EN ISO 13606-2:2019

Health informatics - Electronic health record communication - Part 2: Archetype interchange specification (ISO 13606-2:2019)

This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository.
It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components) that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system.
This document will predominantly be used to support the direct care given to identifiable individuals, or to support population monitoring systems such as disease registries and public health surveillance. Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of this standard series but such secondary uses might also find it useful.
This document defines an Archetype Model to be used to represent Archetypes when communicated between repositories, and between archetype services. It defines an optional serialised representation, which may be used as an exchange format for communicating individual archetypes. Such communication might, for example, be between archetype libraries or between an archetype service and an EHR persistence or validation service.

Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 2: Spezifikation für den Austausch von Archetypen (ISO 13606-2:2019)

Informatique de santé - Communication du dossier de santé informatisé - Partie 2: Spécification d'échange d'archétype (ISO 13606-2:2019)

Le présent document spécifie un moyen de communication de tout ou partie du dossier de santé informatisé (DSI) d'un seul ou de plusieurs sujets des soins identifiés entre systèmes de DSI, ou entre des systèmes de DSI et un référentiel de données de DSI centralisé.
Il peut également être utilisé pour la communication de DSI entre un système ou référentiel de DSI et des applications médicales ou composants intergiciels (tels que des composants d'aide à la prise de décision) nécessitant d'avoir d'accès aux ou de fournir des données DSI, ou pour la représentation des données DSI dans un système réparti (fédéré).
Le présent document est destiné à être principalement utilisé pour prendre en charge les soins directs dispensés à des personnes identifiables, ou les systèmes d'observation de la population tels que les registres de maladies et l'observation de la santé publique. L'utilisation des dossiers de santé pour d'autres finalités telles que l'enseignement, l'évaluation médicale, l'administration et l'établissement de rapports, la gestion des services de santé, la recherche et l'épidémiologie, qui exigent souvent l'anonymisation ou l'agrégation de dossiers individuels, ne constitue pas l'objet de la présente série de normes; néanmoins, ces applications secondaires sont susceptibles d'y trouver un intérêt.
Le présent document définit un modèle d'archétype à utiliser pour représenter des archétypes lorsqu'ils sont communiqués entre des référentiels et entre des services d'archétypes. Il définit une représentation en série facultative qui peut être utilisée comme format d'échange pour la communication d'archétypes individuels. Cette communication peut par exemple avoir lieu entre des bibliothèques d'archétypes ou entre un service d'archétype et un service de permanence ou de validation de DSI.

Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 2. del: Specifikacija za zamenjavo arhetipov (ISO 13606-2:2019)

Ta del standarda ISO 13606 določa informacijsko arhitekturo, ki je potrebna za interoperabilno komunikacijo med sistemi in storitvami, ki potrebujejo ali zagotavljajo podatke EHR. Namen tega dela standarda ISO 13606 ni določitev notranje arhitekture ali oblikovanje podatkovne baze takih sistemov.
Predmet kartoteke ali izvlečka kartoteke, ki ga je treba posredovati, je posameznik, posredovano sporočilo pa večinoma obsega podatke v zvezi z oskrbo tega posameznika.
Uporaba zdravstvenih kartotek za druge namene, kot so upravljanje, vodenje, raziskave in epidemiologija, ki zahtevajo združevanje kartotek posameznikov, niso osrednji predmet tega dela standarda ISO 13606, vendar je ta dokument lahko uporaben tudi za tovrstno sekundarno uporabo.
Ta del ISO 13606 določa model arhetipa, ki se uporablja za predstavljanje arhetipov pri komuniciranju med zbirkami podatkov in med storitvami arhetipa. Določa poljubno serializirano predstavitev, ki se lahko uporablja kot oblika izmenjave za posredovanje posameznih arhetipov. Taka komunikacija lahko na primer poteka med knjižnicami arhetipov ali med storitvijo arhetipa in storitvijo EHR za vzdrževanje ali preverjanje.

General Information

• Status: Published
• Publication Date: 02-Jul-2019
• Withdrawal Date: 30-Jan-2020
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Jul-2019
• Completion Date: 03-Jul-2019
• Ref Project: SIST EN ISO 13606-2:2019 - Health informatics - Electronic health record communication - Part 2: Archetype interchange specification (ISO 13606-2:2019)

Relations

• Replaces: EN 13606-2:2007 - Health informatics - Electronic health record communication - Part 2: Archetypes interchange specification
• Effective Date: 10-Jul-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN 13606-2:2008
Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju
zdravstva - 2. del: Specifikacija za zamenjavo arhetipov (ISO 13606-2:2019)
Health informatics - Electronic health record communication - Part 2: Archetype
interchange specification (ISO 13606-2:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 2: Spezifikation für den Austausch von Archetypen (ISO 13606-2:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 2:
Spécification d'échange d'archétype (ISO 13606-2:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-2:2019
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.

