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

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

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

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

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

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

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

General Information

Status
Published
Publication Date
02-Jul-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
03-Jul-2019
Completion Date
03-Jul-2019

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SLOVENSKI STANDARD
SIST EN ISO 13606-2:2019
01-september-2019
Nadomešča:
SIST EN 13606-2:2008
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 2.
del: Specifikacija za zamenjavo arhetipov (ISO 13606-2:2019)
Health informatics - Electronic health record communication - Part 2: Archetype
interchange specification (ISO 13606-2:2019)

Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -

Teil 2: Spezifikation für den Austausch von Archetypen (ISO 13606-2:2019)

Informatique de santé - Communication du dossier de santé informatisé - Partie 2:

Spécification d'échange d'archétype (ISO 13606-2:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-2:2019
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13606-2:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13606-2:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 13606-2:2019
EN ISO 13606-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13606-2:2007
English Version
Health informatics - Electronic health record
communication - Part 2: Archetype interchange
specification (ISO 13606-2:2019)

Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von

santé informatisé - Partie 2: Spécification d'échange Patientendaten in elektronischer Form - Teil 2:

d'archétype (ISO 13606-2:2019) Spezifikation für den Austausch von Archetypen (ISO

13606-2:2019)
This European Standard was approved by CEN on 2 July 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-2:2019 E

worldwide for CEN national Members.
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SIST EN ISO 13606-2:2019
EN ISO 13606-2:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 13606-2:2019
EN ISO 13606-2:2019 (E)
European foreword

This document (EN ISO 13606-2:2019) has been prepared by Technical Committee ISO/TC 215 "Health

informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by January 2020, and conflicting national standards shall

be withdrawn at the latest by January 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 13606-2:2007.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 13606-2:2019 has been approved by CEN as EN ISO 13606-2:2019 without any

modification.
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SIST EN ISO 13606-2:2019
---------------------- Page: 6 ----------------------
SIST EN ISO 13606-2:2019
INTERNATIONAL ISO
STANDARD 13606-2
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 2:
Archetype interchange specification
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 2: Spécification d'échange d'archétype
Reference number
ISO 13606-2:2019(E)
ISO 2019
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SIST EN ISO 13606-2:2019
ISO 13606-2:2019(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 13606-2:2019
ISO 13606-2:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Abbreviations........................................................................................................................................................................................................... 2

5 Conformance ............................................................................................................................................................................................................. 2

6 Archetype representation requirements .................................................................................................................................... 3

6.1 General ........................................................................................................................................................................................................... 3

6.2 Archetype definition, description and publication information .................................................................. 3

6.3 Archetype node constraints ......................................................................................................................................................... 6

6.4 Data value constraints ...................................................................................................................................................................... 8

7 Archetype object model .............................................................................................................................................................................10

7.1 Preface .........................................................................................................................................................................................................10

7.1.1 Purpose .................................................................................................................................................................................10

7.1.2 Nomenclature ..................................................................................................................................................................10

7.2 Model overview ...................................................................................................................................................................................10

7.2.1 Package structure .........................................................................................................................................................10

7.2.2 Definition and utility classes ..............................................................................................................................11

7.3 The archetype package .................................................................................................................................................................13

7.3.1 Overview ..............................................................................................................................................................................13

7.3.2 Archetype identification .........................................................................................................................................15

7.3.3 Top-level meta-data ........................................................................................................................................... .........16

7.3.4 Governance meta-data .............................................................................................................................................16

7.3.5 Structural definition...................................................................................................................................................18

7.3.6 Class descriptions ........................................................................................................................................................22

7.3.7 Validity rules .....................................................................................................................................................................29

7.4 Constraint model package ..........................................................................................................................................................30

7.4.1 Overview ..............................................................................................................................................................................30

7.4.2 Semantics ............................................................................................................................................................................32

7.4.3 Second order constraints.......................................................................................................................................38

7.4.4 AOM type substitutions ...........................................................................................................................................39

