Overview
EN ISO 10781:2025 (ISO 10781:2023) - Health Informatics - HL7 Electronic Health Records‑System Functional Model, Release 2.1 (EHR FM) - defines a standardized, user‑centric function list for Electronic Health Record Systems (EHR‑S). The standard describes what functions may be present in an EHR‑S and how to express those functions consistently through Functional Profiles for care settings, specialties, services and national realms. It clarifies the distinction between the singular EHR and the broader EHR‑System(s) (a single product or a system of systems) and deliberately avoids prescribing implementation technologies or EHR content.
Key topics and technical requirements
- Function List (Normative): Annex A contains the normative Function ID, Function Name, Function Statement and Conformance Criteria - these are the canonical building blocks for profiles.
- Functional Profiles: Mechanism to create tailored descriptions of required/available functionality for contexts such as intensive care, cardiology, primary care or research.
- Conformance Model: Rules and criteria that govern how EHR‑S implementations or profiles declare conformance (including self‑attestation provisions).
- Scope of functions: Covers both core healthcare functionality (clinical record management) and application‑level capabilities (middleware, integration, cross‑application workflow, location discovery).
- Interoperability: Treated from semantic (consistent meaning) and technical (format, syntax, connectivity) perspectives - but the standard is not a messaging or implementation specification.
- Normative vs Reference content: Sections are explicitly labelled; normative elements (e.g., specific conformance clauses and parts of the function list) must be followed when claiming conformance.
- Privacy, confidentiality and security: Functions support research and other uses by requiring protocols for privacy and security, while not prescribing specific research features.
Practical applications and who uses it
- Health IT vendors use the EHR‑S Functional Model to design product roadmaps, define module capabilities, and produce product feature statements aligned to ISO 10781.
- Hospitals, clinics and health systems adopt Functional Profiles to specify procurement requirements and to compare candidate EHR systems across consistent functional criteria.
- Policy makers and national/regional health IT programs create realm‑specific profiles for public procurement and certification.
- Standards bodies, implementers and integrators map clinical content, interoperability specs and testing artifacts to the EHR‑S FM for traceability and alignment.
- Researchers and research informatics teams benefit from the model’s privacy/security requirements when defining data access and governance, even though research‑specific functions are not exhaustively listed.
Related standards and organizations
- HL7 (developer of the EHR FM work) and ISO/TC 215 (Health Informatics).
- Recommended companion: ISO 13940 - System of Concepts to Support Continuity of Care (for clinical process models).
- Note: EN ISO 10781:2025 is the CEN‑endorsed European version of ISO 10781:2023 and replaces EN ISO 10781:2015.
Keywords: EHR System Functional Model, HL7, ISO 10781, EHR‑S FM, electronic health record, functional profile, interoperability, conformance criteria, health informatics.