Healthcare professionals must be aware that they are
targets of a ack from cybercriminals, simply due to their access to PHI.
Current security vulnerabilities
Current security vulnerabilities can be classified into three types of events:
natural events such as floods or hurricanes, external events such as
malicious messages or hacking, and events internal to an organization.52
Obviously, natural events such as lightning strikes can disable whole
systems, networks, or security servers. In one example, a health
organization abandoned a building but left clinical data in a locked closet.
A power loss unlocked the door; nine servers containing clinical data were
stolen.34 Although natural events are dramatic, these events account for
only a few of the reported security events.
External Events
Examples of external security events include outside a empts to access an
organization’s network (hacking), intrusions though a firewall, and
installing malicious code or sending malicious messages via e-mail. Recent
security conferences such as DefCon and BlackHat featured sessions about
hacking into health systems.34,53
Large health systems have long protected their information systems and
data using security controls described later in this chapter. Small
organizations are more vulnerable44 because they may lack the knowledge
and resources necessary to implement security measures and information
security may not be a high priority for them. For example, the network for
a surgeons’ group in California was hacked and data were stolen and
encrypted to prevent access. Subsequently, the hackers sent a ransom note
to the surgeons for return of their data; the surgeons refused to pay and
lost all of their patients’ data.34 Ransomware has emerged as a new threat
targeting the security of healthcare data.
Other targets for external hackers include systems readily accessible on
the internet. Cloud-based services such as fitness trackers, personal health
records, and even cloud-based EHRs may have many layers of protection
from hackers but are extremely vulnerable to the simple compromise of a
user’s password.
Other methods of healthcare data access can be concerning. For
example, a state-level agency may be a collector of healthcare data, but not
a provider of services as a covered entity, and thus not required to comply
with the HIPAA Privacy Rule. Some states offer collected healthcare data
for sale to the public with less than effective de-identification of the data.
Data collected by states may be subject to data mining and analysis that
has been shown to reveal sensitive healthcare information.54
Internal Vulnerabilities
Prior to 2015, most security events in the healthcare industry were from
internal sources, either unintentional or intentional.44,52 This has changed
so that today external threats are greater than internal ones. For internal
events, security policies and procedures may be lacking in some
organizations, or HIPAA compliance may not be a high priority,32
especially in smaller organizations. Even if internal policies exist, current
practices may not comply with either internal or external policies.
Although security risk assessments or risk analyses are required under
HIPAA, some organizations have never completed one and others do not
complete them regularly.44 In the latest available annual survey of
professionals in health organizations, only 75% of respondents indicated
that their organizations completed required risk analyses. This number
was constant over the previous 4 years of surveys.4 Since the 326
respondents do not represent all U.S. health organizations, the number of
noncompliant organizations is likely much higher. Also, third-party
organizations may not be using due diligence, even if main health
organizations are compliant.
Many internal breaches are lapses in judgment. They may involve
management decisions based on an understanding of relative priorities
and constraints of limited resources. Other internal breaches are due to
ineffective training.
Medical Devices
Medical devices present special security concerns because they interface
directly with patients and therefore may cause immediate harm. This
security concern was highlighted in 2011 when Jay Radcliffe, a security
researcher with diabetes, described and demonstrated at a conference for
security professionals how he was able to wirelessly hack into his insulin
pump and remotely change the insulin dosage to potentially lethal levels.55
Since that revelation, other researchers and investigators have been
inspired to explore the cybersecurity vulnerabilities of medical devices
and associated threats to patient health.56
Medical devices are proliferating and are being used for (1) monitoring
(e.g., glucometers, oximetry, home blood pressure devices), (2)
resuscitating (e.g., defibrillator, IV pumps), (3) surgical procedures (e.g.,
lasers, robotics such as da Vinci), (4) imaging (e.g., computed tomography,
magnetic resonance imaging, echograms), and (5) diagnostic procedures
(e.g., ultrasound, endoscopy). A growing number of life-sustaining
devices, such as pacemakers and defibrillators, are implanted into patients
and controlled externally via wireless communications.56,57 Many of these
devices have the capability to connect and share data through networks or
even operate remotely through wireless or cellular networks.
Because these devices can connect to a network and share data, they also
can be hacked. Multiple government agencies took notice of these
potential cybersecurity and health impacts. The U.S. Department of
Homeland Security Industrial Control Systems Cyber Emergency
Response Team is investigating dozens of potential vulnerabilities in
medical devices.56 The U.S. Food and Drug Administration (FDA) is also
engaged and in 2013 issued statements recommending manufacturers
review cybersecurity aspects of medical devices to prevent unauthorized
access or modification.56 In 2015, the FDA issued a safety communication
regarding vulnerabilities of specific infusion pump systems and confirmed
the ability to access one specific infusion system remotely via a hospital
network.58 At this writing, the FDA has issued draft guidance for safe data
exchange for medical devices. Readers are encouraged to access the FDA
website for the latest material on medical device design and security
recommendations.
In addition to the risks to patient health, medical devices also open a
link to sensitive information about patients. The medical device itself can
store sensitive data, including PHI that are often not encrypted.59 Many
medical devices are sold without common security controls such as
antivirus software. In health organizations, medical devices are typically
deployed and managed by biomedical or clinical engineering staff who
may operate separately from the IT department. This can create issues
about the number and kinds of devices deployed, as well as confusion
about which are connected to the IT network.
Health professionals must also be aware of devices that may hold PHI in
ways that are not obvious. For example, many modern photocopiers and
multipurpose office machines include internal storage that may retain PHI
related to jobs processed. If the device is returned at the end of a lease, or
is removed for maintenance, the data on the internal storage must be
properly erased. In 2013, HHS announced a se lement with Affinity
Health Plan Inc. for a breach that occurred in 2010 when multiple
photocopiers were returned to a leasing agent without hard drives being
properly erased. One of the returned copiers was acquired by the CBS
Evening News and found to contain PHI. After an investigation, the OCR
found PHI for up to 344,579 individuals was impermissibly disclosed.
Affinity Health Plan Inc. se led the potential violations with a payment of
$1,215,780.60
Current security challenges
Healthcare data have become the leading target for hackers due to the ease
of availability. Until recently, not much a ention was paid to the theft of
medical information. Healthcare data contains much more than just
financial information and can be used in multiple ways (e.g. identity theft,
insurance fraud, ransom, exploiting details about VIPs, and even diverting
information for uses such as gambling on sporting events).
Challenges to health data security can be grouped into the following
three main areas:
• The competing goals of gaining access to patient data to support care
and limiting access to patient data to support security
• Competing institutional priorities and competition for institutional
resources
• Multiple and evolving regulations
Health information access and security constitutes a balancing act. The
activities carried out by healthcare organizations involve communications
in shared workspace, work under time constraints, and the need to
transmit sensitive data quickly across se ings. These kinds of needs can
conflict with security goals. Even with privacy and security training, care
goals or productivity losses may discourage clinicians from adhering to
security-related procedures and policies. The Healthcare Information and
Management Systems Society (HIMSS) conducted surveys indicating that
the adoption of security technologies by healthcare organizations was slow
until 2015.
Managing security risks with security
controls
Healthcare shares the need for information security with many other
industries. While no system can ever be completely secure, the ongoing
effort to maintain a system in the most secure state possible is called risk
management. Most solutions to security are relatively simple and not costly
to implement once their need is understood.34
The ONC Guide to Privacy and Security of Electronic Health
Information v2.0 published in 2015 compiles guidance from various
authoritative sources applicable to healthcare organizations of all sizes.
Chapter 4 of the guide summarizes the HIPAA Security Rule that
organizes safeguards required to secure PHI into three categories:
administrative, technical, and physical. NIST SP 800-53 provides a
comprehensive list of over 230 security safeguards or controls spanning
these areas.
Administrative
Administrative safeguards are policies, procedures, and administrative
actions that prevent, detect, contain, and correct violations of security.
These include selection, development, implementation, and maintenance
of security measures and also management of the people involved. One
core requirement is to conduct a risk assessment to identify security risks
and to then implement safeguards to address the risks.27
Administrative controls include establishing and adhering to security
policies and procedures as well as dedicating resources to security. Formal
policies and procedures set internal rules about how an organization and
its employees will protect PHI. These should be based on federal
guidelines for HIPAA and the HITECH Act, as well as the NIST SP 800
series guidelines mentioned previously. Although the health community is
not mandated to adhere to the NIST 800 series guidelines, they can be used
for HIPAA compliance.34
Internal policies should include processes such as installing software
service packs, installing antivirus software, and testing. While most
organizations do install service packs, the issue may be timing and
completeness. Installation of required software patches is sometimes
delayed due to other priorities. Patches require continuous monitoring and
updating to protect patient data.44 Organizations should also have policies
and procedures in place for intrusion protection to avoid malware and
malicious a acks such as ransomware. Finally, policies need to be in place
to encrypt mobile devices used for PHI.34 Wireless handheld devices
should be encrypted, as they are vulnerable to loss.33 Given the increased
a ention to the vulnerabilities of medical devices, organizations should
assess the security capabilities of these devices before purchase. Probably
most important, health organizations need to educate their employees on
their existing policies and procedures and conduct security risk
assessments on an ongoing basis.
Conducting Risk Assessments or Risk Analysis
Risk assessment, also called risk analysis, is required by the HIPAA
Security Rule and by Meaningful Use.44 The purpose of these assessments
is to identify gaps or weaknesses that could lead to security breaches.
These also assist in prioritizing risk remediation efforts.34 More formally,
security risks are assessed by examining vulnerabilities and threats where
• Risk is the likelihood that something adverse will happen to cause
harm to an informational asset (or its loss).
• Vulnerability is a weakness in the information system, device, or
environment that could endanger or cause harm to an informational
asset.
• Threat is a human act or an act of nature that has the potential to
cause harm to an informational asset.61
Risk assessments should be conducted regularly, with at least one
complete assessment done annually. A comprehensive risk assessment can
cost between $10,000 and $100,000, depending on the complexity of the
environment.44 Risk assessments include an evaluation of how and where
PHI is stored within the organization, who is managing these data, how
these data are being used, and where data are transmi ed. A risk
assessment includes a review of the security measures and technical
architecture.34,44
A number of toolkits are available for conducting risk assessments in a
healthcare se ing. A suite of toolkits is available from the HIMSS Privacy
and Security Commi ee as well as the Agency for Healthcare Research
and Quality (AHRQ) website (URLs are available at the end of the
chapter). These toolkits include, for example, risk assessments for small
practices, mobile devices, and cybersecurity.
Technical
Technical safeguards involve protecting the confidentiality, integrity, and
availability of PHI. Common technical security controls for technology
include authentication, access management and control, encryption,
protection from malware and hacking a acks, disaster recovery planning,
and privacy-enhancing technologies.
Authentication is defined as the technology and techniques for verifying
the identity of human users of an information or computer system.61
Authenticating a person means verifying that the person is who he or she
claims to be. Reliable authentication is essential for access control and
auditing. Similar to the critical step of validating patient identity before
administering medications, users must be authenticated before accessing
PHI. Methods are evolving beyond traditional passwords that may be
easily compromised. Biometrics such as fingerprint, iris, palm vein, and
face recognition have been available for some time. Tokens such as access
cards with accompanying PIN codes are widely used, similar to ATM
cards. Such “two-factor authentication” requires users to both know
something (the PIN code) and have something (the card) in order to
authenticate. Two-factor authentication is much more secure than a
password alone. Modern wireless technology permits the token for
authentication to simply be nearby, or within proximity, rather than
requiring insertion into a reader.
Encryption is the mathematical conversion of data into a form, called
ciphertext, that cannot be easily understood by unauthorized people.61
This technical method protects PHI against unauthorized access. To be
able to access the data, an authorized person has to decrypt the data—that
is, change the ciphertext back into the original, understandable data. This
is accomplished through the use of a security key such as a password. This
functions much like a padlock protects physical access: only someone with
the key can unlock the padlock. Likewise, encryption keys must be
carefully controlled to ensure data security. Encryption is a primary
method of rendering PHI unusable, unreadable, or indecipherable to
unauthorized individuals, either when the data are stored (at rest) or
traversing a network (in transit).
Encryption is not required by HIPAA but often makes the difference in
determining whether an incident constitutes a breach or not. The Final
Breach Notification Rule indicates that if data are unusable, unreadable, or
indecipherable to unauthorized individuals, then notification is not
required following an impermissible use or disclosure. To qualify for this
“safe harbor,” the data must have been encrypted in compliance with
NIST guidelines.
Encryption is available for use on many technology platforms (e.g.,
EHRs, desktop computers, laptops). Facilities can also encrypt PHI on
mobile devices, e-mail, and files. This technology is not currently available
for all platforms; for example, not all cellphone devices contain encryption
capability. However, users can purchase encryption software separately
and download it for use on devices. In some cases, the software is free for
individual users but not for enterprise contracts. When cellphones are
used to store PHI, use of encryption capability is critical.
Physical
The third category of security safeguards is physical. This involves
physical methods to protect inappropriate access to PHI.61 Examples are
controlled access to buildings, workstation security, and securing portable
devices such as medical devices or laptops with a cable and locking them
to a desk.59 Defined by administrative controls, actual physical devices or
measures are put into place for improved security. Additional examples of
physical security safeguards are: requiring two forms of identification for
access, security guards and alarm systems, fire detection and suppression
systems, redundancy for power and network connections, securing output
from devices, and logging access to secured equipment.
Resources
A number of resources are available to guide organizations in the
administrative, technical, and physical aspects of information security.
Examples include the following:
• AHRQ security toolkits available at
h p://[Link]/portal/[Link]/community/health_it_tools_and
_resources/919/the_health_information_security_and_privacy_collabora
tion_toolkit/27877
• HIMSS Privacy and Security Commi ee website at
h p://[Link]/get-involved/commi ees/privacy-and-security.
• HIMSS Privacy and Security Toolkit—risk assessments, small provider
privacy and security guides, and mobile devices cloud computing
security—available at h p://[Link]/library/healthcare-privacy-
security/toolkit
• HIPAA Security Rule Guidance from HHS available at
h p://[Link]/hipaa/for-
professionals/security/guidance/[Link]
• HIPAA Security Rule to NIST Cybersecurity Framework Crosswalk
available at h p://[Link]/hipaa/for-professionals/security/nist-
security-hipaa-crosswalk
• NIST Computer Security Resource Center (CSRC) website at
h p://[Link]
• NIST Guidelines for Media Sanitization available at
h p://[Link]/nistpubs/SpecialPublications/[Link].800-
[Link]
• NIST security guidelines available at
h p://[Link]/publications/[Link], including the NIST
Cybersecurity Practice Guides from 2015
Conclusions and future directions
Confidentiality, integrity, and availability are critical to patient care and
for improving outcomes. Practitioners and patients need to be confident
that patient data are accurate and accessible when needed.
Given record privacy breaches in recent years, the need for information
security will continue to be an urgent topic in the future. Currently the
healthcare system is heavily dependent on legislation and regulations to
ensure health information privacy, confidentiality, and security. However,
this approach presents its own set of problems. Innovations in technology
constantly offer the opportunity to improve healthcare delivery. But until
these innovations are available and in use, it is impossible to develop
legislation or regulation ensuring their adherence to ethical principles.
Thus safeguards can lag behind innovations. In addition, “markets can
incentivize irresponsible behaviors. Companies need to build their
trustiness to gain our trust.”62, p. 24 Legislative a empts to prevent these
irresponsible behaviors can act to limit the development of new and
innovative approaches to improve healthcare delivery.
One approach to this challenge is for the industry to proactively
consider the ethical, social, and legal implications in the design of
innovative technologies. An example of this approach can be seen in the
“Guidelines for Personalized Health Technology Final Report” developed
under the direction of the Vitality Institute (h p://[Link]).
These guidelines seek to build collaboration across the public and private
sectors. They have the goal of creating a dialogue for personalized health
technologies and promoting shared values for all stakeholders. The
guidelines are built around five critical principles:
1. Build health technologies informed by science
2. Scale affordable health technologies
3. Guide interpretation of health data
4. Protect and secure health data
5. Govern the responsible use of health technology and data62
Another approach is the newer models for security being developed in
lieu of current role-based models. For example, one model being
developed places information control and release in the hands of
patients.63 These types of security frameworks allow patients to give
informed consent for access to any data. Every data element is tagged
with a unique identification code to prevent linking to unauthorized data.
The framework provides a link to access control with a device such as a
smart card and traceable information flow through the use of data on a
central server should the mobile device be lost. This is more flexible than
HIPAA security, where blanket consent is given.
In summary, privacy and security have been and will continue to be
concerns for patients and healthcare providers. Health informaticians need
a solid grounding in the concepts and solutions for these important
principles.
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Discussion questions
1. Hospitals usually have a policy and related procedure for responding
when patients request a copy of their records. Select a procedure from
your current place of employment or a local hospital. Compare and
contrast the selected procedure with the principles of fair information
practice (FIPs).
2. The European Union created privacy agreements across their 28
members. What are the challenges and resources for creating an
agreement to share health data across the borders of countries near you
(e.g., Canada and the United States or Mexico and the United States)?
3. The following websites include toolkits for completing a risk assessment:
a. [Link]/ASP/topics_pstoolkitsDirectory.asp?faid=569&tid=4
b. h ps://[Link]/health-it-tools-and-resources/health-
information-security-and-privacy-collaboration-toolkit
Review the risk assessment guides available at these sites and then answer
the following question: Since HIPAA requires that a covered entity
appoint a security officer, what is the role of the health professional or
informatics specialist in working with the security officer to complete a
risk assessment? In your discussion, consider who has access to the
information required to complete the assessment and how the
information should be collected.
4. Providing access to healthcare providers and securing a system from
inappropriate access can be a difficult balancing act. In many cases, the
more secure a system is, the more restricted access to that system
becomes. Discuss situations where this balancing act has created conflict
or might create conflict within the clinical area and how that conflict was
(or could be) managed.
5. Increasingly patients are creating and maintaining personal health
records (PHRs) with data from a variety of healthcare providers, as well
as data they have generated about their health. What provisions should
be included in a model privacy and security policy that patients might
use in making decisions related to their privacy and the security of their
PHRs?
Case study
Last month you were hired with the title Health Informatics Specialist at
an independent community care hospital with 350 beds. The hospital
includes a comprehensive outpatient clinic, a rehabilitation center with
both inpatient and outpatient services, a cardiac care center, and an
emergency room. In addition, four family health centers are located
throughout the community. More than 930 primary care and specialty
physicians are associated with the hospital, which has a staff of just over
2000 employees. The hospital has an EHR in place.
The hospital has a working relationship with a major academic medical
center located 23 miles away. Acute care patients who need more extensive
treatment are usually transferred to the medical center. These are often
emergency situations, and data are freely shared among the institutions
with the best interests of the patient in mind.
Located directly beside the hospital is a 194-bed skilled nursing home.
While the nursing home has its own medical staff consisting of a physician
and two nurse practitioners, patients needing consults or additional care
are usually seen at the hospital with follow-up at physicians’ offices. While
the nursing home, most of the physicians’ offices, and the hospital are
independent institutions, there is a long history of sharing health-related
data when treating patients who live at the nursing home and are seen at
the hospital or in the physicians’ offices. This coordination is seen as a
general benefit for a number of patients. It appears that most patients have
signed a form giving the hospital permission to send information to the
nursing home. However, these forms have been stored in individual
offices, so it is difficult to determine who has signed what forms and what
permission has or has not been given to share information among the
nursing home, hospital, and independent medical practices.
Discussion Questions
1. What additional information is needed to clarify what problems may
exist and what changes may be needed in terms of data that are
shared among the institutions?
2. Can the EHR system and/or e-mail be used to share data among these
different institutions more effectively and securely? If yes, how would
this be done? For example, what agreements, policies, and procedures
might need to be developed?
3. In your position as Health Informatics Specialist, how would you go
about determining whether there are other potential security issues
that now need to be managed by the hospital?
27
The Health Information Technology
for Education and Clinical Health
Act, Meaningful Use, and Medicare
Access and CHIP Reauthorization
Act of 2015
Michele P. Madison
Abstract
Healthcare reform and economic stimulus legislation are rapidly advancing
regulations that incentivize the adoption and Meaningful Use (MU) of electronic
health records (EHRs) with the goal of improving the health of Americans. However,
in order to obtain financial incentives, healthcare providers must perform specific
tasks that demonstrate the provider is meaningfully using a certified EHR. The MU
standards also merge into the changes driven by the healthcare reform legislation.
Throughout the stimulus funding and healthcare reformation laws, the federal
government’s policies for improving care coordination by reducing costs and
engaging patients and families remain constant elements, and the initiatives are the
basis for changing healthcare providers’ behavior. This chapter explores these key
legislative initiatives and describes their impact on the healthcare delivery processes.
As federal legislation continues to drive changes in how healthcare is
provided and how payment is received, using information technology will
facilitate enhanced and creative models for new healthcare delivery
designs.
Michele P. Madison
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Discuss key federal legislative initiatives related to the adoption of
health information technology.
2. Describe the Centers for Medicare and Medicaid Services (CMS)
financial incentive program to encourage the adoption of electronic
health records (EHRs).
3. Describe the objectives for each stage of the Meaningful Use (MU)
program.
4. Analyze the progression and impact of the MU program.
5. Describe the Medicare Access and CHIP Reauthorization Act of 2015
(MACRA) and its potential impact on value-based payment models.
KEY TERMS
Children’s Health Insurance Program (CHIP) 472
eligible professional (EP) 460
meaningful objectives 461
Meaningful Use (MU) 455
modified Stage 2 466
Introduction
A new era of government support for health information technology (IT)
began on April 27, 2004, when President George W. Bush addressed the
topic in his State of the Union address: “an electronic health record (EHR)
for every American by the year 2014…by computerizing health records,
we can avoid dangerous medical mistakes, reduce costs and improve
care.”1 Commencing with the American Recovery and Reinvestment Act
of 2009, commonly referred to as the “Stimulus Act,” the federal
government began using legislation supporting financial incentives to
change how healthcare services would be delivered. The Health
Information Technology for Education and Clinical Health (HITECH) Act
portion of the Stimulus Act dedicated billions of dollars to change how
healthcare providers documented the services rendered and
communicated with both patients and payers. The MU program has now
grown from capturing and entering specific forms of data into a certified
EHR to communicating and transferring that data with other providers
and patients with the longer-range goal of building a Nationwide Health
Information Network (NwHIN). Building on these achievements, the
federal government is moving forward with the development of programs
and regulations to implement the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) that will change how providers are
reimbursed by Medicare.
Federal initiatives to drive health
information technology
The challenge for the healthcare system in the United States is to improve
the quality of care for patients while reducing the costs of delivering such
care, with the ultimate goal of achieving improved health and healthcare
outcomes. Implementing health IT has been lauded as a critical element to
address this challenge. Promoting the adoption and implementation of
health IT is a bipartisan initiative that has been endorsed by both
Republican and Democratic presidents, beginning with President George
W. Bush’s State of the Union address in 2004. Bipartisan support continues
today with the approval of MACRA, which includes advanced
practitioners and requires physicians to expand their use of health IT to
maximize Medicare reimbursement.
Executive Order 13335
President Bush followed up on his 2004 State of the Union address by
signing Executive Order 13335. This Executive Order outlined the federal
initiative granting federal dollars to incentivize healthcare providers to
implement and use health IT. The Executive Order created the position of
Office of the National Coordinator for Health Information Technology
(ONC) with the goal of facilitating the widespread adoption and
implementation of EHRs across the United States. Ultimately the goals
were to develop a NwHIN and to ensure that all residents of the United
States had access to a clinical health record by 2014.
The federal initiative was built on six key components that have
continued to serve as the foundation of the revolutionary changes to the
healthcare delivery system. In 2004, the fundamental policies set forth by
President Bush were as follows:
1. Ensure that appropriate information to guide medical decisions is
available at the time and place of care.
2. Improve healthcare quality, reduce medical errors, and advance the
delivery of appropriate, evidence-based medical care.
3. Reduce healthcare costs resulting from inefficiency, medical errors,
inappropriate care, and incomplete information.
4. Promote a more effective marketplace, greater competition, and
increased choice through the wider availability of accurate
information on healthcare costs, quality, and outcomes.
5. Improve the coordination of care and information among hospitals,
laboratories, physician offices, and other ambulatory care providers
through an effective infrastructure for the secure and authorized
exchange of health information.
6. Ensure that patients’ individually identifiable health information is
secure and protected.2
While Executive Order 13335 created the ONC and charged this office
with implementing an interoperable health IT system in both the public
and the private healthcare sectors in order to reduce medical errors,
improve quality, and produce greater value for healthcare expenditures, it
was not until 2009, when the federal government passed the American
Recovery and Reinvestment Act of 2009 (Stimulus Act), that the initiative
was actually funded.3
The American Recovery and Reinvestment Act of
2009
The HITECH portion of the Stimulus Act was designed to (1) encourage
health providers to adopt EHRs, (2) achieve MU of these EHRs, and (3)
support the exchange of health information. These goals and the specific
approaches for achieving them are illustrated in Fig. 27.1 and are
explained later in this section.
FIG 27.1 The HITECH Act’s Framework for Meaningful Use of
Electronic Health Records. From Blumenthal, D. Launching HITECH. N Engl J
Med. 2010;362(5):382–385. Used with permission of the New England Journal of Medicine.
To achieve these goals, the HITECH Act dedicated billions of dollars to
change how healthcare providers documented the services rendered and
communicated with both patients and payers. For example, taking a
concept as simple as paying providers for implementing a certified EHR
and requiring specific actions (called Meaningful Use) when using the
certified HER began the process of changing healthcare providers’
behavior. In order to obtain financial incentives, healthcare providers were
required to perform specific tasks, thereby demonstrating that the
provider was using a certified EHR in a meaningful way. The MU
standards merge into the changes being driven by the healthcare reform
legislation. Throughout the funding and reformation laws, the federal
government’s policies of improving care coordination by reducing costs
and engaging patients and families remain constant elements. The sections
of this legislation are outlined in Box 27.1.
Box 27.1
Sections of the Health Information Technology
for Education and Clinical Health Act
Title XXX—Health Information Technology and Quality
Sec. 3000. Definitions.
Subtitle A—Promotion of Health Information
Technology
Sec. 3001. Office of the National Coordinator for Health Information
Technology.
Sec. 3002. HIT Policy Commi ee.
Sec. 3003. HIT Standards Commi ee.
Sec. 3004. Process for Adoption of Endorsed Recommendations; Adoption
of Initial Set of Standards, Implementation Specifications, and
Certification Criteria.
Sec. 3005. Application and Use of Adopted Standards and Implementation
Specifications by Federal Agencies.
Sec. 3006. Voluntary Application and Use of Adopted Standards and
Implementation Specifications by Private Entities.
Sec. 3007. Federal Health Information Technology.
Sec. 3008. Transitions.
Sec. 3009. Miscellaneous Provisions.
From the American Recovery and Reinvestment Act of 2009. 111th United States Congress. Page
123 STAT. 115 (February 17, 2009). HIT, health information technology; HITECH, health information
technology for economic and clinical health.
Sections 3001, 3002, and 3003 of the HITECH Act establish the
administrative structure for achieving the goals of the act by defining the
responsibilities of (1) the ONC, (2) the Health IT Policy Commi ee, and (3)
the Health IT Standards Commi ee.
Office of the National Coordinator for Health
Information Technology
The HITECH Act established the ONC as a funded position with powers
and authority granted by statutory support. Establishing the ONC through
federal statutes instead of an executive order emphasized the fact that this
position and its operations were approved and endorsed by both parties in
Congress and represented a critical component of the federally mandated
strategic plan. Section 3001 lists the duties of the ONC and groups these
duties into eight areas (Box 27.2). As shown in Box 27.2, Section 3001 of the
HITECH Act directed the ONC to create a strategic plan to address the
following federal initiatives:
Box 27.2
Duties of the National Coordinator
• Standards
• HIT policy coordination
• Strategic plan
• Website
• Certification
• Reports and publications
• Assistance
• Governance for NwHIN
Data from the Health Information Technology for Economic and Clinical Health Act. 42 U.S.C. §
300jj-11. 2009. HIT, health information technology; NwHIN, nationwide health information network.
1. The electronic exchange and use of health information and the
integration of such information
2. The use of an EHR for each person in the United States by 2014
3. The incorporation of privacy and security protections for the
electronic exchange of individually identifiable health information
4. Security methods (a) to ensure appropriate authorization and
electronic authentication of health information and (b) for
specifying technologies or methodologies rendering health
information unusable, unreadable, or indecipherable
5. A framework for coordination and flow of recommendations and
policies under the HITECH Act among the secretary, the ONC, the
Health IT Policy Commi ee, and the Health IT Standards
Commi ee, and other health information exchanges (HIEs) among
other relevant entities
6. Methods to foster the public understanding of health IT
7. Strategies to enhance the use of health IT in improving the quality
of care, reducing medical errors, reducing health disparities,
improving public health, increasing prevention and coordination
with community resources, and improving the continuity of care
among healthcare se ings
8. Specific plans to ensure that populations with unique needs, such as
children, are appropriately addressed in the technology design,
which may include technology that automates enrollment and
retention for eligible individuals3
To establish national uniform standards for the electronic exchange of
health information and to facilitate the strategic plan, the HITECH Act
included in the duties of the ONC responsibility for creating two
commi ees that report to the ONC. These are the Health IT Policy
Commi ee and the Health IT Standards Commi ee.
Health Information Technology Policy Committee
The Health IT Policy Commi ee was charged with making policy
recommendations to the ONC relating to the implementation of a
nationwide health IT infrastructure, including implementation of the eight
components of the strategic plan listed previously. This commi ee is
composed of individual stakeholders representing the full spectrum of the
healthcare delivery system. These stakeholders include individual
healthcare providers, patients, healthcare payer plans, legislative
representatives, technology vendors, privacy and security experts, and
other interested parties. Each stakeholder brings unique expertise and
ultimately creates the policies defining MU of certified EHR systems.
Additional opportunities to participate in the work of the Health IT Policy
Commi ee are offered via workgroups. As of 2016, the workgroups
include
• Advanced Health Models and MU
• Consumer
• Interoperability and HIE
• Privacy and Security
Health IT Standards Committee
The Health IT Standards Commi ee was charged with recommending
standards, implementation specifications, and certification criteria for
EHRs, electronic exchange, and use of health information. Specific
standards for the electronic exchange of health information enable each
healthcare provider, regardless of location, to transmit healthcare
information and allow the receiving party to receive the data directly in its
EHR system. However, to ensure that healthcare providers implement
EHRs that are based on the uniform national standards to permit
meaningful exchange of data, each provider must use an EHR that has
been certified by an ONC certification process. Additional information
about this certification process is included in Chapter 19.
The Health IT Standards Commi ee is also a multi-stakeholder
commi ee that includes healthcare providers, insurance companies, health
IT companies that translate billing claims in nonstandard forms to a
format that complies with specific electronic transaction standards
(clearinghouses), academic institutions, and individuals who have specific
health IT expertise and knowledge. In coordination with the Health IT
Policy Commi ee, the Health IT Standards Commi ee established the
standards and uniform requirements for technology to exchange data and
to be deemed “certified” by the federal government. The Health IT
Standards Commi ee task forces are
• Precision Medicine Task Force
• 2017 Interoperability Standards Advisory (ISA) Task Force
As part of their responsibility related to the standards, the Health IT
Standards Commi ee, along with the ONC, is also responsible for
recommending standards, including the necessary infrastructure to the
state-funded HIEs and the privately run exchanges. Rather than using rule
making through a top-down process for ve ing and selecting the data
transport, content exchange, and vocabulary standards, they chose a
consensus-based bo om-up approach through the Standards and
Interoperability (S&I) Framework Initiatives, working in collaboration
with standards development organizations.
Office of the National Coordinator for Health
Information Technology Standards and
Interoperability Framework
Interoperability is the ability of health information systems to work
together within and across organizational boundaries to improve the
health and healthcare for individuals and communities by sharing data
between all types of health IT. To achieve interoperability, standards for
data transport, content exchange, and vocabulary management are
needed. This is why standards development is so important; it enables the
interoperability needed for regional and nationwide health data exchange
and is essential to the development of patient-centric records. Additional
information about specific standards is included in Chapter 22.
Launched in January 2011, the ONC-sponsored Standards and
Interoperability (“S&I”) Framework is a set of harmonized interoperability
specifications to support national health outcomes and healthcare
priorities, including MU and the ongoing mission to drive be er care,
be er population health, increased patient engagement, and cost reduction
through delivery improvements. The S&I Framework creates a forum for
healthcare stakeholders to focus on solving real-world interoperability
challenges. Each S&I Initiative focuses on a single interoperability
challenge with a set of value-creating goals and outcomes that will
enhance efficiency, quality, and effectiveness of the delivery of healthcare
through the development or modification of standards for data transport,
content exchange, and vocabulary management.
The S&I Framework started with three initiatives but now has 11 active
and completed initiatives. Active initiatives include work on data access,
data provenance, electronic submission of medical documentation, clinical
quality, electronic long-term services and supports, and lab order
interfaces. Each S&I Initiative has a rigorous process that includes the
following:
• Development of clinically oriented user stories and robust use cases
• Harmonization of interoperability specifications and implementation
guidance, including synchronization among the initiatives
• Provision of real-world experience and implementer support through
new initiatives, workgroups, and pilot projects
• Mechanisms for feedback and testing of implementations, often in
conjunction with ONC partners such as the National Institute of
Standards and Technology (NIST)4
The work is done online through a moderated wiki with more than 2300
volunteer participants.5 The focus of the S&I Framework is on delivering
guidance to the health IT community through the development of
standards content and technical specifications, the development of
reusable tools and services, and the effort to unite stakeholders on
common healthcare challenges. This work is necessary to move forward on
data exchange between venues of care and to take healthcare delivery to
the next level in creating a patient-centric rather than facility-centric
healthcare record.
With the recognition that local and regional electronic exchange of
health information is essential to the successful implementation of a
nationwide exchange and to the success of national healthcare reform in
general, the HITECH Act authorized and funded a State HIE Cooperative
Agreement Program. This state-based grant program offered local and
regional assistance and technical support to healthcare providers while
enabling coordination and alignment within and among states. The State
HIE program funding began winding down in 2014, with the HIEs
creating sustainability models with mixed success. Concurrently, private
exchanges with varying business models and value propositions are being
established. Ultimately this will allow information to follow patients
anywhere they go within the U.S. healthcare system.
In addition to the activities described here, both the Health IT Policy
Commi ee and the Health IT Standards Commi ee engaged in research
and workgroups that facilitated the development of specific policies and
standards required for the foundational components of the NwHIN. To
ensure coordination between the two commi ees, the Health IT Policy and
Standards Commi ees meet jointly and collaborate in making
recommendations to the National Coordinator for Health IT.
As pointed out previously in this chapter, the HITECH Act was
designed to improve healthcare by encouraging healthcare providers to
adopt and use EHRs in a meaningful manner. While sections 3001, 3002,
and 3003 established the ONC and related commi ees, additional sections
of the HITECH Act define how both technical assistance provided by
Regional Extension Centers (RECs) and financial incentives are designed
to support the achievement of this goal.
Regional Extension Centers
In addition to financial incentives, HITECH supported the use of EHRs by
establishing RECs and a national Health Information Technology Research
Center (HITRC). This program funded 60 local organizations to create 62
RECs located in virtually every geographic region of the United States.
RECs provided technical assistance to providers concerning EHR
implementation and project management, training, vendor selection and
financial consultation, workflow redesign, and privacy and security.6 The
HITRC promoted communication and learning among the RECs and
collaborated with them by offering technical assistance, guidance, and
information on best practices to support and accelerate healthcare
providers’ efforts to become meaningful users of EHRs.
The REC program funding began winding down in 2014. Currently,
many of the RECs are working to become sustainable through fee-for-
service models. As of August 2015, over 157,000 providers are enrolled
with a REC; of these, more than 146,000 are live on an EHR, with more
than 116,000 having demonstrated MU.7
In 2016, a report documenting the positive impact of RECs was
published with the following key findings:
• REC participation was positively associated with EHR adoption
among primary care physicians working in small practices or
practices with a large underserved patient base.
• REC participation was positively associated with achieving MU at the
level required to receive financial incentives.
• RECs provided needed technical assistance for physicians who were
unable or ineligible to receive assistance from payers or health
systems in their local area.
• The REC program likely helped many physicians who were more
skeptical about EHRs and added these physicians to the pool of
physicians with EHRs.6
Financial Incentives
The purpose of the health IT incentives outlined in the HITECH Act is to
promote reform in the delivery, cost, and quality of healthcare in the
United States. Dr. David Blumenthal, former national coordinator for
health IT, emphasized this point when he said that health IT is the means
but not the end. Ge ing health IT up and running in doctors’ offices is not
the main objective behind the incentives provided by the federal
government under the American Recovery and Reinvestment Act—
improving health is.8
The ultimate goal of the NwHIN is to support significant and
measurable improvements in population health by an improved
healthcare system. The vision includes engaging patients in their
healthcare and ensuring that providers have immediate access to health
information and tools to improve the quality and safety of care delivery.
NwHIN also includes provisions for improved access and decreased
healthcare disparities. To achieve this vision, healthcare providers must
adopt and implement certified EHRs. Due to the cost of an EHR, many
healthcare providers were reluctant to purchase a system. The HITECH
Act amended the Social Security Act (42 U.S.C. 1395w-4) to provide
financial incentives directly to healthcare providers that adopt, implement,
and engage in MU of certified EHR technology. In the first year of the MU
program, if an eligible professional (EP) or entity achieved and
demonstrated to the satisfaction of the Secretary of the Department of
Health and Human Services (HHS) that they had adopted, implemented,
upgraded, and used a certified EHR technology in a meaningful manner,
the EP or entity was entitled to receive financial incentives.
Eligible Entities and Eligible Professionals
Some healthcare providers are eligible to participate in both the Medicare
and the Medicaid programs, while others are limited to only one potential
program. Eligible entities for the Medicare program include the following:
1. All licensed hospitals that are reimbursed based on the prospective
payment system
2. Critical access hospitals (CAHs)
An EP in the Medicare program is a doctor of medicine or osteopathy
legally authorized to practice medicine and surgery, a doctor of dental
surgery, a doctor of podiatric medicine, a doctor of optometry, or a
chiropractor (see HITECH Act, Section 4101). All physicians participating
in the Medicare program are eligible to participate in the financial
incentive program regardless of the total percentage of Medicare patients
treated by each physician.
To be eligible to participate in the Medicaid program, an individual
physician must have a 30% Medicaid patient population. Pediatricians
with a 20% Medicaid patient population are also eligible; however, these
pediatricians will be eligible only for two-thirds of the financial incentives
(see HITECH Act, Section 4201). The Medicaid program’s eligible provider
category also extends to certified nurse midwives and nurse practitioners.
Physician assistants practicing in rural health clinics and federally
qualified health centers are also eligible to participate.
Children’s hospitals are eligible to participate in the Medicaid program
and do not require a specific volume of Medicaid patients; other hospitals
must have at least a 10% Medicaid patient volume to be eligible to
participate in the Medicaid incentive program. Hospitals that satisfy the
eligibility requirements may participate in both the Medicare and the
Medicaid programs. However, individual physicians may participate in
only one financial incentive program. Physicians are allowed to change
from one program to the other, but this change is permi ed only one time
during the program.
Medicare and Medicaid Payments
Medicare payments are based on 75% of an individual physician’s
allowable Medicare charges for the payment year to a maximum cap per
year. To encourage healthcare providers to adopt and implement EHRs
early, physicians are eligible for Medicare incentives up to $18,000 in the
first two payment years, and then the amounts decline each year
thereafter, with a total capped amount of $44,000 during the entire
program. If a physician is providing services in a Health Professional
Shortage Area (HPSA), the physician is eligible for a 10% increase in
payments.
Medicaid payments for EPs are based on 85% of the costs a ributed to
the purchase of a certified EHR. In the first year, the total payment to a
physician by the state Medicaid program is capped at $25,000 and then is
$10,000 for each subsequent year, with a total capped amount of $63,750.
For hospitals that participate in the Medicare program, the payment
amount is based on a calculation that will result in a different amount for
each hospital. Each hospital must calculate its payment based on the
mathematical formula created by the Centers for Medicare and Medicaid
Services (CMS), as described in Table 27.1. For the Medicaid program, the
calculation for hospitals is based on a different formula than the one
described in Table 27.1 and depends on how many Medicaid patients
receive care at the hospital.
Table 27.1
Hospital Medicare Payment Calculation
Source: Centers for Medicare and Medicaid Services (CMS). EHR incentive program for
Medicare hospitals. CMS. <[Link]
Guidance/Legislation/EHRIncentivePrograms/Downloads/MLN_TipSheet_MedicareHospit
[Link]/>. Accessed December 15, 2015.
The financial incentives provided through the Stimulus Act are carrots
to encourage healthcare providers to adopt and implement EHRs in an
expedited manner. As of October 2015, the CMS had paid over
$21,041,137,966 to EPs and hospitals for achieving the MU measures
through the Medicare program and over $10,184,919,115 for the Medicaid
program. By 2016, these amounts increased to $23.5 billion for the
Medicare program and $10.9 billion for the Medicaid program.9
The downside following the financial incentives period is that if
healthcare providers have failed to adopt and implement certified EHR
systems by 2015, their Medicare reimbursement decreases. Specifically, if a
physician or chiropractor has failed to adopt and implement a certified
EHR by 2015, his or her Medicare reimbursement is decreased by 1% for
each year thereafter, to a maximum of 5% decrease (42 USC 1395w-4). If an
EP failed to achieve Stage 1 MU measures by 2015, that EP could apply for
a hardship exception to avoid the payment decrease. However, the EP
must file for a hardship exception annually.
The applicable reasons to receive a hardship exception are limited to the
following scenarios:
1. The EP does not have adequate infrastructure, including sufficient
internet access to report on the MU measures.
2. The EP is a new practitioner who does not have adequate time to
become a meaningful user.
3. The EP suffered unforeseen circumstances such as a hurricane or
other natural disaster.
4. The EP switched vendors during the reporting period.
5. The EP is adversely impacted because the rule was published late in
2015 and the EP did not have adequate time to achieve the
measures.
Other providers may also be exempt because their specialty does not
provide sufficient follow-up face to face with patients or if the provider
practices in multiple locations and the provider does not control the
certified EHR at the practice location. For example, anesthesiologists,
pathologists, and radiologists do not have to apply for a hardship
exception, and they will likely receive a waiver of the penalty.
Meaningful Use
Notwithstanding the monetary incentive plans to ensure that healthcare
providers would electronically enter and exchange patient information to
improve patient outcomes, the federal government determined that
healthcare providers’ behavior must change. Therefore to obtain Medicare
payments, the EP or entity must use certified EHRs “meaningfully.”
Section 4101 of the HITECH Act defines MU as ePrescribing (eRx),
engaging in HIE, and submi ing information on clinical quality measures
and other measures specified by the Secretary of HHS. Therefore by
requiring healthcare providers to adopt certified EHRs and perform and
report on specific measures, the end goal is to change provider behavior
and increase the electronic exchange of patient information.
As described previously, the Health IT Policy Commi ee and the Health
IT Standards Commi ee focused on establishing the underlying policies
and standards to establish the NwHIN. The ultimate goal identified by the
Health IT Policy Commi ee was to enable significant and measurable
improvements in population health through a transformed healthcare
delivery system. The goal of the financial incentive program is to
encourage eligible healthcare providers to change their behavior to achieve
the strategic goals of electronically exchanging health information to
improve patient care while supporting the NwHIN. However, adoption of
certified EHRs without using the EHRs in a meaningful manner was
insufficient to facilitate the NwHIN. Therefore the financial incentives
were only remi ed to healthcare providers that became meaningful EHR
users. The criteria for meeting MU are divided into the following five
initiatives, adapted from the work of the National Priorities Partnership
(NPP)10:
1. Improve quality, safety, and efficiencies, and reduce health
disparities.
2. Engage patients and families.
3. Improve care coordination.
4. Improve population and public health.
5. Ensure adequate privacy and security protections for personal
health information.10,11
In general, each policy conforms to the initiatives from both the 2004
and the 2009 legislation designed to reduce medical errors, improve
communication, and facilitate secure electronic transmission of patient
information. The Health IT Policy Commi ee and the Health IT Standards
Commi ee developed specific measures for each healthcare provider to
perform and report on to successfully be deemed a meaningful EHR user.
Each measure is directly related to driving the use of IT in the clinical care
se ing. Because individual healthcare providers have different types of
practices, the Health IT Policy Commi ee and the Health IT Standards
Commi ee divided the MU metrics into “core” required elements and
“menu” elements. Permi ing healthcare providers an opportunity to
report on required core elements and then choose to report on a select few
“menu” elements addressed the unique aspects of each provider’s practice
or facility and added flexibility to the financial incentives program. Table
27.2 provides a detailed description of the Stage 1 core and menu
elements. As the stages of MU progressed, the menu elements were
removed and standard meaningful objectives controlled the MU
requirements. The Health IT Policy Commi ee is instrumental in
developing and commenting on the MU requirements. Specifically, the
Health IT Policy Commi ee in May 2012 provided comments on the Stage
2 MU requirements and in March 2014 recommended Stage 3 MU
measures.12 The Health IT Policy Commi ee has consistently modified the
MU measures to conform to the underlying policy initiatives of the
commi ee established in 2009.
Table 27.2
Meaningful Use
Source: Centers for Medicare & Medicaid Services. Department of Health and Human
Services: Medicare and Medicaid programs; Electronic Health Record Incentive Program;
Final rule. Federal Register. 2010;75(144).
BMI, Body mass index; CAH, critical access hospital; CMS, Centers for Medicare and
Medicaid Services; CPOE, computerized provider order entry; EHR, electronic health
record; EP, eligible professional; eRx, ePrescribing; POS, place of service.
aUnless an EP, eligible hospital, or CAH has an exception for all of these objectives and
measures, they must complete at least one part of their demonstration of the menu set in
order to be a meaningful EHR user.
Although each year the Medicare program requires a esting to the MU
metrics, the Medicaid program is much more flexible. In the first year,
healthcare providers under the Medicaid program do not have to satisfy
the MU metrics. Instead, if a provider adopts, implements, or upgrades an
EHR system during the first payment year, the individual physician will
be eligible to receive payments to a maximum of approximately $21,000 to
$25,000 during that first year. Because Medicaid is a state program, each
state may require different forms of verification that the healthcare
provider adopted, implemented, or upgraded an EHR system. For each
subsequent year, providers must a est to achieving the MU metrics to
obtain Medicaid incentives. The Medicaid program also extends payments
for 5 years as long as the healthcare provider begins by 2016. Thus
Medicaid funding may continue until 2021.
Further, to effectively change healthcare provider behavior, the
reporting obligations have been divided into three stages. The first stage,
which commenced in 2011 with an end date of 2014, required reporting on
specific measurements to achieve MU. The intention of Stage 1 was to
enable the collection of meaningful data in a coded format to permit
tracking of key clinical conditions and communication of that information
for care coordination purposes. Stage 1 metrics also required the
implementation of clinical decision support tools to facilitate disease and
medication management, reporting clinical quality measures and public
health information. Stage 1 established a foundation of adopting
technology with uniform functions that enable healthcare providers to
change their behavior. Stage 2 measures were delayed until 2014 and were
designed to encourage continuous quality improvement and the exchange
of information. Stage 2 focused on the structured formats created to
electronically transmit patient data between healthcare providers.13 Stage 2
took the Stage 1 objectives that were optional and incorporated these
measures into the required core elements. The final rules for Stage 2 were
announced in August 2012 and make it clear that no healthcare providers
will be required to follow the Stage 2 requirements before 2014.
In late 2015, CMS published a new “modified Stage 2” that was applied
in 2015 for any EP or hospital seeking to start the MU program in 2015.
The modified Stage 2 removed measures from Stage 1 that were
considered “redundant, duplicative or topped out.” Table 27.3 provides a
listing of the measures that were removed for the modified Stage 2. Table
27.4 provides an overview of the modified Stage 2 objectives and measures
for EPs, and Table 27.5 provides an overview of the modified Stage 2
hospital objectives and measures. In order to achieve the MU criteria, the
EP must report on nine core objectives and one public health objective.
Hospitals, including CAHs, must report on eight core objectives and one
public health objective. In 2015 only, the reporting requirements for all
providers was any continuous 90-day period. For EPs the reporting period
was January 1, 2015, through December 31, 2015, and for eligible hospitals,
the reporting period was October 1, 2014, to December 31, 2015. After
2015, the eligible providers are required to report for the full calendar year.
All of the objectives are designed to build upon the initial data captured in
a certified EHR to advance the clinical processes by using the data to make
informed decisions when establishing treatment plans.
Table 27.3
Objectives Are Redundant, Duplicative, or Topped Out
Provider Type Objectives and Measures
EP Record demographics
Record vital signs
Record smoking status
Clinical summaries
Structured lab results
Patient list
Patient reminders
Summary of care: Measure 1—any method;
Measure 3—Test
Electronic notes
Imaging results
Family health history
Eligible hospital/CAH Record demographics
Record vital signs
Record smoking status
Structured lab results
Patient list
Summary of care: Measure 1—any method; Measure 3—test
Electronic medication administration record
Advanced directives
Electronic notes
Imaging results
Family health history
Structure labs to ambulatory providers
Source: Federal Registry. Medicare and Medicaid Programs; Electronic Health Record
Incentive Program-modifications to Meaningful Use in 2015 through 2017. Table 3—
Objectives and Measures Identified by Provider Type Which Are Redundant, Duplicative
or Topped Out. Located <[Link]
08514/medicare-and-medicaid-programs-electronic-health-record-incentive-program-
modifications-to#table_of_tables>. Accessed December 21, 2015.
CAH, critical access hospital; EP, eligible professional.
Table 27.4
Eligible Professional Objectives and Measures for 2015 Through 2017
Source: Federal Registry. Meaningful Use Final Report, Electronic Health Record
Incentive Program: Stage 3. Table 7—Eligible Professional (EP) Objectives and Measures
for 2015 through 2017. <[Link]
25595/medicare-and-medicaid-programs-electronic-health-record-incentive-program-
stage-3-and-modifications>. Accessed December 21, 2015.
CPOE, computerized provider order entry; EHR, electronic health record; HIE, health
information exchange.
Table 27.5
Eligible Hospital and Critical Access Hospitals Objectives and
Measures for 2015 Through 2017
Source: CMS. EHR Incentive Programs for Eligible Hospitals and CAHs: What You Need
to Know for 2015 Tipsheet <[Link]
Guidance/Legislation/EHRIncentivePrograms/Downloads/Stage3_EH.pdf>. Accessed
December 21, 2015.
CAH, critical access hospitals; eRx, ePrescribing; EHR, electronic health record; HIE,
health information exchange; POS, place of service.
In light of the changes in late 2015, CMS provided more flexibility to EPs
and hospitals a empting to achieve MU measures. CMS focused on the
fact that healthcare information technology is the tool to achieve improved
patient outcomes and population health. CMS also pushed the Stage 3
measures to be voluntary in 2017 and mandatory in 2018. Stage 3 measures
will focus on the interoperability of sharing patient information among
providers and patients. Therefore the delay in implementing Stage 3 will
provide technology developers and providers more time to implement the
technology necessary to facilitate the electronic exchange of information to
improve patient information.
Stage 3 will require higher standards for healthcare providers to be
deemed meaningful users of certified EHRs. The optional standards under
Stage 2 will be mandatory measures in Stage 3. If a provider elects to
achieve Stage 3 in 2017, the reporting period will be 90 days during the
year, but 2018 will require reporting for the entire year. In addition, Stage
3 promotes improvements in quality, safety, and efficiency. Stage 3 goes
beyond merely exchanging data electronically and focuses on improving
the general population health. Instead of healthcare providers changing
their behavior in the practice se ing, Stage 3 intends to use technology to
engage in decision support analysis for studying chronic disease and best
practices. The eight objectives of the Stage 3 MU measures focus on the
following:
1. Protecting patient health information
2. Electronic prescribing
3. Clinical decision support
4. Computerized provider order entry (CPOE)
5. Patient electronic access to health information
6. Coordination of care through patient engagement
7. HIE
8. Public health and clinical data registry reporting
Stage 3 is the final phase for the MU incentive program and is intended
to transition providers to the new payment methodology. The payment
adjustments to providers that fail to achieve MU will be superseded by
MACRA. The incentives for the providers will transform to merit-based
reimbursement under MACRA. In order to successfully achieve
reimbursement for services on a merit-based payment schedule, providers
will need to improve patient outcomes and reduce health disparities
through the use of health IT.
Medicare Access and Children’s Health Insurance
Program Reauthorization Act of 2015
MACRA was passed with strong bipartisan support in both the U.S.
House of Representatives and the Senate and was signed into law on April
16, 2015, by President Obama.14. The legislation established significant
changes in how Medicare pays physicians and demonstrates meaningful
support for and progress toward paying physicians for value or the quality
of the care provided and not the volume of care provided.15,16. MACRA
replaces the sustainable growth rate (SGR) formula based on fee for
service, sunsets the Physician Quality Reporting System (PQRS) and the
value modifier, and transitions from MU with two value-based payment
options. These are the Merit-Based Incentive Payment System (MIPS) and
the Alternative Payment Models (APM).
With the MIPS approach, MACRA calculates a composite performance
score for providers, using four categories of measurements that are
weighted to determine an overall MIPS score. The four categories include:
• Quality (50% of total adjustment in 2019, shrinking to 30% of total
adjustment in 2021)
• Resource use (10% of total adjustment in 2019, growing to 30% of total
adjustment by 2021)
• Clinical Practice Improvement Activities (15% of total adjustment)
• Advancing Care Information (formerly MU) (25% of total adjustment)
The score is then used to positively or negatively impact the physician
payment. By 2022, the impact will range from − 9% up to + 27%.17
Providers that are subject to the MIPS payment may receive an increase
in the fee-for-service Medicare reimbursement if the provider participates
in an APM that does not have a financial risk share element. For example,
by participating in an Accountable Care Organization in the one-sided
track that does not have any financial risk, the provider’s reimbursement
will be scored under the MIPS program, and the provider may be eligible
for a slight increase in the fee-for-service model.
Advanced APMs are those in which clinicians accept the risk for
providing coordinated, high-quality care. The proposed rule includes
examples of models that could qualify as Advanced APMs: (1)
Comprehensive End Stage Renal Disease Care Model (Large Dialysis
Organization arrangement), (2) Comprehensive Primary Care Plus, (3)
Medicare Shared Savings Program—Track 2 or Track 3, (4) Next
Generation ACO Model, and (5) Oncology Care Model Two-Sided Risk
Arrangement (available in 2018). Providers who have a sufficient patient
volume participating in the Advanced APM will be considered a
“Qualifying Provider.” However, in order to be a Qualifying Provider, the
provider must utilize a certified EHR. Qualifying Providers are exempt
from the MIPS adjustment and will receive a 5% quality bonus through the
Advanced APM model.17a
The Advanced APM tract provides an alternative to MIPS by offering
incentives and a pathway for physicians to develop and participate in new
models of healthcare delivery and payment. MACRA calls for the creation
of an advisory panel to consider physicians’ proposals for new models.
However, the proposed list of Advanced APMs was initially very limited.
By November 1, 2016, the secretary must establish criteria focused for the
advisory panel to use in making recommendations on APMs.18 These
criteria will be used in determining if (1) the proposed model is a qualified
APM, and (2) quality measures are clearly described and the physician
assumes a reasonable financial risk. However, while there are major
incentives for providers to engage in APMs, currently there are no clear
definitions in the statute other than a few criteria listed.15 The need for
healthcare providers, health informatics specialists, and healthcare
consumers to become actively involved in developing the specific
regulations and criteria is obvious.
While HITECH offered incentives to both physicians and hospitals,
MACRA is for the most part focused on physician payments. However,
there are implications for hospitals and other health systems. Hospitals
that employ physicians directly could bear some implementation costs
related to physician performance reporting requirements, as well as be at
risk for any payment adjustments. Moreover, physicians may call upon
hospitals to participate in APMs so that the physicians with whom they
partner can qualify for the APM track.18 However, until the regulations
have been implemented, these implications will be somewhat unclear.
In addition to changes in how Medicare will pay physicians, MACRA
also extended funding for the Children’s Health Insurance Program
(CHIP) and community health centers for two years. CHIP provides low-
cost health coverage to children in families that earn too much money to
qualify for Medicaid. Each state offers CHIP coverage and works closely
with its state Medicaid program, resulting in coverage variations between
states.
Conclusion and future directions
The three foundational stages of the MU program are designed to modify
provider behavior and transform how healthcare information is shared to
improve patient outcomes, supporting reimbursement in the future. The
incentivized adoption of EHRs continues to be at the core of reform
initiatives to improve care quality and be er manage care costs, meeting
clinical and business needs by capturing, storing, and displaying clinical
information when and where it is needed to improve individual patient
care and provide aggregated, cross-population data analysis. EHRs
manage healthcare data and information in ways that are patient centered
and information rich. Improved information access and availability enable
both the healthcare provider and the patient to be er manage the patient’s
health by using capabilities provided by enhanced clinical decision
support and customized education materials. The Stimulus Act took the
federal policy EHRs leading to NwHIN to a new and elevated level that,
among other initiatives, dedicated $27 billion to incentivize healthcare
providers to adopt and use EHRs by providing the needed funding
At the time of this writing, MACRA is fairly new legislation. Many of
the related regulations and criteria that will be used in implementing this
legislation are currently in development. However, it is clear at this point
that the incentives leading to the adoption and MU of EHRs are just the
beginning of a process whereby the federal government is encouraging the
use of health IT to improve access, decrease cost, and improve quality of
healthcare and in turn the health of all Americans.
References
1 Bush G.W. The 2004 State of the Union Address. 2004.
h p://[Link]/wp-
srv/politics/transcripts/bushtext_012004.html.
2 Executive Order 13335. Incentives for the Use of Health Information
Technology & Establishing the Position of the NHI IT Coordinator.
April 27, 2004.
3 111th Congress. The American Recovery and Reinvestment Act of 2009.
2009.
4 Standards & Interoperability Framework. What is the S&I Framework?
h p://[Link]/[Link]. Accessed January 3,
2016.
5 Standards & Interoperability Framework. Wiki.
h p://[Link]/. 2015.
6 Farrar B., Wang G., Bos H., et al. Evaluation of the Regional Extension
Center Program: Final Report. [Prepared By The American Institutes
For Research Under Contract No. Hhsps23320095626wc].
Washington, D.C: Office of the National Coordinator for Health
Information Technology; 2016.
h ps://[Link]/sites/default/files/Evaluation_of_the_Reg
ional_Extension_Center_Program_Final_Report_4_4_16.pdf.
7 [Link]. Regional Extension Centers (RECs); 2015.
h ps://[Link]/providers-professionals/regional-
extension-centers-recs.
8 Blumenthal D. National HIPAA Summit in Washington, DC.
h p://[Link]/news/healthcare-it-means-not-
end-says-blumenthal. 2009.
9 [Link] Centers for Medicare & Medicaid Services. Data and
Program Reports. h ps://[Link]/Regulations-and-
Guidance/Legislation/EHRIncentivePrograms/[Link]
ml. 2016.
10 National Priorities Partnership. National Priorities and Goals: Aligning
Our Efforts to Transform America’s Healthcare. Washington, DC:
National Quality Forum; 2008.
11 Office of the National Coordinator for Health Information
Technology. HIT Policy Commi ee Meaningful Use Matrix (August
10, 2009).
h ps://[Link]/sites/faca/files/final_mu_recommendatio
ns_table_7_2009.pdf. 2009.
12 Office of the National Coordinator for Health Information
Technology. HIT Policy Commi ee Meaningful Use Stage 3 final
recommendations.
h ps://[Link]/sites/faca/files/HITPC_MUWG_Stage3_R
ecs_2014-[Link]. Accessed December 15, 2015.
13 U.S. Department of Health & Human Services. Medicare and
Medicaid programs; Electronic Health Record Incentive Program
—Stage 2; Final rule. Fed Regist. 2012;77(171).
14 Conway P.H., Gronniger T., Pham, et al. MACRA: New Opportunities
for Medicare Providers through Innovative Payment Systems (Updated).
HealthAffairs Blog; 2015.
h p://healthaff[Link]/blog/2015/09/28/macra-new-opportunities-
for-medicare-providers-through-innovative-payment-systems-3/.
15 Glover S. Overview of the Medicare Access and CHIP Reauthorization
Act (MACRA). The National Partnership for Women & Families;
2015. h p://[Link]/research-library/health-
care/CBC/[Link].
16 [Link]. The Merit-Based Incentive Payment System (MIPS) &
Alternative Payment Models (APMs).
h ps://[Link]/Medicare/Quality-Initiatives-Patient-
Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-
and-APMs/[Link]. Accessed April 16,
2016.
17 Cragun E. The Most Important Details in the SGR Repeal Law. The
Advisory Board Company; 2015.
h ps://[Link]/research/health-care-advisory-
board/blogs/at-the-helm/2015/04/sgr-repeal.
17a Medicare Access and CHIP Reauthorization Act of 2015.[ Public Law
No: 114-10]. h ps://[Link]/114/plaws/publ10/PLAW-
[Link]. Accessed August 3, 2016.
18 American Hospital Association. Physician Payment Reform: What is
MACRA. h p://[Link]/advocacy-
issues/physician/[Link]. Accessed April 16, 2016.
Discussion questions
1. Describe how the NwHIN is facilitated by the MU program.
2. List and describe the federal agencies and commi ees that are
responsible for facilitating electronic exchange of health information in
the United States.
3. What are the current time periods for the MU program under Medicare
and Medicaid, respectively?
4. How do providers avoid payment penalties for failing to satisfy MU
requirements?
Case study
A health system owns and operates a hospital and employs primary care
physicians, general surgeons, and oncologists. The hospital purchased a
surgical practice in 2012. Part of the purchase of the practice included the
purchase of the electronic medical record system that was a certified EHR.
In January 2014, the hospital transitioned the primary care physicians,
surgeons, and the radiologists in the hospital to a new certified electronic
health record, the implementation of which was completed 10 months
later in October 2014. The physicians did not satisfy the MU criteria from
January 1, 2014, to December 31, 2104, because of the transition to a new
certified EHR system. In addition, in 2015 the hospital’s electronic medical
record vendor informed the hospital that it would not be able to satisfy the
Stage 3 interoperability and technology standards by January 2018.
Discussion Questions
1. Determine which (if any) of the following physicians will be subject to
a payment penalty in 2015: (a) primary care physicians, (b) surgeons,
or (c) radiologists.
2. Describe the timeline of the program and its potential financial impact
on the individual healthcare providers who are involved in MU.
3. Describe the process the physicians must complete to avoid the
payment penalties.
4. Describe the time frame for the provider to achieve modified Stage 2
and Stage 3 measures.
5. Discuss what the hospital must do to achieve the MU objectives for
interoperability.
28
Health Policy and Health
Informatics
Joyce Sensmeier; Judy Murphy
Abstract
To improve health delivery and health outcomes, all health practitioners require an
understanding of current health policy initiatives as well as knowledge about the
process for influencing the development of health policy. Informatics and heath
professional leaders must be knowledgeable about current technology-related public
policy initiatives in order to positively impact healthcare practice and care delivery
by leveraging informatics principles and technology within that policy.1 This chapter
begins by identifying informatics-related health issues driving policy initiatives of
the U.S. government. Understanding the driving forces and the resulting initiatives
provides a foundation for understanding the leadership role of health practitioners in
influencing health policy to improve health and healthcare delivery.
Health practitioners and information specialists understand that the effective and
efficient use of health information technology (health IT), when combined with best
practice and evidence-based care, can improve health and healthcare for all. As
leaders, health professionals and informaticians can maximize the use of health IT for
bringing practice standards and decision-making evidence to the point of care,
thereby empowering patients and healthcare consumers as partners.
By understanding current informatics-related health policy issues, the role
of the professional organizations, the current federal infrastructure support
for health informatics, and specific approaches for participating in the
advocacy process, health informatics leaders can positively affect
healthcare policy.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Identify key health policy issues of importance to the practice of health
for informatics.
2. Explain the process for developing and utilizing informatics principles
and concepts in developing health policy.
3. Differentiate the Institute of Medicine (IOM) recommendations in the
HIT and Patient Safety and The Future of Nursing reports.
KEY TERMS
health policy 474
unintended consequences 481
Introduction
Informatics focuses on technology as a tool with the goal of an efficient,
cost-effective healthcare system that ensures health and healthy
communities for individuals, families, groups, and communities.
Therefore policy goals and issues in health informatics are grounded in
broader field of health policy. Health policy refers to the decisions, plans,
and actions that are undertaken to manage healthcare delivery and to
achieve specific healthcare goals.2
Healthcare leaders in the Unites States are being challenged on multiple
fronts by an ever-changing healthcare landscape. The many challenges to
cost-effective, efficient healthcare delivery are the driving forces in creating
current health policy. Current health policy has developed in response to
the challenges faced by the multiple stakeholders and healthcare leaders
within the American healthcare system and by their vision of what is
possible.
In this chapter, current health policy initiatives of major importance in
health informatics are explored. The chapter begins by describing first the
structure and then an example of the process by which a driving force
leads to health IT policy. The concepts of safety and quality in the
healthcare se ing are used as examples of the process by which a driving
force leads to health policy. In many of the reports and studies dealing
with the American healthcare system, the use of health IT is recommended
as an effective tool to manage challenges facing healthcare delivery. The
Quality Chasm Series from the IOM is an excellent example. Box 28.1
provides examples from this series. The complete list of reports in the
series can be seen at h ps://[Link]/catalog/21895/quality-chasm-
series-health-care-quality-reports. The chapter concludes by describing the
leadership role of healthcare providers and health informatics specialists
in influencing the development and implementation of health policy.
Included are specific actions that are effective in moving health policy
forward. These actions are built on foundational competencies that all
practitioners and students should possess to meet the goals of providing
safe, quality, and competent care.
Box 28.1
The Institute of Medicine Quality Chasm Series
• Preventing Medication Errors: Quality Chasm Series—July 20, 2006
• Improving the Quality of Health Care for Mental and Substance-Use
Conditions: Quality Chasm Series—November 1, 2005
• First Annual Crossing the Quality Chasm Summit: A Focus on
Communities—September 14, 2004
• Crossing the Quality Chasm: A New Health System for the 21st Century
—March 1, 2001
• To Err is Human: Building A Safer Health System—November 29, 1999
Developing and implementing health
information technology policy
A clearly stated health policy can achieve several things. It defines a vision
for the future, which in turn helps establish targets and points of reference
for both short- and medium-term planning. Health policy outlines
priorities and expected roles of different groups. It both builds consensus
and informs people.2
While several research studies and reports over the previous decades
have identified health problems and healthcare delivery issues in the
United States, no unified clear statement or consensus identifies the
primary health problems or the primary healthcare delivery issues
impacting the health status of individuals, families, communities, or the
country as a whole. In addition, strong differences of opinion exist on the
responsibilities and rights of the individuals, families, groups, and societal
institutions around questions of health and healthcare delivery. As a
result, health policy in the United States is an ever-changing reflection of
the interactions and negotiations between the many health IT–related
stakeholders. Fig. 28.1 provides several examples of stakeholders who
impact and are affected by health IT policy, including the government,
which plays a primary role in establishing the health IT policy of the
United States.
FIG 28.1 Examples of Health Informatics Stakeholders.
Role of the Federal Government
“Federal agencies are purchasers, regulators, developers, and users of
health IT. In their various roles, they set policy and insure, pay for care, or
provide direct patient care for tens of millions of Americans.”3, p. 5
Government-sponsored programs now make up over 50% of healthcare
spending in the United States,4 as seen in Box 28.2.
Box 28.2
Federal and State Healthcare Expenditures
• Medicare covers seniors (65 +) and some individuals with disabilities.
• Medicaid covers low-income families, children, and individuals with
physical and developmental disabilities.
• CHIP (Children’s Health Insurance Program) covers kids who would
not otherwise qualify for Medicaid.
• VA (Veterans Health Administration) provides services to veterans.
• TRICARE covers members of the military, families, and military retirees
across the Department of Defense.
• FEHBP (Federal Employees Health Benefits Program) covers
government employees and retirees.
• Indian Health Service (IHS) provides healthcare to American Indians
and Alaskan Natives.
• Federal Refugee Health Promotion Program helps refugees rese ling in
the United States.
• Inmates are cared for in state and federal prisons.
• SAMHSA (Substance Abuse and Mental Health Services
Administration) provides programs and funding for people with
behavioral health needs.
• Tax exemption is provided for businesses and individuals with private
insurance from their employer.
• Subsidies provide premium and cost sharing for individuals who are
under 400% of the federal poverty level.
• Public health, research, and infrastructure, which includes activities to
detect and prevent disease outbreaks, biomedical research, and the
construction and improvement of structures to improve the delivery of
healthcare.
Source: James E, Hughes M. Government-sponsored programs make up 52% of what we spend on
healthcare. Forbes; Jul 29, 2015. <h p://[Link]/sites/realspin/2015/07/29/for-the-first-time-
government-programs-make-up-the-majority-of-u-s-health-spending/#4b3f205d8e1c> Accessed
April 23, 2016.
The U.S. Department of Health and Human Services (HHS) is the U.S.
government’s principal agency for protecting the health of all Americans
and providing essential human services. HHS programs and partnerships
demonstrate the health policy of the federal government in action. The
2014–2018 HHS Strategic Plan identifies the current HHS programs, each
having implications for health informatics.5
• Provide healthcare coverage through Medicare, Medicaid, the
Children’s Health Insurance Program, and the Health Insurance
Marketplace.
• Promote patient safety and healthcare quality in healthcare se ings
and by healthcare providers, by assuring the safety, effectiveness,
quality, and security of foods, drugs, vaccines, and medical devices.
• Eliminate disparities in health, as well as healthcare access and
quality.
• Conduct health, public health, and social science research.
• Leverage health IT to improve the quality of care, and use HHS data to
drive innovative solutions to health, public health, and human
services challenges.
• Improve maternal and infant health as well as promote the safety,
well-being, and healthy development of children and youth.
• Promote economic and social well-being for individuals, families, and
communities.
• Support wellness efforts across the life span.
• Prevent and manage the impacts of infectious diseases and chronic
diseases and conditions, including the top causes of disease,
disability, and death.
• Protect Americans from and provide comprehensive responses to
health, safety, and security threats.
• Serve as responsible stewards of the public’s investments.
The work of HHS is carried out by 11 divisions and 14 offices, including
the Office of the National Coordinator (ONC) for Health IT Fig. 28.2. The
ONC serves as the Secretary’s principal advisor, charged with
coordinating nationwide efforts to implement and use the most advanced
health IT and the electronic exchange of health information.6 The “ONC is
at the forefront of the administration’s health IT efforts and is a resource to
the entire health system to support the adoption of health IT and the
promotion of nationwide health information exchange (HIE) to improve
healthcare.”6 But this does not mean that every federal health informatics
project is under the direction of the ONC. Several federal health
informatics projects are based in other government divisions, especially in
the HHS. For example, the Center for Surveillance, Epidemiology and
Laboratory Services (CSELS) is under the direction of the CDC
(h p://[Link]/ophss/).
FIG 28.2 Department of Health and Human Services organizational
chart.
The Health Information Technology for Economic and Clinical Health
(HITECH) Act, which became law in 2009, played a key role in informing
the HHS Strategic Plan covering the years 2010–2015 and in turn is the
basis for many of the current programs and activities of the ONC.7 The
2014–2018 HHS Strategic Plan continues to build on these programs and is
now beginning to incorporate MACRA (Medicare Access and CHIP
Reauthorization Act), which became law in 2015 (see Chapter 27 for
details). In both strategic plans, strength healthcare is the first strategic goal.
Each plan lists the following specific objectives for achieving this goal:
2010–2015: Promote the adoption and Meaningful Use of health
information technology.
2014–2018: Improve healthcare and population health through
Meaningful Use of health information technology.
Each plan then lists the strategic actions for achieving the objectives. The
strategic actions for both plans are listed in Table 28.1, including several
examples of current health informatics initiatives under the direction of
the ONC as well as other initiatives supporting the various HHS
programs. Table 28.1 demonstrates that while the ONC is the lead agency
for health informatics–related projects and programs, these types of
initiatives can be found throughout the federal government (and in several
other chapters of this book). As a result, coordination and cooperation is
imperative to the development and implementation of effective health
policy. Or, as stated in the ONC Strategic Plan, “Federal plans now benefit
from engagement and coordination by a wider spectrum of government
agencies and private sector stakeholders.”3, p. 1
Table 28.1
Examples of Government Initiatives With Policy Implications for
Health Informatics
DHHS, Department of Health and Human Services; EHR, electronic health record; HHS,
Health and Human Services; health IT, health information technology; HIE, health
information exchange; HIPAA, Health Insurance Portability and Accountability Act;
HITECH, Health Information Technology for Economic and Clinical Health; ICD-10,
International Classification of Diseases-10; MACRA, Medicare Access and CHIP
Reauthorization Act; ONC, Office of the National Coordinator; PHSIPO, Public Health
Surveillance and Informatics Program Office.
Office of the National Coordinator for Health
Information Technology
The ONC has submi ed a budget appropriation request of $82 million for
fiscal year 2017. As pointed out in this document, the “ONC leads the U.S.
Government’s work to ensure that actionable electronic health information
is available when and where it ma ers most so that we move
expeditiously to an open, connected community of health.”8, p. 1 The
document goes on to describe a list of key activities, including health
policy. The health policy activities are described as follows: “ONC
develops and coordinates federal health IT policy to achieve national
health priorities set forth by the White House and Secretary of HHS, and
to implement statutory requirements such as those identified in the
HITECH Act and the Medicare Access and CHIP Reauthorization Act
(MACRA).”8, p. 24
The ONC Federal Health IT Strategic Plan for 2015–2020 provides an
overview of the current and future health IT policy directions. Its vision is
focused on four areas and four overarching goals, as shown in Figs. 28.3
and 28.4. These set the priorities for the plan. In viewing Fig. 28.3, note that
the vision is focused on health and not technology. Health IT is a tool to
achieve the goals of the plan and not the purpose of this plan. The four
goals and their respective objectives and strategies are not sequential but
interdependent with the vision and purpose of improving the health and
well-being of individuals and communities.
FIG 28.3 The vision and expected results guiding the Federal
Health IT Strategic Plan 2015–2020. From The Office of the National
Coordinator for Health Information Technology (ONC). Federal health IT strategic plan;
2015–2020, p 13. <[Link]
federalhealthitstratplanfinal_0.pdf>. Accessed April 24, 2016.
FIG 28.4 Federal Health IT Goals from the Federal Health IT
Strategic Plan 2015–2020. Source: The Office of the National Coordinator for
Health Information Technology [ONC]. Federal health IT strategic plan; 2015–2020.
<[Link]
Accessed April 24, 2016.
Driving forces for creating health
information technology policy
As pointed out in the introduction to this chapter, there are a number of
challenges to cost-effective, efficient healthcare delivery. When a problem
or challenge is first recognized, society does not magically create a health
policy to deal with that problem or challenge. Rather, there is an
evolutionary progress that includes:
1. Analysis leading to a be er understanding of the issue
2. Increased public awareness and education leading to both a public
and professional push for change
3. Proposed approaches from multiple stakeholders, as well as
political and legislative action leading to changes in public health
policy
As new approaches to deal with the issue are implemented,
improvements typically exist but also new challenges are introduced by
the technology. Issues related to patient safety and quality of care are used
here to illustrate this process.
Patient Safety
An increased focus on patient safety began with the 1999 IOM report To
Err Is Human. The report estimated that 44,000 to 98,000 lives were lost
every year due to medical errors in hospitals, which in turn led to the
widespread recognition that healthcare is not safe enough and catalyzed a
revolution to improve the quality of care.9 Despite considerable effort,
patient safety has not yet improved to the degree hoped for in the follow-
up IOM report, Crossing the Quality Chasm.10 In 2012, the IOM proposed
new strategies to advance quality and safety in yet another report, Best
Care at Lower Cost: The Path to Continuously Learning Health Care in
America.11 However the challenge of creating a safe healthcare system
continues. In 2013, John T. James published one of the latest studies to
date. “The number of premature deaths associated with preventable harm
to patients was estimated at more than 400,000 per year. Serious harm
seems to be 10- to 20-fold more common than lethal harm.”12, p. 122 Each of
the IOM reports identifies health IT as an effective strategy for safer, more
effective care in all se ings.
When designed and implemented appropriately, health IT can improve
healthcare providers’ performance, support be er communication
between patients and healthcare providers, and enhance patient safety, all
of which ultimately leads to be er care.13 For example, the number of
patients who receive the correct medication in hospitals increases
significantly when hospitals implement computerized prescribing and use
barcoded medication administration.14 However, poorly designed and
implemented health IT can actually create new hazards in the already
complex delivery of healthcare. To protect patients, health IT must be
designed and used in ways that maximize patient safety while minimizing
harm. Information technology can be er help patients if it becomes more
usable, more interoperable, and easier to implement and maintain.
Institute of Medicine Report on Health Information
Technology and Patient Safety
In the wake of more widespread use of health IT and to mitigate the risks
posed by these safety concerns, the U.S. Department of HHS asked the
IOM to evaluate health IT safety concerns and to recommend ways in
which both the government and the private sector can make patient care
safer using health IT. The resulting 2011 IOM report, HIT and Patient Safety,
states that safe use of health IT relies on several factors, including
clinicians and patients.15 Safety analyses should not look for a single cause
of problems but should consider the system as a whole and consider the
interplay of people, process, and technology when looking for ways to
make it safer. Vendors, users, government, and the private sector all have
roles to play. The IOM’s recommendations include improving
transparency in the reporting of health IT safety incidents and enhancing
monitoring of health IT products. A summary of these recommendations
follows:
• HHS should ensure that vendors support users in freely exchanging
information about health IT experiences and issues, including safety.
• ONC should work with the private sector to make comparative user
experiences publicly available.
• HHS should fund a new Health IT Safety Council within an existing
standards organization to evaluate criteria for judging the safety of
health IT.
• HHS should establish a mechanism for vendors and users to report
health IT–related deaths, serious injuries, or unsafe conditions.
• HHS should recommend that Congress establish an independent
federal entity, similar to the National Transportation Safety Board, to
perform investigations in a transparent, nonpunitive manner.
According to the report, these would be the first stages for action, to
advance current understanding of the threats to patient safety. The IOM
report also examined a broad range of health information technologies,
including electronic health records (EHRs), secure patient portals, and
HIEs. While some organizations had very good tracking databases to
prioritize technical issues and human factors issues related to technology,
others were doing li le to track health IT problems and resolutions. The
report also asked that the Secretary of HHS publish a plan within 12
months to minimize patient safety risks associated with health IT and
report annually on the progress being made. As a result, the Health IT
Patient Safety Action and Surveillance Plan was finalized in 2013.16 As part
of the Safety Plan, a new Health IT Safety Center Roadmap was published
by ONC in 2015, laying out a 5-year plan for creating a federal center, as a
public–private partnership, to focus on aggregating data from health IT–
related adverse events. The road map grew out of a series of meetings with
selected stakeholders, including federal agencies, patient safety
organizations (PSOs), researchers, and clinicians. The center’s three major
tasks will be (1) convening groups of stakeholders to learn more about
health IT–related risks; (2) researching hazards and disseminating
information gleaned from these activities, which could include real-world
pilot testing and implementation; and (3) evaluation of health IT safety
solutions.17
Unintended Consequences of Health Information
Technology Implementation
The unprecedented funding provided by the HITECH Act spawned a
flurry of EHR implementations. While expectations were high for
achieving all of the quality, safety, and cost benefits anticipated from these
implementations, experience and research shows that unplanned and
unexpected consequences have resulted from major policy and
technological changes.18,19 Unintended consequences are defined as
positive, negative, or neutral unanticipated outcomes occurring as a result
of a planned activity or event. Thus it is important to consider the
potential unintended consequences that may be produced by adoption of
health IT, particularly when implementations are accelerated.20
Government-sponsored research in this area of health IT began in 2004
with the Agency for Healthcare Research and Quality (AHRQ) grants for
planning, implementing, and testing the value of both EHRs and HIEs. Yet
there is still a great deal that has not yet been explored or understood.
However, health IT implementation science continues to expand (see
Chapters 17 and 19 on project management and system implementation).
Monitoring for and tracking of the unplanned or unexpected consequence,
especially when it has an undesirable outcome, is important. Enhanced
communication among multiple stakeholders in different venues and
disciplines will strengthen the collective ability to identify and address
unintended consequences of health IT. Federal and organizational
leadership can facilitate the sharing of information about technical and
organizational safeguards that address unintended consequences. Further,
mechanisms are needed to share findings of health IT system
implementers so that data captured by individual organizations can have a
broader impact.
One Meaningful Use criterion for both hospitals and healthcare
providers at all three stages is to report Clinical Quality Measures (CQMs)
to the Centers for Medicare and Medicaid Services (CMS) (for Medicare)
or to the state (for Medicaid). As with the other Meaningful Use criteria,
the CQMs mature during each stage of Meaningful Use, with increasing
numbers of measures required and increasing numbers of National
Quality Strategy domains covered. In addition, the CQMs moved from
legacy quality measures to electronically specified measures. These
eMeasures seek to standardize performance and include specific reporting
requirements. Going forward, the CQMs are incorporated into MARCA.
Quality Initiatives
Quality initiatives provide a second example of the process by which
health IT policy continues to evolve. The Stage 1 Meaningful Use
objectives were organized around five quality initiatives adapted from the
work of the National Priorities Partnership (NPP) and are fundamental to
each stage of Meaningful Use. The NPP is a collaborative effort of 51 major
national organizations that brings together public- and private-sector
stakeholder groups as partners in a forum that balances the interests of
consumers, purchasers, health plans, clinicians, providers, communities,
states, and suppliers in achieving the aims of be er care, affordable care,
and healthy people and communities.
Under contract to provide input to the Secretary of HHS on the 2012
National Quality Strategy, NPP published its report on national priorities
in 2011.21 To provide more input on each priority, the structure for this
work allowed the full NPP to serve as an overarching commi ee, while its
partners divided into three subcommi ees responsible for advising on
goals, measures, and strategic opportunities specific to three domains of
the National Quality Strategy: healthy people and healthy communities,
be er care, and affordable care. This important work evolved from NPP’s
previous input to HHS on national priorities and goals, including a report
submi ed in 2010 as well as its 2008 report, Aligning Our Efforts to
Transform America’s Healthcare.
National Quality Strategy
In March 2011, HHS released the National Quality Strategy for health
improvement, the first effort to create a national framework to help guide
local, state, and national efforts to improve the quality of care in the
United States.22 The National Quality Strategy recognizes health IT as
critical to improving the quality of care, improving health outcomes, and
ultimately reducing costs. Each year, an annual Progress Report to
Congress23 on achievement of the quality goals is published.
Pu ing the National Quality Strategy into action, HHS subsequently
launched the following two key initiatives that set specific national targets:
• Partnership for Patients, which is working with a wide variety of
private and public stakeholders to make hospital care safer by
reducing hospital-acquired conditions by 40% and improving care
transitions upon release from the hospital so that readmissions are
reduced by 20%
• Million Hearts campaign, which is a public-private initiative to
prevent 1 million heart a acks and strokes between 2012 and 2016 by
improving access to care and increasing adherence to basic preventive
medicine
The evidence shows that health IT, along with delivery system
improvements, should be a key ingredient in the success of these
campaigns and other efforts around the country to improve health
outcomes. One study published in The New England Journal of Medicine
looked at diabetes care in Cleveland and found the following:
• 51% of patients being treated by physician practices using an EHR
received care that met all endorsed standards of diabetes care,
compared to 7% of patients treated by practices not using an EHR.
• 44% of patients treated by practices using an EHR met at least four of
five outcome standards for diabetes, compared to 16% of patients
treated by paper-based practices with similar outcomes.24
This study speaks volumes about the positive impact that well-
implemented health IT that supports clinical decisions can have on the
quality of clinical practice. With clinical decision support applications,
health IT can facilitate the consistent execution of evidence-based best
practices by healthcare providers, including both nursing and medicine.
Leadership competencies for developing
and implementing health information
technology policies
Healthcare professionals and informaticians have a professional
responsibility to participate in the development and implementation of
effective health policies that maximize the use of health IT and empower
clinicians and patients as partners for health. The following section of the
chapter makes frequent use of nursing as one example of leadership
activities for developing effective health IT policy and for illustrating the
impact such activities can have on healthcare. However, as pointed on in
the IOM report, Assessing Progress on the Institute of Medicine Report “The
Future of Nursing”: “The nursing profession is making a wide-reaching
impact by providing quality, patient-centered, accessible, and affordable
care.”25, p. 1 However, “No single profession, working alone, can meet the
complex needs of patients and communities.”25, p. 3 To truly create a cost-
effective quality healthcare for all, each of the healthcare disciplines must
“continue to develop skills and competencies in leadership and innovation
and collaborate with other professionals in health care delivery and health
system redesign.”25, p. 3
Ensuring That Health Practitioners Are Positioned on
Key Committees and Boards
Over the past few decades, health professionals and health informaticians
have become increasingly engaged with health policy efforts. This is
especially true within the nursing and nursing informatics community,
where nursing leaders are claiming a seat at the policy table and are being
sought after for key national appointments as well as being hired for
executive positions. In 2014 The American Nurses Association (ANA), the
American Academy of Nursing, and the American Nurses Foundation
launched a national coalition to place 10,000 nurses on governing boards
by 2020.26 The Nurses on Boards Coalition is a group of national nursing
organizations working together to increase nurses’ presence on corporate
and non-profit health-related boards of directors throughout the country.