7.4.5 Class definitions.............................................................................................................................................................41

7.5 The rules package ..............................................................................................................................................................................56

7.5.1 Overview ..............................................................................................................................................................................56

7.5.2 Semantics ............................................................................................................................................................................57

7.5.3 Class descriptions ........................................................................................................................................................57

7.6 Terminology package .....................................................................................................................................................................62

7.6.1 Overview ..............................................................................................................................................................................62

7.6.2 Semantics ............................................................................................................................................................................64

7.6.3 Class descriptions ........................................................................................................................................................65

7.7 Templates..................................................................................................................................................................................................67

Annex A (informative) Archetype Definition Language .................................................................................................................69

Annex B (informative) Example Representation ..................................................................................................................................70

Bibliography .............................................................................................................................................................................................................................71

© ISO 2019 – All rights reserved iii
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SIST EN ISO 13606-2:2019
ISO 13606-2:2019(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 of 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 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 13606-2:2008), which has been

technically revised. The main changes compared to the previous edition are as follows:

— Introduction of new internal coding scheme, consisting of id-codes, at-codes and ac-codes.

— Replace string archetype identifier with multi-part, namespace identifier.

— Addition of explicit value-sets replacing in-line value sets in the terms and definitions.

— Renaming archetype ontology section to terminology.
— Expression of all external term bindings as URIs following IHTSDO format.

— Introduction of ‘tuple’ constraints for co-varying attributes within Quantity, Ordinal structures.

— Re-engineering of all primitive constrainer types, i.e. C_STRING, C_DATE etc.
— Removal of the Archetype Profile specification.

— Full specialisation support: the addition of an attribute to the C_ATTRIBUTE class, allowing the

inclusion of a path that enables specialised archetype redefinitions deep within a structure.

— Addition of node-level annotations.
— Structural simplification of archetype ontology section.

— The name of the invariant section has been changed to rules, to better reflect its purpose.

— A template is now just an archetype.
A list of all parts in the ISO 13606 series can be found on the ISO website.
iv © ISO 2019 – All rights reserved
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SIST EN ISO 13606-2:2019
ISO 13606-2:2019(E)

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 13606-2:2019
ISO 13606-2:2019(E)
Introduction

This document is part of a five-part standard series, published jointly by CEN and ISO through the

Vienna Agreement. In this document dependency upon any of the other parts of this series is explicitly

stated where it applies.

Comprehensive, multi-enterprise and longitudinal electronic health records will often in practice be

achieved through the joining up of multiple clinical applications, databases (and increasingly devices)

that are each tailored to the needs of individual conditions, specialties or enterprises.

This requires that Electronic Health Record (EHR) data from diverse systems be capable of being

mapped to and from a single comprehensive representation, which is used to underpin interfaces

and messages within a distributed network (federation) of EHR systems and services. This common

representation has to be sufficiently generic and rich to represent any conceivable health record data,

comprising part or all of an EHR (or a set of EHRs) being communicated.

The approach adopted in the ISO 13606 standards series, underpinned by international research on the

EHR, has been to define a rigorous and generic Reference Model that is suitable for all kinds of data and

data structures within an EHR, and in which all labelling and context information is an integral part of

each construct. An EHR Extract (as defined in ISO 13606-1) will contain all of the names, structure and

context required for it to be interpreted faithfully on receipt even if its organisation and the nature of

the clinical content have not been “agreed” in advance.

However, the wide-scale sharing of health records, and their meaningful analysis across distributed

sites, also requires that a consistent approach is used for the clinical (semantic) data structures that

will be communicated via the Reference Model, so that equivalent clinical information is represented

consistently. This is necessary in order for clinical applications and analysis tools safely to process EHR

data that have come from heterogeneous sources.
0.1 Archetypes

The challenge for EHR interoperability is therefore to devise a generalised approach to representing

every conceivable kind of health record data structure in a consistent way. This needs to cater for

records arising from any profession, speciality or service, whilst recognising that the clinical data sets,

value sets, templates etc. required by different health care domains will be diverse, complex and will

change frequently as clinical practice and medical knowledge advance. This requirement is part of the

widely acknowledged health informatics challenge of semantic interoperability.

