ISO 10781:2023

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

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).

Informatique de santé — Modèle fonctionnel d'un système de dossier de santé informatisé, publication 2.1 (EHR FM)

Ce document fournit une liste de référence de fonctions pouvant figurer dans un système de dossier informatisé de santé (S-DIS). Cette liste de fonctions, décrite du point de vue de l'utilisateur, a pour objet d'exprimer de manière cohérente la fonctionnalité du système. Le présent Modèle fonctionnel de S-DIS, par la création de profils fonctionnels pour des établissements de soins et des aires d'activité, offre une description normalisée et favorise une compréhension commune des fonctions envisagées ou disponibles dans un établissement donné (par exemple, soins intensifs, cardiologie, cabinet dans un pays donné ou soins primaires dans un autre pays).

General Information

• Status: Published
• Publication Date: 07-Nov-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 08-Nov-2023
• Due Date: 24-Feb-2025
• Completion Date: 08-Nov-2023

Relations

• Revises: ISO/HL7 10781:2015 - Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM)
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 10781
First edition
2023-11
Health informatics — HL7 Electronic
Health Record-System Functional
Model, Release 2.1 (EHR FM)
Informatique de santé — Modèle fonctionnel d'un système de dossier
de santé informatisé, publication 2.1 (EHR FM)
Reference number
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
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Published in Switzerland
ii
Contents Page
Foreword . v
0 Introduction . vii
0.1 Notes to Readers . vii
0.2 Changes from Previous Release . vii
0.3 Background . viii
0.3.1 What are Electronic Health Record Systems? . viii
0.3.2 How were the Functions Identified and Developed? . viii
1 Scope . 1
1.1 EHR-S Functional Model Scope . 1
2 Normative References . 2
3 Terms and Definitions . 2
4 Overview and Definition of the Functional Model (Normative) . 3
4.1 Sections of the Function List . 4
4.2 Functional Profiles . 5
4.3 EHR-S Function List Components . 5
4.3.1 Function ID (Normative) . 6
4.3.2 Function Type (Reference) . 6
4.3.3 Function Name (Normative) . 7
4.3.4 Function Statement (Normative) . 7
4.3.5 Description (Reference) . 7
4.3.6 Conformance Criteria (Normative) . 7
5 Anticipated Uses (Reference) . 7
5.1 Development Approach: Functional Profiles . 7
5.1.1 Scenario 1 – Group Practice . 8
5.1.2 Scenario 2 - Hospital . 8
5.1.3 Scenario 3 - IT Vendor . 8
5.2 Examples of Current Use . 8
5.2.1 Functional Profile for Clinical Research based on the EHR-S FM . 8
5.2.2 AHRQ adopts Health Level Seven International (HL7) Child Health Functional Profile
Specification, Release 1 and incorporates key functionalities in the Children’s Electronic
Health Record Format . 9
5.2.3 Linking clinical content descriptions to the EHR-S FM (Reference) . 9
6 Conformance Clause . 10
6.1 Introduction (Reference) . 10
6.2 Scope and Field of Application (Normative) . 10
6.3 Concepts (Normative) . 10
6.3.1 Functional Profiles . 10
6.3.2 Conformance Model . 11
6.3.3 Profile Traceability . 12
6.4 Normative Language (Normative) . 12
6.5 Conformance Criteria (Normative) . 13
6.5.1 Criteria in the Functional Profile . 13
6.5.2 ‘Dependent SHALL’ Criteria . 13
6.5.3 Referencing Other Criteria or Functions . 13
6.6 Functional Model Structure and Extensibility (Normative) . 13
6.6.1 Hierarchical Structure . 13
6.6.2 Naming Convention . 14
6.6.3 Priorities . 14
6.6.4 Extensibility . 15
6.7 Functional Profile Conformance (Normative) . 15
6.7.1 Rules for Functional Domain Profiles . 15
6.7.2 Rules for Creating New Functions in Functional Profiles . 16
6.7.3 Rules for Derived Functional Profiles . 18
6.7.4 Conformance Statement .18
6.7.5 Rules for Functional Companion Profiles .18
6.8 Use Cases and Samples (Reference) .19
6.8.1 Functional Profile Use Cases .19
6.8.2 Sample Functional Domain Profile Conformance Clauses .20
6.8.3 Interpreting and Applying a Conditional ‘SHALL’ (Reference) .20
6.8.4 General Concepts .21
6.8.5 Rationale for ‘Dependent SHALL’ .21
6.8.6 How to Apply the ‘Dependent SHALL’ .22
7 EHR System Conformance Claim via Self-Attestion .23
8 Glossary .24
8.1 Preface (Reference) .24
8.2 Introduction (Normative) .24
8.3 Overview (Reference) .24
8.4 The Action-Verb Structure (Normative) .24
8.4.1 Secure (System) Hierarchy .24
8.4.2 Data Management Hierarchy .25
8.4.3 How Action-Verbs are defined .26
8.4.4 Deprecated Action-Verbs .31
8.5 Guidelines for Use (Reference) .34
8.5.1 General Guidance .34
8.5.2 Constructing Rigorous Conformance Criteria .35
9 Glossary Supplement: Record Lifecycle Events and Descriptions (Normative) .36
9.1 Record Lifecycle Events (See RI.1.1.1) .36
Annex A (normative) Function List .38
Annex B (informative) Glossary of Terms for the EHR-S FM .39
Annex C (informative) Background .67
C.1 What is HL7? .67
C.2 The HL7 Electronic Health Records Work Group .67
Bibliography .68

iv © ISO 2023 – All rights reserved

Foreword
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