The goal of this effort is to bring nurses’ valuable perspectives to
governing boards as well as state-level and national commissions with an
interest in health. Through this effort, an awakening occurred about the
importance of recognizing opportunities to communicate and collaborate
with others to produce favorable outcomes.27
Another notable change is that nurses today proactively reach out to
other colleagues and leaders in positions of influence, including
government agencies, national organizations, professional societies, and
commi ees, to share knowledge and offer expertise, and they have learned
a great deal from these discussions. One key takeaway is that national
leaders and groups respond positively to nursing’s large population. For
example, the Alliance for Nursing Informatics (ANI) and the American
Nurses Association (ANA) are working closely to articulate a unified voice
that more broadly represents the profession, consisting of more than 3
million nurses. ANA works in collaboration with ANI and AAN to
identify and endorse qualified individuals in response to calls for
participation in national activities and testimony opportunities that
advance policies focused on improving quality, patient safety, and
outcomes.28
An example of the ANI and ANA efforts was demonstrated when ONC
launched a consumer campaign to empower and educate patients,
caregivers, and individuals in managing their day-to-day health and
acting as partners in their health through the use of health IT.29 This
campaign includes “Innovation Challenges,” which consist of public
contests for technology developers to create tools related to a particular
problem or need. ONC periodically issues these innovation challenges to
spur innovation related to consumer health information. In support of this
effort, ANI and ANA jointly pledged to coordinate a campaign with other
national nursing organizations to promote use of personal health records
(PHRs) and patient portals. The ultimate goal of the ANI Pledge to
Support the Consumer eHealth Program30 is to help clinicians offer a
wider range of considerations and options for patients, while also
providing patients with resources that encourage proactive behavior, thus
empowering them to be active partners in their health plan.
An additional example is that the ANA, which continually tracks calls
for nominations for agencies and organizations, reported that as of 2015,
11 nurses were appointed to 13 positions at the U.S. ONC for Health IT.31
Responding to Requests for Comments
With the increasing numbers of policies and regulations for healthcare and
health IT, a growing number of opportunities exist for organizations and
individuals to submit comments on the ensuing regulations and other
related federal guidance documents. Laws passed by Congress rarely
contain enough specific language to fully guide their implementation.32
Regulations and the rule-making process are used to clarify definitions,
authority, eligibility, benefits, and standards. Their development is shaped
by the monitoring, involvement, and input of professional societies,
healthcare providers, third-party payers, consumers, and other special
interest groups. (The process for developing regulations from legislation is
explained in Chapter 25.)
Each organization’s internal policies may offer direction as to whether
or when a formal wri en response to federal policy-makers is warranted.
As one example, ANI has developed a policy that describes its process for
member organizations to achieve consensus on policy issues affecting
nursing informatics.30 This policy states:
ANI, as a collaboration that represents multiple nursing informatics
organizations, responds as one voice to federal health policy initiatives by
sharing nursing informatics perspectives for shaping health policy. Due to
limited timing to respond, it is not always possible to have a full review by
all members within each of the ANI member organizations. ANI will make
every effort to provide notification about its intent to respond to a call for
comments for healthcare reform initiatives, requirements and rulings from
ONC or other government agencies and organizations, as soon as ANI
decides to pursue a specific call. The length of time available to respond
will determine the steps in the procedure for obtaining comments.32
The ANA has offered the following guidance on how individual nurses
can affect federal rules and regulations:
• Learn about the federal rule-making process and how to make your
voice heard.
• Become informed about the public policy and health policy issues
currently under consideration at the federal level of government.
• Check out the Federal Register. It is the very best source of information
about proposed rules and changes to existing rules for federal
programs. It is posted every day and contains complete directions on
where to send comments and deadlines for the public comment
period.
• Work with your state nurses association by offering your expertise to
assist in developing new regulations, modifying existing regulation,
or preparing comments on proposed regulations.33
Other tips are offered to individuals. To enhance the credibility of
submi ed comments, address any questions in the notice and take the
time to offer positive feedback on points of agreement with the proposed
regulation. If a template is provided, use it for the response submissions.
Finally, be sure to publicize the response via various media channels,
including social media, and use it as an opportunity to increase awareness
and provide education about the public policy effort and related
publications or activities.
Developing Position Statements
Another mechanism for advancing health policy is through the
development and publication of position statements (sometimes called
policy briefs). A position statement is an explanation or a recommendation
for a course of action that reflects an organization’s stance on an issue of
concern. Position statements are typically developed after an internal
discussion with content experts, then advanced to the broader
membership for review and input, and finally submi ed to the oversight
governance group or board for approval. This development, review, and
approval process allows interested parties to voice their concerns and
opinions on the issue at hand and enables the group to reach consensus.
One example is the Healthcare Information and Management Systems
Society (HIMSS) Nursing Informatics Position Statement titled
Transforming Nursing Practice through Technology and Informatics. This
HIMSS Position Statement was developed by the HIMSS Nursing
Informatics Community and subsequently reviewed and approved by the
HIMSS board of directors. Position statements may also be created in
collaboration with other groups and issued as joint statements. An
example of this type of effort is the ANA Position Statement on the
Inclusion of Recognized Terminologies within EHRs and other Health IT
Solutions.34 The purpose of this position statement is to reaffirm the ANA’s
support for the use of recognized terminologies supporting nursing
practice as valuable representations of nursing practice and to promote the
integration of those terminologies into information technology solutions.
The ANA worked in collaboration with a endees of the Nursing
Knowledge Big Data Science Conference sponsored by the University of
Minnesota to develop and review this position statement, which was
subsequently approved by the ANA board of directors on March 19, 2015.
Leading policy activities through
organizational work and leadership
Health informatics–related organizations actively influencing health
informatics policy through organizational work and leadership include the
ANI, AAN, American Health Information Management Association
(AHIMA), American Medical Informatics Association (AMIA), HIMSS,
and others. A brief summary of the public policy focus of selected
informatics-related organizations is provided in Table 28.2.
Table 28.2
Professional Association in Informatics Influencing Health Policy
AAN, American Academy of Nursing; AHIMA, American Health Information Management
Association; AMIA, American Medical Informatics Association; ANI, Alliance for Nursing
Informatics; CMS, Centers for Medicare and Medicaid Services; EHR, electronic health
record; Health IT, health information technology; HELP, health, education, labor and
pensions; HIPAA, Health Insurance Portability and Accountability Act; HIMSS, Healthcare
Information and Management Systems Society; ICD-10, International Classification Of
Diseases-10; IT, information technology; MACRA, Medicare Access and CHIP
Reauthorization Act; NINR, National Institute of Nursing Research; NQF, National Quality
Forum’s; ONC, Office of the National Coordinator; PHRs, personal health records.
Strategies
Health informaticians working together within professional associations
bring to the health policy table a deep understanding of clinical processes,
technology, and health IT systems in addition to experience as advocates
for patients, groups, communities, and overall populations. Using the
contacts and structure provided with a professional association, these
leaders have a unique opportunity and a professional responsibility to
share this knowledge with the goals of advancing an improved health
system that is increasingly focused on value-based care. Changes in health
policy are one part of necessary reform,35 but how do healthcare providers
and health informaticians prepare to engage in public policy efforts? The
beginner must acquire a basic knowledge of health policy and funding.
An understanding of health policy principles can be gained through
formal coursework, continuing education, reviewing the literature, or even
self-study of the myriad resources available on the internet.36 Ge ing
involved with the policy efforts within one’s own organization is a simple
way to get started. Professional colleagues with the organization are often
willing to act as coaches to offer advice, criticism, information,
encouragement, and support. For example, HIMSS believes that nurses
must lead and be visible, vocal, and present at the table for all significant
healthcare reform initiatives.37 In addition, volunteering to participate in
state-level advocacy activities can provide experience in meeting with
legislators. Applying for a commi ee appointment at the local and state
levels offers other opportunities to learn how to influence policy.
Beyond acquiring knowledge of basic policy principles, demonstrating
leadership skills and leveraging a professional network are necessary to
achieve success. Health practitioners require certain skills to be able to
communicate effectively with policy-makers and take advantage of
relevant advocacy opportunities. According to Alexander and Halley, to
advocate, health professionals and informaticians must be strategists,
leaders, and great communicators, and they must engage stakeholders
across multiple spectrums to ensure that the needs of patients and
professionals are met.27 Communication skills are essential to be able to
craft and articulate key points that will “make the case” as well as to
capture and engage the target audience. Exemplary leadership activity will
move the cause forward in an actionable way toward policy
improvement.30 Demonstrating such leadership requires more than
showing passion for an issue. It also involves being able to connect
evidence to the policy agenda and frame it in a logical context.
Collaboration and unified messaging among all stakeholders are keys to
success.
Discipline-specific policies: nursing
This section provides an example of current influences within the specific
discipline of nursing. All health disciplines are encouraged to research
current policies specific to their areas. Readers in other health disciplines
are encouraged to note the outline and content provided here as a model.
Use of Health Information Technology to Advance the
Future of Nursing
In 2008, The Robert Wood Johnson Foundation (RWJF) and the IOM
launched a 2-year initiative to assess and offer recommendations for
transforming the nursing profession. In 2010, the Commi ee appointed by
the IOM to complete this task released their report entitled The Future of
Nursing: Leading Change, Advancing Health.38 The published report offered
bold recommendations for transforming the nursing profession, leading to
advanced roles and leadership positions for nurses in the redesign of the
healthcare system.
The Future of Nursing Report Recommendations
Many leading nursing organizations, including ANI, provided testimony
to the Commi ee. These contributions from ANI, along with others from
national nursing leaders, were used by the Commi ee in the development
of the report, which has been described by some as the “tipping point in
nursing care,” calling for the nursing profession to be reengineered with a
more educated workforce capacity.39 The Future of Nursing report outlined
several opportunities to transform nursing practice through informatics
and technology.
Implications for Time and Place of Care
Care supported by interoperable digital networks will shift in the
importance of time and place. It is likely that a significant subset of care
delivery will be independent of physical location when health IT is fully
implemented. Nurses provide care in every se ing, particularly in the
community; therefore nurses should be involved in shaping the effective
use of health IT and related policies wherever they practice. Nurses have
identified that lack of an integrated EHR is a barrier to success.37 National
initiatives to address EHR adoption and integration challenges are being
advanced. Nurses should become increasingly more engaged in national,
regional, and local policy efforts in order to drive this agenda of person-
centric, location-independent healthcare information.
Expand Opportunities for Nurses to Lead and Diffuse Collaborative
Efforts
Interoperable EHRs linked with patient portals influence how
collaborative care teams are able to work and share clinical information.
Care teams are no longer bound by physical space but rather can engage in
virtual learning environments to support the care delivery of the future.
The increasing use of communication tools, the proliferation of mobile
devices, and the increasing availability of online health tools are offering
multiple opportunities for healthcare providers to collaborate with each
other and to engage with patients.40 Personal health information is a
valuable resource for individuals, their families, and healthcare
professionals who provide treatment and deliver care in institutional and
community se ings. Examples of personal health information
management systems and tools that can be leveraged include personal
health devices, PHRs, and web-based portals linked to EHRs or clinical
information systems. Well-defined policies are necessary to ensure that the
security and confidentiality of protected health information is safeguarded
in this rapidly evolving virtual healthcare environment. Nurses should
seek opportunities to participate in efforts to define policies that affect
patient care, including volunteering for policy development commi ees
within their own organizations.
While health IT will have an increasing influence on how nurses plan
and document their care, all facets of care are becoming increasingly
digital. From the expanded use of tracking devices and smart beds, data
capture is being automated, and nurses are more able to focus on complex
cognitive decisions using knowledge management and decision support.
Policy-makers should and do work with nurse leaders to leverage these
opportunities to transform nursing practice through the use of new and
existing technologies intended to support decision making and care
delivery. For example, nurses can provide input as to how the proposed
use of health IT may affect their workflow or offer guidance on the optimal
use of these technologies to improve care delivery.
A recent effort to engage consumers in compiling their own health
information is the GetMyHealthData effort. This is a collaborative activity
among leading consumer organizations, healthcare experts, clinicians,
policy-makers, and technology organizations that believe passionately that
consumer access to digital health information is an essential cornerstone of
be er health and be er care. The ANI joined these efforts. ANI
organizations have joined forces to ask their members, nurses, and clinical
colleagues to broadly share and give feedback to GetMyHealthData. The
goal of this effort is to liberate healthcare data for the benefit of consumers
and the health system as a whole so they can use it to improve their health
and care.41
Prepare and Enable Nurses to Lead Change to Advance Health
Other key recommendations in The Future of Nursing report emphasize the
importance of preparing and enabling nurses to lead change to advance
health. Public, private, and governmental healthcare decision makers
should include nurses at every level. Nurses consistently rank at the top of
the Annual Gallup Poll on Honesty/Ethics in Professions, doing so each
year since they were first included in the poll in 1999, except in 2001 when
firefighters were included on a one-time basis to recognize their heroic
actions on September 11.42 But frequently they do not recognize that power
or work as a group to leverage opportunities to influence policy or
strategic direction.
The TIGER (Technology Informatics Guiding Education Reform)
Initiative’s goal of engaging more nurses in leading both the development
of a national health IT infrastructure and healthcare reform is referenced in
The Future of Nursing, as is its goal to accelerate adoption of smart,
standards-based, interoperable technology that will make healthcare
delivery safer, more efficient, timely, accessible, and patient centered,
while also reducing the burden on nurses.43 Through efforts such as
TIGER, nurses are mastering informatics competencies to be er influence
policy efforts in today’s rapid EHR adoption. The TIGER initiative report
on the Leadership Imperative emphasizes that now, more than ever,
innovative nurse leaders are positioned to work closely with local and
national policy leaders and lawmakers through public policy engagement.
Effective engagement requires a comprehensive understanding of policy
processes and the knowledge and skill to effectively evaluate the
interconnections between policy, nursing, and health outcomes, as well as
the critical role of health IT. Using this knowledge to develop programs of
action grounded in the principles of professional nursing, the innovative
nurse leader plays a major role in effecting positive change as our system
of healthcare continues to evolve.
The Future of Nursing report emphasizes that the United States has the
opportunity to transform its healthcare system, and nurses must play a
fundamental role in this transformation. However, this transformation will
require that nurses embrace technology as a necessary tool to innovate the
delivery of nursing care.
Center to Champion Nursing in America
The Future of Nursing: Campaign for Action is an initiative to advance
comprehensive healthcare change. It envisions a healthcare system in
which all Americans have access to high-quality care, with nurses
contributing to the full extent of their capabilities.44 The campaign is
coordinated through the Center to Champion Nursing in America
(CCNA), an initiative of American Association of Retired People (AARP),
the AARP Foundation, and the RWJF. The Center includes 50 state action
coalitions, a wide range of healthcare providers, consumer advocates,
policy-makers, and business, academic, and philanthropic leaders. The
Campaign for Action is moving forward simultaneously on national, state,
and local levels through efforts to accomplish the following:
• Strengthen nurse education and training
• Enable nurses to practice to the full extent of their education and
training
• Advance interprofessional collaboration among healthcare
professionals to ensure coordinated and improved patient care
• Expand leadership ranks to ensure that nurses have a voice on
management teams, in boardrooms, and during policy debates
• Improve healthcare workforce data collection to be er assess and
project workforce requirements45
State-level action coalitions are also working to advance the campaign’s
efforts at the local, regional, and state levels. These action coalitions will
capture best practices, determine research needs, track lessons learned,
and identify replicable models that can be embedded in national policy
efforts. Yearly, the campaign is analyzing established datasets to evaluate
where we are gaining ground and areas that require additional emphasis.
Examples of campaign progress are discussed in the following sections.45
Advancing Education Transformation
• From the fall of 2010 to 2014, the number of students enrolled in RN-to-
BSN programs increased from 77,259 to 130,345, a 69% increase.
• For the first time in its history, Medicare is paying to support the
training of nurses with the Graduate Nurse Education Demonstration, a
$200 million demonstration project in five hospital systems. This historic
legislation is designed to prepare more advanced practice registered
nurses to care for people across all healthcare se ings.
Fostering Interprofessional Collaboration
Three major foundations—the RWJF, the Gordon and Be y Moore
Foundation, and the Josiah Macy Jr. Foundation—collaborated to support
the Health Resources and Services Administration’s National Center for
Interprofessional Practice and Education at the University of Minnesota.
The center is working to provide leadership, scholarship, evidence,
coordination, and national visibility to advance interprofessional
education and practice as a viable and efficient healthcare delivery mode.
Healthcare Information and Management Systems
Society Nursing Informatics Position Statement
To further advance recommendations in The Future of Nursing report,
HIMSS published a position statement in 2011 titled Transforming Nursing
Practice Through Technology and Informatics. This statement asserts that:
Nurses are key leaders in developing the infrastructure for effective and
efficient HIT [health IT] that transforms the delivery of care. Nurse
informaticians play a crucial role in advocating both for patients and fellow
nurses who are often the key stakeholders and recipients of these evolving
solutions. Nursing informatics professionals are the liaisons to successful
interactions with technology in healthcare. As clinicians who focus on
transforming information into knowledge, nurse informaticians cultivate a
new time and place of care through their facilitation efforts to integrate
technology with patient care. Technology will continue to be a fundamental
enabler of future care delivery models and nursing informatics leaders will
be essential to transforming nursing practice through technology.1
To achieve the goals of this position statement, nurse leaders should be
engaged at all levels in health IT policy and strategy-se ing commi ees
and initiatives. In addition, they must be knowledgeable and well versed
in current public policy initiatives and seek opportunities to participate in
advocacy and educational efforts directed toward policy-makers. Through
the efforts of the Nursing Knowledge: Big Data Conference, a workgroup
has been formed to engage and equip all nurses in health IT policy.46 This
effort will make strides in providing nurses with the education, tools, and
resources to equip them as knowledgeable advocates for policy efforts that
are important to nursing.
Assessing Progress on the Institute of Medicine
Report The Future of Nursing
Five years after the IOM’s Future of Nursing report, the RWJF asked the
IOM to convene a commi ee to examine the progress made in
implementing the report’s recommendations. The resulting report,
Assessing Progress on the Institute of Medicine Report The Future of Nursing,31
summarizes progress and offers recommendations for the future campaign
to accelerate implementation of recommendations. The report includes
information about the following:
• Removing barriers to practice and care. Significant barriers still exist
to allowing the full practice of Advanced Practice Registered Nurses.
Nurses should work with other professions to remove scope of
practice scope-of-practice restrictions.
• Transforming education. Recommendations are to provide pathways
to the BSN degree; create and fund residency programs; promote
doctoral degrees, emphasizing the PhD; and promote
interdisciplinary and lifelong learning.
• Collaborating and leading. Nurses are encouraged to serve in
executive and leadership positions. Continued efforts are needed for
interdisciplinary collaborations and leadership development.
• Promoting diversity. While many organizations have increased
diversity, continued emphasis is needed.
• Improving data. Data collection is needed about numbers and types of
health professionals, their roles and places of employment. More
robust and organized datasets are needed.
As described earlier, many of these strategies have implications for
health informatics specifically about improving data and leadership
efforts. In addition, Recommendation 2: Expand Opportunities for Nurses to
Lead and Diffuse Collaborative Improvement Efforts speaks specifically to
health informatics by continuing the following recommendation from the
initial report:
Health care organizations should engage nurses and other front-line staff
to work with developers and manufacturers in the design, development,
purchase, implementation, and evaluation of medical and health devices
and health information technology products.31, p. 191
Conclusion and future directions
This chapter describes current health policy initiatives with a focus on
health IT and the health policy leadership responsibilities of the health
professionals and informaticians. By understanding current informatics-
related health policies issues, the role of the professional organizations, the
current federal infrastructure support for health informatics, and specific
approaches for participating in the advocacy process, health professionals
and informatics leaders can positively affect health policy. As
demonstrated by a variety of nursing initiatives, leadership makes a
difference. Health practitioners can and must take on leadership roles and
influence policy to improve safety and efficiency, thereby bringing
evidence for decision making to the point of care and empowering patients
and consumers as partners. Collectively, health practitioners must respond
to the policy challenges outlined in this chapter to advance the health of
individuals, families, groups, and communities. Whatever their role,
healthcare providers and informatics specialists must be confident that
they can influence health policy at the local and organizational, regional,
state, and national level.
Where are we now, several decades after starting the implementation of
health IT in healthcare? Winston Churchill put it best when he said, “Now
this is not the end. It is not even the beginning of the end. But it is,
perhaps, the end of the beginning.”47, p. 264 We have much more to do.
Through strong leadership and active participation we will be able to
organize and complete the hard work necessary to create the policy
changes that will transform healthcare.
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h p://[Link]/catalog/21838/assessing-progress-on-the-
institute-of-medicine-report-the-future-of-nursing Accessed April
26, 2016.
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Obtaining and Integrating Health Policy Comments.
h p://[Link]/docs/ANI_Policy_ProcedureCommentsHealth
[Link]; 2015.
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World; 2015.
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within EHRs and Other Health Information Technology Solutions.
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h p://[Link]/rdcms-
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R., Staggers N., eds. Health Informatics: An Interprofessional
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[Link].
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47 Churchill W.S. The End of the Beginning. London, England: Cassel;
1943. h p://[Link]/resources/speeches/1941-
1945-war-leader/987-the-end-of-the-beginning.
Discussion Questions
1. Outline the basic health policy competencies for health informatics
leaders.
2. Discuss how the Federal Health IT Strategic Plan could impact future
health IT policy and, in turn, future projects and programs supporting
the use of health IT in the United States.
3. Describe the policy concerns regarding the use of health IT to improve
healthcare quality and control costs as the American healthcare system
moves from HITECH to MACRA.
4. Discuss the interprofessional health IT policy implications of The Future
of Nursing report.
5. Outline the process for developing and implementing informatics policy.
6. Describe four strategies for leading policy activities through
organizational work and leadership.
Case Study
Mr. Smith Goes to Washington is a 1939 American film starring James
Stewart and Jean Arthur about one man’s effect on American politics.
Today, health practitioners make their own trips to our nation’s capital,
and while the focus may be somewhat different, the experience is no less
exciting. Here is a case study outlining one possible scenario.
It all started with a phone call requesting that a nurse testify at a
congressional hearing on Standards for Health IT: Meaningful Use and
Beyond, hosted by the House Subcommi ee on Technology and
Innovation. The testimony would include both wri en and oral comments.
The call launched a flurry of activity aimed at ensuring that the testimony
would be successful, and Johnson was selected to testify. Multiple
documents were prepared in advance, including a draft of the testimony
and Johnson’s curriculum vitae, biography, and financial disclosure form.
The team worked to create testimony that addressed the House
Subcommi ee’s two questions:
1. What progress has ONC made since the HITECH Act was passed in
meeting the need for interoperability and information security
standards for EHRs and health IT systems?
2. What are the strengths and weaknesses of the current health IT
standards identification and development process, and what should
the top standards-related priorities be for future health IT activities?
During preparation of the wri en comments, previous testimony,
position statements, and background materials were leveraged. Several
board members, leaders in privacy and security efforts, leaders in
standards and standards harmonization efforts, and volunteer leaders
from the HIMSS EHR Association were interviewed. Multiple rounds of
editorial and content review took place prior to calling the testimony
“final” and ready for submission.
Next, oral comments were prepared, keeping them to a maximum of
5 min. The testimony was boiled down to the key points that could be
delivered in that brief time frame yet still make sense. Repeated practice
sessions drove home the realization that 5 min is very li le time!
Then came the “murder squad,” a dry run facing a team of experts who
drilled Johnson with questions that she might be asked by House
Subcommi ee members. She said later that it may have been more nerve-
racking to face peers than to face the House Subcommi ee itself! In this
practice session, the key lessons learned were to get to the point quickly
and use the responses to panel members’ questions as an opportunity to
reemphasize key points from the testimony. Other homework included
reviewing the list of House Subcommi ee members to recognize their
faces and learn their districts, political parties, recent activities, and any
relevant legislation they had recently introduced or supported.
On the day of the testimony, a meeting was held with the team in the
House of Commons cafeteria to share last-minute updates and further
refine the strategy. Johnson then proceeded to the office of the House
Subcommi ee chairman, where the panelists were introduced to each
other. The chairman joined the panelists at the prehearing session,
facilitating the dialog in a casual se ing to put the panelists more at ease.
During this session, the panelists learned that the hearing had been at risk
of cancellation since the House had adjourned the night before and many
of the House Subcommi ee members had left Washington for their home
states. However, the chairman’s staff commented that the chairman is very
commi ed to the advancement of health IT as well as to the House
Subcommi ee’s HITECH Act oversight role, and therefore he did not
cancel the hearing.
At the scheduled time, the panelists entered the hearing room and took
their seats at a row of tables on the main floor. The House Subcommi ee
chairman, members, and staff were seated at the front of the room, one
level above the main floor, and the public audience was seated at the back
of the room. In front of each panelist was a microphone, timer, and stop
light that tracked each speaker’s time limit. During the testimony, the stop
light changed from green to yellow and then to red when each speaker’s 5-
min time limit was reached.
Throughout the hearing, the chairman was very gracious, noting his
appreciation of the panelists’ contributions. In part because of her
thorough preparation, Johnson gave her prepared oral testimony
flawlessly. Although not asked any direct questions, she chimed in to help
answer several other questions that were asked of other panelists in order
to offer key points germane to the discussion. The hearing was broadcast
live on the internet; a transcript of the testimony is available in the public
record of the hearing, and a video clip of the testimony can be found on
YouTube.
While Mr. Smith Goes to Washington made James Stewart a major movie
star, Johnson’s aspirations were quite simple: that the recommendations
on how to improve patient care and reduce costs would be heard and that
steps toward implementation would be taken.
Discussion Questions
1. How can healthcare providers best leverage their clinical background
when providing testimony as expert witnesses?
2. When preparing testimony, should a healthcare expert witness focus
primarily on healthcare delivery, or should his or her clinical
background be used more as a context for the discussion? What are
the advantages and disadvantages of each approach?
29
Health Information Technology
Governance
Jim Turnbull; Kensaku Kawamoto
Abstract
Health information technology (health IT)—the leveraging of information systems to
improve health and healthcare—represents a critical enabler for healthcare
organizations to achieve strategic objectives and operational excellence. To optimize
the value of health IT resources, a healthcare organization must have in place
effective governance to ensure IT’s alignment with institutional strategic objectives
and the effective prioritization of limited resources. This chapter provides direction
and insight into various issues that must be considered in establishing that
governance structure. In addition, recommendations are provided for establishing an
effective health informatics governance structure that is aligned with institutional
strategic objectives, effectively prioritizes competing health IT needs, and is tailored
to the unique culture and characteristics of the organization. In particular, effective
health IT governance will be critical for healthcare organizations to survive and
thrive as healthcare payments shift from a pay-for-volume to a pay-for-value
paradigm.
Given the rapidly changing healthcare environment, it is critical that
healthcare organizations develop a health information technology (health
IT) governance structure that allows priorities and direction to be promptly
adapted to these changes.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Describe why health information technology (health IT) governance is
needed.
2. Assess a health IT governance structure.
3. Discuss challenges to establishing effective health IT governance.
4. Describe key considerations for the establishment of health IT
governance.
5. Evaluate the effectiveness of health IT governance approaches.
KEY TERMS
health IT capability maturity assessment 497
health IT governance 492
Informatics Capability Maturity Model 495
Introduction
As an emerging element of our healthcare delivery system, the concept of
health IT governance is far from mature in all but the most advanced
healthcare facilities. There are some relevant resources on health IT
governance available in the literature, such as a book by Kropf and Scalzi
published by the Healthcare Information and Management Systems
Society.1 However, a search of MEDLINE and the general web reveals
relatively li le literature on this topic, and much of the existing literature
focuses on the tactical implementation of transactional (operational) IT
systems rather than on the growing need to optimize information
management broadly within and across organizations by leveraging health
IT. Consequently, the authors of this chapter offer a perspective based
primarily on their extensive experience in providing administrative
leadership in organizations ranging from large multihospital systems to
academic medical centers (AMCs). These organizations demonstrate
varying degrees of sophistication with regard to electronic health record
(EHR) systems and associated health IT capabilities. Because establishing
operational processes (e.g., for proposing and reviewing project proposals)
is much more straightforward compared to establishing an effective
governance structure that appropriately owns and uses these processes,
this chapter focuses on health IT governance structure rather than on the
processes used to operationalize the governance. This chapter focuses on
health IT governance of larger healthcare organizations such as AMCs
because of the expertise of the authors. However, we believe the general
principles and recommendations provided in this chapter should be
equally applicable to other healthcare se ings, such as small and medium-
sized healthcare organizations and postacute facilities.
Health information technology
governance: need and core components
Given that healthcare is an information-intensive endeavor, health IT
represents a core pillar that enables and supports a modern healthcare
organization’s ability to achieve its strategic and operational objectives.
Indeed, health IT encompasses virtually all aspects of a healthcare
organization’s clinical and business activities, including clinical care
delivery, billing, human resource management, staffing, financial
management, population health management, research, education, and the
tracking and improvement of care value. In larger organizations, the
numbers of systems and applications can be in the hundreds. Given the
broad and deep involvement of health IT in all aspects of an organization’s
mission and operations, healthcare organizations must ensure that their
health IT efforts are aligned with their key objectives. Moreover, a
healthcare organization’s strategic and operational initiatives often require
health IT resources to be optimally effective. Whether it is care pathway
implementation, population health management, or medication safety, it is
rare for a key healthcare initiative to not require health IT support. Thus
the need for health IT resources (e.g., analysts and software developers)
will often significantly exceed the available capacity of such resources. The
critical nature of effective health IT governance then arises from the
following fundamental interrelated needs:
1. The need to ensure alignment of health IT resources with
institutional priorities
2. The need to effectively prioritize the use of health IT resources in
the face of numerous competing demands for these limited
resources
Healthcare enterprises are often recognized as being one of the most
complex of all organizational structures. Consequently, when one speaks
of “institutional priorities,” the list is often long and generated from
multiple sources. Historically, beyond priorities established by senior
leadership, requests for health IT resources are received from researchers,
the finance and quality departments, specialists who are refining clinical
processes or investigating clinical variances, and so forth. More recently,
increasing requests from institutional stakeholders are being submi ed as
they work on emerging areas of priority in healthcare, such as payment
reform, personalized medicine, and more sophisticated costing
methodologies. In summary, the demand for health IT resources and
expertise is growing rapidly, the requests are coming from a broader
group of constituencies, and the institutional priorities are becoming much
less clear. Without effective governance, key stakeholders—including
healthcare providers—will be frustrated by delayed or inadequate IT
support and a resource allocation rationale they do not understand.
Moreover, the overall resource allocation is likely to be suboptimal for
addressing institutional strategic priorities, and organizations may even be
supporting conflicting and overlapping projects.
The role of health IT governance is to help clarify priorities, allocate
resources and, if necessary, approve the funding to support the expansion
of available health IT resources. Health IT governance should also be
accountable to track and monitor the benefits of these investments.
To meet these needs, effective health IT governance must include the
following components:
• Organizational structures responsible for clearly defining institutional
priorities. Typically, this function is primarily the responsibility of the
board of directors and senior leadership of a healthcare organization.
• Organizational structures responsible for ensuring that health IT
efforts are aligned with institutional priorities and used optimally.
• Accompanying processes to operationalize the governance. For
example, health IT governance typically incorporates the processes in
Box 29.1.
Box 29.1
Health Information Technology Governance
Activities and Processes
• Formal processes for proposing new projects requiring health IT
resources (e.g., formal submission templates outlining major aspects of a
project such as purpose, scope, estimated timelines, and resources; see
Chapter 17 for details about project management)
• Planning future directions and investments
• Evaluating and prioritizing potential projects; evaluating, approving,
and prioritizing changes to the EHR system (e.g., the introduction of
new clinical decision support alerts and reminders)
• Approving funding
• Monitoring return on investment for projects
Establishing such operational processes is much more straightforward
compared to establishing a governance structure that appropriately owns
and uses these processes; therefore the remainder of the chapter will focus
on health IT governance structure rather than on the processes used to
operationalize the governance.
A sample health IT governance structure, adapted from
recommendations by Hoehn, is as follows:
• Board of directors and executive management, responsible for se ing
the overall health IT strategy and clear expectations within the context
of institutional priorities
• Clinical IT governance commi ee, including chief medical officer,
chief nursing officer, chief medical informatics officer, chief nursing
informatics officer, chief information officer, other relevant
operational executives (e.g., chief operating officer, chief financial
officer), and appropriate clinical and administrative department
chairs, responsible for establishing and overseeing the
implementation of the health IT strategic plan
• Various commi ees reporting to clinical IT governance commi ee,
responsible for overseeing operational execution of clinical IT
initiatives consistent with institutional priorities and the health IT
strategic plan2
Fig. 29.1 shows an example of an organizational chart demonstrating
this kind of health IT governance structure. The figure shows one of many
potential approaches an institution may take to create IT governance. Each
institution may need to adapt this governance structure to incorporate
other commi ees with overlapping responsibilities. The next section
discusses this and other relevant issues that should be considered in
establishing any health IT governance.
FIG 29.1 Sample health IT governance structure. IT, information
technology.
Key insights
Respect Current Decision-Making Structures
In establishing a health IT governance, strong consideration and respect
should be given to the governance structures and decision-making
processes that are already in place within the organization. For example, if
the culture is for clinical department chairs to have a strong voice in
institutional decisions, then the health IT governance should ensure
adequate representation of such chairpersons. Furthermore, it is important
that strong alignment be demonstrated between the initiatives of the
broader organization and the focus of the health IT program. For example,
if understanding and improving care value is a key focus of the institution,
then supporting the measurement and improvement of value (versus only
profit) should be a key priority of the health IT program. If a health IT
governance model does not demonstrate this alignment between
organizational priorities and the priorities of the health IT program,
barriers to effective communication could be erected needlessly.
Time invested in determining who “owns” health IT governance is time
well spent. In some fortunate cases, an existing commi ee can be modified
to embrace the requirements for health IT governance. A much more likely
scenario is that the topic has not been addressed. In those situations, the
health IT team typically responds to “he who yells the loudest is best
heard.” Clearly the governance structure needs to be tightly aligned with
the position within the organization that is perceived to be “highest in the
food chain” when it comes to health IT priorities and resource allocation.
Shift in Organizational Mindset
For several decades, healthcare organizations focused on developing IT
infrastructure and implementing a plethora of applications. The la er have
consisted primarily of transaction-based applications that support the
revenue cycle, back-office functions such as payroll, and the delivery of
clinical care (e.g., EHRs). More recently data warehouses with an array of
decision support and reporting tools developed by both vendors and in-
house resources have emerged. These allow analysis across specialty
systems—for example, robust queries can be made across clinical,
financial, and staffing systems to more accurately understand the value of
care delivered (i.e., outcomes achieved in relation to costs incurred). The
increasing sophistication of the IT environment has enabled both clinical
and administrative leaders to leverage data in support of their programs
and services, while also increasing the expectations that such leaders have
on their colleagues in IT. For example, an institution could conduct
analyses about a new warfarin clinic and its impact on patient outcomes as
well as its associated operational costs to the institution for staffing,
supplies, and management. Litigation avoidance costs could be also
considered in these analyses.
Almost in lockstep, the emergence of the internet in the early 1990s led
to customer expectations that information about all topics should be at the
fingertips of both clinicians and customers (often with li le consideration
being given as to whether the information is accurate or can be trusted).
As a result, patients and families have new expectations in terms of both
access to and transparency of data from their caregivers, with the
expectations of patients, families, and other healthcare consumers often
exceeding that of healthcare providers and institutions.
More recently, the era of Meaningful Use and health reform has brought
regulatory mandates and incentives, as well as new market pressures, to
the forefront. For example, healthcare is increasingly being reimbursed for
the value provided to patients, rather than simply on the volume of
services rendered. To effectively respond to these changes, organizations
have had to commit significant capital to health IT while requiring ever
more sophisticated data analyses to refine clinical care delivery processes
and improve outcomes.
These internal and external forces are causing organizations to rethink
their priorities and how both capital and operational and human resources
are focused. This requires a change in health IT governance for which
many organizational leaders are not prepared. Information has become a
strategic asset that is essential to survival within the current healthcare
context, and the demands on those with health IT expertise are expanding
quickly. As the demands rapidly outstrip the internal capacity to meet the
need, prioritization of projects becomes imperative. This is the role of
governance.
The Continual Increase in Demand for Health
Information Technology
Due in large part to the successful implementation of core enabling
technologies such as EHR systems and computerized provider order entry
(CPOE) systems, a continual increase is evident in the demand for health
IT resources by providers and administrators who increasingly see health
IT as a key tool for achieving their goals. Indeed, the implementation of
core clinical information systems is just the beginning of an institution’s
health IT road map, as the availability of these core infrastructure
components opens up the possibility of ever more advanced uses of health
IT, whether it be data mining, point-of-care decision support, or
population health management. Moreover, especially within AMCs, a
growing demand exists for health IT resources to support research
missions such as health services research, outcomes research, and
personalized healthcare research. Readers are referred to Chapters 8
(telehealth), 12 (ePatients), 15 (mHealth), 23 (data science and analytics),
and 24 (patient safety initiatives) as examples of this growing demand for
IT support. Again, the need to prioritize and manage the continuously
growing demand for health IT resources is a core role of health IT
governance.
Governance Does Not Depend on Specific
Technology Choices
The selection of specific health IT solutions, such as an EHR system, is
certainly a critical health IT decision for an institution. However, health IT
governance should be independent of any particular technology choices
made. Instead, health IT governance should guide those types of
technologies and technology choices. For example, the selection of an EHR
system, population health management tool, or business intelligence
platform should be within the scope of the expected responsibility of a
health IT governance structure. In particular, it is imperative that the
governance structure has mechanisms in place to obtain the perspectives
of all relevant stakeholders and make decisions in a manner that fosters
stakeholder buy-in and sustained support for these oftentimes long-term
health IT investment decisions. For instance, providers and pharmacists
are obvious key stakeholders for EHR governance structures, while
financial analysts are clearly needed for business intelligence initiatives.
Coordination and Collaboration with Diverse
Stakeholders
Because of their very nature, health IT initiatives require the close
coordination and collaboration of various institutional stakeholders. For
example, an EHR system implementation will affect virtually every area of
a healthcare organization. This need for multi-stakeholder engagement is
discussed in detail in Chapters 16 (selecting a system) and 19
(implementing systems). Thus a traditional governance structure that is
informatics centered by nature may present a barrier to the kind of
integrated, cross-stakeholder coordination and collaboration required. A
medication safety initiative, for example, may need the close engagement
of the pharmacy and therapeutics commi ee and other relevant
stakeholders from groups such as pharmacy and nursing, perhaps more so
than a health IT governance commi ee. As discussed earlier, substantial
consideration must be given to how the health IT governance takes into
account and coordinates with existing governance structures outside
health IT. For instance, Chapters 16 (strategic planning and selecting
systems) and 17 (project management) discuss the need for
interdisciplinary project management to ensure projects fulfill the needs of
diverse stakeholder groups.
Recommendations
One of the biggest challenges for organizations addressing health IT
governance is deciding where to begin. As mentioned, there is very li le
literature to provide guidance on the effective governance of health IT. The
following recommendations are provided with the understanding that this
is an evolving area of focus in the industry. Organizations may well need
to make course corrections or experiment with different approaches until a
more permanent solution emerges.
Conduct a Health Information Technology Capability
Maturity Assessment
A good starting point in developing a health IT governance model is
obtaining an understanding of the current health IT structure and culture.
A well-defined resource that can be used for conducting such an
assessment is the Informatics Capability Maturity Model developed by
the United Kingdom’s National Health Service.3 This qualitative model
(Table 29.1) assesses an organization’s capabilities with respect to five
dimensions, measured on a scale of 1 (basic) to 5 (innovative).
Table 29.1
Informatics Capability Maturity Model Dimensions
Dimension Definition
Managing The degree to which users have access to the right information at the right time
information
Using business The degree to which business data are effectively analyzed and presented to inform business
intelligence and clinical decision making
Using information The degree to which IT is innovatively leveraged to enable leaner processes and seamless
technology information flows
Aligning business The degree to which an organization values health IT as a strategic asset and has the
and informatics capability to ensure that it can be exploited to deliver against its business objectives
Managing change The degree to which an organization has a structured and effective approach to realizing the
full benefits of health IT to enable business change
IT, Information technology.
Of note, the effectiveness of health IT governance is measured both
directly and indirectly across each of these dimensions. For example, the
following are governance-related characteristics across the five dimensions
that scored 5 in each category for an organization with an innovative
health IT capability (level 5):
• Managing information. Senior management sees information as being
core to business success and exploits it to improve service quality,
efficiency, and productivity.
• Using business intelligence. Executives and managers embrace business
intelligence and use it to set and manage business strategy.
• Using information technology. IT is a key focus of the business strategy
encompassing all aspects and elements of its business provision.
• Aligning business and informatics. Governance processes support and
sustain the integration of strategic business planning and health IT
planning.
• Managing change. Governance arrangements are a core aspect of
organizational control, with demonstrable reporting lines to the
executive board level and with clear ownership and control
responsibilities embedded within the organization.
The Informatics Capability Maturity Model includes a self-assessment
tool4 that can be completed in approximately 2 hours in a forum that
allows sufficient time for discussion and debate. To understand an
organization’s baseline state with regard to its health IT capabilities
generally and its health IT governance specifically, an organization
looking to enhance its health IT governance should first complete this self-
assessment in a process led by its senior leadership. As part of this self-
assessment, an organization should explicitly identify the current health IT
governance structure and processes, including in particular the various
channels through which commi ees and institutional stakeholders
currently request informatics resources and how those institutional needs
are prioritized.
Upon completing this baseline assessment, an organization should be
able to identify the current maturity of its health IT governance and how
improvements in that governance could advance the organization’s ability
to achieve its strategic objectives. If, for instance, the assessment reveals a
low score across all five dimensions, the establishment of a health IT
governance structure is probably urgently needed, albeit with a somewhat
less mature model than one might find at a more advanced institution. The
next step would be to identify potential health IT governance models that
could be appropriate for the organization, given its current health IT
maturity level.
Investigate Peer Informatics Governance Models
There is unfortunately no single model for health IT governance, just as
there is no single model for other areas of organizational governance.
Rather than offering a prescriptive solution, the organization needs to
investigate health IT governance models that are already in place at
organizations of similar size and complexity. Key questions to consider
when investigating other organizations’ health IT governance include the
following:
• How mature is the health IT capability at the organization? What are
the potential implications to governance if an organization has a
significantly different health IT capability?
• What is the official governance structure and process?
• Are there ad hoc governance processes in place, for example, in terms
of individual institutional leaders requesting health IT governance
support and prioritizing informatics activities?
• What works well with the governance? What could be improved?
• Are there aspects of the governance that are dependent on unique
characteristics of the organization, such as its culture or specific
individuals?
Fig. 29.2 provides a sample health IT governance structure that may be
appropriate for a large academic health system. Note that this structure is
significantly more complicated than the one in Fig. 29.1, which may be
more feasible and appropriate for a smaller healthcare system or a
healthcare system with fewer competing needs related to research and
education. In this sample governance structure there are three main
sources of authority: the dean of the school of medicine, the chief executive
officer (CEO) of the hospitals and clinics, and the CEO of the physician
medical group, which in this case is independent of the university. In this
organizational structure, the primary health IT governance is intended to
be the IT steering commi ee, which oversees the creation and
implementation of the health IT governance strategic plan. However, other
commi ees and organizational subunits also make significant demands on
health IT resources, including a center for health services research, an
office of research informatics, a value council with oversight of initiatives
to improve care value, and various other commi ees such as for finance
and population health management. The key to enabling effective
prioritization in this environment is global prioritization of the various
competing initiatives by the senior leadership and, perhaps more
importantly, determination of what will need to wait until the priority
initiatives are completed. Also critical to enabling this sample health IT
governance structure to work effectively is empowering the IT steering
commi ee to adjudicate competing demands in terms of large-scale
initiatives that require significant capital funding and operational
resources.
FIG 29.2 Sample informatics governance structure for an academic
health system.
Design, Implement, and Iteratively Enhance
Informatics Governance
Following the baseline assessment of current health IT governance and the
evaluation of the benefits and limitations of the governance models in
place at peer institutions, the findings should be synthesized, and a small
number of candidate governance approaches should be generated for
consideration by senior leaders and other key informatics stakeholders. In
developing these candidate approaches, the following principles should be
considered:
• Balance the sophistication of the health IT governance model with the
organization’s health IT capability maturity assessment.
• Develop a health IT governance structure that is reflective of the high
level of organizational collaboration required for an effective health IT
governance program.
• Propose a health IT governance structure that reports to the highest
strategic body within the organization, whether that is an executive-
level commi ee or a senior-level executive position.
• Consider and align with the unique characteristics and culture of the
institution. For example, take into account the viewpoints and
preferences of key senior leaders and whether the organization has a
centralized culture with top-down decision making or a decentralized
culture with consensus-driven decision making.
Following an open discussion of the candidate health IT governance
model by senior leaders and other key stakeholders, the candidate
approach deemed to be most suitable for the organization should be
refined with operational details. Moreover, to the extent possible,
consensus regarding the candidate approach should be developed across
all stakeholder groups, in particular with groups and individuals that have
traditionally had a central role in the use and prioritization of health IT
governance resources.
When sufficient institutional consensus has been a ained, the new
health IT governance model should be implemented. The impact of the
new model, including unintended consequences, should be actively
evaluated. The health IT governance should then be iteratively assessed
and refined as needed, with the ultimate goal of ensuring that health IT is
fully aligned with the strategic direction of the institution and that limited
health IT resources are used optimally.
Conclusion and future directions
Looking forward, healthcare organizations are likely to face ever more
opportunities and challenges that require the effective leveraging of health
IT. Given the rapidly changing healthcare environment, it will be critical
for healthcare organizations to develop a health IT governance structure
that allows priorities and direction to be rapidly adapted to these changes.
Moreover, given the increasingly vital role of health IT in almost all
aspects of a healthcare organization, it is important for health IT
governance to incorporate the viewpoints of relevant stakeholders, such as
providers, from across the enterprise. The governance approach needs to
be balanced and collaborative yet still capable of focusing on strategic
priorities without being pulled in a thousand directions by various
competing demands. In looking toward the numerous opportunities and
challenges ahead for healthcare organizations, a key factor in an
organization’s ability to survive and thrive will be its ability to implement
effective health IT governance.
References
1 Kropf R., Scalzi G. IT Governance in Hospitals and Health Systems.
Chicago, IL: Healthcare Information and Management Systems
Society; 2012.
2 Hoehn B.J. Clinical information technology governance. J Healthc
Inf Manag. 2010;24(2):13–14.
3 United Kingdom Health and Social Care Information Centre.
Informatics Capability Maturity Model.
h p://[Link]/article/4931/Informatics-Capability-
Maturity-Model-ICMM. August 4, 2016 Accessed.
4 United Kingdom Health and Social Care Information Centre.
Informatics Capability Maturity Model tool.
h p://[Link]/article/4933/ICMM-tool. August 4, 2016
Accessed.
Discussion Questions
1. What unique characteristics within the organizational culture at your
institution are relevant in terms of their impact on health IT governance?
2. Using the Informatics Capability Maturity Model as a guide, describe
the current state of health IT governance at your organization.
3. In what ways has health IT governance at your organization been
affected by the Health Information Technology for Economic and
Clinical Health (HITECH) Act?
4. How does the current health IT structure at your institution support or
hinder the effectiveness of informatics specialists in nursing, medicine,
and other disciplines?
5. What opportunities do you see for health IT governance to facilitate the
achievement of strategic priorities at your institution?
Case study
Imagine that you have been hired as the chief information officer (CIO) of
an academic healthcare system. The healthcare system consists of several
large hospitals and several dozen outpatient clinics, all using the same
EHR system. There is an affiliated but independent physician practice
group as well as a School of Medicine with a strong research focus. The
current health IT governance structure is as described in Fig. 29.2, except
that the current commi ees function independently of one another, and as
a result, health IT resources are being overwhelmed by requests coming
from a variety of sources, each with its own priority list. As one of your
first tasks on the job, you have been asked to lead the formulation and
implementation of a new health IT governance structure. The effectiveness
of the new governance structure will be critical to your success and the
success of your team and the institution as a whole.
Discussion Questions
1. How would you go about assessing the current state of health IT
governance and your organization’s health IT governance
capabilities?
2. What issues would you need to consider in recommending improved
health IT governance at your institution?
3. How could the informatics governance at your institution be more
centralized to allow an enterprise-wide approach to prioritizing
informatics efforts?
UNIT 7
Education and Health
Informatics
30
Informatics in the Curriculum for
Healthcare Professionals
E. LaVerne Manos; Helen B. Connors; Judith J. Warren; Teresa Stenner
Abstract
Health and healthcare in this country and around the world are being transformed
by advances in information and communication technology (ICT). Increasingly these
industries are turning to digital information and the use of electronic communication
to fundamentally change the services they provide. The Health Information
Technology for Economic and Clinical Health (HITECH) Act of 2009 laid the
foundation to operationalize the infrastructure for a digital healthcare system. This
unprecedented change has major implications for the workforce and workforce
development. The widespread adoption of electronic health records (EHRs), digital
communications between patients and healthcare providers, accessible web-based
health information, remote diagnosis and treatment, and the availability of large
health data repositories necessitate widespread training and upgrading of skills for
health practitioners and support for workers who will interface with patients and
these technological advances. Health professional education is a vital component of
the Learning Health System (LHS).1 This chapter focuses on the interface between
the LHS and a health professional curriculum that will help drive that system.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Summarize the forces driving the integration of informatics into the
curriculum for health professionals.
2. Recommend appropriate pedagogic approaches for the incorporation
of informatics competencies for generalist and specialist.
3. Articulate the importance of continued professional development.
4. Analyze the challenges of informatics education.
5. Operationalize the interprofessional team approach to informatics
education and practice.
KEY TERMS
health information exchange (HIE) 500
interprofessional education (IPE) 507
Learning Health System (LHS) 500
Introduction and background
Overview of Informatics and Health Information
Technology
To understand the discipline of informatics and the various roles within
informatics, it is important to understand the national, regional, and local
contexts of the use of health information and the political agenda for the
use of health information technology (health IT). Health information and
health IT have received significant federal strategic a ention for more than
a decade. Since 1999, the various Institute of Medicine (IOM) reports have
linked health IT to the improvement of healthcare. In the first IOM report,
To Err Is Human, one of the main conclusions is that the majority of
medical errors are caused by faulty systems, processes, and conditions that
lead people to make mistakes or fail to prevent mistakes.2 The report
emphasized the importance of IT in implementing safe systems to ensure
safe practices at the point of care. The next IOM report, Crossing the Quality
Chasm, not only addressed the importance of health IT but also noted how
crucial it is to all aspects of clinical decision making, the delivery of
population-based care, consumer education, professional development,
and research.3 In 2003, the IOM issued a third report, Health Professional
Education: A Bridge to Quality.4 This report called for including informatics
as a core competency in the educational programs of all health
professionals.
After slow but steady progress over a decade in converting paper-based
health records to electronic delivery, President Obama signed into law the
American Recovery and Reinvestment Act (ARRA) on February 17, 2009.5
Among other initiatives, the HITECH Act, enacted as part of ARRA, put
resources behind the Office of the National Coordinator for Health IT
(ONC). The widespread meaningful use of EHRs and health information
exchanges (HIEs) encouraged by this act has expanded greatly in the past
few years.
In 2010, to be er understand the impact of health IT on patient safety,
the ONC commissioned the IOM to summarize the existing knowledge of
the effects of health IT on patient safety and to make recommendations for
both federal and private sector organizations to maximize health IT and
patient safety. The resulting report, Health IT and Patient Safety: Building
Safer Systems for Be er Care (“IOM Report”), was released in 2012.6
Building upon the 2011 IOM Report, in July 2013, the ONC published the
Health IT Patient Safety Action and Surveillance Plan and established
ONC’s Health IT Safety Program to coordinate activities related to the
plan.7 Although much progress has been made in adoption and
meaningful use of health IT across the nation, much work needs to be
done to see that every person and their care provider can get appropriate
health information when and how they need it. To this end, in June 2014,
the ONC released Connecting Health and Care for the Nation: A 10-Year Vision
to Achieve an Interoperable Health IT Infrastructure.8 This paper described
ONC’s broad vision and framework and was the springboard for the
Shared Interoperability Roadmap and the ONC Strategic Plan, both
released in 2015.
The HITECH Act and its funding positioned informatics and health IT at
the forefront of all healthcare sectors, including health professional
education. The major foundational trends to watch are Meaningful Use
(MU), quality measures, interoperability, patient engagement, data
analytics, and the Learning Health System (LHS), all of which can be
expected to have a major impact on the informatics-related education of all
health professionals. A Learning Health System (also referred to as a
Learning Healthcare System) is defined as one with “goal-oriented
feedforward and feedback loops that create actionable information with
the potential to effect marked improvements in population health and
decreases in the cost of evidence-based care if implemented correctly.” 1, p
20.
Education Reform Initiatives
For the past decade, the previously mentioned driving forces have spurred
health professional organizations and special interest groups to call for
transformation in education. This transformation includes the addition of
health informatics and health IT competencies in the curriculum for all
health professionals. As the United States continues to transform its
healthcare system to be safe, efficient, patient centered, timely, equitable,
and effective, it must invest in the education of individuals to ensure that
the workforce is poised to meet the challenge of this newly integrated
health system. The demand for an increasingly technological and
integrated health system requires educators to use an interprofessional
approach to education while continuing to meet the specific needs of the
different health workers.
Nursing in particular has played a leading role in this transformation. In
1992, the American Nurses Association (ANA) recognized nursing
informatics as a nursing specialty that integrates nursing science,
computer science, and information science to manage and communicate
data, information, and knowledge in nursing practice. The definition was
further articulated and roles and responsibilities were defined in the first
editions of The Scope of Practice for Nursing Informatics9 and The Standards of
Practice for Nursing Informatics.10 As technology and informatics developed
over time, these documents were combined into the ANA’s Scope and
Standards of Nursing Informatics Practice11 and expanded in 2008 and again
in 2015 as Nursing Informatics: Scope and Standards of Practice12,13 to reflect
the growing changes in nursing informatics roles and responsibilities
brought about by the dramatic bolstering of the nation’s health IT agenda.
The Technology and Informatics Guiding Education (TIGER) and the
Quality and Safety Education in Nursing (QSEN) initiatives, launched in
2005, spearheaded the development of informatics competencies across the
nursing curriculum. Later, with the emphasis on interprofessional
competencies (IPE),14 the TIGER and QSEN quality and safety competency
model was adapted by other health professional organizations.
Additionally, accrediting agencies for health professional education
programs added core informatics knowledge and skills as a curriculum
requirement. This is congruent with the IOM’s specification that education
for healthcare professionals includes the use of informatics in the clinical
area.15 Currently, the American Medical Informatics Association (AMIA)
Academic Forum and the Health Informatics Accreditation Commi ee are
working to delineate these competencies for graduate health professional
education. More recently, other health professional organizations and
credentialing agencies have established initiatives to emphasize the
inclusion of core informatics, as well as interprofessional practice,
knowledge, and skill in all undergraduate, graduate, and continuing
education programs for health professionals.
Accreditation, Certification, and Credentialing
Accreditation, certification, and credentialing are quality indicators for
ensuring accountability in a specific field of study. As the field of
informatics expands, it is imperative to ensure a standard of education,
training, and continuing endorsement of informatics professionals. This
standard of excellence is accomplished through three activities:
educational program accreditation, individual certification, and
organization/individual credentialing. These three activities, while
working independently, work synergistically to achieve the goal of
quality. Table 30.1 lists these activities and examples of various
professional associations involved in these activities in health informatics.
Table 30.1
Quality Indicators
Accreditation of educational programs and institutions in the United
States is a means to ensure and improve the quality of higher education
through the use of a set of standards developed by peers. An institution or
program that has successfully completed an accreditation review has in
place the needed curriculum, qualified faculty, student support and other
services to assist students in achieving their educational goals.16 The
primary accreditation organization for accrediting health informatics
programs is the Commission on Accreditation for Health Informatics and
Information Management Education (CAHIIM). As accreditation moves to
a student outcomes focus, the development of health informatics
competencies is critical. Competencies are developed by professional
organizations, such as the AMIA, and then used by the accrediting
organization. The CAHIIM standard concerning curriculum states that the
curriculum must build on health informatics competencies. However, at
this point in time, many informatics-related programs exist within
university programs that are accredited as part of the specialty
accreditation for that program. For example, a nursing informatics tract
offered as part of a school of nursing graduate program could be
accredited by either Accreditation Commission for Education in Nursing
Inc. (ACEN), the Commission on Collegiate Nursing Education (CCNE),
or the NLN Commission for Nursing Education Accreditation (CNEA).
Certification is a process that indicates that an individual or institution
has met predetermined standards. Many specialty areas, such as
informatics, have professional organizations that provide certification to
individual practitioners to ensure that the individuals are qualified in
terms of knowledge and skills. A person is certified as being able to
competently complete a job or task, usually by the passing of an
examination. Certification examinations are developed from job analyses
and professional competencies. Additional information about the history
of the certification process in health informatics is included in Chapter 35.
Credentialing is the process of establishing the qualifications of licensed
professionals, organizational members or organizations, and assessing the
professional’s and/or organization’s background and legitimacy.17 In this
process, the individual or the organization presents evidence that they are
prepared to practice in a competent and safe manner. The evidence may be
graduation from an accredited program, individual certification,
demonstration of continuing education, and other forms of scholarship.
These three quality indicators of health informatics practice depend on
the professional association to develop practice competencies. The
professional organization describes the discipline through these
competencies. Accreditation defines standards and peer review to
determine standard achievement. Certification is accomplished through
examination of the individual’s ability to demonstrate competency and job
mastery. Credentialing requires evidence that includes accreditation and
certification. These activities form a three-legged stool that defines and
promotes the knowledge and skills for the discipline of health informatics.
One of the primary professional organizations engaged in activities to
support accreditation and certification in health informatics is the AMIA.
AMIA became a member of CAHIIM in 2015 and, in cooperation with
CAHIIM, established the Health Informatics Accreditation Commi ee to
coordinate the development of health informatics competencies to be used
in the accreditation of health informatics programs.
In addition, AMIA established the Advanced Interprofessional
Informatics Certification (AIIC) task force to develop a certification process
for professionals who practice clinical/health informatics at an advanced
level.18 AMIA also collaborated with the American Board of Medical
Specialties (ABMS) and American Board of Pathology (ABP) to develop a
certification examination for board certified physicians in the subspecialty
of clinical informatics.
Challenges of Technology-Enhanced Education
Several challenges must be overcome to teach informatics and assist
students at all levels to develop appropriate competencies. The paucity of
faculty prepared to teach informatics competencies is well documented.19
Although advanced informatics education programs are accelerating,
finding qualified faculty to teach in these programs is extremely difficult.
At the same time, health IT tools and applications in the curriculum are no
longer a luxury but a necessity. Teaching informatics requires knowledge
of the content, experience in the use of informatics skills in clinical
practice, and access to health IT tools for the curriculum.
Faculty Expertise
Any strategy to include informatics in health professionals’ education
must involve a ention to faculty informatics expertise. The ability for
faculty to teach informatics competencies at the appropriate level depends
on (1) faculty understanding of the informatics competencies needed by
their students; (2) faculty ability to understand the parallels of health,
healthcare, and health IT as well as quality and safety; (3) faculty
ownership of the need for informatics; and (4) support from their schools
and department leadership, including infrastructure and help with
technology needs as they arise.
“AMIA considers informatics when used for healthcare delivery to be
essentially the same regardless of the health professional group involved
(whether dentist, pharmacist, physician, nurse, or other health
professional).”20 The focus is not the profession but improving the use of
information with the assistance of technology. Health informatics is a
relatively new subject in healthcare and recently has received more
recognition as a specialty area. A growing number of health profession
certifying bodies understand the importance of and the need for students
to learn the concepts and competencies of health informatics and have
started including this information in their national exams. As is not
unusual for a newer specialty, the only alternative is often to recruit
willing but untrained personnel from the existing faculty or healthcare
team and appoint them to cover informatics. These practitioners or faculty
are then expected to teach students and/or colleagues clinical informatics
concepts and methodologies or to begin building or optimizing an EHR.
All programs educating direct and indirect care providers at the various
competency levels need to prepare professionals to “be able to synthesize
knowledge; integrate evidence into practice; work collaboratively and in
interdisciplinary teams; use clinical information and decision support
systems, and provide safe and ethical care”25, p. IX.) Faculty in all healthcare
education programs need formal informatics education or faculty
development that matches the level of learner they teach. The
Competencies Matrix of Health Information Technology and Informatics
Skills is displayed in Box 30.1.
Box 30.1
Competencies Matrix of Health Information
Technology and Informatics Skills
Direct Patient Care
Generalist (All students and health professionals need
this information.)
• Demonstrate skills in using patient care technologies, information
systems, and communication devices that support safe practices.
• Use telecommunication technologies to assist in effective communication
in a variety of healthcare se ings.
• Apply safeguards and decision-making support tools embedded in
patient care technologies and information systems to support a safe
practice environment for both patients and healthcare workers.
• Understand the use of CIS to document interventions related to
achieving positive outcomes.
• Use standardized terminology in a care environment (e.g., functional
independence measures, nursing diagnosis terminology).
• Evaluate data from all relevant sources, including technology, to inform
the delivery of care.
• Recognize the role of IT in improving patient care outcomes and creating
a safe care environment.
• Uphold ethical standards related to data security, regulatory
requirements, confidentiality, and clients’ rights to privacy.
• Apply patient care technologies to address the needs of a diverse patient
population.
• Advocate for the use of new patient care technologies for safe, quality
care.
• Recognize that redesign of workflow and care processes should precede
implementation of care technology to facilitate practice.
• Participate in evaluation of information systems in practice se ings
through policy and procedure development.
Direct and Indirect Patient Care
Graduate Level
Master’s
• Analyze current and emerging technologies to support safe practice
environments and optimize patient safety, cost effectiveness, and health
outcomes.
• Evaluate outcome data using current communication technologies,
information systems, and statistical principles to develop strategies to
reduce risks and improve health outcomes.
• Promote policies that incorporate ethical principles and standards for the
use of health and information technologies.
• Provide oversight, guidance, and leadership in the integration of
technologies to document patient care and improve patient outcomes.
• Use information and communication technologies, resources, and
principles of learning to teach patients and others.
• Use current and emerging technologies in the care environment to
support lifelong learning for self and others.
Practice Doctorate (DPT, DDS, DNP, MD, DOT, PharmD, etc.)
• Design, select, use, and evaluate health IT programs, including
consumer use of healthcare information systems.
• Analyze and communicate critical elements necessary to the selection,
use, and evaluation of healthcare information systems and patient care
technology.
• Demonstrate the conceptual ability and technical skills to develop and
execute an evaluation plan involving data extraction from practice
information systems and databases.
• Provide leadership in the evaluation and resolution of ethical and legal
issues within healthcare systems relating to the use of information, IT,
communication networks, and patient care technology.
• Evaluate consumer health information sources for accuracy, timeliness,
and appropriateness.
Indirect Patient Care
Health IT Support
Workflow and Information Management (IM) Specialist
• Document workflow and IM models of practice.
• Conduct user requirements analysis.
• Develop revised workflow and IM models based on Meaningful Use of a
certified EHR product.
• Develop a set of plans to keep the practice running if the EHR system
fails.
• Work directly with practice personnel to implement the revised
workflow and IM model.
• Evaluate the new processes, identify problems and solutions, and
implement changes.
• Design processes and information flows that accommodate quality
improvement and reporting.
Implementation Support Specialist
• Install hardware and software to meet practice needs.
• Incorporate usability principles in software configuration and
implementation.
• Test the software against performance specifications.
• Interact with the vendors to rectify technical problems that occur during
the deployment process.
• Proactively identify software or hardware incompatibilities.
• Assist the practice in identifying a data backup and recovery solution.
• Ensure that the mechanism for hardware and software recovery and
related capabilities is appropriately implemented to minimize system
downtime.
• Ensure that privacy and security functions are appropriately configured
and activated.
• Document IT problems and evaluate the effectiveness of problem
resolution.
• Assist end users with audits.
Technical and Software Support Staff
• Interact with end users to diagnose IT problems and implement
solutions.
• Document IT problems and evaluate the effectiveness of solutions.
• Support systems security and standards.
• Assist end users with the execution of audits and related privacy and
security functions.
• Incorporate usability principles into ongoing software configuration and
implementation.
• Ensure that the hardware and software “fail-over” and related
capabilities are appropriately implemented to minimize system
downtime.
• Ensure that privacy and security functions are appropriately configured
and activated in hardware and software.
• Interact with the vendors as needed to rectify technical problems that
occur during the deployment process.
• Work with the vendor and other sources of information to find the
solution to a user’s questions or problems as needed.
Informatics Specialists
Consultant
• Analyze and recommend solutions for health IT implementation
problems in clinical and public health se ings.
• Advise and assist clinicians in taking full advantage of technology,
enabling them to make best use of data to drive improvement in quality,
safety, and efficiency.
• Assist in selection of vendors and software by helping practice personnel
ask the right questions and evaluate answers.
• Advocate for users’ needs, acting as a liaison between users, IT staff, and
vendors.
• Ensure that the patient and consumer perspective is incorporated into
the EHR, including privacy and security issues.
• Train practitioners in best use of the EHR system, conforming to the
redesigned workflow.
• Provide leadership, ensuring that implementation teams function
cohesively.
Implementation Project Manager
• Apply project management and change management principles to create
implementation project plans to achieve the project goals.
• Interact with diverse personnel to ensure open communication across
end users and with the support team.
• Lead implementation teams consisting of workers in the roles described
previously.
• Manage vendor relations, providing schedule, deliverable, and business
information to health IT vendors for product improvement.
• Coordinate implementation-related efforts across the implementation
site and with the health information exchange partners, troubleshooting
problems as they arise.
• Apply an understanding of health IT, Meaningful Use, and the
challenges practice se ings will encounter in achieving Meaningful Use.
Trainer
• Be able to use a range of health IT applications, preferably at an expert
level.
• Communicate clearly both health and IT concepts as appropriate, in
language the learner or user can understand.
• Apply a user-oriented approach to training, reflecting the need to
empathize with the learner or user.
• Assess training needs and competencies of learners.
• Accurately assess employees’ understanding of training, particularly
through observation of use both in and out of the classroom.
• Design lesson plans, structuring active learning experiences for users
and creating use cases that effectively train employees through an
approach that closely mirrors actual use of the health IT in the patient
care se ing.
• Maintain accurate training records of the users and develop learning
plans for further instruction.
Data Scientist
• Prepare the dataset using advanced analytics.
• Select appropriate analytics.
• Describe the dataset.
• Create and provide a visualization of the data.
Researcher and Innovator
• Conduct research on design, development, implementation, and impact
of informatics solutions.
• Conduct research on mobile health and telehealth technologies and the
impact on informatics.
• Conduct research on emerging pa erns of care and outcomes.
• Analyze outcomes leading to new evidence-based guidelines.
• Develop new methods of organizing data to enhance research capacities.
• Design and develop informatics solutions.
• Develop new ways to interact with computer systems and access data.
• Assist in se ing the future agenda for health informatics.
• Disseminate process and outcomes of research and product
development.
Note: Competencies apply to both students and their faculty in each category.
Despite these efforts to bring informatics to the forefront and increase
informatics knowledge and competencies in the curriculum, a number of
studies demonstrated slow progress on integrating these competencies in
the curriculum.21-24 Faculty have been cited as the largest barrier to greater
IT integration in education because they lack the knowledge and skills
regarding new technologies and their potential.25 However, recent federal
initiatives to coordinate efforts for the implementation and use of
advanced health IT have included support for faculty development in the
use and integration of information and other technologies. In addition,
private funders and professional organizations have developed initiatives
to enhance informatics in the curriculum.
Health IT Tools
In addition to experienced faculty, many academic institutions do not have
the infrastructure to support the integration of health IT tools, such as an
academic electronic health record (AEHR), essential for informatics
competencies in the curriculum. An AEHR is an adapted version of a
clinical information system used in acute and ambulatory care facilities,
with modifications that customize the product for the learning
environment. To be competent, students need to use the tools that they
will use in clinical practice. One such tool is an AEHR that incorporates
point-of-care evidence-based practice information. In many instances, the
cost of these tools is prohibitive in academic arenas or, if the tools are
available, faculty members often lack the knowledge and expertise needed
to strategically incorporate the tools in their teaching. Successful
implementation requires integration in the curriculum and a change in
workflow. Teaching students to be competent with health IT tools and
practices cannot be an add-on to an already overcrowded curriculum.
Faculty need to adjust their teaching practices to integrate the technology
into teaching and learning across the curriculum. To achieve this goal,
faculty need to critically examine what content is taught and how it
contributes to a workforce that supports the evolving LHS. For example, if
one of the goals of the LHS is to achieve the best outcome for every
patient, we need be er evidence at point of care on which to base
healthcare decisions. However, with the current pace of change, the
problem is the health professional’s ability to acquire the needed evidence
in a timely manner.26 While knowledge of the importance of evidence-
based practice is apparent in faculty publications, it has not yet found its
way extensively into the curriculum framework of many health
professional programs. As evidence-based healthcare practice evolves,
educators need to be ready to transform curriculum to ensure that
graduates have a new skill set that is recognized and used in the
healthcare se ing.26 However, for the most part curriculum is not readily
adaptable to change, thus creating a gap between education and practice
that needs to be resolved in this rapidly changing healthcare environment.
Curriculum that is agile, flexible, and up to date with employers’ needs in
a shifting healthcare environment will serve graduates well.
Teaching and learning in an evolving
healthcare and technology environment
Several reports and white papers published in the past decade suggest
paradigm shifts in health professional education. As the technology-driven
healthcare system continues to evolve, it is only right that we overhaul the
educational platforms to prepare graduates who are the core of the
healthcare environment.27 Health professionals, in all domains of practice
and at all levels, must be “technology competent” to be able to participate
in decision making and evaluation of health IT systems and their MU.
These systems are patient centered and support healthcare providers in
information management, knowledge development, and evaluation of
evidence-based innovative practice strategies that support value-based
care. Currently, the United States is facing transformative changes in
healthcare and living through one of the most dynamic ages in the history
of healthcare. Through technology advancements, drug discoveries, and
new medical device innovations, along with the ability to communicate
worldwide and deliver healthcare in different se ings, graduates will
witness more change in healthcare within the next few years than ever
before. Awareness of the continued transformation in the healthcare
environment is essential for practice.
The Role of Informatics in the Curriculum
The term informatics as it relates to healthcare is ubiquitous and
ambiguous, largely because of the various health professionals and related
disciplines that use health IT and health data.28 AMIA and its classification
of informatics domains—translational bioinformatics, clinical informatics,
clinical research informatics, consumer health informatics, and public
health informatics—provide one structure to the overall categories of
health informatics.
As new health IT evolves to meet the demands of the healthcare system,
informatics competencies need to be addressed at all levels of health
professional curricula. Informatics competencies should be considered
along a continuum from basic to advanced competencies. All health
professionals will need some level of basic informatics knowledge and
skills introduced in their curriculum, while certain clinicians and
informaticians will need advanced specialty education.
The History of Informatics Competency Development
Several disciplines have completed foundational work on needed
competencies: nursing, public health, and medicine. In the case of nursing
in the United States, the Delphi work in 2002 by Staggers et al. spurred
additional work on informatics competencies (e.g., for advanced practice
nurses and BSN students).24 The initial list of competencies was updated in
2011, and a review of informatics competencies was completed in 2012.29,30
This work continued through QSEN31 and the TIGER Informatics
Competency Collaborative.32 In 2007, the American Health Information
Management Association (AHIMA) and AMIA convened a joint task force
to identify basic core competencies expected of a healthcare workforce that
uses EHRs in their daily work. The results of this work is a matrix tool that
addresses cross-cu ing core competencies required of all health
professionals regardless of discipline.33
Likewise, public health experts completed a consensus list of informatics
competencies in the mid-2000s, and their most current work from 2009 is
available online at [Link]/informaticscompetencies.34 More
recently, in 2012 AMIA released a list of informatics competencies for
physicians to be certified in clinical informatics. Information is available on
the AMIA’s general website and at h ps://[Link]/biomedical-
informatics-core-competencies. Unfortunately, no consensus exists as of
yet about informatics competencies despite the large amount of work in
the area. Clearly more work is needed to harmonize informatics
competencies across disciplines and reach consensus about required core
competencies.
The Science of Informatics and Curriculum Design
The science of informatics is inherently interprofessional, drawing on (and
contributing to) a large number of other component fields, including
computer science, decision science, information science, management
science, cognitive science, data science, and organizational theory.
Discipline-specific sciences and practices, such as nursing, medicine,
dentistry, and pharmacology, are what differentiate how informatics is
applied. Knowledge of the interprofessional approach to informatics; the
science that underpins informatics; the relationship among the elements of
data, information, knowledge, and wisdom; and the corresponding
automated support systems drive the framework for curriculum
development.12 Working in teams across disciplines provides a be er
understanding of the various roles of the informatics team and assists in
placing the right competencies with the right role and educational level. In
addition, providing informatics education in an interprofessional
environment will assist in ensuring that health professionals in different
disciplines understand and appreciate the different levels and types of
competencies across disciplines.
Framework for informatics curriculum
The Learning Health System
The term LHS refers to the cycle by which the global health system learns
from itself. In broad terms, the health system starts by absorbing
information about patient treatment, then evaluates and applies the results
to similar patients and researches this data to create clinical guidelines and
policy. Finally, the health system incorporates the resulting
recommendations into the electronic system to support clinical decisions
in real time. The cycle continuously repeats and improves itself. In more
specific terms, the LHS encompasses much more than the healthcare
experience, and more than individual or patient-specific information. It
incorporates the macro system where all stakeholders (patients, healthcare
professionals, private payers, employers, public payers, researchers,
population health analysts, quality measure stewards, technology
developers, HIE, standards development organizations, hospitals and
hospital systems, government—federal, state, tribal, and local, etc.)
contribute, share, and/or analyze data to create information and new
knowledge to benefit patient care. This knowledge is then consumed by
stakeholders and becomes a continuous learning cycle in many
dimensions. The end product of a successful LHS is the emergence of
healthcare data that informs clinical decisions, reports on conditions or
events, and measures the quality of care while providing evidence for the
care of individuals and populations. A graphic of the LHS as visualized by
the ONC is shown in Fig. 30.1.
FIG 30.1 The Learning Health System. Source: ONC. connecting health and
care for the nation: a 10-year vision to achieve an interoperable health it infrastructure.
[Link]
As the LHS unfolds, this is an opportunity for health professional
education to be guided by this national model. Since the release of the
IOM’s LHS series, the ONC has become one of the prime promoters of the
LHS. The ONC released two important documents for public in 2015: the
interoperability roadmap and the strategic plan for 2015–20.35 The
roadmap contains the ONC’s interoperability goal and is ONC’s “vision
for a future Health IT eco system where electronic health information is
appropriately and readily available to empower consumers, support
clinical decision-making, inform population and public health and value
based payment, and advance science.”35 In this document, the ONC
focuses on achieving interoperability for health IT. The purpose of the
interoperability goal is to “support a broad scale learning health system by
2024.” The LHS is a critical element in meeting the goals and outcomes in
the proposed ONC strategic plan. In a system that increasingly learns from
data collected at the point of care and applies the lessons learned to
improve patient care, health professionals will be the cornerstone for
assessing needs, directing approaches, ensuring integrity of the tracking
and quality of the outcomes, and leading innovation.36 However,
practitioners and health professional educators need to know that how
and what they learn will dramatically change as technology, evidence-
based practices, and innovations evolve over time. Orienting the education
system to meet the needs of an evolving LHS requires new ways of
thinking about how we can create and sustain a healthcare workforce that
g
recognizes the by-products of an LHS and uses these by-products to adjust
curriculum and address lifelong learning needs. Therefore it is essential to
have a nimble curriculum that can readily adapt to change.
Pedagogy
Pedagogy is a broad term that includes multiple theories of behavior based
on the learning process. Modern pedagogy has been strongly influenced
by three major categories of theory: behaviorist, cognitive, and
constructivism. Behaviorists believe that learning is a change in behavior
caused by external stimuli—the “know what.” Early computer programs
were based on behaviorist theory. This theory is useful in learning basic
content and concepts. Cognitive psychology claims that learning involves
memory, motivation, thinking, reflection, and abstraction. It is concerned
with how to apply content, access and synthesize information, think
critically, and make decisions—the “know how.” Constructivism asserts
that learners interpret information and the world according to their
personal reality and that they learn by observing, processing, and
interpreting information and then customizing the information into
personal knowledge for immediate application. Learners use previous
knowledge to create new knowledge and act on it—the “know why.” The
LHS model is built on the theory of constructivism.
Teaching Tools and Learning Strategies
Today’s information age students are calling for learner-driven education
environments that provide access to powerful learning tools, knowledge
bases, and scholarly exchange networks for the delivery of learning. New
tools and new approaches must be incorporated to teach fundamental
concepts and methods that can be applied in different situations. For
example, there is no doubt that health professional students will encounter
EHRs in clinical practice; however, in many instances, students in clinical
practice se ings are denied access to documenting in this record. This is a
common but unsafe practice, since it forces the faculty, students, and staff
to develop workarounds for documenting care that was provided by
students. Integrating an AEHR in the curriculum as a teaching tool
provides students a nonthreatening approach to interacting with health IT
while learning discipline-specific content and processes. The interactive
learning approach with this technology includes viewing and entering
clinical documentation, viewing diagnostic results (lab, diagnostic
imaging, reports, etc.), performing chart reviews, order management,
medication administration and reconciliation, and developing plans of
care. It is through these and other learning activities that the student
begins to use evidence-based clinical practices, critical-thinking skills, and
data-driven decision making.
The AEHR also can be used to promote learning about decision support
tools, safety alerts, clinical workflow, population management, quality
improvement, and interprofessional learning. Education programs can
emphasize the importance of the EHR in healthcare, but unless there is an
opportunity for students to use the EHR in the clinical se ing, they will
not develop the competencies required for practice in a progressive,
technology-enriched healthcare environment.37 Yet using an EHR alone is
not sufficient for health professional students to learn the capabilities of
the clinical information system. Health professional students need a
theoretical base often provided via lectures, reading, and discussion to
completely understand the full potential of an EHR and HIE and how both
technologies can empower providers to be meaningful users of these
systems. The AEHR provides a technology teaching platform that
supports higher-order evidence-based teaching strategies such as active
learning, time on task, rapid feedback, collaboration,38,39 and
interprofessional education (IPE) when it is integrated across the health
professional’s curriculum. Interprofessional education is education that
provides students within the health disciplines “with opportunities to
learn and practice skills that improve their ability to communicate and
collaborate. Through the experience of learning with and from those in
other professions, students also develop leadership qualities and respect
for each other, which prepares them for work on teams and in se ings
where collaboration is a key to success.”39A, P 7 Other examples of teaching
and learning strategies that should be incorporated in the curriculum are
collaborative practice, knowledge management, simulation, and web tools.
An example of a collaborative practice tool is TeamSTEPPS®,40 an evidence-
based teamwork system that improves communication and teamwork
skills among health professionals. TeamSTEPPS is an established system
for improving patient safety as well as the efficiency and effectiveness of
the healthcare team. Because graduates are expected to work in
interprofessional teams, this skill needs to be part of all health professional
curricula. Additional information on TeamSTEPPS is located at
h p://[Link]/professionals/education/curriculum-
tools/teamstepps/[Link].
Similarly, knowledge management tools build individual and
organizational intelligence by enabling people to improve the way in
which they capture, share, and use knowledge. Knowledge management
involves not only building your own knowledge repository (personal
knowledge management) but also using the knowledge, ideas, and
experience of others to improve the organization’s performance. An LHS
incorporates knowledge-based decision support tools to build on what
works well and discover which evidence leads to be er practice, strategy,
and policy.
Simulation is a tool used to assist in resolving the patient safety issue
while enhancing student learning. During the past decade, simulation in
health professional programs has increased exponentially. Simulation is an
educational process that replicates the clinical work environment,
including informatics, and requires students to demonstrate an identified
skill set. Simulation-based IPE is a new phenomenon with increasing
evidence to support outcomes. Qualitative feedback regarding IPE
indicates that participants report feeling comfortable learning with
students from other professions and find value in the interprofessional
simulation sessions. Additional information on how to understand and
effectively use simulation can be found in Chapter 29.
Web tools (see Chapters 31 and 32) are on the rise in all aspects of our
lives, including healthcare and education. The emergence of new classes of
web-based applications has introduced new possibilities for healthcare
delivery as well as new environments for teaching and learning. A variety
of web tools is available, and the menu continues to grow. Some of these
tools are blogs, podcasts, social media networks (e.g., Facebook, Twi er,
YouTube), and virtual worlds (e.g., Second Life). For example, Second Life
can be used to set up a virtual conference room so that remote informatics
students can practice interviewing a hospital executive for a mock EHR
installation.
Mobile and connected health technologies are changing the way in which
consumers and healthcare providers access information and learn. The
LHS is a multi-stakeholder collaboration across the public and private
sector, including patients, consumers, caregivers, and families.
Fundamental to the LHS is the full engagement of patients and the public.
New mobile technologies and emerging health apps allow more patient
access to healthcare than ever before and allow for on-demand treatment
and health management. As the momentum for patient engagement
builds, it will be imperative that we prepare health professionals in this
world of connected health.41 Seamlessly integrating mobile and digital
technologies (smartphones, iPads, robots, patient portals, secure
messaging, personal health records, mobile apps, social media, and
patient-generated health data tools) in the curriculum is an efficient and
effective mechanism for bringing health professional education into the
digital age and assisting students to gain the competencies they need in
practice. Table 30.2 shows some examples of suggested learning strategies
to integrate the teaching tools in the curriculum.
Table 30.2
Examples of Teaching Tools and Strategies
It takes a village: roles and competencies
A standard list of informatics competencies does not exist. What is clear is
that all undergraduate, graduate, and practicing health professionals need
to have a certain level of knowledge about and competency in informatics
and its impact on an LHS that supports evidence-based practice, quality
care, and safety. In addition, informatics specialists are needed to work in
interprofessional teams to provide vision, leadership, and management
and to advance the science of health informatics through wisdom,
research, and innovation. Informatics specialists, educated in informatics
specialty programs at the master’s or doctoral level (both the research
doctorate [PhD] and the practice doctorate) will continue to be in high
demand. Currently there are not enough health professionals in this
specialty area of practice. In addition, subspecialties within health
informatics with their own additional education needs are beginning to
evolve. For example, a more recent key player on the informatics team is
the “data scientist.” These individuals bring structure to large quantities of
“big data” generated by the LHS. Data scientists analyze large volumes of
health data, often from various sources, in order to identify trends, extract
knowledge, make discoveries, and visually communicate the data in a
clear, competent, and meaningful manner. The goal is to leverage the
power of analytics to improve care and lower cost. These subspecialists
within informatics needed to be well prepared in the discipline of health
informatics but must also receive additional education for their role as a
data scientist.
Health IT Workforce Roles
Over the past few years, the HITECH Act programs have had a significant
impact on health IT roles and competencies. In 2010, the U.S. Department
of Health & Human Services (HHS) estimated a shortfall of approximately
51,000 qualified health IT workers over the next 5 years based on data
from the Bureau of Labor Statistics, the Department of Education, and
independent studies. In an a empt to address this shortfall, the ONC
awarded grants totaling $84 million to 16 universities and junior colleges
to help support the training and development of more than 50,000 new
health IT professionals. A total of 12 key health IT workforce roles were
identified. Each role has specific required educational preparation and
outcomes. Six roles require 1-year university-based training and the
remaining six roles require 6 months of intense training in a community
college or distance-learning organization. As of October 2013, 20,777
graduates were reported to have completed the university-based (1704)
and community college programs (19,773). This is not even close to the
51,000 shortfall projected in 2010. Recently, ONC issued $6.4 million in
new funding to continue to train the health IT workforce. Specifically,
awardees will update training materials from the original Workforce
Curriculum Development Program and train 6000 incumbent healthcare
workers to use new health information technologies in a variety of
se ings: team-based care environment, long-term care facilities, patient-
centered medical homes, accountable care organizations, hospitals, and
clinics. The workforce efforts will focus on four key topic areas: population
health, care coordination, new care delivery and payment models, and
value-based care.42
Box 30.1 organizes the competencies derived from the ANA’s Nursing
Informatics: Scope and Standards of Practice, QSEN, TIGER, and the ONC
work role descriptions and categorizes the competencies across curriculum
levels. It also includes health IT support professionals, recognizing that
these individuals work closely with informatics specialists, researchers,
and innovators. In some organizations, these support roles may be
subsumed by informatics specialists.
Community College Training Overview
The educational training materials developed for the community college
training program were supported by the ONC Curriculum Development
Centers Program’s grants. The entire set of teaching materials for the
curriculum components is available on the ONC website.43 This is a great
resource and foundation for a strong, short-term training program, but it
should not replace the integration of the content and competencies across
health professional curriculum or the need for advanced education in
health informatics. Since the ONC workforce development plan is
designed to rapidly increase the number of healthcare IT professionals
who will be able to assist healthcare providers in reaching MU, these
competencies need to be cross-mapped in higher education programs to
reach the goal of an LHS. As academic institutions, healthcare
organizations, and accrediting agencies establish competencies for health
IT and health professionals, they need to look to these nationally defined
workforce roles and competencies for guidance. For a health informatics
curriculum to be relevant, it must encompass both current and future roles
of health IT professionals in all types of health organizations. As the LHS
continues to evolve, these roles and competencies will adjust to be er
align with the market demands of students, communities, and employers.
