prEN ISO 10781

Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2.1 (EHR FM) (ISO/DIS 10781:2023)

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).

Medizinische Informatik - HL 7 Funktionales Modell für ein elektronisches Gesundheitsaktensystem, Ausgabe 2.1 (EHRS FM) (ISO/DIS 10781:2023)

Informatique de santé - Modèle fonctionnel d'un système de dossier de santé informatisé, publication 2.1 (EHR FM) (ISO/DIS 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/DIS 10781:2023)

General Information

• Status: Not Published
• Publication Date: 08-Oct-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 6055 - CEN Ratification completed (DOR) - Publishing
• Start Date: 07-Aug-2023
• Completion Date: 07-Aug-2023
• Ref Project: oSIST prEN ISO 10781:2023 - Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2.1 (EHR FM) (ISO/DIS 10781:2023)

Relations

• Revises: EN ISO 10781:2015 - Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2023
Nadomešča:
SIST EN ISO 10781:2015
Zdravstvena informatika - Funkcionalni model HL7 za sistem elektronskih
zdravstvenih zapisov, izdaja 2.1 (ERH FM) (ISO/DIS 10781:2023)
Health Informatics - HL7 Electronic Health Records-System Functional Model, Release
2.1 (EHR FM) (ISO/DIS 10781:2023)
Medizinische Informatik - HL 7 Funktionales Modell für ein elektronisches
Gesundheitsaktensystem, Ausgabe 2.1 (EHRS FM) (ISO/DIS 10781:2023)
Informatique de santé - Modèle fonctionnel d'un système de dossier de santé
informatisé, publication 2.1 (EHR FM) (ISO/DIS 10781:2023)
Ta slovenski standard je istoveten z: prEN ISO 10781
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.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 10781
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-13 2023-07-06
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)
ICS: 35.240.80
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10781:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 10781:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10781
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:

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)
ICS: 35.240.80
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 10781:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 10781:2023(E)
Contents Page
0 Introduction . vi
0.1 Notes to Readers . vi
0.2 Changes from Previous Release . vi
0.3 Background . vii
0.3.1 What are Electronic Health Record Systems? . vii
0.3.2 How were the Functions Identified and Developed? . vii
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
ISO/DIS 10781:2023(E)
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
7.1 The Name and Version of the standard that the software product is compliant with .23
7.2 A full listing of the conformance criteria that the software product is compliant with .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) Category .24
8.4.2 Data Management Category .25
8.4.3 How Action-Verbs are defined .26
8.4.4 Deprecated Verbs .
...