SIST EN ISO 10781:2015
(Main)Electronic health record-system functional model (ISO 10781:2015)
Electronic health record-system functional model (ISO 10781:2015)
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 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). 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. Section 1.1.3 describes the basis and foundation for the HL7 definition of an EHR System. Notably, the EHR-S Functional Model does not address whether the EHR-S is a system-of-systems or a single system providing the functions required by the users. This International 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.
The EHR-S Functional Model is not sufficient to provide a longitudinal health record; however, it will contribute to its development. The information exchange enabled by the EHR-S supports the population of clinical documents, event summaries, minimum data sets, claims attachments, and in the future will enable a longitudinal health record. Additionally, 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 is an international standard that does outline key principles and processes in the provision of healthcare. Users of the EHR-S FM can refer to ISO 13940 for clinical processes that EHR systems support. This EHR-S Functional Model package includes both Reference and Normative sections.
Funktionales Modell für ein elektronisches Gesundheitsaktensystem (ISO 10781:2015)
Modèle fonctionnel d'un système de dossier informatisé de santé (ISO 10781:2015)
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).
Funkcionalni model za sistem elektronskih zdravstvenih zapisov (ISO 10781:2015)
Funkcionalni model sistema HL7 EHR zagotavlja referenčni seznam funkcij, ki so lahko prisotne v
sistemu elektronskih zdravstvenih kartonov (EHR-S). Seznam funkcij je opisan z vidika uporabnika
z namenom, da se omogoči dosledno izražanje funkcionalnosti sistema. Funkcionalni model EHR-S z oblikovanjem funkcionalnih profilov za nastavitve nege in področij omogoča standardiziran opis in skupno razumevanje iskanih funkcij ali funkcij, ki so na voljo v danem okolju (npr intenzivni negi, kardiologiji, pisarniški praksi v eni državi ali primarnem zdravstvu v drugi državi). Funkcionalni model sistema HL7 EHR zagotavlja standardiziran model funkcij, ki so lahko prisotne v sistemih EHR. Od vsega začetka je ključnega pomena jasno razlikovanje med EHR kot edino entiteto in sistemi, ki delujejo v EHR, tj. sistemi EHR. Razdelek 1.1.3 opisuje podlago in temelj za opredelitev modela HL7 sistema EHR. Funkcionalni model EHR-S ne obravnava vprašanja, ali je EHR-S sistem med sistemi ali edini sistem, ki omogoča funkcije, ki jih zahtevajo uporabniki. Ta mednarodni standard ne razlikuje med načini izvajanja; EHR-S, opisan v funkcionalnem profilu, je lahko edini sistem ali sistem med sistemi. V normativnih razdelkih funkcijskega 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 EHR, ne sodijo v okvir tega modela niti sedaj niti v prihodnosti. Funkcionalni model EHR-S ne obravnava ali podpira izvedb ali tehnologije niti ne vključuje vsebine podatkov elektronskega zdravstvenega zapisa.
Po drugi strani funkcionalni model EHR-S 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 EHR;
– merilo skladnosti ali testiranja skladnosti;
– poskus ustvarjanja definicije za EHR ali EHR-S.
Funkcionalni model EHR-S ne zadostuje za zagotavljanje longitudinalnega zdravstvenega zapisa, a bo prispeval k njegovemu razvoju. Izmenjava informacij, ki jo omogoča EHR-S, podpira pripravo kliničnih dokumentov, povzetkov dogodkov, minimalnih podatkovnih nizov, prilog zahtevkov, v prihodnosti pa bo omogočala tudi longitudinalni zdravstveni zapis. Poleg tega je treba opozoriti, da funkcionalni model EHR-S ne vključuje razprave o kliničnih postopkih ali interakcije udeležencev zdravstvenega varstva. Vendar pa je ISO 13940 mednarodni standard, ki predstavlja ključna načela in postopke pri zagotavljanju zdravstvenega varstva. Uporabniki funkcionalnega modela EHR-S lahko s pomočjo standarda ISO 13940 poiščejo klinične postopke, ki jih podpirajo sistemi EHR. Ta paket funkcionalnega modela EHR-S vključuje tako referenčni kot normativni razdelek.
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SLOVENSKI STANDARD
SIST EN ISO 10781:2015
01-december-2015
Nadomešča:
SIST EN ISO 10781:2010
Funkcionalni model za sistem elektronskih zdravstvenih zapisov (ISO 10781:2015)
Electronic health record-system functional model (ISO 10781:2015)
Funktionales Modell für ein elektronisches Gesundheitsaktensystem (ISO 10781:2015)
Modèle fonctionnel d'un système de dossier informatisé de santé (ISO 10781:2015)
Ta slovenski standard je istoveten z: EN ISO 10781:2015
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 10781:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10781:2015
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SIST EN ISO 10781:2015
EUROPEAN STANDARD
EN ISO 10781
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 35.240.80 Supersedes EN ISO 10781:2009
English Version
Health Informatics - HL7 Electronic Health Records-System
Functional Model, Release 2 (EHR FM) (ISO 10781:2015)
Informatique de santé - Modèle fonctionnel d'un système de Funktionales Modell für ein elektronisches
dossier de santé électronique, publication 2 (EHR FM) (ISO Gesundheitsaktensystem (EHRS FM), Ausgabe 2 (ISO
10781:2015) 10781:2015)
This European Standard was approved by CEN on 30 April 2015.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10781:2015 E
worldwide for CEN national Members.
