SIST EN ISO 10781:2010
(Main)Electronic Health Record-System Functional Model, Release 1.1 (ISO 10781:2009)
Electronic Health Record-System Functional Model, Release 1.1 (ISO 10781:2009)
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).
Medizinische Informatik - HL7 funktionales Modell für ein elektronisches Gesundheitsaktensystem (ISO 10781:2009)
Modèle fonctionnel d'un système d'enregistrement électronique de la santé HL7, version 1.1 (ISO 10781:2009)
L'ISO/HL7 10781:2009 décrit le contenu et les moyens de fonctionnement d'un système de dossier informatisé de santé (S-DIS) du groupe de travail HL7.
Funkcionalni model HL7 za sistem elektronskih zapisov na področju zdravstva, izdaja 1.1 (ISO 10781:2009)
Posebna interesna skupina za HL7 elektronske zapise na področju zdravstva (EHR SIG) je bila ustanovljena spomladi leta 2002. Spomladi leta 2003 je HL7 skupina začela z razvijanjem standardizirane funkcionalne specifikacije za sisteme elektronskih zapisov na področju zdravstva (EHR-S). Maja 2004 je SIG napredoval v polni HL7 tehnični odbor in s tem postal EHR TC. EHR TC je predvsem namenjen temu, da služi kot organ, ki spodbuja vnos implementacije elektronskih zapisov na področju zdravstva (EHR) s standardizacijo funkcij, ki so lahko prisotne glede na izbiro uporabnikov v EHR-S. Ministrstvo za zdravje in človeške vire, Uprava za zdravje veteranov, Družba za informacijski nadzorni sistem na področju zdravstva in Fundacija Roberta Wooda Johnsona so v javno-zasebnem partnerstvu pristopile k HL7, da bi pospešile njeno obstoječe delo na razvoju standarda o soglasju, da določijo funkcije EHR-S. HL7 je preko svojega EHR SIG odgovoril z razvojem EHR-S funkcionalnega modela, ki je bil maja 2004 izglasovan kot osnutek standarda za preizkusno uporabo (DSTU). Funkcionalni model DSTU je bil nato v mesecu juliju 2004 objavljen in uradno registriran pri Ameriškem državnem inštitutu za standardizacijo (ANSI). Funkcionalni model je bil nato januarja 2007 izglasovan in sprejet kot normativni standard v okviru sestanka HL7 delovne skupine in je zdaj registriran kot normativni standard. ANSI je pridobil pomembne izkušnje iz postopka glasovanja in ustvarjen je bil funkcionalni model z jasnejšim, bolj poenostavljenim seznamom funkcij. Sistemski funkcionalni model HL7 EHR zagotavlja referenčni seznam funkcij, ki so lahko prisotne v sistemu elektronskih zapisov na področju zdravstva (EHR-S). Seznam funkcij je opisan iz perspektive uporabnika, z namenom omogočiti dosledno izražanje sistemske funkcionalnosti. Ta EHR-S model preko oblikovanja funkcionalnih profilov omogoča standardiziran opis in splošno razumevanje funkcij, ki so iskane ali na voljo v danih nastavitvah (npr. intenzivna nega, kardiologija, uradniška praksa v eni državi ali primarna oskrba v drugi državi).
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SLOVENSKI STANDARD
SIST EN ISO 10781:2010
01-januar-2010
)XQNFLRQDOQLPRGHO+/]DVLVWHPHOHNWURQVNLK]DSLVRYQDSRGURþMX]GUDYVWYD
L]GDMD ,62
Electronic Health Record-System Functional Model, Release 1.1 (ISO 10781:2009)
Medizinische Informatik - HL7 funktionales Modell für ein elektronisches
Gesundheitsaktensystem (ISO 10781:2009)
Modèle fonctionnel d'un système d'enregistrement électronique de la santé HL7, version
1.1 (ISO 10781:2009)
Ta slovenski standard je istoveten z: EN ISO 10781:2009
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 10781:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10781:2010
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SIST EN ISO 10781:2010
EUROPEAN STANDARD
EN ISO 10781
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2009
ICS 35.240.80
English Version
Electronic Health Record-System Functional Model, Release 1.1
(ISO 10781:2009)
Modèle fonctionnel d'un système d'enregistrement Medizinische Informatik - HL7 funktionales Modell für ein
électronique de la santé HL7, version 1.1 (ISO 10781:2009) elektronisches Gesundheitsaktensystem (ISO 10781:2009)
This European Standard was approved by CEN on 7 November 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10781:2009: E
worldwide for CEN national Members.
