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ISO TC 215 Health Informatics Develops Technical Report on Medicinal Products

ANSI serves as ISO TC 215 Secretariat

8/27/2019

The International Organization for Standardization (ISO) Technical Committee (TC) 215, Health Informatics, has developed a technical report on terminology maintenance for medicinal products. It is relevant to organizations in the biopharmaceutical and pharmaceutical industry, including global regulators involved in the development, authorization, marketing, and distribution of medicinal products. The American National Standards Institute (ANSI), the U.S. member body to ISO, currently serves as the ISO/TC 215 secretariat and U.S. Technical Advisory Group (TAG) Administrator.

About the ISO Technical Report 14872

The identification of medicinal products (IDMP) is often a regulatory requirement and is increasingly essential as trends reflect integrated healthcare underpinned by global supply chain verification. ISO's new technical report, ISO/TR 14872, Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms, provides a framework for ongoing maintenance and support of identifiers and terms that meet the criteria of IDMP standards. As ISO explains, it describes a service delivery model and core principles which can be used as evaluation criteria for choosing IDMP terminology service providers. Additionally, it helps with the development of more robust service level agreements and governance processes used by IDMP data owners and terminology providers.

About the U.S. TAG to ISO/TC 215, Health Informatics

U.S. TAG to ISO TC 215, Health Informatics represents national interests on health information technology (HIT) and health informatics standards at ISO. ANSI administers the U.S. TAG to ISO TC 215 to coordinate national standards activities for existing and emerging health sectors. The U.S. TAG is guided by the ANSI cardinal principles of consensus, due process, and openness.

The scope of ISO/TC 215, and consequently the U.S. TAG is: Standardization in the field of health informatics, to facilitate capture, interchange and use of health-related data, information, and knowledge to support and enable all aspects of the health system.

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