SIST EN ISO 13606-3:2019

Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists (ISO 13606-3:2019)

This part of ISO 13606 is for the communication of part or all of the electronic health record (EHR) of a single identified subject of care between EHR systems, or between EHR systems and a centralized EHR data repository. It may 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 part of ISO 13606 (EHR Communications Standard Series), defines term lists that each specify the set of values that particular attributes of the Reference Model defined in ISO 13606-1 may take. It also defines informative reference archetypes that correspond to ENTRY-level compound data structures within the Reference Models of openEHR and HL7 Version 3, to enable those instances to be represented within a
consistent structure when communicated using this part of ISO 13606.

Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 3: Referenzarchetypen und Begriffslisten (ISO 13606-3:2019)

Informatique de santé - Communication du dossier de santé informatisé - Partie 3: Archétypes de référence et listes de termes (ISO 13606-3:2019)

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) ou des applications et appareils de santé personnels nécessitant d'avoir accès aux ou de fournir des données de DSI, ou pour la représentation des données de DSI dans un système réparti (fédéré).
Le présent document relatif à la communication des DSI définit des listes de termes qui spécifient chacune l'ensemble de valeurs pour les attributs particuliers du modèle de référence défini dans l'ISO 13606-1. Elle définit également des archétypes de référence normatifs et informatifs qui permettent de représenter en une structure cohérente les instances de données de DSI qui apparaissent fréquemment, lorsqu'elles sont communiquées à l'aide du présent document.

Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 3. del: Referenčni arhetipi in seznami izrazov (ISO 13606-3:2019)

Ta del standarda ISO 13606 določa komunikacijo nekaterih ali vseh elektronskih zdravstvenih kartonov (EHR) identificiranega subjekta oskrbe med sistemi EHR oziroma med sistemi EHR in centralizirano zbirko podatkov EHR. Lahko se uporablja tudi za komunikacijo med sistemom EHR, aplikacijami za shranjevanje in kliničnimi aplikacijami oziroma komponentami vmesne programske opreme (kot so podporne komponente odločanja), ki potrebujejo dostop do podatkov EHR ali zagotavljajo podatke EHR, ali za predstavitev podatkov EHR v okviru porazdeljenega (združenega) sistema evidentiranja.
Ta del standarda ISO 13606 (vrsta standardov o komunikaciji z elektronskimi zapisi na področju zdravstva) določa sezname izrazov, ki določajo nabor vrednosti, ki jih lahko privzamejo določeni atributi referenčnega modela, opredeljenega v standardu ISO 13606-1. Določa tudi informativne referenčne arhetipe, ki ustrezajo sestavljenim podatkovnim strukturam na ravni ENTRY v referenčnih modelih openEHR in HL7 različice 3 za namen predstavitve teh primerov v konsistentni strukturi pri komunikaciji z uporabo tega dela standarda ISO 13606.

General Information

• Status: Published
• Public Enquiry End Date: 06-Jul-2017
• Publication Date: 18-Jul-2019
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jul-2019
• Due Date: 19-Sep-2019
• Completion Date: 19-Jul-2019
• Ref Project: EN ISO 13606-3:2019 - Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists (ISO 13606-3:2019)

Relations

• Replaces: SIST EN 13606-3:2008 - Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists
• Effective Date: 01-Sep-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13606-3:2019
01-september-2019
Nadomešča:
SIST EN 13606-3:2008
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 3.
del: Referenčni arhetipi in seznami izrazov (ISO 13606-3:2019)
Health informatics - Electronic health record communication - Part 3: Reference
archetypes and term lists (ISO 13606-3:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 3: Referenzarchetypen und Begriffslisten (ISO 13606-3:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 3:
Archétypes de référence et listes de termes (ISO 13606-3:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-3:2019
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13606-3:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13606-3:2019

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SIST EN ISO 13606-3:2019


EN ISO 13606-3
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13606-3:2008
English Version

Health informatics - Electronic health record
communication - Part 3: Reference archetypes and term
lists (ISO 13606-3:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 3: Archétypes de référence et Patientendaten in elektronischer Form - Teil 3:
listes de termes (ISO 13606-3:2019) Referenzarchetypen und Begriffslisten (ISO 13606-
3:2019)
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 13606-3:2019 E
worldwide for CEN national Members.

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SIST EN ISO 13606-3:2019
EN ISO 13606-3:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 13606-3:2019
EN ISO 13606-3:2019 (E)
European foreword
This document (EN ISO 13606-3:2019) 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 13606-3:2008.
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 13606-3:2019 has been approved by CEN as EN ISO 13606-3:2019 without any
modification.

