19BM2015
MEDICAL ETHICS AND
STANDARDS
Handled By
[Link] Saravanan
Assistant Professor
Department of Biomedical Engineering
Module 3: Medical Standards:
1. Evolution of Medical Standards
2. IEEE 11073 - HL7 – DICOM - LOINC – HIPPA
3. Electronics Patient Records
4. Healthcare Standard Organizations – JCAHO (Join Commission on
Accreditation of Healthcare Organization)
5. Evidence Based Medicine
6. Bioethics
1. Evolution of Medical Standards
• In 1960, Professionals in the field of health services research, took on the study of
the cost, quality, and accessibility of health care services using economic and
other social science research methodologies.
• After World War II, The development of medical standards of care took off in the
1980s. Medical professional associations, specialty societies, and voluntary health
organizations became involved in developing standards of care in an increasingly
rigorous fashion
• By the late 1980s, the American Medical Association, working with medical
specialty societies, launched a major initiative that signaled the endorsement of
medical standard-setting by the organized medical profession
[Link]
promise-medical-standards-care/2004-12
1. Evolution of Medical Standards
• In 1981, the American College of Physicians and the Blue Cross and Blue Shield
Association launched the Clinical Efficacy Assessment Project to evaluate use of
specific medical procedures and technologies
• In 1987, the Council of Medical Specialty Societies announced more standard setting
need to be introduced
• In a 1990 report on Medical standards of care, the Institute of Medicine established a
taxonomy of standards that remains relevant today, they are
1. Standards of quality
2. Medical (or clinical) practice guidelines
3. Medical review criteria and
4. Performance measures
2.1. IEEE 11073
• SO/IEEE 11073 is a collection of Personal Health Device (PHD)
standards
• These standards addresses the interoperability of personal health
devices (PHDs) such as weighing scales, blood pressure monitors,
blood glucose monitors
• The standards draw upon earlier IEEE11073 standards work, but differ
from this earlier work due to an emphasis on devices for personal use
(rather than hospital use) and a simpler communications model
[Link]
(PHD)_Standards
2.1. IEEE 11073 (Cont..)
• The IEEE 11073 PHD standards has the concept of
"agents" and "managers"
• Agents and managers may operate in staggered
architectures with multiple layers of agents as well
as of managers.
• The agents are the personal health devices and are
generally small, inexpensive battery-powered
devices that lack much in the way of displays and
other user interfaces.
• The managers are typically small computers or
smart phones with greater computing resources
and required routing capabilities to convey
information autonomously to a delivering source
2.1. IEEE 11073 (Cont..)
• All communications between agents and managers is preferably mobile and autonomous
• When the agents transmit their data to more capable managers then the data can be processed and
displayed on the managers, and then perhaps transferred through the internet to people's carrier and to
health care professionals.
• The standard assumes that each Agent communicates with a single manager at a time.
• A manager could communicate with more than one agent
• Communications is bi-directional to enable transaction security.
• The IEEE 11073 PHD standards define Three transports namely
(i) Bluetooth - for Health Device Profile
(ii) USB - For Personal Healthcare Device
(iii) ZigBee Health Care Profile
2.1. IEEE 11073 (Cont..)
Agent application process(es)
• It is not defined within the standard and as
a result it can be implemented free.
Medical data information base
• MMOs (Managed Medical Objects) are
stored hierarchically within a tree structure
in a form named Domain Information
Model (DIM).
Association service control element
• It has services available, that controlling
the association assembly and disassembly.
2.1. IEEE 11073 (Cont..)
Common medical device information
service element [CMDISE]
• Services for the data exchange of MMOs
(Managed Medical Objects) between Agent-
Manager systems, are defined in this module
Session layer
• This layer controls connection at the session
level
2.1. IEEE 11073 (Cont..)
Association Request - Agent is not Recognised
Association Request - Agent is Recognised
2.2. HL7 Standard
• HL7 (Health Level Seven) is set of international standards for transfer of
clinical and administrative data between software applications used
by various healthcare providers.
• These standards focus on the application layer, which is "layer 7" in
the OSI model.
• HL7 helps bridge the gap between health IT applications and makes
sharing healthcare data easier and more efficient when compared to
older methods
[Link]
2.2. HL7 Standard – Structure of Message
• HL7 suggests a format of which the data
has to be sent on a wire or wireless
medium, which we call the default
encoding
• The format is unreadable without prior
knowledge
MSH – Message Header
PID-Patient Information, demographic data
NK1- Next to kin (contact info of relatives)
PV1-Patient visit (Describes hospital stay)
2.2. HL7 Standard – Structure of Message
• Delimiters are
Module 3: Medical Standards:
1. Evolution of Medical Standards
2. IEEE 11073 - HL7 – DICOM - LOINC – HIPPA
3. Electronics Patient Records
4. Healthcare Standard Organizations – JCAHO (Join Commission on
Accreditation of Healthcare Organization)
5. Evidence Based Medicine
6. Bioethics
2.3 DICOM Standard
• The Digital Imaging and Communications in Medicine (DICOM) Standard specifies
a non-proprietary data interchange protocol, digital image format, and file
structure for biomedical images and image-related information
• The main objectives of DICOM is to ensure the interoperability of systems used
to produce, store, share, display, send, query, process, retrieve and print
medical images, as well as to manage related workflows
• DICOM is most commonly used for storing and transmitting medical images
enabling the integration of medical imaging devices such as scanners, servers,
workstations, printers, network hardware, and picture archiving and
communication systems (PACS) from multiple manufacturers.