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SIST EN ISO 10781:2015
EN ISO 10781:2015 (E)
Contents Page
European foreword .3
2
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SIST EN ISO 10781:2015
EN ISO 10781:2015 (E)
European foreword
This document (EN ISO 10781:2015) 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 DIN.
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 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10781:2009.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10781:2015 has been approved by CEN as EN ISO 10781:2015 without any modification.
3
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SIST EN ISO 10781:2015
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SIST EN ISO 10781:2015
INTERNATIONAL ISO
STANDARD 10781
Second edition
2015-08-01
Health Informatics — HL7 Electronic
Health Records-System Functional
Model, Release 2 (EHR FM)
Informatique de santé — Modèle fonctionnel d’un système de dossier
de santé électronique, publication 2 (EHR FM)
Reference number
ISO 10781:2015(E)
©
ISO 2015
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 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 . 6
4.3.1 Function ID (Normative) . 7
4.3.2 Function Type (Reference) . 7
4.3.3 Function Name (Normative) . 7
4.3.4 Function Statement (Normative) . 8
4.3.5 Description (Reference) . 8
4.3.6 Conformance Criteria (Normative) . 8
5 Anticipated Uses (Reference) . 8
5.1 Anticipated Development Approach: Functional Profiles . 8
5.1.1 Scenario 1 – Group Practice . 9
5.1.2 Scenario 2 - Hospital . . 9
5.1.3 Scenario 3 - IT Vendor . 9
5.2 Examples of Current Use .10
5.2.1 Functional Profile for Clinical Research based on the EHR-S FM .10
5.2.2 AHRQ Announces Children’s Electronic Health Record Format .10
5.2.3 Linking clinical content descriptions to the EHR-S FM (Reference) .11
6 Conformance Clause .11
6.1 Introduction (Reference) .11
6.2 Scope and Field of Application (Normative) .11
6.3 Concepts (Normative) .12
6.3.1 Functional Profiles .12
6.3.2 Conformance Model .13
6.3.3 Profile Traceability .13
6.4 Normative Language (Normative) .14
6.5 Conformance Criteria (Normative) .14
6.5.1 Criteria in the Functional Profile .14
6.5.2 ‘Dependent SHALL’ Criteria .14
6.5.3 Referencing Other Criteria or Functions .15
6.6 Functional Model Structure and Extensibility (Normative) .15
6.6.1 Hierarchical Structure .15
6.6.2 Naming Convention .17
6.6.3 Priorities .17
6.6.4 Extensibility .17
6.7 Functional Profile Conformance (Normative) .17
6.7.1 Rules for Functional Domain Profiles .17
6.7.2 Rules for Creating New Functions in Functional Profiles .19
6.7.3 Rules for Derived Functional Profiles .21
6.7.4 Conformance Statement .22
6.7.5 Rules for Functional Companion Profiles .22
6.8 Use Cases and Samples (Reference) .23
6.8.1 Functional Profile Use Cases .23
6.8.2 Sample Functional Domain Profile Conformance Clauses .24
6.8.3 Interpreting and Applying a Conditional ‘SHALL’ (Reference) .25
6.8.4 General Concepts .25
© ISO 2015 – All rights reserved iii
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
6.8.5 Rationale for ‘Dependent SHALL’ .26
6.8.6 How to Apply the ‘Dependent SHALL’ .26
7 Glossary .28
7.1 Preface (Reference) .28
7.2 Introduction (Normative) .28
7.3 Overview (Reference) .28
7.3.1 Known Issues (Reference) .29
7.4 The Action-Verb Structure (Normative) .29
7.4.1 Secure (System) Category .29
7.4.2 Data Management Category .30
7.4.3 How Action-Verbs are defined .30
7.4.4 Deprecated Verbs .31
7.5 Guidelines for Use (Reference) .31
7.5.1 General Guidance.31
7.5.2 Constructing Rigorous Conformance Criteria .32
7.5.3 Examples of Rewording Conformance Criteria using the Proper Action-Verbs .33
Annex A (normative) Function List .35
Annex B (informative) Glossary of Terms for EHR-S FM .36
Annex C (informative) History of the Action-Verb Hierarchy .60
Annex D (informative) Contributing Organizations .63
Annex E (informative) Background .64
Annex F (informative) Acknowledgements .66
Annex G (informative) Other Offerings and Requests from the EHR Work Group .68
Bibliography .69
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Foreword
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/HL7 10781 was prepared by Technical Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO/HL7 10781:2009), which has been
technically revised.
