EN ISO 10781:2025

SLOVENSKI STANDARD
01-oktober-2025
Nadomešča:
SIST EN ISO 10781:2015
Zdravstvena informatika - Funkcionalni model HL7 za sistem elektronskih
zdravstvenih zapisov, izdaja 2.1 (ERH FM) (ISO 10781:2023)
Health Informatics - HL7 Electronic Health Records-System Functional Model, Release
2.1 (EHR FM) (ISO 10781:2023)
Medizinische Informatik - HL 7 Funktionales Modell für ein elektronisches
Gesundheitsaktensystem, Ausgabe 2.1 (EHRS FM) (ISO 10781:2023)
Informatique de santé - Modèle fonctionnel d'un système de dossier de santé
informatisé, publication 2.1 (EHR FM) (ISO 10781:2023)
Ta slovenski standard je istoveten z: EN ISO 10781:2025
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10781
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 10781:2015
English Version
Health Informatics - HL7 Electronic Health Records-
System Functional Model, Release 2.1 (EHR FM) (ISO
10781:2023)
Informatique de santé - Modèle fonctionnel d'un Medizinische Informatik - HL 7 Funktionales Modell für
système de dossier de santé informatisé, publication ein elektronisches Gesundheitsaktensystem, Ausgabe
2.1 (EHR FM) (ISO 10781:2023) 2.1 (EHRS FM) (ISO 10781:2023)
This European Standard was approved by CEN on 7 August 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10781:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10781:2025) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10781:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 10781:2023 has been approved by CEN as EN ISO 10781:2025 without any modification.

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 10781:2023(E)
ISO 10781:2023(E)
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10781:2023(E)
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
ISO 10781:2023(E)
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 .2
...