Overview
ISO 10781:2023 - Health informatics - HL7 Electronic Health Record‑System Functional Model, Release 2.1 (EHR FM) - defines a user‑focused reference list of functions that may be present in an Electronic Health Record System (EHR‑S). The standard describes functions in a consistent way to support creation of Functional Profiles for specific care settings and jurisdictions (e.g., intensive care, cardiology, office practice, primary care). ISO 10781:2023 updates the EHR FM to Release 2.1, incorporating record lifecycle refinements and conformance guidance to improve interoperability and specification clarity.
Key topics and technical requirements
- Functional model structure: normative components include Function ID, Function Name, Function Statement and Conformance Criteria; descriptive components include Function Type and Description.
- Functional Profiles: method for tailoring the EHR FM to domains, care settings and national “realms” to produce standardized requirements lists.
- Conformance clause and model: rules and normative language for claiming conformance, including profile traceability, dependent SHALL semantics and guidance for derived/companion profiles.
- Record Lifecycle Events: updated to 27 events (including added events verify, encrypt, decrypt) describing how EHR entries are created, managed and retired.
- Trust and clinical model support: Trust Infrastructure updated to support ISO/HL7 Detailed Clinical Models (DCMs) and alignment with terminology and clinical model services.
- Glossary and governance: comprehensive glossary, action‑verb structure and guidance for constructing rigorous conformance criteria.
Applications and who uses it
- EHR vendors and system developers use ISO 10781:2023 to define, design and document system functions and to create product Functional Profiles for procurement and certification.
- Health services organizations (hospitals, clinics, primary care) use Functional Profiles to specify required EHR functionality for particular care settings (intensive care, cardiology, group practice).
- Procurement teams and regulators reference the model to compare vendor claims and to structure certification/conformance programs (including self‑attestation).
- Standards bodies and implementers leverage the EHR FM to align clinical content, terminologies and interoperability frameworks (e.g., FHIR implementations, DCMs).
- Clinical informaticians use the model to map workflows and ensure required capabilities (security, audit, record lifecycle management) are specified.
Related standards
- HL7 EHR‑S FM (base work by HL7) and the HL7 community outputs
- ISO 21089 (Trusted end‑to‑end information flow) - aligned record lifecycle event definitions
- FHIR (Record Lifecycle Event Implementation Guide, R4) - compatibility with lifecycle semantics
- Other harmonized contributors referenced: DICOM, SNOMED, CDISC, GS1
ISO 10781:2023 is essential for anyone specifying, procuring, certifying or implementing EHR systems who needs a consistent, interoperable functional baseline across care settings and jurisdictions.