© ISO 2015 – All rights reserved v
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Introduction
Information for readers
EHR System Functional Model Release 2.0 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, then in 2009 with
Release 1.1, jointly balloted with ISO/TC 215 and CEN/TC 251. Release 2.0 reflects many changes,
including ballot comments that had been made on past ballots and where the HL7 EHR Work Group
had committed to bringing consideration of requested changes forward. It also includes comments that
were considered for future use from the ISO ballot of 2009 as well as considerations of the Comment
Only ballot that was circulated in May 2011.
Other inclusions were made as a result of the multiple EHR System Functional Profiles that have been
written on Functional Model Releases 1 and 1.1. There was great learning in those various domain as
well as companion profiles. The EHR-S FM also incorporated two other Draft Standards for Trial Use:
HL7 EHR Lifecycle Model and HL7 EHR Interoperability Model.
Changes from previous Release
The HL7 EHR-System Functional Model Release 2 had its first normative ballot in May 2012. The key
changes as a result of the first normative ballot included the following.
• Moved the normative parts of the Glossary into the Conformance clause section as use of glossary
consistently is key to ease in reading and understanding the model.
• Improved consistency in representation of Headers, Functions and Conformance Criteria
throughout the model.
• Updated the conformance clause for ease of reading especially as it related to the different types of
profiles: domain profiles and companion profiles.
• Provided clarity for functional description and related conformance criteria.
• Updated the content to be more current.
To see all of the comments and reconciliation of the Normative 1 ballot, please see the HL7 Ballot
Website for the ballot cycle of May 2012.
Background
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 US 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.”(HHS Goals in “Pursuing HL7 EHR Functional Standard” in Memorandum to
HIMSS from C. Clancy and W. Raub co-chairs of HHS Council on the Application of Health Information
Technology, dated November 12, 2003.) A critical foundational component for resolving these system
and infrastructure issues is the Electronic Health Record System (EHR-S).
In developing this EHR-S Functional Model, HL7 relied on three well-accepted definitions: two provided
by the US. Institute of Medicine and one developed by the European Committee for Standardization/
Comité Européen de Normalization (CEN). This Functional Model leverages these existing EHR-S
definitions and does not attempt to create a redundant definition of an EHR-S.
vi © ISO 2015 – All rights reserved
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Existing EHR System Definitions
The IOM’s 1991 report, The Computer-Based Patient Record: An Essential Technology, and updated
in 1997 (Dick, R.S, Steen, E.B., and Detmer, D.E. (Editors), National Academy Press: Washington, DC)
defined an EHR System as follows.
• The set of components that form the mechanism by which patient records are created, used, stored,
and retrieved.
• A patient record system is usually located within a health care provider setting. It includes people,
data, rules and procedures, processing and storage devices (e.g. paper and pen, hardware and
software), and communication and support facilities.
• The 2003 IOM Letter Report, Key Capabilities of an Electronic Health Record System, defined the
EHR System as including:
• Longitudinal collection of electronic health information for and about persons, where health
information is defined as information pertaining to the health of an individual or health care
provided to an individual.
• Immediate electronic access to person- and population-level information by authorized, and only
authorized, users.
• Provision of knowledge and decision-support that enhance the quality, safety, and efficiency of
patient care.
• Support of efficient processes for health care delivery.
The 2003 ISO/TS 18308 references the IOM 1991 definition above as well as ISO 13606:
• A system for recording, retrieving and manipulating information in electronic health records.
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.
© ISO 2015 – All rights reserved vii
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Drafts of the EHR-S Functional Model and of specific functions have been widely reviewed by
healthcare providers, vendors, and other stakeholders. This proposed standard reflects input from all
these reviewers.
viii © ISO 2015 – All rights reserved
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SIST EN ISO 10781:2015
INTERNATIONAL STANDARD ISO 10781:2015(E)
Health Informatics — HL7 Electronic Health Records-
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 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).
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. Section 1.1.3 describes the basis and foundation
for the HL7 definition of an EHR System. Notably, the EHR-S Functional Model does not address whether
the EHR-S is a system-of-systems or a single system providing the functions required by the users.
This International 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
appl
...
SLOVENSKI STANDARD
SIST EN ISO 10781:2015
01-december-2015
1DGRPHãþD
SIST EN ISO 10781:2010
)XQNFLRQDOQLPRGHO]DVLVWHPHOHNWURQVNLK]DSLVRYQDSRGURþMX]GUDYVWYD ,62
Electronic health record-system functional model (ISO 10781:2015)
Funktionales Modell für ein elektronisches Gesundheitsaktensystem (ISO 10781:2015)
Modèle fonctionnel d'un système de dossier informatisé de santé (ISO 10781:2015)
Ta slovenski standard je istoveten z: EN ISO 10781:2015
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 10781:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 10781:2015
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SIST EN ISO 10781:2015
EUROPEAN STANDARD
EN ISO 10781
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 35.240.80 Supersedes EN ISO 10781:2009
English Version
Health Informatics - HL7 Electronic Health Records-System
Functional Model, Release 2 (EHR FM) (ISO 10781:2015)
Informatique de santé - Modèle fonctionnel d'un système de Funktionales Modell für ein elektronisches
dossier de santé électronique, publication 2 (EHR FM) (ISO Gesundheitsaktensystem (EHRS FM), Ausgabe 2 (ISO
10781:2015) 10781:2015)
This European Standard was approved by CEN on 30 April 2015.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10781:2015 E
worldwide for CEN national Members.
