Mark Diehl

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Health Information Architecture, Data Modeling, and Enterprise Architecture Planning

International Health Informatics Standards Development

The U.S. Standards Development Environment

As healthcare extends beyond national boundaries, the impact of standards becomes increasingly critical for healthcare organizations. National health information standards have led the way to systems interoperability within the U.S. Worldwide expansion of healthcare and healthcare IT markets requires health informatics standards to promote efficient exchange of health information. Efficient exchange of healthcare information and the interoperability of health information systems are important for vendor viability in an expanding international market. The principal international body developing health information technology standards is the International Standards Organization Technical Committee 215 (ISO/TC215) on Health Informatics.

The ISO is a worldwide federation of national standards bodies that constitute the ISO member bodies where the actual preparation of International Standards is typically carried out through ISO technical committees ISO TCs). ISO rules give each member body interested in a subject for which a technical committee has been established the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, may also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization, leading to many international standards being designated ISO/IEC.

The scope of this international effort includes standardization in the field of information for health and in health information and communications technology. Specifically excluded from the scope of ISO/TC 215 are standardizing the practice of clinical medicine, and defining a standardized service structure for health care delivery. While the representation and exchange of knowledge is within the scope of ISO/TC 215, standardizing medical knowledge is outside the scope of the committee. Although the definition of standardized comparative performance data is within the scope of ISO/TC215, standardizing the performance of the healthcare delivery system is out of scope. Likewise, the standardization of data structure and the data output from systems and devices is within the scope of ISO/TC215, the standardizing the internal operation of systems and devices is specifically excluded. Standards activities underway in ISO/TC215 as of 2002 are identified in the following table:

ITEM	DESIGNATION	TC DOCUMENT
WG 1 Health Records and Modeling
Ownership and Access Rights to the Electronic Health record	NP 17128	N56
Country Identifier Mechanism in Healthcare	NP 17120	N57
A General Domain Model for Healthcare	NP 17119	N58
Functional Requirements for the Electronic Health Record	18308	N76

WG 2 Messaging and Communication
Method for Developing Messages	NP 17113	N59
Mapping Hierarchical Message Descriptions to XML	NP 17112	N60
P-o-C Medical Device Communications, Physical Layer, Cable Connected	NP 17111	N61
P-o-C Medical Communications Transport Profile, Cable Connected	NP 17110	N62
P-o-C Medical Device Communications, Nomenclature for Vital Signs Documents	NP 17109	N63
P-o-C Medical Device Communications, Domain Information Model	NP 17116	N67
Essential Characteristics Required to Enable Precise Healthcare Messaging and Communication Standards	18307	N95
Standard for Clinical Analyser Interfaces to Laboratory Information Systems – Use Profile	18812	N96
P-o-C Medical Device Communications,	18813	N97
P-o-C Medical Device Communications,	18811	N98

WG 3 Health Concept Representation
Foundation Terminology	NP 17118	N65
Controlled Health Vocabularies – Vocabulary Structure and High Level Quality	NP17117	N66
Health Informatics – Vocabulary on Terminological Systems	NP 17115	N68
System of Semantic Links and Concepts in Medicine	NP 17115	N69
Integration of a Reference Terminology for Nursing	18104	N94

WG 4 Security
Public Key Infrastructure (Technical Specification)	NP 17090	N64

WG 5 Health Cards
References and Record Linkage Information		N114
Patient Healthcare Data – Part 1: General Structure		N115
Patient Healthcare Data – Part 2: Common Objects		N116
Patient Healthcare Data – Part 3: Limited Clinical Data		N117
Patient Healthcare Data – Part 4: Electronic Requirements		N118

The objectives of TC 215 activities are to achieve worldwide compatibility and interoperability among independent systems, to ensure compatibility of data for comparative statistical purposes, and to reduce duplication of effort and redundancies in informatics standards activities. The ISO TC 215 structure consists of several workgroups, each headed by a convenor, with workplans directed by representatives of various nations.

ANSI designates a Secretariat and Technical Advisory Group Administrator (TAG) for this ISO activity. The US TAG develops the national position that is submitted to the TC. Membership in the TAG provides to U.S. citizens an ability to affect the evolution of international standards, through input into the U.S. position and through influence on the standards development work program. Recently the American Society for Testing and Materials withdrew as both the U.S. Secretariat and the U.S. TAG Administrator to the ISO/TC 215, and the Health Information Management Systems Society volunteered to assume these duties.