3

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SIST EN ISO 13606-3:2019

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SIST EN ISO 13606-3:2019
INTERNATIONAL ISO
STANDARD 13606-3
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 3:
Reference archetypes and term lists
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 3: Archétypes de référence et listes de termes
Reference number
ISO 13606-3:2019(E)
©
ISO 2019

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SIST EN ISO 13606-3:2019
ISO 13606-3:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© 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

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SIST EN ISO 13606-3:2019
ISO 13606-3:2019(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 2
5 Conformance . 2
6 Term lists . 2
6.1 Introduction . 2
6.2 Termlist SUBJECT_CATEGORY, Class ENTRY, attribute subject_of_information_category . 3
6.3 Termlist VERSION_STATUS, Class BASE_COMPONENT, attribute version_status. 3
6.4 Termlist MODE, Reference Archetype Healthcare activity participation . 4
6.5 Class LINK, attribute link_description . 4
6.5.1 Termlist RELATED_TO, Class LINK, attribute link_description . 5
6.5.2 Termlist AUTHORISED_BY, Class LINK, attribute link_description . 5
6.5.3 Termlist SAME_HEALTH_ISSUE, Class LINK, attribute link_description . 6
6.5.4 Termlist SAME_PLAN, Class LINK, attribute link_description . 8
6.5.5 Termlist RELATED_DOCUMENTATION, Class LINK, attribute link_description . 8
6.6 Termlist, Class EXTERNAL_LINK, attribute target_information_type . 9
6.7 Termlist, Classes ELEMENT and DEMOGRAPHIC_ELEMENT, attribute null_flavour .10
6.8 Termlist, Class ATTACHMENT, attribute IntegrityCheckAlgorithm .10
7 Reference archetype for null_flavor .10
7.1 Archetype name: Null_flavor .10
8 Reference archetype for the access policy COMPOSITION .11
8.1 Archetype name: Access_policy_rule .11
9 Reference archetypes for demographic entities .12
9.1 Archetype name: EntityIdentifier .12
9.2 Archetype name: useablePeriod .13
9.3 Archetype name: LocationAddress .13
9.4 Archetype name: TelecommunicationAddress .14
9.5 Archetype name: Address . .16
9.6 Archetype name: Namepart .17
9.7 Archetype name: PersonName .18
9.8 Archetype name: Person.19
9.9 Archetype name: HealthcareOrganization .20
9.10 Archetype name: ServiceDepartment .21
9.11 Archetype name: HealthcarePersonnel .22
9.12 Archetype name: MedicalDevice .23
9.13 Archetype name: SubjectOfInformation .25
9.14 Archetype name: Contact .25
9.15 Archetype name: HealthcareActivityParticipation .26
9.16 Archetype name: HealthcareActivityFacility .26
9.17 Archetype name: HealthcareActivityFramework .27
9.18 Summary of demographic-related data types in ISO 21090 .27
9.18.1 Identification and Location Datatypes .27
9.18.2 Name and Address Datatypes .29
10 Reference archetypes for medicinal product .31
10.1 Archetype name: MedicinalProduct .31
11 Reference archetypes for clinical information specifications .37
11.1 General .37
© ISO 2019 – All rights reserved iii

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SIST EN ISO 13606-3:2019
ISO 13606-3:2019(E)

11.2 Archetype name: Health condition .38
11.3 Archetype name: Healthcare activity element.42
11.4 Archetype name: ClinicalContext .47
11.5 Archetype name: Activity management .49
11.6 Archetype name: Association .50
11.7 Archetype name: Consideration.51
11.8 Archetype name: Dosage .52
11.9 Archetype name: Method .52
12 Contsys-based clinical reference information structures as the basis for
development of clinical archetypes .54
12.1 Introduction .54
12.1.1 Criteria/characteristics .56
12.1.2 Basic concepts as bases for the Contsys-based information structure .56
12.1.3 Method for development of Contsys-based clinical reference information
structures .56
12.1.4 Steps in defining the information structures .57
12.2 Content of information structures .58
12.2.1 Structures for single concepts .58
12.2.2 Structures for reuse in clinical situations — Clusters complementing
structures for basic clinical concepts .58
12.2.3 Structures for compound documents in an EHR .59
12.2.4 Other comments .59
12.2.5 Format .60
12.3 Specializations of types of Health condition .60
12.4 Information structures for single concepts .61
12.4.1 Health condition .61
12.5 Healthcare activity element .67
12.5.1 Performer .72
12.6 Pharmacological treatment .73
12.6.1 Pharmacological treatment .73
12.6.2 Dosage .74
12.7 Indirect healthcare activity elements .74
12.7.1 Healthcare assessment .75
12.7.2 Assessments to conclude or exclude health conditions .75
12.7.3 Healthcare needs Assessment .76
12.7.4 Clinical risk assessment .78
12.7.5 Healthcare evaluation . .78
12.8 Care plan .80
12.9 Clusters complementing the information structures for single clinical concepts .83
12.9.1 Activity Management including healthcare planning .83
12.9.2 Assessment scale representation .84
12.9.3 Association .84
12.9.4 Clinical Context . .85
12.9.5 Clinical process concern .87
12.9.6 Clinical risk .87
12.9.7 Consideration .88
12.9.8 Knowledge base .89
12.9.9 Method specification .90
12.9.10 Priority Level .91
12.9.11 Version information .92
12.10 Compound structures as combinations of the Contsys based clinical reference
information structures for clinical content and clinical context .93
12.10.1 Personal health record overview .93
12.10.2 Professional health record overview .93
12.10.3 Knowledge based healthcare activity planning of healthcare investigations .93
12.10.4 Knowledge based healthcare activity planning of healthcare treatments .94
Bibliography .95
iv © ISO 2019 – All rights reserved