The problem is that healthcare organizations are looking for seasoned
health IT professionals, and those individuals are rare at this time. Specific
roles designed for community college training include the following:
• Implementation and support specialist. Individuals in this role provide
support before and during implementation of health IT systems in
clinical and public health se ings. They execute implementation plans
by installing hardware and software, incorporating usability
principles, testing software against performance specifications, and
interacting with vendors to resolve issues during deployment.
Backgrounds for these individuals include IT and information
management.
• Implementation managers. Individuals in this role provide on-site
management of adoption support teams before and during
implementation of health IT systems. Backgrounds for this role
include experience in health and/or IT environments as well as
administrative and management experience. These individuals apply
project management and change management skills to create
implementation plans to achieve project goals, lead implementation
support teams, and manage vendor relations.
• Technical and software support staff. Individuals in this role maintain
health IT systems in clinical and public health se ings. Previous
backgrounds include IT and information management. Workers
interact with end users to diagnose and document IT problems as well
as implement solutions and evaluate their effectiveness.
• Trainer. Individuals in this role design and deliver training to
employees in clinical and public health se ings. Backgrounds for
these workers include experience as a health professional or health
information specialist. Experience as an educator or trainer is also
valued.
University-Based Education Overview
Specific health IT roles requiring university-based education and training
include the following:
• Clinician and public health leader. Individuals in this role are expected to
lead the successful deployment and use of health IT to achieve
transformational improvement in the quality, safety, outcomes, and
value of health services. Training appropriate to this role will require at
least 1 year of study, leading to a university-issued master’s level
certificate or master’s degree in health informatics or health IT as a
complement to the individual’s prior clinical or public health academic
training. The individual entering this program may already hold a
master’s or doctoral degree, or the program may be part of his or her
existing program of study, leading to an advanced clinical practice or
public health professional degree. Career opportunities include chief
information officer and chief informatics officer.
• Health information management and exchange specialist. Individuals in this
role support the collection, management, retrieval, exchange, and
analysis of electronic information in healthcare and public health
organizations. These individuals would require a bachelor’s degree in
health information management (HIM) but would not enter into
leadership or management roles unless they had graduate-level or
master’s education in HIM or health informatics.
• Health information privacy and security specialist. Individuals in this role
are charged with maintaining trust by ensuring the privacy and security
of health information as an essential component of any successful health
IT deployment in healthcare and public health organizations. Education
for this role requires a computer science specialization within
baccalaureate-level programs or a certificate of advanced studies or
post-baccalaureate training in HIM or health informatics. Individuals in
this role would be qualified to serve as institutional and organizational
information privacy or security officers.
• Research and development specialist. Individuals in this role support efforts
to create innovative models and solutions that advance the capabilities
of health IT. They conduct studies on the effectiveness of health IT and
its impact on healthcare quality. Education required for this role is a
doctoral degree. Career opportunities include faculty roles as well as
data science, enterprise-wide analytics, and research and development
positions.
• Program and software engineer. Individuals in this role will be the
architects and developers of advanced health IT solutions. They need to
have knowledge and understanding of health domains to complement
their computer and information science expertise. This knowledge will
enable them to work with the healthcare team (including the patient) to
develop solutions that address their specific concerns. Training
appropriate to this role is specialization within a baccalaureate program
or a certificate of advanced studies or a post-baccalaureate education in
health informatics. A certificate of advanced study or a master’s in
health informatics may be very appropriate for individuals with IT
backgrounds.
• Health IT subspecialist. A small subset of specialized individuals with a
general knowledge of healthcare or public health and in-depth
knowledge of disciplines that inform health IT policy or technology is
critical to the success of the health IT initiative. Such disciplines might
include ethics, economics, business, policy and planning, cognitive
psychology, and industrial and systems engineering. These individuals
might expect to find employment in research and development
organizations or teaching. These positions would require at least a
master’s degree but more likely a doctoral degree.
• Practice workflow and information management redesign specialist.
Individuals in this role assist in reorganizing the work of a healthcare
provider to take full advantage of meeting the MU criteria. These
individuals may have backgrounds in healthcare or IT, but they are not
licensed clinical professionals.
• Clinician or practitioner consultant. This role is similar to the redesign
specialist discussed previously; however, these individuals have
backgrounds and experience as licensed clinical or public health
professionals. In addition to the responsibilities discussed previously,
they address workflow and data collection issues, including quality
outcomes and improvement, from a clinical perspective. They serve as a
liaison between users, IT staff, and vendors.
Educating the Generalist
All health professionals at the generalist level need knowledge, skills, and
a itudes related to informatics. According to QSEN, nurses at the
prelicensure level, as well as other health professionals at the entry level,
should be able to use information and technology to communicate,
manage knowledge, mitigate error, and support decision making in a
caring and secure environment.44 These QSEN competencies, as well as
some of the ONC health IT role competencies, are further delineated in the
AACN’s The Essentials of Baccalaureate Education for Professional Nursing
Practice and the NLN position statement titled Preparing the Next Generation
of Nurses to Practice in a Technology-Rich Environment: An Informatics
Agenda.45,46 Upon examination of these basic competencies, it is obvious
that integrating an EHR into the academic environment is essential to fully
prepare healthcare workers to use EHRs in clinical practice. Several
schools use academic versions of EHRs in the classroom and simulated
case scenarios to create powerful high-fidelity learning environments that
promote informatics competencies.27,37,47-50 Just as pilots are trained in
simulators to fly airplanes, simulation, including the use of an EHR, can be
used to teach health professionals IPE and informatics skills.
Educating Healthcare Specialists at the Graduate
Level
While there is variation across the healthcare disciplines, the overall
pa ern is that increased levels of education correlate with increased
specialization as well as advanced management and leadership. As the use
of technology expands, all master’s- or doctorate-prepared health
practitioners, regardless of specialty, must have the knowledge and skills
to meaningfully use current technologies to deliver and coordinate care
across multiple se ings and analyze point-of-care outcomes. In addition,
they must have the expertise required to communicate with the media, the
public, policy makers, and health professionals regarding health IT and
the secure and trusted use of HIEs. Integral to these skills is an a itude of
openness to innovation and continual learning, since information systems
and care technologies are constantly changing.51 For example, all nurses
educated at the master’s level should be prepared to use information and
technology to communicate, manage knowledge, mitigate error, and
support decision making.52 The IOM and QSEN advanced practice
competencies build on the prelicensure competencies and are embedded
in the AACN’s revised The Essentials of Master’s Education for Professional
Nursing50 and The Essentials of Doctoral Education for Advanced Nursing
Practice.53 The need for an informatics skill set across all levels of the
curriculum further points out the importance of integrating informatics
tools in the curriculum and a shift in teaching approaches to include
collaboration and teamwork. At this level, students use EHR data to
monitor open-loop processes, generate research questions, look for links to
evidence-based decision making, detect unanticipated events, and support
clinical workflow and population management. Clinicians at this level use
a variety of digital technologies to advance their skills as integrators,
aggregating information from patients and their health records,
recognizing pa erns, making decisions, and translating those decisions
into action.
Educating the Health Informatics Specialist
Informatics specialists are formally prepared at the graduate level
(master’s or doctorate) in health informatics programs. Informatics
specialists design, manage, and apply discipline-specific data and
information to improve decision making by consumers, patients, nurses,
and other healthcare providers.12 Informatics specialists must have strong
communication and analytical skills as well as clinical knowledge and
technical proficiency. Most health informatics specialists work in a
hospital or healthcare se ing in management or administrative positions;
however, a significant percentage hold positions with health-related
vendors, suppliers, insurance companies, and consulting firms. As EHRs
and other information and communication technologies become
increasingly important, informatics specialists will become even more vital
in bridging the gap between clinical care skills and technology. These
specialists are expected to practice in interprofessional team environments,
interact with health IT support professionals, and lead change. They need
to be knowledgeable about clinical information systems and how they
support the work of clinicians.
The healthcare industry is looking for informatics specialists to correctly
design, build, test, implement, and maintain health IT systems to meet MU
criteria. The specific job description and activities of an informatics
specialist in any se ing will, of course, be determined by the employing
organization, but these activities can be expected to include
responsibilities such as analysis, project management, software tailoring
and development, designing and implementing educational programs,
administration, management and leadership, consulting, and program
evaluation and research.
Educating the Health Informatics Researcher and
Innovator
The role of the informatics researcher is prominent in the emergence of an
LHS that focuses on best care practices and the generation and application
of new knowledge. Constant innovation is needed to keep pace with
evolving technologies and ever-changing regulatory mandates. As new
health technologies emerge, innovations will grow, and research and
development will be essential to support commercialization. Preparation
for the researcher and innovator role is at the doctoral level. Education for
the researcher focuses on discovering knowledge and analyzing evidence;
at the practice level, the focus is on evaluating, applying, and
implementing evidence.
The role of an informatics researcher includes knowledge of research
designs and applications to develop be er and more efficient ways of
entering, retrieving, and using health informatics to improve health
outcomes and engage consumers. An informatics researcher has a key role
in developing new data collection methods and assisting with finding the
appropriate data to collect for various projects and research grants. This
research ranges from experimental research to process improvement and
from informal evaluation to evidence-based practice.12 Informatics
researchers must be effective wri en and oral communicators, as
dissemination of their work through consultation, publication, and
presentation is an important part of their role. They should have a clear
understanding of research design and how to develop accurate and correct
questions for surveys and research projects. The ability to work in a team
environment with those both familiar and not as familiar with research is
essential. Excellent computer skills and knowledge of databases and
software programs available for research are important. A healthcare
background and experience working with patients and consumers in some
capacity are helpful. Knowledge of healthcare organizations, state and
federal regulations and policies regarding healthcare practices, data
collection, data stewardship, and confidentiality is critical. In addition, a
spirit of entrepreneurship along with knowledge of commercialization and
technology transfer are important to the innovator role.
Continuing Professional Development
Lifelong learning is a key component of an LHS. The acceleration of
national efforts to increase adoption of health IT across all healthcare
arenas (including consumer engagement, public health surveillance, and
research) affects all health professionals. As practice changes and new
technology evolves, continuous learning is necessary to have competent,
up-to-date, skilled professionals who are able to respond quickly to the
needs of the system. Health professionals who are interested in expanding
their education to include informatics have many opportunities for
learning through formal academic education as well as continuing
education programs. The HITECH Act, federal and private initiatives,
professional organizations, the health IT industry, and universities have
increased opportunities for health IT and informatics in continuing
education. A web search for health IT or health informatics seminars and
webinars or conferences will provide a variety of opportunities to help
meet the learner’s specific needs.
Conclusion and future directions
Health, healthcare, and education in this country are going digital, se ing
the stage for an LHS dependent on continuous learning and facilitated by
information and communication technologies. This developing potential
presents opportunities and challenges for health professional education. It
is forcing educators to redefine and rethink how they educate health
professionals.
Health informatics specialty programs will continue to expand, and core
informatics competencies will be taught across all levels of the curriculum
for health professionals. In the future, health informatics education will
see a move to baccalaureate as entry level. The practice doctorate (DNP,
MD, DOT, DPT, etc.) will dominate practice and leadership in health
informatics. The LHS will require a new skill set that will necessitate a
major redesign of educational programs for health professionals, including
a focus on interprofessional collaborative education and practice.
Informatics competencies and new workforce roles will continue to evolve
as the continuous learning loop and new technologies change the way in
which healthcare and education are delivered. Continuous learning
through formal academic programs, short-term courses, conferences,
workshops, and seminars is core to ensuring that clinical practice reflects
the current best evidence. In the future, one can expect to see continued
learning and just-in-time learning incorporated directly into the
information systems used to provide care. For example, as standards of
care change, healthcare providers may not need to a end a workshop to
learn about these new standards but rather will be brought up to date on
these new standards through the decision support systems incorporated in
the EHR.
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Discussion questions
1. As with healthcare systems in many countries, the American healthcare
system is moving from a fee-for-service model to a value-based model.
What are the implications of this change in terms of informatics
education and curriculum for healthcare professionals?
2. Compare and contrast informatics knowledge/competencies,
information literacy, and computer literacy.
3. Compare and contrast the competencies in the Competencies Matrix of
Health Information Technology and Informatics Skills (Table 30.1)—
generalists, advanced practice, health IT support, informatics specialist,
and researcher/innovator. Differentiate between direct and indirect
patient care roles.
4. Describe a set of strategies that could be used to integrate informatics
competences within an undergraduate curriculum as opposed to
teaching this content as a separate course.
5. Describe how health informatics can be used to transform
interprofessional education (IPE).
6. What resources would you need to integrate an academic electronic
health record into healthcare simulations (with and without human
patient simulators)? Include staff in the discussion.
7. Develop an action plan to improve informatics competencies for faculty;
develop an action plan to improve informatics competencies for
students.
8. Develop a plan of study for a researcher to be able to engage in Big Data
analytics.
9. Discuss the Learning Health System in relation to developing a
curriculum and assignments to assist students in gaining the
competencies required for participating in this system.
10. The top health professional in your organization is challenged with
implementing a healthcare information system for the organization and
is pu ing together a commi ee for this purpose. The top health
professional recognizes your talents and abilities to be a major
contributor to this commi ee. What qualities, characteristics, intellectual
strengths, and future ambitions would drive you to be influential in
your role?
Case study
In affiliation with the University of Excellence Medical Center (UEMC), the
University of Excellence (UE) is recognized as a major academic health
center. As defined by Association of Academic Health Centers (AAHC), an
academic health center “encompasses all the health-related components of
universities, including their health professions schools, patient care
operations, and research.”56 The UE includes schools of allied health,
dentistry, medicine, nursing, pharmacy, and public health. The UEMC is a
growing health system that consists of several patient care operations
ranging from small rural hospitals to large multiple-specialty tertiary
referral hospitals.
The health professional schools at UE have agreed to incorporate the
five core competencies identified by the IOM in their report entitled Health
Professions Education: A Bridge to Quality.57 These core competencies include
patient-centered care, interdisciplinary teams, evidence-based practice,
quality improvement, and informatics. With this goal in mind, they are
currently working together to integrate informatics throughout their
revised curricula. The plan is to develop an interprofessional approach
that incorporates informatics across the different educational programs
within these schools. The schools have requested a meeting with clinical
leaders from Best Memorial Hospital to gain a practice perspective on
what information should be included in the curriculums. Best Memorial
Hospital is part of the University of Excellence Medical Center (UEMC)
system. Best Memorial Hospital has a long history of association with local
universities, functioning mainly as a site for student clinical experiences:
• Undergraduate students enrolled at the UE College of Health
Professions often complete a portion of their clinical work at the
hospital.
• Each year the hospital hires a number of healthcare graduates from
this university.
• Several clinicians in first-level management positions at the hospital
are enrolled in graduate programs at the university.
The vice president for clinical practice at Best Memorial Hospital, where
you work, has included you on the list of leaders to a end the meeting
with UE. In preparation for this meeting, complete the tasks below.
Discussion Questions
1. Prepare a list of key references for using an interprofessional approach
to integrating informatics into the curricula of healthcare
professionals.
2. Prepare a list of competencies, concepts, and/or skills that should be
included in the educational preparation of graduates of the healthcare
educational programs at both the undergraduate and graduate levels.
Give examples that include an interprofessional approach to the
practice of informatics.
3. Describe how informatics competencies could be incorporated into the
clinical experiences of students. Be specific. For example, how should
student access to Best Memorial Hospital’s clinical information
systems be developed? Who should provide the needed instruction
for orienting each group of students?
31
Distance Education
Applications, Techniques, and Issues
Irene Joos
Abstract
The changes in our educational environment are reflective of shifts in our
demographics, economic conditions, and technological developments. Technology
(Web 2.0) tools and the semantic web (Web 3.0) are enhancing educational
opportunities for lifelong learning within a diverse global community. This chapter
presents a brief history of distance education, defines related terms, and discusses
course delivery systems, including issues related to the selection of these systems. It
concludes with a discussion of issues related to the development and
implementation of distance education and lifelong learning.
Web 2.0 tools and the semantic web (Web 3.0) are enhancing educational
opportunities for the diverse global community.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Discuss historical developments and their impact on today’s distance
education scene, including developments in nursing and other
healthcare professional fields.
2. Evaluate course delivery systems using appropriate criteria.
3. Examine issues and trends related to development and
implementation of distance education options in a college or
university.
KEY TERMS
course delivery (management) system 520
distance education 518
distributed education 518
Introduction
Technology developments and the internet are providing opportunities to
examine how institutions of higher learning and healthcare corporations
deliver instruction or training and how this delivery may be improved.
Since the late 1990s and early 2000s, distance education has become an
increasingly important part of education. It is one of the “most complex
issues facing higher education institutions today.”1, p. v While this
statement was wri en years ago, it holds true today.2 Most colleges and
universities are now beyond asking whether they should offer distributive
or distance learning options. They are instead addressing how to handle
these offerings in an effective, efficient, and economic way. These
discussions focus on questions such as how to increase enrollment, retain
students, stay competitive, address the needs of a changing student
population, and improve quality. In addition to the many educational
institutions, many healthcare institutions and corporations provide
continuing education and required training as well as patient education
through distance education options.
Given the current work environment and the economic times, a growing
number of health-related programs are offering part or all of their program
content through distance education. Increasingly students come to school
with work and family obligations or live in areas distant from educational
opportunities. Distance education is a viable option for this demographic
of health professions students.3,4 It provides increased flexibility in
meeting the educational needs of the changing student population, while
influencing how publishers deliver textbooks and how instructors
facilitate all learning styles through creative use of interactive activities,
social media, videos, and podcasts, and other means.
Technological developments have an impact on institutions, student
expectations, and how students learn. For example, most institutions
provide wireless connections because students, patients, and family expect
to be able to use their wireless devices in schools, hospitals, and outpatient
facilities. Several recent books addressed how constant technology-
facilitated connections may affect the brain; how constant connections can
affect relationships between family members, friends, and colleagues; how
we understand privacy, community, intimacy, and solitude; and how the
digital revolution changes people.5-8 Frand identified the following 10
a ributes of the information age mindset that influences student
expectations and learning. Think about how these influence your
expectations and learning.
• Computers are not technology.
• The internet is be er than TV.
• Reality is no longer real.
• Doing is more important than knowing.
• Trial and error and experimentation are preferable to logic.
• Multitasking is a way of life.
• Typing is preferable to handwriting.
• Staying connected is essential.
• There is zero tolerance for delays.
• There is a blurring of the lines between consumer and creator.9
Oblinger and Oblinger (2006) proposed that discussions about distance
learning should not be about technology, but the activities that technology
enables: working in teams or with peers, social networking, participatory
learning, interaction, immediacy, and multimedia expression.10 Think
about the impact those mindsets and technology-enabled learning are
having on the educational system and traditional methods of teaching.
This chapter presents a brief history of distance education, defines
evolving terms, examines course management and learning management
systems (LMSs) for delivering distance education, and presents issues
related to development and implementation of distance education in
colleges, universities, and organizations.
Historical development
Four phases divide the historical development of distance education and
its changing nature. Correspondence education characterized the first
phase, encompassing the mid- to late 1800s. Correspondence education
involved receiving printed materials, reading those materials, and sending
back any required assignments. The founding of the Society to Encourage
Studies at Home in 1873 by Anna Ticknor11 and the founding of the
Chautauqua College of Liberal Arts in 188312 were two instrumental
events that moved correspondence education forward, as both of these
programs offered correspondence opportunities. They responded to the
need for a more educated workforce and to the interest of women and the
common man for an education. An inexpensive postal service facilitated
this development. While the number of offered courses grew along with
enrollment, so too did the concerns about quality education and the
effectiveness of this means of delivery—a theme that continues today.
Phase 2, encompassing the 1960s through the early 1980s, enhanced the
delivery method for distance education by involving the broadcast media:
cable and satellite television.13 The terms changed from correspondence to
telecourses and from correspondence education to distance education during
this time. While students were ready to embrace this method of delivery
because of family responsibilities, work responsibilities, geographic
challenges in accessing academic institutions, and disability issues, the
academic institutions continued to question the effectiveness of this new
delivery method and the changes required in teaching methods.
Phase 3, which took place in the 1980s and 1990s, found many colleges
and universities laying fiber optic cables on campus. This high-speed
connection made possible live two-way video communication between
local (main campus) distance education classrooms and remote (branch
campus) classrooms. Students and faculty at both sites could see and hear
each other, although with a slight transmission delay. This was education
at a distance but in real time (synchronous). In addition, developing
technology made it possible for more people to purchase home personal
computers with dial-up internet access, enabling students to access course
materials from a distance and to interact with faculty and other students
through e-mail, telephone, or other communication systems.
Phase 4, which began in the late 1990s and continues to the present, saw
advances in the internet and the development of Web 2.0 tools. This
moved the focus from information retrieval to user-generated content,
interactive learning, and virtual communities. This phase saw a surge in
development of distance education courses and programs to meet the
needs of a mobile society concerned about costs, currency, and lifelong
learning, as well as a need to stay competitive in the job market. In
healthcare education, faculty have been providing distance education
courses and programs for more than 35 years.14,15 Early programs relied on
mostly print materials and some audiotapes, with a few on-campus
meetings during the semester. With changing technology developments,
delivery system formats changed from mostly printed materials to
broadcast courses (e.g., distance learning classrooms that broadcast live
classes to remote sites). Computer-aided instructional programs and
interactive videodiscs ran on freestanding computers.16 The current
generation of course delivery methods increasingly incorporates:
• Mobile devices
• Web 2.0 tools such as podcasts, wikis, blogs, and video conferencing
• Integrated campus LMSs, personal learning systems (PLS), and
personal portals.
These systems integrate learner functions such as registration, billing,
courses, library, tutoring, and other related learner services. Additional
information about the growing interrelationships of these applications and
systems can be seen in Chapter 32. What tools are in development that will
facilitate delivery of courses and improved learner outcomes? The answers
to these questions will become apparent as we move toward Web 3.0 tools
and applications and ever-changing technological developments. What do
you envision your learning environment to look like in 15 to 20 years?
Terminology
Although the phrases distributive (distributed) education, distance education,
distributive (distributed) learning, and distance learning are used
interchangeably, the nuances that can exist between these terms have
broad implications for higher education and related institutions.
Distance education is instruction and planned learning in which the
teacher and the learner are separated by location, and possibly teaching
and learning occurs asynchronously or at different times.3 Others remove
the time element, defining distance education as teaching and learning
where the teacher and learner are geographically separated and rely on
technology for instructional delivery.17,18 Time is not a critical element in
this definition of distance education, but rather distance and the use of
communication technology are the critical elements. For example, Knebel’s
definition17 fits with the distance learning classrooms that educational
institutions use to provide instruction to remote locations through satellite
connections and equipment that permits the teacher and learner to interact
with and see one another in real time. The teacher and learner are
separated by distance but not by time. Note that time here refers to when
students a end to their learning, not the time frame surrounding start and
end of semesters, due dates for completion of assignments, and so forth.
The National Council of State Boards of Nursing (NCSBN) also provides
an example of this definition. The Distance Learning Education Commi ee
defines distance education as “instruction offered by any means where the
student and faculty are in separate physical locations. Teaching methods
may be synchronous or asynchronous and shall facilitate and evaluate
learning in compliance with BON approval status/regulations.”19, p. 9 Note
the focus on learning and expansion to include both views—at the same
time (synchronous) or not at the same time (asynchronous). This definition
aligns with that of Knebel’s in that time is not the issue; distance is the
issue. Given the variations in meaning, many accrediting bodies are
defining distance education within their regulations.20,21
It is also critical to distinguish distance education from independent
learning or programmed computer instruction in that distance education
is planned, mediated instruction. This means that the teacher not only
designs learning experiences to guide the student’s learning but also
provides direction, comments on coursework, and issues a grade on
completion of the course.
Distributive (distributed) education is a change in pedagogy where one
customizes the learning environment to the learning styles of the learners
using technology; the learners may be taking distance, hybrid
(combination of online and face to face), or on-site courses. This method
includes interactive activities using available technologies. The pedagogy
supports a hands-on learning-by-doing approach in which the learners
interact and collaborate during the course of study using appropriate
technology. For example, one might have the learners review a lesson and
video on patient teaching, discuss critical elements of a good patient
teaching guide on a discussion forum, and then work on a wiki to produce
a project such as a patient teaching guide on some aspect of patient care
where there is a wri en lesson, podcast, and demonstration video.
Dede’s characteristics of distributive education:
• Supports different learning styles by using mixed media
• Builds on the learner’s perspective though interactive experiences
• Builds learning and social skills through collaboration
• Integrates learning into daily lives.22
In 2004, Dede defined distributed education as “a term used to describe
educational experiences that are distributed across a variety of
geographical se ings, across time and across various interactive media.”23,
p. 16
Although the terms distributed learning and distance education are used
interchangeably, distance education has a narrower definition. Since the
primary characteristic of distance education is that learners and teachers
are separated by time and distance, learners learn the material on their
own time and in their own place. Distance education may or may not
include the use of emerging technologies. The primary goal of distributed
learning is the customization of the learning environment to be er meet
the learner’s needs through the use of technologies and an interactive
collaborative environment that can take place on or off campus—that is,
through course enhancements embedded in traditional classroom se ings,
hybrid (combination of face-to-face and distance learning), or distance
courses. Distributed learning is more inclusive in its delivery methods.
Additional information concerning the next generation of learners,
learning environments, personal learning assistant initiatives, and related
research can be seen at the Office of the Undersecretary of Defense for
Personnel and Readiness’s Advanced Distributed Learning Network at
h ps://[Link]/adl-research/.
Three other useful terms one might encounter are online education,
eLearning, and mLearning. Each will be defined here, but what is important
is how these terms are used within the context of the content they are
referencing.
• Online education requires the use of the internet or an intranet to
deliver educational materials.
• eLearning (eTraining) is “an approach to teaching and learning that is
based on the use of electronic media and devices.”24, p. 152 Some authors
believe there are three major elements that make eLearning different
from face-to-face learning: asynchronous learning, a different location,
and use of electronic devices that provide for interaction and
communications.25 The consensus seems to be that eLearning requires
a computer or other electronic device such as a smartphone or tablet.
eLearning involves a greater variety of equipment than online
resources or the internet in that any electronic device may be used:
DVDs, CD-ROMs, and so forth.
• mLearning is the use of a mobile device (smartphone, tablet, iPad,
etc.) as an educational tool for meaningful, just-in-time learning any
place and time. Mobile devices refer to those devices that can be held
in the hand. While some consider mLearning an extension of
eLearning, there are differences between the two. These differences
relate to time, information access, context, and assessment.26,27
mLearning has short learning sessions, accessed when needed, driven
by context, and applied immediately. As mobile devices continue to
develop more capabilities, you will see more interactive, stimulating
learning environments. What we need to focus on is the learning
environment that mobile devices can facilitate.
With such variations and overlap in these definitions, schools that offer
distance or distributive education must consistently define these terms and
the related required technology to implement the program or course. This
process should answer the question, “Will these terms be used
interchangeably or not?” If not, what distinctions are faculty making, and
why is that important? Students applying to educational programs need to
know how these terms are being used and, in turn, what will be required
from them.
Faculty should discuss and define these terms during their strategic
planning process when developing distance or distributive education
courses and programs. Box 31.1 provides a sample outline for a strategic
plan, and Box 31.2 provides an outline for a progress report. These same
questions and processes also apply when implementing training initiatives
in the work world. Questions to ask and answer during strategic planning
include:
Box 31.1
Outline for a Strategic Plan for Distributive
Education
Executive Summary
This section sets the background for the plan and generally includes the
following subsections:
• Introduction. This subsection sets the stage for why faculty and the school
are doing this. It addresses what is happening in the broader world,
then locally, and then within the institution. It should answer the
following questions: Why is the institution and faculty doing this? What
are the goals? How will faculty and the institution define related terms?
Some include a strengths, weaknesses, opportunities, and threats
(SWOT) analysis in the introduction. Others place it within the Details
section as a separate subsection called SWOT analysis. Others place it in
an appendix to the plan.
• Mission statement. What is the mission for this initiative? How does that
fit with the mission of the college or university? The mission statement
should include some of the language of the school’s mission.
• Goals. What are the specific goals for this initiative in terms of students,
faculty, programs, and so forth? This can include goals such as
providing flexibility in helping students achieve their educational goals,
targeting the adult and second-degree populations, and developing
faculty. Areas to address in the goals are as follows:
• Students. Who are the target students? What are the rules as to who
can take these courses or enroll in the program? How will students be
oriented to these means of learning?
• Faculty. How will faculty be trained? What training will faculty need?
How will ongoing support be provided? How will this count toward
faculty teaching loads? Who will monitor quality?
• Courses and programs. What programs and courses will be offered in
this delivery method? Who makes these decisions? How are decisions
approved? How do faculty address issues such as the Technology,
Education, and Copyright Harmonization (TEACH) Act and
copyright? What is the target class size? How will that decision be
made?
• Support issues. What course management systems (CMS) will be used?
Can it interface with the school’s other systems? When will faculty
have access to a shell for course development? What library changes
will be needed to support remote students? How will access to other
support services such as registration, paying tuition, and accessing
tutoring be handled? What support services will students need?
• Policy and procedures. Who will develop and approve them? When?
Details
This section provides the details for each of the goals identified.
• Goals. List and number each goal. For example, 1a, 1b, 2a, 2b, 2c, etc.
• Recommendations. After careful review, comparison, and research, what
is the recommendation for each goal? For example, after careful review,
Blackboard is the recommended CMS. Recommendations should also
include who will be responsible for moving each goal forward.
• Budget items. Include projected costs for achieving each goal.
• Time frame. Include a target date for achievement of each goal.
Box 31.2
Content for a Progress or Status Report on a
Strategic Plan
Plan name and date. For example, Distributive Education Plan 2016–2019.
Goal and objective. List each goal and objective.
Tasks, actions, or activities. What is needed to achieve the goal and
objectives, coded to each goal and objective?
Persons responsible. Who is held responsible for this task?
Budget. Original or revised.
Due date. May include original and revised dates for completion of the
task.
Progress note or description. Status of the task: what has been done and what
needs to be done.
• What terms are faculty and the school using to describe the distance
learning initiative? You can turn this question around to say “Describe
the distance training initiative.” What terms do the accreditation
agencies use? How are colleagues in other schools and accrediting
agencies defining the terms? How will these definitions be conveyed
to the learner?
• What technology will the institution use to deliver these courses or
training? How will the institution notify learners about the required
technology—for example, a webcam and broadband connection or a
tablet with broadband connection?
• Does enrollment in online and distance education courses mean that
students will never be required to come to campus? Are faculty using
some hybrid approach that may require some a endance on campus?
Will you use cohorts and, if so, how do you build them?
• What delivery system will the school use? Who will make that
decision? What input do faculty have?
• What are the learning needs of the students? How will you maximize
their learning with the use of technology and personalize learning
environments?
Once the school decides to provide options for students regarding
course delivery methods to complete their degrees, the selection of the
course delivery system usually begins. This generally requires considering
all available options.
Course delivery systems: course
management systems
Course delivery systems (CDS), also known by some as course
management system (CMS) or learning management system (LMS), are
software programs or applications that permit the development and
delivery of a course or training program without requiring knowledge of
programming code. These programs provide the tools necessary to plan,
implement, and assess the learning process by giving the professor/trainer
the ability to create and deliver content, monitor learner participation and
progress, provide for interactive communications, and assess learning
outcomes.28 Many believe there are distinct differences between a CDS
(CMS) and an LMS and that a CMS is a narrower term than an LMS. An
LMS includes course management but also includes additional features
that handle course registration, integration with HR systems,
administrative features, and integration with other institutional
information systems.28,29 In other words, an LMS handles all aspects of
eLearning or corporate training, while a CMS focuses on content delivery
and learner interaction and communication. This distinction, however, is
blurring as CMS vendors incorporate more of the management aspect into
their products.
There are several CMS software programs available, and the market is
constantly changing. See Table 31.1 for CMS usage rankings reported by
Campus Computing in 2015.30 However, it should be noted that three
fifths (61.6%) of campuses responding to the survey report plans to review
their current LMS strategy for budget or other reasons. Although Table
31.1 lists the most frequently used CMSs in the academic higher education
world, the business world uses other CMSs for its training. Some of the
more common examples include Cornerstone, SuccessFactors, Interactyx
TOPYX, LearnUpon, SilkRoad, DigitalChalk, and Grovo, to name a few.31
Other CMSs are popular with the K-12 institutions and still others with the
international market.
Table 31.1
Campus Computing Profile of the Course Management Systems
Market, Fall 2014
CMS Market Share (%)*
Blackboard 39.1
Moodle 21.6
Instructure (Canvas) 14.2
D2L 11.8
Sakai 3.1
Data from Green K. C. The Campus Computing Project.
[Link]
%20Exec%20Summary%20&%[Link]; 2015 [p. 17].
CMS, Course management system, D2L, desire2learn.
* Rounded up.
The CMS selection decision often rests with administrators, information
technology (IT) personnel, and faculty, although some institutions may
have student representatives on the planning commi ee. The process for
the selection of a CMS should be an integral part of the strategic plan for
distance education or corporate training. CMS selection should never be
delegated to the IT department with minor input from other stakeholders.
Considerations for selection include the following:
• Objectives or goals. What are the goals/objectives for distance education
or corporate training? How does a CMS fit with these
goals/objectives? How does this fit with the school’s philosophy and
mission?
• Features. What features do faculty or trainers believe are essential to
delivering the course or training? What are desirable features but not
essential ones? What can the infrastructure support?
• Integration with current institutional systems. How important is this?
Which information systems need to be addressed? Does the CMS
support interoperability with third-party products (e.g., registrar’s
applications, billing, registration)? If interoperability is limited, an
LMS may be a be er choice.
• Compatibility with different student systems such as operating systems,
mobile devices, and related security programs like firewalls and
antivirus programs.
• User base. What is the installed user base (how many institutions and
end users are using the product)? Is the installed user base important
to your organization? Is there a local user group associated with the
CMS?
• What type of support does it provide for the faculty, students, and IT
department?
• How stable is the company offering the CMS? This question may
require the financial department to investigate.
• Customization/Maintenance. Will the CMS require extensive custom
programming or maintenance? Are sufficient resources in place for
that work? Will this require a dedicated staff person?
• Scalability. How scalable is the CMS? Can it easily expand or contract
based on varying needs?
• Usability. How user friendly is the CMS? Does it have the tool set that
faculty or trainers need to deliver the courses? Are there data tracking
and report features? Are those tools intuitive to use for both learners
and faculty or trainers to complete typical tasks?
• Outcome measures. Does the CMS support outcome measures? Is this
important to the organization?
• Sharable Content Object Reference Model (SCORM) compliance. Is the
system SCORM compliant (encourages the standardization of LMSs)?
Is that important? Are there other standards that are important like
Aviation Industry CBT Commi ee (AICC)?
• Cost. What does it cost to buy the CMS; what does it cost to own the
CMS? What is the cost of hosting versus housing the CMS? What are
the mechanism for and frequency of upgrades? What are the costs of
these upgrades?31,32
One way to start the selection process is to first decide on the type of
system that will meet the needs of the institution and its students: campus-
based portal, proprietary CMS, open-source system, Cloud-based, or
partnership.33 Many of these systems are moving toward the campus-
based portal model and a be er fit with most definitions of an LMS.
Portals
Portals are customized, personalized entries or gateways where users,
including students and faculty, can access all of the content they typically
need. A portal is a user-centric web page that includes access to a CMS.
The portal integrates and provides a secure access point to the data,
information, and applications that users need in their roles as a student or
faculty. Portals generally include enterprise resource systems (finance,
human relations, etc.), community building communications, admissions,
retention, web-based academic counseling, CMSs, and metrics to measure
success, to name a few features. Two examples of vendor-based portals are
Ellucian and Jenzabar.
Ellucian
Ellucian’s ([Link]) focus is assisting educational institutions to
grow by offering applications that integrate and interface the systems that
faculty and students need. Fig. 31.1 presents the homepage of their website
with the software submenu showing. At Ellucian Live 2015, the CEO
announced the acquisition of a competency-based education LMS called
Helix and the movement of two of their products to the Cloud—Banner
and Colleague by Ellucian.34
FIG 31.1 Ellucian with Software submenu displayed. Used with
permission.
Jenzabar
Jenzabar ([Link]) is another example of a portal system that
supports a college or university across each department, including
administrative offices and academic departments.35 Jenzabar a empts to
align the school’s mission and goals with technology investments. Fig. 31.2
shows the Higher Education Solutions menu on the homepage and the
range of offerings that Jenzabar provides. Notice the Cloud services on the
left side of the screen. These products are similar for most portal systems.
Their eLearning software includes the typical features of CMS: content
management, course copy, a gradebook, exams, e-mail, calendars, chat,
discussion forums, online meetings, test analytics, and usage statistics.
FIG 31.2 Jenzabar products menu. Copyright 2013 Jenzabar, Inc.
All rights reserved. Used with permission.
Proprietary Course Management Systems and
Learning Management Systems
Proprietary CMSs are “software products that are purchased or licensed
by one vendor.”36, p. viii These vendors provide a license either to install the
system on the customer’s servers or to host the customer’s license on their
servers. For many years, proprietary CMSs were the dominant systems on
the market. Many of these original systems merged, and only a handful
make up the current market of proprietary systems.
Most CMSs provide content management, user management and
enrollment, assessment of learners, communications such as e-mail and
discussion forums, and social learning tools such as wikis, blogs, journals,
and mobile features. Three examples of proprietary CMSs and LMSs are
presented in the following sections: Blackboard, Desire2Learn (D2L), and
SharePoint LMS.
Blackboard
Blackboard ([Link]), founded in 1997 as a small
educational technology company, is the market share leader in proprietary
CMSs. Blackboard’s Learn provides a full range of CMS service (Fig. 31.3).
Blackboard is used across domestic and international markets that
includes K-12, Higher Education, Governments, and Businesses. Their goal
is “to make learning more desirable, accessible and meaningful for
learners.”37
FIG 31.3 Blackboard home page with the platforms menu. From
[Link]. Property of Blackboard and used with permission.
Desire2Learn
D2L Incorporated (h ps://[Link]/), founded in 1999, markets itself
as providing innovative learning solutions to K-12, higher education,
corporate, government, and healthcare organizations worldwide.38 D2L’s
Brightspace includes a variety of modules for managing the creation,
delivery, and management of courses. The functionality is robust, but the
learning curve for novice users can be more challenging than Blackboard.
An example of the products offered by D2L can be seen in Fig. 31.4.
FIG 31.4 D2L product menu. [Link] Copyright 2013
D2L Corporation. Used with permission.
SharePoint Learning Management System
ELEARNINGFORCE (h p://[Link]/Pages/About-
[Link]), based in Denmark and founded in 2003, provides eLearning
services to educational, corporate, and public sector organizations
worldwide with its primary product SharePoint LMS. The company is a
Microsoft Gold Partner, and the LMS is built “in SharePoint from the
ground up.” (See their About Us webpage in Fig. 31.5.) It prides itself on
SharePoint LMS being a product that is easy to use for those familiar with
the Microsoft interface and easy to integrate with Microsoft products such
as the Office suite.39
FIG 31.5 Sharepoint LMS with Product Overview tab displayed.
Used with permission.
Open Source
Open-source software refers to software code that one is “free” to use and
alter to match existing needs. Institutions interested in cost savings may
select an open-source CMS. While the cost to buy may be very low, the
cost to own can be very high. The development of the custom interface, the
needed IT staff, and long-term maintenance costs of a custom-built CMS
can push these costs well above initial expectation. Additionally, updates
for new requirements or security can take significant time and effort.
Institutions must address the cost for IT department time, the skill set to
manage server and network issues, and training time on open-source
CMS. What is free is the code; there is no yearly license fee to pay. Two
examples of open-source software are Moodle and Sakai.
Moodle
Moodle (h ps://[Link]/) is popular among educators around the
world as a tool for creating online websites for students. To work, Moodle
must be on a web server, either on one of the school’s servers or on a
server at a web hosting company such as MoodleCloud
(h ps://[Link]/cloud/), which services small schools and Moodle
Partners like ClassroomRevolution LLC and eLerningExperts.40 There is
generally a fee to use a hosting company, but the overall cost of this
approach may be less because of free access to the code.
Sakai
Sakai (h ps://[Link]/) is an international community that
exists to enhance teaching, learning, and research.41 One joins the
membership institute that includes small colleges, universities, hospitals,
government agencies, and political parties. The organization defines the
needs of academic users, creates software tools, and shares best practices
while pooling knowledge and resources in support of this goal.
Cloud Based
Cloud-based CMSs are increasing in popularity with the movement
toward mobile learning. Cloud-based CMSs refer to systems that others
host on the internet and learners access over the internet using their
browser.42 While many LMS now have Cloud services as one of their
products, this group of CMSs focuses more on employee training. Some of
the benefits of this approach are the same as for others, such as lower
costs, security, and easy access from any device. One of the main
advantages is that Cloud service vendors provide the needed technical
support, thereby freeing up IT staff for other projects. The end user needs
to provide only the internet access and developed courses. Some examples
of Cloud-based CMSs include Litmos LMS (h p://[Link]/),
Agylia (h p://[Link]/), TalentLMS
(h p://[Link]/), Docebo SaaS LMS
(h ps://[Link]/), and G-Cube (h p://[Link]/).43
Partnerships
Book publishers often partner with software vendors to provide a package
of tools to assist with the delivery of distance education. Elsevier’s Evolve
LMS and Pearson’s learning environments (LearningStudio, MyLab,
Mynursinglab) supply everything from customized, concept-to-
completion LMSs to digital content. These online learning environments
offer resources to both faculty and students (e.g., interactive grade book
features, learning tools that simulate clinical experience and charting,
Cloud-based technology). In most cases, the disadvantage to using this
approach is that they may require you to use their textbook or may require
students to purchase an access code. When you change textbooks, you
may lose access to these resources. If students try to resell their textbooks
on the used-textbook market, the access code is not valid.
With all of these options, how do faculty and the school begin to select
the system that will work within their environment and with their faculty
and students? The next section discusses selection criteria and the role of
the faculty.
Selection Criteria and Role of the Selection
Committee
From a faculty perspective, the criteria for the selection of a CMS or LMS
fall into several categories: ease of use, stability, tool set, and support.
Other school considerations relate to compatibility or integration and to
cost issues that require financial and technical support.32 While faculty can
provide valuable insights about what they do best, developing and
teaching courses in the area in which they are experts, to be an effective
participant in system selection, they should review articles such as “The
Top LMS Statistics and Facts For 2015 You Need to Know” to gain a big
picture perspective.44
• Ease of use. There is a learning curve to using CMS software. The
interface should be intuitive to use. Does it use common educational
terms to describe tools such as discussion forums or boards? Does its
design support distance education or is it an adaptation of other
products? Faculty should ask questions and complete typical
educational tasks to assess ease of use for grading papers, projects,
and tests; returning files; and se ing up and using the grading center.
Also important are tools such as wikis, blogs, conferencing, and chat
that are available for collaboration activities for assignments such as
group projects. How easy is it for students and faculty to learn to use
these tools? This could include an analysis of the number of clicks it
takes to upload content, what file formats are acceptable for upload,
and what file size limits are enforced. Another area to analyze is the
ease of content movement between courses and between semesters
and the ease of archiving and exporting courses. Too many required
clicks or difficulty in understanding the screen discourages faculty
from using tools. Does the setup reduce time and effort or demand
more time and effort in delivering the course? Additional information
about usability is included in Chapter 21.
• Stability. How stable is the company offering the CMS? Will it be in
business next year or will the school have to select another system
next year if the company fails or another company acquires it?
Stability also includes system reliability issues such as the frequency
of system crashes and the turnaround time to restore the system after
such a crash. Students and faculty require nearly 24/7 access.
• Tool set (features). What are the bundled tools in the CMS or LMS, and
which ones require additional funds to access? For example, is
Blackboard’s Collaborate tool bundled with the basic version of
Blackboard, or does access to that tool increase the price? Do faculty
want collaborative tools such as video conferencing, podcasting,
blogging, wiki abilities, cha ing, and so forth? What “smart” features
do faculty need? This may include alerts that the system automatically
sends to students and tools that remember who the user is and where
he or she left off in doing work. Do faculty want mobile computing as
part of the tool set? Do they want textbook cartridge capabilities or
online testing tools? Cartridges are files that a textbook publisher
provides faculty who select its textbook. Once uploaded, the cartridge
sets up the course in the CMS. These cartridges contain lessons,
PowerPoint slides, discussion forums, tests, and so forth. It is the role
of faculty to identify what tools they need to teach a course.45
• Support. Is implementation training provided? Is that part of the start-
up costs? What training materials does the CMS offer? Does it have a
24/7 help system, either by phone or by chat? What support does it
offer students?
After considering these factors, faculty are responsible for determining
the essential criteria or features necessary to deliver a quality course using
appropriate technology as well as any “nice to have” but not essential
criteria or features. In many universities, CMS decisions are made for the
academic environment as a whole. Thus knowing school- and profession-
specific requirements is critical.
CMS and LMS products are improving with new technological
developments and arrangements with partners that bring new tools to the
product. For example, most products now provide access to Web 2.0 tools
that facilitate collaboration efforts. These include tools such as wikis, blogs,
conferencing, ePortfolio, and journaling. Most products now also offer
mobile learning options.
The Future of Course Management Systems
What is the future of CMS software? Green and Spencer present the results
of surveys regarding the top trends in eLearning for 2015 and beyond.
These include:
• Mobile and wearable access to eLearning materials
• More sophisticated collaboration tools
• Growing Cloud-based LMS services
• Personalized learning using pull technologies pu ing the learner in
control
• Augmented and gaming learning environments providing practical
experiences46,47
What will this mean to faculty and students? What will this mean for the
selection of CMSs?
Institutions are or have considered adding mobile ability in the criteria
for selection of CMS or LMS software. Does this mean that colleges and
universities that make this decision will require students to have a tablet
or wearable device like glasses, watches, or bracelets of some sort? Think
about how this might affect education of patients with articles like
“Wearable Enhanced Learning for Healthy Ageing: Conceptual
Framework and Architecture of the ‘Fitness MOOC.’”48 What will this
mean for the design of learning materials and learning experiences? What
will this mean for educating our learners in how to work with patient
educational experiences?
Another area of growing technological development is collaborative
tools that are smarter (i.e., remember who users are, what they like, and
what they were doing [Web 3.0]) and provide relevant information to each
user. Users should also see more lifelike virtual 3D worlds integrated into
the LMS or CMS software. These virtual worlds will make use of the latest
technological capabilities, such as Google’s augmented reality 3D glasses
and Corning’s view of the future. The Corning vision integrates glass
surfaces to access information and to interact in the virtual world. Imagine
a time when bathroom mirrors remind students that work is due, when
students can interact with their world on their TV screens, and when
students can chat with classmates and the professor through their kitchen
counter. (See YouTube video—“A Day Made of Glass.”) What will this
mean for the design and teaching of distance education and the new wave
of distributive courses?
Instructional design for distance
education and learning
While most of the principles of instructional design hold true for distance
education, the principal teaching change in a learning environment is the
use of technology to engage and empower the learner. This section is of
this chapter is not a comprehensive treatise about instructional design
concepts but rather a discussion of key factors that should be considered in
the design of eLearning experiences.
Learners and How They Learn
The key is to know the learners and their skill sets. Are these
undergraduate or graduate students? Are these older adults returning to
the educational world? Are these working adults pursuing updated skills?
What technology skills do they bring to the course? What comfort level do
they have with new methods of course delivery and learning? Have they
taken distance education or distributive courses before? Are they ready to
take responsibility for their learning? Do they understand that they must
be an active and not passive learner in this environment? What are their
expectations of response time? For example, some learners expect the
instant access and response that they experience when texting, while other
learners wait much too long to ask for needed help.
As the introduction to this chapter pointed out, there can be a different
mindset among digital natives (learners who grew up with technology)
and students who were schooled using more historical methods. Table 31.2
gives a sense of how technology has evolved over the different
generations. How do faculty design for those differences? Oblinger et al.
identify the following implications for learning and the design of these
courses:
Table 31.2
Who Were the Students, Who Are the Students, Who Will Be the
Students?
Age Name of
Range the Technology Development During Birth Years
in 2016 Generation
51 to 73 Boomers 1943—ENIAC used plug boards and switches for programming, occupied more than 1000
square feet, used about 18,000 vacuum tubes and weighed 30 tons.
1964—Digital Equipment Corporation launch the 12-bit PDP-8, the first successful
commercial minicomputer.
35 to 50 Gen X 1965—The Victor 3900 the first desktop calculator is available.
1981—The first IBM Personal Computer is released with a 4.77 MHz Intel 8088
microprocessor.
19 to 34 Millennials 1982—The personal computer was Time’s “Machine of the Year.” The article was wri en on
a typewriter, but Time was planning to upgrade the office to word processors within the
year.
1990—The first web browser is invented. 42% of American adults have used a computer at
some point.
1998—Apple releases the iMac with a 233-MHz G3 processor, 4GB hard drive, 32 MB of
RAM, a CD-ROM drive, and a 15″ monitor.
0 to 18 Post- 1999—41% of adults are using the internet.
Millennial 2008—75% of Americans are using the internet.
2016—88.5% of Americans use the internet
2015—Almost two thirds of American adults (64%) own a smartphone of some type.
Sources: <[Link]
<[Link] <[Link]
tank/2015/01/16/this-year-millennials-will-overtake-baby-boomers/>;
<[Link]
ownership/>; [Link]
• Using the web as an exploratory tool to access the wealth of
information available
• Offering learners a comprehensive learning experience
• Engaging learners
• Empowering learners to take charge of their own learning1
Faculty will usually see a range of students with a range of abilities.
Knowing this, faculty must provide a range of learning activities to meet
the needs of current students. At the beginning of the course, faculty may
assess students’ learning styles and work with the students to develop
strategies to deal with various learning styles. A faculty member may also
develop interactive activities. For example, the faculty may provide a
wri en lesson about some concept, a podcast with the same content,
discussion questions to engage students in the content, and an exploratory
WebQuest activity that requires students to explore the web for quality
resources that cover this content. A WebQuest is an inquiry-oriented
lesson format in which most or all the information that learners work with
comes from the web. See Google’s Teaching with Technology website
(h ps://[Link]/site/learnteachtech/webquest-projects) for several
examples. Fig. 31.6 provides examples of nursing-related WebQuests
created using the website [Link]. This example was developed
using the keyword “nursing” and limiting the search to “college/adult, all
curriculum.” As can be seen in Fig. 31.6, this search returned several
different nursing-related WebQuests.
FIG 31.6 Nursing Webquest Examples. Used with permission.
Goals and Objectives (Outcomes)
In distance education, writing clear, measurable goals and objectives or
outcomes is critical to ensure that students know the course expectations
and how faculty will assess their learning. Each lesson, module, or activity
should identify the purpose, goals, and objectives; provide clear directions
for what students are to do; and provide a scoring rubric or guide for
evaluation of students’ achievement of the objectives or outcomes. These
should also include due dates and time periods.
Instructional and Learner Activities
Instructional and learner activities should provide learners with the skills,
knowledge, and experience necessary to meet the course objectives. These
activities or experiences should consider the learners’ need for
engagement, activity, and relevance to the content, objectives, and work
world. This means that the professor will need to take advantage of the
tool set available through the CMS software as well as tool sets available
from outside sources. It may also mean that the professor must step
outside his or her comfort zone in learning new ways to deliver the course
and develop relevant learning experiences. Faculty should have access to a
wide variety of collaborative tools that encourage interaction with the
content and with others. These tools include wikis, blogs, discussion
forums, journals, and WebQuests. Other learner activities could include
developing podcasts, videos, and group projects. When designing course
activities, keep in mind that active participation facilitates learning be er
than does passive participation. For training, the same applies, making it
relevant to the work tasks. As an example, teaching how to use Excel and
related features with activities that demonstrate common uses from the
work se ing is much more effective than a basic, intermediate, and
advanced perspective for organizing the learning.
To help guide the selection of learning activities, one should consider
the use of a model like the Community of Inquire Model, with its three
main concepts of social presence, cognitive presence, and teaching
presence.49,50 Social presence refers to establishing a support learning
community where students can engage in meaningful communication and
develop social relationships. Cognitive presence is the development of
learning materials where students construct knowledge through reflection
and discussions. Teaching presence is the last concept that deals with
designing the learning experiences, guiding the learning, and moving the
students to the desired student learning outcomes.
Evaluation
Regular and timely feedback to learners on their progress is important to
learner success and engagement with the content/concepts/skills. Learners
benefit from frequent feedback as they master new content. But this can
also be very time consuming for faculty or trainers.
Faculty members who design learning activities or projects where
grading requires faculty judgment as opposed to “objective testing”
should develop a grading rubric or guide for each activity and place it
with the directions or guidelines file as well as a ach it to the assignment
in the CMS. These guidelines should also convey to learners when
students will receive comments and grades on submi ed work. When
developing these guidelines, trainers should think carefully about how
they will use these same guidelines during the grading process. How will
they actually evaluate the learner’s learning? Will there be feedback
provided directly on the learners work, a review of a sample document
from the work world, or follow-up once the learner is back in the work
se ing?
Once the grading is completed, faculty will also need to enter scores in
the CMS so that these scores can be viewed in the online student grade
sheet. Many online grade sheets now offer the students several ways they
can sort and analyze their grades. Faculty should consider how students
might interpret this information. For example, would a student learning
new information be motivated or discouraged if they determine they have
the lowest score in the class?
In addition to the evaluation of learner’s learning, faculty should give
consideration to evaluation of the course and related learning activities.
Does the school have course evaluation or best practices guidelines? Are
these guidelines appropriate for distance education courses? Many of
these course evaluation forms link to faculty contracts and will not
necessarily help improve the course. Does the faculty member use
something like Quality Ma ers, which is a peer review process to certify
the quality of online and blended courses?51 It might be helpful to use a
guide like Quality Ma ers as the course is developed. There is no one best
practice guide for distance education, but all guides consider these points
as being critical to quality:
• Institutional commitment and resources
• Curriculum and instructional rigor with interactivity and regular
communication between faculty and learners
• Faculty support services
• Student support services
• Evaluation of the course and programs
In the corporate world, the trainer needs to give consideration to how a
training session fits with the rest of the training provided by the
corporation and the corporation’s mission, goals, and values. For example,
in a clinical se ing, are the employees at the completion of the training
able to safely use the electronic health record (EHR), or are there common
data entry errors that are impacting patient care?
On a course-by-course basis, faculty may develop some activities that
provide learner feedback to the professor. A student statement
illuminating what the student learned from completion of the activity
provides feedback as to what is working and what is not. For example, at
the end of each blog entry, have the student identify up to three things that
they have learned and why they found them to be important. As a final
example, require the students to rate themselves on a scale of 1 to 5 on
how well they achieved each course objective and to support that rating
with some data (an activity or a resource that helped them learn, a product
that they produced, etc.).
Equally important to a well-designed and well-delivered course are the
support services available to learners.
Student (learner) support services
Student support services are important to the achievement of learner
outcomes, learner satisfaction, and learner retention. In planning for
learner support services, the faculty may need to assess what support
services online learners expect. Nelson states, “pu ing all student services
online will not eliminate the need for support services specifically
designed for distance education students.”52, p. 186 That statement is still
relevant today. All learners, both on and off campus, must have access to
the same resources, but they may be delivered in a different way.
Library
While most schools have online access to full text databases, interlibrary
loans, and book borrowing, there is a wealth of other library resources of
which the learner should be made aware. The following are two examples:
• Top Sites Blog contains a list of the top 10 free online libraries
(h p://[Link]/free-online-libraries). These online libraries
contain mostly historical information but can assist students with
their general education requirements as well as provide historical
information about healthcare.
• Nursing on the Net: Health Care Resources You Can Use
(h ps://[Link]/training/nursing/[Link]) includes a list of
topics with links such as alternative medicine, drug information,
evidence-based nursing, and mobile apps, to name a few. There is an
extensive listing of links to resources under these categories. This site
is maintained by the National Network of Libraries of Medicine and is
updated regularly.
The Association of College and Research Libraries (ACRL) publishes a
set of standards for libraries servicing the distance education population,
initially approved on July 1, 2008, but referred to as a “living document.”53
Guidance in the use of these standards may be found at the DLS website
(h p://[Link]/DLS/). In addition, a bibliography of recent literature on
distance learning library services can be accessed at
h ps://[Link]/resources-publications/.
During the planning phase, the school should compare its services to
those standards and develop a plan to acquire the services and materials
that do not currently meet those standards. In addition, faculty must
discuss what additional services online students may need that on-campus
students do not. This can vary from institution to institution based on how
the course is delivered. For example, do learners need a different user ID
and password to access the school’s online full text databases, or do they
have one user ID and password to access all resources whether on or off
campus? Do they have access to an online librarian who can help them
with their search strategy?
Tutoring Services
All learners studying at a distance should have the same access to tutoring
services as on-campus learners. There are several online tutoring services
that learners may use for a fee or that the school may provide. Some
examples include [Link] ([Link]), Smarthinking, Inc.
(h p://[Link]/higher-education/products-and-
services/services-and-solutions-for-higher-ed/services/smarthinking/), and
Chegg Study (h ps://[Link]/study). See also
h p://[Link]/higher-education. The tutoring service must be
similar to those that the school offers on campus and must have the same
pricing structure. Faculty should ask questions about these services
regarding the fees, live real-time help, hours of operation, and
qualifications of the tutors. For example, does the service have tutors who
can address the needs of healthcare students?
If there are peer tutoring services for on-campus learners, how will those
same services be available to the distance education learner? What
technology will be in place to provide for these services? For example,
does the school provide a web-based video solution where the writing
center peer tutor can interact with the student and the student’s paper
while talking about needed improvements? If a video conference system is
not available, the learner could e-mail the paper to the tutor and arrange a
phone conversation to discuss it.
Online Textbook Distributors
The cost and acquisition of required textbooks in a timely fashion merits
a ention. How is the campus bookstore responding to the growing
student population that may not reside on campus or live nearby? Does it
provide online ordering and shipping to the student’s residence? What
does that do to the costs? Does it provide eText options? Can learners rent
their textbooks through the bookstore? Will open textbooks (licensed
under an open copyright license) be used that are free to the students?
Other options that learners may use are the growing number of online
textbook distributors such as Chegg, Ecampus, and CourseSmart. Of
course, the student has the option to order from websites like Amazon and
Barnes & Noble College, as well as from traditional booksellers. The
following are a few examples of distributors in the higher education
market:
• Folle ([Link] [Link]). Folle is a leading operator of college
bookstores and a major distributor of textbooks. It operates a service
called CafeScribe, which is a digital textbook platform; this is different
from e-books, which are digital editions of traditional textbooks that
students or faculty read on a computer, tablet, or smartphone.
CafeScribe provides the ability for faculty and students to share notes
and insights in line with the text, search the text for specific
information, take notes directly in the text, bookmark places in the
text, and highlight information.54
• Chegg ([Link]). Chegg provides students with the ability to
rent textbooks as well as buy new and used textbooks at a reduced
cost. Students can also sell their books back to Chegg. It also offers
homework help for many courses, scholarships, and course selection
help. Chegg acquired several companies in 2010 and 2011:
CourseRank, Cramster, Notehall, Student of Fortune, and Zinch.55
• VitalSource (h ps://[Link]/). VitalSource provides
eTextbook and digital learning tools. It provides both online and off-
line access. It has a partnership arrangement with more than 50
publishers and offers more than 90% of the textbook market in higher
education.56
What guidance should the school provide to learners in distance
education courses with regard to acquisition of textbooks? For example,
are these books that the student will need throughout their time in college?
Depending on the answer, the students then must ensure that they are
renting or using digital forms of the textbook that are available to them for
the duration of their time in college. The Higher Education Opportunity
Act (HEOA), discussed later in this chapter, mandates that students be
provided with information about the required textbooks when they
register for a course. What should they know about older editions? Are
they acceptable or not? When will students actually need access to the
textbooks? They may need certain textbooks immediately but may not
need others until later in the course. Knowing this may help students
balance the cost of textbooks. Will students need a code to access the
textbook website? If so, does a used textbook come with the code or will
the student need to buy that separately? Buying codes separately is
generally more expensive and may not save students money when the
used book costs and new code costs are combined. What is the return
policy of these online distributors?
Help Desk
Given the nature of technology and that technical issues will arise during
the course of the semester, the school will need to address technical
assistance for off-campus learners. Should it provide for a university-based
help desk, an outsourced help desk, or some combination? This is not an
easy decision. It requires a cost analysis to assess staffing a help desk with
staff and students versus outsourced staffing. Software will be necessary to
run the help desk and a training budget allocated to train the staff. The
school will need to make decisions about help desk staff’s ability to reset
passwords and access the CMS, with designated privileges for functions
they can perform, such as configuring a student’s browser and firewall
and running virus checks. What is the range of help that a student
working at the help desk can provide? Will more hours be allo ed during
the first few weeks of the semester when more help may be needed? Is
there an orientation program for the students to the CMS?
Because distance learning occurs at any time (24/7) and any place, many
schools are opting for outsourcing. Outsourcing can be offered by either
the CMS vendor or be a freestanding service that is independent of the
vendor. A key question to ask in the CMS selection process is whether a
CMS provides a help desk service. Faculty may want to confirm that the
school’s CMS provider can effectively bundle a help desk product with its
CMS product; many CMSs are moving in this direction (to a portal or
bundled product). If so, what is the fee and what is the advantage of using
that service for the distance education program?
Another approach is to use a general help desk provider. The following
are a few examples of a portal and CMSs help desk services.
• BlackBeltHelp ([Link]) is a freestanding help desk
service that has been working with higher education institutions for
the past 5 years. It offers 24/7, 365 days a year support to students,
faculty, and staff. Support includes LMS and ERP issues, general IT
help, and so forth.
• Ellucian (h p://[Link]/Support-and-Training/Ellucian-
Client-Support/). This portal solution also offers help desk services. It
offers assistance 365 days per year to faculty, staff, and students. Since
it knows the portal software, it may be in a be er position to assist
students than a freestanding help desk service.
• Blackboard (h p://[Link]/higher-education/student-
services-and-technology-support/[Link]). On July 8, 2014,
Blackboard acquired Perceptis to enhance its help desk support
service.
If outsourcing is the solution, then the college must ensure that it
outsources the correct work and tasks. For example, will the help desk be
able to reset passwords? Will it have remote access to see what the student
is doing or to control the student’s desktop? What should it know about
the CMS or LMS? Will it have privileges to enter the CMS? What legal
implications does CMS access have? In either case, the school will need to
monitor the effectiveness of its contract in defining the services to be
provided and the quality of the services provided. The efficiency and
effectiveness of the help desk support must be subject to evaluation to
validate that it is meeting the needs of this student population.
In summary, learners will need access to the help desk 24/7 or close to it,
and this will necessitate a variety of communication channels: phone, chat,
video conference, self-help website, and so forth.
Administrative Services, Academic Support, and
Community Building
The retention rate for students who learn in their own space and time has
been a problem. How should the school adjust certain traditional student
services to provide for a feeling of connectedness and belonging for
distance education students? Will this aid in retention and be er student
outcomes?
• Administrative services. These services include registration, financial
aid, adds and drops, and admissions. Since most schools provide
these services online, the procedures for accessing them should be the
same as those used by on-campus students. The key institutional issue
here is whether this should be a portal solution with one interface or
stand-alone systems.
• Academic support. This includes advising and career services. Many of
these services are already extended to students through web portals
or department websites and through social media tools such as
Facebook and Twi er. The school may need to develop additional
options for use of social media tools to extend the services in both
time and space. For example, use of video conferencing or chat rooms
for advising sessions with extended hours may be appropriate. It may
also be important to put in place an alert and “job well done” system
(such as Starfish, [Link]fi[Link]) to keep students on
track and motivate them to finish. Questions to ask are: Does the
software integrate with the CMS? What are the issues if it does
integrate? If it doesn’t integrate? Some schools also have as a part of
the student information system an online audit for ease of scheduling
courses, reminders for requirements they met, and links to
appropriate content.
• Community building. This is an area that schools may neglect more than
other learner support services. How does the institution build a sense
of belonging and identification with the program or school? Faculty
and the school should consider services such as a cyber cafe either in
or outside the CMS program (some CMSs have a community tab or
feature separate from a course) or a blog that students can use to
interact outside of the course. Faculty might also consider a regular
newsle er or podcast that highlights an event, student, or
opportunity. What about a webinar on an issue of concern to
healthcare or nursing that is open to students in the program? What
about an online student government community? There are other
community-building options, but these must engage the students and
help them identify with their online learning community.
Issues
This section addresses additional issues that relate to distance education—
legal, disability, quality, and readiness.
Legal
Digital Millennium Copyright Act of 1998
The Digital Millennium Copyright Act (DMCA) addresses the demands of
the digital and internet age and conformance to the requirements of the
World Intellectual Property Organization.57 This is a complex act that is
generally outside the scope of this chapter. This chapter highlights those
areas of the law that might affect a distance learning program. DMCA
protects any copyrightable work. Copyrightable work includes wri en
text or literary works, visual works, graphic works, musical works, and
codes that pass between computers.58 Key sections that affect distance
learning include the following:
• Prohibiting the circumvention of protection technologies, including
encryption or password-breaking programs, and the manufacturing
of devices that defeat such protection measures
• Limiting liability of online service providers because of the content
that users transmit over their services
• Expanding existing exemptions for making copies of computer
programs under certain conditions
• Updating rules and procedures for archival preservations
• Mandating studies to examine distance education in a networked
world59
DMCA also established the Takedown Notice, through which copyright
holders can demand removal of infringing content. This requires the
copyright holder to follow the appropriate process and procedures.
Since this is a complex law, students and faculty should check with the
school’s legal counsel if they are in doubt about violating DMCA while
preparing and posting educational materials for a distance course. Many
schools also have a checklist that can be used as a guide to maintain
compliance with this law. This checklist is often posted on the library
website.
Technology, Education, and Copyright Harmonization
Act
The Technology, Education, and Copyright Harmonization (TEACH) Act,
passed in 2002 and signed into law by President George W. Bush,
addresses some of the issues that require a ention when planning and
delivering distance education. The purpose of this act was to clarify
acceptable use of copyrighted materials as it relates to distance education.
Many of the responsibilities for compliance with this act are placed on the
institution and its IT staff. The TEACH Act permits the performance and
display of copyrighted materials for distance education under the
following conditions:
• The institution is an accredited, nonprofit educational institution.
• Only students who have enrolled in the course can have access to
these materials.
• The use must be for either “live” or asynchronous sessions (permits
storage of the materials on a server).
• The institution must provide information to faculty and students
stating that course materials may be copyrighted and provide access
policies regarding copyright.
• The institution must limit access to the materials for the period of time
necessary to complete the session or course.
• The institution must prevent further copying or redistribution of
copyrighted materials.
• No part of the use may interfere with copy protection mechanisms.59–61
For the professor, the law includes the following:
• The materials must be part of mediated (systematic) instructional
activities (i.e., relevant to the course).
• The use must not include the transmission of textbook materials or
other materials generally purchased or works developed specifically
for online uses.
• Faculty can use only reasonable and limited portions of such
materials, as they would typically use in a live classroom.
• The materials must be available only to registered students and not to
guests or observers.
• Faculty must post a notice or message in the CMS that identifies the
copyrighted materials and therefore precludes the student from
copying or distributing these materials to others, as that would be a
breach of copyright law.
• Faculty must pay a ention to “portion” limitations (how much one
can use).59–61
The latest a empt at revisions to the TEACH Act is H.R. 3505,
introduced on November 15, 2013, for the purpose of developing
accessibility guidelines for electronic instructional materials and related
information technologies in higher education institutions. [Link]’s
website (h ps://[Link]/bill/113th-congress/house-bill/3505)
provides a copy of the bill, a summary of the bill, as well as information on
the progress of this bill, which is still in the Subcommi ee on Higher
Education and Workforce Training as of October 14, 2016.
Consult the school’s policy and legal and library authorities when in
doubt about materials necessary for the course. The American Library
Association has an excellent website that further explains the roles of the
institution (administrators or policy-makers and IT staff), faculty, and
librarians.
Higher Education Opportunity Act
The Higher Education Opportunity Act (HEOA) of 2008 is a
reauthorization of the Higher Education Act of 1965. It requires
postsecondary institutions to be more transparent about costs and requires
that the institution post a net price calculator as well as security and
copyright policies on its website.62 While many of the provisions in this act
do not directly affect faculty (since they relate to administrative offices that
deal with fees, growth, public relations, credits, etc.), the following do
affect faculty: the textbook information provision, the definition of
distance education, and the requirement to establish that students are
indeed who they say they are.63,64
HEOA compliance entails the following:
• Faculty must select and submit textbook requirements to the campus
bookstore before posting the next semester’s schedule and registration.
Each institution establishes the process for this. Under certain
circumstances, the institution may post a “to be determined” notice if
textbook selection was not practical before the school posts the next
semester’s schedule.
• Schools must pay a ention to the change in terminology from distance
learning to distance education. Education describes the process from
the institution’s perspective; it includes the use of one or more
technologies to deliver instruction to students who are in a separate
location and to support regular and substantive interaction between
faculty and students. Learning describes the process from the
students’ perspective; it focuses on how the student interacts with the
course content, classmates, and instructor in mastering the course
content.
• Institutions must have a process in place to verify that the enrolled
student is actually the person completing the course. Faculty may
assist in determining how this process will work and with the
development of a policy to cover this provision.
There are periodic updates to HEOA and the related regulations. These
changes can be found at sites such as
h ps://[Link]/special_initiatives/hea101/publications/page/updat
es-on-regulations-and-regulatory-process. Most educational institutions
keep abreast of these updates and notify faculty during faculty in-service
days.
Intellectual Property
The issue of intellectual property is coming to the forefront as a major
concern in the digital age. Faculty are increasingly concerned about the
ownership of distributive course materials and the use of those materials.
Many faculty assume that these course materials are their creative
property, meaning that a requirement exists for others to obtain
permission to use them. Since these materials exist in digital form on a
school’s accessible server, others may have access to these materials with
or without faculty consent. In today’s world, some of these materials may
have commercial value, and institutions are increasingly taking ownership
of these materials. A clear institutional policy will convey to all persons
involved who owns what and what constitutes allowable use of the
materials.
Some questions to consider in developing an intellectual property policy
are:
• What works are included under the policy (e.g., artworks, writings,
software, course learning objects, PowerPoint slides, podcasts)?
• To whom does the policy apply (e.g., all employees, professors,
researchers, postdoctoral fellows, administrators, students)?
• Under what circumstances does the school own the materials? Under
what circumstances does the faculty member own the materials? Can
there be joint ownership? Is this a work for hire or within the scope of
the faculty member’s employment?
• What institutional resources did the faculty member use to create the
materials?
• What key words should the policy clearly define?
• Is there a clear, definitive wri en agreement between the faculty
member and the institution as to ownership and rights?
• Who is responsible for obtaining copyrights, trademarks, etc.?65,66
Family Educational Rights and Privacy Act
The Family Educational Rights and Privacy Act (FERPA) is a federal law
that requires colleges and universities to give students access to their
educational records. Colleges and universities must maintain the
confidentiality of personally identifiable educational records. See
[Link]/policy/gen/guid/fpco/ferpa/[Link] for the U.S.
Department of Education’s summary of FERPA. While distance education
courses were not a direct concern to those who wrote the FERPA rules, any
time a faculty member or a university generates student information
electronically, you must take precautions.
Consider the following guidelines for distance education and student
records:
• Only enrolled students and the faculty teaching the course should
have access to the course. However, the CMS administrator also has
access to the course to manage and troubleshoot problems in using
the CMS. The school must make the administrator aware of FERPA
policies.
• If a college uses a hosting client (someone off campus that maintains
the CMS), this arrangement makes the hosting client a third-party
vendor. While the client should not have access to information that
links a student to a grade, the client’s systems administrator does
have access to the servers and ultimately to everything on them.
• Students should be able to view only their own grades in the online
grade book. They should not be able to see other students’ grades.
• Some issues may arise regarding discussion forums, depending on
how the faculty use them. Faculty should not post evaluative
comments or grades for students’ comments in the discussion forum.
Faculty should also state in the course requirements that students are
required to post to the discussion forum, share their papers, and so
on.
• If faculty use Excel to keep a record of student grades, they should
remove the students’ ID numbers from the spreadsheet, leave no
storage devices where others may access them, password protect the
spreadsheet (but faculty must remember the password), and use an
encryption program that comes with some external drives. This will
protect the confidentiality of student data.
• If faculty lose a portable device such as a thumb drive that contains
student grade sheets where the student names and grades are
identifiable, they must notify the proper college or university
authorities to determine what additional action must be taken.
• If faculty require students to send or post information to sites outside
the college (e.g., blogs; social networking sites such as LinkedIn,
Facebook, and YouTube; etc.), a clear policy must be developed and
followed. This type of assignment can be ripe for FERPA violations.
Disability Issues
Distance learning opportunities can open doors for millions of Americans
with disabilities. When planning for the delivery of distance education
courses, faculty must not create access barriers for the disabled. Laws such
as the Americans with Disabilities Act (ADA) prohibit discrimination due
to disability, and sections 504 and 508 of the Rehabilitation Act provide
protections to learners with disabilities.67
What constitutes a reasonable accommodation for a particular learner
will depend on the situation and the type of program. The
accommodation, however, may not be unduly costly or disruptive for the
school or be for the student’s personal use only. In colleges and
universities, the student has the primary responsibility to identify and
document the disability and to request specific support, services, and other
accommodations. Most schools have a person responsible for assessing
students with disabilities and providing an accommodation le er to
faculty. Each accommodation le er details modifications for each student
with a disability. The modifications may include the following items:
• Providing extended time to turn in assigned work
• Providing extra time for timed exams
• Administering an exam in an alternative format, such as a paper exam
when others will take the exam on a computer through the CMS
• Allowing spelling errors on papers or exams without deduction of
points
Given the disability of the student and the nature of distance education,
the student may need computer assistive devices. Students with
disabilities may need adapted keyboards; magnification software; screen
reader programs, such as Job Access With Speech (JAWS)
(h p://[Link]fi[Link]/products/fs/[Link]) or
Dolphin’s SUPERNOVA (h p://[Link]/[Link]),
that convert the text and images to speech; voice recognition; and
alternative communication programs. Most operating systems support
persons with disabilities by incorporating accessibility utilities into the
system.
For faculty, this may mean providing alternative experiences for a
student with a disability (e.g., use of a captioned video for the hearing-
impaired student). Faculty that teach distance education courses should
review the tutorial entitled Ten Simple Steps toward Universal Design of
Online Courses (located at h ps://[Link]/pace/tenstepsud/) that
addresses these issues. It lists 10 steps and provides examples and details
for each one.
Quality
The traditional model of quality evaluation is site based, but distance and
distributive education are not site based.68 Distance education is changing
the thinking about quality assessment methods. Pond suggests that this
new paradigm creates opportunities and challenges for quality assurance
and accreditation.69 Pond further suggests that the traditional items of
quality assurance, such as physical a endance, contact hours, proctored
testing, and library holdings, are impractical or simply not rational in a
distance education course. Pond makes the following three suggestions:
• Use a consumer-based means of judging quality much like Amazon or
eBay.
• Accredit the learner by having the learner demonstrate competencies
rather than earn credits or certify the teacher’s competencies.
• Move quality assurance toward an outcomes- or product-based model.
This new model will look at quality indicators such as continuity
between “advertising” and reality, personal and professional growth of
the learner, relevance, and multidirectional interactions.
Eaton states that accreditation institutions or agencies need to do the
following70, p. 6:
• Identify the distinctive features of distance learning delivery.
• Modify accreditation guidelines, policies, or standards to meet the
needs of this distinctive environment.
• Pay a ention to student achievement and learning outcomes.
In the Eaton article, Appendix A features guidelines for quality
assurance in distance education, and Appendix B includes 12 important
questions about external quality review that are worth examining.
Faculty must answer these questions: How will they evaluate quality in
the distance education environment? How will the approach be the same
as or different from that used for on-campus courses or programs? What
are the current criteria that educational accrediting agencies will use to
accredit or review the program? How do faculty address these criteria?
What issues arise when states serve as the primary arbiters of policy and
governance issues in U.S. education but the student population resides in
one state and does not physically go to the campus in another state where
the student is taking distance education courses?71
Readiness
This section examines both the institution’s readiness and the learner’s
readiness for teaching and learning in a distance education model.
Institution
Some institutions may enter the distance education market to maintain
competitiveness; others may do so because their recruitment staff
identified a market need. Some see this movement as a means to increase
revenues in these difficult financial times without the need for brick and
mortar facilities. Regardless of the reason, the critical issues for readiness
are as follows:
• Does the movement to distance education fit with the institution’s
missions and goals?
• Is the institution ready to invest in the technologies necessary to
produce a quality program?
• Does the institution have the resources—people, money, and time—to
develop and implement the program?
• Does the institution have faculty buy-in? Does it have administrative
commitment? Does it have staff buy-in?
• Are faculty ready and prepared? Some institutions, such as
Pennsylvania State University (PSU) and SUNY, have developed a
faculty readiness assessment; the SUNY document is available at
h ps://[Link]/teaching/ge ing-started/faculty-
self-assessment-preparing-for-online-teaching/. Does the institution
have such an assessment or survey?
Without this readiness and commitment, distance education will not
work or at best will result in a program of marginal quality. Just as the
institution needs to be ready, it also needs to assess the students and
potential student population for their readiness. That being said, the move
to this method is moot for many institutions, because competition is
forcing distance education solutions and most universities have already
made this transition. In the corporate world (i.e., hospitals), it is also moot
because of the need to provide mandatory training that takes into account
employees working all shifts and all days. What is essential is the
assessment of technologies necessary to deliver the training, resources
necessary to make it happen, and trainer readiness to prepare the training
materials.
Students (Learners)
Students who enter distance education courses need to consider their
interest and ability to succeed in this learning environment. Inappropriate
expectations about requirements for succeeding in these types of courses
can lead to frustration and failure. Key questions include:
• What information does the institution provide to these learners to
assess their readiness to learn in distance courses?
• Does the institution provide learners with a self-assessment tool such
as Kizlik’s readiness assessment
(h p://[Link]/[Link]) or Cypress College’s readiness
assessment
(h p://[Link]/DistanceEdquiz/[Link])?
• How will the institution make learners aware of the requirements for
learning in this manner? For example, do learners know that distance
courses require discipline and organization in se ing aside time to
complete the learning, as well as reading and comprehension skills to
understand the concepts and develop the skills necessary for this
program or course? Do students have the ability to follow directions
and ask questions and the ability to work on their own under the
guidance of a faculty member?
• How does the institution make eLearners aware of their
responsibilities? For example, students will have to meet course
deadlines, check in to the course regularly, interact with faculty and
classmates, ask questions as necessary, and conduct themselves in a
professional manner in all interactions.
The institution should list or outline learner requirements in a policy
and procedures document and make this document available to students
to ensure that they understand their responsibilities.
Conclusion and future directions
The changes in our educational environment are reflective of shifts in our
demographics, economic conditions, and technological developments.
Web 2.0 tools are opening up educational opportunities for lifelong
learning to a diverse global community. Emerging terms, course
management and learning management systems, and issues related to the
development and implementation of distance education and distributive
learning are all elements resulting from these budding educational
opportunities.
The next generation of CMSs and LMSs will be integrated portals that
are smarter, track more information, and analyze learner data across
functions such as e-mail, wikis, chats, forums, and so forth. They will
include personal learning environments (PLEs), immersive, 3D learning
worlds with be er communication channels and collaboration for any time
and any place learning with tablets and mobile devices.72 This will result
in just-in-time, customized learning environments where the focus is on
outcomes rather than traditional credit hours. This emerging environment
is about the learners, the learners’ needs, and the integration and use of
appropriate technologies.
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Discussion Questions
1. Research how constant connectivity affects you socially, cognitively, and
physically. Refer to such books as Carr, N., The Shallows; Turkel, S., Alone
Together: Why We Expect More From Technology and Less From Each Other;
Lanier, J., You Are Not A Gadget: A Manifesto; and Carr, N., The Glass
Cage: How Our Computers Are Changing Us. Ask yourself how technology
is changing the way you think and focus, and how this affects your
learning style. Provide two examples and resources that support how
technology is changing how we socialize.
2. From a student or faculty perspective, develop criteria to use in
comparing and evaluating two course management systems (CMS) or
learning management systems (LMS) delivery systems. Select two
systems and compare them using the developed criteria. Discuss what
you learned in developing these criteria and in comparing two products
against them. Include answers to the following questions: How useful
were these criteria, what was missing, and how would you revise the
criteria next time?
3. Think of a situation where distance education might be appropriate.
Identify three technology tools that might be useful for the specific
audience and how they would be used. What skills would the learner
need to use them? What skills would the instructor/trainer need?
4. Research the future of higher education, distance learning, and the
movement toward personal learning environments (PLEs). What will
the day in the life of a nursing student be like in 2026? What impact will
technologies have on license renewal?
Case Study
You are a faculty member serving on the online learning commi ee. The
university requires an assessment of which learning strategies are working
and which are not and an examination of the current standards, emerging
trends, and how the school should plan for the distance education and
elearning movement. The commi ee is charged with se ing the course for
this initiative for the next 2 years. There are many subcommi ees, each
with a specific charge. You are serving on the subcommi ee charged with
developing the stakeholder matrix, a document identifying all
“stakeholders”—those who have an interest in this initiative, how they fit
in the organizational structure, what influence they exert, and so forth.
These are the people from whom you will collect data and who you will
involve in the process and many times in the decision making.
Create a five-column table with the following headings for the columns:
Stakeholder Name and Organization; Organizational Role; Influence and
Power; Unique Information About This Person/Organization; and
Strategies for Communicating and Working With This Person. Each
stakeholder will be entered as a new row in the matrix.
Once you design the stakeholder matrix, analyze its importance and
how it will be used. Using what you learned in this chapter, create a
strategy for each column. For example, determine how you would
systematically identify each stakeholder. Develop up to three questions to
guide your collection of the data for each column. Then complete this
matrix for your college.
Discussion Questions
1. Discuss the pertinent laws that should be considered for this initiative.
2. Describe next steps in the process that would help assure the success
of the initiative.
3. Using what you learned in this chapter and by searching the web for
distance learning materials, list two likely future directions.
32
Informatics Tools for Educating
Healthcare Professionals*
William Sco Erdley; Kay M. Sacke -Fi gerald
Abstract
While all levels of education are affected by computerization and the use of
technology tools (e.g., course management systems, the internet, computer-based
instructional games), it is at the collegiate level that the impact of technology is most
keenly felt in health informatics. The educational preparation of healthcare providers
is the foundation of a safe, effective, and efficient healthcare delivery system. This
chapter addresses the use of education information systems and technical tools to
support the work of healthcare faculty and educators charged with the preparation
of competent healthcare providers. The impact of the computerization of higher
education is described, computerized teaching tools are presented, the impact of
computerization on the faculty role is discussed, and the implications for health-
related faculty are explored. The increased computerization in institutions of higher
education is now creating sets of big data (large datasets). In this chapter the
implications of these data and the potential for predictive analytics are explored with
a focus on future directions.
In education, the final record of a student’s learning is the limited
information included on the transcript. In the manual world of education, for
the most part, all other data collected by individual faculty and academic
departments are maintained, if at all, in file cabinets or individual faculty
files. This can be called the ultimate system for creating an island of lost
data and information.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Discuss the effectiveness of computerized teaching tools that can be
used to deliver education within the traditional classroom
environment.
2. Explore computerized applications that can be used to manage
educational information and support the work of health-related
faculty.
3. Examine the increasing impact of automation, including
comprehensive education information systems on the academic
policies and procedures of the academy.
4. Outline the impact of computerization on the role and career
development of healthcare faculty within the academy.
5. Analyze how technical tools and education information systems can
be used to increase the effectiveness and efficiency of faculty.
KEY TERMS
academy 539
avatar 546
big data 538
clicker 543
comprehensive education information system (CEIS) 539
eBooks 541
ePortfolio 545
interactive whiteboard 540
Introduction
Over the last several decades, the implementation of healthcare computer-
based information systems has transformed the healthcare delivery
system. That impact is now incorporated within the educational process of
healthcare providers. A primary mission of higher education is the
education of students to ultimately create an improved healthcare system.
These may be students in current degree programs or continuing
education. No ma er the program, the educational process is supported
by a complex administrative infrastructure. The computerization of the
academy can be considered from academic and administrative
perspectives. The academic perspective focuses on the delivery of learning
and student assessment. The administrative perspective focuses on the
development of systems and processes supporting the day-to-day
operation of the institution. This includes student information systems,
financial information systems, and human resources and payroll systems.1
Both the education of students and the surrounding administrative
infrastructure have benefited from the opportunities provided by
technology integration. In addition, as new systems in both areas evolve,
their functions increasingly overlap, moving toward a comprehensive
education information system. Such a system creates the opportunity for
increased effectiveness of the learning process and efficiency of the
academy. For example, predictive analysis of big data can result in
innovative curricula that may prevent academic problems for future
students. In this chapter, the computerization of the academy is described,
computerized teaching tools are presented, the impact of computerization
on the faculty role is discussed, and the implications for health-related
faculty are explored.