• CT and MRI images are acquired in a special digital format, called the DICOM
format. DICOM ensures that the high quality of the images is retained
[Link]
2.3 DICOM Standard (Cont..)
• DICOM was initiated by the ACR (Americal
College of Radiology) to address the need
for connectivity between imaging
equipment. The current version of DICOM is
called DICOM version 3.0.
• Image files that are compliant with part 10
of the DICOM standard are generally
represented as “. dcm.”
• Like TIFF, DICOM is a completely open
standard, free to obtain, read and
implement without license fees
2.3 DICOM Standard -Data format
• DICOM groups information into data sets
• For example, a file of a chest x-ray image may contain the patient ID within the
file, so that the image can never be separated from this information by mistake
• A DICOM data object consists of a number of attributes, including items such as
name, ID, etc., and also one special attribute containing the image pixel data
• A single DICOM object can have only one attribute containing pixel data. This
corresponds to a single image. However, the attribute may contain multi-frame
data
• DICOM uses different data element encoding schemes to achieve high fidility
LOINC
• Logical Observation Identifiers Names and Codes (LOINC) is
a database and universal standard for identifying medical
laboratory observations.
• LONIC is clinical terminology that is important for laboratory test orders
and results, and is one of a suite of designated standards for use in U.S.
• LOINC was identified by the HL7 Standards Development Organization as
a preferred code set for laboratory test names in transactions between
health care facilities, laboratories, laboratory testing devices and public
health authorities.
• In the future, LOINC is likely to become a HIPAA standard for certain
segments of the Claims Attachment transaction
[Link]
LONIC (cont..)
• LOINC applies universal code names and identifiers to medical
terminology related to Electronic health records.
• The purpose is to assist in the electronic exchange and gathering of clinical
results (such as laboratory tests, clinical observations, outcomes
management and research).
• LOINC has two main parts: Laboratory LOINC and clinical LOINC.
• Clinical LOINC contains a subdomain of Document Ontology which captures
types of clinical reports and documents
• Several standards, such as IHE or HL7, use LOINC to electronically transfer
results from different reporting systems to the appropriate healthcare
networks
LONIC-Format
• A formal, distinct, and unique 6-part name is given to each term for test or
observation identity.
• The database currently has over 71,000 observation terms that can be accessed and
understood universally.
• Each database record includes six fields for the unique specification of each
identified single test, observation, or measurement:
1. Component- what is measured, evaluated, or observed (example: urea,...)
2. Kind of property- characteristics of what is measured, such as length, mass, volume, time
stamp and so on
3. Time aspect- interval of time over which the observation or measurement was made
4. System- context or specimen type within which the observation was made (example: blood,
urine,...)
5. Type of scale- the scale of measure. The scale may be quantitative, ordinal, nominal or
narrative
6. Type of method- procedure used to make the measurement or observation
HIPPA
• The Health Insurance Portability and Accountability Act of 1996
(HIPAA) is a Federal law that required the creation of national
standards to Protect sensitive patient health information from being
disclosed without the patient's consent or knowledge
• Compliance to HIPPA demands safeguards at 3 levels namely
(i) Technical safeguards
(ii) Physical safeguards
(iii) Administrative safeguards
[Link]
compliance-guide-what-is-hipaa/
• Network encryption- Encrypt any ePHI to
meet cryptographic standards for all data transmitted
over an external network (Mandatory)
• Control access-Each user is assigned a centrally-
controlled unique username and PIN code to access the
systems (Mandatory)
• Authenticate ePHI – You must identify and authenticate
ePHI and protect it from corruption, unauthorized
changes, and accidental destruction. (Recommended)
• Encrypt devices-All end-point devices that access the
system should be able to encrypt and decrypt data, this
is particularly important for mobile and laptop devices
(Recommended)
• Control activity audits – Detailed logging is needed to
track all ePHI access attempts and to monitor how ePHI
data is manipulated. (Recommended)
• Enable automatic logoff – Users must be logged out
after a certain set time frame, usually between 30
seconds and 3 minutes depending on the application
or system (Recommended)
• Control facility access –track the specific
individuals who have physical access to data
storage. You must also take reasonable steps
to block unauthorized entry. (Required)
• Manage workstations -Write a policy that
limits which workstations can access health
data (Mandatory)
• Protect mobile –it is a mobile device policy
that removes data before a device is
circulated to another user. (Mandatory)
• Track servers – it is about Copying all data
completely before you move servers.
