ISO 10781:2023 PDF

Name: ISO 10781:2023 — Health informatics — HL7 Electronic Health Record-System Functional Model, Release 2.1 (EHR FM)
SKU: ISO 10781:2023
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Health informatics — HL7 Electronic Health Record-System Functional Model, Release 2.1 (EHR FM)

Название (английский):

ISO 10781:2023

Health informatics — HL7 Electronic Health Record-System Functional Model, Release 2.1 (EHR FM)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 68
Дата публикации:: 8 ноября 2023 г.
Издание:: ISO IS 10781 edition 1 version 1
ICS:: 35.240.80

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Описание (английский):

This document provides a reference list of functions that may be present in an Electronic Health Record System (EHR-S). The function list is described from a user perspective with the intent to enable consistent expression of system functionality. This EHR-S Functional Model, through the creation of Functional Profiles for care settings and realms, enables a standardized description and common understanding of functions sought or available in a given setting (e.g. intensive care, cardiology, office practice in one country or primary care in another country).

Abstract

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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.

ISO 10781:2023 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

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