Comprehensive education information
system
Comprehensive education information systems (CEISs) include the
hardware, applications, overlapping and integrated functionality, and data
produced by all information systems within an academic se ing. This is
depicted in Fig. 32.1, which divides the CEIS into three overlapping areas.
These are the administrative information systems, the learning
management system (LMS), and the academic information tools used in
teaching. Overlap of functionality and data flow occurs across the system.
For example, a group of students preregisters for an online three-credit
theory course and a five-credit related clinical course. As each student
registers, the course shell roster for the online course is populated with the
student’s name. The faculty member then assigns the students to their
clinical sections, and these data are sent back to the registration system for
transcript and tuition purposes.
FIG 32.1 Comprehensive education information system.
Increasingly a common database depicted on the model as big data
allows data integration across the institution. The model demonstrates the
concept of a CEIS as it applies to an academic institution; however, the
concept can be applied to several educational institutions within a larger
system. For example, in Ohio, the Higher Education Information (HEI)
system ([Link]/hei) includes a comprehensive database
with student enrollment, courses, financial aid, personnel, facilities, and
finance data submi ed by Ohio’s colleges and universities. Data are used
for a variety of purposes, including reporting on higher education
outcomes, funding formula and financial aid, policy analysis, and strategic
planning.
One module within the HEI system is the Course Inventory Expert
System, which includes decision rules for classifying undergraduate
courses with the goal of achieving consistent treatment of undergraduate
courses across the system (h ps://[Link]/ap/1?
12861140478913). This makes it possible to implement a comprehensive
credit transfer system across Ohio’s entire public higher education system
of 14 universities, 24 regional campuses, and 23 community colleges. In
contrast to traditional approaches, an individual faculty member does not
need to review a syllabus and other course materials to decide whether a
student can transfer a course.
A second example of how educational administrative systems are
changing faculty responsibilities can be seen with the commercially
available Typhon Group (h p://[Link]) products. This
company offers a student tracking system targeted at health professional
programs. Available packages include modules addressing a wide range of
content, stretching from case logs to curriculum mapping to clinical site
databases. These examples suggest the potential impact that academic
systems will have on the roles and responsibilities of faculty within the
academy.
To ensure information systems implemented in health-related education
programs support the teaching-learning process and take full advantage of
the potential for innovative opportunities offered by automation, health-
related faculty must assume a proactive role. Nelson and others identified
the following four key areas where faculty should become proactive:
• Identifying data elements and developing standard terminology
needed to capture the essence of education with the healthcare
professions
• Participating in the development of policies and procedures for
securely collecting, accessing, and using faculty, staff, administrative,
and student data
• Contributing to the process for selecting, implementing, and
integrating education information systems
• Designing educational opportunities to ensure faculty clearly
understand the potential of automated academic systems and the
importance of participating in these activities1
Participating in these activities obviously requires time and effort; at the
same time, these activities may not contribute to achieving tenure and
promotions. Given this reality, faculty teaching in the health disciplines
must decide whether they will play a leadership role or step back and
have the transformation of higher education managed by others. Just as
the design of effective healthcare information systems requires input from
healthcare providers and health informatics experts, the design of effective
systems supporting the teaching-learning process requires the advice of
educators and informatics experts within healthcare.1 Often the best way
to begin moving into an education leadership role involves working with
the implementation of computerized teaching tools.
Computerized teaching tools
Computerized teaching tools are hardware and software used in the
design, implementation, and evaluation of student learning. These tools
make it possible to develop creative and innovative learning experiences
as well as assess and track student learning.
Hardware
Hardware refers to tangible physical items used in the educational
process. These devices are used by students and faculty to engage with
each other and educational content, with the goal of increased learning.
Hardware includes computer-related tools used in all areas of society,
such as laptop computers, tablets, cellphones, and tools specifically
designed for education, such as interactive whiteboards and clickers.
Interactive Whiteboards
Historically conventional classrooms within a college or university se ing
included at minimum a chalkboard across the front of the room. Over
time, the chalkboard was supplemented with the use of overheads. The
computerization of these basic tools early in the 1990s resulted in the
“smart whiteboard” or “interactive whiteboard,” which offered innovative
approaches to education and the related administrative functions.2 The
boards come in a wide variety of sizes to complement or meet general, and
unique, user and environment requirements. These interactive
whiteboards are sold with a variety of possible functions, allowing for
real-time consultation between faculty and students, real-time editing of
documents by geographically distinct persons, and the ability for
videoconferencing. Typical features of these interactive tools include the
following:
• The ability to project materials from a computer, a document camera,
or the internet.
• The ability to write directly on the board, creating figures, documents,
and notes that can be edited as they are created. These materials can
be saved or printed for distribution to students.
• A touch interface, making it possible for a user to interact with the
board by using a finger. A single digit is used for the most part;
multifinger use is not common at this time.
See Box 32.1 for additional features.
Box 32.1
Common Features of an Interactive Whiteboard
• Wireless (Wi-Fi connectivity, interface with users)
• Touch, keyboard, and mouse capable
• Conferencing capable with multiple concurrent users
• Document editing with two or more concurrent users
• Short projection distance to eliminate walking in front of projection
• Multiple USB ports with easy access
The features offered on interactive whiteboards have been evolving over
time and now often include collaborative functionality such as
conferencing between users anywhere a connection is available. Faculty
can use these boards for videoconferencing between classes held on
different university campuses or with colleagues located in different areas
of the world. However, not all universities provide an interactive
whiteboard with a video camera available at both sites. As a result,
videoconferencing may be one-sided. Other uses include note creation,
thus allowing the instructor to insert notes into a document projected to
both sites and create a collaborative distributed classroom. Because of the
interactive capabilities, participants in the distance classroom are able to
respond by entering their own viewable notes. On the downside, these
tools can be expensive, ranging from $1500 for low-end models to $15,000
or more for models with all possible features.
Cheaper priced applications, with many of the same functions as
interactive whiteboards, are also available. One example is Google
Hangouts (h ps://[Link]), a part of Google +, which includes
desktop sharing, Google docs, and other functionalities found on more
costly hardware and/or software. However, the price is not without
barriers. For instance, typically the number of concurrent video-
conferencing a endees is capped. Additional technical issues are possible
due to use of Java. Some browsers (for example Chrome) do not work well
with Java due to inherent security policies that may conflict with Java. And
perhaps not all have access or use of this application for whatever reason
(company policy, security concerns, and so forth). Nonetheless,
applications such as Hangouts may prove the most cost-effective approach
for many users with proper IT support.
However, of special concern when using these types of apps is the issue
of student privacy. In 2014, the U.S. Department of Education released
guidance on protecting student privacy while using online educational
services. Additional information about the Federal Education Records
Privacy Act (FERPA) as it applies to institutions of higher education can be
found at the U.S. Department of Education Privacy Technical Assistance
Center (PTAC). PTAC functions as a resource for education stakeholders to
learn about data privacy, confidentiality, and security practices related to
student-level longitudinal data systems and other uses of student data.
PTAC (h p://[Link]/) provides current information and updated
guidance on privacy, confidentiality, and security practices. It offers a
variety of resources, including training materials and opportunities to
receive direct assistance with privacy, security, and confidentiality of
student data systems.3
As educators and legislators become increasing aware of these issues,
one can expect to see increasing state and federal legislation and
regulations controlling the use of these types of apps. For example, in the
fall of 2015, two Pennsylvania representatives, Dan Miller and Tedd
Nesbit, introduced a two-bill package, whereby schools could use
education technology products that amass, sell, or share student data, but
only after notifying parents and allowing them to opt out. “The bills
wouldn’t ban apps like the poster-making program Glogster, which
markets to teachers and indicates in its privacy policy that it may share
‘personal information’ with ‘consumer products, telecom, financial,
military, market research, entertainment, and educational services
companies and their third party service providers.’”4
eReaders and Digital Books
eBooks are an emerging technology for educational users. Initially
designed for reading books, eReaders are now branching out to challenge
tablet computers. eBook readers have electronic “ink” or electronic paper
to render a “page” similar to a printed page found in a book. Only a few
technology companies have created digital ink, and many reading devices
license the technology from these companies (e.g., Adobe and E Ink). Sony
(Reader), Amazon (Kindle), and Barnes & Noble (Nook) are examples of
suppliers of these digital reading devices. The advantages of using these
media include portability, the ability to adjust font sizes for easier viewing,
and large storage capabilities. Some disadvantages are limited
backlighting of the page, a need to maintain adequate ba ery charge, and
limited ability for text markup. In the past, these devices were single
function, although this is changing. Newer versions of the Kindle (Fire)
and Nook (Touch) are evidence of the shift toward multifunctional
devices, as these now provide an ability to browse the internet, check e-
mail, connect via cellular plan and Wi-Fi, and watch movies on the device,
along with reading text-based content. Newer models also support text
markup or highlighting.
Additional applications (or apps) are available, permi ing eReader
functions on non-eReader devices (e.g., iPads and Google devices).
However, these apps have limited functionality compared to native
eReader devices. Despite this limitation, users are able to connect using the
app to access and read current materials without having to use a dedicated
eReader. This allows mobile devices such as laptops, smartphones, and
tablets to become, in essence, eBook readers making the purchase of a
separate eReader unnecessary.
In the health education arena, textbook suppliers are offering electronic
texts for students at all levels. Vendors offering electronic textbooks,
including Elsevier, Lippinco Williams & Wilkins, McGraw-Hill, and
Pearson, often including web-based resources. These books are available in
an eReader format such as Kindle and Nook, as well as browser-based
format. The browser-based format usually requires a “plug-in” and
functions within a LMS software such as Blackboard. The ability to link to
web-based resources has appeal for students. Faculty resources are
available in a similar fashion in particular, allowing faculty to quiz
students via e-textbook-created tests and quizzes. In the last few years,
textbook suppliers are also altering the eBook model to allow faculty to
purchase or rent (a.k.a. use) needed chapters versus an entire textbook.
The limitations of these eText offerings include cost, availability only as
a proprietary publisher eBook or in Adobe Reader file format, reduced
print selections, and restricted ability to mark up or highlight text. An
early study reported student reluctance to pay for the use of eBooks as
well as frustration with the search function within eBooks.5 In addition,
depending on the size of the screen, viewing charts, figures, and other
nontext content can be difficult.
The obvious advantages are user mobility and content portability. The
ability to integrate graphics, multimedia, and text material is becoming
more prominent. eReaders are now able to download files, so the need to
maintain online access while reading a text is not required. The prevalence
of students interacting with eBooks is increasing, and students are now
able to connect to additional resources cited in a text via a URL. Text
highlighting is becoming more available. Students may also copy and save,
in some cases, text information for later use and/or sharing with others. In
the clinical realm, texts, compendiums, and reference materials are now
more available to students and other users of this information for patient
care at the point of care. However, how these tools can be effectively
integrated into the educational process at the point of care is in many ways
an unanswered question from both a technical and an academic
perspective. For example, if a student is reading a patient’s EHR and needs
to check a reference for additional information about a drug, lab test, or
diagnosis, should the student reference materials be on a separate device,
or integrated with the decision support content in the EHR?
A search of the literature using the terms “electronic books” and
“nursing education” demonstrates limited information on how these tools
are being used. Nonetheless, eBooks, in general, are gaining popularity by
users and vendors. Many of the vendor solutions can be integrated with
course management software such as Blackboard or Merlot. There is also
limited research reported regarding use of such tools by learners. In one
study, undergraduate nursing students were very pleased to use eBooks
and personal digital assistant (PDA) devices as tools during their clinical
rotation.6
Smartphones
A smartphone offers a host of additional functionality beyond calling and
texting between callers. They have become handheld computers. Some are
be er at handling graphics (such as movies, pictures, and games), while
others offer improved functionality for internet browsing and social media
use. Many smartphones are able to take advantage of wireless networks
for data transmissions. At this point in time, smartphones with the largest
market share operate using either Google’s Android or Apple’s iOS
platform. There are advantages and disadvantages with each operating
system and device. Android-based smartphones tend to employ a larger
screen size and more powerful chipsets or computer processing units
(CPUs) and are able to use additional storage via mini storage disk (SD)
cards. iPhones now have variable screen sizes, are not able to take
advantage of additional storage, and do not interact well with Adobe
Flash–based web applications. However, iPhones do have access to the
largest app store, iTunes. Many current smartphones are powered by dual-
core low power CPUs. This power, coupled with the size, allows for a
large amount of computational horsepower in a small portable device.
Due to their computational power and increasing popularity, the
integration of smartphones into both healthcare delivery and education is
growing. As of 2014, there were more electronic gadgets (smartphones,
cellphones, and tablets) than there are people in the world.7 In the United
States, more than 60% of all adults own a smartphone,8 with higher rates
of ownership in the college se ing. In 2014, Pearson reported that 83% of
college students regularly use a smartphone. This is up significantly from
72% in 2013.9 One can expect these numbers to continue growing until
they reach almost 100%.
Regardless of the operating system, many smartphones are able to
interact with a variety of mainstream educational LMSs, such as
Blackboard, Canvas (h p://[Link]), and Instructure
(h p://[Link]/). Smartphones can even be “substituted” for
handheld classroom interactive devices within CMS software such as
Canvas (e.g., i > clicker,
h p://[Link]/customer/portal/topics/662688-ic-lms-
canvas/articles).
A variety of applications are available for smartphones for health
students and practitioners. The more common types are drug reference
software such as Davis’s Drug Guide and Epocrates. iTunes and Android
app stores offer an increasing variety of healthcare applications beyond
drug references, including formula calculators, physical assessment
guides, protocols such as Advanced Cardiac Life Support (ACLS),
Pediatric Advanced Life Support (PALS), and audio assist applications for
lung and heart sounds. Many of these apps are free, while others are
available for a nominal fee. The free version of an app may not have the
full features of the same app with an associated cost. Textbooks and other
typically hard copy–only reference manuals are becoming increasingly
available for smartphone platforms. There is limited regulation of these
types of apps, so one should use caution in assuming every app selected
from iTunes and Android app stores will function as described. Testing of
apps before using in an educational se ing is strongly recommended.
Due to their increasing popularity among students, healthcare
providers, and patients, smartphones are increasingly included as
requisite tools for education and healthcare practice. Smartphones can
interact not only with educational management systems (e.g., Blackboard,
Moodle, Joomla) but also with different electronic health record systems.
While a wide variety of apps are available, some caution is warranted.
Some institutional policies may preclude smartphone use because of
potential patient privacy and information security breaches. Every
organization has a policy and protocol detailing Health Insurance
Portability and Accountability Act (HIPAA) requirements and the use of
mobile devices. See Chapters 13 and 26 for additional information on this
topic.
Tablets
Tablet computers are another tool available to faculty and students. Tablets
are increasing in popularity and use in higher education. Early tablets
were bulky and heavy, but the iPad, first available in early 2010,
revolutionized widespread tablet use. Lightweight and novel in design,
the iPad is a device with strong support from a wide range of software
companies. The iPad employs a touch screen user interface that allows
users’ fingers to maneuver through the internet and documents. A virtual
keyboard, with an optional Bluetooth keyboard, provides standard data
entry capability. Using almost the same iOS platform as the iPhone, the
iPad is rapidly becoming a dominant tablet on the market if not already the
dominant tablet. However, Windows 10 has succeeded Windows 8, which
made it possible to convert a laptop into a tablet computer.
Tablets such as the iPad have proven useful for educators, students, and
healthcare providers. Apple has recently released a new version of the
iPad to counter the latest version of Microsoft’s Surface model. Both are
tablets with removable keyboard covers. With the availability of
applications similar to the Microsoft Office suite, these devices are
becoming increasingly functional for a wide variety of activities. Some
current examples include SmartOffice 2 and Documents To Go—Office
Suite. The price for these applications can range from free to $50 or more,
and they are available only at the App Store run by Apple. Equivalent
applications are available for Android platform tablets via the Android
App store.
One concern with using these sorts of devices is storage. iPads do not
have USB ports for accessing flash storage. Instead users must access
online or cloud environments to store and retrieve material. An example of
cloud storage is Dropbox ([Link]), a free service that works
on a wide variety of devices and operating systems. The free account for
this service includes 2.5 GB of space, which is a fair amount of space for
access and storage of a wide variety of documents for educational use. Of
a more serious concern is not only reliability and/or accessibility but also
security of cloud services. As this storage modality increases in popularity,
all too soon preservation of data may require much more than “strong”
password accessibility.
Despite the positives, some issues remain. As with any mobile device,
ba ery life varies depending on how the device is used. Simple browsing
and word processing will drain the ba ery at a slower rate than using
multiple applications simultaneously. The iPad has a sealed ba ery, which
means that the entire device must be returned to Apple Service for any
ba ery service. Another limitation relates to use. Tablets, for the most part,
are not replacements for office computers but rather adjuncts to them. The
built-in virtual keyboard is not conducive to long periods of use. Tablets,
including the iPad, are more suited to an educational environment than
smartphones. Because common eReader devices have applications
available for tablets, reading textbooks and accessing course management
applications is feasible. Most tablets include a built-in webcam, providing
users with the ability to videoconference on many courses and seminars.
The physical footprint of these devices makes them more appealing to
some users than a laptop.
Laptops and Desktop Computers
Historically, the desktop computer was the mainstay of academic
computing; however, desktop computers are declining in popularity.
Laptops are now more popular computing devices for educational use. A
fairly robust laptop can be purchased for around $500, about the same cost
as a comparably equipped or more powerful desktop. The portability of
laptops or tablets is often the deciding factor for students and faculty. The
increasing availability of broadband access is an additional strong
influence for users. Students and faculty are able to access courses and
content from anywhere with internet access. Many online courses promote
this aspect of their respective programs. For an in-person class, students
often bring a computing device with them to take notes, research a topic,
and link items for reference at a later time. A subcategory of the laptop
category, called ultrabook, is a smaller and lighter device that sacrifices a
device drive (typically a DVD) and a spinning hard drive for a solid-state
drive (SSD). Most major vendors now offer at least one ultrabook model.
Clickers
A clicker is a device used with an audience response system; however, the
term clicker is often used to refer to the complete system. These systems
provide faculty with real-time feedback from learners during a
presentation. The device itself is about the size of a deck of cards or
smaller and wirelessly linked, via sensors in the room, to a computer that
records the responses. Software is available for those who want to use their
own smartphone as the feedback device. Instructors phrase questions as if
administering a poll and ask students to respond using the clickers.
Questions can be basic (“Do you understand the concept?—Yes or no”) or
more complex (“What are the best options to solve a stated problem?”).
Many users employ a multiple-choice approach, and feedback questions
can be embedded in a Microsoft PowerPoint presentation. Real-time
feedback can be depicted in graphic format to help the instructor and
audience understand the results of the poll. Examples of companies
offering this technology include eInstruction ([Link]),
i > clicker ([Link]), and Turning Technologies
([Link]).
Audience response systems, also available for conference se ings, have
been integrated into webinar delivery type products. Uses include
determining the winner of a competition, helping the audience understand
a concept or information by helping the presenter to shape the
presentation to meet the audience’s needs, and facilitating interactivity.
There are several positive aspects of this technology. No ma er the device,
responses are typically anonymous, although the system can be set up to
tie the response to the user, for example, to take classroom a endance. The
anonymity may provide more honest responses. Audience response
technology provides course instructors or conference presenters with
immediate feedback. The immediacy of the response allows presenters to
customize content to clarify audience concerns, meet audience needs, and
facilitate user interaction and involvement with the educational content.
Barriers to this technology include instructor resistance to changing a
class format; the time commitment to reformat a course; the cost of the
devices, sensors, setup time, and software; system maintenance; and
possible student resistance to the cost of the technology (i.e., another fee)
and the need to learn and use more technology. For some instructors, the
device is a novelty, good for occasional use rather than a mainstream
method of learning. For many faculty, their respective educational
employer provides readily accessible guides, suggestions, and/or
evidence-based research regarding use of clicker and other pedagogical
technologies in the classroom and beyond. A good example of this can be
found at the University of Wisconsin–Milwaukee
(h p://[Link]/ltc/srs/faculty/articles_research.cfm).
Educational Software
Many choices exist for faculty and students, but there are some general
considerations when selecting educational software. Many schools provide
assistance to their respective faculty regarding the selection and/or use of
educational software. This type of software can be proprietary, such as
Microsoft Word, or open source, such as OpenOffice. Even though
downloading and installing open source software is free, there are costs
associated with obtaining support and maintenance for the software.
Support and maintenance can also be an additional cost with proprietary
software and should be negotiated before signing a contract. In addition,
many educational software products have hardware limitations that
should be carefully evaluated during the selection process. A number of
products are discussed in this section, including learning and content
management systems, mind maps, gaming, and ePortfolios.
Learning and Content Management Systems
An LMS is generally defined as software used to address educational
functions, ranging from class administration and document and grade
tracking to report generation and delivery of online courses.7 These
systems are mainly used as course management systems delivering hybrid
or online courses. However, they can also be used for other group
activities such as se ing up access to online advising or university
enrollment services.
LMSs can also provide content management functionality at the
program or university level. However, a separate content management
system or application can also be used for this purpose. A content
management system encompasses the process of content development
(create, edit, store, and deliver) and storage of learning materials such as
PowerPoint slides, videos, and so forth that can be used in different
courses for different purposes. Depending on the vendor, a content
management system may be a component of an LMS or can function in a
solo capacity with an interface to an LMS.10 It should be noted that when
used in higher education literature, the acronym CMS usually refers to a
course management system, as denoted in Chapter 30, but can also refer to
a content management system, as described here.
LMSs are increasingly used by higher education institutions for distance
education and as a supplement to traditional classroom education. LMSs
allow for asynchronous access, online meetings, and remote testing and
grading, as well as inline grading of learner assignments. Student
assessment is a large component of an LMS. Blackboard, for instance,
includes a dashboard for faculty to monitor student progress. Barriers to
use of an LMS include the need for a broadband connection by students
and the use of certain operating systems, although these barriers are
fading over time. The largest barrier is the cost to purchase and maintain
an LMS, especially a proprietary system. A detailed discussion of distance
education, and the use of LMSs, is provided in Chapter 31.
Mind Maps
Mind maps are graphic or visual representations connecting words, ideas,
tasks, or other items to a central core word or idea.11 This type of activity
may also be called a concept map. The visualization provides students
with a tool to see how various components are related to a particular core
idea or item (e.g., categories of medications and pain management, specific
drug side effects related to a specific disease process). An example of a
mind map is shown in Fig. 32.2.
FIG 32.2 An example of a mind map. (From Litemind. What is mind
mapping? [and how to get started immediately]. [Link]. <[Link]
mind-mapping/>; 2012.)
While individual students can use mind map software, it can also be
used by students collaborating in face-to-face or online groups to create
mind maps via an assortment of point devices (from fingers to color-coded
digital markers). Maps can be saved and referenced for later review or
incorporated into a student’s ePortfolio (discussed later) as an example of
his or her work. The interactive creation of mind maps or concept maps
can also be a tool for educators in healthcare. Studies indicate concept
maps facilitate critical thinking as well as student engagement.12,13 Mind
maps are also visually appealing for students. However, software costs
may be a barrier, although other hardware platforms such as interactive
whiteboards or LMSs can reduce overall costs.
Digital Portfolios
The electronic portfolio, or ePortfolio, reflects a shift from the pen-and-
paper portfolio model to a digital environment. The components of an
ePortfolio are basically the same as a traditional portfolio but stored and
presented in a digital format. The general structure, with some variation
depending on the profession or department, includes a curriculum vita, a
personal statement of some sort, a description of personal skills, and
examples of the individual’s work. The work example category, using the
digital format, allows for digitization of pictures, movies, and other similar
interactive presentations of personal work. The ePortfolio provides an
improved process for an individual to present a detailed picture of his or
her work. Examples of commercial software supporting this concept
include Google (h ps://[Link]/site/eportfolioapps/overview),
Desire2Learn ePortfolio
(h ps://[Link]/en/ePortfolio), and Brightspace.
(h p://[Link]/products/eportfolio/). In addition, many
higher education institutions offer homegrown as well as proprietary
products to their users and learners.
Many educational programs require ePortfolios as a component of
student learning and evaluation. However, the requirement that students
complete an ePortfolio and the procedures for using portfolios and
ePortfolios vary greatly from one institution to another. For example,
requiring that a student complete an ePortfolio could ensure that students
would be able to show future employers examples of their work.
However, many institutions do not provide students with access to their
ePortfolios after graduation.
A significant advantage of using ePortfolios is that faculty can use them
to provide individualized feedback and advice to students. Drawbacks
include a lack of quality assurance and the amount of time that ePortfolios
consume for both student and faculty.14 Research on using portfolios (and
ePortfolios) in educational applications is limited. Nonetheless, this
application facilitates student self-evaluation and continues to be a useful
tool in education.
Web-Based Student Testing
Other educational tools include applications that facilitate online, or web-
based, student testing. Web-based testing is usually independent of an
operating system, and the testing software is accessed using a web
browser. Most LMSs (e.g., Blackboard, Moodle) support web-based testing
options. Within an application, tests can be customized to question type
(e.g., multiple choice, multiple answer, write-in, matching, essay).
Common features of online testing solutions include the ability to control
student access, length of tests, time available to take the test, feedback
customization, and score analyses. Instructors can randomize the order of
questions for each person taking the test. Obviously randomization helps
discourage screen sharing and easy answer sharing between students.
Testing within an LMS is advantageous because the test score is
automatically integrated into the LMS grading module and students
receive immediate feedback on their performance. In nursing, web-based
NCLEX review content is available. Examples of companies providing this
testing include ATI (h p://[Link]/[Link]) and Kaplan
(h p://[Link]/NCLEX/Home/[Link]). Both companies
provide materials and tests for faculty to use and integrate in their
programs.
Online testing tools usually can be configured to administer surveys to
students. Other freestanding survey-specific tools are available for limited,
if any, cost (e.g., SurveyMonkey, [Link]). More
powerful and costly tools are also available. Proprietary applications often
include a free version with limitations, but these are useful for trying out
the software. A well-known example is Qualtrics ([Link]).
The advantages of web-based testing include faculty control and
customization, the ability to incorporate feedback on a question-by-
question basis, and immediate scoring available to the student. Faculty
may incorporate these tests into mastery learning, where students who
have not done well on the test can relearn and retest before moving on to
new content.
Security issues can present a major disadvantage for online testing.
Students may share tests either visually (si ing next to each other),
remotely, or by using a browser with less security (allowing screenshots to
be saved and shared); they may even report a power failure to quickly
look up answers to a test. Solutions to security issues such as plagiarism
and sharing may be found with an application such as Proctorio, a remote
software proctoring application ([Link]). Proctorio can be
integrated into the CMS for greater ease of use by faculty and learners.
Another software example is Software Secure ([Link]).
Each of these examples allows for remote student proctoring, which
decreases the need for on-site personal proctoring.
As with all software in academia, the users, such as faculty, should
agree on the software as needed, appropriate, and functional for all users,
including students, before adoption. Additional concerns for use of this
type of software may be how the webcam is placed (for remote viewing),
along with the scan intervals of the student learner during the assessment
and/or test. In addition, policy and procedure needs should be addressed
prior to development and implementation of such software.
Student Journaling Software
Journaling is a methodology to engage students in reflective learning.
Reflective journaling is often used to evaluate students’ clinical or
practicum progress; at the same time, it improves critical thinking by
providing students with insight into their own experiences and
performance. Paper journals with handwri en faculty comments and
questions were cumbersome and have been replaced by digital
applications providing easy access for faculty and more timely responses
for students. These applications can be as simple as using blog
applications to create an online diary. Free services are available, such as
Blogger ([Link]) or Google Drive
(h p://[Link]/drive/). In both of these examples, the preference
section includes the option of adjusting privacy se ings to protect the
students’ work from the general public. Before using these types of free
services for class assignments, faculty should review the site’s terms and
conditions as well as the privacy statement students must accept before
use. These documents are legal contracts, and using the site is the same as
signing a printed contract. A number of LMSs also include this option but
usually do not raise the same legal issues.
Gaming
Learning games, often termed “serious games,” are designed to entertain
players as they educate, train, or change behavior.15 They may be used to
vary course content delivery and provide students with an active learning
environment. As such, they are useful teaching strategies in healthcare.15
Gaming commonly involves competition (a winner and a loser). This
element helps compel students to engage in the content, thereby
improving learning. A number of topics can be used for gaming, from
learning metabolic pathways to critical care for surgical patients.16
Gaming software typically involves the use of a game format, such as
Jeopardy, Wheel of Fortune, a board game, or a card game, to engage
students. PowerPoint templates of some television games are even
available for faculty. Gaming does not always require information
technology; it can be very low tech and still work well. Simple gaming
formats can be relatively easy and inexpensive to use. In addition, a
number of higher complexity computer games have been developed to
provide interactive learning for students. Some examples include Critical
Decisions (h p://[Link]/portfolio/Medical/Critical-Decisions)
and Virtual Pain Manager (h p://[Link]/).
Other applications use a computer gaming interface without being a
game. For instance, one vendor, Anesoft ([Link]), produces a
wide variety of browser-based software targeting for clinical specialties
such as critical care and anesthesia. The two-dimensional application
simulates patient care by providing the student with a picture of the
patient along with vital signs and laboratory results. The student is able to
evaluate patient data, make decisions, and view the results of those
decisions. These materials can be especially useful in teaching groups of
interprofessional students to work together in teams. Regardless of the
format, gaming provides active learning and student engagement in an
approach that is usually well received by students.
Virtual Worlds
Virtual worlds are computerized se ings that simulate a world without
traditional boundaries. Typically the se ing in a virtual world is viewed as
three-dimensional. Avatars (computer-generated objects that may or may
not be humanlike) are characters that users adopt and portray as their own
personalities in the virtual world. Avatars then interact with each other
within the virtual world se ing. For example, the se ing may be a
hospital, a clinic, or a community se ing. The virtual environment can
provide different experiences for health education students by allowing
students to experience different se ings and/or different roles via their
avatars. They can practice different aspects of care, ranging from
communication (since avatars can speak) to clinical skills. This makes the
use of virtual worlds an excellent tool for simulation-type learning with
groups of students from a variety of disciplines.
One of the earliest well-developed virtual world–based applications is
Second Life (h p://[Link]), a browser-based experience requiring
the user to install a viewer on his or her computer. Users create their own
avatar or virtual person and experience the environment of Second Life.
Another example of a virtual world software application is OpenSimulator
(h p://[Link]/wiki/Main_Page). OpenSimulator is an open
source application used to simulate virtual environments similar to Second
Life, with much of the same functionality.
Although there could be several potential advantages to the use of
virtual world applications, their use has been limited by four major
constrictions:
• Creativity. Creating a realistic simulation requires that one is able to
conceptualize all of the complex detail and interaction present in an
actual healthcare se ing. As a result, faculty often find it helpful to
select one of these applications and work together in developing
learning environments.
• Time requirements. Major time commitments can be required for
learning the software and developing stimulation.
• Direct and indirect costs. For example, access to Second Life is available
to the viewer without charge. However, there are costs associated
with developing student-learning environments within Second Life.
In general, for one private region in Second Life (or what is sometimes
called an “island”), the initial one-time set-up fee listed on their
website
(h p://[Link]/wiki/Second_Life_Education/FAQs) on
October 15, 2016, was $1000 USD and then $295 USD a month in
maintenance costs, per region. Educators can be offered a 50%
discount. In addition, indirect costs can increase quickly when one
hires an assistant to develop or maintain the virtual environment.
• Technology limitation. For example, there is no sensory feedback such as
odor or touch (haptics), which can be a barrier for some experiences.
Originally these virtual worlds were designed for fantasy experiences,
but they have evolved to support not only education but also others such
as those with compromised health. For example, in a virtual world,
physically handicapped persons are without limitations and can enjoy
activities such as dancing, swimming, and walking. Healthcare sites,
created by health professionals, representing hospitals, clinics, and
recreational areas, can provide a potential means of engagement and
support for patients. However, research suggests that the use of online
virtual environments has not yet reached this potential opportunity.
Suomi, Mäntymäki, and Söderlund reported in 2014 on the results of a
review of the current health-related activity in Second Life. The intent of
the study was to determine whether Second Life was a working and
functional platform supporting the empowerment of people in health-
related issues. They concluded from their research that “For the average
user, Second Life offers very li le unique value compared to other online
health resources.”17
Impact on the teaching and learning
process
Today, technology drives a teaching-learning process that is increasingly
student centered, faculty facilitated, collaborative, open sourced, and
globally focused, using a blend of synchronous and asynchronous
modalities focused on contextual learning to enhance the acquisition of
new knowledge for both students and faculty. The ripple effects of the
paradigm change is evident, with intergenerational differences in teaching
and learning styles, the time requirements of teaching, faculty evaluations,
and impact on tenure.
The use of technology in education is changing both educators’ and
students’ roles and responsibilities. For example, educational theorists
have acknowledged that individuals learn in different ways. Several
examples of learning theories are provided in Chapter 2. Perhaps one of
the most adopted theoretical approaches used in education to explain
these individual differences is Gardner’s multiple intelligences. Gardner
determined that people learn through nine different intelligences:
linguistic, logical-mathematical, spatial, bodily-kinesthetic, musical,
interpersonal, intrapersonal, naturalistic, and existentialist. Gardner
determined that while everyone uses all nine intelligences with some
degree of competence, one or two of the intelligences are more dominant
in each individual (Box 32.2).18
Box 32.2
Examples of Learning Activities Using
Gardner’s Nine Multiple Intelligences
• Develop podcasts, wikis, or blogs for the expressive linguistic learner.
• Play online strategy games, search databases for information, or use
graphics packages for the logical-mathematical learner.
• Create a digital story, develop a digital art project, or create a concept
map for the visual creative spatial learner.
• Interact with software programs to write and create music or to create a
music video or podcast for the auditory musical learner.
• Create experiences with simulation, virtual field trips, or virtual role-
playing games for the bodily-kinesthetic learner.
• Expound on discussion boards or develop embedded audio and video
PowerPoint presentations for online class introductions for the
interpersonal learner.
• Write a blog, develop online survey tools, and encourage independent
exploration of any of the aforementioned activities for the intrapersonal
learner.
• Develop photo journals or use mapping and graphic organizing software
for the naturalistic learner.
• Use web research, presentation applications, e-mail, and chat to
encourage big-picture thinking (questioning, analyzing, and figuring
out why things work) for the existentialist learner.
For several decades, educators have a empted to individualize the
process of educating students by creating instructional materials and
experiences to address individual students’ intelligences or learning styles.
Today’s technology can make that goal a reality. Matching students’ nine
intelligences or learning styles through the use of technology allows for
more meaningful educational experiences.19,20 Essentially, faculty and
students are engaged in subtle and not-so-subtle shifts in technology-
driven changes that will continue to transform the process of teaching and
learning.
Teaching From a Global Perspective
Creating and delivering learning relevant to students is a challenge for
educators and education systems worldwide. The advent of twenty-first
century technologies and global connectivity offers students who are
geographically dispersed the opportunity to enroll in online courses
around the world. Busy adults worldwide especially appreciate the
predominantly asynchronous format of online courses. Culturally,
however, students worldwide are exposed to a variety of different
teaching and learning experiences; teachers’ expectations of student
behavior differ; and communication styles differ; as does the reading,
writing, comprehension, speaking and idioms/slang of a foreign language.
The need for social presence, patience, cultural context, extra student
mentoring, and a designated virtual place for all students to ask questions
and discuss course information becomes extraordinarily important. It is
essential faculty and instructional designers who create and deliver online
courses are mindful of how everyone’s personal cultural lens influences
learning.21–23 Brodrick provides several suggestions for managing classes
with online global students:
• Learners who may not be used to the specifics of the typical U.S.
online classroom. Provide easy, clean, and clear navigability of online
courses and content.
• Students who may not have ideal internet connectivity in their
locations abroad. Consider accessibility and speed when creating
learning experiences.
• Learning groups who may not share time zones, culture, and
language. Provide support in complex logistical planning such as
identifying and managing student time zones, managing deadlines,
and se ing up cooperative.
• Provide culturally sensitive imagery, content, and graphics for a
global audience.
• Students from a wide variety of language backgrounds may have
difficulty hearing or reading the language used in the course. When
possible, provide clear text and voice/video recording of course
content.
• All students like to make a good impression and can be somewhat
uncomfortable in new situations with strangers. Use
videoconferencing and live chat to put them at ease and help them to
connect with the instructor and fellow students.
• Consider using more smartphones and mobile applications, since not
everyone has computer access.
• End the traditional lecture and replace it with easily accessible, open
source, short educational videos.
• Use free web tools for course discussions and projects to be er
prepare students for jobs after college.
• Encourage scholarly associations to set up blog-like online forums to
allow scholars to share ideas and openly conduct peer review.
When offering courses on an international stage, there is a need to
evaluate the changes in education and consider both student and faculty
self-expectations for learning.24–26 Proponents of interprofessional learning,
both nationally and internationally, suggest that students and faculty need
to learn with, from, and about each other. As the emphasis on teacher-
centered, didactic instruction changes to a student-centered,
interdisciplinary, faculty-facilitated, and collaborative approach to
learning, shared experiences and collaborative learning have the potential
to break down the traditional professional silos that exist both nationally
and internationally. The use of information systems and technology
strategies, such as online course delivery, could help facilitate shared
interprofessional knowledge building and knowledge mobilization and
transfer this collaboratively generated new knowledge into practice.26–28
Impact on the faculty role
Faculty are now being asked to be proactive in the adoption and
integration of technology while maintaining traditional research, practice,
and service requirements. The impact of this demand on faculty
satisfaction, time related to teaching, student evaluations, and tenure can
be dramatic. While many faculty have enthusiastically embraced the use of
technology in the classroom, faculty have also expressed concerns about
being undervalued, the changing focus of pedagogy, compensation and
workload issues (especially the amount of time necessary to create and
maintain technology-enhanced courses), the lack of institutional support
for these new teaching methods, and the need to continually update their
own technology skills without compensation or institutional support.29,30
Nelson et al.1 and Moseley31 remind us the cultures of technology and
academia differ, as demonstrated by a quote from Nelson: “The cultures of
information technology and academia are characterized by competing
traits. Words like ubiquitous, youthful, volatile, instantaneous, and profitable
are used to define information technology. Conversely, words such as
steadfast, autonomous, venerable, persistence, resistant, patient, and non-
lucrative are words we associate with academia.”1, p. 194 Faculty are now
being asked to reach across this divide. Institutions of higher education
must help by investing in high levels of support and training for faculty
and students who use technology.
Technology-enhanced courses as well as online and hybrid courses have
become an integral part of the teaching-learning experiences provided in
today’s higher educational se ings. Historically, the majority of faculty of
many disciplines had limited education in the teaching-learning process
and had limited knowledge about the process of effectively transitioning
from the traditional lecture-based classroom to a technology-enhanced
course. In many traditional academic se ings, the distance learning
infrastructure has only recently been retooled to fully facilitate health
professional faculty preparedness to create and teach using current
technology. If they have not already developed a formal faculty
development program, institutions of higher education may want to
consider partnerships with other institutions to develop such programs as
well as pair faculty with instructional designers (ID) to provide support
and training for creating robust, quality, and pedagogically sound
courses.32–37 Effective collaboration between an ID and health profession
faculty member does not occur in a happenstance manner but must be
carefully structured. The collaboration requires knowledge of the best
practices available to develop, implement, and evaluate an online course,
plus the content expertise of health professions faculty. Box 32.3 uses
Outlaw’s Six-Phase Course Development Model32 as a framework for
demonstrating the process of collaboration between an ID and expert
faculty, with the goal of collaboratively developing, reviewing,
implementing, and evaluating a quality technology-enhanced course.
Box 32.3
Phases in the Process of Structured
Collaboration Between an Instructional
Designer and Expert Faculty
Phase Description
1 This phase involves conducting a comprehensive needs analysis of (1) the subject ma er expert, (2) the
course, and (3) the audience.
2 In this phase, faculty begin the process of designing the course in its entirety, including readings, lectures,
assignments, discussions, assessments. The instructional designer reviews this work, making edits and
recommendations concerning instructional strategies and instructions; they also provide guidance where
accessibility, copyright, and media are concerned, and design instruction and learning objects.
3 It is at this point in the process the faculty is ready to be trained on the use of the selected technology. This
not only includes how to use the technology but also includes pedagogy so that the faculty is prepared to
effectively use the technology to support learning.
4 In this phase, the course is built into the technology. Any issues or concerns in design, pedagogy, or
technology should be resolved during this phase.
5 The course review and quality assurance phase is where the course as a whole is reviewed in detail to
identify and resolve any pending issues across the course or between sections of the course.
6 The phase can be considered a “shakedown cruise” when the course is implemented. The ID should be
available to help resolve immediate problems. In addition, a weekly journal should be kept, noting what
worked well as well as problems. In addition, faculty should keep notes on new and innovative ideas
about how the course may be strengthened in the future.
7 In the last phase, the course will be revised and taught to a new group of students using all that was
learned in the first six phases.
Using Best Practices for Technology-Enhanced
Course
The phrase best practice refers to an industry-wide agreement concerning
the most efficient and effective procedure or process to accomplish a
desired outcome.38 The drive toward best practice is increasingly based on
professionals’ use of evidence-based research to support quality online
education.32,35,40–42,47–50 The following websites, which are excellent
examples of toolkits and online references for best practice in online
education, are provided for your reference:
• <h ps://[Link]/faculty/instructional-development/online-
education-best-practice-reference-list/>51
• <h p://[Link]/onlineguide/>52
• <h p://ci .ufl.edu>50
• <h p://[Link]/best-practices/graduate-education-2020>47
Quality may be defined as “how good or bad something is; a
characteristic or feature that someone or something has; something that
can be noticed as a part of a person or a thing; and/or a high level of
value.43 Quality Ma ers (QM) is a quality assurance program used inter-
institutionally both nationally and internationally. QM is one example,
based on ongoing research evidence and best practice, of how higher
education faculty who use a proprietary peer review process for course
development and an established rubric are able to continuously enhance
the design quality of online and blended courses.44 There are eight general
standards and specific review standards that must be aligned with course
components.44 The eight general standards are (1) course overview and
introduction, (2) learning objectives (competencies), (3) assessment and
measurement, (4) instructional materials, (5) course activities and learner
interaction, (6) course technology, (7) learner support, and (8) accessibility
and usability. Course components that are aligned include learning
objectives, assessment and measurement, resources and materials, learner
engagement, and course technology, all linked together to support
students’ course learning objectives.45
Courses approved by QM certified peer reviewers are considered to
have a ained a gold standard in higher education. For further exploration
of QM, the contents of The American Journal of Distance Education
September 2015 edition is dedicated to articles that address the use of
research and quality, QM as an ongoing design-based research project,
measuring the impact of the QM rubric, small student focused studies to
determine the effect of standardization of online course design and peer
review, peer review and feedback as an intervention, and the exponential
growth of QM used nationally and internationally, plus a vision for the
future.44,46.
A scenario with two short exemplars incorporating best practices is
presented next to illustrate a course development partnership between a
nursing faculty member and an ID working together at an institution of
higher education.
Scenario
A nursing faculty member wanted to create an engaging online course for
undergraduate and graduate students participating in an international
experience with Japanese faculty and students. Collaboration with an ID
facilitated development and use of an online learning environment created
in Blackboard for American students. The incorporation of best practices
for online experiential teaching and learning by faculty, students, and the
ID were shared with a consortium of Japanese school faculty and selected
students. Sequelae included multiple presentations at traditional
conferences as well as a virtual conference. Tables 32.1 and 32.2 briefly
describe the technology tools used, collaborative design partnership roles,
and selected best practices for creating an engaging, quality online
educational experience for nursing students.
Table 32.1
Nursing Faculty Exemplar #1
Technology Tools, Collaboration Between Experts, and Best
Practices
ID, Instructional designers; QM, quality matters.
Table 32.2
Nursing Faculty Member Scenario Exemplar #2
A Nursing Faculty Member With the Assistance of an Instructional
Designer Incorporates Experiential Learning Activities in Selected
Online Graduate Courses
APA, American Psychological Association; ID, Instructional designer; LMS, learning
management system.
Impact of Technology Enhanced Courses on Faculty
Evaluation
While faculty are working to maximize the benefits of technology in the
classroom, the inclusion of technology can potentially have a significant
impact on student course evaluations. Student evaluations for faculty
teaching with technology in general are limited, and as a result, some have
looked to research concerning faculty teaching online where more data is
available. These findings have been mixed, ranging from lower scores for
faculty teaching online versus face to face to no difference in scores.50,51 In
addition, if the students experience a number of technical problems, their
overall satisfaction with the course will be decreased, and this
dissatisfaction can be reflected in their rating of the teacher. This can be
especially troublesome in se ings where student evaluations of faculty
play a significant role in determining promotion and tenure decisions.
Other related barriers to the tenure process possibly affected by the
implementation of technology include the following:
• Outdated policies and explicit expectations for performance
• Escalating expectations for the quantity and quality of publications,
practice, service, and especially funded research
• Lack of or infrequent feedback or formal mentoring by seasoned
faculty
• Marrying online education information systems and technology tools
with a changing teaching-learning process
• The need for work-life balance55
New models may be in order for technology and tenure. The following
two examples exemplify technology-driven scholarly activities that may be
considered during the tenure process for health professions faculty:
• A collaborative, international, digitally developed, implemented, and
evaluated project rather than a wri en dissertation by one person
• Rewriting scholarly activity guidelines for tenure to include the
creation and use of open source resources and publication
opportunities available globally and free of charge56–58
Teaching, learning, and the tenure process are in a state of flux for
faculty and students. How university administrators will factor the impact
of technology into faculty promotion and tenure remains a focus for
discussion far into the future.
Conclusion and future directions
Bartholomew wondered whether higher education is really ready for the
information revolution.59 Despite recommendations from a multitude of
organizations, government, and the business sector, some institutions of
higher education have been slow to adopt and use information
management and technology tools and to view technology enhanced
learning as a strategic asset.60 A myriad of reasons are described, including
the cost of purchasing technologies; administrative, staff, faculty, and
student dislike or fear of change; a parochial view of traditional education;
and the need to generate a new model for education other than student
credit hours.58,60,61
In the United States, there are an estimated 4400 institutions of
postsecondary education. Three vendors provide approximately 3000
administrative systems, such as student information systems for managing
student records. In addition, many larger research universities have built
their own solutions, and others are using a best-of-breed approach to
create their administrative information systems.62 As a result, “colleges
and universities are swimming in an ever widening sea of data” and
creating pools of big data.63, p. 11 In the future, analysis of these data with
appropriate data mining tools will create a be er picture of what does and
does not work in education. For example, a number of the health
professions require students to complete courses from the physical
sciences, such as chemistry, anatomy, or physiology, before they are
introduced to the health-related sciences, such as pathophysiology. From
an intuitive perspective, this makes sense, but is it possible students may
comprehend a chemistry course be er if it follows a course such as
pathophysiology? In actual practice, this progression rarely happens, but
in big data repositories there may be the numbers to answer this question
and other questions one currently may not think to ask.
While many universities are now using administrative systems and the
technology used to deliver education has become increasingly robust,
much of the teaching-learning process is still manually managed. A
number of computerized teaching tools have been discussed in this
chapter. Currently these tools are being used to provide innovative
approaches to delivering content and engaging students in learning the
content, but they do not track data related to a student’s individual
learning process. For example, in most cases, clickers record a student’s
response and discard that response with the introduction of the next
question. A few of these applications, especially in the area of LMS, are
beginning to track each student’s progress with the assessment tools used
in an individual course. For example, LMSs are designed to track a
student’s amount of participation in various discussion groups.
However, in most university se ings, very li le data (other than the
course grade) about the individual student’s learning across educational
programs are recorded and maintained. The current system could be
compared to a paper patient chart with additional limitations. In the
healthcare system, health-related data are maintained in one chart for each
patient. In education, the final record of a student’s learning is the limited
information included on the transcript. In the manual world of education,
for the most part, all other data collected by individual faculty or academic
departments are maintained, if at all, in file cabinets or individual faculty
files. This can be called the ultimate system for creating an island of lost
data and information. In the future, with the computerization of the
academy, the student record will become rich with data related to
individual learning, thereby creating new options for academic success.
Over the next several years, education information systems and
technical tools will continue to increase in number and complexity. User
interfaces will become more intuitive and learning curves less steep.
Increased technical presence will drive increased use. Interactions with
applications may become more “natural,” using voice and motion
recognition. Greater functionality for education is likely for smartphones
and tablets. As hardware increases in capacity and shrinks in size, mobile
learning (mlearning) will likely become easier and easier. Questions for
the future are as follows: How much and what data should be collected
about individual administrators, faculty, staff, and students, and why? Do
faculty and students want 24/7 learning? Can learning truly become
ubiquitous? Should the formal learning process truly become lifelong?
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Discussion Questions
1. How might comprehensive academic information systems affect the
work of faculty within an academic se ing?
2. What role should faculty play in the selection, implementation, and
evaluation of information systems and computerized teaching tools?
3. What are some advantages and disadvantages of the current
computerized education tools?
4. How are interprofessional education, the tenure process, and
information technology educational tools connected?
5. Describe how computerized teaching tools might be employed in an
interdisciplinary environment.
6. What do you think are the key questions one might consider when using
big data in health education programs?
7. The future has many pathways. What do you see in the future regarding
information systems and technology tools in healthcare education?
Case study
You are a baccalaureate-prepared health practitioner in the school system
and are also certified to teach kindergarten to 12th grade. You are
intrigued by the teaching-learning process and decide that you are now
interested in teaching new health professionals in an institution of higher
education about the importance of school health. You begin your
education to obtain the necessary degrees and experience. You select a
program with an emphasis on education, teaching, and learning. Through
your course work, you acquire knowledge about education’s history and
learn how cognition processes transform knowledge gained from social,
biological, cultural, and historical contexts. You are also introduced to a
number of new computer-based technologies designed for educational
use. Informatics and its application to education and the process of
teaching and learning fascinate you. You eagerly begin to incorporate
student-centered learning, technology-related activities in your classes and
frequently work collaboratively with interdisciplinary faculty peers and
staff in planning, assessing, implementing, and evaluating the addition
and adoption of new student-centered learning activities. You and the
students learn both individually and collaboratively during, for example,
the adoption of online testing, ePortfolio development, the use of
videoconferencing, online courses, and other similar activities, including
online class chats and discussions with international nursing faculty and
their students.
You begin to do research and publish your findings in online journals as
well as on a blog that focuses on the use of technology in health education
programs. However, in your annual review, you are advised that you now
need to take a more traditional approach to teaching, research, and
publications. Using technology to create the innovative classes you are
teaching is taking up too much of your time, and this is time that would be
be er spent in developing grants from traditional sources.
Discussion Questions
1. Resistance to change is a formidable foe to progress. What are some
possible options to facilitate change in education and the introduction
of technology?
2. Suppose that the educational se ing in this case study decides to
become interdisciplinary. Describe educational technologies and
methods that would facilitate the process.
3. If you could collect and track learning data related to individual
students across their educational program, what data elements would
you consider a priority? For example, would you want to track
learning preferences; writing ability, including specific strengths and
weaknesses; or clinical strengths and weaknesses?
*Acknowledgments: We acknowledge the assistance of Dr. Veronica Outlaw, PhD,
Director of Distance Learning at the University of South Carolina Aiken. We appreciate
her thoughtful comments and suggestions from an instructional design and evidence-
based perspective. We also acknowledge the assistance of Dr. Ernesto Perez, Dr. Mary
Smith, Dr. Vincent Sperandeo, and Dr. Dara Warren from the DNP graduating class of
2011, Capstone College of Nursing, University of Alabama. We appreciate their
thoughtful comments and suggestions for this chapter.
33
Simulation in Healthcare Education
Valerie M. Howard; Kim Leighton; Teresa Gore
Abstract
The use of simulated learning experiences has rapidly emerged in healthcare
education as a method of training healthcare providers in a safe environment
without subjecting patients to harm. Multiple definitions of simulation-related terms
exist, so the importance of the use of standardized terminology is stressed. Best
practice standards for implementing simulated learning experiences are discussed.
These should be provided in a standardized manner while adhering to guidelines to
maximize learning. Simulated learning experiences directly correlate with the Core
Competencies for Interprofessional Collaborative Practice. Finally, issues, challenges,
and opportunities for the future of healthcare education and the use of simulation are
outlined.
The emergence of technology for educational purposes creates a need for
faculty and health science educators to understand how to not only
operate the technology but also implement it within the academic and
service settings while using sound academic principles.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Define the different types of simulation modalities available.
2. Describe the challenges and opportunities inherent to simulation.
3. Apply the 2016 International Nursing Association for Clinical
Simulation and Learning (INACSL) Standards of Best Practice:
SimulationSM in developing educational experiences.
4. Discuss the use of simulation-based education in interprofessional
experiences.
5. Analyze the similarities and differences related to the available
simulation resources.
6. Develop evidence-based simulation activities.
KEY TERMS
clinical scenario 564
debriefing 566
fidelity 558
learning environment 561
simulation 557
simulation learning environment 557
standards of best practice: simulationSM 561
theory-based debriefing 564
Introduction
Simulation is a time-honored method of teaching that has been used in
health education for decades. It is defined as the use of “one or more
typologies to promote, improve, and/or validate a participant’s
progression from novice to expert,”1, p. S9 in which the novice to expert
continuum is consistent with that promoted by Benner.2 Experiential
learning theory is used in health professions education to emphasize the
importance of clinical practice in the educational process.3 Simulation is
one method of experiential, hands-on applied learning and can range from
a simple activity used to mimic reality (e.g., the process of injecting an
orange to create the feel of puncturing skin) to the use of high-fidelity
simulation to create the comprehensive experience of interacting with a
healthcare team during a clinical emergency. In each case, the simulation-
based learning experience includes “an array of structured activities that
represent actual or potential situations in education and practice and allow
participants to develop or enhance knowledge, skills, and a itudes or
analyze and respond to realistic situations in a simulated environment or
through an unfolding case study.”1, p. S9
Types of Simulations
The term simulation learning environment refers to the physical set-up,
context, and culture in which a simulated learning experience occurs.
Virtual simulation in the educational environment involves the use of a
device or tool such as an avatar, partial task trainers, or patient simulators
and a realistic environment in which to teach cognitive processing,
supportive a itudes, and skills. Several types of simulation are used in
healthcare education, including wri en case studies, virtual environments
(e.g., Second Life, computerized gaming, virtual reality), standardized
patients, partial task trainers, and medium- to high-fidelity patient
simulators. “Virtual simulation may be used by educators to enhance
lecture or web based courses, replicate high-risk clinical experiences, act as
clinical makeup, foster intradisciplinary and interdisciplinary education,
and address practical challenges and barriers to contemporary nursing
education.”4, p. 412
Gaming is the use of games designed to teach about a specific subject or
specific skills. They can be especially useful in the education of health
professionals. Gaming is a type of virtual simulation technique that creates
an environment that can meet the needs of millennial learners and has
been embraced more fully in the past few years by educators.5 Both
gaming and virtual simulations are examples of experiential learning
techniques.
Simulators are used to help students improve critical thinking, clinical
judgment, communication, and teamwork skills while assisting learners to
meet psychomotor, cognitive, and affective learning objectives. Most of the
growth in simulation is with standardized patients, partial task trainers,
and simulators.
Standardized patients consistently portray a patient or other individual
in a scripted scenario for the purposes of instruction, practice, or
evaluation.6 Standardized patients may be actors who require li le
training. Others may be people who respond to requests for assistance
with healthcare training and require significant resources for training. Still
others may actually have the disease, illness, symptom, or injury under
study. In most cases, standardized patients are paid for their assistance to
the educational process.
Partial task trainers typically represent anatomic parts of the human
body and are used to practice skill acquisition.7 This type of simulator
assists learners to meet psychomotor objectives, those accomplished when
a student demonstrates the ability to perform a task such as inserting a
urinary catheter, giving an injection, or a aching a heart monitor. Partial
task trainers can range from low to high levels of realism, also known as
fidelity. Examples of low-fidelity partial task trainers are when learners
practice giving intradermal injections using a silicone pad that is flexible
enough to allow a bleb to form when fluid is injected or using a hot dog
with skin for the same purpose. An example of a more realistic partial task
trainer is a model that promotes practice of intravenous needle insertion
through a virtual model that includes haptic technology. Haptics is a
feature allowing tactile sensation, for example, when the needle enters a
vein.
Simulators include full-body mannequins and can range from static
mannequins that do not respond to any intervention to high-fidelity
computerized simulators designed to realistically respond to learner
interventions. High-fidelity mannequins can have blinking eyes, a chest
that rises and falls with breaths, heart and lung sounds, and palpable
peripheral pulses, and can be capable of being intubated, having chest
tubes inserted, and having other assessments and procedures performed
on them. High-fidelity simulators are particularly useful for
interprofessional training on interdisciplinary activities such as
cardiopulmonary arrest, in which a variety of clinicians have specific roles
to enact. An example is the mannequin shown in Fig. 33.1, marketed by
Laerdal. These types of simulators are considered the most lifelike
compared to human patients. The most realistic simulators in healthcare
education are, of course, real persons. Obviously, numerous skills and
conditions cannot be recreated for safety reasons. Instead, educators often
use a hybrid simulation involving two types of simulators. A student can
explain the procedure, risks, and potential complications to the
standardized patient while performing the procedure on the partial task
trainer. Standardized patients can assist learners to meet objectives while
enhancing communication, clinical judgment, critical thinking, and
teamwork skills.
FIG 33.1 Sample high-fidelity simulator. Photo courtesy of Laerdal Medical
Corporation.
Fidelity
Fidelity, also known as realism or authenticity, is “the degree to which a
simulated experience approaches reality; as fidelity increases, realism
increases.”1, p. S6 There are a variety of ways to create fidelity in the learning
experience. It has recently been recognized that fidelity has very li le to do
with what equipment is used and much more to do with how that
equipment is used. Fidelity can involve a variety of dimensions, including
the following1, p. S6:
• Physical factors such as environment, equipment, and related tools
• Psychological factors such as the emotions, beliefs, and self-awareness
of participants
• Social factors such as participant and instructor motivation and goals
• Culture of the group
• Degree of openness and trust, as well as participants’ modes of
thinking
On a trajectory from low fidelity to high fidelity, task trainers are
considered of lower fidelity than high-fidelity simulators and finally
standardized patients. However, this type of classification is not without
controversy. Alinier places computer-controlled simulators above
standardized patients in his continuum.8 This continuum may actually
depend on how the learning experience is designed. For example, a high-
fidelity mannequin used in a cardiopulmonary arrest simulation may not
even be turned on, depending on the level of the learner. A low-fidelity
task trainer used in a high-fidelity environment may allow the
combination to rank higher than the task trainer alone. Other types of
simulation (e.g., wri en, screen-based) fall into the trajectory, depending
on how they are used. The decision about the level of fidelity needed for
any simulation-based learning experience should always be based on the
learning objectives. Thus it is not always necessary to have high fidelity,
especially when cost as well as technology needs are considered. The
example in Table 33.1 involves inserting a central line.
Table 33.1
Fidelity Correlated With Objectives
Objective: The Learner Will Type of Simulator
Accurately place central line catheter Task trainer
Maintain sterile technique when placing a central line Task trainer
Clearly communicate risks when obtaining consent from patient Standardized patient
Use various communication techniques to calm patient’s anxiety Standardized patient
Recognize need for central line insertion during hypotensive crisis High-fidelity simulator
Insert central line when rapid blood transfusion is required High-fidelity simulator
The most common fidelity consideration is the type of simulator to be
used; however, educators have become aware of additional types of
fidelity such as environment and holistic dimensions of a person. Fidelity
of the environment considers the location in which the simulation-based
learning experience takes place. A high-fidelity mannequin may need to be
used within a psychomotor skills lab, a classroom, outside environment, or
even office space. An environment most similar to where real patient care
takes place is highly desirable. Additionally, the equipment, furniture, and
supplies should all be as realistic as possible to the traditional clinical
environment. Creating methods to add patients’ emotions, beliefs,
spirituality, culture, and communication are also ways to make the
experience more realistic. Table 33.2 outlines ideas for assessing and
meeting learning needs in the developmental, spiritual, sociocultural, and
psychological dimensions.
Table 33.2
Dimensions of Learning and Fidelity
Dimension Simulated Patient Improving Fidelity
Developmental Forty-two-year-old male Place frame with picture of young family at bedside. Does the learner
patient with myocardial recognize that the patient likely will not be able to return to work?
infarction (MI); works as Does he or she consider how the family will have their financial needs
laborer met?
Spiritual Patient will be having Place religious or spiritual book or icon at the bedside. Does the
emergent surgery learner recognize the need to ask the patient about his or her beliefs
and practices?
Sociocultural Patient is being Provide discharge instruction sheet. Does the learner determine
discharged with five new whether the patient has the resources to get new prescriptions filled?
prescriptions
Psychological Post-operative knee The patient reveals that there are 10 steps before entering his home.
replacement and patient Does the learner explore how the patient feels about the loss of his or
cannot return home to her independence?
care for self
MI, Myocardial infarction.
Benefits of Simulation
Simulation offers the opportunity for learners to practice in a safe
environment without placing patients at risk. Simulation significantly
increases learners’ knowledge,9,10 competence,11 self-efficacy,12 and
confidence13 at no added risk to patients. While the former are
intermediate outcomes, a longer-term outcome of be er training is to
improve the quality and safety of patient care. Deliberate practice, the
process of practicing a skill multiple times until mastery is reached, is
facilitated within the simulation environment through the use of task
trainers, further reducing the risk of harm to patients.11 Simulation also
offers the opportunity to create standardized learning experiences in a
controlled environment and provides exposure to low-occurrence, high-
risk situations with opportunities to practice critical thinking skills,
problem solving, and decision making.
An evaluation of any educational training program should align with
evaluation models of training. Two examples are Kirkpatrick’s model14
and translational science research (TSR).15 TSR and Kirkpatrick identified
the following levels of outcomes of training programs, which were
summarized in a review article by Adamson et al.16:
• Level 1 (TSR Level 0): Reaction measures the learners’ reactions to the
training program. For example, were the learners satisfied with the
program, and how do they plan to use the information provided?
• Level 2 (TSR Level 1): Learning measures the amount of knowledge,
a itudes, or skills that have changed and the level of the change as a
result of the training.
• Level 3 (TSR Level 2): Behavior or Training Transfer measures the amount
of “on the job” behavior change by the learner following the training
sessions, or if the simulation training translated into behavioral
changes in the clinical se ing.
• Level 4 (TSR Level 3): Results measures the organizational impact of the
training program on either performance or cost savings, or, in the case
of simulation training, to improved health outcomes.
Much of the research related to simulation has focused on the first
levels, measuring the learner’s perspective, satisfaction, and knowledge
gain related to the experience. However, ultimately simulation researchers
will want to demonstrate the benefit of simulation training and its impact
on patient outcomes (level 4 or T3). As an example, most recently
simulation training has been correlated with lower central line infection
rates,17 decreased complications resulting from shoulder dystocia
obstetrical emergencies,18 and healthcare cost savings related to decreased
malpractice claims.19
Challenges and Opportunities
While simulation is an ideal environment for creating standardized
learning opportunities and applying theoretical knowledge in the practice
se ing, inherent challenges exist related to the ease of implementation.
Cost
High-fidelity simulation mannequins can be expensive to purchase;
however, the costs extend well beyond equipment. A fortunate aspect of
technology is that costs tend to decrease over time as technology advances.
Many features originally only found in the higher-priced mannequins are
now available in lower-cost models. The most commonly overlooked costs
include long-term maintenance and replacement costs for equipment and
the initial and ongoing training and development of faculty and staff.
Table 33.3 outlines some of the major initial and ongoing expenses related
to simulation education.
Table 33.3
Initial and Ongoing Major Expenses Related to Simulation Education
Expense Initial Costs Additional Expense
High-fidelity $30,000– Maintenance and replacement costs, depreciation, upgrades, warranties, insurance
mannequins $250,000
Task trainers $250 and up Maintenance and replacement costs
Standardized $12–$40/h Hire and training costs, vary based on region of country and level of experience
patients
Audiovisual $10,000– Upgrades, training
systems $50,000/room
Faculty $5000 Training on use of mannequins and systems, ongoing system updates, ongoing
development initially, then development on use of simulation pedagogy, consultants, conference a endance and
$1000/year association dues, journals
To cover these costs, many health professional programs include
student simulation lab fees. Others may seek grant funding from
foundations, corporations, or private donors to support these efforts.
Funding success can be maximized by developing a relationship with the
potential funder, correlating the funding proposal with the mission and
vision of the funding agency, and forming collaborative partnerships to
demonstrate a unique and sustainable project.
Technology
High-fidelity simulation mannequins can be difficult to operate by faculty
who lack technological experience or knowledge. In addition, skills are
required to operate the digital audiovisual equipment used to record
simulation experiences. Recently, the use of electronic health record (EHR)
systems has increased in simulation learning environments. With each
layer of technology comes the associated challenges involved in managing
multiple systems. One must consider the benefits that come with
consolidating purchases to one or two vendors: centralized ordering,
management of warranties, and individualized customer service. Also,
with volume purchases, costs are often decreased. However, purchasing
from a variety of vendors may result in lower initial purchase prices and
the ability to customize to existing spaces; on the other hand, this also
increases the number of customer service contacts and cost of individual
warranties. The budget allocated toward simulation tends to dictate these
decisions.
Partnering with simulation equipment vendors may allow specific
training opportunities to enhance understanding of the simulator
technology and promote ease of use. Hiring a full-time or part-time
simulation technician may be necessary. Generally, previous experience
with computers, information technology, and audiovisual systems can
enhance the effectiveness of the simulation technology. The Society for
Simulation in Healthcare (SSH) offers the opportunity to become a
Certified Healthcare Simulation Operations Specialist (CHSOS) for those
with a bachelor’s degree or equivalent experience and 2 years of
experience in an operations role. In a forecast of the importance that this
role has taken on, several institutions have announced associate degree
programs that teach basic medical knowledge with the skills needed to
manage the technology and environment. Box 33.1 offers a sample job
description for a simulation technician.
Box 33.1
Job Description for Simulation Technician
Under the direction of the Simulation Center Director, the technician will
provide technical support for all simulation experiences and operations,
including preparation, maintenance, and repair of computerized
mannequins, task trainers, simulation-related hardware and software
systems, audiovisual equipment, administrative website management,
and digital recording systems.
Faculty Development
Simulation is just one example of an experiential teaching and learning
strategy, but many faculty lack the understanding of educational
principles related to the best methods for implementing experiential
learning strategies within the curriculum. Therefore knowledge of the
following educational principles as they apply to experiential learning will
assist the simulation facilitator in developing educationally sound
experiences:
• Educational theory
• Application of theory to practice
• Development of clear and measurable objectives
• Instructional design
• Facilitation of learning
• Creating a safe learning environment in the simulation lab
• Debriefing strategies
• Formative and summative learner evaluation
• Program evaluation
To maintain a supportive learning environment and ensure commitment
to academic principles, each simulation facilitator should have an
orientation period to learn the aforementioned principles and observe
experienced simulation facilitators, similar to a mentorship model. If
schools do not have the appropriate experts within their organizations,
resources should be commi ed to educate the simulation facilitator.
Likewise, institutions will need to develop policies that require the
simulation facilitator to have appropriate training before interacting with
learners in the lab.
As a result of the landmark experimental, longitudinal multisite study
of simulation, the National Council of State Boards of Nursing (NCSBN)
identified criteria that must be met if undergraduate nursing schools are to
consider replacing up to 50% of traditional clinical time with simulation-
based learning experiences:
1. Faculty must be formally trained in simulation pedagogy.
2. There must be an adequate number of faculty members to support
the student learners.
3. Subject ma er experts must conduct theory-based debriefing.
4. Equipment and supplies must be available to create a realistic
environment.
5. The INACSL Standards of Best Practice: SimulationSM should be
incorporated.20
These criteria should not be limited to consideration only by
undergraduate programs, as the principles of simulation-based education
apply across the educational continuum. Graduate program
administrators and faculty should also consider the following
recommendations. Due to concern that programs might substitute
simulation without adequate preparation, support, and resources, the
NCSBN convened an expert panel to provide recommendations intended
to assist the individual state boards of nursing and nursing education
programs.21 These guidelines include the following2, p. 40:
1. There is commitment on the part of the school for the simulation
program.
2. Program has appropriate facilities for conducting simulation.
3. Program has the educational and technological resources and
equipment to meet the intended objectives.
4. Lead faculty and simulation lab personnel are qualified to conduct
simulation.
5. Faculty are prepared to lead simulations.
6. Program has an understanding of policies and processes that are a
part of the simulation experience.
Several organizations, such as the INACSL, the National League for
Nursing (NLN), the SSH, and the Association of Standardized Patient
Educators (ASPE) offer annual meetings, conferences, and faculty
development webinars to assist with this challenge. A group of simulation
scholars in the NLN Leadership Development Program has designed a
theory-based simulation educator resource that is available through the
Simulation Innovation Resource Center (SIRC).22 In addition, several
higher education institutions offer graduate-level certificates with
concentrations in simulation. Four scholarly journals are devoted to
simulation: Clinical Simulation in Nursing, Simulation in Healthcare, Advances
in Simulation, and the International Pediatric Simulation Societies’ (IPSS)
[Link] channel, which offers publication opportunities in a new peer-
reviewed online journal. Finally, many organizations offer continuing
education programs for credit through their ongoing developmental
programs.
Organizations
The two largest simulation organizations are the International Nursing
Association for Clinical Simulation & Learning (INACSL) and the
International Nursing Association for Clinical Simulation & Learning
(SSH). INACSL was founded after discussions by several a endees of the
annual Learning Resource Center Conference in 2001. The nonprofit
organization has grown to more than 1800 members worldwide. The
organization’s mission statement reads as follows: advancing the science of
healthcare simulation. The vision of INACSL is to be a global leader in
transforming practice to improve patient safety through excellence in healthcare
simulation.23 The majority of members are nurses, although anyone is
welcome to become a member. Institutional membership is also available.
The organization is affiliated with SSH and a founding member of the
Global Network for Simulation in Healthcare (GNSH), an organization
composed of the leadership of simulation organizations worldwide.
INACSL spearheaded the development of the Standards of Best Practice:
SimulationSM and offers research grant funding, scholarships for conference
a endance, and fellowships for simulation education.
SSH was founded in 2004 and has a membership of approximately 3000
healthcare providers in all specialty areas. Their mission states: “The
Society for Simulation in Healthcare is a leading inter-professional society
that advances the application of simulation in healthcare through global
engagement.”24 SSH is affiliated with numerous multiprofession
simulation organizations and is also a founding member of GNSH. SSH
offers a simulation center accreditation program and certification for
healthcare simulation educators (CHSE), as well as the previously
mentioned CHSOS certification.
An additional key organization supporting simulation in nursing
education is the National League for Nursing (NLN). The NLN, founded
in 1893, boasts over 40,000 individual and 1200 institutional members,
focuses on the support of nursing education. The mission of the NLN is to
“promote excellence in nursing education to build a strong and diverse
nursing workforce to advance the health of our nation and the global
community.”25
Most notably for simulation educators, the NLN has partnered with
industry to create simulation products, supports research, and provides
ongoing resources. The NLN Jeffries Simulation Theory is one outcome of
these endeavors.26 In addition, unfolding case studies have been
developed to help teach concepts related to Alzheimer’s patient care and
care of the veteran. The SIRC was created as a repository for development
opportunities for simulationists of all levels and offers numerous courses
of study on various aspects of simulation-based learning experiences.27
Lastly, the NLN has partnered with Laerdal to develop vSim, a product
designed to develop clinical reasoning skills, competence, and confidence
in nursing students.
The Association of Standardized Patient Educators (ASPE) is an
international organization for simulation educators that focuses on the use
of standardized patient methodology. It is their mission to: “promote best
practices in the application of standardized patient methodology for
education, assessment and research; foster the dissemination of research
and scholarship in the field of standardized patient methodology; and to
advance the professional knowledge and skills of its members.”28 ASPE
offers a mentorship program, recognizes outstanding educators through
awards, and offers a scholars certificate program as well as a variety of
professional development opportunities.
In the area of gaming, the Games + Learning + Society (GLS) is one of
the oldest organizations in the world devoted to game-based learning and
research. “GLS investigates how games engage, enrich, and transform,
then design great games based on this research.”29 Games are developed
strategically, in partnerships with various organizations from conception
to finished products. An annual conference is held to provide education
opportunities to educators using game-based theory.
There are many additional simulation organizations that have become
active around the world, some of which offer support in geographical
locations, while others support specialty areas of healthcare or
practitioners. Several of these are listed on the website of The Society in
Europe for Simulation Applied to Medicine (SESAM; h ps://[Link]-
[Link]/network/nationalsocieties/), including simulation organizations
located in the United Kingdom, Australia, Brazil, Latin America, Canada,
Holland, France, Italy, Japan, Korea, New Zealand, Poland, Russia, Chile,
Portugal, Swi erland, and across Europe. Specialty organizations include
those supporting pediatric educators and practitioners, and those who are
simulation operators.
Faculty or Administrative Buy-In
The use of simulation modalities to enhance learning can be considered an
organizational change, and resistance to change efforts has been widely
reported in all disciplines, including business, organizational behavior,
psychology, and healthcare. Faculty may be resistant to learning new
methods of teaching and technology. Administrators may not understand
the importance of dedicating time and resources to the successful
implementation of the simulation efforts. Students may be anxious about
the possibility of being recorded as they practice in the simulation lab.
Successful change efforts can be facilitated by having a thorough
understanding of change theories and using this theoretical knowledge to
guide the efforts. One change model useful in healthcare was developed
by John Ko er, who suggests following eight steps when leading a change
effort (Table 33.4).30 Creating a mission and vision statement for the
simulation program and developing a strategic plan can also guide future
efforts related to integrating advanced practice experiences within the
simulation program.31 Evaluating the participants’ satisfaction related to
the simulation experiences through the use of postsimulation surveys can
provide necessary data to share with administrators in an effort to gain
support. Faculty members can be given an opportunity to visit the
simulation lab and experience firsthand the learners’ reaction to this
powerful educational tool. It is also helpful to involve faculty in their own
simulation-based educational experience and have them perform in the
learner role. This immersive experience has been reported to be helpful in
increasing understanding of the value of this type of learning. Finally,
sharing the positive experiences of students both quantitatively and
qualitatively, through reflections and stories, can also generate buy-in.
Table 33.4
Kotter’s Principles Applied to Simulation
Adapted From Kotter, JP. Leading Change. Boston, MA: Harvard Business Review Press;
1996.
The simulation process
Learning Theories Applied to Simulation
Simulation is often accepted without any validation and based on the
technology instead of a theoretical grounding. However, many learning
theories are applicable to simulation-based learning, and several are
presented below. Kneebone identified the following four concepts to lay
the foundation for simulation:
1. Gaining technical proficiency with psychomotor skills
2. Learning theory with repetitive practice and frequent reinforcement
3. Tailoring support to the individual learner’s need using situated
learning
4. Addressing the affective domain of emotions with learning32
In addition, Kneebone identified the following four criteria for
evaluating existing and new simulations. These are discussed further in
the next section focused on standards:
1. Allow sustained, repetitive, and purposeful practice in a safe,
controlled environment
2. Level interaction with the expert or mentor, depending on the
proficiency of the student
3. Simulation should mimic actual life experiences
4. The simulated environment should foster a learner-centered
approach that inspires and supports students32
The theoretical foundation for simulation can be based on experiential
learning theory, as well as several other learning theories, models, and
frameworks that are applicable to the use of simulation, as follows:
• Knowles’s adult learning theory. This theory originally stated that adults
learn differently due to andragogy (theory of adult learning).33
Characteristics of adult learners are that they are self-directed, want to
be involved in planning and evaluating their learning experience, use
past experiences to build new learning, need to understand the reason
for learning, want immediate application of knowledge to solve
problems, and are more invested when the learning is associated with a
new role. In 1984, Knowles changed his position to recognize that the
assumptions about andragogy are situation specific and not unique to
adults.34 In 2010, Clapper expanded on this assumption of what adult
learners wanted educators to know, sharing that learners want
educators to create a safe learning environment that uses active and
collaborative learning experiences, encourage reflection on current and
past experiences, and focus more on the assessment of improvements
made instead of pure evaluation.35
• Kolb’s experiential learning. This theory refers to a person’s ability to
transfer knowledge from theory into practice, thereby leading to
acquisition of knowledge.36 Foronda and Bauman4 discuss how students
using gaming are immersed in learning environments with
preconceived beliefs and judgments. They reflect on their activities and
form abstract conceptualizations. They then will experiment and form
new concrete experiences, then beginning again in the learning cycle.4
• Situated cognition. Learning occurs as a social activity incorporating the
mind, the body, the activity, and the tools in a context that is complex
and interactive. This incorporates all domains of learning: psychomotor,
cognitive, and affective.37 Wyrostok et al.38 describe how learning is
socially situated so that learning occurs as a result of human interactions
and the social context of the situation when teaching end-of-life care to
undergraduate nursing students.
• Lasater’s Interactive Model of Clinical Judgment Development. Four areas of
clinical judgment are noticing, interpreting, responding, and
reflecting.39,40 This model can be applied to simulation for noticing and
assessing patient situations and conditions, interpreting the assessment
findings, responding by developing a plan of care and interventions,
and reflecting during the debriefing process.
• Jeffries/NLN Simulation Theory: This theory was established as a
conceptual framework developed for use in nursing education to
design, implement, and evaluate simulation experiences, formerly
known as the Jeffries/NLN Simulation Framework.41 Based on the
evidence from literature review and dialogue with simulation
researchers and educators, the NLN Jeffries Simulation Framework has
progressed to a mid-level theory.26 This evolution occurred after groups
evaluated each of the constructs of the framework and a theorist
reviewed and provided additional recommendations for advancing the
framework. A literature review was conducted42 and synthesized to
conclude there was enough evidence to progress the framework to a
theory with a few minor edits. The major edits occurred within the
educational practices of the simulation experience with teacher and
student to facilitator and participants to more clearly reflect the current
practice in simulation. Within the simulation experience, there must be
an environment of trust; it must be experiential, interactive,
collaborative, and learner centered. The outcomes of the simulation
experience are measured on a system, patient, or participant level. This
theory depicts the triadic relationship of participants, facilitators, and
educational practices, and their influence on the simulation design and
desired outcomes. Five possible outcomes of simulations are increased
knowledge, improved skill performance, enhanced learner satisfaction,
improved critical-thinking abilities, and increased self-confidence of the
participants.
• Gaba’s 11 dimensions of simulation. Gaba’s vision of 2004 remains relevant
today, as he outlines various components of simulation-based learning43,
p.13-16
:
1. The purpose and aims of simulation activity
2. Unit of participation
3. Experience level of participants
4. Healthcare domain in which simulation is applied
5. Healthcare disciplines of participants
6. Type of knowledge, skills, a itudes, or behavior addressed in
simulation
7. Age of patient being simulated
8. Applicable or required technology
9. Site of simulation participation
10. Extent of direct participation
11. Feedback method accompanying simulation
The many aspects of simulation-based education have been studied to
determine best practices. A clinical scenario should be developed based
on the specific learning objectives of the participants. During the planning
and development of a scenario, it is important to construct an experience
that is appropriate to the participant’s level of learning as well as the
participant’s objective. Since many simulation experts believe that the
majority of learning occurs during the debriefing process, a planned
theory-based debriefing strategy should guide the facilitator in the
process. A theory-based debriefing is an active discussion that follows a
simulation experience. The debriefing is led by a facilitator who is
prepared to apply educational principles in guiding the discussion of
clinical content underlying the simulation experience. The feedback
provided via the discussion should provide the participants with an
opportunity to use reflective thinking to analyze their performance and the
clinical concepts presented in the stimulation experience. In developing,
implementing, and evaluating a simulation, faculty should strive to ensure
the identification and application of a theoretical framework proving the
theoretical underpinning for that simulation and simulation
program.1,41,44,45 These aspects will be explored further in the next section.
International Nursing Association for Clinical
Simulation and Learning Standards of Best Practice:
Simulation
The INACSL Standards of Best Practice: SimulationSM was developed by
the INACSL board of directors at the request of its membership after an
extensive needs analysis was conducted via member e-mail and listserv.1
The purpose of the analysis was to identify, prioritize, and rank the areas
of simulation education required standards that would serve to improve
this teaching strategy. Top priorities were established as standards and the
lower priorities were developed as guidelines. The simulation standards
have been developed to assist with developing simulation experiences that
will lead to be er learning experiences and improved learning outcomes
for participants.1
The first seven standards were presented at the 2011 conference and
published for all members in the fall of 2011 by Elsevier, sponsored by an
educational grant from CAE. These initial standards included (1)
terminology, (2) professional integrity of the participants, (3) participant
objectives, (4) facilitation methods, (5) simulation facilitator, (6) the
debriefing process, and (7) evaluation of expected outcomes.
In 2013, guidelines were established and published online by Elsevier.
The paper publication of the standards was funded by CAE and Elsevier
Simulation. In 2015, two additional standards focused on simulation-
enhanced interprofessional education (Sim-IPE) and simulation design
were created and published.
In 2016 INACSL Standards of Best Practice: Simulation SM 46 were again
updated. This latest update is based on current practice and incorporated
external feedback from 20 professional healthcare organizations. The 2016
INACSL Standards update includes a new format that more effectively
reflects the relationship between the standards and describes their non-
hierarchical nature. The Standards of Best Practice: SimulationSM include:
• Simulation Design47
• Debriefing48
• Facilitation49
• Outcomes and Objectives50
• Participant Evaluation51
• Professional Integrity52
• Simulation-Enhanced Interprofessional Education (Sim-IPE)53
For full information about the updates to the 2016 INACSL Standards,
visit [Link]/INACSLStandards.
The major changes that occurred with the revised INACSL Standards
include:
• Removal of numeration with each standard
• Revision of the standard template
• Replacement of the terminology standard with a glossary of terms
• Combination of existing standards to reduce duplication
Each standard includes the statement, background, and criteria
necessary to meet the standard, as well as the required elements for each
criterion.
Glossary46
The Terminology Standard from the previous Standards was moved to a
Glossary in the 2016 revision.46 This was accomplished when the INACSL
Terminology was incorporated into the Healthcare Simulation Dictionary54
published in June 2016. The glossary was incorporated into the revised
Standards to ensure that those using simulation are speaking a “common
language.” The definitions in the Glossary were developed using current
literature and practice. Standard definitions make it possible for consistent
use of educational principles within educational application, clear
communication within publications, replication of research, and evidence-
based practices.
Professional Integrity of the Participants
This standard states that “professional integrity is demonstrated and
upheld by all involved in simulation-based experiences.”52, p. S30 Four
criteria are necessary to meet this standard52, p. S31:
• Foster and role model a ributes of professional integrity at all times.
• Follow standards of practice, guidelines, principles, and ethics of one’s
profession.
• Create and maintain a safe learning environment.
• Require confidentiality of the performances and scenario content
based on institution policy and procedures.
Participant Objectives and Outcomes
This standard states that “all simulation-based experiences begin with the
development of measureable objectives designed to achieve expected
outcomes.” 50, p. S13 The simulated clinical experience should align with
course, clinical, or program objectives and should be based on the
participants’ level of experience rather than on the fidelity, or realism, of
the equipment. Clearly stating the objectives and outcomes helps guide the
simulation experience toward an end point or goal Two criteria are
necessary to meet this standard50, p. S14:
• Determine expected outcomes from simulation-based activities and/or
programs.
• Construct S.M.A.R.T. objectives based on expected outcomes.
Facilitation
This standard states that “facilitation methods are varied and use of a
specific method is dependent on the learning needs of the participants and
the expected outcomes. A facilitator assumes responsibility and oversight
for managing the entire simulation-based experience.”49, p. S16 Five criteria
are necessary to meet this standard49, p. S17:
• Effective facilitation requires a facilitator who has specific skills and
knowledge in simulation pedagogy.
• The facilitative approach is appropriate to the level of learning,
experience, and competency of the participants.
• Facilitation methods prior to the simulation-based experience include
preparatory activities and a pre-briefing to prepare participants for
the simulation-based experience.
• Facilitation methods during a simulation-based experience involve the
delivery of cues (pre-determined and/or unplanned) aimed to assist
participants in achieving expected outcomes.
• Facilitation after and beyond the simulation-based experience aims to
support participants in achieving expected outcomes.
The facilitation method should be determined by the level of the
participant and the type of evaluation for the simulation.49 Several types of
facilitation can be used and must be appropriate to the participants’ level
of experience. Beginning participants usually require more instructor
cueing or prompting. As the level of experience increases, less instructor
prompting is required. During a summative evaluation, such as high-
stakes testing, minimal to no prompting by the instructor is performed.
The facilitator is the major component that provides the link between
the scenario and the participant to provide guidance for meeting the
objectives of the simulation. The role of the facilitator is to adjust the
scenario to respond to the actions or inactions of the participants according
to the objectives of the scenario. The facilitator also leads the participants
in the debriefing process in a positive manner to reflect on ways to
improve the care provided for be er patient outcomes.
The Debriefing Process
This standards states that “all simulation-based experiences include a
planned debriefing session aimed at improving future performance.” 48, p.
S21
The purpose of a debriefing is to promote reflective thinking by
allowing participants to think about and clarify actions that occurred
during the simulation (Box 33.2). The debriefing process has been reported
as the most important component of simulation because of the learning
that occurs when concepts are clarified.55,56 Literature suggests that
debriefing should last at least as long as the simulation scenario, but
current practices vary.57 Five criteria are necessary to meet this standard48,
p. S21–S22
:
Box 33.2
Sample Debriefing Questions for a Pediatric
Patient in Isolation for Pneumonia With Cystic
Fibrosis
Ask at least one question from each section.
