Overview
ISO/TR 14872:2019 - "Health informatics - Identification of medicinal products - Core principles for maintenance of identifiers and terms" provides high-level guidance for the ongoing maintenance, governance and service delivery of terminologies that support the IDMP (Identification of Medicinal Products) family of standards. It describes core principles and a proposed federated service delivery model to help organizations evaluate or design operations and service level agreements (SLAs) for systems that create, maintain and distribute IDMP identifiers and controlled vocabularies.
Key topics and technical requirements
- Scope and purpose: Guidance for supporting the five IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239, ISO 11240) and their terminologies.
- Federated service delivery model: Hybrid approach where some maintenance services are centralized (global authorities) and others decentralized (regional or national providers).
- Data governance: Roles and processes for data owners, data stewards and governance groups to ensure quality, consistency, usability and access control.
- Terminology maintenance services: Procedures for creation of value sets, identifiers, change management, mapping and translations.
- Change management: Principles for consistent update cycles, reconciliation of regional variations and enforcement of SLAs between providers and stakeholders.
- Mapping and translations: Recommendations for mapping regional terminologies to IDMP-compliant value sets when a single global terminology is not feasible.
- Relationships with stakeholders: Coordination between regulators, standards development organizations (SDOs) and maintenance organizations; emphasis on vendor neutrality and interoperability.
- Interoperability considerations: Alignment with HL7 messaging and emerging specifications such as FHIR, and references to terminology authorities like SNOMED CT, LOINC, and EDQM.
Applications and who uses it
ISO/TR 14872:2019 is practical for organizations that create, manage or consume medicinal product data, including:
- National and regional regulators (e.g., EMA, FDA)
- Pharmaceutical and biopharmaceutical companies
- Clinical research organizations (CROs)
- Health IT vendors, dictionary and terminology service providers
- Standards bodies and implementers working on IDMP, pharmacovigilance, regulatory submissions, drug dictionaries and interoperability projects
Use cases include designing SLA-backed terminology services, evaluating maintenance workflows, establishing data governance, and planning mappings between local drug dictionaries and IDMP-compliant value sets.
Related standards
- IDMP family: ISO 11615, ISO 11616, ISO 11238, ISO 11239, ISO 11240
- Supporting technical specifications: ISO/TS 20440, ISO/TS 20443, ISO/TS 20451, ISO/TS 19844
- IT and process frameworks: ISO/IEC 20000-1, ISO/IEC 20000-2, ISO/IEC 33002
- Interoperability: HL7 FHIR, SNOMED CT, LOINC, EDQM
Keywords: ISO TR 14872:2019, IDMP, terminology maintenance, federated service delivery model, data governance, value set management, medicinal product identifiers, change management, HL7 FHIR.