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SIST EN ISO 10781:2015
EN ISO 10781:2015 (E)
Contents Page
European foreword .3
2
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SIST EN ISO 10781:2015
EN ISO 10781:2015 (E)
European foreword
This document (EN ISO 10781:2015) 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 DIN.
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 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10781:2009.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10781:2015 has been approved by CEN as EN ISO 10781:2015 without any modification.
3
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SIST EN ISO 10781:2015
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SIST EN ISO 10781:2015
INTERNATIONAL ISO
STANDARD 10781
Second edition
2015-08-01
Health Informatics — HL7 Electronic
Health Records-System Functional
Model, Release 2 (EHR FM)
Informatique de santé — Modèle fonctionnel d’un système de dossier
de santé électronique, publication 2 (EHR FM)
Reference number
ISO 10781:2015(E)
©
ISO 2015
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 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 . 6
4.3.1 Function ID (Normative) . 7
4.3.2 Function Type (Reference) . 7
4.3.3 Function Name (Normative) . 7
4.3.4 Function Statement (Normative) . 8
4.3.5 Description (Reference) . 8
4.3.6 Conformance Criteria (Normative) . 8
5 Anticipated Uses (Reference) . 8
5.1 Anticipated Development Approach: Functional Profiles . 8
5.1.1 Scenario 1 – Group Practice . 9
5.1.2 Scenario 2 - Hospital . . 9
5.1.3 Scenario 3 - IT Vendor . 9
5.2 Examples of Current Use .10
5.2.1 Functional Profile for Clinical Research based on the EHR-S FM .10
5.2.2 AHRQ Announces Children’s Electronic Health Record Format .10
5.2.3 Linking clinical content descriptions to the EHR-S FM (Reference) .11
6 Conformance Clause .11
6.1 Introduction (Reference) .11
6.2 Scope and Field of Application (Normative) .11
6.3 Concepts (Normative) .12
6.3.1 Functional Profiles .12
6.3.2 Conformance Model .13
6.3.3 Profile Traceability .13
6.4 Normative Language (Normative) .14
6.5 Conformance Criteria (Normative) .14
6.5.1 Criteria in the Functional Profile .14
6.5.2 ‘Dependent SHALL’ Criteria .14
6.5.3 Referencing Other Criteria or Functions .15
6.6 Functional Model Structure and Extensibility (Normative) .15
6.6.1 Hierarchical Structure .15
6.6.2 Naming Convention .17
6.6.3 Priorities .17
6.6.4 Extensibility .17
6.7 Functional Profile Conformance (Normative) .17
6.7.1 Rules for Functional Domain Profiles .17
6.7.2 Rules for Creating New Functions in Functional Profiles .19
6.7.3 Rules for Derived Functional Profiles .21
6.7.4 Conformance Statement .22
6.7.5 Rules for Functional Companion Profiles .22
6.8 Use Cases and Samples (Reference) .23
6.8.1 Functional Profile Use Cases .23
6.8.2 Sample Functional Domain Profile Conformance Clauses .24
6.8.3 Interpreting and Applying a Conditional ‘SHALL’ (Reference) .25
6.8.4 General Concepts .25
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
6.8.5 Rationale for ‘Dependent SHALL’ .26
6.8.6 How to Apply the ‘Dependent SHALL’ .26
7 Glossary .28
7.1 Preface (Reference) .28
7.2 Introduction (Normative) .28
7.3 Overview (Reference) .28
7.3.1 Known Issues (Reference) .29
7.4 The Action-Verb Structure (Normative) .29
7.4.1 Secure (System) Category .29
7.4.2 Data Management Category .30
7.4.3 How Action-Verbs are defined .30
7.4.4 Deprecated Verbs .31
7.5 Guidelines for Use (Reference) .31
7.5.1 General Guidance.31
7.5.2 Constructing Rigorous Conformance Criteria .32
7.5.3 Examples of Rewording Conformance Criteria using the Proper Action-Verbs .33
Annex A (normative) Function List .35
Annex B (informative) Glossary of Terms for EHR-S FM .36
Annex C (informative) History of the Action-Verb Hierarchy .60
Annex D (informative) Contributing Organizations .63
Annex E (informative) Background .64
Annex F (informative) Acknowledgements .66
Annex G (informative) Other Offerings and Requests from the EHR Work Group .68
Bibliography .69
iv © ISO 2015 – All rights reserved
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Foreword
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/HL7 10781 was prepared by Technical Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO/HL7 10781:2009), which has been
technically revised.