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SIST EN ISO 13606-3:2019
ISO 13606-3:2019(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health Informatics.
This second edition cancels and replaces the first edition (ISO 13606-3:2009), which has been technically
revised. The main changes compared to the previous edition are summarised in the Introduction.
A list of all parts in the ISO 13606 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
© ISO 2019 – All rights reserved v

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SIST EN ISO 13606-3:2019
ISO 13606-3:2019(E)

Introduction
0.1  General
This document is part of a five-part series of standards, published jointly by CEN and ISO through the
Vienna Agreement. In this document, dependency upon any of the other parts of this series of standards
is explicitly stated where it applies.
0.2  Preface
ISO 13606-3 defines two kinds of specifications.
1) A normative set of (coded) term lists that each defines a controlled vocabulary for a Reference
Model attribute that is defined in ISO 13606-1;
2) A set of Reference Archetypes that specify how the ISO 13606-1 Reference Model should be applied
for communicating information for:
— null_flavor;
— access policies;
— demographic entities;
— example clinical reference archetypes, conforming to ISO 13940 (Contsys).
0.3  Term Lists
Each term list is referenced by its corresponding attribute as an invariant constraint in ISO 13606-1,
by referring to its term list name. For each term list, every code value is accompanied by a phrase and
description; however, in each case it is the code that is used as the Reference Model attribute value.
Language translations of the phrase and description will therefore not affect the instances of RECORD_
COMPONENT that are communicated using this document.
Should any revision prove necessary in the future to these term lists, a technical revision to this
document will be required. Such a revised document should specify an updated Reference Model
identifier that should then be used as the value of the rm_id of an EHR_EXTRACT, to inform the recipient
of the version of this document that was used in its creation.
0.4  Reference archetypes
An archetype, sometimes known as a clinical model, specifies a pattern for representing an aspect of
clinical documentation within an electronic health record. An archetype defines the structural and
semantic relationships between fine-grained data items, including the domains of content each data
item may contain in order to be a valid component of that archetype. The concept of archetypes is
outlined in the introduction of ISO 13606-1, and the formal representation of archetypes is specified
in ISO 13606-2. Archetypes are used in this document to shape parts of an EHR extract, in order to
provide predictability of the way in which clinical information is represented within it.
Given the vast domain of health and healthcare, there might eventually be hundreds of archetypes
covering its many different documentation and communication needs. Because archetypes might be
created by different communities in different countries and settings, there is a risk that archetypes
for similar areas of documentation will be made differently by different groups, and therefore hamper
interoperability. Reference archetypes are archetypes that represent very fundamental areas of clinical
documentation, which might be used as they are or may serve as a kind of base pattern for more
specialised archetypes. By acting as the base pattern for a set of specialised archetypes, the members
of the set are likely to be better structurally and semantically aligned with each other. Their use will
facilitate semantic interopera
...

