EN ISO 10781:2015
(Main)Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015)
Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015)
ISO 10781:2015 provides a reference list of functions that may be present in an Electronic Health Record System (EHR-S). The function list is described from a user perspective with the intent to enable consistent expression of system functionality. This EHR-S Functional Model, through the creation of Functional Profiles for care settings and realms, enables a standardized description and common understanding of functions sought or available in a given setting (e.g. intensive care, cardiology, office practice in one country or primary care in another country).
Funktionales Modell für ein elektronisches Gesundheitsaktensystem (EHRS FM), Ausgabe 2 (ISO 10781:2015)
Informatique de santé - Modèle fonctionnel d'un système de dossier de santé informatisé, publication 2 (EHR FM) (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.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword .3
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.
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
ISO 10781:2015(E)
© 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
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 10781:2015(E)
6.8.5 Rationale for
...
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword .3
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.
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
ISO 10781:2015(E)
© 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
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 10781:2015(E)
6.8.5 Rationale for ‘Dependent SHALL’ .
...
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