© ISO 2015 – All rights reserved v
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Introduction
Information for readers
EHR System Functional Model Release 2.0 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, then in 2009 with
Release 1.1, jointly balloted with ISO/TC 215 and CEN/TC 251. Release 2.0 reflects many changes,
including ballot comments that had been made on past ballots and where the HL7 EHR Work Group
had committed to bringing consideration of requested changes forward. It also includes comments that
were considered for future use from the ISO ballot of 2009 as well as considerations of the Comment
Only ballot that was circulated in May 2011.
Other inclusions were made as a result of the multiple EHR System Functional Profiles that have been
written on Functional Model Releases 1 and 1.1. There was great learning in those various domain as
well as companion profiles. The EHR-S FM also incorporated two other Draft Standards for Trial Use:
HL7 EHR Lifecycle Model and HL7 EHR Interoperability Model.
Changes from previous Release
The HL7 EHR-System Functional Model Release 2 had its first normative ballot in May 2012. The key
changes as a result of the first normative ballot included the following.
• Moved the normative parts of the Glossary into the Conformance clause section as use of glossary
consistently is key to ease in reading and understanding the model.
• Improved consistency in representation of Headers, Functions and Conformance Criteria
throughout the model.
• Updated the conformance clause for ease of reading especially as it related to the different types of
profiles: domain profiles and companion profiles.
• Provided clarity for functional description and related conformance criteria.
• Updated the content to be more current.
To see all of the comments and reconciliation of the Normative 1 ballot, please see the HL7 Ballot
Website for the ballot cycle of May 2012.
Background
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 US 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.”(HHS Goals in “Pursuing HL7 EHR Functional Standard” in Memorandum to
HIMSS from C. Clancy and W. Raub co-chairs of HHS Council on the Application of Health Information
Technology, dated November 12, 2003.) A critical foundational component for resolving these system
and infrastructure issues is the Electronic Health Record System (EHR-S).
In developing this EHR-S Functional Model, HL7 relied on three well-accepted definitions: two provided
by the US. Institute of Medicine and one developed by the European Committee for Standardization/
Comité Européen de Normalization (CEN). This Functional Model leverages these existing EHR-S
definitions and does not attempt to create a redundant definition of an EHR-S.
vi © ISO 2015 – All rights reserved
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Existing EHR System Definitions
The IOM’s 1991 report, The Computer-Based Patient Record: An Essential Technology, and updated
in 1997 (Dick, R.S, Steen, E.B., and Detmer, D.E. (Editors), National Academy Press: Washington, DC)
defined an EHR System as follows.
• The set of components that form the mechanism by which patient records are created, used, stored,
and retrieved.
• A patient record system is usually located within a health care provider setting. It includes people,
data, rules and procedures, processing and storage devices (e.g. paper and pen, hardware and
software), and communication and support facilities.
• The 2003 IOM Letter Report, Key Capabilities of an Electronic Health Record System, defined the
EHR System as including:
• Longitudinal collection of electronic health information for and about persons, where health
information is defined as information pertaining to the health of an individual or health care
provided to an individual.
• Immediate electronic access to person- and population-level information by authorized, and only
authorized, users.
• Provision of knowledge and decision-support that enhance the quality, safety, and efficiency of
patient care.
• Support of efficient processes for health care delivery.
The 2003 ISO/TS 18308 references the IOM 1991 definition above as well as ISO 13606:
• A system for recording, retrieving and manipulating information in electronic health records.
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.
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SIST EN ISO 10781:2015
ISO 10781:2015(E)
Drafts of the EHR-S Functional Model and of specific functions have been widely reviewed by
healthcare providers, vendors, and other stakeholders. This proposed standard reflects input from all
these reviewers.
viii © ISO 2015 – All rights reserved
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SIST EN ISO 10781:2015
INTERNATIONAL STANDARD ISO 10781:2015(E)
Health Informatics — HL7 Electronic Health Records-
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 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).
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. Section 1.1.3 describes the basis and foundation
for the HL7 definition of an EHR System. Notably, the EHR-S Functional Model does not address whether
the EHR-S is a system-of-systems or a single system providing the functions required by the users.
This International 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 p
...
SLOVENSKI STANDARD
oSIST prEN ISO 10781:2012
01-julij-2012
)XQNFLRQDOQLPRGHO]DVLVWHPHOHNWURQVNLK]DSLVRYQDSRGURþMX]GUDYVWYD
,62',6
Electronic health record-system functional model (ISO/DIS 10781:2012)
Funktionales Modell für ein elektronisches Gesundheitsaktensystem (ISO/DIS
10781:2012)
Modèle fonctionnel d'un système de dossier informatisé de santé (ISO/DIS 10781:2012)
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 10781:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 10781:2012
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oSIST prEN ISO 10781:2012
EUROPEAN STANDARD
DRAFT
prEN ISO 10781
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2012
ICS 35.240.80 Will supersede EN ISO 10781:2009
English Version
Electronic health record-system functional model (ISO/DIS
10781:2012)
Modèle fonctionnel d'un système de dossier informatisé de Funktionales Modell für ein elektronisches
santé (ISO/DIS 10781:2012) Gesundheitsaktensystem (ISO/DIS 10781:2012)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 251.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 10781:2012: E
worldwide for CEN national Members.