(Recommended)
• Risk Assessment-Mandatory
• Systematic risk management-Mandatory
• Train your staff -Recommended
• Build contingencies-Mandatory
• Test your contingencies -
Recommended
• Block unauthorized access-Mandatory
• Document all security incidents-
Recommended
Module 3: Medical Standards:
1. Evolution of Medical Standards
2. IEEE 11073 - HL7 – DICOM - LOINC – HIPPA
3. Electronics Patient Records
4. Healthcare Standard Organizations – JCAHO (Join Commission on
Accreditation of Healthcare Organization)
5. Evidence Based Medicine
6. Bioethics
Electronics Patient Record
• Electronic Health Record (EHR) are real-time, patient-centered records that make information
available instantly and securely to authorized users.
• EHR does contain the medical and treatment histories of patients
• The Ministry of Health and Family Welfare has notified Electronic Health Record (EHR) Standards
Version 2016 for India in December 2016
• EHR Standards are the building blocks for the exchange of health information. They provide a
common reference framework to promote uniformity in the definition and identification of
health system components.
• The main use of EHRs is portability (i.e.) they were built to be shared with other health care
providers
Electronics Patient Record- The 10 Components Of
Medical Records
1. Identification Information
2. Medical History
3. Medication Information
4. Family History
5. Treatment History
6. Medical Directives
7. Lab results
8. Consent Forms
9. Progress Notes
10. Financial Information
[Link]
JCAHO (Join Commission on Accreditation of
Healthcare Organization)
• JCAHO is a nonprofit organization based in the United States that accredits over
20,000 healthcare organizations and programs in the country
• The Joint Commission accredits and certifies more than 22,000 health care
organizations and programs in the United States, including hospitals and health
care organizations that provide ambulatory and office-based surgery, behavioral
health, home health care, laboratory and nursing care center services
• Joint Commission standards are the basis of an objective evaluation process that
can help health care organizations measure, assess and improve performance
• The standards focus on important patient, individual, or resident care and organization
functions that are essential to providing safe, high quality health care services
JCAHO (Join Commission on Accreditation of
Healthcare Organization)
JCAHO- 4 key principles:
• You must treat all customers, fellow employees and contracted
third parties with Respect, Honesty, Fairness and Integrity.
JCAHO - benefits of accreditation
• You must treat all customers, fellow employees and contracted third parties
with respect, honesty, fairness and integrity.
JCAHO – accreditation Process
• Accreditation is Awarded upon successful completion of an on-site survey
• The on-site survey is conducted by a specially trained Joint Commission surveyor or
team of surveyors who assess the organization's compliance to our standards.
[Link]
jcaho/#:~:text=The%20Joint%20Commission%20on%20Accreditation,and%20pro
grams%20in%20the%20country.
Module 3: Medical Standards:
1. Evolution of Medical Standards
2. IEEE 11073 - HL7 – DICOM – IRMA - LOINC – HIPPA
3. Electronics Patient Records
4. Healthcare Standard Organizations – JCAHO (Join Commission on
Accreditation of Healthcare Organization)
5. Evidence Based Medicine
6. Bioethics
Evidence Based Medicine
• Evidence based medicine (EBM) is a process of life-long, self-directed learning in
which caring for patients creates the need for clinically important information
about diagnosis, prognosis, therapy, and other clinical and health care issues.” -
The EBM Working Group
• Evidence based medicine is an integration of individual clinical expertise,
patient’s values and relevant clinical research to make the best decision for
patient care
• The practice of evidence-based medicine is a process of self-directed problem-
based learning in which clinically relevant information about diagnosis and
therapy is considered according to the best data available through research
[Link]
[Link]
Evidence Based Medicine
• EBM works along with the Cochrane Collaboration
• The Cochrane Collaboration is a non-profit organization based in the UK
• The main mission of this organization is to go through and prepare systematic
reviews of new research that is being published every day in various specialties
based on the strongest evidence available, in order to help make informed
decisions on healthcare interventions for the best possible patient outcome
• These reviews are then published electronically within The Cochrane Library and
are freely accessible to healthcare professionals as well as consumers
EBM- Levels of Evidence from Sackett
• Levels of clinical evidence are an important aspect of EBM
• The levels of evidence were originally classified by the Canadian Task
Force on the Periodic Health Examination in 1979
I Large Randomised Control Trials with clear cut results
II Small Randomised Control Trials with unclear results
III Cohort and case-control studies
IV Historical cohort or case-control studies
V Case series, studies with no controls
Bioethics:
• Bioethics is the study of ethical, social, and legal issues that arise in
biomedicine and biomedical research
• Examples of areas that have been the focus of bioethics for a long time
are organ donation and transplantation, genetic research, death and
dying, and environmental concerns
• Bioethics includes
(i) Medical ethics which focuses on issues in health care;
(ii) Research ethics which focuses issues in the conduct of research
(iii) Environmental ethics, which focuses on issues pertaining to the
Relationship between human activities and the environment and
(iv) Public health ethics which addresses ethical issues in public health
Thank You