ISO 13972:2022

Overview

ISO 13972:2022 - Health informatics - Clinical information models - Characteristics, structures and requirements - defines Clinical Information Models (CIMs) as reusable health and care concepts used to define and structure clinical information across systems. The standard describes what a CIM should contain, how its data elements, relationships, metadata and versioning are specified, and provides guidance and examples for transformation and application across diverse health IT. ISO 13972:2022 aims to support semantic interoperability for EHR and PHR systems, system integration, reference architectures and secondary data use (e.g., public health reporting).

Key technical topics and requirements

• CIM content and structure: Requirements for concept specification, data element definitions, datatypes, values and value set expressions, and localization considerations.
• Data relationships and context: How data elements relate within a CIM, and how context and constraints are documented to preserve meaning.
• Metadata and version management: Required metadata elements and a version management approach to maintain traceability, compatibility and lifecycle information for CIMs.
• Quality Management System (QMS): Principles for governance, development, testing, distribution, maintenance and measurement of CIMs across their lifecycle (QMS approach referenced, e.g., ISO 9001).
• Transformation and implementation guidance: Principles for mapping CIMs to different technology representations (examples include UML, ADL and transformation to HL7® FHIR® representations).
• Architectural placement: Discussion of CIMs in architectural views and reference architectures (e.g., use with ISO 23903 interoperability framework).

Note: ISO 13972:2022 explicitly excludes prescriptive content of any specific CIM, detailed modelling methodologies, full-document compositions (e.g., entire discharge summaries) and instructions for clinician engagement, governance processes or patient safety procedures.

Practical applications

• Enabling semantic interoperability between EHRs, PHRs and clinical systems.
• Standardizing clinical data capture for decision support, quality measurement, research, registries and public health reporting.
• Serving as building blocks for system integrators, health IT architects and implementers to compose interoperable solutions.
• Supporting vendors and national/regional repositories in maintaining consistent, versioned clinical models.

Who should use this standard

• Health informaticians and clinical modelers
• EHR/PHR vendors and software architects
• Standards developers and implementers (integration teams)
• Health authorities, registries and researchers seeking standardized data definitions

Related standards

• ISO 23903 (Interoperability and integration reference architecture)
• ISO 9001 (as an example QMS framework)
• HL7® FHIR® (common target for CIM transformations; examples provided in the document)

ISO 13972:2022 is a practical reference for anyone implementing or governing clinical information models to achieve reliable, reusable and semantically interoperable clinical data.