The approach adopted by this standard series distinguishes a Reference Model, used to represent the

generic properties of health record information, and Archetypes (conforming to an Archetype Model),

which are meta-data used to define patterns for the specific characteristics of the clinical data that

represent the requirements of each particular profession, speciality or service.

The Reference Model is specified as an Open Distributed Processing (ODP) Information Viewpoint

model, representing the global characteristics of health record components, how they are aggregated,

and the context information required to meet ethical, legal and provenance requirements. In the 13606

standards series, the Reference Model is defined in Part 1. This model defines the set of classes that

form the generic building blocks of the EHR. It reflects the stable characteristics of an electronic health

record, and would be embedded in a distributed (federated) EHR environment as specific messages or

interfaces (as specified in Part 5 of this standard series).

Archetypes are effectively pre-coordinated combinations of named RECORD_COMPONENT hierarchies

that are agreed within a community in order to ensure semantic interoperability, data consistency and

data quality.

For an EHR_EXTRACT, as defined in ISO 13606-1, an archetype specifies (and effectively constrains)

a particular hierarchy of RECORD_COMPONENT sub-classes, defining or constraining their names

and other relevant attribute values, optionality and multiplicity at any point in the hierarchy, the

datatypes and value ranges that ELEMENT data values can take, and might include other dependency

constraints. Archetype instances themselves conform to a formal model, known as an Archetype Model

vi © ISO 2019 – All rights reserved
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SIST EN ISO 13606-2:2019
ISO 13606-2:2019(E)

(which is a constraint model, also specified as an ODP Information Viewpoint Model). Although the

Archetype Model is stable, individual archetype instances can be revised or succeeded by others as

clinical practice evolves. Version control ensures that new revisions do not invalidate data created with

previous revisions.

Archetypes can be used within EHR systems to govern the EHR data committed to a repository.

However, for the purposes of this interoperability standard series, no assumption is made about the

use of archetypes within the EHR Provider system whenever this standard series is used for EHR

communication. It is assumed that the original EHR data, if not already archetyped, can be mapped to a

set of archetypes, if desired, when generating the EHR_EXTRACT.

The reference model defined in ISO 13606-1 has a property that can be used to specify the archetype

to which any RECORD_COMPONENT within an EHR_EXTRACT conforms. The class RECORD_

COMPONENT includes an attribute archetype_id to identify the archetype and node to which that

RECORD_COMPONENT conforms.

Part 3 of this standard series includes a set of Reference Archetypes: which are base archetypes that

are likely to be specialised further before they are used. Those archetypes are example instances of

this Archetype Model.

The Archetype Model specified in this document was originally developed by the openEHR Foundation,

which publishes its archetypes using Archetype Definition Language, conforming to this Archetype

Model, referenced within Annex A. The Archetype Model has been the subject of collaborative updating

to incorporate the requirements and modelling inputs from the Clinical Information Modeling Initiative

(CIMI). CIMI is in the process of submitting a modelling language (Archetype Modeling Language, AML)

to the Object Management Group. AML also aligns to this Archetype Model.
0.2 Archetype datatypes

It should be noted that ISO 13606-1 and ISO 13606-2 use datatypes for different purposes.

Part 1 defines datatypes to represent the properties of the Reference Model, as a profile of ISO 21090,

in 5.3. It separately defines in Clause 7 the data types that can be the values of Element, also a subset

of ISO 21090. All these datatypes are finally expressed in terms of the so-called “primitive” datatypes

(Integer, Real, String, Boolean, Date/Time/Datetime).

Part 2 uses the same set of primitive datatypes to represent the properties of the Archetype Object

Model. Additionally, Part 2 defines a set of classes that allow defining constraints over primitive

datatypes of Part 1. These constraining classes are shown in Figure 9 of Part 2, as descendants of the

C_PRIMITIVE_OBJECT class.

