SIST EN ISO 10781:2025
(Main)Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2.1 (EHR FM) (ISO 10781:2023)
Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2.1 (EHR FM) (ISO 10781:2023)
The HL7 EHR System Functional Model 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, realms, services and specialties, 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).
The HL7 EHR-S Functional Model defines a standardized model of the functions that may be present in EHR
Systems. From the outset, a clear distinction between the EHR as a singular entity and systems that operate on
the EHR – i.e., EHR Systems is critical. This Standard makes no distinction regarding implementation - the EHRS
described in a Functional Profile may be a single system or a system of systems. Within the normative sections
of the Functional Model, the term “system” is used generically to cover the continuum of implementation options.
This includes “core” healthcare functionality, typically provided by healthcare-specific applications that manage
electronic healthcare information. It also includes associated generic application-level capabilities that are
typically provided by middleware or other infrastructure components. The latter includes interoperability and
integration capabilities such as location discovery and such areas as cross application workflow. Interoperability
is considered both from semantic (clear, consistent and persistent communication of meaning) and technical
(format, syntax and physical connectivity) viewpoints. Further, the functions make no statement about which
technology is used, or about the content of the electronic health record. The specifics of 'how' EHR systems are
developed or implemented is not considered to be within the scope of this model now or in the future. This EHRS
Functional Model does not address or endorse implementations or technology, nor does it include the data
content of the electronic health record.
Finally, the EHR-S Functional Model supports research needs by ensuring that the data available to researchers
follow the required protocols for privacy, confidentiality, and security. The diversity of research needs precludes
the specific listing of functions that are potentially useful for research.
This Functional Model is not:
• a messaging specification
• an implementation specification
• a conformance specification
• an EHR specification
• a conformance or conformance testing metric
• an exercise in creating a definition for an EHR or EHR-S
It is important to note that the EHR-S Function Model does not include a discussion of clinical processes or the
interaction of the healthcare actors. However, ISO 13940 Health Informatics – System of Concepts to Support
Continuity of Care, is an international standard that does outline key principles and processes in the provision of
healthcare. It is recommended that users of the EHR-S FM refer to this standard for clinical processes that EHR
systems support.
This EHR-S Functional Model package includes both Reference and Normative sections. Table 1 explains the
differences between Reference and Normative sections.Each section within this document is clearly labeled "Normative" if it is normative. For example, in section 5
(Overview) section 5.3 is normative. In section 7, Conformance Clause; sections 7.1 through 7.6 are normative.
In the external Annex A, Function List, the Function ID, Function Name, Function Statement, and Conformance
Criteria components are Normative in this Functional Model.
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)
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).
Zdravstvena informatika - Funkcionalni model HL7 za sistem elektronskih zdravstvenih zapisov, izdaja 2.1 (ERH FM) (ISO 10781:2023)
Funkcionalni model HL7 za sistem elektronskih zdravstvenih zapisov zagotavlja referenčni seznam funkcij, ki so lahko prisotne v sistemu elektronskih zdravstvenih zapisov (EHR-S). Seznam funkcij je opisan z vidika uporabnika z namenom, da se omogoči dosledno izražanje funkcionalnosti sistema. Funkcionalni model za sistem elektronskih zdravstvenih zapisov z oblikovanjem funkcionalnih profilov za nastavitve oskrbe, področja, storitve in specialistično zdravljenje omogoča standardiziran opis ter skupno razumevanje iskanih funkcij ali funkcij, ki so na voljo v danem okolju (npr. intenzivna nega, kardiologija, pisarniška praksa v eni državi ali primarno zdravstvo v drugi državi).
Funkcionalni model HL7 za sistem elektronskih zdravstvenih zapisov opredeljuje standardiziran model funkcij, ki so lahko prisotne v sistemih elektronskih zdravstvenih zapisov. Od vsega začetka je ključnega pomena jasno razlikovanje med elektronskimi zdravstvenimi zapisi kot edino entiteto in sistemi, ki delujejo v okviru elektronskih zdravstvenih zapisov, tj. sistemi elektronskih zdravstvenih zapisov. Ta standard ne razlikuje med načini izvajanja – sistem elektronskih zdravstvenih zapisov, opisan v funkcionalnem profilu, je lahko edini sistem ali sistem med sistemi. V normativnih razdelkih funkcionalnega modela se izraz »sistem« uporablja na splošno za poimenovanje neprekinjenih možnosti izvajanja.
To vključuje »ključno« zdravstveno funkcionalnost, ki jo običajno zagotavljajo specifične zdravstvene aplikacije za upravljanje elektronskih zdravstvenih podatkov. Vključuje tudi pridružene splošne zmogljivosti na ravni aplikacij, ki jih običajno zagotavlja vmesna programska oprema ali druge komponente infrastrukture. Slednje vključujejo interoperabilnost in integracijo, na primer prepoznavanje lokacij in področja, kot je potek dela med aplikacijami. Interoperabilnost velja tako s semantičnega (jasen, dosleden in trajen prenos pomena) kot tehničnega (format, sintaksa in fizična povezljivost) vidika. Nadalje funkcije ne določajo, katera tehnologija se uporablja ali kakšna je vsebina elektronskega zdravstvenega zapisa. Podrobnosti o tem, »kako« se razvijajo ali izvajajo sistemi elektronskih zdravstvenih zapisov, ne sodijo v okvir tega modela niti sedaj niti v prihodnosti. Ta funkcionalni model za sistem elektronskih zdravstvenih zapisov ne obravnava ali podpira izvedb ali tehnologije niti ne vključuje vsebine podatkov elektronskega zdravstvenega zapisa.
Po drugi strani funkcionalni model za sistem elektronskih zdravstvenih zapisov podpira raziskovalne potrebe s tem, da so podatki, ki so na voljo raziskovalcem, v skladu z zahtevanimi protokoli zasebnosti, zaupnosti in varnosti. Raznolikost raziskovalnih potreb izključuje poseben seznam funkcij, ki so potencialno koristne za raziskave.
Ta funkcionalni model ni:
• specifikacija sporočanja;
• specifikacija izvedbe;
• specifikacija skladnosti;
• specifikacija elektronskega zdravstvenega zapisa;
• merilo skladnosti ali testiranja skladnosti;
• poskus ustvarjanja definicije za elektronski zdravstveni zapis ali sistem elektronskih zdravstvenih zapisov.
Treba je opozoriti, da funkcionalni model za sistem elektronskih zdravstvenih zapisov ne vključuje razprave o kliničnih postopkih ali interakcije udeležencev zdravstvenega varstva. Vendar pa je standard ISO 13940, Zdravstvena informatika – Sistem pojmov za podporo neprekinjeni oskrbi, mednarodni standard, ki predstavlja ključna načela in postopke pri zagotavljanju zdravstvenega varstva. Priporočljivo je, da uporabniki funkcionalnega modela za sistem elektronskih zdravstvenih zapisov s pomočjo tega standarda poiščejo klinične postopke, ki jih podpirajo sistemi elektronskih zdravstvenih zapisov.
Ta paket funkcionalnega modela za sistem elektronskih zdravstvenih zapisov vključuje tako referenčni kot normativni razdelek. V preglednici 1 so pojasnjene razlike med referenčnim in normativnim razdelkom. Vsak razdelek v tem dokumentu, ki je normativen, je jasno označen kot »normative
General Information
Relations
Standards Content (Sample)
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
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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
...
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