SLOVENSKI STANDARD
SIST EN ISO 13606-3:2019
01-september-2019
Nadomešča:
SIST EN 13606-3:2008
Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju
zdravstva - 3. del: Referenčni arhetipi in seznami izrazov (ISO 13606-3:2019)
Health informatics - Electronic health record communication - Part 3: Reference
archetypes and term lists (ISO 13606-3:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 3: Referenzarchetypen und Begriffslisten (ISO 13606-3:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 3:
Archétypes de référence et listes de termes (ISO 13606-3:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-3:2019
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13606-3:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 13606-3:2019

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SIST EN ISO 13606-3:2019


EN ISO 13606-3
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13606-3:2008
English Version

Health informatics - Electronic health record
communication - Part 3: Reference archetypes and term
lists (ISO 13606-3:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 3: Archétypes de référence et Patientendaten in elektronischer Form - Teil 3:
listes de termes (ISO 13606-3:2019) Referenzarchetypen und Begriffslisten (ISO 13606-
3:2019)
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 13606-3:2019 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 13606-3:2019
EN ISO 13606-3:2019 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 13606-3:2019
EN ISO 13606-3:2019 (E)
European foreword
This document (EN ISO 13606-3:2019) 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 13606-3:2008.
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 13606-3:2019 has been approved by CEN as EN ISO 13606-3:2019 without any
modification.

3

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SIST EN ISO 13606-3:2019

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SIST EN ISO 13606-3:2019
INTERNATIONAL ISO
STANDARD 13606-3
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 3:
Reference archetypes and term lists
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 3: Archétypes de référence et listes de termes
Reference number
ISO 13606-3:2019(E)
©
ISO 2019

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SIST EN ISO 13606-3:2019
ISO 13606-3:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© 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