Aesthetic Questions
“I would like each of you to talk to me about the problems _________ was
experiencing today.”
“What was your main objective during this simulation?”
“How did patient safety and isolation issues affect the patient care you
provided?” (scenario specific)
Personal Questions
“Was there any point during the scenario when you felt unsure of your
decisions? If yes, how did you manage your feelings and focus on the
patient’s needs?”
“What made you choose the actions, interventions, and focus that you
chose for _________?”
Empirical Question
“I would like each of you to talk with me about the knowledge, skills,
a itudes, and previous experiences that provided you with the ability to
provide evidence-based care to _________.”
Ethical Question
“Talk to me about how your personal beliefs and values influenced the
care provided to _________.”
Reflection Questions
“Please tell me how you knew what to do for a cystic fibrosis patient with
pneumonia in isolation and why.”
“If we could repeat this scenario now, what would you change and why?”
“How will you use this in your professional practice?”
• The debrief is facilitated by a person(s) competent in the process of
debriefing.
• The debrief is conducted in an environment that is conducive to
learning and supports confidentiality, trust, open communication,
self-analysis, feedback, and reflection.
• The debrief is facilitated by a person(s) who can devote enough
concentrated a ention during the simulation to effectively debrief the
simulation-based experience.
• The debrief is based on a theoretical framework for debriefing that is
structured in a purposeful way.
• The debrief is congruent with the objectives and outcomes of the
simulation-based experience.
Participant Evaluation
This standard states that “all simulation-based experiences require
participant evaluation.”51, p. S26 The evaluation and assessment of the
participants’ performance during the simulation should be based on the
focus and desired outcomes of the simulation scenario. The participants
should be aware of the evaluation or assessment methods being used
before beginning the simulation.44,58 Four criteria are necessary to meet this
standard51, p. S26–S27:
• Determine the method of participant evaluation prior to the
simulation-based experience.
• Simulation-based experiences may be selected for formative
evaluation.
• Simulation-based experiences may be selected for summative
evaluation.
• Simulation-based experiences may be selected for high-stakes
evaluation.
Simulation-Enhanced Interprofessional Education
This standard states that “simulation-enhanced interprofessional
education (Sim-IPE) enables participants from different professions to
engage in a simulation-based experience to achieve shared or linked
objectives and outcomes.”53, p. S34
Interprofessional education (IPE) in healthcare is essential to produce
high-performing, effective teams to improve patient safety and outcomes.
The Sim-IPE is designed for the individuals involved to “learn about, from
and with each other to enable effective collaboration and improve health
outcomes.”59, p. 2 Four criteria are necessary to meet this standard53, p. S34–S35:
• Conduct Sim-IPE based on a theoretical or a conceptual framework.
• Utilize best practices in the design and development of Sim-IPE.
• Recognize and address potential barriers to Sim-IPE.
• Devise an appropriate evaluation plan with Sim-IPE.
Simulation Design
This standard states that “simulation-based experiences are purposefully
designed to meet identified objectives and optimize achievement of
expected outcomes.”47, p. S5 This standard has eleven criteria47, p. S6:
• A needs assessment provided the foundational evidence of the need
for a well-designed simulation-based experience.
• Measureable objectives are determined.
• The format of a simulation is structured based on the purpose, theory,
and modality for the simulation-based experience.
• A scenario or case provides the context for the simulation-based
experience.
• Various types of fidelity are used to create the required perception of
realism.
• The facilitator/facilitative approach is participant-centered and driven
by the objectives, participant’s knowledge or level of experience, and
the expected outcomes.
• Simulation-based experiences begin with a pre-briefing.
• Simulation-based experiences are followed by a debriefing and/or
feedback session.
• The evaluation process includes an evaluation/assessment of the
participant(s), facilitator(s), the simulation-based experience, the
facility, and the support team.
• Participant preparation and resources promote participants’ ability to
meet identified objectives and achieve expected outcomes of the
simulation-based experience.
The simulation process should follow the steps outlined in Box 33.3 in
designing the scenario or experience to assist the participants in achieving
the objectives.
Box 33.3
Steps for the Simulation Process
1. Assign the pre-simulation or pre-scenario exercises to be completed by
the participants
2. Pre-briefing sessions immediately prior to the simulation
3. Simulation scenario with appropriate facilitation by a trained facilitator
4. Debriefing and/or guided reflection
5. Postsimulation exercises
Application of simulation
General Application of Simulation to Education
The use of simulation in undergraduate nursing, graduate schools for
advanced practice nurses (especially nurse anesthetists), medical schools,
and IPE has been well documented in the literature. However, literature is
limited for simulation applied to doctoral education.
Multiple research studies revealed that students have higher satisfaction
with higher levels of fidelity.10,60 However, studies have not shown that
high-fidelity simulation increases students’ clinical reasoning skills.10
There is a growing body of health literature evaluating the differences in
student outcomes using low- and high-fidelity simulation experiences.
Multiple studies indicated no statistically significant differences in student
learning outcomes using traditional pencil-and-paper testing scores,
compared to varying levels of fidelity teaching strategies.61–65
Some studies have demonstrated a statistically significant difference in
students’ self-perceived improvements, depending on the level of fidelity
used in simulation.66–70 The participants of these studies preferred high-
fidelity teaching strategies as compared to low-fidelity strategies.
Several studies recommend that educators need to compare the level of
fidelity when considering cost and short- and long-term participant
outcomes.62,63 Some authors have questioned the choice of appropriate
evaluation method: an objective structure clinical examination (OSCE) or a
paper-and-pencil test.63,70 However, there have not been consistent results
with OSCEs in terms of finding differences in participants’ performances
to compare acquisition of knowledge and applying that knowledge to
clinical practice.61
Application of Simulation for Evaluation
Although there is growing interest in the adoption of clinical simulation
within educational programs, there is a gap in empirical research to
identify valid and reliable tools for evaluating simulation effectiveness,
especially in translating knowledge and skills from simulation experiences
to actual clinical practice; research is needed.45,71,72
The American Association of Colleges of Nursing (AACN) has
published a white paper for re-envisioning clinical education for nurse
practitioner programs as a result of a national think tank group.73 One of
the themes identified was the need for standardized preclinical
preparation using simulation activities and standardized core content
before students enter the clinical environment. These two factors could
impact performance and skills in the patient care environment. Another
theme identified was incorporating technology into the curriculum to
improve the transition into clinical practice. This could include the use of
simulation, both mannequins and standardized patients, in the clinical
education of nurse practitioner students. However, the National
Organization of Nurse Practitioner Faculties (NONPF) sets the standards
for nurse practitioner education and does not currently allow any of the
nurse practitioner students’ 500 mandatory clinical hours to be obtained
using simulation. Clinical hours used for simulation activities must be in
addition to the required clinical hours. Several published studies
regarding nurse practitioner students or advanced practice nursing (APN)
students74–78 and simulation state that simulation was effective, but this
was in addition to the mandatory 500 hours for clinical performance.
Types of evaluations include a formative assessment of performance, or
summative evaluation. Skills checklists may be used during a skills
validation, such as an indwelling catheter or chest tube insertion for
students or an endotracheal intubation for respiratory therapy students.
Formative assessments measure a participant’s progress toward overall
or long-term program objectives. This type of assessment provides the
participant with feedback that will aid in professional growth and
promote self-reflection.
Summative evaluations are traditionally measured at the end of a
learning experience to correlate with the end of the course or program.
This type of evaluation may have a grade assigned or use another method
to determine student progression. An example of a summative evaluation
is an OSCE. An OSCE summative evaluation can be a graduate student’s
evaluation at the end of the advanced assessment course to determine his
or her ability to perform in a traditional clinical se ing. Some medical
boards require successful completion of an OSCE to become certified.
Regardless of the type of evaluation, the instrument used should have
reported psychometric data demonstrating reliability and validity.
The evaluation tools currently used in simulation were described in a
review by Kardong-Edgren et al. and were categorized within the
cognitive, psychomotor, and affective learning domains.79 The cognitive
domain focuses on application with thinking, such as performing,
identifying, maintaining, communicating, prioritizing, and providing. An
example is that the participant will be able to identify the signs and
symptoms of congestive heart failure and provide appropriate
interventions for best patient outcomes. The psychomotor domain focuses on
the precision of performing the assessment or skill, such as insertion of an
intravenous catheter and effective therapeutic communication using
situation-background-assessment-recommendation (SBAR)
communication. The affective domain focuses on the emotion of reflective
thinking by responses to and prioritization of patient care (Box 33.4).
Box 33.4
Learning Domains
Cognitive domain. Simulation evaluation tools included the Basic
Knowledge Assessment Tool 6 (paper-and-pencil test); the Outcome
Present State Test Model for Debriefing (worksheets that participants
complete during the structured debriefing); the Lasater Clinical
Judgment Rubric, based on Tanner’s Clinical Judgment Model for
student evaluation during simulation; and the Simulation Evaluation
Instrument, developed to evaluate the AACN core competencies for
undergraduate nursing students during simulation.
Psychomotor domain. There were no tools identified for the psychomotor
domain for simulation that reported validity and reliability testing.
Affective domain. The evaluation tools identified in this section were
developed to measure student satisfaction and perceived effectiveness of
the simulated clinical experience. The tools identified included a
satisfaction survey, the Emergency Response Performance Tool (ERPT),
and the Simulation Design Scale. Other tools were reviewed for group
evaluation.
AACN, American Association of Colleges of Nursing; ERPT, Emergency Response Performance
Tool.
The Clinical Learning Environment Comparison Survey (CLECS) was
designed to determine how well undergraduate students’ learning needs
were met in the simulated clinical environment and in the traditional
clinical environment.80 The CLECS was used during the national
simulation study by the NCSBN.20 Psychometric analysis shows this to be
a valid and reliable tool.
The Creighton Simulation Evaluation Instrument (C-SEI)—now known
as the Creighton Competency Evaluation Instrument (C-CEI)—is a tool
that evaluates simulation experiences by measuring assessment skills.81 C-
CEI was the second tool used in the NCSBN’s study and also has
established reliability and validity.20 The C-CEI tool was designed to be
modifiable to meet the specific outcomes of the simulation. The goal of this
tool was to evaluate student assessment skills for improvement. As the
assessment skills improve, so will clinical performance.
The Simulation Effectiveness Tool-Modified (SET-M)82 was updated in
2015. The original SET tool was developed in 2005 to evaluate the
effectiveness of the simulation experience. In 2015, the tool was modified
to reflect the INACSL Standards of Best Practice: SimulationSM, the Quality
and Safety Educating Nurses (QSEN) practices, and the AACN
baccalaureate essentials. This tool remains valid and reliable for evaluating
simulations. The modification of this tool demonstrates the importance of
reassessing evaluation instruments as our knowledge of best practices in
simulation progresses.
Application of Simulation to Interprofessional
Education
Many professional medical organizations stated an increasing need for
IPE, as evidenced by the newly introduced Core Competencies for
Interprofessional Collaborative Practice sponsored by the Interprofessional
Education Collaborative (IPEC) (Table 33.5).59 IPEC was a collaborative
effort of multiple associations, including the AACN, American Association
of Colleges of Osteopathic Medicine, American Association of Colleges of
Pharmacy, American Dental Education Association, Association of
American Medical Colleges, and Association of Schools of Public Health.
Table 33.5
Core Competencies for Interprofessional Collaborative Practice
Data from Interprofessional Education Collaborative Expert Panel. Core Competencies for
Interprofessional Collaborative Practice: Report of an Expert Panel. Washington, DC:
Interprofessional Education Collaborative; 2011.
IPE, Interprofessional education.
To improve patient safety, evidence-based practice, and translational
research, more IPE opportunities are needed. New teaching strategies have
evolved. Some of these are in response to the changing technology that has
proliferated over the past 25 years. The strategies include the following:
1. Communication tools such as SBAR (situation, background,
assessment, recommendation) for more effective professional and
interprofessional communication.
2. Simulation scenarios to practice skills and techniques, assessment,
therapeutic communication, interprofessional collaboration,
reflection on actions and inactions of participants, and
incorporation of evidence-based practice throughout the curriculum
and applying these in simulation.
3. Informatics capabilities to improve patient care with point-of-care
access to information through handheld devices and EHRs.
If the interprofessional members of the healthcare team have access to
the pertinent information about a patient, healthcare delivery can be more
holistic and potentially decrease harm to the patient. Health sciences
students can learn the roles and responsibilities of other healthcare team
members for collaborative purposes through IPE simulations to ensure the
best patient outcomes. For students in the healthcare profession, IPE
simulations are an excellent way to learn how to function and adapt
practices to achieve the best outcomes.
Simulation is a strategy to assist team members with effective
communication and promote collaboration with other professionals.
According to an INACSL survey in 2010, only about half of the
respondents provided any IPE. Of the programs providing IPE
experiences, only a few institutions stated that the practice was used more
than occasionally in the simulation community.56 Challenges to this type of
education exist. In particular, the logistics of scheduling multiple
professions for simulation is one of the major obstacles for IPE
experience.83–86 The Institute of Medicine (IOM) also called for the federal
government and professional organizations to study the approaches and
foci to determine their contribution to improving the workforce.87,88 The
professional organizations have a responsibility to determine the best
resources and methods for improving the education of the healthcare
workforce, both in initial education and in continuing professional
development.
Example
The following scenario was used in a doctorate of nursing practice
program to evaluate nurse practitioner students’ ability to assess and
develop a differential diagnosis for a patient presenting with angina.
Students participated in this experience at the end of their clinical
diagnostics course, and this was used for summative evaluation purposes.
Prior to any simulation experience, a curricular simulation integration
form was used to document objectives, evaluation measures, and the
specific details related to the scenario (Fig. 33.2). This plan mapped out the
specific details related to the simulation experience and contributed to a
successful simulation experience for both the faculty and the students. To
prepare, the students received the evaluation rubric to review prior to
entering the simulation lab for testing (Fig. 33.3). The detailed evaluation
rubric (Fig. 33.4) was used by the faculty member to evaluate the students
and provide summative feedback. After the scenario, the students
completed a Scenario Evaluation Form to evaluate the quality of the
learning experience (Fig. 33.5).9 These evaluation data were reviewed by
the simulation facilitators after the scenario activity to ensure that the
scenario met the needs of the students and reflected the highest quality
and evidence.
FIG 33.2 Simulation integration and planning form. ASA,
Acetylsalicylic acid; BP, blood pressure; CAD, coronary artery
disease; DNP, doctor of nursing practice; HTN, hypertension; NP,
nurse practitioner; prn, as needed; SL NTG, sublingual nitroglycerin;
SOAP, subjective, objective, assessment, and plan; SOB, shortness
of breath. Developed by C. Ross, PhD, RN, and V. Howard, EdD, RN. Courtesy of RMU
Regional RISE Center.
FIG 33.3 Student evaluation rubric. BP, Blood pressure; NP, nurse
practitioner; PVC, premature ventricular contraction; RR, respiratory
rate; SOAP, subjective, objective, assessment, and plan. (Developed by
C. Ross PhD, RN, and V. Howard EdD, RN. Courtesy of RMU Regional RISE Center.)
FIG 33.4 Detailed faculty evaluation rubric. JVD, jugular venous
distention; PQRST, provokes, quality, radiates, severity, time; SOAP,
subjective, objective, assessment, and plan.
FIG 33.5 Simulation evaluation. DNP, Doctor of nursing practice.
Developed by V. Howard. 2010. Courtesy of RMU Regional RISE Center.
Conclusion and future directions
The use of simulation is rapidly emerging as a preferred way to train
healthcare professionals in a safe, controlled manner with no risk to
patients. One of the reasons for its emergence is that simulation can
overcome current barriers with traditional clinical experiences. There may
be a shortage of clinical sites; patients may have complex conditions that a
novice learner is unprepared to manage; and clinical sites may have
limited student experiences for EHRs, administering medications to
pediatric patients, and other situations. These factors, combined with a
nursing and nurse educator shortage and the aging population, will
further increase the need to teach healthcare providers in a simulation
environment. IPE experiences are essential to the development of
healthcare workers that function as an effective team to improve patient
safety and outcomes. Educators must seek out IPE collaboration
opportunities for students to improve their experiential learning and
working in teams.
Newer approaches that reflect the advances in technology are virtual
reality computer-based simulations and gaming. Gaming is a type of
simulation technique that meets the needs of millennial learners and has
been embraced more fully in the past few years by educators.89 However,
gaming faces some of the same challenges as simulation has in its
understanding, growth, and acceptance as a teaching strategy. The
emergence of technology for educational purposes creates a need for
faculty and health science educators to understand how to not only
operate the technology but also implement it within the academic and
service se ings while still using sound academic principles. Standards of
Best Practice: Simulation will continue to serve as a foundation for all
types of simulation-based teaching methodologies.
Simulation use and guidelines will provide a foundation to build
experiential learning experiences, evaluate student performance, and learn
to practice as a healthcare team. As the science and technology of
simulation advances, so will the learning opportunities. The NCSBN
Simulation guidelines for prelicensure nursing programs were released in
fall 2015 as a guideline for including simulation as part of clinical hours in
nursing education. This will impact nursing education and practice
depending on how each state adopts the guidelines. One area that will
need to be investigated is simulation and the APN degree. Some nursing
leaders have stated the NCSBN National Simulation Study results indicate
that simulation could be beneficial in the education and training of APNs.
This is an area for future research that could require policy change also.73
High-stakes testing, such as OSCEs similar to those for medical
students, may someday be required for licensure into nursing practice. The
NLN has been evaluating the possibility of including a high-stake testing
OSCE for licensure to practice nursing for greater than 5 years However,
there are many challenges involved with faculty wanting to use high-
stakes testing, especially for licensure. Some of these challenges are a lack
of trained faculty and quality simulations for validity and reliability, lack
of students with enough experience in other types of simulation, and the
concept that “no student should be judged via one single test.”90, p. 302 The
NCSBN National Simulation Study results and simulation guideline may
begin to move this concept forward.
As technology advances, so will healthcare simulations. We do not know
the possibilities that await us. Everyday new technology is invented that
will assist with the education and training of healthcare providers. The
current technology allows for tracking eye movement during simulation
and patient care to see where the healthcare provider is focusing. This is
accomplished by utilizing glasses, which can be bulky or cumbersome.
However, newer technology may advance, and this could become
common practice. Newer virtual technology under development is similar
to the hologram deck seen in futurist space shows and is beginning to be
used in some labs. These include the ability to view the human body on
different levels: whole body, muscles, bones, and internal organs. This will
provide more learners the ability to apply didactic learning to the clinical
se ing without the need for cadavers and some simulators.
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Discussion questions
1. You are a graduate teaching assistant at the local university. A faculty
member approaches you to “do” a simulation for class. What
information do you need prior to developing the simulation? Provide a
rationale for the information needed.
2. As a faculty member facilitating a debriefing, list five questions that you
would ask to promote self-reflection.
3. Provide an example of an interprofessional simulation that would
facilitate your graduate-level education. List the specific learning
objectives, the team members, the participants’ experience level and
learning, and the type of facilitation and debriefing to guide this
simulation scenario.
4. You are a faculty member struggling with generating support for your
simulation program. You are experiencing resistance from faculty
members and administration with the implementation of this new
technology. What can you do to enhance buy-in?
Case study
You have been hired to teach in a graduate health program. Your newly
developed course has an objective that states: Upon completion of this course,
the learner will be able to demonstrate interprofessional team-building concepts.
As a new educator, you would like to include simulation as a teaching
methodology to achieve this and other course objectives.
After you are hired, you find a rarely used, high-fidelity human patient
simulator in the corner of your skills lab. You inquire about using it for
your course but are met with resistance from other faculty members, who
tell you that “There is no reason to use simulation. We tried that approach
and it takes much too much time to learn the technology and develop the
teaching materials. We’ve always taught our content using wri en case
scenarios, and the students are doing just fine.”
Discussion Questions
1. Use Ko er’s eight steps leading to successful change to develop a plan
for using simulation to teach team concepts.
2. Which published documents can assist you in clarifying the
interprofessional competencies and objectives for a team-building,
simulation-based learning experience?
3. What information should you incorporate when developing the
scenario?
4. Develop an evaluation plan for determining the effectiveness of the
learning experience.
5. Unfortunately, students who experienced the scenario at 8 AM are
sharing information with students scheduled later in the day. Which
INACSL standard addresses this issue, and how can you deter this
behavior?
UNIT 8
International Health Informatics
Efforts
34
International Efforts, Issues, and
Innovations
Hyeoun-Ae Park; Nicholas R. Hardiker
Abstract
This chapter highlights international eHealth initiatives, international organizations
involved in these initiatives, and the challenges faced by these organizations.
Numerous international eHealth-related activities have been initiated across the
different regions of the world. Several international organizations are also involved
in the development of eHealth, such as the World Health Organization (WHO), the
International Medical Informatics Association (IMIA), the International Organization
for Standardization (ISO), the International Council of Nurses (ICN), the
International Health Terminology Standards Development Organisation (IHTSDO),
and Health Level Seven (HL7). These activities and organizations are introduced
here, prior to a wider discussion of global challenges to eHealth.
The promotion of eHealth internationally requires the engagement of
people and organizations in the development of national and regional
eHealth initiatives and strategies.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Outline key international eHealth initiatives.
2. Describe key organizations that are leading international initiatives to
promote eHealth.
3. Discuss global challenges to eHealth.
KEY TERMS
eHealth 577
information and communication technology (ICT) 577
international standards 587
Introduction
Healthcare is one of the largest sectors of the economy in many parts of the
world. As a result, health spending plays a major role in economic policy.
The healthcare industry is challenged by economic uncertainty to
streamline costs, gain efficiencies, and become more innovative to improve
and maintain population health. Today the health industry seeks be er
ways to provide global healthcare. The use of information and
communication technology (ICT) for health, referred to by the World
Health Organization (WHO) as eHealth, is seen as key to realizing this
aim. The shared goal is to use technology to effectively and efficiently
improve the health of individuals, families, and communities.
eHealth faces many international challenges. A coordinated effort is
necessary to overcome these challenges. This chapter highlights
international eHealth initiatives and describes the work of health
professionals such as nurses in meeting these challenges. Throughout the
chapter, eHealth and health informatics will be used interchangeably,
depending on the context.
Key initiatives in world regions
The following sections explore key initiatives to promote eHealth region
by region. For each region, government-supported eHealth initiatives are
described, along with an overview of the regional groupings of the
International Medical Informatics Association (IMIA). These regional
initiatives in turn contribute to a coordinated global effort.
eHealth Initiatives in Europe
eHealth emerged in Europe in the late 1950s and early 1960s. The
European Union (EU) was formed under the Maastricht Treaty in 1993.
The European Commission (EC), through its executive body, provided
billions of euros in research funding to develop eHealth tools and systems.
These EU-supported projects helped establish Europe as a leader in the
use of national and regional health networks and electronic health records
(EHRs)—for example, through the deployment of digital health cards in
primary care.
In 2004, the EU adopted an eHealth action plan, “Making Healthcare
Be er for European Citizens: An Action Plan for a European e-Health
Area,” to facilitate a more harmonious and complementary European
approach to eHealth.1 The action plan covered a range of functions, from
electronic prescriptions to new information systems that reduce medical
errors, for example, through electronic prescribing. The plan identified
actions required for widespread European adoption of eHealth
technologies and encouraged individual members to customize strategies
based on individual needs. Each member state also developed a national
or regional road map for eHealth. The strategies addressed the challenges
of providing citizen-centered healthcare services in order to meet rising
expectations of Europeans, while concomitantly dealing with issues raised
by increasing mobility, aging populations, and budgetary constraints.
National and regional strategies currently focus on deploying eHealth
systems, ensuring interoperability, using EHRs and reimbursing eHealth.
The revised EU eHealth action plan, “eHealth Action Plan 2012–2020:
Innovative Healthcare for the 21st Century,”2 combines previously
implemented actions while looking toward the future of eHealth in
Europe. The EU also supports eHealth research programs and projects
under Horizon 2020, its Research Framework Programme for Research
and Innovation.
The EC created two expert groups, the stakeholder group and a
temporary task force (TF), to further the eHealth Action Plan. Details of the
groups can be found at h ps://[Link]/digital-agenda/en/ehealth-
experts. Members of the eHealth stakeholder group are appointed for a 3-
year term to contribute to legislation and policy, focusing on patient access
to health records, the deployment of telemedicine, health inequality,
eHealth workforce, and issues related to interoperability (see
h ps://[Link]/digital-agenda/interoperability-standardisation-
connecting-ehealth-services). TF members—healthcare professionals,
patient representatives, representatives of pharmaceutical and ICT
industries, legal experts, and policy makers—advise the EC and provide
recommendations related to unlocking the eHealth potential (see
h p://[Link]/digital-agenda/en/news/eu-task-force-ehealth-
redesigning-health-europe-2020).
The work of these two groups is complemented by the eHealth network,
a voluntary network of representatives from EU member states that aims
to enhance interoperability between electronic health systems to promote
continuity of care and to ensure access to safe and quality healthcare. The
network meets annually. Health ministers and secretaries of state from EU
member states also meet annually at a high-level conference to discuss and
move eHealth initiatives forward.
Part of the eHealth Action Plan concerns collaboration between the EC
and the United States. The U.S. Department of Health and Human Services
(HHS) and the EC’s DG CONNECT signed a Memorandum of
Understanding (MoU) in 2010 to strengthen transatlantic cooperation in
eHealth. The two organizations published a draft road map, which has
been the subject of public consultation, with a focus on standards to
support transatlantic interoperability and workforce development for both
regions (see h ps://[Link]/digital-single-
market/en/news/transatlantic-ehealthhealth-it-cooperation-roadmap). The
road map has subsequently been extended to include innovation.
The European Federation for Medical Informatics
The European Federation for Medical Informatics (EFMI) was created in
1976 with the assistance of the WHO Regional Office for Europe. Its main
purpose was and is to enhance European health sciences by encouraging
the implementation of information science in the field. Each country
within the European Region of WHO is entitled to be represented in EFMI
by a suitable health informatics society. At this writing, 32 countries in
Europe have joined EFMI. The footprint for these countries can be seen in
Fig. 34.1.
FIG 34.1 EFMI member countries: Armenia, Austria, Belgium,
Bosnia Herzegovina, Croatia, Cyprus, Czech Republic, Denmark,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel,
Italy, Netherlands, Norway, Poland, Portugal, Republic of Moldova,
Romania, Russia, Serbia, Slovenia, Spain, Sweden, Switzerland,
Turkey, Ukraine, and United Kingdom.
The objectives of EFMI (established when it was founded) are to3:
• Advance international cooperation and dissemination of information
in Medical Informatics on a European basis.
• Promote high standards in the application of medical informatics.
• Promote research and development in medical informatics.
• Encourage high standards in education in medical informatics.
• Function as the autonomous European regional Council of IMIA
For EFMI, the term medical informatics includes health informatics and
all disciplines concerned with health and informatics (this would include
eHealth). EFMI is a regional member of the International Medical
Informatics Association (IMIA) and has formal liaison relations with WHO
and the Council of Europe. Activities of EFMI include academic
conferences and publications, including the Medical Informatics Europe
(MIE) congress, which has been running since 1978. Congress proceedings
are published as a series: Lecture Notes in Medical Informatics and Studies
in Health Technologies and Informatics. A selection of the best papers
from the MIE conferences is published in special volumes of the
International Journal of Medical Informatics and Methods of Information
in Medicine. Open access to the latest MIE conference proceedings is
provided on the EFMI website at
h ps://[Link]/[Link]/publications/conference-proceedings.
Less well known but important are the Special Topic Conferences. A
Special Topic Conference is organized by an EFMI member society in
combination with its annual meeting. The topic of the conference is
defined by the needs of the member society. Relevant EFMI working
groups (WGs) are engaged for content selection. EFMI’s WGs also
organize their own working conferences or business meetings. Currently
there are 17 WGs within EFMI (Box 34.1).
Box 34.1
European Federation for Medical Informatics
Working Groups
• Education (EDU)
• Electronic Health Records (EHR)
• Assessment of Health Information Systems (EVAL)
• Health Informatics for Interregional Cooperation (HIIC)
• Health Information Management Europe (HIME)
• Human and Organizational Factors of Medical Informatics (HOFMI)
• Information and Decision Support in Biomedicine and Healthcare (IDeS)
• Libre/Free and Open Source Software in Health Informatics (LIFOSS)
• Casemix, Resources Management and Outcomes of Care (MCRO/MBDS)
• Medical Image Processing (MIP)
• Natural Languages Understanding (NLU)
• Nursing Informatics in Europe (NURSIE)
• Primary Healthcare Informatics (PCI)
• Personal Portable Devices (PPD)
• Security, Safety and Ethics (SSE)
• Traceability of Supply Chains (TRACE)
• Translational Health Informatics (THI)
eHealth Initiatives in the Asia-Pacific Economic
Cooperation Region
One of the three priorities of the Asia-Pacific Economic Cooperation
(APEC) Health Working Group ([Link]) is “strengthening
health systems of economies including health financing, human resources,
and health information technologies which would contribute to inclusive
and secure growth.”4 Because eHealth has great potential to support
healthcare improvements in the APEC region, investing in eHealth could
address the health challenges facing the region.
Asia Pacific Association for Medical Informatics
The Asia Pacific Association for Medical Informatics (APAMI) began in
1993 as a regional group within IMIA ([Link]) to promote the
theory and practice of health informatics within the APEC region. At this
writing APAMI has 18 society members, as seen in Fig. 34.2 and listed in
Box 34.2.
Box 34.2
Asia Pacific Association for Medical
Informatics
Member Countries
• Australia
• China
• Hong Kong
• India
• Japan
• South Korea
• New Zealand
• Philippines
• Singapore
• Sri Lanka
• Taiwan
• Thailand
Corresponding Members
• Bangladesh
• Bhutan
• Indonesia
• Malaysia
• Nepal
FIG 34.2 APAMI member countries: Australia, China, Hong Kong
(China), India, Japan, South Korea, New Zealand, Philippines,
Singapore, Sri Lanka, Taiwan (China), Thailand. Via corresponding
members: Bangladesh, Bhutan, Indonesia, Malaysia, Nepal, and
Vietnam.
APAMI activities include biennial conferences and WGs. The inaugural
APAMI conference was held in Singapore in 1994. Over the last several
years, these conferences have been held in eight different Asian countries.
WGs within APAMI have included Standardization, Health Informatics
for Developing Countries, Decision Support, and Nursing Informatics.
Each WG has hosted a workshop during the APAMI conference.
APAMI actively promotes telemedicine, bioinformatics, and public
health informatics. Because of the large size of its countries, the low
specialist-to-population ratio, the affordable cost of technology and
telecommunication, and the high penetration rate of eHealth for equitable
distribution of healthcare services, telemedicine is an important aspect of
eHealth within the Asia-Pacific region. One example is a project called
Med@Tel, which began in 2010 and has involved the introduction of
telehealth to the Thai Health Care System by the Thai National Health
Security Office to revitalize existing telehealth programs in Thailand. This
telehealth program supports remote, underserved populations in Southern
Thailand. It links hospitals in the region with a videoconferencing system
for consultation and education; provides real-time, web-based
consultation and education for healthcare providers and patients; provides
telehome care using webcams, notebooks, and videophones installed in
patients’ homes and home care centers; and broadcasts selected tele-
consultations, lectures, and presentations on a real-time internet TV.5
Another example comes from Japan, where telemedicine practice was
strongly promoted by the Japanese government after the Great East Japan
Earthquake of March 2011 as an a empt to revive medical services in the
disaster area, along with the computer-based patient record network. The
earthquake will be marked in history as an important trigger for the
spread of telemedicine in Japan. Telemedicine practice in Japan includes
telepathology, telemonitoring, telemedicine for cancer therapy,
telemedicine for ophthalmology, telemedicine for pregnant women, home
telemedicine, telenursing, mobile telemedicine, and telehealth for health
promotion.6 Other Asia-Pacific countries with active telemedicine projects
include China, Korea, Australia, India, Bhutan, Malaysia, Singapore,
Indonesia, Hong Kong Special Administrative Region (SAR), and New
Zealand.
Many countries in the Asia-Pacific region, including Australia, China,
Japan, Korea, Singapore, India, Malaysia, Taiwan, Thailand, and New
Zealand, are actively promoting bioinformatics. APAMI plays a key role in
advancing, developing, and promoting bioinformatics through
cooperation within the region.
China, Hong Kong SAR, Singapore, Taiwan, and Korea have been
particularly active in public health informatics since the outbreak of severe
acute respiratory syndrome (SARS) in early 2003 and Middle East
respiratory syndrome (MERS) in mid-2015. The SARS and MERS
outbreaks provided an opportunity for APAMI to demonstrate the
importance of a public health informatics approach to population health
for each country within the region. APAMI continues to address public
health informatics research and development through contact tracing,
epidemiologic reporting, and monitoring for acute disease outbreaks.
eHealth Initiatives in the Pan American Health
Organization Region
The Pan American Health Organization (PAHO), in conjunction with
WHO, initiated the PAHO eHealth Program, a joint effort to increase
research, teaching, and technology knowledge and transfer and to
improve public health in the Americas and the Caribbean through the use
of innovative eHealth tools and methodologies (see
[Link]/ict4health).7 The PAHO eHealth Program was a strategic
response to the Health Agenda for the Americas presented by the
Ministers of Health of the Americas in 2007.8 The PAHO eHealth Strategy
and Plan of Action (2012–2017)9 describes the following components of
eHealth:
• EHRs
• Telehealth
• mHealth (mobile health)
• eLearning
• Continuing education in ICT
• Standardization and interoperability
The eHealth Strategy and Plan of Action is focused around four strategic
areas:
1. Policies on the use and implementation of ICT for health
2. Improvements in public health through innovative ICT tools and
techniques
3. Cooperation among countries toward development of a digital
health agenda for the region
4. Knowledge management, digital literacy, and education in ICT
The overall objective is the development of sustainable health systems.
Examples of indicators include the following:
• Extent of funding for health ICT activities
• Strategies for strengthening infrastructure
• A common framework for patient identification
• Use of mobile technologies for electronic disease surveillance
• A common framework for data exchange
• A common framework for the development of portals
• Strategies for the use of social media in emergencies
International Medical Informatics Association for
Latin America and the Caribbean
The Regional Federation of Health Informatics for Latin America and the
Caribbean (IMIA-LAC) was founded in 1996 to promote theory
development and the practice of health informatics within Latin America
and the Caribbean (LAC). The IMIA-LAC board proposed the following
two goals to develop health informatics within the region and strengthen
regional ties10:
1. Strengthen the network of health informatics societies in Latin
America and the Caribbean
2. Define the main health informatics topics to promote and the best
groups to engage in such initiatives
Member societies of IMIA-LAC include Argentina, Brazil, Chile,
Columbia, Cuba, Mexico, Peru, Uruguay, and Venezuela, as shown in Fig.
34.3.
FIG 34.3 IMIA-LAC member countries: Argentina, Brazil, Chile,
Columbia, Cuba, Mexico, Peru, Uruguay, and Venezuela.
Activities include regional congresses, national conferences, and WGs.
An inaugural regional congress of IMIA-LAC was held in 2008 in Buenos
Aires, Argentina, coordinated by Asociación Argentina de Informática
Médica (AAIM). As part of the conference, IMIA held its board meeting,
demonstrating its support for the IMIA-LAC regional congress. The IMIA
Health and Medical Informatics Education workgroup convened the
business meeting, which was coordinated by the Hospital Italiano de
Buenos Aires. Spanish (SEIS) and American (AMIA) health informatics
societies/associations continue support and participate in regional
congresses and other activities with IMIA-LAC.
The major WGs within IMIA-LAC are the Health and Medical
Informatics Education workgroup and the Health Information Systems
workgroup, coordinated by Argentinean, Brazilian, and Cuban experts,
with participation from several countries in the region. The Health and
Medical Informatics Education workgroup has devised a work plan,
including an assessment of the situation in each country and a
coordination of health informatics education. Three additional WGs have
been established by experts working in the region:
1. Bioinformatics workgroup
2. Nursing Informatics workgroup
3. Informatics and Quality in Healthcare workgroup
eHealth Initiatives in Africa
Africa is one of the least economically developed areas of the world. The
wealth of a nation depends, in part, on the health of its population, making
healthcare an area of high priority with regard to economic development.
The progress of countries in sub-Saharan Africa in reaching WHO’s
Millennium Development Goals (MDGs) related to health—reducing child
and maternal mortality, improving access to reproductive health, and
reducing the spread of HIV/AIDS and tuberculosis—has fallen behind
other countries in other regions.11
The WHO regional office in Africa predicted that eHealth might play a
significant role in strengthening national health systems to accelerate
progress toward the MDGs and improving health outcomes in the
region.12 WHO called for strengthened health information systems, public
health surveillance systems, mobile devices at the point of care, EHRs, and
other applications that provide patient billing, patient scheduling, and the
electronic transmission of prescriptions. It is hoped that telehealth will also
contribute to improving access to health services for underserved
populations in rural areas.
Key challenges impeding the wide-scale implementation of eHealth
solutions in Africa include:
• The “digital divide,” as demonstrated by the need for increased
awareness of eHealth among health professionals and patients
• A cohesive policy environment, providing leadership and
coordination with improved financial and human resources
• A technical infrastructure and services within the health sector with
monitoring and evaluation systems
More recently, Africa has seen a rapid rise in use of mobile devices and
mobile health (mHealth) services across the region and their potential role
in the transformation of maternal care, management of noncommunicable
diseases, and management of epidemics such as Ebola, through more
effective tracking and reporting and by extending health services to
underserved areas.13
Health Informatics in Africa
Health Informatics in Africa (HELINA), the Pan African Health
Informatics Association and IMIA’s African regional arm was created in
1993 with three main goals14:
1. To encourage African countries to develop their own National
Health Informatics Societies
2. To develop education and research programs adapted to the
African context, fostering alliance with government and the private
sector
3. To develop a strategic plan for the sustainable development of
Health Informatics and eHealth in Africa
The latest available information lists 10 countries as members of
HELINA: Burundi, Cameroon, Ghana, Ivory Coast, Kenya, Malawi, Mali,
Nigeria, South Africa, and Togo, as shown in Fig. 34.4. Algeria,
Democratic Republic of the Congo, Egypt, Kenya, Madagascar, Tanzania,
Uganda, Zambia, and Zimbabwe are corresponding members. HELINA
organizes health informatics conferences within the African region. The
first was held in Nigeria in 1993, and six more conferences have been
organized since that inaugural meeting.
FIG 34.4 HELINA member countries: Burundi, Cameroon, Ghana,
Ivory Coast, Kenya, Malawi, Mali, Nigeria, South Africa, and Togo.
The HELINA Education Working Group, established in 2015, provides a
platform for the development of initiatives to support health informatics
education, training, and research. Activities will be channeled through
eight worksets15:
• Workset One: Develop health informatics curricula for French-
speaking participants.
• Workset Two: Develop a repository of training materials for health
informatics.
• Workset Three: Compile a database of health informatics curricula
from Africa.
• Workset Four: Develop a repository of tools to enable the
development of curricula at a master’s level.
• Workset Five: Work with education and training providers to foster
the provision of health informatics using Web 2.0 technologies to
provide free access to events for African health informatics
participants.
• Workset Six: Develop a network of authors within each HELINA
country in collaboration with the country representative, to help and
advise health informaticians who wish to publish a paper but lack the
skills or confidence to do so.
• Workset Seven: Develop a short-term certification program via
blended learning for professionals in English- and French-speaking
countries.
• People living in different regions of the world face very different
challenges. However, the ongoing work around eHealth within these
regions and within the IMIA regional bodies has much in common.
The various interrelated regional agendas coalesce at an international
level through a number of international organizations and standards
efforts.
International organizations with ehealth
involvement
International health-related organizations have played a major leadership
role in the development of eHealth from the outset. This section of the
chapter provides an overview of key organizations that are providing that
leadership, along with a brief description of their programs and efforts.
eHealth and Health Informatics at the World Health
Organization
WHO plays a key role in the development of global eHealth. The vision of
WHO’s Department of Knowledge Management and Sharing (KMS) is “a
world with be er and more equitable health outcomes.”16 The mission of
KMS is “to improve the understanding and application of knowledge
management.”16 One strategic direction is “to promote the use of
information and communication technologies to improve health services
and systems.”16 WHO has recently taken steps to make eHealth a priority
in strengthening health systems worldwide.
The eHealth Resolution
In 2005 the 58th World Health Assembly took a historical step toward
supporting eHealth by adopting a resolution for a global movement
recognizing the role of the ICT in strengthening health systems and
improving the safety, quality, and efficiency of services.17 The resolution
urged member states to do the following:
• Create a lasting plan for eHealth development.
• Create eHealth infrastructure.
• Encourage private and nonprofit collaboration.
• Broaden the reach of eHealth services.
• Encourage universal collaboration to determine eHealth standards
supported by evidence-based practice.
• Create centers and networks for sharing best practices, policies,
technical innovations, service improvement, communications,
capacity building, and surveillance.
• Think about developing national public health information systems.
• Enhance surveillance and response to public health emergencies
through increased flow of information.18
The 66th World Health Assembly in 2013 recognized the need for health
data standardization as part of eHealth systems and services, as well as the
importance of proper governance and operation of health-related global
top-level internet domain names, including “health.”19 The resolution
urged member states to do the following:
1. Consider collaborating with a range of relevant stakeholders in
order to draw up a road map for implementation of eHealth and
health data standards at national and subnational levels.
2. Consider developing policies and legislative mechanisms to ensure
compliance in the adoption of eHealth and health data standards, as
well as to ensure the privacy of personal clinical data.
3. Consider ways to coordinate national positions toward the
delegation, governance, and operation of health-related global top-
level domain names, including “.health.”
Information about major eHealth projects at WHO is available at
h p://[Link]/ehealth/programmes. These projects cover eLearning
on a range of health-related topics, support for eHealth standards
development, governance and national strategy development, and the
Global Observatory for eHealth.
Global Observatory for eHealth
In direct response to the 58th World Health Assembly eHealth resolution,
the Global Observatory for eHealth was established in 2005 to monitor and
analyze eHealth and to support national planning through the provision
of strategic information in member countries. Four global surveys were
conducted, the first in 2005 to establish a baseline, then in 2009, 2013, and
2015. Key findings of the first survey included20:
• Acknowledging a digital divide in eHealth as well as other areas
• A willingness to implement eHealth policies
• A need for assistance and guidance in the eHealth domain
• A lack of national eHealth governance mechanisms
• A need to promote public-private partnerships for eHealth projects as
effective management practices
• A lack of citizen protection policies to ensure patient data
confidentiality
• A need to focus on interoperability issues
• Health information in electronic formats should be provided in
relevant community languages.
The second survey, conducted in late 2009, was designed to build on the
knowledge base generated by the first survey and identify and analyze
trends in eHealth, including21:
• Uptake of eHealth foundation policies and strategies
• Deployment of mHealth initiatives
• Application of telehealth solutions and adoption of eLearning for
health professionals and students
• Collection, processing, storage, and transfer of patient information
• Legal and ethical frameworks for electronic patient information
• Legislation and initiatives concerning online child safety, internet
pharmacies, and health information on the internet
• Governance and organization of eHealth within countries
The second survey proved to be a rich source of data, which has been
used to create a series of publications titled the Global Observatory for
eHealth series.22 For example, the third survey (conducted in 2013) focused
on the use of eHealth for women’s and children’s health; the fourth (2015)
focused on the use of eHealth in support of universal health coverage.22 A
list of publications from the global surveys is included in Table 34.1.
Readers may view the detailed results on the Global Observatory eHealth
website at h p://[Link]/goe/data/en/.22
Table 34.1
Global Observatory for eHealth Publications
Date of
Title
Publication
Atlas of eHealth country profiles 2015: The use of eHealth in support of universal health covered February 1,
2016
Atlas of eHealth country profiles 2013: eHealth and innovation in women’s and children’s health May 3, 2014
eHealth and innovation in women’s and children’s health: A baseline review full report March 16, 2014
eHealth and innovation in women’s and children’s health: A baseline review executive January 13,
summaries 2014
Global observatory for eHealth series—Volume 6, Management of patient information: Trends November 1,
and challenges in member states 2012
Global observatory for eHealth series—Volume 5, Legal frameworks for eHealth February 1,
2012
Global observatory for eHealth series—Volume 4, Safety and security on the internet: Challenges December 1,
and advances in member states 2011
Global Observatory for eHealth series—Volume 3 June 7, 2011
mHealth: New horizons for health through mobile technologies
Global Observatory for eHealth series—Volume 2 January 13,
Telemedicine: Opportunities and developments in Member States 2011
Global Observatory for eHealth series—Volume 1 December 22,
Atlas: eHealth country profiles 2010
From WHO (nd) Global Observatory for eHealth: Publications.
<[Link] Accessed July 13, 2016.
World Health Organization Family of International
Classifications
WHO is responsible for developing, disseminating, and maintaining
international classifications on health, collectively referred to as the WHO
Family of International Classifications (WHO-FIC), to promote a
consensual, meaningful, and useful framework that governments,
healthcare providers, and consumers can use as a common language in
health information systems ([Link]/classifications/). Internationally
endorsed classifications facilitate the storage, retrieval, analysis, and
interpretation of data as well as allow data within and between
populations to be compared (see Chapter 22 for detailed discussions about
standard taxonomies).
The classifications within the WHO-FIC fall into three main categories:
reference classifications, derived classifications, and related
classifications. Reference classifications are classifications of the basic
parameters of health. Derived classifications are developed by modifying
or rearranging reference classifications. Related classifications are
associated with the reference classification at specific levels of structure
only. Box 34.3 provides a list of the WHO classifications and their related
types.
Box 34.3
World Health Organization Family of
International Classifications
Reference Classifications
Main classifications based on basic parameters of health. These
classifications have been prepared by the World Health Organization
(WHO) and approved by its governing bodies for international use.
• International Classification of Diseases (ICD)
• International Classification of Functioning, Disability and Health (ICF)
• International Classification of Health Interventions (ICHI)
Derived Classifications
Those based on reference classifications (i.e., ICD and ICF). Derived
classifications may be prepared either by adopting the reference
classification structure and categories and providing additional detail
beyond that provided by the reference classifications or by rearranging or
aggregating items from one or more reference classifications.
• International Classification of Diseases for Oncology, 3rd edition (ICD-
O-3)
• ICD-10 for Mental and Behavioral Disorders Clinical Descriptions and
Diagnostic Guidelines
• ICD-10 for Mental and Behavioral Disorders Diagnostic Criteria for
Research
• Application of the International Classification of Diseases to Neurology
(ICD-10-NA)
• Application of the International Classification of Diseases to Dentistry
and Stomatology, 3rd edition (ICD-DA)
Related Classifications
Those that partially refer to reference classifications or are associated with
reference classifications at specific levels of structure only.
• International Classification of Primary Care, Second edition (ICPC-2)
• International Classification of External Causes of Injury (ICECI)
• Technical aids for persons with disabilities—Classification and
terminology (ISO9999)
• The Anatomical Therapeutic Chemicals Classification with Defined
Daily Doses (ATC/DDD)
• International Classification for Nursing Practice (ICNP)
Adapted from World Health Organization (WHO). Derived and Related Classifications in the WHO-
FIC. Geneva, Swi erland: WHO. <h p://[Link]/classifications/related/en/[Link]>; 2016.
International Medical Informatics Association
IMIA is the world body for health and biomedical informatics
(h p://[Link]/new2/), originating in 1967 as Technical
Commi ee (TC) 4 of the International Federation for Information
Processing (IFIP; www.ifi[Link]). It evolved from a special interest group
(SIG) of IFIP to its current status in 1979. IMIA is connected with WHO as
a nongovernmental organization (NGO) and with the International
Federation of Health Information Management Associations (IFHIMA).
Membership in IMIA is limited to organizations, societies, and
corporations. For example, each country can be represented by only one
member society. At this writing, there are 58 member societies. The
regional members, with the exception of the North America member
countries shown in Fig. 34.5 and the Middle East Association for Health
Informatics (MEAHI) member countries included in Fig. 34.6, were
discussed earlier in the sections dealing with informatics regions of the
world. In a country where no representative society exists, IMIA
accommodates involvement through corresponding members, especially
within developing economies. At the time of this writing, there were 31
corresponding members.
FIG 34.5 IMIA North America member countries: United States and
Canada.
FIG 34.6 MEAHI member countries: Afghanistan, Bahrain, Djibouti,
Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman,
Pakistan, Palestine, Qatar, Saudi Arabia, Somalia, South Sudan,
Sudan, Syrian Arab Republic, Tunisia, United Arab Emirates, and
Yemen.
IMIA is an important player in ensuring that information science and
technology are integrated into all fields of healthcare. Its main goals are
to23:
• Promote informatics in health care and research in health, bio and
medical informatics
• Advance and nurture international cooperation
• Stimulate research, development and routine application
• Move informatics from theory into practice in a full range of health
delivery se ings, from physician's office to acute and long-term care
• Further the dissemination and exchange of knowledge, information
and technology
• Promote education and responsible behaviour
• Represent the medical and health informatics field with the World
Health Organization and other international professional and
governmental organizations.”
In its function as a bridge organization, IMIA’s goals are23:
• “Moving theory into practice by linking academic and research
informaticians with caregivers, consultants, vendors, and vendor-
based researchers
• Leading the international medical and health informatics communities
throughout the 21st century
• Promoting the cross-fertilization of health informatics information and
knowledge across professional and geographical boundaries
• Serving as the catalyst for ubiquitous worldwide health information
infrastructures for patient care and health research
IMIA provides networking opportunities as well as an international
platform for eHealth providers, consultants, and publishers. IMIA
organizes a bi-annual conference called the World Congress on Medical
and Health Informatics, commonly known as MedInfo. The event provides
opportunities to share and exchange ideas and research as well as to hold
formal meetings and facilitate informal networking of members.
IMIA also publishes the annual IMIA Yearbook of Medical Informatics and
additional official journals. Since its inception in 1992, the IMIA Yearbook of
Medical Informatics has been one of the most valuable products that IMIA
provides to its members and to the health informatics community. IMIA’s
official journals include Applied Clinical Informatics ([Link]),
International Journal of Medical Informatics ([Link]/home),
and Methods of Information in Medicine ([Link]).
IMIA pursues its scientific activity in specific fields of the wider domain
of health and biomedical informatics through WGs and SIGs. A WG or SIG
consists of a group of experts with a specific interest. At this writing there
are 28 WGs and SIGs (Box 34.4). Activities of WGs and SIGs include
organizing business meetings at IMIA conferences or IMIA regional
meetings, publishing papers related to WG activity wri en by members of
WGs and SIGs, and collaborating with other organizations within IMIA or
IMIA regional or member societies. The International Medical Informatics
Association Nursing Informatics (IMIA-NI) SIG is one of the initial and
most consistently active SIGs.
Box 34.4
International Medical Informatics Association
Working Groups and Special Interest Groups
(SIGs)
• Biomedical Pa ern Recognition
• Consumer Health Informatics
• Critical Care Informatics
• Data Mining and Big Data Analytics
• Dental Informatics (inactive)
• Francophone SIG
• Health and Medical Informatics Education
• Health Geographical Information Systems (GIS)
• Health Informatics for Development
• Health Informatics for Patient Safety
• Health Information Systems
• Health Record Banking
• History of BioMedical and Health Informatics
• Human Factors Engineering for Healthcare Informatics
• Informatics in Genomic Medicine (IGM)
• Language and Meaning in Biomedicine
• Mental Health Informatics (inactive)
• Open Source Health Informatics
• Organizational and Social Issues
• Primary Healthcare Informatics
• Security in Health Information Systems
• Nursing Informatics SIG
• Smart Homes and Ambient Assisted Living
• Social Media
• Standards in Healthcare Informatics
• Technology Assessment & Quality Development in Health Informatics
• Telehealth
• Wearable Sensors in Healthcare
Data from IMIA: Working Groups. <h p://[Link]/new2/WG>; 2016.
IMIA-NI
The Nursing Informatics component of IMIA, IMIA-NI (see
h p://[Link]/new2/node/151), was originally called WG 8
in 1983. The main goals of IMIA-NI are listed in Box 34.5.
Box 34.5
Goals of IMIA-NI
• To foster collaboration among nurses and other professionals who are
interested in nursing informatics
• To explore the scope of nursing informatics and its implication for
information-handling activities associated with nursing care delivery,
nursing administration, nursing research, nursing education, and
various relationships with other healthcare information systems
• To support the development of nursing informatics in member countries
and worldwide
• To provide appropriate informatics meetings, conferences, and
postconferences and to provide opportunities to share knowledge and
research to facilitate the communication of developments in the field
• To encourage the publication and dissemination of research and
development materials in the field of nursing informatics
• To develop recommendations, guidelines, and courses related to nursing
informatics
• To work with patients, families, and communities to implement
informatics in healthcare
Adapted from International Medical Informatics Association (IMIA). SIG NI Nursing Informatics.
Geneva, Swi erland: IMIA. <h p://[Link]/new2/node/151>; 2016.
IMIA-NI currently has 33 members from 33 member societies of IMIA.
IMIA-NI pursues its scientific activity in specific fields of the wider
domain of nursing informatics through WGs. Currently there are four
IMIA-NI WGs: Consumer/Client Health Informatics, Education, Evidence-
Based Practice, and Health Informatics Standards.
IMIA-NI organizes a biennial International Congress on Nursing
Informatics, which provides a scientific exchange of current research and
thinking in nursing informatics, formal meetings on nursing informatics
topics, and informal networking. The first meeting of IMIA-NI was held in
1982 in London, England, as an international open forum titled “The
Impact of Computers on Nursing.” A list of the IMIA-NI conferences with
locations and themes is in Table 34.2.
Table 34.2
List of Past International Conferences on Nursing Informatics
International standards efforts
Over the past several decades, significant efforts have been made in
terminology development and standards. This section summarizes
international work in this area, and readers are referred to Chapter 22 for
more details.
International Organization for Standardization
The International Organization for Standardization (ISO) is the world’s
largest developer and publisher of international standards ([Link]).
It is managed by a Central Secretariat in Geneva, Swi erland, and
currently includes national standards institutes of 162 countries. ISO is not
affiliated with governments and provides a link between the public and
private sectors. Although many member institutes belong to the
governmental structure of their countries (or are mandated by their
government), others have private sector origins (i.e., they were established
through national partnerships of industry associations). Therefore ISO is
uniquely able to establish a consensus on standards-related solutions for
business and the broader needs of society. Currently there are 238 TCs
developing standards in different domains.
ISO TC 215 is the ISO’s TC on health informatics. The scope of ISO TC
215 is to achieve compatibility and interoperability between independent
systems, achieve compatibility and consistency of data for comparative
statistical purposes (classifications), and reduce duplication of effort and
redundancies through standardization. Currently there are 32 active
participating (P-member) countries and 27 observing (O-member)
countries. At this writing, the number of published ISO standards under
the direct responsibility of TC 215 (including updates) is 150 (in May 2012,
there were just 94). ISO TC 215’s current work program comprises 50
items, comprehensively covering the contemporary health information
standards spectrum. Table 34.3 presents ISO TC 215’s subcommi ees and
WGs and their activities. Fig. 34.7 illustrates the current structure of ISO
TC 215.
FIG 34.7 The current structure of ISO TC 215 and its eight working
groups. EHR, Electronic health record; ISO, International
Organization for Standardization; JWG, joint working group; SDO,
standard development organization; TC, technical committee; TF,
task force; WG, working group.
Table 34.3
List of ISO TC 215 Subcommittees/Working Groups
Subcommi ee/Working
Scope
Group
ISO/TC 215/CAG 1 Executive council, harmonization, and operations
ISO/TC 215/WG 1 Architecture, frameworks, and models
ISO/TC 215/JWG 1 Joint ISO/TC 215-ISO/TC 249 WG: Traditional Chinese medicine (informatics)
ISO/TC 215/WG 2 Systems and device interoperability
ISO/TC 215/WG 3 Semantic content
ISO/TC 215/WG 4 Security, safety, and privacy
ISO/TC 215/WG 6 Pharmacy and medicines business
ISO/TC 215/JWG 7 Joint ISO/TC 215–IEC/SC 62A WG: Application of risk management to IT networks
incorporating medical devices
CAG, Corporate Advisory Group; IEC, International Electrotechnical Commission; ISO,
International Organization for Standardization; IT, information technology; JWG, joint
working group; TC, technical committee; WG, working group.
Many health professionals are involved in ISO activities. For example,
nurses have played an active and important role in different WGs of ISO
TC 215 in the development and testing of ISO 18104: Integration of a
Reference Terminology Model for Nursing. This provides an agreed
structure for statements that represent nursing diagnoses and nursing
actions which will make it easier to combine and compare information
from different se ings in different regions worldwide.24
International Council of Nurses
The International Council of Nurses (ICN) is a federation of 136 national
nurses associations (NNAs) representing more than 16 million nurses
globally.25 ICN began in 1899 with the goal of encouraging quality
healthcare, solid health policies, advanced health knowledge, and a
respected global nursing presence.
The aim of the ICN eHealth Programme24 is to transform nursing
through the visionary application of information and communication
technologies. The Programme encompasses a range of ICN activities,
including the International Classification for Nursing Practice (ICNP),
which provides a “standard [nursing terminology] for comparing nursing
practice locally, regionally, nationally, and internationally,”26 and the ICN
Telenursing Network, which encourages and assists nurses in the
development and use of telehealth. A third workstream is Connecting
Nurses, supported by Sanofi, which provides a platform for sharing
knowledge and best practice. ICN has also participated in other
international terminology standards development activities, such as the
ISO reference terminology standard described previously and the
International Nursing Minimum Data Set (i-NMDS). The i-NMDS builds
on the Nursing Minimum Data Set work of Werley and Lang, explained in
more detail in Chapter 22.
International Classification for Nursing Practice
ICNP is a vocabulary system developed by the ICN after the ICN
Congress passed a resolution in 1989 (see also Chapter 22 for a discussion
on ICNP). ICNP provides a systematic way of describing nursing practice
across the world, with the goal of improving communication within
nursing and with other disciplines. Using the ICNP, reliable information
about nursing practice can be generated to influence decision making,
education, and policy; be er meet the needs of individuals and groups;
deliver more effective interventions; enhance safety and quality; improve
health outcomes; and be er use resources. ICNP has been implemented
and is used in several countries around the world.27 For example, Paulino
Sousa, an NI expert in Portugal, estimated that over 90% of nurses in
Portugal use ICNP daily to support their practice.
The ICN Telenursing Network
The Telenursing Network is one of 10 networks that ICN introduced as a
mechanism to provide opportunities for nurses to communicate and
pursue common professional interests ([Link]/networks/telenursing-
network/). ICN acknowledges that nurses using eHealth extend nursing’s
reach and improve access to care. Telenursing represents an advance in
healthcare delivery and is ideal for addressing health system challenges
(e.g., an ageing population; higher incidence of noncommunicable
diseases; community- and home-based care; geographic, social, and
financial issues; increased costs and reduced funding; nursing shortages).
Telehealth is defined and described in Chapter 8.
The history of the ICN Telenursing Network dates back to early 2000.
ICN published a monograph on telenursing in 2000 entitled Telehealth and
Telenursing: Nursing and Technology Advance Together and in 2001 published
International Professional Standards for Telenursing Programmes.28 Through
publications like International Competencies for Telenursing in 2007,
telenursing was recognized as an important contributor to the ICN’s
mission of advancing nursing and health worldwide.
The Telenursing Network was launched in 2009 with the aim of seeking,
educating, supporting, and collaborating with nurses and other
telenursing supporters worldwide. The overarching goal of the
Telenursing Network is to improve healthcare services for individuals and
institutions worldwide.29
Connecting Nurses
Connecting Nurses provides a forum for nurses from around the world to
share their ideas, advice, and innovations, and contribute to patient
empowerment. The aim is simply to bring nurses together. Connecting
Nurses provides an online platform for nurses from around the world to
share ideas, advice, and innovations, both among themselves and with
other health professionals, patients, caregivers, and the general public.30
As an integrated part of Connecting Nurses, Care Challenge31 was
created to celebrate the important role the nursing community plays in
healthcare provision around the world, while addressing the challenges
arising within modern healthcare systems. Taking a social media
approach, nurses are able to submit and showcase, on an ongoing basis, a
summary of an innovation from their practice. Best projects are supported,
for example, through the production of high-quality video to further
showcase the innovation.
Health Level Seven
Health Level Seven (HL7) is an international community composed of
healthcare subject ma er experts and information scientists. Its goal is to
create and sustain standards for the exchange, management, and
integration of data that facilitate patient care and management, delivery,
and evaluation of healthcare services.32 As explained in Chapters 6 and 22,
HL7 encourages the use of such standards within and among healthcare
organizations to optimize healthcare delivery for all.
International Health Terminology Standards
Development Organisation
International Health Terminology Standards Development Organisation
(IHTSDO) ([Link]) is an international nonprofit organization. It
owns and administers the rights to Systematized Nomenclature of
Medicine—Clinical Terms (SNOMED CT) and related terminology
standards. The goal of IHTSDO is to establish and maintain optimum
interoperability and harmonization between SNOMED CT and standards
produced by other international standards development organizations
(e.g., American Academy of Ophthalmology; GS1; HL7; ICN; Institute of
Electrical and Electronics Engineers; Logical Observation Identifiers
Names and Codes; Nomenclature, Properties and Units; openEHR; WHO;
and World Organization of National Colleges, Academies). Additional
details on SNOMED CT are included in Chapter 22.
Global challenges to ehealth
Multiple challenges face eHealth usage, at the local, national, and
international levels. This section explores some of the more important
challenges.
Global Interoperability
A key problem in achieving global interoperability in eHealth is the lack of
semantic (the meaning of terms) interoperability. Key barriers include
issues relating to the terminology used in describing and documenting
healthcare such as cost and accessibility, gaps in exhaustiveness, and lack
of granularity.33 Many international efforts are underway to solve this
problem, such as the development of international standards to underpin
clinical terminologies, the development of clinical data models like HL7
Clinical Document Architecture (CDA) documents, openEHR Archetypes,
and integration of standard data models with terminologies such as
SNOMED CT.34 Harmonization activities among international standards
development organizations, such as ISO TC 215, HL7, and European
Commi ee for Standardization (CEN) TC251, are ongoing. For example,
tables of equivalents have been developed for concepts within ICNP and
SNOMED CT under a formal collaboration agreement between ICN and
IHTSDO, to ensure that data recorded in one terminology can be easily
transformed into the format of the other. This will ensure, for example,
that nursing remains connected to a wider health informatics
infrastructure.
Human Resources for eHealth
According to the first global survey on eHealth carried out in 2005 by
WHO, and described previously in this chapter, all respondents expressed
a need for education and training in eHealth. The lack of human resources
with the necessary skills and competencies is a problem for the
introduction and use of eHealth in many parts of the world. Different
types of professionals with an appropriate mix of skills are needed for the
best use of ICT in healthcare (e.g., health informatics professionals, health
information management professionals, and others with specialized
informatics skills). Current shortages of skilled workers in the healthcare
profession demand a human resource strategy and long-term plan for the
education and training of eHealth personnel to ensure the quality of
collected health data and its security and confidentiality and to manage
and maintain the systems and data in the future.35
Based on the 2005 WHO survey data, eLearning programs and
professional development for professional education were recommended
in the health sciences. In addition, collaborations were needed that could
establish databases of existing eLearning courses. Finally, it was
recommended that WHO should advocate for the inclusion of eHealth
courses within university curricula.36 While progress has been made over
the last 15 years, there is clearly still some way to go.
eHealth Infrastructure
If eHealth infrastructure or services are missing or deficient, eHealth
becomes less effective. The digital divide37 is the result of a gap in
information exchange between different demographics and remains a
major problem in terms of internet, and especially broadband, uptake. This
divide continues to expand as healthcare systems and providers and
citizens increasingly depend on information from the internet to guide
day-to-day care. This is most evident in comparing fixed broadband
penetration in developed countries (29%) to that in developing countries
(7.1%).38 While the gap may be closing slowly over time, significant
differences also exist in the percentage of internet users, ranging from
87.9% in North America to 27% in Africa.39 The persisting digital divide
inspired ICN to publish a position statement on people’s right to connect
via information and communication technology.40 As with the solutions to
problems caused by a lack of knowledgeable personnel, awareness of the
disparity and its impact on healthcare is the first step in narrowing the
gap. Education programs will prove beneficial in the a empt to close the
digital divide.
On the other hand, developments in the mobile sector have been
phenomenal. In 2015, 96.8 mobile phone subscriptions per 100 inhabitants
existed worldwide (from 120.6 in developed countries to 91.8 in
developing countries). This particular digital divide was reduced due to a
high level of competition and a decrease in prices.38 However, having a
tool does not necessarily indicate that functionality is available, and the
lack of data communication services prevents isolated mobile phones from
being an effective tool for health management. Improved infrastructure to
store data and transfer data securely and in a cost-effective manner and
full compatibility, interoperability, and possibly integration with other
services would help address this challenge.
Legal and Regulatory Framework for eHealth
Patient privacy is a core element of good healthcare practice, and
legislation and regulation are key tools in protecting privacy. According to
the second global survey on eHealth by WHO, a reasonably high level of
legal protection of the general privacy of health-related information exists.
However, the number of countries adopting more specific eHealth-related
privacy protection legislation is still low.41
Legal and regulatory eHealth challenges vary from ambiguous legal
frameworks to poor data management (e.g., access to personal data and
lack of data security rules). A lack of regulations in the transfer of data
leads to any number of challenges at the international level, including the
following:
• Misinformation
• Unethical use
• Concealed bias
• Covert self-dealing
• Fraudulent practices
• Evasion of legitimate regulation
Security is another area within eHealth presenting many challenges.
eHealth applications using mobile terminals and internet services require
authentication methods that are both convenient and highly secure. The
increasing use of technology such as biometric authentication for
identification is generating new challenges in security, safety, and privacy
protection for healthcare providers and consumers alike.
Conclusion and future directions
Healthcare faces unprecedented challenges: an aging population, greater
citizen engagement, unanticipated disasters, new advances in medicine,
and increasing public expectations, all within a context of a shrinking
healthcare workforce and ongoing financial constraints. While eHealth
cannot resolve the underlying causes of these challenges, it has a
significant role to play in supporting the transformation of health services
in order to make contemporary healthcare sustainable.
Individuals and organizations are working together within countries
and across regions on eHealth strategy, capacity and capability,
infrastructure, tools, and techniques. However, many of the challenges to
healthcare are not confined to particular regions. For example, outbreaks,
epidemics, and pandemics such as SARS, MERS, Ebola, Zika, HIV/AIDS,
and tuberculosis do not recognize national and regional boundaries. Their
effective management requires an international approach. Many eHealth
solutions are applicable at a global level.
Several international organizations are helping facilitate greater global
collaboration on eHealth between countries and regions. This sharing of
knowledge and experience helps strengthen national and regional
initiatives, increasing the uptake of eHealth at a local level in order to
improve the quality and safety of healthcare while driving efficiency.
eHealth is also improving access to scarce healthcare services, thereby
establishing a more equitable global healthcare environment.
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Discussion questions
1. Compare and contrast the aims and activities of eHealth initiatives for
two different regions of the world.
2. Discuss two international organizations involved in eHealth initiatives.
Describe their roles and provide examples of their activities.
3. What types of international academic organizations exist in different
regions of the world? Based on your specialty, choose the conferences
most appropriate for you to a end and explain why.
4. What types of roles can a health professional in your specialty play in
global eHealth initiatives?
5. How can the different disciplines in health informatics use the current
international efforts to work together with an interprofessional
approach to improving the health of individuals, families, and
communities?
Case study
You are applying, through a competitive process, for a 3-month internship
to the ICN eHealth Programme. According to the call for applications, the
internship involves a number of activities, including the development of a
strategy to promote collaboration between the major global eHealth
organizations on (1) international standards development, (2) initiatives to
promote the implementation of eHealth across different regions, and (3)
eHealth workforce development.
Discussion Questions
1. Review the ICN goals. Think about what your internship goals might
be in relation to the ICN goals.
2. Now consider what ICN hopes to achieve with internships, your
knowledge about global eHealth, and your suitability for an
internship. What information would be critical for you to include in
your application?
UNIT 9
Historical Implications and
Future Directions in Health
Informatics
35
The Evolution of Health
Informatics
Ramona Nelson
Abstract
Health informatics has evolved as both a discipline or field of study and an area of
specialization within the health professions. This chapter describes the historical
progression of that evolution as a basis for understanding the current status of health
informatics as both a discipline and a specialty within healthcare. The historical roots
within computer and information science are explored. The development of
professional organizations, educational programs, and the knowledge base, as
documented in conference presentations, proceedings, journals, and books, is
described. The history of and process for naming the specialty and the discipline are
then analyzed.
Over time, the collaborative opportunities to create a more effective and
efficient healthcare system will become more interesting and motivating
than the historical struggles and hierarchical relations of the past.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Discuss the development of health informatics as a discipline,
profession, and specialty.
2. Analyze how historical events have influenced the definition and
current scope of practice of health informatics.
3. Explore informatics-related professional organizations and their
contributions to professional development and informatics.
4. Analyze the history and process for naming the specialty and the
discipline.
KEY TERMS
biomedical informatics 606
clinical informatics 603
computer science 595
dental informatics 598
health informatics 594
informatics 596
information science 595
medical informatics 597
nursing informatics 598
Introduction
Health informatics has evolved as a discipline and an area of
specialization within the health professions. It incorporates processes,
procedures, theories, and concepts from a number of different health
professions and is therefore a unique interprofessional field of study as
well as an area of specialization within the different health professions. As
both a practice specialty and a field of study, health informatics
incorporates processes, procedures, theories, and concepts from computer
and information sciences, the health sciences (e.g., nursing and medical
science), and the social sciences (e.g., cognitive psychology and
organizational science). Health informatics professionals use information
technology (IT) tools to collect, store, process, and communicate health
data, information, knowledge, and wisdom. IT and related hardware, as
well as software, are viewed as tools to be used by consumers, patients,
and clients; healthcare providers; and administrators to achieve the goals
of health informatics. The goals of health informatics include both
supporting healthcare delivery and improving the health status of all
people. This chapter explores the evolution of health informatics as both a
discipline and a specialty practice within healthcare.
The roots of informatics within the
computer and information sciences
Health informatics emerged as a distinct specialty within healthcare over
time as nurses, physicians, and other healthcare visionaries applied
innovative developments in the computer and information sciences to
complex problems in healthcare. Computer science brings to health
informatics the technology and software coding required for this specialty,
while information science contributes the procedures and processes
needed to develop and process data, information, and knowledge. The
health professions provide the knowledge and wisdom to use computer
and information science effectively in delivering healthcare and improving
the health of all people. Understanding the scope and boundaries of health
informatics begins with an appreciation of its roots within computer and
information sciences.
Computer Science
Computer science is defined as the “systematic study of algorithmic
methods for representing and transforming information, including their
theory, design, implementation, application, and efficiency. The roots of
computer science extend deeply into mathematics and engineering.
Mathematics imparts analysis to the field; engineering imparts design.”1
The word computer is derived from the Latin word computare, which means
to count or sum up. The word first appeared in English in 1646, meaning a
person who computes or processes mathematical data.
A key problem with these early human computers was that they made
errors. In the early 1800s, Charles Babbage, a mathematician, became
increasingly concerned with the high error rate in the calculation of
mathematical tables. Impressed by existing work completed with
calculating machines, he proposed the development of a “difference
engine.” As a result of his efforts to create a general-purpose,
programmable computer employing punch cards, he is often identified as
the first person to create a nonhuman computer or a programmable
mechanical device aimed at solving problems.2 While Babbage was not
successful in building a functioning computer, the process of using punch
cards to input data and obtain output did become an effective technology
in other fields, such as rug making.
The Babbage approach to creating a computer included input and
output but not storage. Herman Hollerith took this idea a step forward in
the late 1800s when he used punch cards for input, processing, creating
output, and storing data. Hollerith, like Babbage, was motivated by his
concern with laborious, time-consuming, and error-prone human
operations. In Hollerith’s case, the problems were evident in the processes
used for collecting and calculating the 1880 U.S. Census and related data.
His invention, which both sorted and tabulated data, “was the first wholly
successful information processing system to replace pen and paper.”3, p. 2 In
1896, starting with this and related inventions, Hollerith founded the
Tabulating Machine Company. In 1911, the Tabulating Machine Company
merged with two other companies, creating the company that is now IBM.
Hollerith’s technology, developed for completing the U.S. Census for 1890,
was used well into the 1960s, by which time automation was becoming
part of healthcare, and health informatics was beginning to emerge as a
new discipline.
The move from a mechanical to an electronic digital computer is usually
dated to the creation of the Electronic Numerical Integrator and Computer
(ENIAC) in the 1940s. This was a large machine requiring huge amounts of
space, a specialized environment, and specially trained personnel. It
initiated the concepts of centralized computing and the information
services department. Twenty years after ENIAC began functioning, the
first Department of Computer Sciences in the United States was
established in 1962 at Purdue University, within the school’s Division of
Mathematical Sciences.4 The foundational relationship between the science
of mathematics and the development of computer science provides certain
benefits for health informatics. The culture of mathematics brings to the
study of informatics systematic, logical approaches, processes, and
procedures for understanding natural phenomena and solving problems.
In the 1980s, the personal computer (PC) emerged and forever changed
the role of the user as well as the organizational infrastructure for
supporting computerization within institutions. Computerization within
healthcare institutions was no longer totally centralized, and computer use
was no longer limited to specially trained personnel. As healthcare
providers became direct users of computers, they began to discover a wide
range of new uses for the tools contained therein. The increased interest in
the value of computers and the increased level of computer literacy among
a number of healthcare providers proved a major advantage in the
creation of the informatics specialty. These same factors have also created
a certain tension between centralized and decentralized infrastructures to
support technology within healthcare se ings.
Information Science
“Information science is a discipline that investigates the properties and
behavior of information, the forces governing the flow of information, and
the means of processing information for optimum accessibility and
usability. It is concerned with that body of knowledge relating to the
origination, collection, organization, storage, retrieval, interpretation,
transmission, transformation, and utilization of information. This includes
the investigation of information representations in both natural and
artificial systems, the use of codes for efficient message transmission, and
the study of information processing devices and techniques, such as
computers and their programming systems.”5, p. 3
Establishing the origins of information science is difficult since it
emerged from the convergence of various disparate disciplines, including
library, computer, communication, and behavioral sciences.6 However,
there are key dates and events that can be used to demonstrate the
evolution of information science as a distinct specialty whose roots extend
deeply into the profession of library science, including the following:
• 1937: The American Documentation Institute (ADI) was established.
The initial organizational focus was the development of microfilm as
an aid to information dissemination. Because of the expansion and
diversification of its members, ADI changed its name to the American
Society for Information Science in 1968 and then to the American
Society for Information Science and Technology in 2000.7
• 1948: The Royal Society of Great Britain held a conference bringing
together “libraries, societies, and institutions responsible for
publishing, abstracting, and information services to examine the
possibility of improvement in existing methods of collection,
indexing, and distribution of scientific literature, and for the extension
of existing abstracting services.”8, p. 136 The decision by this prestigious
group to hold such a conference demonstrated the growing
importance of managing information.
• 1963: The first textbook that treated information science as a discrete
discipline was published. The book was titled Information Storage and
Retrieval: Tools, Elements and Theories.6
• 1964: The National Library of Medicine (NLM) began using the
computerized Medical Literature Analysis and Retrieval System
(MEDLARS) as a mechanism to create Index Medicus.9
• 1971: The NLM began offering national online access to MEDLINE.
• 1972: The NLM began training physicians and other health scientists
in the use of computer technology for medical education and the
provision of healthcare. This was the beginning of its informatics
training programs.10 The NLM would go on to play a major role in the
development of the health informatics specialty.
The relationship between library science and the development of
information science provides certain benefits for health informatics. The
culture of library science brings to the study of informatics policies and
procedures for managing information, an awareness of the value of the
information to the user of that information, and a culture of service.
Evidence of this cultural value is demonstrated by the guiding principles
of the American Library Association as outlined in Box 35.1.
Box 35.1
American Library Association: Guiding
Principles
• Advocacy for libraries and the profession
• Diversity
• Education and lifelong learning
• Equitable access to information and library services
• Intellectual freedom
• Literacy
• Organizational excellence
• Transforming libraries in a dynamic and increasingly global digital
information environment
Source: American Library Association. About. (n.d).
h p://[Link]/aboutala/missionpriorities/keyactionareas
Health Informatics
The development of health informatics is usually traced to the 1950s, with
the beginning uses of computers in healthcare.11 This early period in the
history of informatics extended into the 1960s and was characterized by
experimenting with the use of this new technology in medicine and in
nursing education.12 For example, Robert Ledley, a dentist interested in
biomedical research, published with Lee Lusted one of the first papers in
this field. The paper, titled “Reasoning Foundations of Medical
Diagnosis,” discussed computer-based medical diagnosis.13 Ledley went
on to invent the computed tomography (CT) scanner in the 1970s. An
example from nursing is the work of Connie Se lemeyer, a graduate
student in the University of Pi sburgh School of Nursing in the late 1960s.
Se lemeyer designed a mainframe-based computer-assisted instruction
program for teaching students how to chart using the common problem-
oriented format referred to as SOAPE or SOAP. See Table 35.1 for an
overview of this format. This program was then used to teach
undergraduate nursing students at the University of Pi sburgh
throughout the 1970s.
Table 35.1
Charting Using the SOAPE Format
Le er Item Description
S Subjective data or Data provided by the patient, family, or others that cannot be observed, such as
observations pain
O Objective data or Data that can be observed, such as the condition of an incision (inflamed, open
observations with purulent drainage)
A Assessment The conclusion, diagnosis, or interpretation of the data, such as wound infection
P Plan A list of goals and planned interventions
E Evaluation A description of the outcomes or responses to the interventions
The term informatics was established in the late 1960s and into the 1970s.
Informatics is actually the English translation of terms used in other
languages. Because of differences in language, it is difficult to determine
whether the initial use of the word informatics was referring to the
discipline of informatics, information science, computer science, or a
combination of these. A. I. Mikhailov at Moscow State University is
credited with first using the Russian terms informatik and informatikii. In
1968, Mikhailov published the book Osnovy Informatiki, which was
translated as Foundations of Informatics. In 1976, he published a second
book, Nauchnye Kommunikatsii i Informatika, which was translated as
Scientific Communication and Informatics. In this book, he defined
informatics as the science that “studies the structure and general
properties of scientific information and the laws of all processes of
scientific communication.”14, p. 39
In the 1960s, the word informatique began to appear in the French
literature. Informatique translates to English as informatics or computing,
data processing, or the handling of information, especially by a computer.
During these same years, the German term informatik was used. Informatik
translates as meaning computing, calculating, figuring, or reckoning. The
term medical informatics began to appear in English publications in the
early 1970s. While the term medical informatics was not explicitly defined
in these initial publications, it was generally accepted to mean the use of a
computer to process medical data and information.14
While the period before the 1970s was characterized by experimentation
and the establishment of the term informatics, the next 10 to 15 years were
characterized by the beginning use of computers in actual patient care and
the development of health informatics as a discipline. Beginning in 1971, El
Camino worked in partnership with Lockheed to install the world’s first
computer-aided medical information system, known as MIS.15 A number
of hospitals followed this example by installing information systems to
manage business and inventory data.
At that time, nurses and unit secretaries under the direction of nurses
were responsible for completing the paper forms necessary to implement
physicians’ orders that had been handwri en on patients’ charts. These
paper forms were used to communicate the orders to other departments
and to capture the hospital charges associated with these orders. As a
result, “order entry” and “results reporting” were some of the first
hospital information system functionalities with direct patient care
implications. Nurses, along with employees in specialty departments such
as labs and radiology, were some of the first healthcare providers directly
affected by the use of this technology in healthcare. During this same
decade, computers were beginning to be used in specialty areas. One
example is the use of hemodynamic monitoring systems in the cardiac lab.
In these environments, computers were used to do calculations, returning
accurate results within seconds. By the end of the 1970s, both commercial
and academic developments in computers, libraries, and healthcare had
created a fertile environment for the growth and development of the new
discipline of health informatics.
Establishing the specialty of health
informatics
Evidence during the next several decades indicated that a new specialty
was being established, as seen in the following:
1. Publications of health informatics books
2. Development of new journals
3. Establishment of professional organizations
4. Number of informatics conferences that are now recurring events
5. Creation of university-level educational programs
6. Development of certification programs
7. Recognition by the U.S. Bureau of Labor Statistics
The history of each of these activities contributed to the development of
the knowledge base unique to the discipline. Over time, a result of these
activities is an organized body of knowledge that is specific to the
discipline. The newest information within the discipline is often presented
at conferences. While a conference may have a theme and even subthemes,
the focus is on presenting the newest information and not an organized
body of knowledge. “The timeliest articles on computer applications in
medicine [are] found in proceedings and transactions of meetings
sponsored by professional and commercial organizations.”14, p. 46 As
journals develop, the information and knowledge specific to the discipline
become more established and organized. As the knowledge increases, the
organizational structure of that knowledge is recognized and accepted
within the discipline. At this point in the development of any discipline,
including health informatics, books play a key role in presenting the
knowledge of the discipline in an organized format. For example, scan the
table of contents of this book and notice the overall organization of the
knowledge specific to this discipline. This general pa ern of increasing
organization within publications over time is demonstrated in Fig. 35.1. As
the discipline matures, these elements intersect with conferences and
journal material, coinciding and then feeding more formal material to
books.
FIG 35.1 General trends in the development of knowledge within a
discipline.
Books
Books related to computers and healthcare began appearing in the 1960s.
Examples of these types of books are included in Box 35.2. However, the
use of the word informatics in a book title did not appear until 1971, when
the International Federation for Documentation published An Introductory
Course on Informatics/Documentation by A. I. Mikhailov and R. S.
Giljarevskij. This was followed in 1977 by Informatics and Medicine: An
Advanced Course, edited by P. L. Reicher and G. Goos. In the 1980s, books
related to computers and nursing began to appear. The first of these books,
Nursing Information Systems by Werley and Grier, established and
explained the minimum dataset in nursing practice.16 This was quickly
followed by one of the classic publications in informatics, Computers in
Nursing by Rita Zielstorff.17
Box 35.2
Early Books on Computers and Healthcare
• Computer Applications in the Behavioral Sciences (1962) by Harold Borko
• Computer Applications in Medicine (1964) by Edward Eaton Mason and
William G. Bulgren
• Use of Computers in Biology and Medicine (1965) by Robert Steven Ledley,
with the assistance of James Bruce Wilson
• Computers in Biomedical Research (1965) by Ralph W. Stacy and Bruce D.
Waxman
The 1980s were characterized by several publications dealing with
computers and nursing. Well-recognized examples include the first edition
of Essentials of Computers by Virginia Saba and Kathleen McCormick in
1987 and Guidelines for Basic Computer Education in Nursing by Diane Skiba
and Judith Ronald. In 1988, the first book using the term nursing
informatics (NI) in its title was published. This book, authored by Ball,
Hannah, Newbold, and Douglas, was titled Nursing Informatics: Where
Caring and Technology Meet.18 In 1990, one of the first medical informatics
textbooks, titled Medical Informatics: Computer Applications in Health Care
and Biomedicine, was published by Shortliffe, Perreault, Wiederhold, and
Fagan.19 In this same year, the first dental informatics book, Dental
Informatics: Strategic Issues for the Dental Profession, part of the series Lecture
Notes in Medical Informatics, was edited and published by John J. Salley,
John L. Zimmerman, and Marion Ball. Today most if not all of the major
publishers in the healthcare arena publish books related to health
informatics. A search of offerings on Amazon or the Books in Print
database can result in well over 1000 hits. However, because different
editions, as well as hardback and paperback editions, are counted as
separate books, it is impossible to get an accurate count of the total
number of informatics books now in print. See Table 35.2 for a brief book
list.
Table 35.2
Examples of Informatics Books
Edition and Date of
Title Authors or Editors
Copyright
Biomedical Informatics: Computer Applications in Health Edward H. Shortliffe and James 4th edition, 2013
Care and Biomedicine J. Cimino
Health Informatics: Practical Guide for Healthcare and Robert E. Hoyt, Nora Bailey, and 6th edition, 2014
Information Technology Professionals Ann Yoshihashi
Information Technology for the Health Professions Lillian Burke and Barbara Weill 4th edition, 2012
Essentials of Nursing Informatics Virginia Saba and Kathleen 6th edition, 2015
McCormick
Introduction to Computers for Healthcare Professionals Irene Joos, Ramona Nelson, and 6th edition, 2013
Marjorie J. Smith
Informatics and Nursing: Opportunities and Challenges Jeanne Sewell 5th edition, 2016
Journals
Following the same pa ern as books, new journals began to be published
in the 1960s and used the word computer as opposed to informatics. Homer
Warner at the University of Utah edited the first peer-reviewed journal
within the new discipline. This journal, titled Computers in Biomedical
Research, began publishing in 1967.14 Table 35.3 includes the names and
beginning dates of other initial health informatics journals from this time
period.
Table 35.3
Early Journals in Health Informatics
Name Beginning Date Publisher
Computers and Medicine 1972 American Medical Association
Journal of Clinical Computing 1972 Gallagher Printing
Journal of Medical Systems 1977 Plenum Press
MD Computing 1983 1983 Springer-Verlag
In 1982, the first edition of the journal Computers in Nursing was
published as a newsle er. The newsle er became an official journal
published by Lippinco in 1984. Today the journal is known as CIN:
Computers Informatics Nursing. While these journals provided a publishing
resource for the evolving discipline, articles were also being published in
other professional journals. In 1960, a total of 38 articles were indexed
under the subject “computers in medicine.”14 Since that date, close to
15,000 articles have been indexed in MEDLINE and CINAHL using the
key word “informatics.”