EN ISO 13606-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13606-2:2007
English Version
Health informatics - Electronic health record
communication - Part 2: Archetype interchange
specification (ISO 13606-2:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 2: Spécification d'échange Patientendaten in elektronischer Form - Teil 2:
d'archétype (ISO 13606-2:2019) Spezifikation für den Austausch von Archetypen (ISO
13606-2:2019)
This European Standard was approved by CEN on 2 July 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-2:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13606-2:2019) 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 13606-2:2007.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13606-2:2019 has been approved by CEN as EN ISO 13606-2:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 13606-2
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 2:
Archetype interchange specification
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 2: Spécification d'échange d'archétype
Reference number
ISO 13606-2:2019(E)
©
ISO 2019
ISO 13606-2:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 13606-2:2019(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 2
5 Conformance . 2
6 Archetype representation requirements . 3
6.1 General . 3
6.2 Archetype definition, description and publication information . 3
6.3 Archetype node constraints . 6
6.4 Data value constraints . 8
7 Archetype object model .10
7.1 Preface .10
7.1.1 Purpose .10
7.1.2 Nomenclature .10
7.2 Model overview .10
7.2.1 Package structure .10
7.2.2 Definition and utility classes .11
7.3 The archetype package .13
7.3.1 Overview .13
7.3.2 Archetype identification .15
7.3.3 Top-level meta-data . .16
7.3.4 Governance meta-data .16
7.3.5 Structural definition.18
7.3.6 Class descriptions .22
7.3.7 Validity rules .29
7.4 Constraint model package .30
7.4.1 Overview .30
7.4.2 Semantics .32
7.4.3 Second order constraints.38
7.4.4 AOM type substitutions .39
7.4.5 Class definitions.41
7.5 The rules package .56
7.5.1 Overview .56
7.5.2 Semantics .57
7.5.3 Class descriptions .57
7.6 Terminology package .62
7.6.1 Overview .62
7.6.2 Semantics .64
7.6.3 Class descriptions .65
7.7 Templates.67
Annex A (informative) Archetype Definition Language .69
Annex B (informative) Example Representation .70
Bibliography .
...

SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN 13606-2:2008
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 2.
del: Specifikacija za zamenjavo arhetipov (ISO 13606-2:2019)
Health informatics - Electronic health record communication - Part 2: Archetype
interchange specification (ISO 13606-2:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 2: Spezifikation für den Austausch von Archetypen (ISO 13606-2:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 2:
Spécification d'échange d'archétype (ISO 13606-2:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-2:2019
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.

EN ISO 13606-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13606-2:2007
English Version
Health informatics - Electronic health record
communication - Part 2: Archetype interchange
specification (ISO 13606-2:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 2: Spécification d'échange Patientendaten in elektronischer Form - Teil 2:
d'archétype (ISO 13606-2:2019) Spezifikation für den Austausch von Archetypen (ISO
13606-2:2019)
This European Standard was approved by CEN on 2 July 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-2:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13606-2:2019) 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 13606-2:2007.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13606-2:2019 has been approved by CEN as EN ISO 13606-2:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 13606-2
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 2:
Archetype interchange specification
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 2: Spécification d'échange d'archétype
Reference number
ISO 13606-2:2019(E)
©
ISO 2019
ISO 13606-2:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 13606-2:2019(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 2
5 Conformance . 2
6 Archetype representation requirements . 3
6.1 General . 3
6.2 Archetype definition, description and publication information . 3
6.3 Archetype node constraints . 6
6.4 Data value constraints . 8
7 Archetype object model .10
7.1 Preface .10
7.1.1 Purpose .10
7.1.2 Nomenclature .10
7.2 Model overview .10
7.2.1 Package structure .10
7.2.2 Definition and utility classes .11
7.3 The archetype package .13
7.3.1 Overview .13
7.3.2 Archetype identification .15
7.3.3 Top-level meta-data . .16
7.3.4 Governance meta-data .16
7.3.5 Structural definition.18
7.3.6 Class descriptions .22
7.3.7 Validity rules .29
7.4 Constraint model package .30
7.4.1 Overview .30
7.4.2 Semantics .32
7.4.3 Second order constraints.38
7.4.4 AOM type substitutions .39
7.4.5 Class definitions.41
7.5 The rules package .56
7.5.1 Overview .56
7.5.2 Semantics .57
7.5.3 Class descriptions .57
7.6 Terminology package .62
7.6.1 Overview .62
7.6.2 Semantics .64
7.6.3 Class descriptions .65
7.7 Templates.67
Annex A (informative) Archetype Definition Language .69
Annex B (informative) Example Representation .70
Bibliography .
...