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SIST EN ISO 10781:2010
EN ISO 10781:2009 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 10781:2010
EN ISO 10781:2009 (E)
Foreword
This document (EN ISO 10781:2009) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics”, the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the
latest by May 2010.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries a
...
SLOVENSKI STANDARD
oSIST prEN ISO 10781:2008
01-julij-2008
=GUDYVWYHQDLQIRUPDWLND)XQNFLRQDOQLPRGHO+/]DVLVWHPHOHNWURQVNLK]DSLVRY
QDSRGURþMX]GUDYVWYDL]GDMD ,62',6
Health informatics - HL7 Electronic health record system functional model, release 1
(ISO/DIS 10781:2008)
Medizinische Informatik - HL7 funktionales Modell für ein elektronisches
Gesundheitsaktensystem (ISO/DIS 10781:2008)
Informatique de santé - Modèle fonctionnel d'un système d'enregistrement électronique
de la santé HL7, version 1 (ISO/DIS 10781:2008)
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 10781:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
DRAFT
prEN ISO 10781
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2008
ICS 35.240.80
English Version
Health informatics - HL7 Electronic health record system
functional model, release 1 (ISO/DIS 10781:2008)
Informatique de santé - Modèle fonctionnel d'un système Medizinische Informatik - HL7 funktionales Modell für ein
d'enregistrement électronique de la santé HL7, version 1 elektronisches Gesundheitsaktensystem (ISO/DIS
(ISO/DIS 10781:2008) 10781:2008)
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 Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 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: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 10781:2008: E
worldwide for CEN national Members.
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prEN ISO 10781:2008 (E)
Contents Page
Foreword.3
2
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prEN ISO 10781:2008 (E)
Foreword
This document (prEN ISO 10781:2008) 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.
Endorsement notice
The text of ISO/DIS 10781:2008 has been approved by CEN as a prEN ISO 10781:2008 without any
modification.
3
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DRAFT INTERNATIONAL STANDARD ISO/HL7 DIS 10781
ISO/TC 215 Secretariat: ANSI
Voting begins on Voting terminates on
2008-04-24 2008-09-24
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Health informatics — HL7 Electronic health record
system functional model, release 1
Informatique de santé — Modèle fonctionnel d'un système d'enregistrement électronique de la santé HL7,
version 1
ICS 35.240.80
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month
FDIS vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 7/2002 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 7/2002, ce document est
distribué en version anglaise seulement.
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, 2008
© Health Level Seven (HL7) Standards, 2008
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ISO/HL7 DIS 10781(E)
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO/HL7 2008 – All rights reserved
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ISO/HL7 DIS 10781(E)
Contents Page
Foreword .iv
Introduction.v
1 Background.1
1.1 What is HL 7?.1
1.2 What are Electronic Health Record Systems? .1
1.3 Existing HER System Definitions .1
1.4 How were the Functions Identified and Developed?.2
1.5 What is the EHR-S Functional Model Package? .2
2 Purpose and Scope (Normative).4
2.1 EHR-S Functional Model Scope.4
2.2 This Functional Model is not:.5
3 Overview and Definition of the Functional Model (Normative).5
3.1 EHR-S Functional Outline: The Functions and Their Use.6
3.2 Components of EHR-S Functional Outline .7
© ISO 2008 – All rights reserved iii
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ISO/HL7 DIS 10781(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.
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.
iv © ISO 2008 – All rights reserved
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ISO/HL7 DIS 10781(E)
Introduction
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. A broad constituency - including intensive outreach to
industry, care providers, and healthcare organizations - has worked to refine the initial EHR-S Functional
Model. This version reflects the changes made as part of the reconciliation process in the successful
membership level balloting that took place at the January 2007 HL7 Workgroup Meeting.
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).
© ISO 2008 – All rights reserved v
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COMMITTEE DRAFT ISO/HL7 DIS 10781(E)
Health informatics — HL7 Electronic health record
system functional model, release 1
1 Background
1.1 What is HL 7?
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
1.2 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 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.
1.3 Existing HER 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:
© ISO 2008 – All rights reserved 1
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ISO/HL7 DIS 1
...
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