While the term informatics began appearing in the titles of articles in the
early 1970s, it was not until 1986 that the first journal article using the term
nursing informatics (NI) was indexed in MEDLINE as well as CINAHL.
This article, titled “The NI Pyramid—A Model for Research in Nursing
Informatics,” presented a model for research in NI.20 This model is
described in Chapter 2 of this book. As with books, the number of journals
has expanded significantly. As of January 2016, the NLM catalog of
journals included 219 informatics-related journals. Updated numbers can
be seen by searching the database online at
h p://[Link]/nlmcatalog. Note that not all of the
referenced journals are traditional print journals. The Online Journal of
Public Health Informatics
(h p://fi[Link]/htbin/cgiwrap/bin/ojs/[Link]/ojphi/index),
established in 2009, is and always has been an online journal. The journals
in this growing database reflect the overall field of informatics as well as
subspecialties within informatics. For example, one of the journals indexed
in MEDLINE—CIN: Computers Informatics Nursing—is specific to NI. The
proceedings from the International Medical Informatics Association
(IMIA) NI Conferences were added to this list starting in late 2012.
Professional Organizations
Many of the early practitioners interested in the field of health informatics
soon discovered there were no formal education programs or colleagues in
their professional associations and local community who were also
interested in the growing impact of computers. As a result, beginning in
the late 1960s and early 1970s, professional organizations began to emerge,
playing a significant role in the development of this specialty and
providing a major source of education and networking for these early
pioneers.21 Initially informatics groups formed within other larger
professional groups. For example, the American Medical Association
(AMA) formed a commi ee on computers in medicine in 1969.14 As these
initial efforts expanded, professional organizations focused on health
informatics began to split off from the larger organizations. At the same
time that national and international groups were being established, a
number of health informatics groups were established as smaller local
groups.
The 1980s was a key decade for these activities. IMIA, which was
established in 1967 as a technical commi ee of the International Federation
for Information Processing (IFIP), became an independent organization in
1987. Prior to this, IMIA established Working Group 8 on NI in 1981, with
representatives from 25 countries. The IMIA NI group continues to this
day as a special interest group within IMIA. In the United States, the
Symposium on Computer Applications in Medical Care (SCAMC) merged
with the American Association for Medical Systems and Informatics
(AAMSI) and the American College of Medical Informatics (ACMI) in 1989
to become the American Medical Informatics Association (AMIA). AMIA
established a special interest group, Computers in Nursing, that same
year.
In 1986, the Hospital Management Systems Society (HMSS), an affiliate
of the American Hospital Association (AHA), became the Healthcare
Information and Management Systems Society (HIMSS), reflecting the
growing influence of information systems and telecommunications
professionals within HIMSS as well as healthcare. In 1993, HIMSS became
an independent, not-for-profit corporation.22
The American Nurses Association (ANA) established the Council on
Computer Applications in Nursing in 1984, and the National League for
Nursing (NLN) established the National Forum on Computers in Health
Care and Nursing. Beginning in the 1980s and continuing over the next
three decades, several local NI groups were formed. One of the largest and
best known of these organizations was the Capital Area Roundtable on
Informatics in Nursing (CARING), established in 1982. In 2010, the
American Nurses Informatics Association (ANIA) from California and
CARING from Washington, DC, merged, creating ANIA-CARING, a
national NI organization that includes five regions. In 2012, the word
CARING was dropped from the name, and today the group is known as
ANIA. ANIA is one of the largest NI organizations in existence.23 Their
membership, as reported on their website, has remained steady at about
3000 members.
Today a number of other local or regional NI groups continue to exist.
In 2004, realizing the advantage of collaboration between these different
nursing groups, 18 national and regional NI groups established the
Alliance for Nursing Informatics (ANI) with the financial and leadership
support of AMIA and HIMSS.24 As of August 2016, there were 32 member
groups and two associated organizations listed on their website. Box 35.3
lists examples of ANI’s accomplishments.
Box 35.3
Examples of the Alliance for Nursing
Informatics’ Accomplishments
• Successfully asked Google to appoint a nurse to the Google Health
Advisory Council
• Worked closely with Technology Informatics Guiding Educational
Reform (TIGER) initiative to increase the knowledge and awareness of
students and practicing nurses concerning informatics
• Provided expert testimony for the Institute of Medicine and the Robert
Wood Johnson forum on the Future of Nursing
• Recommended numerous nursing experts for service on national
commi ees and expert panels
• Submi ed comments to the National Institute of Standards and
Technology (NIST) on the Usability Framework as well as a number of
other such documents
• Created a 2-year program to enhance leadership skills and competencies
in (1) communication and networking, (2) strategic planning, (3)
negotiation and persuasion, as well as (4) leading and managing change
for emerging leaders in NI
• Created a Consumer eHealth toolkit for use by nurses and other health
professional
NI, Nursing informatics.
An additional major informatics organization is the American Health
Information Management Association (AHIMA). This association has
taken a slightly different path than the other significant informatics-related
organizations. In 1928, the Association of Record Librarians of North
America (ARLNA) was formed. One of the goals of this new organization
was to improve the record of care provided to patients through the use of
standards. Professionals within ARLNA were titled as registered record
librarians (RRLs). In the mid-1940s the association changed its name to the
American Association of Medical Record Librarians (AAMRL). However,
this was not the last name change. As medical records were increasingly
computerized and as members assumed increasing responsibility within
that process, the emphasis on information management became obvious.
In 1991, the AAMRL changed its name to AHIMA.25 Today, AHIMA
continues to play “a leadership role in the effective management of health
data and medical records needed to deliver quality healthcare to the
public.”26 Box 35.4 lists the major health informatics organizations and
includes additional information on NI groups.
Box 35.4
Major Health Informatics and Nursing
Informatics Groups
Health-Related Informatics Associations With Special
Interest Groups
AMIA: [Link]
• “AMIA leads the way in transforming health care through trusted
science, education, and the practice of informatics, a scientific
discipline.”
• Regular member dues are $350.
• A significant number of members are involved in academic se ings.
• Publishes a monthly peer-reviewed journal: Journal of the American
Medical Informatics Association (JAMIA)
• Is the official American representative to the IMIA
• Includes a special interest group in nursing located at
h ps://[Link]/programs/working-groups/nursing-informatics.
This group is responsible for appointing the nursing representative to
the IMIA—Nursing Informatics Special Interest Group.
HIMSS: h p://[Link]/ASP/[Link]
• “Advancing the best use of information and management systems for the
be erment of health care”
• Regular individual member dues are $199.
• A significant number of members are involved in the practice se ing or
work for IT vendors.
• HIMSS North America includes 61,000 individual members, 640
corporate members, and over 450 nonprofit organizations as of January
2016.
• Includes a NI community located at h p://[Link]/get-
involved/community/nursing-informatics
Health-Related Informatics Associations With Specific
Areas of Interest
American Telemedicine Association (ATA):
[Link]
• “Telemedicine will be fully integrated into healthcare systems to
improve quality, access, equity and affordability of healthcare
throughout the world.”
• Regular member dues are $235.
• Members include individuals and organizations interested in
telemedicine, including healthcare and academic institutions and
corporations that provide products and services supporting remote
healthcare.
• Includes a telehealth nursing special interest group located at
h p://[Link]/members/ata-members/ata-member-
groups/special-interest-groups/telehealth-nursing#.VqvgM1l7Lws
AHIMA: [Link]
• “Leading the advancement and ethical use of quality health information
to promote health and wellness worldwide.”
• Regular dues are $175.
• Members are employed mainly in medical records management.
College of Healthcare Information Management
Executives (CHIME): [Link]
• “CHIME was created as a complement to HIMSS, intending to provide a
specific focus for healthcare CIOs.”
• Regular dues are $498 for joint CHIME-HIMSS membership or $375 for
CHIME-only membership.
• Members are the highest-ranking IT executives within their
organizations.
Nursing Informatics Associations
ANI: [Link]
• “Transform health and health care through NI”
• The organization is jointly sponsored by AMIA and HIMSS; there are no
dues for members.
• Regular membership is open to NI-related organizations. A list of the
members with links to each organization is located at
h p://[Link]/[Link]. A comprehensive list of the
local NI groups can be found in this list.
ANIA: [Link]
• “To provide education, networking, and information resources that
enrich and strengthen the roles in the field of NI”
g
• Regular membership dues are $79.
• Membership is open to individuals interested in NI and includes around
3000 members in 15 countries.
AHIMA, American Health Information Management Association; AMIA, American Medical
Informatics Association; ANI, Alliance for Nursing Informatics; ANIA, American Nursing
Informatics Association; HIMSS, Healthcare Information and Management and Systems Society;
IMIA, International Medical Informatics Association; IT, information technology; NI, nursing
informatics.
Given the number of health informatics–related professional
organizations with similar names, it is not surprising that there is
sometimes confusion, even among specialists in the field, concerning the
missions and goals of the different groups. For example, because of the
overlapping and complementary interests of AMIA and AHIMA,
members of these organizations have at times expressed confusion about
how the interests and activities of these organizations relate to one
another. In response to this, AMIA and AHIMA jointly developed a
document addressing potential questions about the two professional
associations and their relationship: “AMIA is the professional home for
informatics professionals who are concerned with basic research in the
field or any of the biomedical or health application domains, either as
researchers or practitioners. AHIMA is the professional home for health
information management professionals, with a focus on those elements of
informatics that fall under the health informatics area of applied research
and practice.”27 The need for such a statement and the wide range of
professional organizations focused on informatics reflect the
interprofessional nature of informatics and the evolution of health
informatics as a distinct area of specialization within the different health
professions.
Educational Programs
During the 1950s, selected medical schools at major universities began to
fund medical computer centers to support the computing requirements of
a variety of new biomedical research projects. During the 1960s and 1970s,
the federal government, mainly via the National Institutes of Health
(NIH), played a major role in supporting these efforts. In 1962, NIH was
authorized to spend an additional $2 million to fund regional biomedical
instrumental centers. By 1968, there were 48 fully operational biomedical
computer centers. By introducing medical students, interns, and residents
to informatics, these centers were fertile ground for the future
development of medical informatics as a specialty. Individual lectures,
elective courses, and, in time, medical informatics programs began to
develop. In 1968, James Sweeney at Tulane University became the first
professor of computer medicine in the United States.14 One of the earliest
departments of medical informatics was established in 1964 at the
University of Utah.28
Beginning in the 1980s, the NLM became more active in supporting
medical informatics education through its extramural grants program. In
1984, the NLM began the Integrated Advanced Information Management
Systems (IAIMS) grant program, with the goal of helping health science
institutions and medical centers integrate information systems to support
patient healthcare, health professions education, and basic and clinical
research. By 1986, the NLM was supporting five academic sites, training a
total of 29 students.29 Two decades later, the NLM was supporting 18 sites
around the nation, with 270 students.29 While most of these informatics-
related educational programs were located in medical schools and
a racted mainly physicians, a number of programs offered master’s and
doctoral degrees that were interprofessional in their recruitment of
students.
The early acceptance of other professions in these programs may have
supported the position that medical informatics programs are
interprofessional and that the term medical was meant to be inclusive of all
health-related professions in the same way that the term man can refer to
both men and women. However, a number, if not most, of the health
professions did not and still do not consider the term medical as inclusive
of all health-related specialties. This is especially true for nurses who
continued to develop their own university-based educational programs
and be recognized as a separate profession in their own right. By 2012,
AMIA took a formal position that medical informatics and NI are both
subspecialties; medical informatics is not an inclusive name for both.30
In 1977, the State University of New York at Buffalo offered the first
computer-related course in a nursing program, a three-credit elective. Just
one decade later, in 1988, the University of Maryland offered the first
master’s program in NI. Within just a few years, a doctoral degree with a
focus in NI was offered. This was followed in 1990 by a master’s program
at the University of Utah and in 1995 by a graduate program at New York
University.31 Over the next several years, a number of educational
programs in NI were established. These programs reflected their unique
se ing as well as the strengths and interests of their individual faculty and
varied from postbaccalaureate certificate programs to doctoral programs.
Because of the wide variation in programs and the lack of any
organization tracking them, it is impossible to determine how many NI
programs have actually existed over the years.
In 2002, the AMIA Nursing Informatics Working Group (AMIA NI-WG)
established a task force on NI curriculum that was charged with
developing a working document on the status of graduate curricula in NI.
The goal was to achieve a consensus on the requirements for a master’s
level informatics program. The task force identified 18 graduate programs
that had been in existence for at least 2 years and issued their report in
2004, which concluded the following:
Despite several attempts, the task force did not reach consensus on a
model that would represent the underlying themes and concepts, yet be
flexible. The need for flexibility is important so that individual programs can
determine the depth and breadth of the underlying themes and concepts,
as well as the development of niche informatics areas, such as consumer
informatics, telehealth, or educational applications. Such a model was
deemed premature at this time. So a narrative organization of the concepts
and themes and content was selected to represent the work of this task
force.32
Today, as the number of NI educational programs and other informatics
educational programs expand, a variety of degrees and certificates are
offered. While nursing and medicine make up the largest groups within
the healthcare specialties, a number of other healthcare disciplines have
developed informatics programs specific to each discipline. For example,
in 1996, Temple University established the nation’s first department of
dental informatics.33
The Health Information Technology for Economic and Clinical Health
(HITECH) Act of 2009 included funding for workforce development
through health IT education. Funding ran from 2010 until 2013 and
included the following four programs:
• The creation or expansion of university-based health IT training
programs
• The development or improvement of nondegree health IT training
programs at 81 community colleges in 50 different states
• The development at five universities of health IT educational materials
for use in community college–based health IT programs. These
materials were also made freely available to other schools outside of
the workforce development program.
• The development of the Certified Healthcare Technology Specialist
(CHTS) Exam administered by AHIMA for individuals completing
the nondegree training34
In 2015, the Office of the National Coordinator (ONC) again funded
workforce development grants. With this funding, seven grantees received
a total of $6.7 million to both update training materials from the original
curriculum development program funded and train 6000 incumbent
healthcare workers to use new health information technologies. Through
this funding, the HITECH act has established a new educational program
for health informatics specialists, a certificate (nondegree) program.
Recognizing the shortage of informatics specialists, the designers of this
program wanted to provide beginning formal education to health
professionals to quickly increase the numbers of available informatics
specialists. The creation of these community college–based programs
means that additional avenues of informatics education are available;
however, it is unclear how these different levels of education will relate to
each other and to the needs of healthcare. Chapter 30 includes additional
information on this program.
Accreditation for Health Informatics Education
Programs
By the turn of the century, a number of health informatics related
educational programs had been established. The first professional
association to express interest in accreditation for these emerging
programs was AHIMA. In 2003, the AHIMA House of Delegates
determined that the profession of health information management was
strong, unique, and should be able to conduct and confirm final
accreditation actions for all health information management (HIM)
programs. As part of this process, they incorporate within their scope the
field of health informatics.35 In March 2005, the Council on Accreditation
for Health Information and its sponsoring organization, AHIMA, left the
Commission on Accreditation of Allied Health Education Programs to
form a freestanding accrediting body, the Commission on Accreditation
for Health Informatics and Information Management Education
(CAHIIM).36 Only a small number of health informatics programs
obtained accreditation through CAHIIM over the next few years. In
September 2014, AMIA joined (CAHIIM) as an organizational member,
thereby becoming an equal partner with AHIMA in CAHIIM’s
governance. AMIA brought to this union the involvement of the AMIA
Academic Forum. The AMIA Academic Forum is a membership unit
within AMIA with close to 60 full, emerging, and affiliate members who
are responsible for the management of educational and research programs
in universities and colleges. This group is “dedicated to serving the needs
of postbaccalaureate biomedical and health informatics training
programs.”37 With AMIA’s involvement, CAHIIM has established a new
health informatics accreditation council, with the goal of revising the
accreditation standards for masters’ degree programs in health
informatics. The revised standards are now under development.
Certification
While a empts to create a consistent and systematic approach to
educating health informatics professionals have not been successful, some
level of success has been achieved in informatics specialty recognition,
developing certification processes and identifying competencies within a
scope of practice.
Nursing was the first group to develop a certification process within
health informatics. As a result, other groups have looked to nursing’s
process as a model. In 1992, the ANA designated NI a specialty within the
practice of nursing. Subsequently, an ANA task force developed a
monograph outlining the scope of practice and describing the specialty
a ributes of NI.38 The scope of practice was followed a year later by a
second monograph outlining the standards of practice and professional
performance for NI.39 These resources defining the scope and standards of
practice provided the necessary groundwork for the development of a
certification process. In 1995, a certification examination was created at the
generalist practitioner level by the American Nurses Credentialing Center
(ANCC). A baccalaureate degree in nursing (BSN) was and still is required
to sit for the certification exam.
In 2001, a new task force was established to update and combine the
scope and standards documents. That document was updated and revised
again in 200840 and again in 2015.41
The NI certification examination is revised on a 3-year schedule to
reflect evolving practice. Nurses who successfully complete the
certification process include the le ers RN-BC after their names to indicate
they are registered nurses with board certification. In 2010, 15 years after
certification was first available, the ANCC reported that there were only
779 nurses certified in informatics. In January 2013, there were 1039.42 By
December of that same year, the ANA reported there were 1326 nurses
certified in informatics.41 Clearly the AANC certification is being
increasingly recognized by NI nurses as an important credential.
While the AANC offers only one level of certification for the informatics
nurse, the ANA scope and standards of practice makes a clear distinction
between an informatics nurse and an informatics nurse specialist. An
informatics nurse specialist requires graduate preparation, while the
informatics nurse does not require this level of preparation. However, with
only one level of certification, this distinction is not always clear. For
example, in 2002 Johnson & Johnson launched a campaign to deal with the
predicted nursing shortage. The website [Link] is an online
extension of that campaign. As of 2016, the site included 104 specialties,
including Informatics Nurse. The educational requirement listed on the
site is a BSN, with a diagram showing a path that includes ANCC
certification. Internet searches for available NI positions frequently show a
requirement of a nurse with a BSN, or baccalaureate in a related field such
as computer science, with a master’s degree preferred.
The 2015 ANA task force that wrote the current scope and standards of
practice followed the 2008 task group in recognizing the wide variation in
job titles, broad scope of responsibilities, and wide range of roles of
informatics nurses. Rather than focus on roles and titles, they identified
twelve functional areas within the NI scope of practice:
• Administration, leadership, and management
• Systems analysis and design
• Compliance and integrity management
• Consultation
• Coordination, facilitation, and integration
• Development of systems, products, and resources
• Educational and professional development
• Genetics and genomics
• Information management and operational architecture
• Policy development and advocacy
• Quality and performance improvement
• Research and evaluation
NI specialists employed in research, administration, or education
employ each of these functional areas to varying degrees, depending on
the specific task at hand. The task force’s conclusion was further supported
by a national informatics nurse role delineation and job analysis survey
completed by ANCC in 2013 as a basis for updating the certification
examination. This survey included 412 informatics-certified nurses from
across the United States. The majority of certified informatics nurse
specialists are employed in healthcare se ings, providing leadership and
support during the life cycle of a healthcare information system within
healthcare institutions.42 This is reflected in the content areas of the
certification examination (Box 35.5).
Box 35.5
Content Areas in the American Nurses
Credentialing Center Certification Examination
for Nursing Informatics
I. Foundations of Practice (47.33%)
A. Professional Practice
B. Models and Theories
C. Rules, Regulations, and Requirements
II. System Design Life Cycle (26.00%)
A. Planning and Analysis
B. Designing and Building
C. Implementing and Testing
D. Evaluating, Maintaining, and Supporting
III. Data Management and Health Care Technology (26.67%)
A. Data Standards
B. Data Management
C. Data Transformation
D. Hardware, Software, and Peripherals
The next group to develop a certification examination was HIMSS. In
2002, HIMSS launched Certified Professional in Healthcare Information
and Management Systems (CPHIMS). The “certification examination is
designed to test a well-defined body of knowledge representative of
professional practice in healthcare information and management systems.
Successful completion of a certification examination is an indicator of
broad-based knowledge in healthcare information and management
systems.”41, p. 2 As with ANCC, the content tested on the CPHIMS
examination was developed by conducting a role delineation study.
However, with this exam, IT professionals were surveyed to identify tasks
that were performed routinely and considered important to competent
practice. The content developed from the survey is divided into three
major topics with subsections. Box 35.6 outlines the topic areas tested on
this examination. A detailed outline is provided in the Candidate
Handbook.43
Box 35.6
Content Areas in the Certified Professional in
Healthcare Information and Management
Systems Certification Exam for Information
Technology Professionals
1. General
a. Healthcare Environment
b. Technology Environment
2. Systems
a. Analysis
b. Design
c. Selection, Implementation, Support, and Maintenance
d. Testing and Evaluation
e. Privacy and Security
3. Administration
a. Leadership
b. Management
HIMSS’s publications concerning the development of the certification
examination do not describe how the IT professionals were selected.
However, the qualifications to sit for the exam do indicate how the term IT
professional is defined. These qualifications include (1) a baccalaureate
degree, or global equivalent, plus 5 years of associated information and
management systems experience, with 3 of those years in healthcare; or (2)
a graduate degree, or global equivalent, plus 3 years of associated
information and management systems experience, with 2 of those years in
healthcare. Associated information and management systems experience is
defined as including experience in administration or management, clinical
information systems, eHealth, information systems, or management
engineering.
As with the ANCC exam, there is a heavy emphasis on systems life
cycle. In addition, both certifications require recertification (including
fees). ANCC has a 5-year period of certification, and CPHIMS requires
recertification in 3 years. As of 2011, there were 1651 individuals with
CPHIMS certification. Of these individuals, 251 were healthcare providers,
divided as follows:
• 68.5% registered nurses
• 18.3% medical doctors
• 8.8% registered pharmacists
• 4.4% other44
AMIA is the third group to begin the process of formally recognizing an
area of specialization related to informatics. A town hall discussion in 2005
at the AMIA annual meeting concluded the following:
1. Informatics as a discipline is more than clinical informatics.
2. Clinical informatics is an interprofessional domain.
3. There is social value in formal clinical informatics training and
certification.45
While the town hall discussion described clinical informatics as an
interprofessional domain and AMIA adopted this as formal policy, the
actual process for recognizing clinical informatics as a specialty since then
has limited this recognition to clinical informatics as a medical specialty
for physicians only. In 2007, AMIA was awarded a grant to develop two
documents that are required by the American Board of Medical Specialties
(ABMS) to establish a medical subspecialty. In 2009, the core content for
the subspecialty of clinical informatics46 and the program requirements for
fellowship education in clinical informatics47 were published. In July 2009,
the American Board of Preventive Medicine (ABPM) agreed to sponsor the
specialty application, and in March 2010, ABPM submi ed the application
to ABMS. After an extensive review, the proposal was approved by the
ABMS Board in a vote on September 21, 2011.48 While the proposal was
sponsored by ABMS, all 24 American Board of Medical Specialties boards
agreed that diplomates in good standing with their primary boards can sit
for this subspecialty certificate.49 As of December 2015, there were 1105
board-certified clinical informatics diplomates.50
The Accreditation Council for Graduate Medical Education (ACGME)
accredits training programs in clinical informatics for physicians. In
February, 2014, ACGME released its program requirements for graduate
medical education in clinical informatics. Initially a grandfathering process
was used for physicians who had not completed a formal fellowship in
clinical informatics. Beginning in 2018, the board exam will be available
only for those physicians who have completed an ACGME-accredited
fellowship in clinical informatics.47
As mentioned earlier in this chapter, AHIMA is the fourth group to offer
certification. In 2010, the ONC for Health Information Technology
awarded a $6 million grant to Northern Virginia Community College to
support the development of a competency examination program for
individuals who complete the community college–based certificate
(nondegree) for training in IT Professionals in Health Care. The HIT Pro
competency exam, developed through this grant, laid the groundwork for
the establishment of a competency examination for health IT professionals
who have completed the HITECH-funded nondegree community college
program. As of July 29, 2013, the HIT Pro exam was transitioned to the
AHIMA CHTS credentials.34 The six exams currently offered include:
• Clinician/Practitioner Consultant
• Implementation Manager
• Implementation Support Specialist
• Practice Workflow and Information Management Redesign Specialist
• Technical/Software Support Staff
• Trainer
As of 2016 two additional certification exams and certification processes
in health informatics is currently under development. In February 2012,
the AMIA Academic Forum created a Task Force on Advanced
Interprofessional Informatics Certification (AIIC). This task force issued a
consensus statement (1) supporting the development of a certification
process for individuals not eligible for the subspecialty certification offered
to physicians, (2) recommending the certification process focus on core
informatics content that is relevant to all professions, and (3)
recommending that the interprofessional informatics certification should
be at the graduate level. As of 2015, AMIA was in the process of collecting
data to inform the development of recommended eligibility pathways. The
goal is to provide recommendations for the core content, eligibility
pathways, and an approach for creating a neutral organization to
administer the new certification process.51
In April 2016 AHIMA announced that they were in the process of
developing two new informatics-related certifications: “By December of
this year, AHIMA and CCHIIM plan to make the beta exam available for
an AHIMA health informatics credential.”51a Following this
announcement, a brochure outlining the exam content topics and the cost
to take the beta version of the exam was posted on the AHIMA website.51b
In July 2016 Tom Payne, AMIA Board Chair, sent a “special message” to
the membership of AMIA entitled AMIA Board of Directors Action on
AHIMA Health Informatics Certification Efforts. This message described the
AMIA Board of Directors concern with AHIMA's announcement of the
new health informatics certification exam and process: “Development of a
certification process with a very similar name—Certification for Health
Informatics and Information Management—that does not collaborate with
AMIA’s clinical and health informatics certification efforts will confuse our
colleagues and key stakeholders about the role of informatics and
information management.”51c A meeting between the two professional
associations was then scheduled for August 2016.
As demonstrated by this review of events from published books to the
development of credentialing processes, health informatics evolved as a
fragmented interprofessional specialty from a variety of disciplines having
their own histories, cultures, and established structures. Books are wri en
with “nursing informatics” or “medical informatics” in their titles,
suggesting that these are texts for different health-related disciplines;
however, core informatics domain knowledge spans these disciplines.
Credentialing exams with overlapping content are developed by different
informatics-related professional organizations and are targeted to select
specialties within health informatics. The next section explores the
implications of the history of health informatics.
Recognition by the U.S. Bureau of Labor Statistics
For several years the professional associations concerned with health
informatics have lobbied for health informatics to be included as a
recognized occupation by the U.S. Bureau of Labor Statistics and included
in the Standard Occupation Classification (SOC) system. The SOC was
established by the Office of Management and Budget (OMB) for use in the
federal statistical system. The SOC and the statistics generated by use of
this standard classification system are widely used by individuals,
businesses, researchers, educators, and public policy makers.51d
In 2012 the SOC Policy Commi ee (SOCPC) began to revise the 2010
occupations and definitions in order to develop the 2018 SOC occupations
and definitions. Public input was solicited in 2014, and in 2016 the SOCPC
posted the draft document and requested public comments on the SOCPC
recommendations.51e Health informatics was included for the first time,
but the SOCPC recommendations proposed a single code and a definition
that included health information management (HIM) and health IT
occupations along with health informatics. In September 2016, 39 health
informatics–related organizations sent a joint response strongly
recommending separate codes for health information management
professionals, health informatics, and health IT.51f Their posed definitions
are included in Box 35.7. The final version of the 2018 SOP codes,
occupations, and definitions is scheduled to be released in spring 2017.
Box 35.7
Response From 39 Organizations to SOCPC
Concerning Recommended Definitions for
Health Informatics and Related Occupations
• Health informatics professionals: Design, develop, select, test,
implement, and evaluate new or modified informatics solutions, data
structures, and clinical decision support mechanisms to support
patients, healthcare professionals, and improved usability of such
systems for patient safety within healthcare contexts.
• HIM professionals: Acquire, analyze, and protect digital and traditional
medical information vital to the daily operations management of health
information and electronic health records (EHRs).
• Health IT professionals: Apply knowledge of healthcare and
information systems to assist in the design, development, and continued
modification of computerized health care systems.
From American Medical Informatics Association (AMIA). AMIA Responds to Proposed Updates to
Standard Occupational Classification Codes. h ps://[Link]/public-policy/amia-responds-
proposed-updates-standard-occupational-classification-codes; September 2016.
Recognition of the specialty
While health informatics has evolved as an interprofessional informatics
specialty with a focus on healthcare, combining the words interprofessional
and specialty may have created an oxymoron. First, the study of
informatics is not limited to healthcare. Informatics as a field of study has
been combined with a number of other professions. For example, Indiana
University–Purdue University Indianapolis (h p://[Link]/)
has established a School of Informatics, which offers, along with a number
of other programs, an undergraduate degree in informatics with the
opportunity to specialize in biology, business, computer IT, computer
science, health science, human-computer interaction, or legal informatics,
among other options. Purdue also offers a graduate program in
bioinformatics that prepares students to design and execute translational
research linking data to medicine and drug discoveries, as well as a
separate graduate program in health informatics prepares students to
analyze and protect patient data, increase healthcare efficiencies, and
produce quality patient care.52
Second, while health informatics is considered an area of specialization
with a focus on healthcare, the question of which discipline it falls within
has never been established. In other words, is health informatics (1) a
specialty within computer science, (2) a specialty within information
science, (3) a specialty within each of the various healthcare disciplines, (4)
an interdisciplinary healthcare specialty with students from the different
healthcare specialties combined, or (5) a new specialty distinct from its
historical roots in the other disciplines? Currently, examples of educational
programs representing each of these approaches can be found in colleges
and universities across the United States. These programs vary, offering
certificates, associate degrees, and postdoctoral fellowships. As a result,
the type and amount of previous education required for admission to
these different health informatics programs can vary widely. In addition,
there is limited consistency in the number of credits and types of courses
required in programs of the same type. In recognition of these issues, key
leaders within the professional organizations have a empted to establish
the appropriate name of this specialty, describe the relationship of the
specialty to other related fields of study, and develop a scope of practice
with core competencies for the specialty.
Naming the specialty—naming the
discipline
Earliest references in the late 1950s used the term bioengineering. However,
as the computer emerged as integral to health informatics, a number of
terms combining the disciplines of medicine and computing, including
medical computer science, medical computing, and computer medicine, were
used to reflect the new specialty.14 As other healthcare disciplines continue
to develop a focus on informatics, using the terms medicine or medical to
include all specialties has become more controversial, as noted earlier in
this chapter. Many disciplines solved this problem by combining the name
of their field of practice with the word informatics. Box 35.8 provides
several examples. This approach is consistent with the strong division of
labor, often called scope of practice, and hierarchical structures in
healthcare education and healthcare delivery. This approach is also based
on the assumption that informatics is a subspecialty within a specific
health-related profession. However, the approach of modifying the term
informatics with a specific health-related discipline, area of interest, or
specialization does not provide a name and definition for the discipline as
a whole. As pointed out previously, over the years, some have argued that
medicine was an inclusive term covering all aspects, including all
healthcare roles in preventing, diagnosing, and treating health problems,
including disease. This is demonstrated by the current names of the
international and national associations: the IMIA and the AMIA. These are
interdisciplinary informatics associations with members from various
healthcare disciplines. The 5000 + members of AMIA include individual
members such as physicians, nurses, dentists, biomedical engineers,
medical librarians, those in IT, and other health professionals and
institutional or corporate members such as nonprofit organizations,
universities, hospitals, libraries, and corporations with an interest in
biomedical and health informatics.53 Many educational programs changed
their names to biomedical informatics to solve this issue, and there have
been suggestions to change the names of the IMIA and AMIA to use
biomedical in place of the term medical30; however, not all members may
consider the term biomedical as more inclusive than medical informatics.
Box 35.8
Naming Health Informatics: Related
Disciplines
• Biomedical imaging informatics
• Biomedical pa ern recognition
• Clinical informatics
• Clinical research informatics
• Consumer health informatics
• Critical care informatics
• Dental informatics
• Global health informatics
• Health and medical informatics education
• Informatics in genomic medicine (IGM)
• Intensive care informatics
• Mental health informatics
• Nursing informatics
• Open source health informatics
• Pediatric health informatics and technology (PHIT)
• Pharmacoinformatics or pharmacy informatics
• Primary care informatics or primary healthcare informatics
• Public health informatics
• Public health / population informatics
• Telemedicine and mobile computing informatics
• Translational bioinformatics
• Veterinary informatics
Others have pointed out that the practice of medicine defines the scope
of practice for a physician and therefore have suggested that health or
healthcare is a more inclusive term, since it includes all levels of wellness as
well as disease and other health problems. For example, the HIMSS can be
described as an interprofessional informatics association but uses the term
healthcare.
The challenge has been and may still be to select a name that describes
the discipline as a whole and yet acknowledges the different informatics
disciplines and their relationship with the broader field of study. In 2002,
Englebardt and Nelson used the term health informatics but presented two
different “interdisciplinary” models in response to these issues. Fig. 35.2
shows an umbrella model that recognizes the clear boundaries between
the different health informatics disciplines at the same time as it
demonstrates that it is the connections between the boundaries or the
frame of the umbrella that create the discipline. Fig. 35.3 uses a Venn
diagram to describe health informatics as overlapping the different health
informatics disciplines yet being distinct. However, neither model
suggests a name that would be inclusive of the different health informatics
specialties and their relationships.
FIG 35.2 Umbrella model of health informatics. Copyright Ramona
Nelson. Reprinted with permission. All rights reserved.
FIG 35.3 Venn Diagram Model. Copyright Ramona Nelson. Reprinted with
permission. All rights reserved.
In 2006, Shortliffe and Blois recommended the term biomedical informatics
(BMI) in the first chapter of a book that was retitled for the third edition,
Biomedical Informatics: Computer Applications in Health Care and Biomedicine.
“In an effort to be more inclusive and to embrace the biological
applications with which many medical informatics groups had already
been involved, the name medical informatics has gradually given way to
BMI. Several academic groups have already changed their names, and a
major medical informatics journal Computers and Biomedical Research was
reborn as The Journal of Biomedical Informatics.”19, p. 23 In arriving at this
position, Shortliffe and Blois explain within the chapter why they believe
the terms health and health informatics are not inclusive but rather exclude
key groups:
Many observers have expressed concern that the adjective “medical” is
too focused on physicians and fails to appreciate the relevance of this
discipline to other health and life science professionals, although most
people in the field do not intend that the word “medical” be viewed as
being specifically physician-oriented or even illness-oriented. Thus, the
term health informatics, or healthcare informatics, has gained some
popularity, even though it has the disadvantage of tending to exclude
applications to biology . . . and, as we will argue shortly, it tends to focus
the field’s name on an application domain (public health and prevention)
rather than the basic discipline and its broad range of applicability.19, p. 23
The term biomedical and the rationale for selecting it resonated with a
number of other leaders within AMIA. Six years later, the AMIA Board
white paper, Definition of BMI and Specifications of Core Competencies for
Graduate Education in the Discipline, was formally approved by the AMIA
Board on April 17, 2012, and published online in June 2012.30 With the
acceptance of this paper, AMIA now defined BMI as “the interdisciplinary
field that studies and pursues the effective uses of biomedical data,
information, and knowledge for scientific inquiry, problem solving and
decision making, motivated by efforts to improve human health.”30, p. 3 The
areas of research and application within BMI range from molecules to
populations and societies.
In selecting the term biomedical informatics, the authors of the paper
noted that they had adopted the newer position that the term medical
informatics refers solely to the “component of research and practice in
clinical informatics that focuses on disease and predominantly involves
the role of physicians. Thus AMIA now uses medical informatics primarily
as a parallel notion to other subfields of clinical informatics such as NI or
dental informatics.”30, pp. 2–3 The term health informatics is also seen as
limited in scope: “BMI is the core scientific discipline that supports applied
research and practice in several biomedical disciplines, including health
informatics, which is composed of clinical informatics (including subfields
such as medical, nursing, and dental informatics) and public health
informatics.”30, p. 3 Fig. 35.4 demonstrates the relationships of these
previously used terms, now under the broad definition of BMI. The
distinction between BMI and health informatics is further clarified in a
slide set on the AMIA website. Fig. 35.5 is a slide taken from the slide set
demonstrating this distinction.
FIG 35.4 AMIA position: BMI and its areas of application and
practice. AMIA, American Medical Informatics Association. BMI,
biomedical informatics; CRI, clinical research informatics; HI, health
informatics; TBI, translational bioinformatics. Redrawn from Kulikowski CA,
Shortliffe EH, Currie LM, et al. AMIA Board white paper: definition of biomedical informatics
and specification of core competencies for graduate education in the discipline. J Am Med
Inform Assoc. 2012;19(6):931-938. With permission from BMJ Publishing Group Ltd.
FIG 35.5 Biomedical informatics in perspective. Used with permission
from the American Medical Informatics Association.
However, the authors of the AMIA paper may have realized that the
term biomedical informatics may not have sounded inclusive to all health-
related informatics disciplines in stating that “the phrase ‘biomedical and
health informatics’ is often used to describe the full range of application
and research topics for which BMI is the pertinent underlying scientific
discipline” (emphasis added).30, p. 1
Not all groups within healthcare identify biomedical as the inclusive
term, in that it contains the term medical as opposed to health. However,
combining the terms health and BMI, as in the previous quote, may be
more acceptable. For example, the Northwestern University Feinberg
School of Medicine, Department of Preventive Medicine, chose to name its
program the Department of Health and Biomedical Informatics. This was
after careful consideration of the evolution of the names for the discipline.
A summary of this consideration is posted at
h p://[Link]/divisions/hbmi/about-
us/[Link] and is illustrated in Fig. 35.6. As can be
seen in these two figures, a common consensus has not yet been achieved,
but there are more similarities than there are differences. In both diagrams,
informatics is the broader or parent discipline, and nursing, medicine,
dentistry, and so forth are subspecialties within that broader field.
FIG 35.6 Hierarchy of informatics. This diagram shows the
relationships between various sub-domains of Health and BMI. The
domains are shown as blobs rather than as discrete boxes to
emphasize the high degree of overlap among the domains. This
hierarchy should be considered a snapshot in time rather than a
definitive final solution. Northwestern University Feinberg School of Medicine,
Department of Preventive Medicine.
Conclusion and future directions
This chapter has traced the evolution of informatics as a specialty within
healthcare and as a discipline. The history of health informatics has been
strongly influenced by the history of the health professions and their
current infrastructures, such as the educational systems, professional
organizations, and professional cultures. As informatics-related education
among the professions becomes more consistent and as computerization
becomes more integrated into every aspect of healthcare, these historical
struggles will become yesterday’s story. The emphasis will move from
defining the differences and establishing boundaries between the
professions to creating an interprofessional approach to meet the health-
related needs of individuals and societies. Within this environment, one
can expect the healthcare-related specialties to move forward in reaching a
working consensus on their individual roles as well as their ever-changing
scope of practice within health informatics as well as BMI. The focus will
evolve to shared core competencies, knowledge, and skills rather than
emphasizing differences. Over time, the collaborative opportunities to
create a more effective and efficient healthcare system will become more
interesting and motivating than the historical struggles and hierarchical
relations of the past.
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28 University of Utah School of Medicine. Biomedical Informatics: About
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30 Kulikowski C.A., Shortliffe E.H., Currie L.M., et al. AMIA Board
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33 University of Pi sburgh School of Dental Medicine, Center for
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Accessed July 5, 2016.
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38 American Nurses Association. Scope of Practice for Nursing
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40 American Nurses Association. Nursing Informatics: Scope & Standards
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41 American Nurses Association. Nursing Informatics: Scope & Standards
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42 American Nurses Credentialing Center (ANCC). 2013 Role
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47 Safran C., Shabot M.M., Munger B., et al. Program requirements for
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48 American Medical Informatics Association (AMIA): News Releases.
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and-publications/press-release/ci-is-subspecialty.
49 American Medical Informatics Association (AMIA). Frequently asked
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50 American Medical Informatics Association (AMIA). 2015 Clinical
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51 American Medical Informatics Association (AMIA). Advanced
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Connection; April 2016. h p://[Link]/2cBw4om.
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h p://[Link]/topics/ida?tabid=certification. Accessed
September 28, 2016.
51c American Medical Informatics Assocation (AMIA). AMIA Board
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51d U.S. Bureau of Labor Statistics. Revising the Standard Occupational
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Discussion questions
1. Healthcare as a professional field of practice is often traced to the Middle
Ages. Its historical roots are tied to the hierarchical structure of the
church and the military. How does this history influence the current
structure and relationships among the subspecialties within health
informatics?
2. Which professional associations would be most appropriate for
professionals interested in nursing informatics, pharmacy informatics,
or public health informatics? Explain the combination selected and the
rationale for each choice.
3. Is health informatics a discipline or is this an area of subspecialization of
interest to health professionals such as nurses, physicians, dentists, and
so forth?
4. Should there be one certification process and set of credentials for all
health informatics specialists, or should each of the health professions
develop a certification process specific to that specialty?
5. What interprofessional name would you recommend and why?
Case study
In this case study, you, as the reader, will need to fill in a number of the
details. The case study begins at the point when you return to school for a
graduate degree. Details related to your previous education, professional
experience in healthcare, and goals in returning to school should be filled
in from your own life story.
The program of study for your graduate degree includes an
Introduction to Informatics course. This is a required course for all
students in the program. One of the first course requirements is that you
join an informatics organization and complete a short paper explaining
why and how you selected that specific organization. Be sure to explain
how you analyzed the options and narrowed your choice to the one
organization.
Discussion Questions
1. Talk to several faculty members or others with an interest in
informatics to see what organizations they belong to and why. Ask
how they became interested in informatics and see if you can match
their history with informatics to what you learned about the history of
informatics in this chapter.
2. Review the organization websites in Box 35.4 to determine which
organization fits best with your interests. Explain how you matched
your areas of interest to the information on the website of your chosen
organization.
3. Discuss how you would use the information from questions 1 and 2 in
selecting appropriate mentors.
36
Future Directions and Future
Research in Health Informatics
Nancy Staggers; Ramona Nelson; David E. Jones*
Abstract
This chapter expands on the future directions sections included in the individual
chapters and provides broad guidance about the future of health informatics. First,
healthcare trends in society are outlined. Second, futures studies or futurology
(methods to analyze probable future directions in any field) is discussed. Third, an
overview of future directions in healthcare and informatics is given: (1) person-
centered health, the fusion of health information technology (health IT) into
healthcare and concomitant implications for health informatics; (2) technical trends
in health IT, such as the internet of things (IoT) and cybersecurity issues; and (3)
clinical informatics trends, including analytics, data visualization, and improving the
user experience (UX). Last, this chapter offers a section on nanotechnology and
nanoinformatics. The last topics are discussed in more detail because of their likely
profound impacts on society, healthcare, and health informatics in the future.
Health informatics can be described as an interprofessional discipline that
is grounded in the present while planning for the future.
OBJECTIVES
At the completion of this chapter, the reader will be prepared to:
1. Explore major trends and their implications for future developments
in healthcare, health informatics, and informatics research.
2. Analyze techniques and challenges of planning for future directions
and trends.
3. Apply futurology methodologies in identifying trends and possible,
probable, and preferred futures.
4. Describe the fields of nanomaterials and nanoinformatics, the role of
these fields in healthcare, and implications for the future.
5. Analyze the advantages and disadvantages of nanotechnology in
health and health informatics.
KEY TERMS
backcasting 617
cytotoxicity 625
data visualization 623
extrapolation 616
futures research 613
nanofabrication 624
nanoinformatics 625
nanomaterials 624
nanomedicine 625
nanotechnology 624
trend analysis 616
Introduction
Health informatics can be described as an interprofessional discipline
grounded in the present while planning for the future. Health
professionals and informatics specialists are implementing today’s health
information technology (health IT), while creating the foundation for the
technology of tomorrow. By reviewing current trends and predictions, as
well as employing tools for predicting and managing the future, health
professionals and informatics specialists can prepare for their leadership
roles in planning effective and innovative future healthcare information
systems.
Clearly, health IT and informatics will play integral roles in the future of
all aspects of healthcare. Precisely which informatics trends will prevail is
not completely clear; however, emerging areas can be seen. In each of the
chapters in this book, authors outlined evolving areas of influence. This
final chapter offers material on healthcare trends in society, methods for
predicting the future, directions in health informatics and, finally, a section
on nanomaterials and nanoinformatics.
To understand the future of health informatics, healthcare providers and
informaticians need to be aware of societal trends. Examples of trends in
society include the following:
• Healthcare costs. Analysts initially predicted continual increases in
healthcare costs at about 6% annually through 2020.1,2 Although costs
are predicted to still rise over time, current spending projections are
now $2.5 trillion less due to the Affordable Care Act in the United
States and the economic recession that occurred in the late 2000s.3
• Aging populations. From 2000 to 2050, the global population of those
aged 60 years or older will rise from 600 million to more than 2
billion.4
• Increasing numbers of patients with chronic diseases. By 2030, chronic
diseases will be the leading cause of deaths worldwide.5 The rate for
diabetes alone across the globe is predicted to increase from 382
million in 2013 to 592 million by 2035.6
• Predicted shortage of healthcare providers. By 2025, the United States will
have a shortage of nurses in 16 states7 and a national shortage of
46,000 to 90,000 physicians, mostly in primary care and surgical
specialties.8
These trends clearly have implications for the future practice of health
informatics. But how does one determine and plan for these implications?
Futures research, or futurology, the method used to determine future
directions and trends in any field, can help answer this question.
Futures research (futurology)
This section introduces readers to levels of change that can be anticipated
in future trends. By analyzing methodologies and tools for predicting,
planning for, and managing the future, health professionals and
informatics specialists are able to prepare for the leadership roles they will
play in planning future healthcare information systems. With a be er
understanding of the potential future, healthcare providers and
informatics professionals can make be er decisions today.
Defining Futures Research (Futurology)
Futures research is the rational and systematic study of the future, with
the goal of identifying possible, probable, and preferable futures. The
focus can be anywhere from 5 to 50 years in the future. The formal study
of the future goes by a number of names, including foresight and futures
studies, strategic foresight, prospective studies, prognostic studies, and
futurology. Using a research approach to study the future formally began
after World War II. Initially this field of study aroused skepticism. Since
that time, a number of institutes, foundations, and professional
associations have been established supporting the field of futures studies.
Examples of these are included in Box 36.1. In addition, a number of
educational programs related to futures studies now use the various
futurology terms to describe their programs. Box 36.2 includes examples of
university programs in futures studies. Researchers and corporate
strategists are also using numerous concepts, theories, principles, and
methods based on the field of futures research. Despite the initial
skepticism today, the futures studies techniques are accepted, educational
programs are available, and these methods can be very useful for
healthcare providers and informaticians.
Box 36.1
Futures Studies
Selected Associations, Institutes, and Foundations
• Acceleration Studies Foundation, h p://[Link]/[Link]
• Copenhagen Institute for Future Studies, h p://[Link]/about-us/
• Foresight Canada, h p://[Link]
• Fullerton and Cypress Colleges, and School of Continuing Education:
Center for the Future, h p://[Link]
• The Arlington Institute, h p://[Link]
• Association of Professional Futurists, h p://[Link]
• The Institute for Alternative Futures (IAF)
h p://[Link]/home
• The Club of Rome, h p://[Link]
• The Futurist, h p://[Link]/futurist/about-futurist
• Institute for the Future, h p://[Link]/home
• The Millennium Project, h p://[Link]
• World Future Society, h p://[Link]/node/920
• World Futures Studies Federation (WFSF), h p://[Link]
IAF, Institute for Alternative Futures; WFSF, World Futures Studies Federation.
Box 36.2
Selected University Programs in Futures
Studies
• University of Southern California (USC) Annenberg Center for the
Digital Future h p://[Link]
• Regent University: School of Business and Leadership,
h p://[Link]/acad/global/degree_programs/masters/strategic_
foresight/[Link]
• TamKang University: Graduate Institute of Futures Studies,
h p://[Link]/en/
• University of Advanced Technology, h p://[Link]/Emerging-
Tech
• University of Hawaii: Hawaii Research Center for Futures Studies,
h p://[Link]/academic-off[Link]
• University of Houston: College of Technology,
h p://[Link]/[Link]
• University of Stellenbosch: Institute for Futures Research,
h p://[Link]/Pages/[Link]
• University of Turku: Finland Futures Research Centre (FFRC),
h p://[Link].fi/en/units/ffrc/Pages/[Link]/
FFRC, Finland Futures Research Centre; USC, University of Southern California.
Health and informatics professionals can use traditional forecasting and
planning methods in combination with futures studies methods. Strategic
planning in health informatics typically focuses on projects 1 to 3 years in
the future. Institutional long-range planning tends to focus on 5 to 10 years
in the future. Vendor contracts for major healthcare informatics systems
often cover a 10-year period, spanning both strategic and long-range
planning.
There are some differences between forecasting and futures studies.
First, forecasters focus on incremental changes from existing trends, while
futurists focus on systemic, transformational change. Second, futurists do
not offer a single prediction. Rather, they describe alternative, possible,
and preferable futures, keeping in mind that the future will be created, in
most part, by decisions made today. The technical, political, and
sociocultural infrastructure being built today will have a major impact on
the choices of tomorrow. Both traditional forecasting and futures studies
methods are key to planning health informatics projects.9 Understanding
the impact of future trends and using this information for planning begins
by understanding the degree and scope of change that occurs over time.
Future Directions and Scope of Change
Degrees or the scope of change can be divided into three levels.10 First-
level change does not really change the process being used or the goal one
might want to achieve. This level of change makes the process in use more
effective and efficient. Replacing a typewriter with a word processor is an
example of a first-level change. The user is still producing a document, but
the technology makes the process more effective and efficient. Within the
levels of change, first-level change is the least disruptive and the most
comfortable. In many ways, requests that new technology be designed to
fit the workflow of healthcare providers is, in reality, a request, or perhaps
a demand, for first-level change only. In fact, if the equipment and related
procedures do not support the current roles and responsibilities of the
healthcare providers, they quickly develop workarounds to meet their
requirement that the degree of change be limited to a first-level change.
A second-level change involves changing how a specific outcome is
achieved. For example, historically the peer review process used by
professional journals involved sending a submi ed manuscript to a
limited number of selected experts for anonymous opinions. The goal was
to ensure that only the highest quality articles were published. The process
of review and revision could take several weeks or months. In addition,
with a limited number of experts screening what was published, some
degree of professional censorship existed. Articles representing a
paradigm shift in thinking risked being rejected by this limited set of
reviewers. Today, professional online journals and journals that
prepublished online versions of an article usually offer all readers the
opportunity to comment. Opening up the opportunity for all readers to
comment is now changing who is ultimately involved in peer review and
how the peer review process is completed.
Another example of second-level change is demonstrated by patient
groups within social media applications. These are changing what and
how patients learn about their health problems. Groups of patients help
each other read and interpret the latest research to create a new level of
health literacy within these groups. Social media interactions not only
change the process for achieving an outcome, but also change the
relationships between the participants. As patients become organized and
knowledgeable, they take a more active role in their own care and move
from the role of patients needing education about their diseases into more
of a collegial role, even sharing new and innovative findings with
healthcare providers.
The scope of change at this level creates both excitement and anxiety
within professional groups and among individual healthcare providers.
The scope of practice, policies, procedures, and established professional
customs, such as professional boundaries, are challenged, and resistance to
this challenge can be expected. For example, in healthcare, the goals of
improved health for individuals, families, groups, and communities have
not changed, but technology is changing the roles and responsibilities
related to how these goals might be achieved.
A third-level change alters the process and can also refocus the goal. For
example, a hyperlinked multimedia journal, with a process for adding
reader comments and linking to related publications, may change not only
the definition of an expert but also the historical gold standard for review
of new information and knowledge.
Another example is the use of knowledge discovery and data mining in
the research process. In the traditional approach to scientific research, the
researcher begins with a theory and a theoretically based hypothesis. This
foundation is used to determine what variables or data are collected and
how those data are analyzed. With knowledge discovery and data mining,
the goal is to discover clusters and relationships among existing data with
no preconceived concept of theories, data collection, or how these data are
related, redefining (or at least expanding) the concept of the research
process.
Third-level change involves changes at the societal and institutional
level, typically occurring over long periods of time. For instance, the
evolving role of the nurse from a handmaiden for the physician to a leader
in healthcare delivery can be seen as a third-level change. Both the goal of
nursing, from an efficient and effective handmaiden to a leader, is
changing, as well as the activities that make up the nursing process.
Today, innovations in healthcare and computer technology are
interactively creating first-, second-, and third-level changes, creating the
future of healthcare within a society that is also undergoing change in
most other society based institutions. Informatics experts are among the
key leaders managing and guiding these change processes within
healthcare. However, they face a number of challenges in achieving these
goals.
The Challenge of Anticipating Future Directions
Almost 50 years ago in 1970, Toffler published the book Future Shock.11 One
of the themes in the book was “what happens to people when they are
overwhelmed by change. It is about how we adapt or fail to adapt to the
future.”11, p. 1 Interestingly, Future Shock was wri en long before the
widespread use of personal computers or the internet. As Toffler identified
many decades ago in a slower-paced world, the degree and speed of
change was overwhelming for many. Today, this includes both providers
and consumers of healthcare who are in the midst of exponential
knowledge growth and must adapt to the overwhelming changes in
healthcare.
While there are no research methods for predicting the future with
absolute certainty, techniques can be used to rationally predict future
directions and trends. A historical example of this is the publication of the
book Megatrends by Naisbi ,12 well before the general population was
aware of the internet or the potential of owning a computer. Megatrends
are trends that affect all aspects of society. The 10 trends identified by
Naisbi are listed in Box 36.3. These trends, identified many years ago,
continue to have a major influence on health informatics today.
Box 36.3
Naisbitt’s Megatrends for the 1980s
• Industrial society → Information society
• Forced technology → High tech/High touch
• National economy → World economy
• Short term → Long term
• Centralized → Decentralized
• Institutional help → Self-help
• Representative democracy → Participatory democracy
• Hierarchies → Networking
• North → South
• Either/Or → Multiple options
While health providers and health informatics specialists clearly
recognize the importance of planning and the long-term implications of
building today’s healthcare information systems, immediate challenges
exist in thinking about the future. First, present issues are often more
pressing and take a higher priority over tasks that can wait for another
day. This type of thinking is sometimes referred to as “pu ing out fires.”
For example, a health informatics specialist may spend an afternoon
answering users’ questions, but as the number of communications
increases, the notes documenting these calls can become increasingly
sparse. Trends and pa erns that could be used as a basis for a new
education and training program, or for upgrading functions in the current
healthcare informatics system, can be lost in the pressing demands of the
moment.
Second, small rates of growth often seem insignificant. However, major
trends start from small, persistent rates of growth. This is especially true
when dealing with exponential growth. A few years ago, very few patients
asked for copies of their health reports, and a very small percentage of
those patients would have considered accessing their healthcare data via
the internet. As of October 2015, the Office of the National Coordinator
(ONC) reported that over 90% of hospitals provide patients the option of
viewing their health data online. See Table 36.1 for additional details about
how hospitals and providers are engaging patients in their own healthcare
via the internet and personal health records (PHRs).
Table 36.1
Extent of Patient Engagement Functions in Hospitals
From Office of the National Coordinator for Health Information Technology. U.S. hospital
adoption of patient engagement functionalities: Health IT Quick-Stat #24.
[Link]/quickstats/pages/FIG-Hospital-Adoption-of-Patient-Engagement-
[Link]; September 2016.
* Measure was not collected in survey year.
† Secure messaging was added to survey in 2014.
Third, there are intellectual, imaginative, and emotional limits to the
amount of change that individuals and organizations can anticipate. The
imagined future is built on assumptions developed in the past and
therefore includes gaps and misinterpretations. Future predictions can
seem vague, and the further one looks into the future, the more
disconnects exist between the present and the significance of the future.
For example, nurses educated in small diploma schools in the 1950s and
1960s usually called a physician to restart an intravenous (IV). If nurses
from that era were asked to predict the future of nursing, they would have
struggled to anticipate the high levels of responsibility common in today’s
staff nurse role, where starting an IV is a common task.
Approaches for Predicting
Qualitative and quantitative methods are used in traditional forecasting
and planning as well as by futurists to foresee, manage, and create the
p g y g
future. The use of established research methods separates these
researchers from soothsayers. Multiple methods used in concert are
needed to identify and address future challenges. Selected examples of
methods used in conduction futures research are presented here. In
addition, Box 36.4 includes resources for exploring a number of other
methodologies used in this field of study.
Box 36.4
Futures Studies Methodologies Resources
• The Institute for Ethics and Emerging Technologies,
h p://[Link]/[Link]/IEET/more/brin20150909
• Methods and Approaches of Futures Studies,
h p://[Link]/~goer el/[Link]
• World Future Society:
• Methods, h p://[Link]/methods
• Methodologies Forum, h p://[Link]/[Link]
• Futures Research Methodology Version 3.0, h p://[Link]-
[Link]/millennium/[Link]
• Five Views of the Future: A Strategic Analysis Framework,
h p://www.tfi.com/pubs/w/pdf/5views_wp.pdf
• Methodologies for Studying Change and the Future,
h p://[Link]/global_options/[Link]#FSMethodols
• The Millennium Project Presentations and Speeches,
h p://[Link]/millennium/[Link]
Trend Analysis and Extrapolation
Trend analysis involves looking at historical data to identify trends over
time. For example, a log of help desk calls demonstrates that over the past
2 months, there has been an increasing number of calls from clinical
managers and department heads concerning the institution’s newly
introduced budget software. This new software offers a number of options
and levels of analysis that are more robust and complex than the software
that was used in the past. Initially several calls occurred from three
managers who work in the same division. However, these managers are
now making very few calls. Instead, the majority of the calls are coming
from a different division. Extrapolation consists of extending these
historical data into the future. For example, if the trend line is sloping
upward, one would continue this line at the same degree of slope into
future time periods. Needless to say, this historical upward trend line will
not continue forever. Eventually the growth will start to slow and an S
curve will develop. With an S curve, the growth is initially slow but then
becomes very rapid. Once the event begins to reach its natural limit, the
rate of growth slows again, creating an S-shaped curve.
A potential example of this pa ern is the future use of PHRs by the
general public. Initially only a small number of people were using this
resource. Google, an early entrant in PHR development, withdrew from
this market because of lack of interest by the general public. However, the
current Blue Bu on data from the Veterans Health Administration (VHA)
suggests that the use of PHRs may be at the beginning of an S curve, with
the possibility of very rapid growth in the next few years. The expected
pa erns of growth can be used to plan educational programming as well
as support services. The need for these services can be expected to grow
and then level off.
While trend analysis and extrapolation demonstrate using numerical
data or quantitative methods to foresee the future, qualitative methods are
also important. One example of qualitative methods is content analysis.
Content Analysis
Content analysis was the major research approach used to identify the
trends in the book Megatrends.12 Content analysis within the futures
research realm involves reviewing a number of information resources and
noting what topics are discussed, what is being said about these topics,
and what topics are not discussed. A current example of this type of
analysis can be seen in the website created as an informational tool for
public health. This application searches open-source Twi er data for
health topics and delivers an analysis of that data for both a specified
geographic area and the national level, thereby serving as an indicator of
potential health issues emerging in the population, building a baseline of
trend data, and engaging the public on trending health topics. A
screenshot showing the types of data being tracked is provided in Fig.
36.1. The assumptions made in identifying resources, topics, and trends to
monitor can have a major impact on determining the forecasts produced.
This is one of the reasons it is important that informatics specialists review
several different resources from several different perspectives in analyzing
trends.
FIG 36.1 What is now trending. Following disease trends 140
characters at a time. From U.S. Department of Health and Human Services.
<[Link]
Scenarios
Scenarios involve asking individuals to envision possible futures within a
certain context. For example, people may be asked to describe the
electronic health record (EHR) they might expect to see 10 to 15 years in
the future. This can be done as a group process or individually.
Participants should be encouraged to envision scenarios that are
multifaceted and holistic, internally consistent, and free of personal bias.
Elements in the scenario should not be contradictory or improbable. A
well-constructed scenario may suggest events and conditions not presently
being considered.
The following three major approaches can be used to construct a
scenario:
1. The Delphi method can be used to elicit expert forecasts for a
specific time frame. A combination or synthesis of opinions is used
to develop the scenario.
2. Experts develop scenarios that reflect the viewpoint of their
disciplines. These are modified and combined to produce an overall
scenario.
3. A cross-impact technique is used to test the effect of one aspect of
the scenario on all of its contributing parts.
The creation of scenarios can be used in concert with backcasting.
Backcasting
With backcasting, one envisions a desired future end point and then
works backward to determine what activities and policies would be
required to achieve that future. Backcasting involves the following six
steps:
1. Determine goals or the desired future state.
2. Specify objectives and constraints.
3. Describe the present system.
4. Specify exogenous variables.
5. Undertake scenario analysis.
6. Undertake impact analysis.
The end result of backcasting is to develop alternative images of the
future, thoroughly analyzed as to their feasibility and consequences.13
With the rapid changes in informatics, the use of futures research
methods is likely to increase. Informatics specialists concentrated on
implementation and change issues during first generation of EHRs, data
warehouses, and mHealth. For the next generations of health IT products,
futurology can more readily be incorporated in the health professional or
informatician’s suite of skills.
Application of Futures Research
Health and informatics professionals can use methodologies and strategies
from futures studies in two primary ways. First is foreseeing or predicting
future trends and directions. For example, in the 1970s and 1980s, much of
healthcare was financed via fee-for-service funding approaches. Health
information systems were designed to capture charges but not to measure
the cost of care. A number of items, including nursing and other services,
are included in the patient’s charge for a hospital room. In a fee-for-service
approach, the contribution of nursing and other services to the total cost
was irrelevant. Cost and charges did not need to correlate. The charge
could be whatever the market would bear.
The introduction of the prospective payment system in the 1980s and
managed care in the 1990s is now followed by the current value-based
approach, Merit-Based Incentive Payment System (MIPS), included with
the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.
These initiatives require that healthcare institutions capture costs and
quality rather than just charges. Existing information systems were never
designed to facilitate capturing discrete costs (versus charges). The ability
to predict these kinds of major changes in healthcare delivery could be a
significant advantage to vendors and healthcare institutions alike. By
predicting the potential costs and benefits, one is be er prepared to
manage these events. Cost-benefit analysis is an example of using futures
studies for management.
Creating the future is the second way in which health informatics
specialists use futures studies methods. By thinking of possible futures
scenarios, health and informatics professionals can work toward creating
the environment in which these futures might be possible. By using the
work of futurists, as well as applying futures studies methods and tools, it
is feasible to imagine possible future trends and directions and thereby
work to create preferable future directions.
The future of health informatics
Health informatics is and will remain a dynamic and complex field. Thus
accurately predicting precise directions for its future is inherently
uncertain. To determine likely directions for the future in healthcare and
health informatics, the authors searched traditional literature databases,
publicly available white papers such as the National Institute of Health’s
plan for 2016–2020,14 and reports from major analytic firms such as
Mana ’s Megatrends Shaping Healthcare 2016–202015 and
Pricewaterhouse Coopers' (PwC) Top Health Industry Issues,16 as well as
less formal sources such as futures presentations by national and regional
experts.
Formal literature does not provide consensus about emerging or future
directions for informatics. Authors in the past wrote about the future of
academic biomedical informatics,17 created a nursing informatics research
agenda for 2008–2018,18 and provided an analysis of the past, present, and
future of medical informatics19; however, none of these was published
recently. Within informatics and nursing, major past efforts internationally
centered on terminology development.20 Future trends will certainly
include this emphasis but likely will expand into new areas, as outlined in
the following discussion.
Looking further into the future can influence thinking about near-term
trends. Outside the field of healthcare, contemporary issues of The Futurist
(h p://[Link]/futurist) list annual outlooks. A sampling of trends
pertinent to healthcare include the following:
• Tiny chips. Computer chips will shrink to the size of dust and be
ubiquitous.21
• Huge amounts of transmi ed personal health data. Embedded or
swallowed sensors will collect and transmit an array of personal
data.22
• New leader skills. These will be shaped by those with social networking,
content management, data mining, and data meaning skills. New job
titles will include Chief Content Officer and Chief Data Scientist.23
• Nanotechnology products. Buckypaper is composed of industrial-grade
carbon nanotubes and is 100 times stronger than steel per unit of
weight. It conducts electricity like copper and disperses heat like steel
or brass.24
• Nanorobots or nanobots. These carry molecule-sized elements, can
detect cancer, and are being developed by researchers at Harvard
University.25
• Full-body firewalls. These are necessary to prevent hackers from
tampering with wireless medical devices and internal drug delivery
systems. Researchers at Purdue and Princeton Universities are
developing a medical monitor (MedMon) designed to identify
potentially malicious activity.26
• Ubiquitous computing environments. Workplaces will become
ubiquitous computing environments that include computing
capabilities and connectivity.27 Likewise, homes and personal devices
will provide constant communication and computing outside work.
• Image-driven communication. Graphics and images will be more heavily
relied on for communication, allowing faster comprehension and
possibly new ways of thinking, but at the cost of eloquence and
precision.28
• Living data. Connectivity will expand to millions of devices, and
sensors will gather more data that will be processed by more
computers. Data may become too big, so channeling the power of data
will become important.29
• The intelligent “cloud.” This will become not just a place to store data
but will evolve into an active resource, providing analysis and
contextual advice.30
These more futuristic trends are important to monitor, and some inform
near-term trends. Near-term future trends are (1) person-centered health
and concomitant implications for health informatics; (2) technical trends in
health IT such as the internet of things (IoT) and cybersecurity issues; and
(3) clinical informatics trends, including what is beyond traditional EHRs,
improving the user experience (UX), predictive analytics, and data
visualization.
Person-Centered Health and Informatics
An obvious shift has occurred away from provider-centric healthcare
toward person-centered health.31,32 The importance of this shift is
underscored in a number of chapters of this book: Chapter 8 (Telehealth),
Chapter 9 (Home Health), Chapter 12 (ePatients), Chapter 13 (Social
Media), Chapter 14 (Personal Health Records) and Chapter 15 (mHealth).
This direction will continue to accelerate over time, although healthcare
and informatics will likely see the fusion of several of these separate areas
in the future.
The term person-centered health is used as a generic term to encompass
ideas about the various terms in use today: person-centered care, patient-
centered care, precision medicine, and consumer-centered care. Person-
centered care embodies personal choice and autonomy in healthcare
decision making.33 More specifically, this newer term most frequently
includes these six principles: (1) whole-person care, (2) respect and value,
(3) choice, (4) dignity, (5) self-determination, and (6) purposeful living.
They are being applied to the care of older adults in particular.33 Precision
(or personalized) medicine includes a central premise that health
interventions are tailored to specific individual differences such as
genome, environments, and lifestyle.34 For example, therapeutics would be
tailored specifically to individuals’ genetic tumor compositions and their
responses to previous interventions. In support of research for precision
medicine, an initial $215 million investment was recently included in the
U.S. budget.34 No ma er the current term, the shift is toward tailoring care
to and improved support of health decision making for individuals. This
shift has substantial implications for informatics because these areas are
highly data-centric. Demiris and Kneale35 outlined initial informatics
support for the move toward person- and patient-centric care (e.g.,
improvements in clinical decision support, e-tools to support care
transitions, PHRs, and telehealth). Two other near-term informatics trends
are outlined in support of person-centered health in the future: (1) care
anywhere and everywhere and (2) personal data integration.
Care Anywhere
EHRs by design are organization- and provider-focused. The movement
toward person-centered health requires rethinking the design of disparate
health data into a person-centric format. Aspects of traditional care
se ings, supported by EHRs and to a lesser extent by PHRs, are evolving
into remote, on-demand services for many nonemergent services. Through
informatics tools, consumers are supported as they assume more
responsibility for their own care, especially consumers with chronic
diseases. Informatics support via apps and the internet is expanding at an
enormous rate. From 2013 to 2015 alone, mHealth applications expanded
fourfold from 40,000 to over 165,000,36 and on-demand services are easily
accessible via the internet (e.g., dermatology).37 Although the care models
of the future are not precisely clear, the move is toward care anytime,
anywhere for areas such as primary care and chronic care.
The design of tailored, person-centered applications provides a wealth
of opportunities for research and development, including the following:
• Theory-based studies on the impact of person-centered health IT
products
• The effectiveness of changing care models on care collaboration for
individuals focused on person-centered health
Personal Data Integration
As information in Chapter 8 points out, simple personal monitoring tools
such as electronic scales and remote blood glucose monitors are already
expanding into a suite of robust biometric sensor technologies. One source
indicated that by 2018, 130 million wearable sensors will be acquired by
the public.38 Smart textiles and other personal devices such as smart
contact lenses and smart homes in the future could provide constant
monitoring of individuals’ health and chronic conditions. No doubt many
people will be actively monitoring and interpreting their own data from
these devices.
Care anywhere and the increase in personal data mandates an
amalgamation of pertinent health data beyond a casual level and away
from informal personal records or users keeping data in their heads.
Instead, these will need to include data integration across disparate
sources for an interpretable individual view. Today, mHealth apps and
online services result in stand-alone data viewed primarily by patients and
families. Thus the challenge will be to effect data integration across diverse
sources and to provide monitoring with appropriate interventions for any
acute changes. Future research and evaluation might include the
following:
• Evaluating the impact of role changes from provider-centric to patient-
centric data
• Exploring outcomes of the new digital divide among individuals who
cannot or choose not to be “quantified” by personal data
Technical Trends
Technical aspects of health informatics are trending toward cloud
computing and remote application services, as indicated in Chapter 5. Two
other important technical trends are especially relevant for the near future:
the IoT and increased cybersecurity threats.
The Internet of Things
Simply put, the IoT refers to a network of connected devices.39 Currently,
the IoT might be used to remotely monitor a patient after discharge40 or to
track equipment or people inside health facilities. In the future, the IoT has
broader applications. With multiple devices and people connected via the
internet, new applications are possible. A simple application might involve
improved remote physiologic monitoring using sensors. For example,
flexible and wearable sensors, which adhere to skin be er, and silicon-
based materials, which conduct signals be er, can combine with the IoT to
allow improved, remote physiologic monitoring for patients.41 More
complex IoT applications in a facility might include a suite of interacting
devices and applications, including:
• Physiologic monitoring across hospital units and areas without
equipment changes
• Inpatient assignments coordinated with nurses’ experience levels due
to the integration of smart staffing and scheduling applications with
patient conditions
• Consumable supplies and medications automatically creating their
own charges on patients’ bills
• Consumable supplies automatically reordering themselves when
supplies run low
• Durable medical equipment that automatically appears on units when
a discharge order is wri en
In fact, Gartner estimates that by the year 2020, nearly 26 billion devices
will be on the IoT.42 Trends in healthcare informatics will likely mirror the
increase in connectivity via the IoT. Imagine the potential of this kind of
capability combined with care anywhere, personal device data, and EHRs.
Future research might include the following:
• Evaluation of the timeliness of diagnoses with newer models of data
availability
• Changes in provider and patient treatment adherence and monitoring
with the IoT data
However, with this expanded connectivity, the available health data
increases but so do the risks to health data privacy and security.
Cybersecurity Threats and Mitigation
One of the most ominous risks in health informatics now and in the future
is the increase in cybersecurity threats (see Chapter 26). With the
proliferation of devices, their connectivity to the IoT, the increased use of
mHealth apps, and the increase in health data posted on social media,
cybersecurity threats will only increase in volume and severity. New
threats are emerging. For example, hackers cut off health data access at a
California hospital and demanded a $3.5 million ransom.43 All data were
affected, from prescriptions to CT scans and even e-mails, forcing the staff
to revert to paper methods and potentially compromising patient care. The
hospital executives decided to pay a $17,000 ransom in bitcoins to end the
incident. These incidences will likely be more prevalent in the future.
The informatics future will surely include more emphasis on health IT
security, improved security using thorough risk assessments, and
increased fiscal allocations for cybersecurity. A particular emphasis will be
on improving the cybersecurity of personal health devices and preparing
for the IoT connections. Policies, procedures, and code will be developed
to prevent hacking and to avert paying ransoms in the future. Future
research might include the following:
• The impact of threats on patients’ willingness to share private data
such as mental health concerns
• National efforts to combat cybersecurity threats
Clinical informatics
Beyond EHRs 1.0
With EHR adoption rates rising, especially for ambulatory practices,44
leaders and informaticians are shifting the focus away from basic
implementations to other issues such as system optimization and data
science (discussed in Chapter 23 and later in this chapter). One of the most
common foci is system optimization. The term optimization is used for both
initial and postimplementation efforts. Users can benefit from applying
known principles for project management and systems implementation
(Chapters 17 and 19), as well as by using available guides such as
Strategies for Optimizing an EHR System45 from the ONC for Health IT.
Optimization, more importantly, includes post-implementation
evaluations, ongoing training, and system re-tailoring where needed.
Installations obviously do not end with go-live. Many institutions consider
EHR installations as continual transformation instead.
Unfortunately, the Health Information Technology for Economic
Clinical Health (HITECH) Act did not include funding for research to
evaluate the impact of EHRs,17so this type of research constitutes a future
direction for informatics practice and research. In an editorial for The New
England Journal of Medicine, Mandl and Kohane argue that vendors
propagated a myth of complexity that precludes innovation and that EHRs
are different than more flexible and robust consumer technology.46 The
authors' impatience and health IT leaders could drive needed changes for
EHRs in the future. One change might be that vendors no longer are full-
service providers of EHRs. Instead, they may become smaller service and
application providers, allowing sites to pick and choose best options
among vendors, including among nontraditional vendors such as Google
or Microsoft.
Another approach is described by Celi et al.,47 who propose the
construction of what they call optimal data systems. They recommend a
focus on clinical decision making through the collection of data from
various sources (Box 36.5). Although UX and data visualization issues
would need to be central to development, this approach certainly provides
an interesting vision beyond EHRs 1.0.
Box 36.5
Elements of an Optimal Data System 4 6
• Automatic collection and display of new data (real-time data), including
alternative sources such as prehospital and personal device data
• Capture and integration of new data with historical to visualize trends
and determine the current clinical state of the patient
• Integration of clinical decision support systems and Watson capabilities
for diagnostic, therapeutic, and prognosis activities
• Use of machine learning to improve the quality of information
• User-tailored views of data
• Data sharing for population management
• Reports on adherence to best practice management
• Flexible system architecture to allow importing new modalities for
decision support
• Prioritization of information types to allow urgent information to be
incorporated (e.g., epidemics, disaster information)
• Use of user-centered design techniques (prototyping)
Source: Celi LA, Csete M, Stone D. Optimal data systems: the future of clinical predictions and
decision support. Curr Opin Crit Care. 2014;20(5):573-580.
Newer infrastructures, such as cloud computing, middleware, and
mobile applications, could allow more robust integration efforts at the
healthcare provider and consumer end of computing. Facilities are already
incorporating mHealth apps into their suite of applications, although
current statistics indicate only about 2% of patients are using them
currently.48 User demands may force vendors to incorporate newer tools in
their offerings, such as more robust clinical documentation tools with
integrated graphics and drawing capabilities and even a basic spell-
checker, currently lacking in today’s EHRs. Previous authors indicated
that disruptive technologies for EHRs are needed to displace the current
model of EHRs.46
EHR interoperability efforts will continue, especially in the United
States, where the diversity of products and components has caused the
nation to lag behind others in creating integrated, person-centered, and
longitudinal EHRs. Regional integration efforts have helped in the effort to
share data, although interoperability beyond regions will be a continuous,
costly future direction for the U.S. informatics research, and operational
efforts on ontologies will continue to facilitate this work. What is urgently
needed in the short term is a decision about the use of one or two specific
ontologies, versus an endorsement of a suite of competing ontologies,
especially for nursing. A more long-term solution may be found in the
current research on national language processing and semantic mapping,
where the process of mapping concepts can be automated. An early
example of this can be seen with the diagnostic reasoning of IBM Watson,
where analysis occurs at the cognitive level and does not require consistent
use of the exact same terminology.
As is being seen with care anywhere efforts already, the traditional view
of EHRs may fade. EHRs may be less organization- and site-specific and
may become dispersed with data owners related to their roles (patient,
healthcare provider, insurer, lab, pharmacy, etc.). In this case, data are
pulled and integrated from geographic or other defined areas. A particular
need for the future is more team-based, interdisciplinary views, and
collaborations based on EHR data. New visions for EHRs are needed to be
more patient-centric (beyond initial PHRs) and to serve as communication
hubs.49 Given the importance of teams in healthcare, the next generation of
EHRs, no ma er how they are instantiated, should offer collaborative
workflow tools and methods for synthesizing data and information for
“at-a-glance” views across disciplines, sites, types of agencies, and
traditional modules.
Potential areas for future research include the following:
• Evaluative research on the impacts of EHRs from various viewpoints
of consumers, healthcare providers, teams, care outcomes, and quality
of care
• Impacts of integrative views of patient-centered data across traditional
EHR modules and disciplines
• Cost-effectiveness research and comparative effectiveness for EHR
designs
Improving the user experience for health
information technology
Efforts to improve the UX for health IT have now begun after years of
relative neglect. More are needed. Leaders are recognizing that UX issues
can affect patient safety as well as user efficiency and satisfaction.
Healthcare providers deplore the poor usability of today’s EHRs.
Improving the UX for health IT is an obvious future trend. As noted in
Chapter 21, the American Medical Association (AMA) and 30 physician
groups wrote to the ONC for health IT about poor EHR usability and its
impact on physician productivity and reimbursements.50 In late 2015, the
AMA held two town hall meetings to outline usability issues and
subsequently released a framework for sites to gauge the effectiveness of a
vendor’s user-centered design techniques.51 Other professions need similar
efforts to improve the UX. Within nursing, Staggers et al. issued a recent
call to action to improve the UX for health IT for nurses. UX efforts are
needed, especially for vexing designs such as care transitions, medication
management (Electronic Medication Administration Recordsor [eMARs]),
and clinical documentation.52
On a more hopeful note, some large health IT vendors have hired UX
professionals and are beginning to employ user-centered design
techniques like those discussed in Chapter 21. These efforts were
incentivized by Meaningful Use requirements. Whether these efforts
continue as robustly remains to be seen. At this writing, UX improvements
are occurring more slowly for nurses and allied health professionals than
for physicians.
What is needed in the future are repositories for excellent designs and
solutions to current UX issues. Typically, each site grapples with problems
de novo, meaning wasted effort across the nation. Excellent, generic designs
should be constructed and shared for common applications such as
assessments, eMARs, and the like.
Due to current complaints by users, federal UX requirements will likely
expand (beyond medical devices regulated by the U.S. Food and Drug
Administration), and vendors will have to respond to the need for
improved products. Organizations will need to increase their knowledge
about and skills for improving the UX. Excellent resources for meeting this
challenge are the Healthcare Information and Management Systems
Society (HIMSS) Usability Maturity Model,53 the ONC’s SAFER (Safety
Assurance Factors for EHR Resilience) guides,54 and documents from the
National Institute for Standards and Technology (NIST).55 Research
directions for improving the UX are many. Examples include the
following:
• Comparative effectiveness research on EHR and device designs,
especially for complex patient views, such as clinical summaries, care
transitions, and eMARs.
• Developing and implementing best design practices agnostic of
vendors. Perhaps decoupling user views from underlying code could
occur so that optimal designs could be downloaded by healthcare
providers and layered onto their local data.
• Determining outcomes for varying application designs. For instance,
improved displays can positively affect clinicians’ situation awareness
and performance in intensive care units (ICUs).56–58 Similar studies for
other applications could be completed.
Analytics (big data) and data
visualization
The world is generating mass amounts of data. IBM estimates that 2.5
quintillion bytes of information are generated each day. That is three times
the equivalent of the Library of Congress each second.59 In the life sciences,
genomic data have created large datasets for analyses. Bioinformatics
efforts are underway to integrate data across disparate fields. For example,
the National Center for Integrative Biomedical Informatics from the
National Institutes of Health is developing interactive, integrated, analytic,
and modeling technologies from molecular biology, experimental data,
and the published literature.60
Within healthcare, data warehouses combine longitudinal,
administration, and financial data into a searchable database, although
typically at the local or healthcare enterprise level. Now, the boundaries
are blurring among personal health data sources: mHealth, social media,
wearable and sensor devices, and PHRs,61 so opportunities for increased
data collection are manifest. Thus data from personal devices such as
sensor data and mobile and remote technologies could be integrated with
EHR data in the near future. Personalized medicine efforts, including
genomic data and nanotechnology, promise the expansion of these kinds
of databases even further.
With these super-sized datasets, an unparalleled opportunity exists to
examine data and issues across thousands of data points integrated across
fields (population data, genomics, etc). The challenge is that the ability to
collect these types of data has outstripped the ability to analyze them.62 Data
science was discussed in Chapter 23, and as readers recall, data analytics
help in sense making by revealing pa erns in datasets. A current trend is
the shift from retrospective to predictive analytics.
Predictive analytics
According to current national and regional presentations, Chief
Information Officers (CIOs) and health IT leaders are moving their foci to
predictive analytics. As mentioned in Chapter 23, predictive analytics is
the use of past data to predict future trends. The goal is to present data to
decision makers as close to real time as possible. A simple example might
be the real-time analysis of vital sign trends in a patient on a medical-
surgical unit to predict the need to call a rapid response team and prevent
a code. On a more complex level, the description about the optimal data
system for EHRs discussed previously would rely on predictive analytics
for decision making about intensive care patients—that is, the system
would amass near real-time data from traditional sources like physiologic
monitoring and less traditional sources including IBM Watson, analyzing
them and displaying data in near real time for care decisions across
complex datasets.
From an analytics tools perspective, Shameer et al.63 depict a model for
data integration and subsequent analyses at the individual level (Fig. 36.2).
Here, data from different sources would be integrated for uses in person-
centered health and precision medicine to provide individualized
predictive analytics. This type of real-time analysis is a marriage of EHRs,
decision support, and computer science and is being proposed for clinical
se ings, although it is not yet actualized.63 As this type of real time
analysis becomes available at the individual level, healthcare providers
will be challenged to integrate yet more information into their cognitive
processes and workflow.
FIG 36.2 Healthcare and wellcare data model. From Shameer K,
Badgeley MA, Glicksberg BS, Morgan JW, Dudley JT. Translational bioinformatics in the
era of real-time biomedical health care and wellness data streams. Brief Bioinform. 2016,
pii: bbv118. Reprinted with permission from Oxford University Press.
In other examples, predictive analytics could be useful at the population
level in detecting global diseases such as the Zika virus or even in real-
time fraud detection for someone a empting to use information to cheat
on insurance coverage, much like credit card fraud detection is done
today. These kinds of advanced applications are predicated on having
quality source data, standards for integration and appropriate integrated
data, and a capability of being able to interpret data using tools like data
visualization.
Data visualization
One of the pressing issues with analytics is making sense of vast amounts
of stored data. Unlike traditional graphs and charts, new methods are
being developed outside healthcare. Fig. 36.3 provides an example from
biology and computer science. At the intersection of science, design, and
data, data visualization involves understanding principles of human
perception, design, and computing capabilities.64
FIG 36.3 Example of visualization tools used to compare fruit fly
attributes. From Fowlkes CC, Eckenrode KB, Bragdon MD, et al. A conserved
developmental patterning network produces quantitatively different output in multiple
species of Drosophila. PLoS Genet. 2011;7(10):e1002346.
In the life sciences, interdisciplinary teams of biologists and computer
scientists developed interactive visualization tools like MulteeSum to
compare genes in fruit flies.65 In healthcare, analytic tools for searching
data warehouses are emerging, but data visualization tools like those from
the life sciences are still very limited in their application to health data,
and they do not yet exist at the point of care. Because analyzing data and
making conclusions from stored data can affect organizational and patient
care decisions, data visualization efforts for healthcare will be an
important future trend.
Research directions for analytics and data visualization include the
following:
• Developing and implementing at the key decision points and
interactive visualization tools for health practitioners, especially for
nursing, pharmacy, and other healthcare providers whose analytic
and decision support needs are often neglected.
• Developing big datasets, combining published literature, population
data, and regional data warehouses.
• Detecting pa erns for interventions and outcomes in national
databases, including databases that incorporate include newer data
such as sleep monitoring, metabolic values such as pO2, and patient-
generated fitness data with more traditional EHR data.
Nanotechnology
Nanotechnology is the study of controlling and altering ma er at the
atomic or molecular level.66 The focus of the field is the creation of
materials, devices, and other structures at the nanoscale (1 to 1000 nm).
The produced items are referred to as nanomaterials, which are composed
of smaller subunits called nanoparticles. Nanotechnology is a diverse field
that requires a collaborative environment across multiple domains (e.g.,
surface engineering, physics, organic chemistry, molecular biology, and
materials science).
History of Nanotechnology
Even though the majority of research in the field of nanotechnology was
conducted in the past few decades, the field began in 1959 when Feynman
presented a lecture titled “There’s Plenty of Room at the Bo om.”67 In this
talk, he discussed being able to manipulate individual atoms, which
would allow for more flexibility and use in synthetic chemistry.
The field expanded in the 1980s with the invention of the scanning
tunneling microscope and the discovery of fullerenes, a carbon molecule.
With the scanning tunneling microscope, scientists could visualize
particles at the nanoscale. In 1985, Kroto and his collaborators discovered a
molecule composed solely of carbon, which they named
Buckminsterfullerene.68 Buckminsterfullerene is a spherical molecule
composed of 60 carbon atoms. This gives the molecule a high structural
integrity and makes it very stable. This discovery laid the foundation for
the development of a well-recognized nanoparticle, the carbon nanotube.
