Standards In

Biomedical Informatics

Standards are essential for ensuring interoperability, efficiency, and

effectiveness in the collection, manipulation, and transmission of
biomedical information.
The Idea of Standards
Standards have been instrumental in facilitating processes and products since Eli
Whitney's interchangeable parts for rifle assembly. A standard is essentially a set
of rules and definitions that specify how to carry out a process or produce a
product. Standards are beneficial because they provide a common framework
for collaboration, allowing individuals and organizations to work together
effectively.

The development of computers and software quickly highlighted the need for
standards. Standard character sets like ASCII and EBCDIC were developed to
make computer languages more readable for humans. The first standard
computer language, COBOL, was created to simplify program development and
enable code sharing. Hardware components also depend on standards for
exchanging information, ensuring interchangeability.
 The Need for Health Informatics Standards

The healthcare environment has traditionally been fragmented,

with loosely connected and organizationally independent units. Fragmented Care
Patients receive care across various settings, often with limited
Lack of communication and coordination between healthcare units.
communication and coordination between services. This lack of
integration creates inefficiencies and hinders effectiveness.
Value-Based Care
Increased need for information sharing and coordination.
The transition to a value-based care model further emphasizes
the need for information sharing and coordination. To address
these challenges, health informatics standards are crucial for Interoperability
enabling seamless data exchange between healthcare providers Seamless data exchange between providers and IT systems.
and their IT systems.
Early Standards to Support the Use of IT in Health Care

Early efforts in standards development focused on exchanging data between clinical laboratories and clinical systems, as well as between independent units
within a hospital. These early standards were primarily for data exchange and were referred to as messaging standards.

The first uses of computers in hospitals were for billing and accounting purposes. As computers became more affordable, hospital information systems (HISs)
were developed to support service operations within a hospital. However, these systems often followed a pattern of diversity, with independent departments
and functional applications.

1 2 3

Early Systems Hospital Information Systems Departmental Systems

Focus on data exchange between clinical Minicomputers enabled the development of
laboratories and clinical systems. Developed to support service operations departmental systems, but connectivity
within a hospital, but often lacked integration. remained a challenge.
Transitioning Standards to Meet Present Needs
Early standards were often applied within a single unit or department, addressing mainly local requirements. However, the increasing need for data
reuse across multiple departments and institutions has led to a shift towards more comprehensive standards.

Newer models for healthcare delivery, such as integrated delivery networks, health maintenance organizations (HMOs), and accountable care
organizations (ACOs), require coordinated and consolidated information. This has increased the demand for standardized identifiers for individuals,
healthcare providers, health plans, and employers.

1 Data Reuse 2 Standardized Identifiers 3 Integrated Delivery Networks

Shift towards more comprehensive Need for standardized identifiers for
standards to support data reuse across individuals, healthcare providers, health Newer models for healthcare delivery
multiple departments and institutions. plans, and employers. require coordinated and consolidated
information.
Settings Where Standards Are Needed
The patient care process, with its complexity and variations, requires standardization to improve efficiency and effectiveness. A hospital
admissions system records diagnoses, a pharmacy system records medications, a laboratory system records test results, and a radiology
system records imaging orders. All these systems need to store, present, and analyze data, requiring standardized approaches.

The inclusion of medical knowledge in clinical systems is becoming increasingly important. Encoding this knowledge in a standardized
way allows for sharing and reuse, facilitating the development of clinical decision support systems.

Patient Care Process Medical Knowledge Data Transfer

Standardization is needed for recording Standardized encoding of medical Messaging standards are needed for
diagnoses, medications, test results, and knowledge facilitates sharing and reuse transferring information between
imaging orders. for clinical decision support. systems.
Standards Undertakings and Organizations
The process of creating standards is often complex and competitive, involving multiple stakeholders with diverse interests. Standards are typically developed through a
consensus-building process, where volunteers representing various parties work together to reach agreement.

There are four main methods for producing standards: ad hoc, de facto, government-mandate, and consensus. The consensus method, where a group of volunteers works
in an open process, is the most common approach for developing healthcare standards.

Method Description Example

Ad hoc Informal agreement between interested parties. DICOM standard for medical imaging.

De facto A single vendor's product becomes the market Microsoft's Windows operating system.
standard.

Government-mandate A government agency creates and legislates a HIPAA standard.

standard.

Consensus Volunteers representing interested parties work in Health Level 7 (HL7) standard for clinical data
an open process. interchange.
The Standards Development Process

Identification
The standards development process typically involves several stages,
Recognizing the need for a standard. beginning with the identification of a need for a standard. This is followed by a
conceptualization stage, where the characteristics of the standard are defined,
including its scope, format, and intended purpose. The discussion stage
Conceptualization involves a detailed analysis of the pros and cons of various concepts and
approaches.
Defining the characteristics of the standard.

Discussion
The writing of the draft standard is usually the work of a few dedicated individuals,
Analyzing the pros and cons of various concepts and approaches. typically representing vendors in the field. The draft is then reviewed by other
stakeholders, and controversial points are discussed and resolved. The standard
goes through several versions as it evolves, with backward compatibility being a
Drafting major concern.
Writing the initial draft of the standard.

Review and Revision

Reviewing the draft, discussing controversial points, and revising the standard.
Data Standards Organizations
Several organizations are dedicated to fostering standards in healthcare. Some organizations include members with expertise in specific areas, while others
provide a framework for standards development and rely on participation by knowledgeable experts. These organizations play a crucial role in ensuring the
development and adoption of effective standards.

Most influential health-related standards development organizations (SDOs), with key standards. It is important to note that standards are constantly
evolving, so it is essential to consult current primary resources for the most up-to-date information.

American National Health Level Seven Digital Imaging and Systematized Nomenclature
Standards Institute (ANSI) International (HL7) Communications in of Medicine - Clinical Terms
Medicine (DICOM) (SNOMED-CT)
HL7 is an international standards
ANSI is a private, non-profit body that develops standards for DICOM is a standard for the
membership organization that the exchange of clinical data. exchange of medical images and SNOMED-CT is a comprehensive
approves official American National waveforms. coding system for medical terms.
Standards.
Detailed Clinical Models, Coded Terminologies, Nomenclatures,
and Ontologies
The capture, storage, and use of clinical data in computer systems are complicated by the lack of agreement on terms and meanings. To address this challenge, detailed
clinical models, coded terminologies, and ontologies have been developed to facilitate the communication of coded medical information.

Clinical information models provide a structured representation of medical data, defining the relationships between different data elements. Terminology binding involves
linking specific sets of codes from standard terminologies to the coded elements in the models. This ensures that data is represented consistently across different systems.

1 2 3

Clinical Information Models Terminology Binding Interoperability

Provide a structured representation of medical Linking specific sets of codes from standard Ensuring that data is represented consistently
data, defining the relationships between different terminologies to the coded elements in the across different systems.
data elements. models.