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oSIST prEN ISO 10781:2012
prEN ISO 10781:2012 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 10781:2012
prEN ISO 10781:2012 (E)
Foreword
This document (prEN ISO 10781:2012) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 10781:2009.
Endorsement notice
The text of ISO/DIS 10781:2012 has been approved by CEN as a prEN ISO 10781:2012 without any
modification.
3
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oSIST prEN ISO 10781:2012
DRAFT INTERNATIONAL STANDARD ISO/HL7 DIS 10781
ISO/TC 215 Secretariat: ANSI
Voting begins on Voting terminates on
2012-04-26 2012-09-26
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Electronic Health Record-System Functional Model,
Release 2.0 (EHR FM)
Modèle fonctionnel d'un système de dossier informatisé de santé (MF S-DIS), publication 2.0
[Révision de la première édition (ISO/HL7 10781:2009)]
ICS 35.240.80
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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 NATIONAL REGULATIONS.
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.
© International Organization for Standardization, 2012
© Health Level Seven (HL7) Standards, 2012
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oSIST prEN ISO 10781:2012
ISO/HL7 DIS 10781
Copyright notice
All rights reserved. Unless otherwise specified, 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 or HL7 at the respective address below:
ISO copyright office Health Level Seven, Inc.
Case postale 56 • CH-1211 Geneva 20 Standards Publishing Department
Tel. + 41 22 749 01 11 3300 Washtenaw Avenue, Suite 227
Fax + 41 22 749 09 47 Ann Arbor, MI 48104
E-mail copyright@iso.org USA
Web www.iso.org E-mail hq@hl7.org
Web www.hl7.org
Reproduction or use may be subject to royalty payments or licensing agreements.
Violators may be prosecuted.
Published in Switzerland.
ii © ISO/HL7 2012 – All rights reserved
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oSIST prEN ISO 10781:2012
ISO/HL7 DIS 10781
Foreword
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.
A pilot project between ISO and Health Level Seven, Inc. (HL7) has been formed to develop and maintain a
group of ISO/HL7 standards in the field of medical devices as approved by Council resolution 7/2002. Under
this pilot project, HL7 is responsible for the development and maintenance of these standards with
participation and input from ISO member bodies.
Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. Neither ISO nor HL7 shall be held responsible for identifying any or all such patent
rights.
ISO/HL7 10781 was prepared by HL7 and Technical Committee ISO/TC 215, Health informatics, in parallel
with its approval by the ISO member bodies.
This second edition cancels and replaces the first edition (ISO/HL7 10781:2009), which has been technically
revised.
© ISO/HL7 2012 – All rights reserved iii
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oSIST prEN ISO 10781:2012
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oSIST prEN ISO 10781:2012
HL7 EHR Work Group
Electronic Health Record-System
Functional Model, Release 2.0
May 2012
Chapter One:
Overview
Gary Dickinson
Co-Chair, Hl7 EHR Work Group
CentriHealth
Don Mon PhD
Co-Chair, Hl7 EHR Work Group
Research Triangle Institute International
John Ritter
Co-Chair, Hl7 EHR Work Group
Centers for Disease Control and Prevention, National Center for Health Statistics
Helen Stevens Love
Co-Chair, Hl7 EHR Work Group
Gordon Point Informatics, Ltd.
Patricia Van Dyke
Co-Chair, Hl7 EHR Work Group
The ODS Companies, Delta Dental Plans Association
HL7® EHR Standard, © 2012 Health Level Seven®, Inc. ALL RIGHTS RESERVED. The reproduction of this material in
any form is strictly forbidden without the written permission of the publisher.