A carbon nanotube is a nanoparticle composed of carbon atoms bound to
one another to form a tubelike structure (Fig. 36.4). Thus carbon nanotubes
are a member of the fullerene family of molecules. They have a unique
combination of thermal conductivity, mechanical properties, and electrical
properties that makes them useful in the development of structural
materials like steel.
FIG 36.4 A carbon nanotube. Copyright Owen Thomas/123RF Stock Photo.
Reprinted with permission.
Nanofabrication and Nanomedicine
Nanomaterials and nanoparticles are used in electronics, biomaterials, and
healthcare. Some claim that this area of science and technology has the
opportunity to revolutionize our world. Manipulation of particles at the
nanoscale allows the creation of unique materials with special properties
(e.g., unique chemical, physical, or biologic properties, such as increased
electrical conductivity or strength). The special properties are due to the
particles’ incredibly small size, which allows absorption or unique
movement, and also due to increased surface areas that interact with their
environments, creating increased interactions among materials.
Nanofabrication
Nanofabrication is the development of materials used in structures,
electronics, and commercial products. Fabricated nanoparticles are
typically added to larger physical structures to enhance them, resulting in
increased strength, elasticity, conductivity, or antimicrobial properties.
Much work has been done with carbon nanotubes, because the tubelike
structure provides increased material strength. Carbon nanotubes are now
commonly used in electronics as wiring for electrical components. For
example, a research group at Rice University bound carbon nanotubes to
Kevlar fibers to make durable, conductive wires that can be used in
wearable electronics and ba ery-heated body armor.69 Quantum dots,
semiconductor devices whose elements move in all three dimensions, are
another nanoparticle often used in electronics as semiconductors.
The number of commercially available items containing nanoparticles
has increased at an aggressive pace over the past two decades. When the
Project on Emerging Nanotechnologies (PEN) began its inventory in 2005,
212 products were listed. The latest inventory in 2015 estimates that more
than 1800 manufactured, nanotechnology-enabled products have entered
the commercial marketplace; the majority are in the health and fitness
category.70 Items containing nanoparticles are very diverse, ranging from
everyday items such as nonstick cookware and lotions to unique items
such as self-cleaning window treatments. Probably the most commonly
used and commercially available product is silver nanoparticles, due to its
antimicrobial properties.
Nanomedicine
Nanomedicine centers on the application of nanoparticles and
nanoscience techniques to healthcare and clinical research.71 Its primary
goal is the use of nanotechnology for the diagnosis, treatment, and
prevention of diseases. Applications include nanoparticles as delivery
devices for pharmaceutics, diagnostic devices, and tissue replacement.72
Nanoparticles, due to their size and structure, behave differently than
traditional particles because they avoid the body’s immune defense
mechanisms, avoid filtration by the body, and interact more with tissues.
Antibodies and a variety of other surface-engineered materials can be
conjugated to the surface of nanoparticles, increasing their specificity for
individual cell types (e.g., tumors). Importantly, the use of nanomaterials
reduces medication dosages and effects on nontargeted tissues. Current
research focuses on exploiting the highly soluble, targeting properties of
nanoparticles to improve the delivery of cancer drugs to tumor-containing
tissues73 and on using nanoparticles to deliver nonviral genes and small
interfering ribonucleic acid (RNA) to combat viruses and cancer.74
Another very intriguing area of nanomedicine research is advanced
imaging and thermotherapy. Quantum dot nanoparticles are used in
conjunction with magnetic resonance imaging (MRI) techniques to
produce exceptional images of tumorous tissues. Chemical or physical
groups can be a ached to these nanoparticles via surface engineering, so
that they seek out tumor cells and increase the resolution of images.75
These same nanoparticles can then be used in the treatment of tumor cells
using techniques such as thermotherapy. The process aggregates
nanoparticles in tumorous tissues and then excites the nanoparticles using
targeted radio waves, lasers, or focused magnetic waves. The excitation
causes the metals in these nanoparticles to heat up, raising the temperature
of nearby tissues (localized hyperthermia) and causing targeted cell
death.76
Work is being done to develop in vitro early disease detection methods
using nanoparticles. Thus nanoparticles are being used as diagnostic tools.
One example is the use of a dime-sized microfluidic device containing a
network of carbon nanotubes coated with tumor-specific antibodies.77 A
patient’s blood sample passes through the device, and any tumor cells are
bound to the nanotubes. Another sensor includes chips containing
thousands of nanowires able to detect proteins and other biomarkers
produced by cancerous cells. These types of advances could, in the future,
enable the widespread detection and diagnosis of cancer in very early
stages.
Cautions About Nanotechnology
Even though nanoparticles are incredibly effective and useful, caution is
warranted. Unintended consequences of nanomaterials are due to
secondary effects, such as cytotoxicity. For the same reasons that
nanoparticles are effective (i.e., their size and increased surface
interactions), they also can cause toxicity to the environment and humans.
This is a key area of concern and current research in the nanoscience and
nanomedicine community.78,79 Many authors discuss inherent toxicity due
to nanomaterials’ surface charge.78–81 This surface charge is necessary for
cellular uptake. However, if the charge is too high, it can create holes
within the cell membranes, resulting in membrane degradation, erosion,
and ultimately cell lysis. Clearance of nanoparticles from the human body
is another key area of concern, because nanoparticles may be rapidly
eliminated by the kidneys or, alternatively, remain in circulation for long
periods of time, increasing exposure and potential toxicity.
Synthetic methods such as the use of surface engineering and
biodegradable components to construct nanoparticles are being employed
to counteract the inherent toxicity of nanoparticles. These processes are
used to alter the cationic surface charge of most nanoparticles by reducing
the cationic charge, making it neutral or completely changing it to an
anionic charge. However, if the surface charge of nanoparticles is reduced
too much, the bioavailability of the nanoparticles is also decreased.
Because of potential toxicity, nanoparticles must be evaluated carefully
before they are approved for routine use in the clinical arena.81,82
Nanoinformatics
Nanoinformatics was created in an effort to help manage the large
volumes of data being produced by the field of nanotechnology. The
foundations for nanoinformatics began in 2007 at the U.S. National Science
Foundation. The focus of nanoinformatics is the use of biomedical
informatics techniques and tools for nanoparticle data and information. In
October 2011, the U.S. National Nanotechnology Initiative (NNI)
document was developed, which outlined the following three major goals
for nanoinformatics:
1. Enhance the quality and availability of data about nanoparticles.
2. Expand nanotechnology theory, modeling, and simulation.
3. Develop an informatics infrastructure.83
The first goal has received the most a ention to date. A number of
groups are standardizing nanotechnology terms and developing
ontologies to represent the relationships among the terms. The two most
recognized standards organizations in nanotechnology are the
Nanotechnology Standards Panel of the American National Standards
Institute and the Nanotechnology Technical Commi ee of the
International Organization for Standardization. The National Cancer
Institute leads one of the most well-recognized ontology programs in
nanotechnology, the NanoParticle Ontology.
Some progress has been made on the second and third NNI goals. The
U.S. National Science Foundation hosts a site named nanoHUB that offers
a wide variety of nanotechnology simulation tools for use by the general
public and researchers. Recently, 10 federal organizations formed the
Nanotechnology Knowledge Infrastructure Signature Initiative, or NKI. Its
purpose is to create a knowledge infrastructure to speed nanotechnology
innovations by developing a cyber toolbox, models, and an information
infrastructure.84 The latest collection of nanotechnology cybertools are
shown at h p://[Link]/NKIPortal/CyberToolbox. Also, many
different research groups have been working on the development of
predictive models to determine a number of different properties of
nanoparticles. Overall, good progress has been made in the young field of
nanoinformatics. However, the future will include much more work in this
area.
In the future, one of the most pressing goals is to create an available
public database of easily computable, nanoparticle data. To accomplish
this, the extensive available literature on nanoparticles needs to be mined
for relevant properties matched to existing standards systems or
ontologies. This type of database could then be used for future data
mining and model development. Beyond that, a next goal could be to
develop predictive modeling software for developing quantitative
structure activity relationships for nanoparticles. This would allow
researchers to develop computer-generated structural images of
nanoparticles and test them in a simulated environment, allowing toxicity,
bioavailability, and many other functional property predictions for
nanoparticles.
Issues in Regulation and Ethics
Previous authors are debating the regulatory and ethical implications of
nanomaterials because of the unique properties and potential toxicity
inherent in these materials. While some indicate that current frameworks
are adequate to allow regulatory and ethical assessments,85,86 pressing
considerations are evident. For example, current cosmetic products such as
sunscreens are seldom labeled as containing nanomaterials,87,88 leaving
consumers uninformed. No regulations require such labeling as yet.
Scientists can manufacture completely new materials with nanoscience,
yet reliable information about the safety of nanomaterials lags behind their
fabrication.88 Exact risks for patients, employees, and scientists are not yet
known. The potential applications for nanomaterials are enormous;
likewise, their risks and regulatory and ethical implications are equally
grand. Future applications could enhance oxygen storage in blood. This
would, of course, be a boon to patients with illnesses such as emphysema
or chronic anemia, but it has implications for ethics and regulation of
sports competitions, as well as general use in humans.89
More alarming findings are emerging. For instance, researchers found
that nanoparticle uptake by salmon negatively altered feeding behavior
and lipid metabolism.90 This finding is of particular concern because this
kind of nanoparticle ingestion mimics typical feeding activity in the
world’s food chain. Whether regulatory controls will keep pace with
discoveries such as these is an issue.
Once nanomaterials are more commonplace in healthcare, ethical issues
will arise for the workplace related to hazards, risks, and projected
controls.91 Ethically, workers will need to be informed about potential
exposure to nanomaterials and risks related to inhalation, skin absorption,
or unintended ingestion. This implies a responsibility for accurate
assessment by employers, communication about risks, and perhaps even a
form of informed consent by workers. For patients, expanded informed
consent may be needed for nano-based medications, because all
interactions are unlikely to be identified during testing.72,92 Clearly, safety,
regulatory, and ethical concerns are paramount for nanomaterials.
The field of nanotechnology is exciting, but caution is warranted. By
virtue of the rapid advancements, nanotechnology is a major future
direction for informatics, informatics research, commercial product
development, health products, and impact assessment.
Conclusion and future directions
Health professionals, informatics specialists, and leaders cannot afford to
leave the future to chance. They must proactively and systematically
identify future trends and directions in society, healthcare, technology,
and informatics. This information and knowledge can provide the
foundation for designing and building health information systems of the
future. The methods and trends discussed in this chapter provide tools
and ideas for health professional informaticians to use in identifying
important future trends locally, regionally, and nationally.
As the rate of change continues to expand, it is expected that healthcare
providers and informaticians will increase their use of e-tools and methods
of futures research to predict and plan for an informatics-supported future
in healthcare.
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Discussion questions
1. In your work se ing, which future trend(s) are likely to have the largest
effect on patient care and related information systems?
2. Select one of the chapter topics in this book. For example, you might
select mHealth in Chapter 15. Use the three levels of change to describe
how your selected area of informatics might evolve over the next several
years.
3. Use Box 36.4 to access and explore a futures research methodology that
was not discussed in this chapter. Describe the methodology and how it
could be used in health informatics.
4. Compare and contrast the trends of EHR directions and personal
healthcare informatics. Where do they overlap and where do they
differ?
5. Describe how nanomaterials might affect your own life in the near
future. Consider the consumer products you use and your role in
healthcare.
6. Using futures research methods, identify how you think nanotechnology
might impact both health IT and health informatics.
Case study
You have just been hired as a clinical informatics leader for a new health
system. The health system has 23 acute care facilities and 36 outpatient
clinics. It serves as a regional referral center for three states in the Midwest.
Your installed base includes a vendor-supplied EHR from a national
vendor. Work on the data warehouse is being rethought. Your site has
more than 300 varying applications across sites, including everything from
a stand-alone pharmacy application for drug interactions to a cancer
registry. Your goal is to provide IT support for the organizational vision of
being the premier health organization in patient safety for the region. Your
goal is also to provide predictive analytics for patient care for your ICUs.
One of the first things you want to do is to plan for the future of IT.
Discussion Questions
1. Given the future directions discussed in this chapter, select the two
directions you want to emphasize. Provide rationale for your choices.
2. Discuss how you can use methodologies from futures research to plan
for your preferred future with the future directions you selected in
Question 1.
3. Outline steps to introduce the chief executive officer to
nanotechnology and its potential impact on the organization.
4. You want to increase collaborative work with a local university. What
future directions for education do you think are most important as
CIO?
CIO, Chief information officer; ICU, intensive care units.
*Acknowledgment: David E. Jones’s contribution was supported by Grant Number
T15LM007124 from the National Library of Medicine.
Glossary
A
Academy Higher education in general with an emphasis on the
institution as a society of scholars, scientists, and artists.
Accountable Care Organization A network of doctors and hospitals
that share responsibility for providing care to a specific group of
patients and in return receive bonuses when these providers keep
costs down and meet specific quality benchmarks.
Accounts payable The monies that are owed to companies such as
vendors and suppliers for items purchased on credit.
Accounts receivable The monies that are owed to the institution.
Accreditation A form of recognition provided to a healthcare or
educational institution by an accrediting agency indicating that
the institution has meet the standards of that agency.
Advanced practice nurse Nurses educated at the graduate level and
authorized to practice as a specialist with advanced expertise in a
specialty of nursing.
Adverse event An unintended and unfavorable event associated
with the provision of medical care, use of a medical product, or
treatment protocol.
American Recovery and Reinvestment Act (ARRA) Federal
legislation, commonly referred to as the Stimulus or The Recovery
Act, that was enacted in 2009 to help the United States economy
recover.
Analytics Techniques for managing and processing data.
Analytics Maturity Model A model depicting how organizations
mature over time in their use of data science and analytics by
moving from descriptive to prediction to prescription.
Ancillary systems Software applications used by patient care
support departments such as laboratory, radiology, and
pharmacy.
Anti-Kickback Statute A criminal statute that prohibits the
exchange or offer to exchange anything of value in an effort to
induce referral of a federal healthcare program beneficiary.
Application A software program designed to help the user perform
specific tasks.
Application service provider (ASP) A company, located remotely,
that hosts an electronic health record or departmental system
solution for a healthcare enterprise and provides access to the
application via a secure network.
Architecture The formal description and design of information
technology components, the relationships among them, and their
implementation guide.
Assets Property items that can be converted easily into cash.
A ributes The characteristics or properties of the components of a
system. A ributes are used to describe a system.
Automated system A computer system that responds to an event
with li le or no human intervention.
Availability A general term used to describe the amount of time that
computer system resources are available to users. This is usually
calculated for a 1-year period.
Avatar A graphic image representing a person or other entity,
usually on the internet or in a video game.
B
Backcasting A technique for predicting the future by envisioning a
desired future end point and then working backward to
determine what activities and policies would be required to
achieve that future.
Bar Code Medication Administration (BCMA) A method for
administering medications using medication administration
software, barcodes, and scanners, with the goal of reducing errors
during the medication administration process.
Basic literacy The ability to identify, understand, interpret, create,
communicate, and compute, using printed and wri en materials
in a variety of se ings and context.
Bayesian knowledge base A knowledge base built using decision
trees and a branch of statistical inference that permits the use of
prior knowledge in assessing the probability of an event in the
presence of new data. For example, if a patient has a fever and
increased white blood cells, the Bayesian knowledge base
provides the probability that the patient has an infection versus
another disorder that also creates an inflammatory process.
Best of breed An approach to selecting applications involving
reviewing vendors’ products to determine the “best” for a
department or se ing. When this approach is used, each
department selects the “best” and the organization is tasked with
achieving interoperability among them all.
Big bang A go-live approach in which all applications or modules
are implemented at once.
Big data Very large datasets.
Biomedical informatics The interdisciplinary scientific field that
studies and pursues the effective uses of biomedical data,
information, and knowledge for scientific inquiry, problem
solving, and decision making, motivated by efforts to improve
human health (AMIA); h p://[Link]/biomedical-
informatics-core-competencies.
Bolt-on system A software program or application that is used in
association with a larger application to give users their full
required functionality. Users often require interfaces between the
primary and bolt-on system. An example is an application for
U.S. Mail address verification used in conjunction with a billing
system.
Boundary The demarcation between a system and the environment
of the system.
Business associate An organization supporting the work of a
covered entity and having access to personal health information.
Business continuity The process created to ensure that essential
functions and services continue during an adverse event.
Business intelligence Automated tools for analyzing massive
amounts of data with the goal of improved decision making,
typically at the organizational or departmental level.
C
Certification Commission for Health Information Technology
(CCHIT) CCHIT tested and certified new EHR software
applications in cooperation with the ONC from 2006 to 2015.
Change theory The study of change in individuals or social systems
such as organizations.
Channel A physical element that carries a message between a sender
and a receiver. Examples of channels are radio waves, fiber optic
lines, and paper.
Chaos theory The qualitative study of unstable aperiodic behavior
in deterministic, nonlinear dynamical systems.
Charge description master file A list of all prices for services (e.g.,
diagnosis-related group, Healthcare Common Procedure Coding,
and Current Procedural Terminology 4) or goods provided to
patients that serves as the basis for billing.
Children’s Health Insurance Program (CHIP) Provides health
coverage to eligible children, through both Medicaid and separate
CHIP programs. CHIP is administered by states, according to
federal requirements.
Citizen science People who volunteer to help scientists with their
research.
Claims denial management The tracking and follow-up of denials
for payment from insurance companies.
Claims processing and management The submission of an
insurance claim or bill to a third-party payer, either manually or
electronically, and the follow-up on the payment from the payer.
Classification A single hierarchical terminology that aggregates data
at a prescribed level of abstraction for a particular domain.
Clicker A device that is part of a classroom or audience response
system that allows real-time feedback to an instructor on, for
example, comprehension of presented material.
Clinical application A software program used to perform specific
tasks supporting the clinical aspects of healthcare—for example,
documentation or orders management.
Clinical data repository The storage component for all patient
clinical records data.
Clinical decision support (CDS) Tools and applications that assist
the healthcare provider with some aspect of clinical decision
making.
Clinical documentation Software that provides a medium for
recording, managing, and reporting patient care activities by a
variety of disciplines.
Clinical informatics The application of informatics and information
technology to deliver healthcare services.
Clinical practice guidelines (CPGs) Statements and
recommendations created from evidence-based practice or
consensus-based processes and used to guide patient care.
Clinical scenario The plan of an expected and potential course of
events for a simulated clinical experience. The clinical scenario
provides the context for the simulation and can vary in length and
complexity, depending on the objectives.
Closed system A system that is enclosed in an impermeable
boundary and does not interact with the environment.
Cloud-based license A license for software that resides and runs on
the vendor’s server(s). The licensee remotely accesses and uses
that software through the internet (e.g., via a web browser).
Cloud computing A model for enabling convenient, on-demand
network access to a shared pool of computing resources that can
be rapidly provisioned and released with minimal management
effort or service provider interaction.
Cold site A relocation site for a company pending a disaster (e.g.,
fire, flood, terrorist event). It usually does not include backed-up
copies of data from the original location. Hardware may be
available but may need to be configured.
Comparative effectiveness research Studies designed to determine
which methods to prevent, diagnose, treat, and monitor a health
condition work best in terms of both benefit and harm, for which
patients, and under what circumstances.
Complex adaptive systems (CAS) An entity consisting of many
diverse and autonomous parts that are interrelated,
interdependent, linked through many interconnections, and
behave as a unified whole in learning from experience and in
adjusting to changes in the environment.
Complexity theory Complexity theory builds on chaos theory using
a qualitative approach to the study of dynamic nonlinear social
systems that change with time and demonstrate complex
relationships.
Comprehensive educational information system The hardware,
applications, data, and integrated functionality designed for
managing an academic se ing such as a university.
Computer science The “systematic study of algorithmic methods for
representing and transforming information, including their
theory, design, implementation, application, and efficiency…. The
roots of computer science extend deeply into mathematics and
engineering. Mathematics imparts analysis to the field;
engineering imparts design” (University at Buffalo School of
Engineering and Applied Sciences;
h p://[Link]ff[Link]/undergrad/academics/degrees/cs-vs-
cen).
Computerized provider order entry (CPOE) Software designed to
allow clinicians to enter and manage a variety of patient care
orders, such as medications, laboratory, nutrition care, and other
diagnostic tests, via the computer.
Concept A term that represents a group of ideas or items. It may
represent an abstract idea, such as love, or be concrete, such as
fruit.
Conceptual framework A description and explanation of concepts
and their relationships and interactions related to a specific
phenomenon. Conceptual frameworks can be used to propose
theories and generate research questions. A conceptual
framework can also be used to develop a conceptual model.
Confidentiality Ensuring that data or information is disclosed only
to authorized personnel.
Configuration management database (CMDB) A data repository
containing all related components of an information system or
information technology (IT) environment. A CMDB represents
the authorized configuration of the significant components of the
IT environment. A key goal of a CMDB is to help an organization
understand the relationships between these components and
track their configuration.
Connected health Healthcare that is provided remotely through the
use of technology.
Contextual inquiry A method of usability testing that involves
interacting with users in their actual sites or se ing.
Course delivery system Software programs or applications that
permit the development and delivery of a course or training
program without requiring knowledge of programming code.
Course management systems/Learning management systems
(CMS/LMS) Software programs or applications that permit a
faculty member to deliver a course without knowing any
programming code. Students use the programs to learn the
concepts/skills being taught.
Covered entity A health plan, a healthcare clearinghouse, or a
healthcare provider that transmits health information in
electronic form.
Critical (key) application Defined by the stakeholders as an
application that must be recovered first in the case of a disaster or
downtime, as it is critical to some aspect of the organization and
its operations (business).
Crowdsourcing The process of tapping into the collective
intelligence of a group to complete business-related tasks that a
company would normally either perform itself or outsource to a
third-party provider.
Cytotoxicity The property of an agent being toxic to cells.
D
Dashboard An application designed to provide a visual display of
specific data points, for example, for organizational performance
data.
Data Uninterpreted elements such as a person’s name, weight, or
age. Because they are uninterpreted, they do not have meaning.
Data center A housing facility for computer systems, applications,
and related components (e.g., servers and storage systems).
Data dictionary Stores standard terms for healthcare. Defines the
terms and structure in a database and is used to control and
maintain integration in large databases. It records (1) what data is
stored, (2) the description and characteristics of the data, (3)
relationships among data elements, and (4) access rights and
frequency of terms.
Data exchange The sharing of data among systems using an agreed-
upon standard electronic communication, convention, or “rule.”
Data governance Formal mechanisms within an organization for
determining who has authority over data-related ma ers and
decision-making procedures.
Data integrity The accuracy and consistency of stored and
transmi ed data. Data integrity can be compromised when
information is entered incorrectly or deliberately altered or when
the system protections are not working correctly or suddenly fail.
Data mining A step in the knowledge discovery process of finding
correlations or pa erns among dozens of fields in large relational
databases.
Data science The science of extracting knowledge or insights from
data in various forms, either structured or unstructured.
Data standards Data processes that have been approved by a
recognized body and provide for common and repeated use,
rules, guidelines, or characteristics for activities or their results,
aimed at achieving the optimum degree of order in a given
context.
Data visualization Using software tools to detect visual pa erns in
large datasets.
Debriefing A review and self-reflection activity led by a facilitator
following a simulation or other IT-related experience.
Decision making The process of considering available data and
information, which is then matched with available knowledge to
reach a conclusion or to make a judgment.
Dental informatics The application of computer and information
sciences to improve dental practice, research, education, and
management.
Derivative works A work based upon one or more preexisting
works, including software application.
Derived classifications World Health Organization classifications
based on reference classifications but adapted by either providing
additional detail or becoming a compilation of multiple reference
classifications.
Design thinking A formal process of addressing ill-defined
problems through creative design, using an iterative process of
creating and testing multiple designs, as in UCD, to evaluate their
fit as an appropriate solution.
Digital divide The gap between groups of users in the adoption and
use of personal electronic devices and the internet.
Digital health The use of a wide range of technologies such as
smartphones, social networks, and internet applications to both
obtain and provide healthcare, including health-related
information.
Digital literacy The ability to operate and understand digital
devices of all types, including the technical skills to operate these
devices, the conceptual knowledge to understand their
functionality, and the ability to creatively and critically use these
devices to access, manipulate, evaluate, and apply data,
information, knowledge, and wisdom in activities of daily living.
Disaster recovery Plans and procedures that organizations use when
essential services or systems will not be available for an extended
period of time or when it is expected that the disaster or event
will have a significant impact on operations. Includes plans for
response during the event or disaster, as well as plans for
recovery.
Discount usability evaluations Cost-effective methods to determine
usability issues for applications. These methods require minimal
human resources and time, yet still find about 80% of critical
design issues.
Discount usability methods A set of usability methods that offer
economies of time, effort, and cost and can be completed at any
point in the system’s life cycle.
Disruptive technology An innovation that replaces long-held
traditional ideas and ways of doing things. A technology that
abruptly causes a change in thinking or direction.
Distance education Instruction and learning that takes place when
the teacher and the learner are in two different se ings and
possibly teaching and learning at two different times.
Distance learning The process of learning using distance education
technology, which separates the learner in time and space from
his or her peers and instructor.
Distributed learning Learning that occurs through the use of
technologies (such as video and Web 2.0 tools) and interactive
activities and that may include augmented classrooms, hybrid
courses, or distance education courses.
Distributive education A change in pedagogy where the course
developer uses technology to customize the learning environment
to the learning styles of the learners; the learners may be taking
distance, hybrid (combination of online and face to face), or on-
site courses. Includes interactive activities using available
technologies.
Downtime A time during which a computer or software is not
available or not functioning due to hardware, operating system,
or application program failure.
Dynamic homeostasis The constantly changing processes used by a
system to maintain a steady state or balance. The normal
fluctuations seen in body chemistry levels demonstrate dynamic
homeostasis.
Dynamic system A system that is in a constant state of change in
response to a reiterative feedback loop.
E
e-books Books in a digital format that may or may not require a
proprietary device to read (e.g., Kindle, Nook).
Education games Games that engage students in active learning.
They generally include some sort of competition related to teams
and winning a contest.
eHealth Refers to the broad use of information and communication
technologies (ICT) to support health and health related fields;
electronic communication and information technology related to
health information and processes accessible through online
means.
eHealth initiatives Efforts and programming implemented to
standardize and transform the use of technology in healthcare,
with the goal of improving patient care.
EHR adoption The depth and breadth of use or penetration of
electronic health records in healthcare provider organizations and
practices.
EHR donation A program whereby a healthcare institution
underwrites the cost of an EHR for a physician or group of
physicians who are independent practitioners from the hospital.
eIatrogenesis Patient harm caused at least in part by the use of
health IT.
eLearning A change in the learner’s knowledge and/or skills that is
a ributable to an experience with an electronic device.
Electronic data interchange (EDI) The standards or act of
transferring data via computer technology between organizations
(trading partners).
Electronic health record (EHR) A longitudinal electronic record of
patient health information produced by encounters in one or
more care se ings.
Electronic medical record (EMR) Electronic information resource
used in a single healthcare se ing to capture patient data. Term
often used interchangeably with electronic health record.
Electronic Medication Administration Record (eMAR) Software
used to view and document patient medications.
Eligible professionals Healthcare professionals who meet the
eligibility criteria defined by law to receive incentive payments
from the CMS for implementing electronic health records.
Enterprise resource planning (ERP) Facilitates the flow of data or
information for business functions inside an organization and
manages the connections to outside vendors or stakeholders.
Most often associated with the supply chain functions.
Entropy A measure of the disorder or unavailability of energy
within a system.
ePatient A person who uses technology to actively engage in his or
her healthcare and manages the responsibility for his or her own
health and wellness.
ePatient movement A movement in which patients play an
increasing role in their own healthcare and contribute to the care
of others.
ePortfolio A portfolio that is maintained in a digital format.
Equifinality The tendency of open systems to reach a characteristic
final state from different initial conditions and in different ways.
Ergonomics In the United States, this focuses on the physical design
and implementation of equipment, tools, and products as they
relate to human safety, comfort, and convenience. The term is
used interchangeably with human factors in Europe and
elsewhere.
Evaluation A systematic collection of information about the
activities, characteristics, and results of programs to make
judgments about the program, improve or further develop
program effectiveness, inform decisions about future
programming, and/or increase understanding.
Evidence-based practice (EBP) The use of research, data, and
scientific evaluation as a basis for clinical decision making and the
provision of patient care.
Expert system A computer system that uses knowledge and a set of
rules or procedures to interpret data and information and make
decisions. Such a system differs from a decision support system in
that the final decision is made by the computer as opposed to the
provider. This term has also been used to refer to a type of clinical
decision support system that provides diagnostic or therapeutic
advice in a manner consistent with a clinical domain expert.
Exploratory data analysis An approach to analyzing datasets to
summarize their main characteristics
Extrapolation Extending historical data to create future predictions
and trend lines.
F
Fat client A personal computer with full functionality and disk
storage that exists in a client–server environment. It contrasts
with a thin client that is, in essence, solely a terminal with no
embedded software (e.g., a dummy terminal).
Fidelity Believability or the degree to which a simulated experience
approaches reality; as fidelity increases, realism increases.
Financial information system (FIS) A system that records, stores,
and manages financial operations within an organization for the
purposes of reporting and decision making.
FIT persons People who are fluent with information technology. FIT
people go beyond proficiency in using a computer; they are able
to express themselves creatively, reformulate knowledge, and
synthesize new information using a wide range of information
technology.
Fixed asset management The management of objects that cannot be
easily converted to cash or sold or used for the care of a patient.
Focused ethnographies Research methods borrowed from
anthropology and sociology in which the focus is on the person’s
point of view and his or her experiences and interactions in social
se ings.
Formative evaluation Feedback provided with the goal of
improving a program or a person’s performance, typically given
in the early or middle portion of the program.
Fractal type pa erns Irregular geometric shapes that are repeatedly
subdivided into parts that are a smaller copy of the whole (e.g., a
snowflake).
Framework A basic conceptual structure for organizing ideas.
Futures research A rational and systematic approach to identifying
possible, probable, and preferable futures. The formal study of
the future is also called foresight and futures studies, strategic
foresight, prospective studies, prognostic studies, and futurology.
G
General ledger A listing of all financial transactions made by the
healthcare organization.
Generalist nurse A professional nurse educated at the
undergraduate level for the broad practice of nursing in primary,
secondary, and tertiary healthcare.
Guided discovery A process by which clinicians engage ePatients in
developing a shared hypothesis and plan of care based on data
and reported experiences.
H
Harmonization The process of adjusting for differences and
inconsistencies among different measurements, terms, methods,
procedures, schedules, specifications, or systems to make them
uniform or mutually compatible.
Health 1.0 Use of the internet to search for health-related
information. The user can read but cannot interact in any way
with the website or the information.
Health 2.0 Internet-based healthcare resources that allow interactive
communication with other patients and healthcare resources
across the country and around the world.
Health 3.0 Anticipated internet-based healthcare resources that learn
from a user’s behaviors and search activities.
Health advocacy Supports and promotes patient’s healthcare rights
as well as enhances community health and policy initiatives that
focus on the availability, safety, and quality of care.
Health communication A process whereby practitioners create
social change by changing people’s a itudes and external
structures, modify or eliminate certain behaviors using multiple
behavioral and social learning theories and models to advance
program planning, and identify steps to influence audience
a itudes and behavior.
Health informaticians The title of a professional who whose
proactive is focused on the discipline of health informatics. Other
spellings or titles include informaticist or informatician and
informaticien.
Health informatics An interdisciplinary specialty and scientific
discipline focused on integrating the health sciences, computer
science, and information science to discover, manage, and
communicate data, information, knowledge, and wisdom
supporting the provision of healthcare for individuals, families,
and communities.
Health information exchange (HIE) The process of reliable and
interoperable electronic health-related information sharing
conducted in a manner that protects the confidentiality, privacy,
and security of the information.
Health information organization (HIO) An organization that
oversees and governs the exchange of health-related information
among organizations according to nationally recognized
standards.
Health information technology (health IT) The use of electronic
methods for managing health-related date and information.
Health Information Technology for Economic and Clinical Health
(HITECH) Act A law that established programs designed to
improve healthcare quality, safety, and efficiency using health
information technology.
Health IT Capability Maturity Assessment A qualitative model that
can be used to assess an organization’s capabilities with respect to
five dimensions, measured on a scale of 1 (basic) to 5 (innovative).
Health IT governance The process of establishing an overarching
structure for health IT in organizations, including establishing
goals and objectives; creating policies, standards, and services;
and developing mechanisms and processes for the oversight,
enforcement, and coordination of the policies, standards, and
services.
Health IT support personnel Individuals who assist in the design,
development, implementation, ongoing support, and
maintenance of the health IT hardware and software.
Health literacy The degree to which individuals have the capacity to
obtain, process, and understand basic health information and
services needed to make appropriate health decisions.
Health policy Includes the decisions, plans, and actions that guide
the achievement of healthcare goals within a society.
Heuristic evaluations Assessments of a device or product against
accepted guidelines or published usability principles.
High availability Processes that allow full functioning of systems
during downtimes. Includes a redundant system in place,
configured and waiting in standby mode if the primary
production node fails. Requires manual intervention for end users
to access it.
Home health Healthcare and social services provided by free-
standing and facility-based community agencies at patients’
residences, work sites, or other locations.
Hospice Item Set (HIS) A set of quality measures that must be
reported by hospice programs to the Secretary of Health and
Human Services under the Affordable Care Act of 2010.
Hot site An alternative site that is an exact duplication of the
original site with real-time synchronization to allow an
organization to relocate with minimal losses.
Human factors The scientific discipline concerned with the
understanding of interactions among humans and other elements
of a system. The term also refers to the profession that applies
theory, principles, data, and methods to product design to
optimize human well-being and overall system performance.
Human resources information system (HRIS) A computerized
information system and applications used to record, store, and
manage human resource data and information.
Human–computer interaction (HCI) The study of how people
design, implement, and evaluate interactive computer systems in
the context of users’ tasks and work. Used interchangeably with
the term ergonomics in Europe and elsewhere.
Human-made disaster A disaster created by humans that results in
significant injuries, deaths, or damage to property.
I
Immunization information system (IIS) A confidential, population-
based, computerized database that records all immunization-
related data and information, such as doses administered by
participating healthcare providers to persons residing within a
given geopolitical area. Can be used at the healthcare provider,
patient, and population level.
Incentive management Use of monetary and point-based rewards
for staff who volunteer to meet institutional needs, such as
staffing needs.
Incident response team (IRT) A group of people from the
organization who prepare for and respond to incidents,
downtimes, or other emergencies.
Informatics The study and use of information processes and
technology in the arts, sciences, and the professions.
Informatics nurse specialist A nurse formally educated at the
graduate level in nursing informatics, health informatics, or
biomedical informatics.
Informatics researcher and innovator A nurse educated in a
doctoral-level education program who uses health data,
information, knowledge, and wisdom to generate new knowledge
and best practices or to develop new technologies to continuously
improve health outcomes.
Information A collection of data that has been processed to produce
meaning.
Information and communication technology (ICT) Includes any
communication device or application such as radio, television,
cellular phones, computer networks, and the services and
applications associated with these devices. The term is more
commonly used outside of the United States and usually used
within a context such as ICTs in education or healthcare.
Information ecology A science that studies the laws governing the
influence of information summary on the formation and
functioning of biosystems, including those of individuals, human
communities, and humanity in general, and on the health and
psychological, physical, and social well-being of the human being,
and that undertakes to develop methodologies to improve the
information environment.
Information literacy A set of abilities requiring individuals to
recognize when information is needed and have the ability to
locate, evaluate, and effectively use the needed information.
Information science The discipline that investigates the properties
and the means of processing information for optimum
accessibility and usability. It is concerned with the origination,
collection, organization, storage, retrieval, interpretation,
transmission, transformation, and use of information.
Information supply chain A full set of elements (technology based,
process specific, and organizational in nature) that is necessary to
support logistics and supplies in organizations. It includes (1)
collecting information from discrete processes, (2) transforming
this information from data to knowledge, and (3) distributing this
information efficiently and in a timely manner to the appropriate
data consumers.
Information system A combination of information technology, data,
and human activities or processes that support operations and
decision making.
Information theory Two theoretical models dealing with
information, the Shannon-Weaver information-communication
model and the Nelson data-information-knowledge-wisdom
model.
Informed consent Permission given by an individual who has been
provided with an understanding of the risks, benefits, limitations,
and potential implications of consent.
Infrastructure The hardware and software used to connect
computers and users, including cables; equipment such as
routers, repeaters, and other devices that control transmission
paths; software used to send, receive, and manage the signals that
are transmi ed; and often the computers themselves, although
this component is not consistently considered infrastructure.
Integrated system A fully integrated health information system or a
fully interoperable system. It may be monolithic (from one
vendor) or best of breed.
Integrity Data are complete and have not been altered in an
unauthorized manner.
Interactive whiteboard An interactive display controlled by a
computer, typically with a touch screen, videoconferencing, and
note-taking functionality.
Interface engine Software that transforms or maps data from one
application to a receiving application’s (or system’s) requirements
while a message is in transit to allow it to be accepted. The
software is built with one-to-many concepts in mind. These
import-export modules then are connected to an interface engine
so that the mapping, routing, and monitoring are managed by
this system.
Interface terminology A set of designations or representations
structured to support representation of concepts for data entry
and display on the graphical user interface.
International standards Terms, definitions, and/or information
transmission guidelines adopted by international organizations
and made available to the public.
Interoperability The ability for systems to reliably exchange data
and operate in a coordinated, seamless manner.
Interprofessional education (IPE) An environment in which
students from two or more disciplines learn from, with, and
about each other to enable effective collaboration and improve
health outcomes.
Intervention scheme A comprehensive, hierarchical taxonomy
designed to organize patient assessment.
Intrusion detection Involves software, policies, and procedures
used to detect a empted entry or inappropriate access to a
computer or network.
J
Joint cognitive systems Systems in which information is shared or
distributed among humans and technology.
K
Knowledge Created when data and information are identified and
the relationships between the data and information are
formalized.
Knowledge base A component, typically within an electronic health
record, that stores and organizes a healthcare enterprise’s
information and knowledge used by the enterprise for clinical
operations.
Knowledge discovery and data mining (KDDM) An approach to
identifying pa erns in large datasets that entails methods such as
statistical analysis, machine learning methods, and data
visualization. In some literature, the terms knowledge discovery
and data mining are used interchangeably. Also, the terms
knowledge discovery and knowledge discovery in data are
sometimes used to refer to the broad process of finding
knowledge in data.
Knowledge transformation Converting knowledge from research
results, to evidence summary, to practice guidelines, to
integration, and then evaluation of the impact.
L
Lead part The unit of a system that plays the dominant role in the
operation of the system.
Learning An increase in knowledge, a change in a itude or values,
or the development of new skills.
Learning environment An atmosphere that is created by the
facilitator to allow for sharing and discussion of participant
experiences without fear of humiliation or punitive action. The
goals of the simulation learning environment are to promote trust
and foster learning.
Learning health system (LHS) A health system in which science,
informatics, incentives, and culture are aligned for continuous
improvement and innovation, with best practices seamlessly
embedded in the delivery process and new knowledge captured
as a by-product of the delivery experience.
Learning theory Provides a framework for understanding how
patients and healthcare providers as open learning systems take
in, process, and output data, information, knowledge, and
wisdom.
Liability Something (typically monetary) for which an organization
or person is legally responsible.
Limitations and exclusions of liability The specific contractual
exceptions and specifications for liabilities (i.e., something
[typically monetary] for which an organization or person is
legally responsible).
Logic model A graphical depiction of the logical relationships
between the resources, activities, outputs, and outcomes of a
program.
M
Machine learning Adjustment of a computer model or algorithm
based on exposure to training examples.
Man-made disaster A disaster created by humans that results in
significant injuries, deaths, or damage to property.
Master person index (MPI) The information used to uniquely
identify each person, patient, and customer of a healthcare
enterprise. Synonyms for this term include master patient index,
master member index, and patient master index.
Material management The storage, inventory control, quality
control, and operational management of supplies,
pharmaceuticals, equipment, and other items used in the delivery
of patient care or the management of the patient care system.
Material management is a subset of the larger function of supply
chain management; the supply chain also includes the acquisition
of materials of care and the logistics or movement of those
materials to caregiving facilities and organizations.
Meaningful Use Sets of specific objectives that must be achieved to
qualify for federal incentive payments. Meaningful Use means
that healthcare providers must show that they are using certified
electronic health record technology in ways that can be measured
using specific criteria.
Meaningful Use Objectives Specific targets that must be achieved
for providers and/or hospitals to qualify for incentive payments
under the HITECH Act. These include the use of certified EHRs
and specific usage such as ePrescribing, CPOE, medication
reconciliation, information exchange and patient electronic access,
and clinical decision support.
Medical informatics The branch of informatics that focuses on
disease diagnosis and management.
Medicine 2.0 The evolution of healthcare across seven themes:
technology, patients, professionals, social networking, health
information and content, collaboration, and change of healthcare.
mHealth Medical and public health practice supported by mobile
devices, such as mobile phones, patient monitoring devices,
personal digital assistants (PDAs), and other wireless devices.
Microblogging A form of blogging (online journaling of an author’s
thoughts) in which entries are kept brief using character
limitations (e.g., Twi er).
Mobile applications Applications (apps) on mobile devices.
Modified Stage 2 (Meaningful Use) Specific Meaningful Use Stage 2
requirements updated in 2015 that provide a consolidated list of
objectives.
N
Nanofabrication The development of nanomaterials used in
structures, electronics, and commercial products.
Nanoinformatics The use of informatics techniques and tools for
nanomaterial or nanoparticle data management and storage;
information to improve research in the field of nanotechnology.
Nanomaterials Materials, devices, and other structures at the
subatomic level, specifically the nanoscale of 1 to 1000 nm.
Nanomedicine A subspecialty of nanotechnology, centering on the
application of nanoparticles and nanoscience techniques to
healthcare and clinical research.
Nanotechnology The study of controlling and altering ma er at the
atomic or molecular level.
Nationwide Health Information Network (NwHIN) A set of
standards, services, and policies that enable secure health
information exchange over the internet and across diverse
se ings.
Natural disaster A disaster created by nature.
Natural language processing Computer processing of text wri en
or spoken by humans.
Negentropy A measure of energy that can be used by a system for
maintenance as well as growth.
Networked personal health record A personal health record that is
electronically linked to multiple data sources (e.g., electronic
health records, pharmacies, labs). Entities that are linked to the
networked record may provide services to the user (e.g., secure
messaging). These systems also allow for the storage of
personally entered data.
Niche applications Specialty software applications created to
address the requirements of specific departments and groups of
users.
Noise Anything that is not part of a message but occupies space on
the channel and is transmi ed with the message.
Nurse-managed health center A site that primarily offers outpatient
clinic and primary healthcare and social services provided by
nurses.
Nursing informatics A specialty that integrates nursing science,
computer science, and information science to manage and
communicate data, information, knowledge, and wisdom in
nursing practice, education, research, and administration.
O
Omaha System A research-based taxonomy designed to support
documenting client care from admission to discharge in various
se ings. It exists in the public domain and can be used without
licensing fees. Its primary application has been in the home health
arena.
Online education A version of distance education that requires the
use of the internet to deliver the educational materials.
Ontology A model of a domain that defines the concepts existing in
that domain as well as taxonomic and other relationships existing
between the concepts. Within health informatics, an ontology
would be a formal, computer-understandable description of a
domain.
Open shift management A web-based self-scheduling solution in
which the manager uses a variety of instant communication tools
to announce openings in the schedule and staff members respond
by tendering schedule and shift requests for consideration and
approval.
Open system A system that is enclosed in a semipermeable
boundary and interacts with the environment.
Open-source software Source code are typically made available to
the public.
Outcome and Assessment Information Set (OASIS) A
standardized assessment tool and core dataset mandated by the
Centers for Medicare and Medicaid Services, for use by Medicare-
certified home health agencies.
Outcomes-based quality improvement (OBQI) A risk-adjusted
outcome reporting tool that is based on Outcome and Assessment
Information Set and mandated by the Centers for Medicare and
Medicaid Services for use by Medicare-certified home health
agencies.
P
P4 Medicine Medicine that is predictive, preventive, personalized,
and participatory.
Palliative care and hospice Healthcare and social services provided
to those with life-threatening or terminal illnesses.
Participatory healthcare A healthcare model that includes patients,
caregivers, and healthcare professionals working together in all
aspects of a patient’s health.
Participatory medicine A cooperative model of healthcare that
encourages and expects active involvement by all connected
parties, including patients, caregivers, and healthcare
professionals, as integral to the full continuum of care.
Patient accounting A process for collecting and tracking debits and
credits for patient care provided by clinicians that is billed to
insurance companies and/or the patient.
Patient generated data (PGD) Data input or uploaded from patients,
such as into a PHR or from wearable devices.
Patient safety Freedom from accidental injury due to healthcare,
medical care, or medical errors, where error is defined as the
failure of a planned action to be completed safely or as intended
or the use of a wrong plan to achieve an aim.
Patient-centered care An essential partnership between
interprofessional care providers and the individuals, families, and
communities that are the recipients of care.
Pay for performance (P4P) A strategy to pay healthcare providers
for high-quality care, as measured by selected evidence-based
standards and procedures. A network of doctors and hospitals
share responsibility for providing care to a specific group of
patients and in return receive bonuses when these providers keep
costs down and meet specific quality benchmarks.
Payroll system An application that creates and disburses
compensation payments to employees. This is also referred to as a
disbursement system.
Phased go-live A gradual go-live approach within an institution by
service line, selected areas, or departments.
Phenomenon An observable fact or event.
Picture archiving and communication system (PACS) A
combination of hardware and software configured to provide for
the storage, retrieval, management, distribution, and presentation
of radiological images.
Point of care Patient care and procedures that are performed at or
near the patient care site.
Portfolio management Common programs and projects that are not
necessarily related but are important to combine and view as a
whole, such as a clinical portfolio in which all projects and
programs that directly affect patient care are managed or aligned
in a common category.
Practice-based evidence A specific research design using
observations and cohorts of patients. Used to answer questions of
treatment effectiveness that involves meticulous prospective data
collection in a naturalistic clinical se ing of multiple interventions
and outcomes, with rigorous statistical control of relevant patient
differences.
Practice management system (PMS) An application designed to
assist in the management of a practice by collecting patient
demographic information, insurance information, appointment
scheduling, reason for the visit, patient care procedures done for
the patient, charging information for the billing process, and
collection and follow-up.
Predictive analytics The development of analytic models that
predict future probabilities or trends based on the analysis of
retrospective or real-time data.
Predictive scheduling Resource scheduling based on a predictive
model used to forecast bed demand changes in patient acuity,
workload distribution, and variability caused by shift, day of the
week, month, and seasonality.
Preprocessing (of data) Preparation of data for data mining (e.g.,
data cleaning, transformation, replacement of missing values).
Prescriptive analytics The use of models to evaluate and determine
new ways of operating in a health system. The models predict
system output under a range of system configurations, allowing
decision makers to choose the best of potential alternatives.
Privacy The capacity to control when, how, and to what degree
information about oneself is communicated to others.
Problem classification scheme A comprehensive, hierarchical
taxonomy designed to identify diverse patients’ health-related
concerns.
Problem rating scale for outcomes A comprehensive, recurring
evaluation framework designed to measure patient progress.
Program evaluation The systematic collection of information about
the activities, characteristics, and results of programs to make
judgments about the program, improve or further develop
program effectiveness, inform decisions about future
programming, and increase understanding.
Program management Multiple, aligned projects affecting many
teams or departments that are coordinated and managed in
concert.
Project management A temporary endeavor undertaken to create a
unique product, service, or result. The project has specific
boundaries, including initialization and a defined end.
Protected health information (PHI) Personally identifiable health
information, such as name, birth date, and social security number,
created or received by a covered entity.
Public health The science and art of protecting and improving the
health of communities through education, promotion of healthy
lifestyles, and research for disease and injury prevention.
Public health informatics The application of informatics in areas of
public health, including disease or condition surveillance,
reporting, and health promotion. Public health informatics and its
corollary, population informatics, are concerned with groups
rather than individuals.
Public health surveillance Collecting, analyzing, and interpreting
health-related data for the planning, implementation, and
evaluation of public health.
Q
Quality of care The degree to which health services for individuals
and populations increase the likelihood of desired health
outcomes and are consistent with current professional
knowledge.
Quantified self A person invested in using tools and data to
quantify and monitor his or her daily experiences using personal
metrics.
R
Radio frequency identification (RFID) Technology that uses
electronic tags to track and monitor equipment and activities.
Typically used in patient bands, lab specimens, or surgical
sponges.
Randomized controlled trial A specific research design involving
random assignment of subjects to experimental and control
groups and other design features to assure as much variable
control as possible. With this research design approach, the
differences between the groups are most likely related to the
treatment each group received.
Receiver A device or individual that receives a message that has
been sent over a channel.
Reference classifications Main terminology classifications based on
basic parameters of health.
Reference terminology A set of atomic level designations,
representing a domain knowledge of interest, structured to
support representations of both simple and compositional
concepts independent of human language (within machine) that
facilitates data collection, processing, and aggregation.
Regional Health Information Organization (RHIO) Characterized
as a quasi-public, nonprofit organization whose goal is to share
secure health-related data within a region.
Reiterative feedback loops Feedback loops where the effect of the
system’s actions or output is continuously returned to the system
as input, thereby effecting the system’s future output.
Related classifications World Health Organization classifications
that partially refer to reference classifications, or are associated
with the reference classification at specific levels of structure only.
Remote hosting An application hosted off site, typically by a
vendor, at a site with vendor-owned hardware.
Request for information (RFI) A document that is developed and
sent to vendors requesting basic or overview information to
determine which vendors are most likely to meet the institution’s
requirements for a new information system. Not as formal as a
request for proposal (RFP). Both RFP and RFI are used as part of
the purchasing process.
Request for proposal (RFP) A detailed document developed and
sent to vendors outlining the institution’s requirements to request
a proposal describing the vendors’ capabilities to meet the listed
requirements and the related costs. RFPs and requests for
information (RFIs) are used as part of the purchasing process.
Requirements definition The process of determining the specific
needs that the organization has for an information system and the
specific functionality that is desired.
Revenue cycle All business components (administrative and
clinical) dealing with patient service revenue.
Reverberation The process of change throughout a system that
occurs in response to change in one part of a system.
Risk A person or situation that poses a threat to the security of an
information system.
Risk analysis or assessment A systematic process for examining an
information system to identify the security vulnerabilities and
potential risks to an information system or organization. Also
referred to as risk assessment.
S
SaaS (software as a service) A software distribution model where
applications are hosted by a vendor and made available to
customers over a network, typically the internet.
Safeguard In cybersecurity, this refers to three processes to lessen or
alleviate threats to security: administrative, technical, and
physical.
Scope creep Occurs when requirements are added on after the initial
project was defined and approved. Added requirements are
substantial enough to affect the project costs and/or timeline.
Security The administrative, technical, and physical safeguards in
an organization or information system to prevent privacy
breaches.
Sender The originator of a message to be sent over a channel.
Service level agreement (SLA) An agreement made between
information technology and a key stakeholder where the level of
service is formally defined and agreed upon. This can include
uptime guarantees, response time to issues, and even disaster
recovery timelines.
Service-oriented architecture (SOA) An architecture design
configuration where services are business oriented, loosely
coupled with other services and system components, vendor and
platform independent, message based, and encapsulated with
internal architecture and program flow that are hidden from the
service user.
Simulation A pedagogy, or instructional method, using one or more
teaching strategies to promote, improve, and validate a
participant’s progression from novice to expert.
Simulation experience A term often used synonymously with
simulated clinical experience or scenario.
Simulation learning environment An atmosphere that is created by
the facilitator to allow for sharing and discussion of participant
experiences without fear of humiliation or punitive action. The
goals of the simulation learning environment are to promote trust
and foster learning.
Social media An application used to create an online environment
that is established for the purpose of mass collaboration.
Social networking The use of social media and online platforms that
enable groups and individuals to connect with others sharing
similar interests.
Sociotechnical Refers to complex systems recognizing the
interaction between people and technology in work se ings,
particularly se ings such as healthcare.
Software escrow A neutral third-party company holds the source
code, programming documentation, and other items needed for
maintenance and modification of the software.
Software license agreements Contracts for software.
Software warranty A wri en guarantee from a vendor promising
repair or replacement within a specific time period.
Stakeholders People affiliated with an organization (internal and
external) who share a vested interest in the outcomes produced
by that organization.
Stand-alone personal health record A personal health record that is
not electronically linked to other data sources and can serve as a
portable electronic store of personally entered data.
Standardized terminology Terms and definitions adopted by a
national or international standardizing and standards
organization and made available to the public.
Standards development organizations (SDO) Entities whose
primary activities are developing, coordinating, disseminating,
and maintaining standards addressing a large group of users.
Also called standards se ing organizations.
Standards of Best Practice: Simulation Seven sets of definitions and
principles developed by the International Nursing Association for
Clinical Simulation and Learning that should be considered and
incorporated when developing all simulation-based learning
experiences for learners (terminology, professional integrity,
participants’ objectives, facilitation methods, facilitator, debriefing
process, and evaluation of outcomes).
Standards se ing organizations (SSO) Entities whose primary
activities are developing, coordinating, disseminating, and
maintaining standards addressing a large group of users. Also
called standards developing organizations.
Stark A law passed in 1992 that governs physician self-referral for
Medicare and Medicaid patients. It generally prohibits a
physician from referring patients for certain designated health
services (DHS) to entities where the physician has a financial
relationship.
Strategic alignment The process of matching two or more
organizational strategies to ensure that they synergistically
support the organization’s goals and vision.
Strategic vision The desired future state of an organization or
institution.
Subsystem Any system within the target system.
Summative evaluation An evaluation that determines the effects or
outcomes of a person’s, program’s, or organization’s
performance; a program’s impact; or a technology’s effectiveness.
The goal is to determine the merit of the evaluation target.
Supersystem The overall system in which the target system exists.
Supply chain management (SCM) The acquisition, movement of,
storage, inventory control, quality control, and operational
management of supplies, pharmaceuticals, equipment, and other
items used in the delivery of patient care or the management of
the patient care system.
Supply item master file A list (hard copy or electronic) of all items
used in the delivery of care for a health organization that can be
requested by healthcare providers and managers. This file
typically contains between 30,000 and 100,000 items.
Systems life cycle A conceptual model or framework used to
describe each stage in the life of a living or nonliving system, such
as an information system.
T
Tall Man le ering The use of mixed case le ering, allowing easy
differentiation of similar terms such as look-alike medication
names.
Target system The system of interest.
Task analysis A suite of well-known usability methods to
decompose and understand users’ actions and behaviors.
Composed of more than 100 different methods, it is used to
determine goals, tasks, issues with interactions, the flow of work,
and other activities in sociotechnical systems.
Telehealth The use of telecommunication methods to provide
patient care and education as well as public health and health
administration.
Telehealth competency Having and using knowledge,
understanding, and judgment when providing telehealth.
Telemedicine The use of medical information exchanged from one
site to another via electronic communications for the health and
education of the patient or healthcare provider and for the
purpose of improving patient care, treatment, and services.
Telenursing The use of telehealth technology to deliver nursing care
and conduct nursing practice.
Terminology cross-mapping Assigning an element or concept in
one set to an element or concept in another set through semantic
correspondence.
Terminology harmonization A process of ensuring consistency of
terms and the definitions of those terms within and across
different terminologies.
Tethered personal health record A personal health record that is
electronically linked to the clinical information systems of a given
healthcare provider or organization. It may include functions
such as secure messaging and online scheduling as well as
storage of personally entered data.
Theoretical model A visual representation of a theoretical
framework, a relationship among concepts.
Theory A scientifically acceptable explanation of a phenomenon.
Thin client A centrally managed computer workstation without a
hard drive that has its operating system and application delivered
from a central server via the network and all data stored on
network storage. This is in contrast to a fat client, which has
software embedded in the client.
Think-aloud protocol A usability method in which users talk aloud
about what they are doing as they interact with a product. These
interactions are observed or recorded and then analyzed.
Threat An act of man or nature that has the potential to cause harm
to an informational asset.
Transaction history file A running log of all material transactions of
the healthcare organization.
Transparency Indicates that the policies, procedures, and
technologies affecting health information use for individuals’
health information are easily accessed and understood.
Trend analysis The process of analyzing historical data and
identifying trends over time.
U
uHealth Ubiquitous health technologies that integrate core
components of computers, wireless networks, sensors, and other
modalities, such as mHealth (mobile) devices, to create an
environment that can monitor, respond to, and assist in meeting
healthcare needs of individuals.
Unintended consequences Unplanned and unexpected
consequences from a device, process, or event such as the
adoption of health IT.
Untethered personal health record A personal health record that is
not electronically linked to other data sources, such as a host
EHR.
Usability The extent to which a product can be utilized by specific
users in a specific context to achieve specific goals with
effectiveness, efficiency, and satisfaction.
User interface A boundary between users and products, typically a
display or computer screen or interaction device. It allows
humans and products to cooperatively perform tasks.
User-centered design A structured application development process
with three primary emphases: an early and central focus on users
in the design and development of products, iterative design, and
systematic measures of the interactions between users and
products.
V
Vendor A person or business that sells products, goods, or services
to a company or institution.
Vendor master file A list of all manufacturers and distributors
(vendors) who provide materials needed for the healthcare
organization that also contains the associated contract terms and
prices for specific items. This file typically contains between 200
and 500 different vendors and suppliers.
Virtual community An online community that shares many
characteristics with traditional social groups.
Vulnerability A weakness in an information system, system security
procedures, internal controls, or implementation that could be
exploited.
W
Wearable devices Accessories, sensors, or clothing that have
embedded computers or advanced technologies. Examples are
activity trackers.
Web 2.0 Sophisticated web functionality with social engagement,
interaction, and networking capabilities.
Web 3.0 Emerging functionality in which browsers learn from user
search behavior and adapt accordingly.
Wisdom The appropriate use of knowledge in managing or solving
human problems. It involves knowing when and how to use
knowledge in managing a client need or problem.
Workaround A temporary and potentially unsafe fix for a problem
which fails to provide a genuine solution to the problem.
Index
Note: Page numbers followed by f indicate figures, t indicate tables,
and b indicate boxes.
A
AACN See American Association of Colleges of Nursing (AACN)
AAMC See Association of American Medical Colleges (AAMC)
AAN See American Academy of Nursing (AAN)
ABC Codes 375–376t
Abuse
digital 229
electronic health record and 428–429
Academic electronic health record (AEHR) 505, 507, 509t
Academic Forum and the Health Informatics Accreditation
Commi ee 500
Academic support, for distance learners 530–531
Academy, computerization of 538–539
Access
in Code of Ethics for health informatics professionals 439t
management and control of, for information security 450
to patient care information as electronic health record benefit 99
to technology, and mHealth 261
Accountability
in Code of Ethics for health informatics professionals 439t
definition of 437t
description of 438t
Accounts payable 113
Accounts receivable 113
Accreditation 429–431
of educational programs 501t, 502
Accreditation Council for Graduate Medical Education
(ACGME) 604
ACGME See Accreditation Council for Graduate Medical Education
(ACGME)
ACRL See Association of College and Research Libraries (ACRL)
Action steps, from clinical decision support system 172
Active ePatients 208–209
Activities list, PERT 293f
Acute care focus, in downtime and response planning 345–346, 346b
Acute care se ing, special considerations by area for 340t
Adapt Telehealth 144–145
Adaptive process, within complex organization 19
Adaptive response, of complex system 19
ADI See American Documentation Institute (ADI)
Administrative applications 111–130
business intelligence systems as 126–127, 127f
financial systems as 112–119 See also Financial information system
(FIS)
future directions for 127–128
human resources information systems as 124–126, 125b See also
Human resources information systems (HRISs)
materials management as 121, 124b See also Materials management
practice management systems as 119–121
supply chain management as 121–124
integrated applications 122, 122–123f
vendor resource guides as 112
Administrative process, as EHR essential components and functions
for care delivery 92–93t
Administrative services, for distance education 530–531
Adoption, health informatics and 409–411, 410–411t
ADT (admission, discharge, and transfer) testing, during
information system implementation and post go-live 327–328t
Advanced executive scorecards 118–119
Advanced Interprofessional Informatics Certification (AIIC) 502
Advanced practice clinicians, specialty requirements in 340t
Adverse events 411
Advisory opinions 425
Advocacy group-consumer, social media structure 222b
AEHR See Academic electronic health record (AEHR)
Affective learning domain, in evaluating simulation 567–568, 568b
Affective skills, values and a itudes relate to 27
Africa, eHealth initiatives in 582
Agency for Healthcare Research and Quality (AHRQ)
Health Care Innovations Exchange of 47
National Guideline Clearinghouse of 44
National Healthcare Quality Report of 39
National Quality Measures Clearinghouse (NQMC) of 48–49, 49b
website of, U.S. Preventive Services Task Force (USPSTF) segment
of 44–45
Aging populations, health informatics future and 613
AHIMA See American Health Information Management Association
(AHIMA)
AHRQ See Agency for Healthcare Research and Quality (AHRQ)
AIIC See Advanced Interprofessional Informatics Certification
(AIIC)
AliveCor 259
AllergyCast 259
Alliance for Nursing Informatics (ANI) 599, 599–600b
public policy focus of 485–486t
Allocation, resource 292
AMA See American Medical Association (AMA)
American Academy of Nursing (AAN), public policy focus of 485–
486t
American Association of Colleges of Nursing (AACN) 567
health informatics 2
American Board of Preventive Medicine 603
American Documentation Institute (ADI) 595
American Health Information Management Association
(AHIMA) 599, 600b
in informatics competency development 505
public policy focus of 485–486t
American Library Association 596, 596b
American Medical Association (AMA) 621
Code of Ethics of, on confidentiality, social media and 227
American Medical Informatics Association (AMIA) 599, 600b
( )
Academic Forum and the Health Informatics Accreditation
Commi ee 500
accreditation and certification 502
in informatics competency development 505
public policy focus of 485–486t
American Nurses Association (ANA) 133–134, 599
Code of Ethics of, on confidentiality, social media and 227
Competencies for Telehealth Technologies in Nursing of 137
Core Principles on Telehealth of 133–134
minimum datasets of 375
in nursing informatics 500
Principles of Social Networking and the Nurse of, on patient
privacy 227
telehealth protocols of 137
American Nurses Credentialing Center Certification (ANCC) 603,
603b
American Nurses Informatics Association (ANIA) 599, 600b
American Recovery and Reinvestment Act (ARRA) 318–319, 319f,
409, 409b, 500
electronic health records and 456–459
electronic personal health records and 243
HITECH Act in 456
American Telemedicine Association (ATA) 600b
Expert Consensus Recommendations for Videoconferencing-
Based Telepresenting of 137
telehealth promotion by 134
Americans with Disabilities Act (ADA) 533
AMIA See American Medical Informatics Association (AMIA)
( )
Ancillary systems, in electronic health record 98–99
Andragogy 27
Anesthesia, specialty requirements in 340t
ANI See Alliance for Nursing Informatics (ANI)
ANIA See American Nurses Informatics Association (ANIA)
Anti-Kickback Statute, federal 426–427
APAMI (Asia Pacific Association for Medical Informatics) 579–581,
580f, 580b
APEC (Asia-Pacific Economic Cooperation Region), eHealth
initiatives in 578–581
Application service provider 83–84
ARRA See American Recovery and Reinvestment Act (ARRA)
ARRA-related Meaningful Use testing, during information system
implementation and post go-live 327–328t
Artificial neural networks, data mining method 398t
Asia Pacific Association for Medical Informatics (APAMI) 579–581,
580f, 580b
Asia-Pacific Economic Cooperation Region, eHealth initiatives
in 578–581
ASPE See Association of Standardized Patient Educators (ASPE)
Assessing Progress on the Institute of Medicine Report The Future of
Nursing 488–489
Assets 113
Association of American Medical Colleges (AAMC) 6
Association of College and Research Libraries (ACRL) 529
Association of Standardized Patient Educators (ASPE) 562
Association rules, predictive analytics and 394
Association studies, on personal health records and outcomes 248
Asynchronous technology, telehealth 136
ATA See American Telemedicine Association (ATA)
A itudes, affective skills and 27
A ributes, of system 17
Auditing, description of 438t
Authenticity, definition of 437t
Automated charge capture, specialty requirements in 340t
Automated report generation, as method of deployment 401, 402f
Automated system 24
Availability, definition of 437t
Avatars, in healthcare education 546
AvayaLive, as technology tools 550–552t
Awareness, as barrier to personal health record adoption 249
B
Babbage, Charles 595
Backcasting, in predicting future research 617
Balance sheet 115, 115t
The Balancing Act: Patient Care Time Versus Cost 3–4
Bandwidth, in telehealth implementation 138–139, 138f
Bar Code Medication Administration (BCMA) 96, 414–415
in clinical se ing 96
Basic literacy, definition of 11–12
Bayesian knowledge base, in de Dombal computer-aided diagnosis
of acute abdominal pain 171
Bayesian networks, data mining method 398t
BCMA See Bar Code Medication Administration (BCMA)
Behavior, inappropriate, as social media challenge 227–228
Behavior change, on mHealth 258
Behavioral health at-a-distance 3
B.E.L.T. framework, for telehealth implementation 138–139, 138f
Best of breed approach, integrated health system and 323
Big bang approach, to go-lives 330–331, 331b
Big data 392
characteristics of 393, 393b
in education information system 538–539
in future of informatics 621
technology 6
Billing issues, related to electronic health record 426–429
Billing solutions, for home health, hospice care, and community-
based systems 158
Biomedical informatics 2t, 605, 607, 607–608f
Biometric sensors, telehealth and 145–147, 145b
BlackBeltHelp 530
Blackboard 522, 523f
as technology tools 550–552t
Blogging 222
Blue Bu on+ 244
Blue bu on, for patient access to electronic health records 243–244,
244f
Blue Bu on Co-Design Challenge 244
Blue Bu on Connector 244
Blue Bu on Mash Up Challenge 243–244
Blue Bu on Video Challenge 243–244
Blum, Bruce L., on healthcare computing applications 22
Blum model, of information theory 22
Body privacy 437
Bolt-ons system, integrated 118–119
Books See also Textbooks
digital 541–542
health informatics and 597–598, 597b, 598t
Boundary, of system 16–17
Breach, termination for, software licensing agreement 310–311
Buckminsterfullerene, discovery of 624
Business, and mHealth 262–263
Business associates, under HIPAA Privacy and Security Rules 440–
441, 440b
Business continuity management, in disaster planning 348–349
Business intelligence systems 126–127, 127f
C
C-CEI See Creighton Competency Evaluation Instrument (C-CEI)
CAH See Critical access hospitals (CAHs)
CAHIIM See Commission on Accreditation for Health Informatics
and Information Management Education (CAHIIM)
Campaign for Action 487–488
Campus Computing, in course management system 520t
Capability maturity assessment, for health IT 495–497, 496t
Capital Area Roundtable on Informatics in Nursing (CARING) 599
Carbon nanotube 624, 624f
Cardiac catheterization lab, specialty requirements in 340t
Care anywhere, future directions and 619
CARING See Capital Area Roundtable on Informatics in Nursing
(CARING)
CAS See Complex Adaptive System (CAS)
Cash flow statements 115, 116t, 117f
Causality 413
Causation, as continuum 51
CBPRs See Computer-based patient records (CBPRs)
CDC See Centers for Disease Control and Prevention (CDC)
CDR (clinical data repository) 76–77
CDS See Clinical decision support (CDS)
CDS systems See Clinical decision support (CDS) system(s)
CEA (cost-effectiveness analysis), in program evaluation 71
CEIS See Comprehensive education information system (CEIS)
Center to Champion Nursing in America 487–488
Centers for Disease Control and Prevention (CDC)
guidance on HIPAA Privacy Rule 190
limitations on authority of 189
Public Health Information Network of 199
Centers for Medicare and Medicaid Services (CMS) 424t
electronic personal health records and 243
Central storage model 77
Central versus distributed storage 77
Centralization, of organizations 30
Certification 501t, 502
in health informatics 602–604, 603b
Certified Professional in Healthcare Information and Management
Systems (CPHIMS) 603, 603b
Change
scope of, future directions and 614
stages of 29
systems life cycle model of 31
Change model Ko er's applied to 562, 563t
Change process
in complex systems 18
systems and 17–18
Change theory 28–31
diffusion of innovation 29–31
planned change in 29
using 31
Channel, in communication system 21–22
Chaos, definition of 18
Chaos theory 18
Chaotic domain, of Cynefin Framework 21
Chaotic systems, characteristics of 18b
Charge description master file 122
Chasm report, on healthcare 39
Chautauqua College of Liberal Arts 517
Chegg 530
Children's Health Insurance Program (CHIP) 472, 475b
CHIME See College of Healthcare Information Management
Executives (CHIME)
CHIP See Children's Health Insurance Program (CHIP)
Chronic diseases, increasing numbers of patients with, health
informatics future and 613
Chronic illness screening, and management 415–416
Chronically ill online healthcare consumers 208
Claims denial management application 114
Claims processing and management system 114
Classification(s)
definition of 373
derived 584–585
predictive analytics and 394
reference 584–585
related 584–585
Classification matrix, of data mining 399, 400f
Clickers, in healthcare education 543–544
Clinical applications 78
Clinical Care Classification 375–376t, 379, 379t
mapping nursing concepts to 384t
Clinical data, preprocessing, in KDDM 396–397, 397b
Clinical data repository (CDR) 76–77
Clinical decision making, evidence-based 40
Clinical decision support (CDS)
adoption of 177
challenges and barriers to 177–178
Meaningful Use incentives for 179
on national level, recent progress toward 178–180
open source, freely available resources and 180
best practices for 178
definition of 171
effectiveness of, evidence of 176
examples of, from HELP system 172
future directions for 180–181
history of 171–172
for home health, hospice care, and community-based systems 159
impact of 176–178
financial 177
studies, examples of 176–177
implementation of, challenges in 177
logic and capabilities of, lack of framework for sharing, as barrier
to clinical decision support adoption 178
for medication dosing support 172–173, 172f
national, knowledge management initiatives and 179–180
for relevant information display 173–175, 175–176f
research challenges in 180, 180b
standards of 179
support types and examples of 172–176
for workflow support 175–176
Clinical decision support (CDS) system(s) 5, 80–81, 97–98, 98f, 170–
183
as expert systems 175
in healthcare information system 320–321
as order facilitators 173, 173f
as point-of-care alerts and reminders 173, 174f
Clinical documentation systems, in clinical se ing 96–97
Clinical informatics 603
Clinical Learning Environment Comparison Survey (CLECS) 568
Clinical practice, public health practice compared with 186–187, 188f
Clinical practice guidelines (CPGs)
critical appraisal of 45, 45b
translation to guidelines and 44
Clinical scenario, for simulation 564
Clinicians
behavioral healthcare, inappropriate social media use by 227
convergence of 210–213
in ePatient care, new role of 211
inappropriate behavior as challenge in 227–228
productivity of 79
social media use by 225–226
in university-based education 510
Closed systems 15
Closing activities, project process groups and 288
Cloud-based CMSs 524
Cloud computing 84
Cloud computing systems, in public health informatics 200
Cloud licensing, “on-premises” licensing versus 300–301
Clustering, predictive analytics and 394
CMS See Centers for Medicare and Medicaid Services (CMS)
CMS Hospital-Acquired Conditions 410–411t
Code of Ethics
for health informatics professionals in 438, 439t
on privacy and confidentiality, social media and 227
Coded (structure) data, preprocessing, in KDDM 397
Cognitive behaviors, intellectual skills, reflect by 27
Cognitive engineering theories, in evaluation 63
Cognitive learning, hierarchical order in 26
Cognitive learning domain, in evaluating simulation 567–568, 568b
Cognitive learning theories 25–27
Cognitive systems engineering 357
Cognitive task analysis 361
Collaborative practice tool, for informatics curriculum 507, 509t
College of Healthcare Information Management Executives
(CHIME) 600b
Commission on Accreditation for Health Informatics and
Information Management Education (CAHIIM) 502, 602
Communication
and connectivity, as EHR essential components and functions for
care delivery 92–93t
in disaster planning 349–350
mHealth and 259–260
Communication management 289
system 119
Community-based systems 153–169
core values and 155–156, 156b
evolution and milestones in 154
future directions for 166–167
nurse-managed health centers as 155
public health and 155
skills and 156
standardized datasets in 156–157
standardized terminologies and 159
Omaha System as 159–166 See also Omaha System
vendors of 166, 166b
Community building 530–531
Community college training 509–510
Companies (life sciences)-consumers, social media structure 222b
Comparison tests, in usability tests 365
Compatibility, of innovation 30
Compensation, benefits, and pension administration-payroll
interface, as human resources subsystems 126
Competencies for Telehealth Technologies in Nursing (ANA) 137
Competencies Matrix of Health Information Technology and
Informatics Skills 503, 503–504b
Complex Adaptive System (CAS)
characteristics of 18–19
managing uncertainly in, Cynefin Framework for 19–21, 20f
Complex domain, of Cynefin Framework 21b
Complex organizations 19
Complex systems 18
Complexity, of organizations 30
Complexity theory 18
Complicated domain, of Cynefin Framework 20
Comprehensive education information system (CEIS) 539–540, 539f
Comprehensive Severity Index (CSI), in practice-based evidence
study 52–53
Computer-based patient records (CBPRs) 91
Computer hacking skills, for data science personnel 402
Computer literacy/fluency, definition of 12
Computer patient records (CPRs) 91
Computer science, roots of informatics in 595
Computerized provider order entry (CPOE) 95
in clinical se ing 95
Computerized teaching tools 539f, 540–547, 540b
clickers as 543–544
desktop as 543
digital books as 541–542
digital portfolios as 545
educational software as 544–547
eReaders as 541–542
future directions 553–554
gaming as 546
hardware as 540–544
impact of
on faculty role 540b, 548–553
on teaching and learning process 547–548, 547b
interactive whiteboards as 540–541, 540b
laptops as 543
learning and content management systems as 544
mind maps as 544, 544f
smartphones as 542
student journaling software as 545–546
tablets as 542–543
virtual world as 546–547
web-based student testing as 545
Computers, in healthcare education 543
Concepts
definition of 14, 373
foundational 12
in theory structure 16–17
Conceptual framework 15
Concurrent powers 423
Confidentiality
definition of 437, 437t
in electronic health record (EHR) 102
exceptions to 314b
as social media challenge 226–227
in software licensing agreements 313–314
telehealth and 137–138
Configuration management database (CMDB) 341
Connected health 255
Connected health technologies, for informatics curriculum 508, 509t
Connected healthcare, and mHealth 262
Connecting Nurses 589–590
Consolidated framework for implementation research, in program
evaluation 66
Constitution 423
Constructionist learning theories 25–27
Consumer Assessment of Healthcare Providers and Systems
(CAHPS) 157
Consumer-consumer, social media structure 222b
Consumers
engagement and empowerment of, and mHealth 261–262
as stakeholders in EHR implementation 99–100
Contemporary ePatients 208–209
Contemporary skills, of FIT persons 12
Content analysis, in predicting future research 616, 617f
Content management systems, in healthcare education 544
Contextual control model 357
Contextual inquiry, in traditional usability methods 361–362
Continua Health Alliance (CHA), telehealth technical standards
and 136
Continuing professional development 512
Contract management application 114–115
Contract negotiations 298–316
Copyright 300
Corcoran, Sheila, on study of nursing informatics 23
Correspondence education 517
Cost(s)
development of, decreased, from improved health IT user
experience 356–357
maintenance of, decreased, from improved health IT user
experience 356
management 289
personal health records utilization and 248
saving of
as electronic health record benefit 99
and mHealth 263
of simulation 560, 560t
training and support, customer and individual, decreased, from
improved health IT user experience 356
Cost-effectiveness analysis (CEA), in program evaluation 71
Course delivery systems 520–525, 520t
Course management system 520–525, 520t
cloud-based 524
future of 525
open source 522–524
partnerships 524
proprietary 522
selection commi ee for 524–525
selection criteria for 524–525
Covered entity 440–441, 440b
CPGs See Clinical practice guidelines (CPGs)
CPHIMS See Certified Professional in Healthcare Information and
Management Systems (CPHIMS)
CPRs See Computer patient records (CPRs)
CPT See Current Procedural Terminology (CPT)
Credentialing 501t, 502
in telehealth 143–144
Creighton Competency Evaluation Instrument (C-CEI) 568
Creighton Simulation Evaluation Instrument (C-SEI) See Creighton
Competency Evaluation Instrument (C-CEI)
Critical Access Hospitals (CAHs) 318
objectives and measures for, Meaningful Use 469–471t
Cross-mapping, terminology 383
Crossing the Quality Chasm (IOM) 39, 481
on value of applications of health IT 499–500
Crowdsourcing, definition of 212
CSI See Comprehensive Severity Index (CSI)
Culture, organizational, electronic health record and 103
CuRE framework, in advancing telehealth 148, 148f
Current Procedural Terminology (CPT) 375–376t
Curriculum, in informatics 505
continuing professional development 512
framework for 506–508
for healthcare professionals 499–515
learning strategies in 507–508, 509t
pedagogy 507
roles and competencies 508–512
teaching tools for 507–508, 509t
Curriculum Development Centers Program’s grants 509–510
Customization, of personal health records 245
Cyberbullying 229
Cyberharassment 229
Cybersecurity Framework 445, 445b
Cybersecurity threats 620
Cyberstalking 229
Cytotoxicity, of nanomaterials 625
D
Data
access to, ePatients and 212–213
a ributes of 25b
big See Big data
control of, in personal health records 244
health
electronic, secondary uses of 443
privacy of 437 see also Privacy, information
healthcare, standardization of 373–382
in knowledge base 22
multiple, sources of, with li le information exchange, as barrier to
clinical decision support adoption 177
privacy, in personal health records 244
privacy of, risk in, and mHealth 264
safety, regulation, and oversight of, and mHealth 264–265
Data analytics, in healthcare 391–407
Data collection
electronic health record applications for 78
intensive, in practice-based evidence study 53
and mHealth 259
Data dictionary, in electronic health record 79–80
Data exchange 382–384
HL7 standards in 383
terminology harmonization in 383–384
Data governance 404, 404f
Data Governance Institute 404
Data integrity, in electronic health record (EHR) 102
Data minimization, description of 438t
Data mining, in knowledge discovery and data mining 398–399
machine learning in 398–399
methods of 398t
models of, evaluating 399
statistical approaches to 398
Data ownership
of personal health records 244
software licensing agreements 315
Data quality and integrity, description of 438t
Data science
benefits of 394
characteristics of big data in 393, 393b
for clinical and translational research 393–394
future directions of 404–405
in healthcare 391–407, 392t, 393b
organizational considerations for 401–404, 402f
