oSIST prEN ISO 10781:2023
(Main)Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2.1 (EHR FM) (ISO/DIS 10781:2023)
Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2.1 (EHR FM) (ISO/DIS 10781:2023)
ISO 10781:2015 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)
L'ISO 10781:2015 le Modèle fonctionnel d'un système de dossier informatisé de santé de l'HL7 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 10781:2023
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
oSIST prEN ISO 10781:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 10781:2023
---------------------- Page: 2 ----------------------
oSIST prEN ISO 10781:2023
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
---------------------- Page: 3 ----------------------
oSIST prEN ISO 10781:2023
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
COPYRIGHT PROTECTED DOCUMENT
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: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
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
© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
---------------------- Page: 4 ----------------------
oSIST prEN ISO 10781:2023
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 2023 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 10781:2023
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 .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) .24
9.1 Record Lifecycle Events (See RI.1.1.1) .36
Annex A (normative) Function List .38
Annex B (informative) Glossary of Terms for 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
Annex D Bibliography .68
iv © ISO 2023 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 10781:2023
ISO/DIS 10781:2023(E)
Foreword [from ISO template]
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10781 was prepared by Technical Committee ISO/TC 215, Health Informatics, Working Group 1 on Models
and Frameworks.
© ISO 2023 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 10781:2023
ISO/DIS 10781:2023(E)
0 Introduction
0.1 Notes to Readers
EHR System Functional Model Release 2.1 is based on a series of predecessors, starting in 2004 with the
release of the first consensus Draft Standard, followed in 2007 by Release 1, followed in 2009 with Release 1.1
(jointly balloted with ISO TC215 and CEN TC251), followed in 2014 with Release 2.0 (jointly balloted with ISO
TC215, CEN TC251, DICOM, SNOMED (IHTSDO), CDISC and GS1). HL7 also published Release 2.01 as an
unballoted errata version in 2017.
0.2 Changes from Previous Release
The HL7 EHR-System Functional Model Release 2.1 had its first normative ballot in December 2019. Following
are key changes from Release 2.0:
• Includes updates from HL7 errata Release 2.01;
• Record Infrastructure Section is updated to include three new Record Lifecycle Events: verify, encrypt
and decrypt. There are now a total of 27 Record Lifecycle Events, describing how an Electronic Health
Record System manages health record entries their lifespan, from first point of entry
origination/retention to last point of entry deletion or destruction. The 27 Record Lifecycle Events match
those specified in ISO 21089-2018, Health Informatics – Trusted end-to-end information flow and HL7
Fast Health Interoperable Resources (FHIR) Record Lifecycle Event Implementation Guide, published
a spart of FHIR Core STU-3 (March 2017) and now part of FHIR Core R4 (in ballot, September 2018).
• The 27 Record Lifeycle Event definitions/descriptions are updated according to agreements of the HL7
Vocabulary Alignment project (in joint collaboration of the HL7 EHR and Security Work Groups). The
Glossary Section also includes those definitions/descriptions.
• The Conformance Clause is updated to include a definition/description of a new type of EHR-S FM
Functional Profile (FP): Derived Companion FP.
• Trust Infrastructure is updated to include functions and conformance criteria to support ISO/HL7
Detailed Clinical Models (DCMs).
vi © ISO 2023 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 10781:2023
ISO/DIS 10781:2023(E)
0.3 Background
0.3.1 What are Electronic Health Record Systems?
The effective use of information technology is a key focal point for improving healthcare in terms of patient safety,
quality outcomes, and economic efficiency. A series of reports from the U.S. Institute of Medicine (IOM)
identifies a crisis of "system" failure and calls for "system" transformation enabled by the use of information
technology. Such a change is possible by "an infrastructure that permits fully interconnected, universal, secure
network of systems that can deliver information for patient care anytime, anywhere.