---------------------- Page: 8 ----------------------

SIST EN ISO 13606-3:2019
ISO 13606-3:2019(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 2
5 Conformance . 2
6 Term lists . 2
6.1 Introduction . 2
6.2 Termlist SUBJECT_CATEGORY, Class ENTRY, attribute subject_of_information_category . 3
6.3 Termlist VERSION_STATUS, Class BASE_COMPONENT, attribute version_status. 3
6.4 Termlist MODE, Reference Archetype Healthcare activity participation . 4
6.5 Class LINK, attribute link_description . 4
6.5.1 Termlist RELATED_TO, Class LINK, attribute link_description . 5
6.5.2 Termlist AUTHORISED_BY, Class LINK, attribute link_description . 5
6.5.3 Termlist SAME_HEALTH_ISSUE, Class LINK, attribute link_description . 6
6.5.4 Termlist SAME_PLAN, Class LINK, attribute link_description . 8
6.5.5 Termlist RELATED_DOCUMENTATION, Class LINK, attribute link_description . 8
6.6 Termlist, Class EXTERNAL_LINK, attribute target_information_type . 9
6.7 Termlist, Classes ELEMENT and DEMOGRAPHIC_ELEMENT, attribute null_flavour .10
6.8 Termlist, Class ATTACHMENT, attribute IntegrityCheckAlgorithm .10
7 Reference archetype for null_flavor .10
7.1 Archetype name: Null_flavor .10
8 Reference archetype for the access policy COMPOSITION .11
8.1 Archetype name: Access_policy_rule .11
9 Reference archetypes for demographic entities .12
9.1 Archetype name: EntityIdentifier .12
9.2 Archetype name: useablePeriod .13
9.3 Archetype name: LocationAddress .13
9.4 Archetype name: TelecommunicationAddress .14
9.5 Archetype name: Address . .16
9.6 Archetype name: Namepart .17
9.7 Archetype name: PersonName .18
9.8 Archetype name: Person.19
9.9 Archetype name: HealthcareOrganization .20
9.10 Archetype name: ServiceDepartment .21
9.11 Archetype name: HealthcarePersonnel .22
9.12 Archetype name: MedicalDevice .23
9.13 Archetype name: SubjectOfInformation .25
9.14 Archetype name: Contact .25
9.15 Archetype name: HealthcareActivityParticipation .26
9.16 Archetype name: HealthcareActivityFacility .26
9.17 Archetype name: HealthcareActivityFramework .27
9.18 Summary of demographic-related data types in ISO 21090 .27
9.18.1 Identification and Location Datatypes .27
9.18.2 Name and Address Datatypes .29
10 Reference archetypes for medicinal product .31
10.1 Archetype name: MedicinalProduct .31
11 Reference archetypes for clinical information specifications .37
11.1 General .37
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11.2 Archetype name: Health condition .38
11.3 Archetype name: Healthcare activity element.42
11.4 Archetype name: ClinicalContext .47
11.5 Archetype name: Activity management .49
11.6 Archetype name: Association .50
11.7 Archetype name: Consideration.51
11.8 Archetype name: Dosage .52
11.9 Archetype name: Method .52
12 Contsys-based clinical reference information structures as the basis for
development of clinical archetypes .54
12.1 Introduction .54
12.1.1 Criteria/characteristics .56
12.1.2 Basic concepts as bases for the Contsys-based information structure .56
12.1.3 Method for development of Contsys-based clinical reference information
structures .56
12.1.4 Steps in defining the information structures .57
12.2 Content of information structures .58
12.2.1 Structures for single concepts .58
12.2.2 Structures for reuse in clinical situations — Clusters complementing
structures for basic clinical concepts .58
12.2.3 Structures for compound documents in an EHR .59
12.2.4 Other comments .59
12.2.5 Format .60
12.3 Specializations of types of Health condition .60
12.4 Information structures for single concepts .61
12.4.1 Health condition .61
12.5 Healthcare activity element .67
12.5.1 Performer .72
12.6 Pharmacological treatment .73
12.6.1 Pharmacological treatment .73
12.6.2 Dosage .74
12.7 Indirect healthcare activity elements .74
12.7.1 Healthcare assessment .75
12.7.2 Assessments to conclude or exclude health conditions .75
12.7.3 Healthcare needs Assessment .76
12.7.4 Clinical risk assessment .78
12.7.5 Healthcare evaluation . .78
12.8 Care plan .80
12.9 Clusters complementing the information structures for single clinical concepts .83
12.9.1 Activity Management including healthcare planning .83
12.9.2 Assessment scale representation .84
12.9.3 Association .84
12.9.4 Clinical Context . .85
12.9.5 Clinical process concern .87
12.9.6 Clinical risk .87
12.9.7 Consideration .88
12.9.8 Knowledge base .89
12.9.9 Method specification .90
12.9.10 Priority Level .91
12.9.11 Version information .92
12.10 Compound structures as combinations of the Contsys based clinical reference
information structures for clinical content and clinical context .93
12.10.1 Personal health record overview .93
12.10.2 Professional health record overview .93
12.10.3 Knowledge based healthcare activity planning of healthcare investigations .93
12.10.4 Knowledge based healthcare activity planning of healthcare treatments .94
Bibliography .95
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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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health Informatics.
This second edition cancels and replaces the first edition (ISO 13606-3:2009), which has been technically
revised. The main changes compared to the previous edition are summarised in the Introduction.
A list of all parts in the ISO 13606 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
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SIST EN ISO 13606-3:2019
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Introduction
0.1  General
This document is part of a five-part series of standards, published jointly by CEN and ISO through the
Vienna Agreement. In this document, dependency upon any of the other parts of this series of standards
is explicitly stated where it applies.
0.2  Preface
ISO 13606-3 defines two kinds of specifications.
1) A normative set of (coded) term lists that each defines a controlled vocabulary for a Reference
Model attribute that is defined in ISO 13606-1;
2) A set of Reference Archetypes that specify how the ISO 13606-1 Reference Model should be applied
for communicating information for:
— null_flavor;
— access policies;
— demographic entities;
— example clinical reference archetypes, conforming to ISO 13940 (Contsys).
0.3  Term Lists
Each term list is referenced by its corresponding attribute as an invariant constraint in ISO 13606-1,
by referring to its term list name. For each term list, every code value is accompanied by a phrase and
description; however, in each case it is the code that is used as the Reference Model attribute value.
Language translations of the phrase and description will therefore not affect the instances of RECORD_
COMPONENT that are communicated using this document.
Should any revision prove necessary in the future to these term lists, a technical revision to this
document will be required. Such a revised document should specify an updated Reference Model
identifier that should then be used as the value of the rm_id of an EHR_EXTRACT, to inform the recipient
of the version of this document that was used in its creation.
0.4  Reference archetypes
An archetype, sometimes known as a clinical model, specifies a pattern for representing an aspect of
clinical documentation within an electronic health record. An archetype defines the structural and
semantic relationships between fine-grained data items, including the domains of content each data
item may contain in order to be a valid component of that archetype. The concept of archetypes is
outlined in the introduction of ISO 13606-1, and the formal representation of archetypes is specified
in ISO 13606-2. Archetypes are used in this document to shape parts of an EHR extract, in order to
provide predictability of the way in which clinical information is represented within it.
Given the vast domain of health and healthcare, there might eventually be hundreds of archetypes
covering its many different documentation and communication needs. Because archetypes might be
created by different communities in different countries and settings, there is a risk that archetypes
for similar areas of documentation will be made differently by different groups, and therefore hamper
interoperability. Reference archetypes are archetypes that represent very fundamental areas of clinical
documentation, which might be used as they are or may serve as a kind of base pattern for more
specialised archetypes. By acting as the base pattern for a set of specialised archetypes, the members
of the set are likely to be better structurally and semantically aligned with each other. Their use will
...