HL7 and Health Level Seven are registered trademarks of Health Level Seven, Inc. Reg. U.S. Pat & TM Off
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oSIST prEN ISO 10781:2012
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oSIST prEN ISO 10781:2012
HL7 EHR System Functional Model Chapter 1: Overview
Table of Contents
Preface. 2
i. Notes to Readers . 2
ii. Acknowledgements. 2
iii. Changes from Previous Release . 3
Chapter 1 Introduction and Overview . 4
1.1 Background . 4
1.1.1 What is HL7? . 4
1.1.2 What are Electronic Health Record Systems? . 4
1.1.3 Existing EHR System Definitions . 5
1.1.4 How were the Functions Identified and Developed? . 5
1.1.5 What is the EHR-S Functional Model Package? . 6
1.2 Purpose and Scope (Normative) . 6
1.2.1 EHR-S Functional Model Scope . 7
1.3 Overview and Definition of the Functional Model (Normative) . 8
1.3.1 Functional Profiles . 8
1.3.2 EHR-S Function List Components . 9
1.2.3.1 Function ID (Normative) . 10
1.2.3.2 Function Type (Reference) . 10
1.2.3.3 Function Name (Normative) . 10
1.2.3.4 Function Statement (Normative) . 10
1.2.3.5 Description (Reference) . 10
1.2.3.6 Conformance Criteria (Normative) . 10
1.4 Anticipated Uses . 10
1.4.1 Anticipated Development Approach: Functional Profiles . 11
1.1.4.1 Scenario 1 – Group Practice . 11
1.1.4.2 Scenario 2 - Hospital . 11
1.1.4.3 Scenario 3 - IT Vendor . 12
1.4.2 Example of Current Use . 12
1.2.4.1 The Certification Commission for Health Information Technology . 12
May 2012 Page 1
Copyright © 2012 HL7, All Rights Reserved Ballot #1 Draft
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oSIST prEN ISO 10781:2012
HL7 EHR System Functional Model Chapter 1: Overview
Preface
i. Notes to Readers
The HL7 EHR-S Functional Model, which was approved in July, 2004 as a Draft Standard for
Trial Use (DSTU), has undergone a series of enhancements in the last year as it made its way to
a fully approved American National Standards Institute (ANSI) standard in February of 2007. A
broad constituency - including intensive outreach to industry, care providers, and healthcare
organizations - has worked to refine the initial and subsequent versions of EHR-S Functional
Model. Release 2.0 reflects many changes—including ballot comments that had been made on
past ballots and where the Work Group had committed to bringing the requested changes forward
to the next release. It also includes comments that were considered for future used form the ISO
ballot of 2009 as well as the considerations of the Comment Only ballot that was circulated in
May, 2011.
Other inclusions were made as a result of the multiple profiles that have been written based off of
the functional model. There was great learning in those various domain as well as companion
profiles. And last but not least, the EHR-S FM has incorporated two other Draft Standards for
Trial Use including the EHR Lifecycle Model and the EHR Interoperability Model.
ii. Acknowledgements
The committee is indebted to the following past co-chairs and facilitators for their contributions
towards all parts of this model and the material presented here. We are thankful to every person
who was able to contribute, whether for a short period of time, or week-in/week-out work. For the
early mornings and the late evenings and weekends. We cannot thank you enough. Direct and
indirect participants in the development of the model, including workgroup contributors and other
participants, can be found in the “Contributor Listing” found at www.HL7.org/EHR in the
“documents” section.
Name Role Organization
Peter DeVault Past TC Co-Chair Epic Systems Corporation
Gary Dickinson Past TC Co-Chair CentrifyHealth, Inc.
Linda Fischetti Past TC Co-Chair U.S. Department of Veterans Affairs
Sam Heard Past TC Co-Chair Ocean Informatics
David Rowlands Past TC Co-Chair Standards Australia
Corey Spears Past TC Co-Chair McKesson Corporation
Lenel James Co-Facilitator Blue Cross Blue Shield Association
Sue Mitchell Co-Facilitator Independent Consultant
Publication Working Group
Corey Spears Publication & Tooling Lead McKesson Corporation
Andre Boudreau Section Lead Independent Consultant
Gora Data Section Lead Cal2Cal
Michelle Dougherty Section Lead AHIMA
Steve Hufnagel Section Lead DOD/MHS
Mark Janczewski Section Lead DOD/MHS
Hetty Khan Section Lead CDC
Wes Knox Section Lead Independent Consultant
Don LaVigne Section Lead Xifin
Jim McClay Section Lead DOD/MHS
Nancy Orvis Section Lead MHS/DOD
Peter Park Section Lead DOD/MHS
Table 1: Acknowledgements
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iii. Changes from Previous Release
The HL7 EHR-S Functional Model was promoted to an ISO International Standard after passing
HL7 consensus ballot as a normative standard and achieving ANSI approval. This promotion
follows the process outlined in the ISO/HL7 Pilot Agreement. The June, 2009 R.1.1 of this
document includes updates from the joint ISO/HL7 ballot. The dates of the comment for the 60
day Draft International Standard (DIS) ballot were February through April, 2009. The HL7
comment period was a 30 day window that coordinated with the last 30 days of the ISO-DIS ballot
period. Reconciliation was accomplished in May and early June of 2009.
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Chapter 1 Introduction and Overview
The HL7 Electronic Health Records Special Interest Group (EHR SIG) was established in the
spring of 2002. In the spring of 2003 the HL7 group began efforts to develop a standardized
functional specification for Electronic Health Records Systems (EHR-S). In May 2004 the SIG
was promoted to a full HL7 Technical Committee, becoming the EHR TC. The EHR TC is
intended primarily to serve as a body which promotes the uptake of Electronic Health Record
(EHR) implementation by standardizing the functions that may be present, based on user
selection, in an EHR-S.
