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

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), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system.
This document defines term lists that each specify the set of values for the particular attributes of the Reference Model defined in ISO 13606-1. It also defines normative and informative Reference Archetypes that enable frequently-occurring instances of EHR data to be represented within a consistent structure when communicated using this document.

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
Withdrawn
Publication Date
30-Oct-2019
Withdrawal Date
30-Jan-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
03-Jul-2019
Completion Date
03-Jul-2019

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 13606-3:2019
---------------------- Page: 2 ----------------------
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

---------------------- 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.
---------------------- Page: 5 ----------------------
SIST EN ISO 13606-3:2019
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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

© 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
---------------------- Page: 10 ----------------------
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
---------------------- Page: 11 ----------------------
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
---------------------- Page: 2 ----------------------
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

---------------------- 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.
---------------------- Page: 5 ----------------------
SIST EN ISO 13606-3:2019
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
SIST EN ISO 13606-3:2019
ISO 13606-3:2019(E)
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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

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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

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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

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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).

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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

...

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