data governance in 404, 404f
data science personnel in 401–403
data standardization in 404
tools and platforms in 403, 403t
Data science personnel 401–403
skills for 402–403, 403f
Data sharing
networking systems for 82
of personal health records 245
Data standardization 404
Data storage, comprehensive longitudinal, personal health records
and 244
Data usage, software licensing agreements 315
Data visualization 623–626
Database
of practice-based evidence study, create of 53
size and flexibility of 84
Dataflow maps, in requirements definition 275, 275–276f
Dataset(s)
large, in education information system 538–539
minimum, American Nurses Association (ANA) of 375
standardized, in home health and community-based systems 156–
157
DaVinci robot 3
de Dombal’s computer-aided diagnosis of acute abdominal pain, in
history of CDS 171
De-identification of data 443, 444f
deBronkart, Dave, in evolution of ePatient movement 209
Decision making
clinical, evidence-based 40
clinical decision support systems for 170
structures for, respect for, in health IT governance 494
Decision rules, data mining method 398t
Decision support, as EHR essential components and functions for
care delivery 92–93t
Decision trees, data mining method 398t
Deficit Reduction Act of 2006 416
Dental informatics 598
Dentistry, EHR essential component and functions for care
delivery 92–93t
Department of Defense (DOD), telehealth programs and 132
Department of Justice 424t
Derivative works 299–300
as software licensing agreement component 304–305, 305b
Derived classifications 584–585
Design thinking 355
Desire2Learn 522, 523f
Desktop computers, in healthcare education 543, 550–552t
Development time and cost, decreased, from improving the user
experience for health information technology 356–357
Diffusion of innovations theory 29–31
in evaluation 63
Digital abuse 229
Digital books 541–542
Digital divide
as barrier to personal health record adoption 249
bridging, as incentive to social media adoption 231
mHealth and 261
Digital literacy
definition of 12–13
telehealth adoption and 147
Digital Millennium Copyright Act of 1998 531
Digital portfolios, in healthcare education 545
Dimensional Insight 127
Direct delivery, as method of deployment 401
Direct patient health services, telehealth and 144–147
Disability issues, in distance education 533
Disaster planning 347–350, 348t
business continuity in 348–349
communication in 349–350
disaster recovery in 348
responsibilities in 350
Disaster recovery 337–351
in disaster planning 348
future directions for 350
plan consideration, information technology contingency and 348t
Discount usability methods 359–360
[Link] 602
Discovery research, in knowledge transformation 42, 42f, 43t
Disorder domain, of Cynefin Framework 21
Dispute resolution, in software licensing agreements 313
Disruptive technology, electronic health record as 103
Distance education 516–537
course management system in 520–525, 520t
definition of 518
evaluation of 528–529
future directions for 534–535
goals and objectives (outcomes) in 528
historical development of 517
instructional and learner activities in 528
instructional design for 526–529, 526t
issues in 531–534
disability 533
legal 531–533
quality 533–534
readiness 534
strategic plan for 519–520, 519b
student (learner) support services 529–531
terminology in 517–520
Distance Learning Education Commi ee 518
Distributed learning 518
Distributed storage model 77
Distribution, of coded data 397
Distributive (distributed) education 518
District Health Management Information Software System version 2
(DHIS 2) 259
Document literacy 11
DOD See Department of Defense (DOD)
Donabedian model 413, 413b
Donation safe harbor, health and human services 427, 427t
Downtime, in health information systems 337–351
decision tree 343f
information technology impact of, planning and 347
levels 343t
response planning and 342–347, 342t, 344–345f
clinical impact and planning in 345–346, 346b
future directions for 350
redundant systems in 346–347
risk assessment for 338–342, 338b, 340t, 341b
vulnerabilities, common human-made and natural disasters 339t
Downtime Determinator 344–345
Draft contract, tips on how to control versions of 301b
Dynamic homeostasis 17
Dynamic systems, chaotic systems as 18
E
EACH programs See EHR Alternative Certification for Healthcare
Providers (EACH) programs
Early adopters, of innovation 30
Early majority, response of, to innovation 30
Eaton article, in quality assurance, of distance education 534
EbolaTXT 259, 260f
eBooks 541
EBP See Evidence-based practice (EBP)
EBP InfoBot 97–98, 98f
Ecology, information, in public health practice 198
Economic potential, of mHealth 263
eCQI See Electronic Clinical Quality Improvement (eCQI)
EDIS (emergency department information system) 97
Education See also Curriculum See also Learning; Teaching
for client, on mHealth 258
computerized teaching tools in 539f, 540–547, 540b See also
Computerized teaching tools
distance See Distance education
for electronic health record implementation 331–333
in evolving healthcare and technology environment 505–506
for generalist 511
for healthcare professionals 499–515
for healthcare specialists at graduate level 511–512
informatics and 6, 6f
interprofessional, simulation 568–569, 569t
reform initiatives 500–502
simulation 557–576
technology-enhanced, challenges of 502–505
in telehealth implementation 138f, 139
Education information system(s)
comprehensive 539–540, 539f
future directions 553–554
Educational programs, health informatics and 600–602
Effectiveness, in goals of usability 354
Effectiveness level of analysis, information defined as 63
Efficiency
of care delivery as electronic health record benefits 99
in goals of usability 354
objectives, as system requirement 277b
EFMI (European Federation for Medical Informatics) 578, 579f, 579b
eHealth 205, 255 See also Health information technology (health IT)
global challenges to 590–591
global interoperability in 590
human resources for 590
infrastructure 590–591
legal and regulatory framework 591
Global Observatory for 584, 584t
involvement, international organizations with 583–587
at World Health Organization 583–584
eHealth Action Plan 2012-2020 578
eHealth exchange 83
eHealth initiatives
in Africa 582
in Asia-Pacific Economic Cooperation Region 578–581
in Europe 577–578
in Pan American Health Organization Region 581–582
eHealth literacy, telehealth adoption and 147
eHealth Resolution 583–584
EHR See Electronic health record (EHR)
EHR Alternative Certification for Healthcare Providers (EACH)
programs 318
EHR Collaborative 92
eLearning (eTraining) 518
ELEARNINGFORCE 522, 524f
Electronic Clinical Quality Improvement (eCQI) 412
Electronic decision support, and mHealth 259
Electronic expert system 24
Electronic health data, secondary uses of 443
Electronic health record (EHR) 75–76, 90–110, 100b
adoption of 93–94
cost of 99
EMR adoption model and 94, 94t
health practitioner role in 94
key issues related to 101–104
low, as barrier to clinical decision support adoption 177
applications of, used in clinical se ing 95–99
ancillary systems as 98–99
Bar code medication administration as 96
clinical decision support system as 97–98, 98f
clinical documentation as 96–97
computerized provider order entry as 95
electronic medication administration record as 95–96, 96f
specialty 97
a ributes of 92, 93b
benefits of 99
billing issues related to 426–429
component model 75–81, 76f
components and functions of 92, 92–93t
data integrity in 102
definitions of 91
donation safe harbor 427, 427t
in downtime risk assessment 341
electronic medical record versus 91–92
example of, screen images 165–166f, 166
fraud and abuse and 428–429
future directions for 105, 620–621
HITECH Act and 456, 457f
human factors in 103
implementing and upgrading
go-live in 333
big bang approach for 330–331, 331b
detailed plan 331
education and training 331–333
incremental approach in 330–331, 331b
preparing 330–333
improvement in, opportunities for 323–324
post-live maintenance for 333–334
project planning for 324–327
building or tailoring the product 327
defining success 324–325, 325b, 326f
engage stakeholders for 325
executive management support for 325
redesigned workflows for 325–327
testing in 327–330, 327–328t, 329f, 330b
systems life cycle and 324
knowledge discovery and 50
Meaningful Use of
adoption of 94
health practitioner role in 94
incentives for, clinical decision support adoption and 179
patient safety and improved quality of care in 409
mHealth and 259
organizational culture and 103
ownership of 101–102
privacy and confidentiality of 102
sociotechnical perspectives on 93–94
stakeholder perspectives on 99–101
standardization and 102–103
supporting home health with 157–159
technical infrastructure of 75–89 See also Technical infrastructure,
of electronic health record
Electronic medical record (EMR), electronic health record versus 91–
92
Electronic Medication Administration Record (eMAR) 95–96, 96f,
414–415
in clinical se ing 95
Electronic Numerical Integrator and Computer (ENIAC) 595
Electronic personal health record
development of 242–244, 242f
HITECH Act and 242–243
patient access to, blue bu on for 243–244, 244f
Eligible entities
for Medicaid 460
for Medicare 460
Eligible professionals
for Medicaid 460
for Medicare 460
objectives and measures for, Meaningful Use and 467–468t
Ellucian 521, 521f, 530
eMAR See Electronic Medication Administration Record (eMAR)
Emergency department, specialty requirements in 340t
Emergency department information system (EDIS) 97
EMR See Electronic medical record (EMR)
EMR adoption model 94, 94t
Encounter-based storage, for clinical data repository, versus
longitudinal-based 77
Endoscopy, specialty requirements in 340t
ENIAC See Electronic Numerical Integrator and Computer (ENIAC)
Enterprise vendors 112
“Entire Agreement” clause 302, 302b
Entropy 17–18
ePartogram 259–260
ePatient(s) 4
access to data and 212–213
characteristics of 205
connected world in 205–207, 206f, 207b
convergence of 210–213
engaged 204–219
evolution 204–210
future directions for 215–216, 216f
health informatics and 211–212
health information access by, personal health records and 208
historical background of 204–210
patient-focused virtual communities and 213
personal health records and 208
as pioneering concept 204–205
research networks and 213–215
social media sites and 211b
transparency and 212–213
ePatient care
guided discovery and 211
role of clinicians and informaticians in 211
ePatient movement 205
economic influences on 208
policy and legislative influences on 208
Episodic order, in information retention 26
ePortfolio, in healthcare education 545
Equifinality 17
eReaders 541–542
Ergonomics 353–354
Erroneous data, in preprocessing of coded data 397
Ethics, issues in, in nanotechnology 626
Ethnographies, focused, in traditional usability methods 361–362
Ethnography, in program evaluation 69–70
EU Directive on the Protection of Individuals with Regard to the
Processing of Personal Data and on the Free Movement of such
Data 439–440
Europe, eHealth initiatives in 577–578
European Federation for Medical Informatics (EFMI) 578, 579f, 579b
Evaluation
formative
questions to pose during 61b
versus summative 61b
future directions for 71
generalizability and scope of 62
in knowledge transformation 48–49, 48–49b, 48f
methods, tools, techniques for 68–71
instruments as 70–71
qualitative 68–70
quantitative 70
models in
program implementation 64–66
program theory 67–68
outcome of 60–61
program 60–74 See also Program evaluation
program continuance versus growth resulting from 62
purposes of 61–62, 61b
summative, questions to pose during 61b
theory in 62–68
information technology 64, 65f
social science 63–64
Evaluation research
questions, by stage of project and type of question 69t
scope of 62
Everyday Health 147
Evidence, strength of, hierarchy of 44, 45f
Evidence-based practice (EBP) 39–40, 39b
future directions for 55–56
in healthcare information system 320–321
informatics and 49
knowledge discovery and 50
models of 40–42, 41t
ACE Star Model of Knowledge Transformation as 41–42
practice-based evidence (PBE) and, relationship of 50
quality of care and 40
Evidence summary, in knowledge transformation 42f, 43–44, 43t
examples of 44–46, 44b
resources for 44–46
Exceptions
to confidentiality 314b
in software licensing agreements 313
Exchange specialist 510
Exclusions of liability 313
Executable code 300t
Execution activities, project process groups and 288
Executive management support, in project planning 325
Executive Order 13335, driving health IT 456
Experiential learning theory 27
simulation and 557
Expert consensus, in guideline development 44
Expert determination, for de-identification of data 443, 444f
Expert systems 24, 24f
clinical decision support systems as 175
Exploratory data analysis 394
Express powers 423
Extrapolation, in predicting future research 616
F
Facebook 222
Faculty
collaboration with instructional designer 549b, 550–553t
role of, impact of technology on 540b, 548–553
enhanced courses 549–553
in simulations, development of 560–561
Faculty expertise 502–505
Fair Information Practice Principles (FIPPs) 437–438, 438t
Faith community nurses 155
False Claims Act 427–428
Family Educational Rights and Privacy Act 532–533
FCC See Federal Communication Commission (FCC)
FDASIA See Food and Drug Administration Safety and Innovation
Act (FDASIA)
Federal Communication Commission (FCC), in social media
regulation 229
Federal Employees Health Benefits Program (FEHBP) 475b
Federal government, role of, health informatics and 475–477, 475b,
476f
Federal Health Information Technology (IT) Strategic Plan 2015-20,
and mHealth 256, 262
Federal initiatives, driving health IT 456–472
Federal laws and regulations
on health IT 422–435, 455–473
on information privacy 440–442, 440b
state collaboration with 443
requests for comments on, responding to 483–484
Federal Refugee Health Promotion Program 475b
Federal Trade Commission 424t
Federalism 423
Feedback clauses, in software licensing agreements 314
Fees, maintenance and support, in software licensing agreement 309
FEHBP See Federal Employees Health Benefits Program (FEHBP)
Fidelity 558–559
definition of 558
high-fidelity simulator 558f
in simulation 559, 559t
Financial incentives, for health IT 459–471
Financial information system (FIS) 112
architecture of 112, 113f
challenges with 115–118
claims denial management application in 114
claims processing and management system in 114
contract management application in 114–115
definition of 112
efficiency tools in 119
financial functions using 112
in financial reporting 115, 115–116t
fixed asset management application in 115
general ledger in 113
healthcare, evolution of 112–115
integration of 118–119, 123f
patient accounting application in 114
payroll application in 113–114
Financial ratios 115, 117t
Financial reporting 115, 115–116t
Financial transactions, and mHealth 260
FIPPs See Fair Information Practice Principles (FIPPs)
FIS See Financial information system (FIS)
FIT persons 12
Fixed asset management application 115
Flickr 223
Flipbook, as technology tools 550–552t
Focused ethnographies, in traditional usability methods 361–362
Folle 529
Food and Drug Administration Safety and Innovation Act
(FDASIA) 431, 432f
Formal user testing, for improving the user experience for health
information technology 362
Formalization, of organizations 30
Formative assessments, in evaluating simulation 567
Formative evaluation
questions to pose during 61b
versus summative evaluation 61
Formative tests, in usability tests 364
example of 364
Forum clauses, in software licensing agreements 314–315
Foundational concept, of FIT persons 12
Foursquare 223
Fractal-type pa erns, in chaotic systems 18
Framework
conceptual 15
theoretical 15
Fraud, electronic health record and 428–429
Frequency, in preprocessing of coded data 397
Friending, malicious, on social media 228
Full-body firewalls 618
Functional reach 154
Functional testing, during information system implementation and
post go-live 327–328t
Future directions
for administrative applications 127–128
challenge of anticipating 615, 615t
for clinical decision support (CDS) 180–181
clinical informatics and 620–621
for community-based systems 166–167
for computerized teaching tools 553–554
for disaster recovery 350
for distance education 534–535
for downtime response planning 350
for electronic health record 105, 620–621
for ePatients 215–216, 216f
for evidence-based practices 55–56
in health informatics 612–629
big data 621–622
data visualization in 621–622
EHRs 1.0 620–621
nanotechnology in 624–626
predictive analytics 622–623
technical trends 619–620
for health information technology (health IT) 472
for health IT governance 497
for health policy in informatics 489
for home health 166–167
for hospice care 166–167
for improving the user experience for health information
technology 366
for informatics curriculum 512
level of change 614
for patient safety and quality initiatives in health informatics 417–
418
predicting, approaches to 616–617, 616b
project management 296
for simulation 571–573
for social media 234
for software licensing agreements 315
for technical infrastructure of electronic health record 85–87
for telehealth 147–149, 148f
for theoretical foundations, of health 33–34
The Future of Nursing Report, recommendations of 486–487
Future research 613–618, 613b
on anticipating future directions 615, 615t
application of 617–618
defining 613–614, 613b
future directions and scope of change 614
in health informatics 612–629
Future shock 615
Futurology 613–618 See also Future research
G
Gaba’s 11 dimensions of simulation, applied to simulation 564
Games + Learning + Society (GLS) 562
Gaming
in healthcare education 546
simulation 571
Gan charts 294
key tasks and durations in 294f
simplified 295f
task relationships and predecessors in 294f
Gardner's nine multiple intelligences, examples using 547b
Gartner, fee-based ratings services of 112
Gartner Analytics Maturity Model 402f
Gartner Magic Quadrant 2015 295f
General ledger 113
General systems support, elements for 341b
Generalist, education for 511
Genetic Information Nondiscrimination Act of 2008 (GINA), HIPAA
Omnibus Final Rule and 441
GeriPal, weblog 3
GetMyHealthData effort 487
GIGO (“garbage in garbage out”), open systems and 15–16
Global health, and mHealth 262
Global Observatory for eHealth (GOe) 584, 584t
WHO's, mHealth definition 255
Global perspective, on education 547–548
GLS See Games + Learning + Society (GLS)
Go-live, in information system 333
preparing 330–333
big bang approach in 330–331, 331b
detailed plan 331
education and training 331–333
class and class schedule, length of 332–333
methodology in 332
trainers in 332
incremental approach in 330–331, 331b
GOe See Global Observatory for eHealth (GOe)
Google earth, as technology tools 550–552t
GoogleFit 265
Goosen’s Framework for Nursing Informatics Research 34t
Governance, health IT 492–498
activities and processes 493b
continual increase in demand for health IT and 495
core components of 493–494
designing, implementing, and iteratively enhancing 497
future directions for 497
health IT capability maturity assessment for 495–496, 496t
investigating peer informatics governance models for 496–497,
496f
key insights of 494–495
need for 493–494
recommendations for 495–497
respect current decision-making structures of 494
shift in organizational mindset and 494
on specific technology choices, independence from 495
stakeholders in, diverse, coordination and collaboration with 495
structure of 494, 494f, 496f
Governing law, in software licensing agreements 314–315
Governments, as stakeholder in EHR implementation 101
Grand theories 14
Graves, Judy, on study of nursing informatics 23
Green screens, as technology tools 550–552t
Guidance documents 425
Guided discovery, in ePatient care 211
Guidelines, clinical practice 44 See also Clinical practice guidelines
(CPGs)
H
Hardware 540–544
home telehealth and 135
testing, during information system implementation and post go-
live 327–328t
Harmonization, terminology 383–384
HCI See Human-Computer Interaction (HCI)
HCOs See Healthcare organizations (HCOs)
Health 1.0 207
Health 2.0 207
Health 3.0 207
emerges 213–215
environment for 213–214
virtual patient communities and 213–215, 214f, 214t
Health AppScript 264–265
Health care, redesigning, STEEEP principles for 39, 40t
Health Care Innovations Exchange 47, 47b
Health data
electronic, secondary uses of 443
management, resource guide of 112
privacy of 437 see also Privacy, information
Health Human-Computer Interaction Framework 357–358, 358f
Health informaticians 2
Health informatics 1–9
clinical decision support in 171 See also Clinical decision support
(CDS)
definition of 2–3, 2t
development of 596–597
education programs, accreditation for 602
ePatient and 211–212
evidence-based practice and 39–40 See also Evidence-based
practice (EBP)
evolution of 594–611
future directions for 607–609
exploring past and future of 7
foundational literacies for 11, 11f
fundamental concepts in 3
future directions for 8
future of 618–620 See also Future directions, in health informatics
governance of 492–498 See also Governance, health IT
health policy and 474–491
developing and implementing 475–480, 477–479t
leadership competencies for 482–484
driving forces for creating 480–482
future directions for 489
nursing-specific 486–489
professional association influencing 485–486t
hierarchy of 608f
patient safety and quality initiatives in 408–421
future directions for 417–418
practice, quality indicators of 500, 501t
professionals in, Code of Ethics for 438, 439t
project management principles for 284–297
public 184–203
definition of 184
future strategies for 197–201
advancing technical infrastructure as 199–201
transforming practice with 197–199
social and political challenges affecting 189, 190f
value of, for public health domain 191–197 See also Public health
informatics, value of
health information exchange and 194–195, 195b
immunization information systems and 193–194, 194b
in public health reporting 195–197, 196f, 198f
in surveillance 191–193, 192–193t
quality data standards of, national efforts related to 411–413, 412t
roots of 594–597
computer science and 595
information science and 595–596, 596b
specialty of
establishing 597–605, 597f
books 597–598, 597b, 598t
certification 602–604, 603b
educational programs 600–602
journals 598–599, 598t
professional organizations 599–600, 599–600b
naming 605–607, 605b, 606–608f
recognition of 605
success factors and lessons learned in 416–417, 417b
theories and models in 15
at World Health Organization 583–584 See also eHealth
Health Informatics in Africa (HELINA) 582, 583f
Health informatics specialist, education for 511
Health information, specialty requirements in, for acute care
se ing 340t
Health information and data, as EHR essential components and
functions for care delivery 92–93t
Health information exchange (HIE) networks 93
Health information exchanges (HIEs)
for data sharing 82
public health informatics in 194–195, 195b
statewide, clinical decision support and 179
Health information management 510
Health Information Management Systems Society (HIMSS) 3–4
Health information organizations (HIOs), for data sharing 82
Health information privacy and security specialist 510
Health Information Security and Privacy Collaboration (HISPC) 443
Health information system, life cycle of, management of 5
Health Information Technology for Economic and Clinical Health
(HITECH) Act 6, 93, 275, 299, 455–473, 499–500, 601, 620
data sharing networks and 82
electronic health record and 456, 457f
electronic personal health records and 242–243
health IT policy and 476–477
provisions of HIPAA expanded by 441, 441b
sections of 457b
Health information technology (health IT) 60–61, 69t, 496t
adoption and use of, national initiatives driving 409–411, 410–411t
capability maturity assessment for 495–496, 496t
demand for, continual increase in, health IT governance and 495
federal initiatives driving 456–472
financial incentives for 459–471
future directions for 472
governance of 492–498 See also Governance, health IT
implementation of, unintended consequences of 481–482
improving user experience for 621
Institute of Medicine report on, patient safety and 481
knowledge building using 50
legal issues in 422–435
Office of the National Coordinator for 456
overview of 499–500
specific, independence of health IT governance from 495
success factors and lessons learned in 416–417, 417b
supporting home health with 157–159
in telehealth 136
tools in 505
use of, to advance future of nursing 486–488
workforce roles of 508–511
Health Information Technology Research Center (HITRC) 459
Health Information Trust Alliance (HITRUST) 444, 445b
Health Insurance Portability and Accountability Act (HIPAA) 6, 299
and electronic personal health record 242
Fair Information Practice Principles and 437–438
history of 440–441, 440b
Omnibus Final Rule of 2013 441–442, 441–442b
Privacy Rule
CDC guidance on 190
de-identification of data 443, 444f
on protected health information, social media and 226
provisions of, expanded by the HITECH Act 441, 441b
Security Rule of 444, 445b
Version 5010, transition from Version 4010 to, EHR
implementation and 319
violations and related fines, examples of 447t
health IT See Health information technology (health IT)
Health IT Policy Commi ee 458
policy initiatives of 461
Health IT Safety Center 431, 432f
Health IT Standards Commi ee 458
Health IT subspecialist 510
Health Level Seven (HL7) 590
standards 383
Health literacy, definition of 13–14
Health policy 6
health informatics and 474–491
developing and implementing 475–480, 477–479t
leadership competencies for 482–484
driving forces for creating 480–482
future directions for 489
nursing-specific 486–489
professional association influencing 485–486t
Health practitioners
in EMR adoption and Meaningful Use 94
on key commi ees and boards, in developing and implementing
health IT policies 483
Health Professional Education: A Bridge to Quality, on informatics as
core competency 499–500
Health Vault 246–247
Healthcare
access to, telehealth in 149
clinical decision support systems in 170–183 See also Clinical
decision support (CDS); Clinical decision support (CDS)
system(s)
consumers of, telehealth technology and 147
costs, health informatics future and 613
data science in 391–407, 392t, 393b
information systems and applications for delivery of 3–4, 4f
for Islanders 3
participatory
definition of 210
informatics 4–5
patient-centered 210–211
social networking in 221–222
Healthcare and wellcare data model 622f
Healthcare data
security threats to, increasing 447–448
standardization of 373–382
Healthcare delivery
administrative applications supporting 111–130
at distance, telehealth and 131–152 See also Telehealth
Healthcare ERP and SCM Information Systems: Strategies and Solutions
(HIMSS) 122
Healthcare Information and Management Systems Society
(HIMSS) 112, 599, 600b
electronic health record defined by 91–92
Healthcare ERP and SCM Information Systems: Strategies and
Solutions of 122
nursing informatics position statement of 488
Policy Center, public policy focus of 485–486t
vendor resource guides of 112
Healthcare organizations (HCOs)
culture of, electronic health record and 103
elements in agreement typically paid for by 302b
indemnification by 314
name, marks, and logos of, in software licensing agreements 315
project management in, need for 285–286
software license agreements 298
as stakeholders in EHR implementation 99
vendor's contract and 301
Healthcare portfolio management structure 290f
Healthcare program 290f
Healthcare provider(s)
predicted shortage of, health informatics future and 613
shortages in, telehealth in 149
as stakeholder in EHR implementation 100
Healthcare regulatory framework, federal 423–425, 424f
guidance and advisory opinions 425
laws 423–424, 424t
regulations and rule making 424–425
HealthKit 265
HELINA (Health Informatics in Africa) 582, 583f
Help desk 530
HELP System, clinical decision support examples from 172
Henry Street Se lement House 154
HEOA See Higher Education Opportunity Act (HEOA)
Heuristic evaluation, in discount usability methods 359–360, 360t
project, example of 359–360
HHS See U.S. Department of Health and Human Services (HHS)
Hierarchical order, in information retention 26
HIEs See Health information exchanges (HIEs)
Higher Education Opportunity Act (HEOA) 530, 532
HIMSS See Health Information Management Systems Society
(HIMSS)
HIOs See Health information organizations (HIOs)
HIPAA See Health Insurance Portability and Accountability Act
(HIPAA)
HISPC See Health Information Security and Privacy Collaboration
(HISPC)
HITECH Act See Health Information Technology for Economic and
Clinical Health (HITECH) Act
HITRC See Health Information Technology Research Center
(HITRC)
HL7 See Health Level Seven (HL7)
Hollerith, Herman 595
Holliday, Regina, in evolution of ePatient movement 209
Home health 153–169
core values and 155–156, 156b
electronic health record and health IT
with billing solutions 158
with clinical-decision-support systems 159
with point-of-care solutions 158–159, 158f
supporting 157–159
evolution and milestones in 154
future directions for 166–167
Outcome and Assessment Information Set (OASIS) 156–157
patient experience surveys in 157
practice models for 154–156
skills and 156
standardized datasets in 156–157
standardized terminologies and 159
Omaha System as 159–166 See also Omaha System
vendors of 166, 166b
Home telehealth 134–135
Home visits, remote, telehealth in 145–146
Homeostasis, dynamic 17
Hospice care See also Palliative care and hospice
evolution of 154
future directions for 166–167
Hospice Item Set and 157
information system vendors for 166, 166b
practice models for 155
quality measures for 157
standardized terminologies and 159
Omaha System as 159–166 See also Omaha System
Hospice Item Set 157
Hospital, eligible, objectives and measures for, Meaningful Use
and 469–471t
Hospital-healthcare provider connection, in practice management
systems 120–121
Hospital information system 91
Hospital Management Systems Society (HMSS) 599
HRISs See Human resources information systems (HRISs)
Human-Computer Interaction Frameworks, for health
informatics 357–358
human factors and 357
Human-Computer Interaction (HCI) 354
Human factors 353
in electronic health record (EHR) 103
human-computer interaction frameworks and 357
Human-made disasters, downtime from 338–341, 339t
Human resource management 289
Human resources information systems (HRISs) 125, 125b
as competitive advantage 124–125
subsystems of 125–126
vendors of 125, 125b
Hypotheses test, in practice-based evidence study 53–54
I
IaaS model See Infrastructure as a service (IaaS) model
IBM Cognos Business Intelligence 127
ICD See International Classification of Diseases (ICD)
ICF See International Classification of Functioning, Disability and
Health (ICF)
ICN Telenursing Network 589
ICNP See International Classification for Nursing Practice (ICNP)
ICT (Information and communication technology) 577 See also
eHealth
Identifiers, in preprocessing of coded data 397
Identity theft, social networking and 228
IHI See Institute for Healthcare Improvement (IHI)
IHTSDO See International Health Terminology Standards
Development Organisation (IHTSDO)
IISs (immunization information systems), as public health
informatics application 193–194, 194b
Image-driven communication 618
IMIA See International Medical Informatics Association (IMIA)
IMIA-LAC (Regional Federation of Health Informatics for Latin
America and the Caribbean) 581–582, 581f
IMIA-NI (International Medical Informatics Association Nursing
Informatics) 586–587, 587b, 588t
Immunization information systems (IISs), as public health
informatics application 193–194, 194b
Implementation managers 510
Implied powers 423
Improved project performance, benefits of 289
Improving Outcomes with CDS: An Implementer’s Guide (HIMSS) 178
In Case of Emergency (ICE) record 244
INACSL See International Nursing Association for Clinical
Simulation & Learning (INACSL)
Incentives
financial, for health IT 459–471
mHealth and 260
Income statement 115, 115t
Incremental approach, in go-lives 330–331, 331b
Indian Health Service (IHS) 475b
Individual effectiveness, increased, in improving the user experience
for health information technology 356
Individual participation, description of 438t
Infectious diseases, surveillance of 191, 193t
Infobu on
in electronic health record
in data collection 78
in review and reporting 78
in knowledge-based environment 80
“Infodemiology” data, in surveillance of disease outbreaks 193
Informaticians, in ePatient care, new role of 211
Informatics 596, 618–619 See also Health informatics
biomedical 2t
competencies in 502
development of, history in 505–506
convergence of 210–213
curriculum in 505
continuing professional development 512
framework for 506–508
for healthcare professionals 499–515
learning strategies in 507–508, 509t
pedagogy 507
roles and competencies 508–512
teaching tools for 507–508, 509t
education and 6, 6f
generating knowledge in 5–6
healthcare and 3
international, efforts 7, 7f
legal issues for 6, 433
organizational structures for 6
overview of 499–500
patient improvement in 5–6
provider experience in 5–6
science of, curriculum design of 506
topics and areas of study in 3–7
Informatics Capability Maturity Model, in health IT capability
assessment 495, 496t
Informatics Research (IRO) Model 34t
Informatics researcher and innovator, education for 512
Information
a ributes of 24–25, 25b
definition of 21b
in knowledge base 22
privacy of 437
in Code of Ethics for health informatics professionals 439t
Information and communication technology (ICT) 577 See also
eHealth
Information Builders WebFOCUS Business Intelligence and
Analytics Platform 127
Information ecology, in public health practice 198
Information foraging theory 63–64, 64b
Information literacy, definition of 12, 13t
Information science, roots of informatics in 595–596, 596b
Information supply chain, future of 198
Information system(s)
disaster planning in 347–350, 348t
business continuity and 348–349
communication and 349–350
disaster recovery and 348
responsibilities and 350
downtime in 337–351
levels of 343t
policies and procedures 347
response planning and 342–347, 342t, 343–345f
risk assessment for 338–342, 338b, 340t, 341b
vulnerabilities, common human-made and natural disasters 339t
education, comprehensive 539–540, 539f
healthcare
clinical decision support in 170–183 See also Clinical decision
support (CDS);; Clinical decision support (CDS) system(s)
contract for, negotiations for 281
current, updating inventory and functionality of 274
life cycle of 273–282
analysis and requirements definition in 273–277, 274b
develop or purchase of 278–282
project planning 277–278
research firms in 280t
selection of 271–283, 272b
future directions for 282
strategic vision and alignment in 271–273
team creation for 278
vendors of
establishing a working relationship with 281–282
evaluation 279
healthcare, implementing and upgrading 317–336
go-live in 333
big bang or incremental 330–331, 331b
detailed plan 331
education and training 331–333
preparing 330–333
improvement in, opportunities for 323–324
integrated health system in, best of breed versus 323
life cycle of 324
phases of 324
project planning in 324–327
online environments 330b
post-live maintenance in 333–334
reasons for 318–321
changing government regulations in 318–319
clinical decision support systems in 320–321
incorporating evidence-based content in 320–321
patient safety in 321–322
quality of care in 321–322
risk factors for 322
scope creep in 322–323
sufficient resources in 322
in home health 154 See also Home health
information technology impact and planning in 347
telehealth and 149 See also Telehealth
Information system success model, in evaluation 64, 64f
Information technology (IT)
architecture of 75
contingency, disaster recovery plan consideration and 348t
impact of, in downtime 347
infrastructure, sample elements of 338, 338b
physical structure, examples of 338b
Information technology (IT) theories, in evaluation 64, 64–65f
Information theory 21–25
Blum model of 22
in evaluation 63
Graves model of 23
Nelson model of 23–25
Shannon-Weaver information-communication model of 21–22
Informed patients, telehealth and 137–138
Infrastructure as a service (IaaS) model, of cloud computing 84
Initiating activities, project process groups and 287
Innovation
a ributes of 30
diffusion of 29–31
Innovators 29–30
Input data, from clinical decision support system 172
Institute for Healthcare Improvement (IHI) 247
Institute of Medicine (IOM)
Crossing the Quality Chasm of 39, 481
on value of applications of health IT 499–500
To Err Is Human 481, 499–500
finding of, on 2001 level of current care compared with standards
of care 39b
framework 186
The Future of Nursing, assessing progress on 488–489
Health Professional Education: A Bridge to Quality 499–500
Quality Chasm Series 475b
report on health IT, patient safety and 481
STEEEP principles of 39
Institution, issues in, of distance education 534
Instructional designer, collaboration with faculty 549b
Instruments, user-satisfaction, in program evaluation 71
Insurance, software licensing agreements 313
Insurance claim
claims denial management application of 114
claims processing and management system of 114
Insurance payers, as stakeholder in EHR implementation 101
Integrated “bolt-ons” 118–119
Integrated health system, best of breed versus 323
Integrated testing, during an implementation and post go-live 327–
328t
Integrity, definition of 437t
Intellectual capabilities, of FIT persons 12
Intellectual property, in distance education 532
Intellectual property infringement 314
Intellectual skills, cognitive behaviors reflecting 27
Interactive whiteboards 540–541, 540b
Interconnectedness, of organizations 30
Interface engine, in system integration 81–82
Interface terminology 373
“Internal use” restrictions 304
International Classification for Nursing Practice (ICNP) 375–376t,
380, 380b, 588
mapping nursing concepts to 384t
International Classification of Diseases (ICD) 375–376t
ICD-10-CM codes, transition from ICD-9-CM to 319, 320t
International Classification of Functioning, Disability and Health
(ICF) 375–376t
International Competencies for Telenursing (ICN) 137
International Council of Nurses (ICN) 134
International Competencies for Telenursing of 137
Telenursing Network of 134
International efforts 577–593
future directions for 591
global challenges to 590–591
international standards efforts 587–590
key initiatives in world regions and 577–582
International Health Terminology Standards Development
Organisation (IHTSDO) 590
International laws, on information privacy 439–440
International Medical Informatics Association (IMIA) 585–587, 586f,
586b, 599
Code of Ethics for Health Informatics Professionals of 438, 439t
for Latin America and the Caribbean (IMIA-LAC) 581–582, 581f
Nursing Informatics (IMIA-NI) 586–587, 587b, 588t
International Nursing Association for Clinical Simulation &
Learning (INACSL) 561–562
Standards of Best Practice: Simulation 564
International Organization for Standardization (ISO) 587–588, 588t,
589f
certification by 282
International organizations, with eHealth involvement 583–587
International Medical Informatics Association as 585–587, 586f,
586b See also International Medical Informatics Association
(IMIA)
WHO as 583–584 See also World Health Organization (WHO)
Internet
access to, and mHealth 261
health-related resources on 207
usage of, ePatient movement and 205, 206f
Internet of things (IoT) 619
Internet search, in surveillance of disease outbreaks 193
Interoperability 383, 458
as barrier to personal health record adoption 250
standards, for electronic health records 82
Interpretive code 300t
Interprofessional competencies 500, 507
Interprofessional education (IPE), simulation in 568–569, 569t
Interventions, from clinical decision support system 172
Interview, of staff, in requirements definition 274, 274b
Inventory items, in downtime risk assessment 341b
IOM See Institute of Medicine (IOM)
IPE See Interprofessional education (IPE)
Islanders, healthcare for 3
ISO See International Organization for Standardization (ISO)
ISO/TS 17117:2002, Health Informatics-Controlled Health
Terminology-Structure and High-Level Indicators 375
IT See Information technology (IT)
IT department objectives, as system requirement 276
J
JAWS See Job Access With Speech (JAWS)
Jeffries/NLN Simulation Theory, applied to simulation 564
Jenzabar 521, 522f
Job Access With Speech (JAWS) 533
Joint cognitive systems 357
Joint Commission National Patient Safety Goals 410–411t
Joint Commission Standards 415, 415t
Joint Public Health Informatics Taskforce (JPHIT), public policy
focus of 485–486t
Journal of the American Geriatrics Society 3
Journaling
blackboard, as technology tools 550–552t
software, in healthcare education 545–546
Journals, health informatics and 598–599, 598t
JPHIT See Joint Public Health Informatics Taskforce (JPHIT)
K
Kaiser Permanente (KP) 246
KDDM See Knowledge discovery and data mining (KDDM)
Key Capabilities of an Electronic Health record System 92
KLAS, fee-based ratings services of 112
Knowledge
a ributes of 25b
as barrier, form of 42
building of
practice-based evidence in 50
using health information technology 50
components, of project process groups 288–289
in health care computing 22
volume of 42
Knowledge base
Bayesian, on de Dombal's computer-aided diagnosis of acute
abdominal pain 171
in electronic health record 80
Knowledge discovery, electronic health records and 50
Knowledge discovery and data mining (KDDM) 395–404
data mining in 398–399
evaluating data mining models in 399, 399–400f
model deployment in 400–401, 402f
organizational considerations for data science in 401–404
preprocessing clinical data in 396–397, 397b
preprocessing coded (structured) data in 397
preprocessing text data in 397
retrieving dataset for analysis of 395–396, 396f
sampling and partitioning in 397–398
Knowledge management tools, for informatics curriculum 508, 509t
Knowledge transformation
definition of 42
in evidence-based practice (EBP)
discovery research in 42, 42f, 43t
evaluation in 42f, 48–49, 48f
evidence summary in 42f, 43–44, 43t
practice integration in 42f, 46–47, 47b
translation to guidelines in 42f, 44–46, 46b
Knowles’s adult learning theory, applied to simulation 563
Kolb’s experiential learning theory 27
applied to simulation 563
Ko er's principles applied to 562, 563t
L
Laboratory information systems (LISs), ancillary to electronic health
record of 98
Laggards, response of, to innovation 30
The Lancet 133
Laptops, in healthcare education 543, 550–552t
Lasater’s Interactive Model of Clinical Judgment Development,
applied to simulation 564
Late majority, response of, to innovation 30
Latin America and the Caribbean, International Medical Informatics
Association for 581–582, 581f
Laws
healthcare regulatory framework 423–424, 424t
on information privacy 438–443
Lead part, in hierarchical model 16
Leadership, in telehealth implementation 138f, 139
Leapfrog Group 410–411t
Learning
input into system in 26
input processing/retention in 26
learned behaviors exhibited as output in 27
principles of, theory-based 28b
process of, impact of technology on 547–548, 547b
Learning domain, in evaluating simulation 567–568, 568b
Learning Health System (LHS) 499–500
framework for informatics curriculum 506–507, 506f
in health IT tools 505
Learning management system (LMS) 520, 522
comprehensive education information system 539, 539f
in computerized course management 544
SharePoint 522, 524f
Learning theory(ies) 25–28
adult 27, 28t
applied to simulation 562–564
cognitive, and constructionist 25–27
databases and 25b
experiential 27
learning styles and 27–28
Least intrusive alternative, in Code of Ethics for health informatics
professionals 439t
Ledger, general 113
Legal issues, in health IT 422–435
Legal requirements, on information security, and fines 446–447, 447t
Legal system 423–426
Constitution 423
enforcement 425–426
federal healthcare regulatory framework 423–425, 424f
federalism 423
Legitimate infringement, in Code of Ethics for health informatics
professionals 439t
Lewin, Kurt, on change theory 28–29
LHS See Learning Health System (LHS)
Liability 425
telehealth and 144
Library 529
Licensing, versus sale, concept of 300
Licensure, in telehealth 142–143, 143t
Life cycle
healthcare information system 273–282
of systems 273–282
analysis and requirements definition in 273–277, 274b
develop or purchase of 278–282
project planning 277–278
of terminology 375
Limitation, use, description of 438t
Limitation of liability, in software licensing agreements 313
Linked information retention 26
LISs See Laboratory information systems (LISs)
Literacy
basic 11–12
computer 12
digital 12–13
health 13–14
information 12
Living data 618
LMS See Learning management system (LMS)
Logic models, in evaluation 67–68, 68f
Logical Observation Identifiers Names and Codes (LOINC) 375–377t,
376–377
LOINC See Logical Observation Identifiers Names and Codes
(LOINC)
Long-term memory 26, 27t
Longitudinal-based storage, for clinical data repository, encounter-
based versus 77
M
Machine code See Executable code
Machine learning, in data mining 398–399, 398t
MACRA See Medicare and CHIP Reauthorization Act (MACRA)
Mail fraud 428
Maintenance cost, decreased, in improving the user experience for
health information technology 356
Malicious friending, on social media 228
Malpractice, telehealth and 144
Managing human resources strategically and operationally, as
human resources subsystems 125
Mannequins, simulation
cost of 560t
high-fidelity simulator 558f
Manual reports, collection of, in requirements definition 274
Market pressure, for social media use 229–231
MARS See Mobile app rating scale (MARS)
Master person index (MPI), in electronic health record 77–78
Materials management 121, 124b
process standardization in 124b
supply chain management in 121–124 See also Supply chain
management (SCM)
Maternity care information system (MCIS) 97
Mayo Clinic Center for Social Media 224
MCIS See Maternity care information system (MCIS)
McMurtrey, Mark, systems life cycle and 5
MEAHI See Middle East Association for Health Informatics
(MEAHI)
Meaningful Use (MU) 318, 410–411t, 455–473
in clinical decision support adoption, incentives for 179
in electronic health record adoption 93–94
incentives for 179
of electronic health records
core and menu elements of 465t
improved quality of care and 409
stages of 243
financial incentives and 461–471
health IT policy and 482
health practitioner role in 94
stage 1 of 466
stage 2 of, modified 466, 466–471t
stage 3 of 466–471
Media 300
Medicaid 475b
eligible entities for 460
eligible professionals for 460
payments from 460–461
eligibility for 461–466
Medical devices 431, 431t, 432f
security vulnerabilities and 448–449
Medical informatics 596
Medical information system (MIS) 91
Medicare 475b
eligible entities for 460
eligible professionals for 460
payments from 460–461, 460t
eligibility for, Meaningful Use in 461, 465t
Medicare Access and Children’s Health Insurance Program
Reauthorization Act of 2015 471–472
Medicare and CHIP Reauthorization Act (MACRA) 6
Medicare Patient Safety Monitoring System (MPSMS) 1
Medication dosing support, clinical decision support systems as 172–
173, 172f
Medication errors 413–414
Medication safety 414–415, 415t
Medicine, participatory, definition of 210
Metadata model 80
mHealth See Mobile health (mHealth)
Micro theories 14
Microblogging 222
Microsoft Gold Partner 522
Middle East Association for Health Informatics (MEAHI) 585, 587f
Middle range theories 14
Million Hearts campaign 482
Mind maps, in healthcare education 544, 544f
MIS See Medical information system (MIS)
Missing data, in preprocessing of coded data 397
Mitigation 620
mLearning 518
Mobile app rating scale (MARS) 265
Mobile apps
for health IT infrastructure 85–86
for mHealth 257–258, 258f
Mobile devices 518
Mobile health (mHealth) 255–270
applications for 256–260, 256–257t, 258f
benefits of 263–265
challenges to
data privacy risks as 264
and leading organizations, key resources, and information
repositories 265, 266t
legal risks in 264–265
patient misinterpretation of data and 264
data collection and reporting in 259
device type for 258t
driving forces for 261–263
consumer/patient engagement and empowerment 261–262
global health and connected healthcare as 262
research, policy, and business as 262–263
technology as 261
economic potential and cost savings in 263
evolution and evidence in 263
examples of uses 256–260
client education and behavior change as 258
communication as 259–260
electronic decision support as 259
electronic health records as 259
financial transactions and incentives as 260
human resource management and 260
provider work planning and scheduling as 260
registries and vital events tracking as 259, 260f
sensors and point-of-care diagnostics as 259, 259f
supply chain management as 260
future directions of 265
tools for 256–260
wearable devices and 432–433
Mobile money applications 260
Mobile phone
and landlines, replacement with 261
range and capabilities of 261
subscribers to, growth of 261
Mobile technology
and health, intersection of 255–270
health applications via 207
for informatics curriculum 508, 509t
Mobile Technology for Community Health (MoTeCH) 260
Model deployment, knowledge discovery and data mining
(KDDM) 400–401, 402f
MomConnect 258
Monitoring, public health, electronic health data in 443
Monitoring devices, remote, telehealth in 145–146
Moodle 523–524
MoTeCH See Mobile Technology for Community Health (MoTeCH)
Moving stage, of planned change 29
MPI See Master person index (MPI)
mPower 259
MPSMS See Medicare Patient Safety Monitoring System (MPSMS)
MU See Meaningful Use (MU)
Multidisciplinary terminologies 376–379
Logical Observation Identifiers Names and Codes as 376–377, 377t
RxNorms as 375–376t, 378–379
Systematized Nomenclature of Medicine-Clinical Terms
(SNOMED CT) as 375–376t, 377, 378f
Multiple Baseline With Single Subject Design, in program
evaluation 70, 70f
Myers-Briggs Type Indicator , 32 28
MyHealtheVet (MHV) 246
N
NAHIT See National Alliance for Health Information Technology
(NAHIT)
Naisbi 's Megatrends 615b
NANDA International (NANDA-I) 375–376t, 380, 381t
mapping nursing concepts to 384t
Nanobots 618
Nanofabrication 624–625
Nanoinformatics 625–626
Nanomedicine 624–625
Nanorobots 618
Nanotechnology 624–626
cautions about 625
ethical issues in 626
history of 624
nanofabrication in 624–625
nanomedicine in 624–625
products 618
regulatory issues in 626
Nanotube, carbon 624, 624f
NASA See National Aeronautics and Space Administration (NASA)
National Aeronautics and Space Administration (NASA) 133
National Alliance for Health Information Technology (NAHIT) 91
National Commi ee for Quality Assurance (NCQA) 410–411t
National Council of State Boards of Nursing (NCSBN), in distance
education 518
National governments, as stakeholders in EHR implementation 101
National Guideline Clearinghouse 44
National Healthcare Disparities Report (NHDR) 39
National Healthcare Quality Report (NHQR) 39
National Initiative for Telehealth Framework of Guidelines (NIFTE
Guidelines) 137
National Institute of Standards and Technology (NIST) 445, 446f
National Institutes of Health (NIH), biomedical computer centers
funded by 600–601
National Labor Relations Board (NLRB) 424t, 433
National League for Nursing (NLN) 562
National Library of Medicine (NLM) 596
RxNorm of 375–376t
National Notifiable Disease Surveillance System (NNDSS),
limitations on authority of 189
National Organization of Nurse Practitioner Faculties (NONPF) 567
National Patient Safety Goals (NPSG) 415, 415t
National Priorities Partnership (NPP), quality initiatives of 482
National Quality Forum (NQF) 48, 48b
National Quality Measures Clearinghouse (NQMC) 48–49, 49b
National Quality Strategy, for health improvement 482
Nationwide Health Information Network (NwHIN) 83
on financial incentives 459–460
Natural disasters, downtime from 338–341, 339t
Natural language processing (NLP) 54, 397
Naturalistic decision making (NDM), in evaluation 63
NCQA See National Commi ee for Quality Assurance (NCQA)
NCSBN See National Council of State Boards of Nursing (NCSBN)
Negentropy 18
Negotiating team 281
for software agreement 298–299, 299b
Networked personal health record 246, 247f
Networking, social 221–222 See also Social media
Networking systems, for data sharing 82–83
New leader skills 618
Newborn intensive care, specialty requirements in 340t
Newly diagnosed online healthcare consumers 208
NI Pyramid Model 34t
NIC See Nursing Interventions Classification (NIC)
Niche applications, of electronic health record 97
NIH (National Institutes of Health), biomedical computer centers
funded by 600–601
Nine multiple intelligences, Gardner's 547b
NIST See National Institute of Standards and Technology (NIST)
NLM See National Library of Medicine (NLM)
NLN See National League for Nursing (NLN)
NLP (natural language processing) 54, 397
NLRB See National Labor Relations Board (NLRB)
NMDS See Nursing Minimum Data Set (NMDS)
NNDSS (National Notifiable Disease Surveillance System) 189
NOC See Nursing Outcomes Classification (NOC)
Noise, in communication system 21–22, 22f
Nonclinical telehealth services 132
Noninfectious events, surveillance of 191
NONPF See National Organization of Nurse Practitioner Faculties
(NONPF)
North American Nursing Diagnosis Association (NANDA)
International Nursing Diagnosis 380, 381t
NPP See National Priorities Partnership (NPP)
NPSG See National Patient Safety Goals (NPSG)
NQF (National Quality Forum) 48, 48b
NQMC See National Quality Measures Clearinghouse (NQMC)
Nurse-managed health centers 155
Nurses
social media use by 224
as stakeholders in EHR implementation 100
Nurses on Boards Coalition 483
Nursing
health informatics policies specific to 486–489
specialty requirements in 340t
Nursing informatics 598
models of 34t
Nursing Informatics: Scope and Standards of Practice 509
Nursing Interventions Classification (NIC) 375–376t, 380–381, 381t
mapping nursing concepts to 384t
Nursing Management Minimum Data Set (NMMDS) 375
Nursing Minimum Data Set (NMDS) 375
Nursing on the Net: Health Care Resources You Can Use 529
Nursing Outcomes Classification (NOC) 375–376t, 381, 381t
Nursing terminologies
Clinical Care Classification as 375–376t, 379, 379t
International Classification for Nursing Practice (ICNP) as 375–
376t, 380, 380b
Nursing Interventions Classification (NIC) as 375–376t, 380–381,
381t
Nursing Outcomes Classification (NOC) as 375–376t, 381, 381t
Omaha system as 375–376t, 381–382, 382t
Perioperative Nursing Data Set (PNDS) as 375–376t, 382, 382t
in standardized healthcare terminologies 379–382
Nutrition care, specialty requirements in 340t
O
OASIS (Outcome and Assessment Information Set ) 156–157
Object code See Executable code
Objective structured clinical examination (OSCE summative
evaluation 567
Observability, of innovation 30
Observation, of staff, in requirements definition 274
Observation analysis, in program evaluation 69
Obstetrics, specialty requirements in 340t
Occupational therapies, specialty requirements in 340t
Office for the Advancement of Telehealth (OAT) 134
Office of Civil Rights 424t
Office of the National Coordinator for Health Information
Technology (ONC) 242–243, 424t, 456–458, 477–480, 479–480f, 500
creation of 456–458
duties of 456–458, 457b
Health IT Policy Commi ee created by 458
Health IT Standards Commi ee created by 458
Standards and Interoperability Framework 458–459
tool for integrating privacy and security into health practices 442–
443
Omaha System 159–166, 375–376t, 381–382, 382t
clinical example of, from practice 162–163b, 163–166
interpretation of 163–165
description of 160–162, 160f
development of 160, 160b
electronic health record, screen images of, example of 164b
Intervention Scheme of 161, 162–163b
targets of 164b
mapping nursing concepts to 384t
Problem Classification Scheme of 160–161, 161–163b
Problem Rating Scale for Outcomes of 161–162, 162–163b, 164t
“On-premises” licensing, versus licensing through “cloud” 300–301
ONC See Office of the National Coordinator for Health Information
Technology (ONC)
Online billing and payment tool, in practice management
system 120, 120b
Online education 518
Online healthcare consumers See also ePatient
characteristics of 208–210
Online Journal of Public Health Informatics 598–599
Online textbook distributors 529–530
Ontology 373, 374f
Open source 522–524
Open source software, for health IT infrastructure 86–87, 300
Open source software systems, in public health informatics 200
Open systems 15, 15f
characteristics of 16
functions of 16
GIGO and 15–16
purpose of 16
structure of 16
hierarchical model of 16, 17f
web model of 16
OpenCDS 180
OpenInfobu on 180
Openness, in Code of Ethics for health informatics professionals 439t
Optimal data system, elements of 620b
Optometry, EHR essential component and functions for care
delivery 92–93t
Order-entry management, as EHR essential components and
functions for care delivery 92–93t
Order facilitators, clinical decision support systems as 173f
Organization(s)
complex 19
international, with eHEalth involvement 583–587
mindset of, shift in, health IT governance and 494
public policy focus of 485–486t
supporting simulation 561–562
work and leadership through, health IT policy and 484–486, 485–
486t
Organization objectives, as system requirement 277
Organizational efficiencies, increased, in improving the user
experience for health information technology 356–357
Organizational slack 30
Outcome and Assessment Information Set (OASIS) 156–157
Outcome factors, controls for, in practice-based evidence study 53
Outcomes-based quality improvement (OBQI), in home health 158
Outliers, in preprocessing of coded data 397
Outpatient procedure areas, specialty requirements in 340t
Outsourcing to data centers, for hosting and software management
services 310
Ownership, in electronic health record (EHR) 101–102
P
P4 Medicine 215
PaaS See Platform as a service (PaaS)
PAHO eHealth Program 581
Palliative care and hospice
practice models for 155
standardized datasets in 156–157
Pan American Health Organization Region (PAHO), eHealth
initiatives in 581–582
Paper documents and forms, inventory 274
PARiHS model, in evaluation 65, 66f
Partial task trainers, as simulators 558
Participant observation, in program evaluation 69–70
Participation, individual, description of 438t
Participatory healthcare
definition of 210
patient-centered 210–211
Participatory healthcare informatics 4–5
Participatory medicine, definition of 210
Partitioning of data, in KDDM 397–398
Partnership for Patients 482
Partnerships 524
Patent 300
Patient(s)
access to electronic health record (EHR) 103–104
debriefing questions, sample of 566b
engagement and empowerment of, and mHealth 261–262
experience of care of, with personal health record 247
misinterpretation of data by, and mHealth 264
standardized, as simulators 558
Patient accounting application 114
Patient care objectives, as system requirement 276, 277b
Patient-centered healthcare, participatory 210–211
Patient-centered models of care, convergence of 210–213
Patient experience surveys 157
Patient factor controls, in practice-based evidence study 52
Patient falls 416
Patient-generated health data (PGHD) 212
in electronic health record (EHR) 104
Patient management, electronic health record applications for 79
Patient monitoring technologies, in telehealth 134–135
Patient outreach system, in practice management system 120
Patient portal 246
Patient safety 409
evaluating 413–416
conceptual framework for 413–414, 414f
in health informatics 408–421
health IT policy and 481
in healthcare information system 321–322
Institute of Medicine report on health IT and 481
nursing sensitive quality outcomes in 416
unintended consequences of health IT implementation and 481–
482
Patient safety and quality research design (PSQRD) framework 413–
414, 414f
success factors and lessons learned in 416
Patient support, as EHR essential components and functions for care
delivery 92–93t
Pay for Performance (P4P) 410–411t, 416
Payments
Medicare and Medicaid 460–461, 460t
models of, value-based, clinical decision support adoption and 179
in software licensing agreements 310
Payroll application 113–114
PBE See Practice-based evidence (PBE)
PCT See Project clinical team (PCT)
Peer informatics governance models, investigation of 496–497
Performance, service level agreements and 306
Performance evaluation, as human resources subsystems 126
Perioperative Nursing Data Set (PNDS) 375–376t, 382, 382t
mapping nursing concepts to 384t
“Permi ed use” restrictions 304
Person-centered health 618–619
Personal data integration 619
Personal health data, transmi ed, huge amounts of 618
Personal health ecosystem 135f
Personal health records (PHRs) 241–254
adoption of, barriers to 249–250
awareness as 249
digital divide as 249
interoperability of 250
privacy concerns as 249
provider management as 249
summary of 250
usability of 249
benefits of, current evidence of 247–248
costs/utilization in 248
current use of 248–249
definitions of 241
development of 242–244, 242f
electronic health record as data source for 92
ePatient health information access and 208
existing, examples of 246–247
Health Vault 246–247
Kaiser Permanente (KP) as 246
MyHealtheVet (MHV) as 246
experience of care with 247
future of 250–251
ideal
principles of 244–246, 245t
proposed benefits of 245–246
networked 246, 247f
quality of care with 248
stand-alone 246
types of 246, 247f
untethered 246
Personnel administration, as human resources subsystems 125
PERT See Program evaluation review technique (PERT)
Pew Research Center’s Internet & American Life Project 206
PGHD See Patient-generated health data (PGHD)
Pharmacy, specialty requirements in 340t
Pharmacy department system, ancillary to electronic health
record 99
Phased go-live approach 330
Phenomenon, theories and 14
PHIN (Public Health Information Network) 199
PHRs See Personal health records (PHRs)
Physical examination, remote, telehealth applications in 138
Physical infrastructure, information technology and 339b
Physical therapies, specialty requirements in 340t
Physicians
social media use by 224
specialty requirements in 340t
Physiologic monitoring, specialty requirements in 340t
Pilititis, on mHealth 263
Planning activities, project process groups and 287
Platform as a service (PaaS), in public health informatics 200
Platform as a service (PaaS) model, of cloud computing 84
Platforms, in data science 403, 403t
PMI See Project Management Institute (PMI)
PMSs (practice management systems) 119–121, 120b
PNDS See Perioperative Nursing Data Set (PNDS)
Point-of-care alerts and reminders, clinical decision support as 173,
174f
Point-of-care diagnostics, in mHealth 259
Point-of-care solutions, for home health, hospice care, and
community-based systems 158, 158f
Point-of-care terminologies, Omaha System as 159–166 See also
Omaha system
Policy
and mHealth 262–263
social media 231–234
development of, resources for 234
guidelines for writing 232–234, 233b
Political challenges, affecting public health 189, 190f
Population health, as mission of public health 185, 186f
Population health management, as EHR essential components and
functions for care delivery 92–93t
Portability, of personal health records 245
Portals 521
Portfolio governance 291
Portfolio management 285, 290–291
benefits of 290–291
healthcare structure 290f
software selection 294–296, 295f
Portfolio managers 293
Portfolios, digital, in healthcare education 545
Position statements, developing, in developing and implementing
health IT policy 484
Practice-based evidence (PBE)
challenges of 50–51
characteristics of 51t
evidence-based practice (EBP) and 50
features of 50–51
future directions for 55–56
informatics and 54–55
knowledge discovery and 50
limitations and strengths of 54
study using
controlling for differences in patient severity of illness in 52–53,
52t
creating multisite, multidisciplinary project clinical team in 51–
52, 52t
creating study database in 52t, 53
hypotheses testing in 52t, 53–54
implementing intensive data collection and checking reliability
in 52t, 53
steps in 51–54, 52t
validating and implementing findings in 52t, 54
Practice management systems (PMSs) 119–121, 120b
Practice workflow and information management redesign
specialist 511
Practitioner consultant, in university-based education 511
PRECEDE-PROCEED model, in evaluation 65, 66f
Predictive analytics 394, 622–623
Prescriptive analytics 394
Pressure ulcers 416
Privacy 436–454
body 437
in Code of Ethics for health informatics professionals 438, 439t
concerns in, as barrier to personal health record adoption 249
definition of 437, 437t
in electronic health record (EHR) 102
information 437
legal and historical context of 437–438
principles, laws, and regulations on 438–443
federal-state collaboration on 443
international laws 439–440
U.S. federal law 440–442, 440b
as social media challenge 226–227
telehealth and 137–138
Privacy Act (1974) 438
Privileging, in telehealth 143–144
Problem severity, service level agreements and 307, 307b
Process maps, in requirements definition 275, 275–276f
Procurement management 289
Professional(s)
eligible
for Medicaid 460
for Medicare 460
objectives and measures for, Meaningful Use and 467–468t
healthcare, curriculum for, informatics in 499–515
Professional organizations, health informatics and 599–600, 599–600b
Program and software engineer 510
Program evaluation 60–74
future directions for 71
methods, tools, and techniques for 68–71
purposes of 61–62, 61b
scope of 62
theories and frameworks 62–68
Program evaluation review technique (PERT) 293
activities list 293f
charts 293–294, 294f
Program implementation models
definition of 62
in evaluation 64–66
Program management 285, 289–290
Program manager 293
Program theory models 67–68
definition of 62
six steps of 67
Programming language-based platforms, for data analytics 403
Project clinical team (PCT), multisite, multidisciplinary, creating, in
practice-based evidence study 51–52, 52t
Project integration 288
Project management 285–289
benefits 289b
coordination areas of 286f
in healthcare organizations 285–286
phases 287f
software selection 294–296, 295f
theory 288
tools 293–294
Project Management Institute (PMI) 285
Project manager 291–293
Project performance, improved, benefits of 289
Project planning, in systems life cycle 277–278, 324–327
building or tailoring the product 327
defining success 324–325, 325b, 326f
engage stakeholders for 325
executive management support for 325
redesigned workflows for 325–327
testing of 327–330, 327–328t, 329f, 330b
Project process groups 287–288, 287t
knowledge components of 288–289
Promoting Action on Research Implementation in Health Services
(PARiHS) model, in evaluation 65, 66f
Prose literacy 11
Protected health information (PHI), social media and 226
Protocol analysis, in program evaluation 69
Provider, work planning and scheduling for, and mHealth 260
Provider-consumer, social media structure 222b
Provider management, as barrier to personal health record
adoption 249
Provider-provider, social media structure 222b
Psychomotor learning domain, in evaluating simulation 567–568,
568b
Psychomotor skills 27
Public health
causal pathway of disease in 187, 187f
crowdsourcing and 212
definition of 185
functions of 186, 186f
services related to 187b
goal of 185
population perspective on 185–191
practice of, clinical practice compared with 186–189, 188f
in risk reduction 187–189, 188f
sociological context of 189–191
world view of, versus clinical world view
information systems integration and 190
sharing of information 190
Public Health Data Standards Consortium (PHDSC) 443
Public health departments, established 154
Public health informatics 184–203
definition of 184
future strategies for 197–201
advancing technical infrastructure as 199–201
transforming practice with 197–199
social and political challenges affecting 189, 190f
value of 191–197
health information exchange and 194–195, 195b
immunization information systems and 193–194, 194b
in public health reporting 195–197, 196f, 198f
in surveillance 191–193, 192–193t
Public Health Information Network (PHIN) 199
Public health information systems, integrating clinical systems
with 190
Public health monitoring, electronic health data in 443
Public health-provider/consumer, social media structure 222b
Public health reporting 195–197, 196f, 198f
informatics in 197
Public health services, practice models for 155
Public health surveillance, informatics in 191–193, 192–193t
Public trust, information security and 444–446
Purdue Usability Testing Questionnaire 362
Q
QSEN See Quality and Safety Education in Nursing (QSEN)
Qualitative methods, in evaluation 68–70
Qualitative questions, versus quantitative questions 68, 69t
Quality 548–549
of care delivery as electronic health record benefit 99
evaluating 413–416
conceptual framework for 413–414, 414f
of terminology, evaluation of 373–375
Quality and Safety Education in Nursing (QSEN) 500
Quality Chasm Series, Institute of Medicine (IOM) 475b
Quality data standards of, national efforts related to 411–413, 412t
Quality improvement, in evaluation 67
Quality indicators 500, 501t
Quality initiatives
in health informatics 408–421
of National Priorities Partnership (NPP) 482
Quality management 289
Quality measures 500
Quality of care 409
definition of 40
evidence-based practice and 40
improved, in healthcare information system 321–322
Quality-safety continuum 414f
Quantified self 209
Quantitative literacy 11
Quantitative methods, in evaluation 70
Quantitative questions, versus qualitative questions 68, 69t
Queries, in knowledge discovery and data mining (KDDM) 396
Questionnaire for User Interaction Satisfaction (QUIS) 362
Qui Tam relators 428
Qui Tam suits 428
QUIS See Questionnaire for User Interaction Satisfaction (QUIS)
R
Radio frequency identification (RFID)
for medication administration 96
in smart home 146–147
in supply chain management 122
Radiology, specialty requirements in 340t
Radiology information systems (RISs), ancillary to electronic health
record 98
RAI See Resident Assessment Instrument (RAI)
Random forests, data mining method 398t
Randomized controlled trial (RCT), for Twine-Health 258
Randomized trials, on personal health records and outcomes 248
RATs See Remote access Trojans (RATs)
RCT See Randomized controlled trial (RCT)
RE-AIM, in evaluation 65–66
Reach Effectiveness Adoption Implementation Maintenance (RE-
AIM), in evaluation 65–66
“Real-time” technologies 134–135
Receiver, in communication system 21–22, 22f
Receiver operating characteristic (ROC) curve, in data mining
models 399, 400f
Reciprocity, in software licensing agreements 313
RECs See Regional Extension Centers (RECs)
Redundant systems, in downtime and response planning 346–347
Reference classifications 584–585
Reference terminology 373
Refreezing stage, of planned change 29
Regenstrief Institute, computer reminders at 171
Regional Extension Centers (RECs) 459
Regional health information organization (RHIO) 82
Registries, in mHealth 259, 260f
Regression, predictive analytics and 394
Regression discontinuity design, in program evaluation 70
Regulations, on information privacy 438–443
Regulatory issues
for nanotechnology 626
for social media 229
Rehabilitation Act 533
Reimbursement, for telehealth 144
Reiterative feedback loops, in nonlinear systems 18, 18b
Related classifications 584–585
Relative advantage, of innovation 30
Relay-Health 145
Relevant information display, clinical decision support tools for 173–
175, 175–176f
Remedies
for rejection 308, 308b
service level agreements and 307
Remote access Trojans (RATs) 228
Remote telehealth home visits and monitoring devices, telehealth
in 145–146
Reporting
electronic health record applications for 78
mHealth and 259
Repository, clinical data, in electronic health record 76–77
Repository reliability 76
Request for information (RFI) 276, 278
developing, obtaining, and evaluating 278–279
response to 278
sections of 278b
software licensing agreement and 302
Request for proposal (RFP) 276
components of 279b
developing, obtaining, and evaluating 278–279
software licensing agreement and 302
Requirements definition 274–276
Research
discovery, in knowledge transformation 42, 42f, 43t
evaluation
questions, by stage of project and type of question 69t
scope of 62
future 613–618, 613b
on anticipating future directions 615, 615t
application of 617–618
defining 613–614, 613b
future directions and scope of change 614
and mHealth 262–263
Research and development specialist 510
Research challenges, in clinical decision support, challenges in 180,
180b
Research design, in program evaluation 70
Research networks, ePatients and 213–215
Researcher and innovator, health informatics, education for 512
Resident Assessment Instrument (RAI) 156
Resolution time, service level agreements and 306–307
Resource allocation 292
Resource management, human 289
Respiratory therapy, specialty requirements in 340t
Response planning, downtime and, in health information
systems 342–347, 342t, 344–345f
clinical impact and planning in 345–346, 346b
redundant systems in 346–347
Response time, service level agreements and 306–307
Restrictive covenants clauses 314
Results management, as EHR essential components and functions
for care delivery 92–93t
Revenue cycle 119, 119f
Reverberation, in change process 18
Review, electronic health record applications for 78
RFI See Request for information (RFI)
RFID See Radio frequency identification (RFID)
RFP See Request for proposal (RFP)
RHIO See Regional health information organization (RHIO)
Rights
to assign agreement and license 315
software 304
Risk, definition of 450
Risk analysis 450
Risk assessment 450
Risk factors, for implementing and upgrading information
system 322
Risk reduction, public health in 187–189, 188f
RISs See Radiology information systems (RISs)
Robot
DaVinci 3
TUG 4
Robotics 3
Rochester General Health System, telehealth program of 132
Rogers, Evere , innovation theory of 29
Royal Society of Great Britain 596
RxNorm 375–376t, 378–379
S
SaaS See Software as a Service (SaaS)
Safe harbor method, for de-identification of data 443, 444f
Safe harbors, Anti-Kickback statute 427
Safeguard 437t
definition of 437t
SAFER checklist 430
Safety 409
of care delivery as electronic health record benefits 99
medication 414–415, 415t
patient 409 See also Patient safety
Safety Assurance Factors for EHR Resilience 430
Sakai 524
Sale, licensing versus, concept of 300
Sampling, in KDDM 397–398
Satisfaction, in goals of usability 354
Scenarios, in predicting future research 616
School nurses 155
SCM See Supply chain management (SCM)
Scope creep, in information system 322–323
Scope management 288
SDO See Standards development organizations (SDO)
Sea Coast Mission Telehealth Program 133
Second Life 223
Security 436–454
challenges, current 449
in Code of Ethics for health informatics professionals 438, 439t
definition of 437, 437t
information
importance of 444–448
legal requirements and fines in 446–447, 447t
public trust in 444–446
threats to, increasing 447–448
as social media challenge 228–229
testing, during information system implementation and post go-
live 327–328t
vulnerabilities, current 448–449
external events 448
internal 448
medical devices 448–449
Security controls 449–451
administrative 449–450
physical 450–451
technical 450
Selection team
in contract negotiation planning 281
creation of 278
Semantic interoperability 82
informatics infrastructure 411–412
Semantic level of analysis, information defined as 63
Semi-structured interviews, in program evaluation 69
Sender, in communication system 21–22
Sensor technology 146–147
Sensors 3
in mHealth 259, 259f, 262
Sentinel event alerts 430–431
Service level agreements, software licensing 305–307
Service-oriented architecture (SOA) 86
in public health informatics 200
SET-M See Simulation Effectiveness Tool-Modified (SET-M)
Severity rating scheme, of Zhang heuristics and Nielsen 360t
Shannon, Claude, on information theory 21–22
Shannon-Weaver information-communication model, of information
theory 21–22
SharePoint learning management system 522, 524f
Short messaging service (SMS), and mHealth 256–257
Short-term memory 26–27
Simple domain, of Cynefin Framework 20
Simplified Gan chart 295f
Simulation 557–576
administrative buy in 562
application of 567–570
for evaluation 567–568
example of 569–570, 570–573f
general, to education 567
to interprofessional education 568–569, 569t
challenges to 560–562
cost of 560
faculty buy in 562
fidelity 558–559, 558f, 559t
future directions 571–573
for informatics curriculum 508, 509t
Ko er's principles applied to 562, 563t
learning theories applied to 562–564
opportunities to 560–562
partial task trainers in 558
process 562–567
standardized patients in 558
steps for 567b
types of 557–558
Simulation Effectiveness Tool-Modified (SET-M) 568
Simulation experience, recording of 560
Simulation technician, job description of 561b
Simulators 558, 558f
Single database clinical and revenue cycle system 118–119, 119f
SIS (surgical information system) 97
Site visit team 281
Situated cognition, applied to simulation 564
Situation awareness (SA), in evaluation 63, 63t
Six steps, in program theory models 67
Skill checklists, in evaluating simulation 567
Skilled nursing facilities (SNF) 3
SLC model See Systems life cycle (SLC) model
Smart home 146–147
Smart infusion pumps 415
SMART (Substitutable Medical Applications, Reusable
Technologies) 87
Smartphones
in healthcare education 542
mHealth and 257
SMS See Short messaging service (SMS)
SNA (social network analysis), in program evaluation 71
SnapDx 259
SNF See Skilled nursing facilities (SNF)
SNOMED CT See Systematized Nomenclature of Medicine-Clinical
Terms (SNOMED CT)
SOA See Service-oriented architecture (SOA)
SOAPE, health informatics and 596, 596t
Social bookmarking 222–223
Social challenges, affecting public health 189
Social cognitive theories, in evaluation 63
Social constructivism 26
Social engineering, social media and 228
Social media
benefits of 224–225
challenges of 225–231, 226t
inappropriate behaviors as 227–228
market pressure as 229–231
privacy and confidentiality as 226–227
regulatory issues as 229
security as 228–229
definition of 220–221
future directions for 234
legal issues and 433
malicious friending on 228
in media 231
policy on 231–234
development of, resources for 234
guidelines for writing 232–234, 233b
for practice and education 220–240
statistics 223–224
structure of 221, 222b
in surveillance of disease outbreaks 193
tools 221–223, 221t
blogging 222
microblogging 222
social bookmarking 222–223
social networking 221–222
Twi er 222
video, and image sharing content 223
wikis 222
Social media sites, ePatients and 211b
Social network analysis (SNA), in program evaluation 71
Social networking 221–222 See also Social media
sites for 221–222
Social science theories, in evaluation 63–64
Society for Participatory Medicine 210
Society for Simulation in Healthcare (SSH) 560, 562
Society to Encourage Studies 517
Sociological context, of public health 189–191
Sociotechnical model, for informatics interventions 66–67
Sociotechnical system 352
Software
acceptance of 307–308, 307b
educational, in healthcare education 544–547
in home telehealth 135
intellectual property concepts relevant to 299–300
warranties 305, 306b
Software as a Service (SaaS) 300
escrow 305
Software as a service (SaaS) model, of cloud computing 84
Software license
agreements 298
mechanics and process of contract negotiation for 301, 301b
metrics 304, 304b
Software licensing 298–316
contracts for 300
Software licensing agreements
disclaimers or protections 306b
exclusive remedy clauses 312–313
future directions for 315
key points about 299b
major steps or stages in performance of 302, 303b
overview of 299–302
service level agreements 305–307
before signing due to diligence 301–302
specific components of 303–315, 303b
definitions of terms 303
derivative works 304–305, 305b
dispute resolution 313
insurance 313
maintenance and support 308–309, 308b
other services 309–310, 309b
rejection remedies 308, 308b
revenue recognition and payments 310
scope of license 303–304
scope of use 304, 304b
software acceptance 307–308, 307b
software and software as a service escrows 305
special clauses 313–315
specifications 305, 305b
termination, overview 310–312
time schedule 303
warranties 305, 306b
typical negotiating process for 301b
Software Usability Measurement Inventory (SUMI) 362
Source code 300t
Sparsity, in preprocessing of coded data 397
Specialization, in change process 18
Specialty applications, in electronic health record 97
Specialty of health informatics
establishing 597–605, 597f
books 597–598, 597b, 598t
certification 602–604, 603b
educational programs 600–602
journals 598–599, 598t
professional organizations 599–600, 599–600b
naming 605–607, 605b, 606–608f
recognition of 605
Specifications, of license agreement 305, 305b
Speech therapies, specialty requirements in 340t
Spreadsheet software, for data analytics 403
SRs See Systematic reviews (SRs)
SSH See Society for Simulation in Healthcare (SSH)
Staffing and scheduling, as human resources subsystems 125–126
Staggers and Nelson systems life cycle model 32–33, 32f
Stakeholders
coordination and collaboration with, in health IT governance 495
electronic record implementation perspectives of 99–101
on health IT policy 475, 475f
in project planning 325
Stand-alone analytical programs, for data analytics 403
Stand-alone personal health records 246
Standardized datasets, in home health and community-based
systems 156–157
Standardized healthcare terminologies, relevant to patient care 371–
373
Standardized patient(s), as simulators 558
Standardized terminology(ies)
application of 384–385
definition of 373
designing user interfaces using 384–385
in discovering knowledge through research 385
future directions for 386
for home health, hospice care and community-based systems 159
See also Omaha System
in monitoring the quality of care 385
Omaha System 159–166
relevant to nursing practice 375, 375–376t
in supporting data retrieval and exchange 385
Standards 370–390
data exchange efforts and 382–384
in healthcare data standardization 373–382
definitions of 373, 374f
terminologies in
multidisciplinary 376–379
nursing 375–376t, 379–382
quality of, evaluation of 373–375
Standards and Interoperability Framework 458–459
Standards development organizations (SDO) 371
Standards of Best Practice: Simulation 564
debriefing process 565–566, 566b
design 566–567
facilitation 565
glossary 565
outcomes 565
participant evaluation 566
participant objectives as 565
professional integrity of the participants 565
simulation-enhanced interprofessional education 566
Standards-se ing organizations (SSO) 371, 372t
Stark law 426
State governments, as stakeholders in EHR implementation 101
State law 429
Statement of financial position 115, 115t
Statement of operations 115, 115t
STEEEP principles, for redesigning healthcare 40t
Stevens Star Model, of knowledge transformation 42–49, 42f
Stimulus Act 455–456
“Store-and-forward” technology, telehealth 136
Strategic alignment, in information system selection 271–273
Strategic planning 272
Strategic vision, in information identification and selection 271–273
Structured interviews, in program evaluation 69
Student journaling software, in healthcare education 545–546
Student (learner) support services, for distance education 529–531
academic support 530–531
administrative services 530–531
community building 530–531
help desk 530
library 529
online textbook distributors 529–530
tutoring services 529
Students (learners), issues in, in distance education 534
Subsidies 475b
Substance Abuse and Mental Health Services Administration
(SAMHSA) 475b
Substitutable Medical Applications, Reusable Technologies
(SMART) 87
Subsystem, in hierarchical model 16
SUMI See Software Usability Measurement Inventory (SUMI)
Summative evaluation(s)
in evaluating simulation 567
versus formative evaluation 61
questions to pose during 61b
of simulating 565
Supersystem, in hierarchical model 16
Supply chain management (SCM) 121–124
cost capture in 123–124
informatics and 121–122
integrated applications in 122, 122–123f
mHealth and 260
process standardization in 124b
Supply cost capture, in supply chain management 123–124
Supply item master file 122, 122f
Support specialist, implementation and 510
Support vector machines, data mining method 398t
Surgical information system (SIS) 97
Surveillance
public health
electronic health data in 443
informatics in 191–193, 192–193t
public health reporting in 195–197
purposes of, matching methods with 191–192, 192t
SUS See System Usability Scale (SUS)
SWOT strategic analysis tool 274
Synchronous technologies, telehealth 134–135
Syntactic interoperability 82
System implementation or installation support, in software licensing
agreement 309, 309b
System integration 81–82
System inventory, in downtime risk assessment 340t, 341
System Usability Scale (SUS) 362
Systematic reviews (SRs), in evidence summary 43, 43t, 43b
Systematized Nomenclature of Medicine-Clinical Terms (SNOMED
CT) 375–376t, 377, 378f
Systems
a ributes of 17
automated 24
boundary of 16–17
change process and 17–18
chaotic 18
characteristics of 16–17
complex 18
definition of 15
expert 24, 24f
open 15, 15f
target, in hierarchical model 16
Systems life cycle (SLC) model 5
of change 31–32, 32f
in evaluation 68
using 5
Systems theory 15–21
characteristics of systems in 16–17
T
Tablets, in healthcare education 542–543
Takedown Notice 531
Target system, in hierarchical model 16
Task analysis, in traditional usability methods 361, 361t
Task Force on Advanced Interprofessional Informatics Certification
(AIIC) 604
Tax exemption 475b
TCO See Total cost of ownership (TCO)
TEACH Act See Technology, Education, and Copyright
Harmonization (TEACH) Act
Teaching
computerized teaching tools for 539f, 540–547, 540b
from global perspective 547–548
process of, impact of technology on 547–548, 547b
TeamSTEPPS® 507
Technical and software support staff 510
Technical infrastructure, of electronic health record 75–89
application service provider for 83–84
central versus distributed storage of 77
clinical applications in 78
clinical data repository in 76–77
clinical decision support system of 80–81
clinician productivity in 79
cloud computing for 84
component model in 75–81, 76f
current challenges in 84–85
data collection in 78
data dictionary in 79–80
encounter-based versus longitudinal-based storage 77
future directions for 85–87
interface engine in 81–82
interoperability standards for 82
knowledge base in 80
master person index in 77–78
mobile apps in 85–86
networking systems for data sharing in 82–83
open source software in 86–87
other infrastructure models 83–84
patient management 79
service-oriented architecture in 86
SMART in 87
system integration and 81–82
Technical/statistical level of analysis, information defined as 63
Technology
as challenge to simulation use 560
as driving force of mobile health 261–263
access to 261
range and capabilities of 261
in telehealth implementation 138f, 139
Technology, Education, and Copyright Harmonization (TEACH)
Act 531–532
Technology-enhanced course
best practices for 548–549, 550–552t
impact of, in faculty evaluation 549–553
Technology Informatics Guiding Education Reform (TIGER) 487
on health care professionals 500
Tele-intensive care units (ICUs) 2
Telecardiology 138
Telecourses 517
Teledermatology Program 133
Telehealth 131–152, 432–433
acceptance and training for 139–140
adoption of, eHealth literacy and 147
advantages of, to patients 132
B.E.L.T. framework for 138–139, 138f
biometric sensors and 145–147, 145b
challenges to 141–144
changes in healthcare delivery due to 132, 132f
clinical, applications of, types of 138
clinical competency in 137
clinical practice considerations for, for health care
professionals 136–138
components of 148f
confidentiality, privacy, and informed patients and 137–138
credentialing and privileging in 143–144
definition of 131
direct patient health services and 144–147
future directions for 147–149, 148f
health information technology and 136
historic milestones 133
home 134–135
implementation of 141, 141b, 142t
in improve healthcare provider shortages and access to care 149
and in-person care 137
industry growth in 148–149
liability and 144
licensure in 141–144, 143t
malpractice and 144
operational and organizational success factors and barriers to 138–
141, 140t, 141b, 142t
operationalizing 139, 140t
organizations of, leading 133–134
patient-to-provider care by 144–145
programs, successful, examples of 132–133
reimbursement for 144
for remote home visits, and monitoring devices 145–146
scope of, clinical practice of 138
technical standards in 136
technologies 134–136
asynchronous or “store-and-forward” 136, 145
healthcare consumers and 147
patient monitoring 134–135, 135f
synchronous or “real-time” 134–135
to uHealth 149
video conferencing in 134, 144
Telehealth competency 137
Telehealth Network 132
Telehomecare 134–135
Telemedicine 131
Telenursing 131
Teleradiology 138
“Ten Commandments for Effective CDS: Making the Practice of Evidence-
Based Medicine a Reality.” (Bates) 178
Term, definition of 373
Termination
for breach 310–311
curable 311–312
overview of 310–312
transition and transition period 312
Terminology(ies)
definition of 373
interface 373
multidisciplinary 376–379
nursing 379–382
quality of, evaluation of 373–375, 374f
reference 373
standardized healthcare 371–373 See also Standardized
terminology(ies)
Terminology change request 375
Terminology cross-mapping 383
Terminology editing 375
Terminology harmonization 383, 384t
Terminology life cycle 375
Terminology publication 375
Tethered personal health record 246
Text data, preprocessing, in KDDM 397
Textbooks
distributors of, online, for distance education 529–530
electronic 541–542
The intelligent “cloud” 618
The Joint Commission, health information management
standards 429–430, 430t
Theoretical foundation, of health informatics 10–37
change theory in 28–31 See also Change theory
chaos theory in 18, 18b
complexity theory in 18
future directions for 33–34
informatics-related models in 33
information theory in 21–25 See also Information theory
learning theory 25–28 See also Learning theory(ies)
systems theory in 15–21 See also Systems theory
theories and models, understanding of 14–33
Theoretical framework 15
Theoretical model, definition of 15
Theory
concepts in 15
definition of 14
Theory-based debriefing 564
Think-aloud protocol, in traditional usability methods 361
Threat, definition of 450
TIGER See Technology Informatics Guiding Education Reform
(TIGER)
Time
development, decreased, from improving the user experience for
health information technology 356–357
management, as knowledge component 288
Time series analysis, in program evaluation 70
Tiny chips 618
To Err Is Human (IOM) 481, 499–500
Top Sites Blog 529
Total cost of ownership (TCO) 281
Trade secrets 300
Traditional usability methods 360–361
Trainers
in community college training 510
partial task, as simulators 558
Training
and development, as human resources subsystems 126
for electronic health record implementation 331–333
evaluation model of 559–560
in telehealth 139–140
Transaction history file 122
Transforming Nursing Practice Through Technology and Informatics
(HIMSS) 484, 488
Translational research, data science for 393–394
Transmi ed personal health data, huge amounts of 618
Transparency
description of 438t
ePatient movement and 212–213
Treatment and process factors, controls for, in practice-based
evidence study 53
Trend analysis, in predicting future research 616
Trialability, of innovation 30
TRICARE, on healthcare spending 475b
Triggers, of clinical decision support 172
Triple Aim model for healthcare 156, 156b
TUG, robot 4, 4f
Turley’s Nursing Informatics Model 34t
Tutoring services 529
Twine-Health 258
Twi er 222
Typhon Group 540
U
Ubiquitous computing environments 618
Ubiquitous (uHealth) technologies, telehealth and 149
uHealth
in advancing telehealth 148
telehealth to 149
Umbrella model, of health informatics 606, 606f
UMLS® See Unified Medical Language System (UMLS®)
Unfreezing stage, of planned change 29
Unified Medical Language System (UMLS®), Metathesaurus®
of 373, 374f
Unified Theory of Acceptance and Use of Technology, in
evaluation 64, 65f
Unintended consequences, of health IT implementation 481–482
Unit testing, during information system implementation and post
go-live 327–328t
United States federal government agencies, telehealth programs
of 134
University-based education 510–511
University of Miami, Miller School of Medicine, telehealth program
of 133
Unstructured Information Management Architecture (UIMA) 397
Untethered personal health records 246
Uptime, service level agreements and 306
U.S. Department of Health and Human Services (HHS) 476, 476f,
508–509
National Quality Strategy of 482
U.S. Department of Veterans Affairs (VA)
home telecare program of 133
social media tools used by 224
U.S. Food and Drug Administration (FDA) 424t
in social media regulation 229
U.S. Preventive Services Task Force (USPSTF), in appraising clinical
practice guidelines 46t
U.S. Preventive Services Task Force (USPSTF) segment of the AHRQ
website 44–45
Usability 354
as barrier to personal health record adoption 249
goals of 354, 354f
as system requirement 276, 277b
Usability issues, identifying of, with fielded health IT products 365
Usability measures 362, 363t
Usability questionnaires 362
Usability test
comparison test in 365
formative test in 364
selecting a type of 362–366
determining user needs and requirements in 362–364
validation test in 364
Use limitation, description of 438t
User
needs and requirements of, in selecting a type of usability test 362–
366
productivity and efficiency, increased, from improved health IT
user experience 356
User-centered design 354–357
User experience 353
for health information technology 352–369
current 352–353
definitions of terms and their relationships in 353–354, 353f
improving 352–353
future directions for 366
potential benefits of 355–357, 355f
increased individual effectiveness as 356
increased organizational efficiencies as 356–357
improving
essential components of 364
future directions for 621
selecting methods for 358–362, 359b
tests, steps for conducting of 365–366
User generated content, in social media 220
User interface
designing, using terminologies 384–385
well-designed, return rate for 356
User-satisfaction instruments, in program evaluation 71
Utilization, personal health records utilization and 248
Utilization Review Accreditation Commission (URAC) 410–411t
V
VA See U.S. Department of Veterans Affairs (VA)
Validation of findings, in practice-based evidence study 54, 55b
Validation tests, in usability tests 364
example of 364
Validity, internal and external, in research design 51
Value(s)
affective skills and 27
big data and 393
Value-based payment models, clinical decision support adoption
and 179
Variety, of big data 393
Velocity, of big data 393
Vendor(s)
contract, healthcare organizations and 301
establishing a working relationship with 281–282
evaluation of 279
of human resources information systems 125, 125b
responsibility, disclaimers by 314
Vendor master file 122
Vendor resource guides 112
Venn diagram, of health informatics 606, 606f
Veracity, of big data 393
Veterans Health Administration (VA) 475b
Video and image sharing content 223
Video conferencing, in telehealth 134, 144
Virtual communities
characteristics of 214
patient-focused, ePatients and 213
risks of 215
Virtual machines, cloud computing and 84
Virtual world, in healthcare education 546–547
Visiting nurse associations (VNAs) 154
Visualization tools, example of 623f
Vital events tracking, in mHealth 259, 260f
VitalSource 530
Vocabulary, definition of 373
Volume, of big data 393
Volume testing, during information system implementation and
post go-live 327–328t
Vulnerabilities
definition of 450
for information security, current 448–449
external events 448
internal 448
medical devices 448–449
W
Wearable devices 432–433
Wearable technology, and mHealth 265
Weaver, Warren, on information theory 22
Web 1.0 207
Web 2.0 207
Web 2.0 tools, in distance education 517
Web 3.0 207
Web-based student testing, in healthcare education 545
Web tools, for informatics curriculum 508, 509t
WebQuest 526–528, 527f
Websites, health information, telehealth technology and 147
Well online healthcare consumers 208
WelTel 259–260
Whiteboards, interactive 540–541, 540b
WHO See World Health Organization (WHO)
Whole System Demonstrator (WSD) program, for effectiveness of
telehealth 133
Wikis 222
Wire fraud 428
Wisdom, in Nelson model, of information theory 23, 23f
Word, definition of 373
Workarounds, in redesigning workflows 414–415
Workflow(s)
clinical, clinical applications of EHR with 78
redesigning, in implementing electronic health record 325–327
Workflow rules engines 118–119
Workflow support, clinical decision support tools in 175–176
World Health Organization (WHO)
eHealth and health informatics at 583–584
Global Observatory for eHealth (GOe) of 255
World Health Organization (WHO) Family of International
Classifications 379, 584, 585b
Y
YouTube 223
Z
ZigBee/IEEE 802.15 136
Common questions
Powered by AITelehealth redefines healthcare access by eliminating geographical barriers, providing quicker care access, and empowering patients through greater involvement in their health management. Benefits include decreased travel time, enhanced monitoring capabilities, timely interventions, and improved patient satisfaction and empowerment in their care journey .
Healthcare providers face several challenges when integrating CDS systems with EHRs, including ensuring the alerts and reminders effectively support clinical decisions without overwhelming clinicians. Additionally, integration must maintain seamless access to linked external resources and adapt to evolving clinical guidelines, enhancing decision-making without disrupting workflow .
EHRs have the potential to transform personalized medicine by integrating genetic and clinical data, enabling tailored treatments. However, challenges such as ensuring data accuracy, patient privacy, interoperability, and infrastructure support need addressing to successfully harness personalized medicine's full potential through EHRs .
Ongoing evaluation in healthcare settings during the SLCM is essential for refining system functionalities post-implementation. This process starts from the planning stage and involves testing systems in simulated environments to address gaps early. Continuous evaluation ensures systems evolve through upgrades and refinements, supporting improved healthcare delivery and integration into normal operations .
Healthcare organizations can adopt strategies such as establishing a dedicated project management team, involving clinical champions, and ensuring comprehensive training for staff on telehealth technologies. Identifying necessary technical support and infrastructure, as well as developing clear policies and procedures, formulates an effective approach to overcoming implementation challenges .
Digital literacy is crucial for health literacy in today's communications as it encompasses skills like evaluating online information and understanding social media, which are increasingly important for effective health dialogues. With the integration of digital literacy into health literacy, healthcare professionals face challenges in updating policies and procedures to incorporate these skills, ensuring patients can navigate the complex, technology-driven healthcare environment .
Integrating PGHD with EHRs is important for comprehensive healthcare insights but poses challenges such as ensuring data authenticity and security. Transforming PGHD into meaningful information for better decision-making requires overcoming technical and procedural challenges to assure data quality and patient trust in the accuracy and privacy of their data .
EHR integration significantly enhances clinical research and data management by providing efficient access to comprehensive patient data, facilitating data aggregation across multiple sites. This streamlines research processes, improves study accuracy by reducing manual data errors, and ultimately supports advanced healthcare insights and innovation .
Theoretical perspectives in health IT evaluation are controversial because some argue evaluations are local and limited in scope, providing little generalizable knowledge. Others advocate for using theory to frame evaluation issues, promoting broader understanding and facilitating accurate measurement. The controversy lies in balancing localized relevance with the need for comprehensive, theory-driven insights .
The implementation of CDS systems in healthcare settings significantly reduces medication error rates by providing real-time alerts and reminders for potential drug interactions, allergies, and dosing errors. This proactive approach enhances patient safety and supports healthcare providers in making informed clinical decisions .
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