In developing this EHR-S Functional Model, HL7 relied on three well-accepted definitions: two provided by the
U.S. Institute of Medicine and one developed by the European Committee for Standardization/ Comité Européen
de Normalisation (CEN). This Functional Model leverages these existing EHR-S definitions and does not
attempt to create a redundant definition of an EHR-S.
0.3.2 How were the Functions Identified and Developed?
To achieve healthcare community consensus at the outset, the functions are described at a conceptual level,
providing a robust foundation for a more detailed work. Functions were included if considered essential in at
least one care setting. Written in user-oriented language, the document is intended for a broad readership.
Functional Granularity is a term used to describe the level of abstraction at which a function is represented.
Functions that are commonly grouped together in practice or by major systems have been consolidated where
appropriate; functions requiring extra or separate language or involving different workflows have been kept
separate where appropriate. For example, decision support is maintained as a separate section, but mapped to
other key sections, to indicate the "smart" function behind an action. All of the functions could be expanded into
more granular elements but a balance between a usable document and an unwieldy list of functions has been
agreed upon. The goal of determining an appropriate level of functional granularity at this time is to present
functions that can be easily selected and used by readers of this standard, but that are not so abstract that
readers would need to create a large number of additional functions within each function.
Although the determination of functional granularity is a relatively subjective task, systematic evaluation of each
function by diverse groups of industry professionals has resulted in a level of granularity appropriate for this
EHR-S Functional Model. Every attempt has been made to provide supporting information in the functional
descriptions to illustrate the more granular aspects of functions that may have been consolidated for usability
purposes.
Keeping with the intent of this EHR-S Functional Model to be independent with regard to technology or
implementation strategy, no specific technology has been included in the functions, but may be used in the
examples to illustrate the functions. Inclusion of specific technologies in the examples does not endorse or
support the use of those technologies as implementation strategies.
The EHR-S Functional Model and specific functions have been widely reviewed by healthcare providers,
vendors, public health agencies, regulatory and accreditation bodies, professional societies, trade associations,
researchers and other stakeholders. This Standard reflects input from all these reviewers.
© ISO 2023 – All rights reserved vii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 10781:2023
---------------------- Page: 10 ----------------------
oSIST prEN ISO 10781:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 10781:2023(E)
Health Informatics — HL7 Electronic Health Record-System
Functional Model, Release 2 (EHR FM)
1 Scope
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).
1.1 EHR-S Functional Model Scope
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 EHR-
S 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 EHR-
S 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.
Status Description
Reference Content of the EHR-S Functional Model Package that contains information which clarifies
concepts or otherwise provides additional information to aid understanding and comprehension.
Reference material is not balloted as part of the standard.
Normative Content that is part of the EHR-S Functional Model which HL7 committee members and
interested industry participants have formally reviewed and balloted following the HL7
© ISO 2023 – All rights reserved 1
---------------------- Page: 11 ----------------------
oSIST prEN ISO 10781:2023
ISO/DIS 10781:2023(E)
procedures for Balloting Normative Documents. This HL7 developed Functional Model
document has been successfully balloted as a normative standard by the HL7 organization.
Table 1: Normative Status Types
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.
2 Normative References
The following referenced documents are indispensable for the application of this document.
ASTM E1769:1995, Standard guide for properties of electronic health records and record systems
HL7 Fast Health Interoperable Resources (FHIR), Release 4, January 2019
HL7 FHIR Record Lifecycle Event Implementation Guide, part of FHIR Core Release 4, January 2019
ISO 13606:2018, Health Informatics – Electronic health record communication, Parts 1-5
ISO 13940:2015, Health Informatics – System of concepts to support continuity of care
ISO 16527:2017, Health Informatics – HL7 personal health record system functional model, Release 1
ISO 20514:2005, Health Informatics – Electronic health record – definition, scope and context
ISO 21089:2018, Health Informatics – Trusted End-to-End Information Flows
3 Terms and Definitions
3.1
access control
a means of ensuring that the resources of a data processing system can be accessed only by authorized entities
in authorized ways
3.2
base functional profile
an existing domain or companion functional profile from which new f
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.