The Department of Health and Human Services, the Veterans Health Administration, the Health
Information Management Systems Society and the Robert Wood Johnson Foundation, in a
public-private partnership, approached HL7 to accelerate their existing work to develop a
consensus standard to define the functions of an EHR-S. HL7, through its EHR SIG, responded
by developing an EHR-S Functional Model that passed ballot as a Draft Standard for Trial Use
(DSTU) in April 2004. The Functional Model DSTU was published and formally registered with
the American National Standards Institute (ANSI) in July 2004. The Functional Model was then
balloted and passed as a normative standard as part of the January 2007 HL7 Workgroup
Meeting and is now registered as a normative standard with ANSI
Learning important lessons from the ballot process, a Functional Model with a clearer, more
simplified list of functions, has been created. 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 Model, through the creation of Functional Profiles,
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 Background
1.1.1 What is HL7?
Established in 1987, Health Level Seven (HL7) is an American National Standards Institute
(ANSI) accredited, not-for-profit standards-development organization, whose mission is to provide
standards for the exchange, integration, sharing, and retrieval of electronic health information;
support clinical practice; and support the management, delivery and evaluation of health services.
ANSI accreditation, coupled with HL7's own procedures, dictates that any standard published by
HL7 and submitted to ANSI for approval, be developed and ratified by a process that adheres to
ANSI's procedures for open consensus and meets a balance of interest requirement by attaining
near equal participation in the voting process by the various constituencies that are materially
affected by the standard (e.g., vendors, providers, government agencies, consultants, non-profit
organizations). This balance of interest goal ensures that a particular constituency is neither
refused participation nor is it allowed to dominate the development and ratification of a proposed
standard. More information and background on ANSI is available on their website
at: http://www.ANSI.org
1.1.2 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."( HHS Goals in Pursuing HL7 EHR
Functional Standard" in Memorandum to HIMSS from C. Clancy and W. Raub co-chairs of HHS
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Council on the Application of Health Information Technology, dated November 12, 2003.) A
critical foundational component for resolving these system and infrastructure issues is the
Electronic Health Record System (EHR-S).
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.
1.1.3 Existing EHR System Definitions
The IOM's 1991 report, The Computer-Based Patient Record: An Essential Technology, and
updated in 1997 (Dick, R.S, Steen, E.B., & Detmer, D.E. (Editors), National Academy Press:
Washington, DC) defined an EHR System as:
• The set of components that form the mechanism by which patient records are created,
used, stored, and retrieved.
• A patient record system is usually located within a health care provider setting. It includes
people, data, rules and procedures, processing and storage devices (e.g., paper and
pen, hardware and software), and communication and support facilities.
• The 2003 IOM Letter Report, Key Capabilities of an Electronic Health Record System,
defined the EHR System as including:
• longitudinal collection of electronic health information for and about persons, where
health information is defined as information pertaining to the health of an individual or
health care provided to an individual
• immediate electronic access to person- and population-level information by authorized,
and only authorized, users
• provision of knowledge and decision-support that enhance the quality, safety, and
efficiency of patient care; and
• support of efficient processes for health care delivery
• The 2003 ISO/TS 18308 references the IOM 1991 definition above as well as CEN
13606, 2000:
• A system for recording, retrieving and manipulating information in electronic health
records.
1.1.4 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
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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.
Drafts of the EHR-S Functional Model and of specific functions have been widely reviewed by
healthcare providers, vendors, and other stakeholders. This proposed standard reflects input from
all these reviewers.
1.1.5 What is the EHR-S Functional Model Package?
The EHR-S Functional Model Package includes the following materials:
Document Title File Name
EHR-S Functional Model Read Me EHRS_FM_R2_C0_Readme_2012MAY
EHR-S Functional Model Chapter 1: Overview EHRS_FM_R2_C1_Overview_2012MAY
EHR-S Functional Model Chapter 2: Conformance EHRS_FM_R2_C2_ConformanceClause_2012MAY
EHR-S Functional Model Chapter 3: Functions List EHRS_FM_R2_C3_FunctionList_2012MAY_EXCEL
EHRS_FM_R2_C3_FunctionList_2012MAY_HTML
EHRS_FM_R2_C3_FunctionList_2012MAY_PDF
EHRS_FM_R2_C3_FunctionList_2012MAY_XML
EHR-S Functional Model Chapter 4: Glossary EHRS_FM_R2_C4_Glossary_2012MAY
EHR-S Errata List EHRS_FM_R2 2011DEC to 2012MAY Errata List
Table 2: Functional Model Package
Note that the related document “How-To Guide for Creating Functional Profiles” is published
separately.
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 procedures for Balloting Normative Documents. This HL7 developed
Functional Model document has been successfully balloted as a normative standard
by the HL7 organization.
Table 3: Normative Status Types
Each section within a chapter of the Functional Model document is clearly labeled "Normative" if it
is normative. For example, in Chapter 1 (Overview) is Normative. In Chapter 2 (Conformance
Clause); sections 1 through 6 are normative.
In Chapter 3 (Function List); the Function ID, Function Name, Function Statement, and
Conformance Criteria components are Normative in this Functional Model.
1.2 Purpose and Scope (Normative)
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 and realms,
enables a standardized description and common understanding of functions sought or available
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in a given setting (e.g., intensive care, cardiology, office practice in one country or primary care in
another country).
1.2.1 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
...
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