A single Part 1 complex datatype (e.g. PHYSICAL_QUANTITY) can be constrained by a combination of

the constraining classes of the Archetype Object Model, defining constraints on both the complex and

primitive datatypes it contains. Thus, Part 1 complex datatypes are treated as classes when defining

constraints with Part 2, while Part 1 primitive data types are constrained by the C_PRIMITIVE_OBJECT

hierarchy.

An example of a PHYSICAL_QUANTITY archetype can be seen in the example below. In this example,

the value on a PHYSICAL_QUANTITY shall be between 0.0 and 1000.0 and their units shall be UCUM

‘mm[Hg]’ code.
PHYSICAL_QUANTITY matches {
value matches {|0.0..<1000.0|}
units matches {
CODED_SIMPLE matches {
value matches {"mm[Hg]"}
© ISO 2019 – All rights reserved vii
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SIST EN ISO 13606-2:2019
ISO 13606-2:2019(E)
}
}
}

This example archetype, expressed in terms of the Archetype Object Model, would have the structure

shown in Table 1.
Table 1 — Example structure for representing physical quantity
Reference Model class, attribute or primitive
Archetype Model constraining class
value
PHYSICAL_QUANTITY C_COMPLEX_OBJECT
value C_ATTRIBUTE
Real C_REAL
units C_ATTRIBUTE
CODED_SIMPLE C_COMPLEX_OBJECT

value C_ATTRIBUTE

String C_STRING

Since the Archetype Object Model is also used to constrain other reference models, as for example

the openEHR Reference Model, there will be a need to transform openEHR archetypes to ISO 13606

archetypes, and vice versa. The openEHR Reference Model also uses the same primitive datatypes, but

includes a different set of complex datatypes, such as DV_ORDINAL, or DV_TEXT . When transforming

an openEHR archetype constraint to an ISO 13606 archetype, it might be necessary to introduce an

additional CLUSTER structure to represent the equivalent openEHR sub-components as ELEMENTs.

For example, a representation of an openEHR DV_ORDINAL in ISO 13606 would have the structure

shown in Table 2.
Table 2 — Example structure for representing an ordinal data value
openEHR ISO 13606
DV_ORDINAL CLUSTER matches { -- DV_ORDINAL
parts matches {
symbol ELEMENT matches { -- symbol
value matches {

DV_CODED_TEXT CODED_VALUE matches {*}

}
}
value ELEMENT matches { -- value
value matches {
Integer INTEGER matches {*}
}
}
}

An example of how the LINK class defined in Part 1 of this standard series can be represented using the

Archetype Object Model defined in this document is given in Annex B.

1) Please see http: //www .openehr .org/releases/RM/latest/docs/data _types/data _types .html # _text _package for

the specification of this datatype.
viii © ISO 2019 – All rights reserved
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SIST EN ISO 13606-2:2019
ISO 13606-2:2019(E)
0.3 Archetype repositories

The range of archetypes required within a shared EHR community will depend upon i

...

SLOVENSKI STANDARD
SIST EN ISO 13606-2:2019
01-september-2019
Nadomešča:
SIST EN 13606-2:2008
Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju
zdravstva - 2. del: Specifikacija za zamenjavo arhetipov (ISO 13606-2:2019)
Health informatics - Electronic health record communication - Part 2: Archetype
interchange specification (ISO 13606-2:2019)

Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -

Teil 2: Spezifikation für den Austausch von Archetypen (ISO 13606-2:2019)

Informatique de santé - Communication du dossier de santé informatisé - Partie 2:

Spécification d'échange d'archétype (ISO 13606-2:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-2:2019
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13606-2:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13606-2:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 13606-2:2019
EN ISO 13606-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13606-2:2007
English Version
Health informatics - Electronic health record
communication - Part 2: Archetype interchange
specification (ISO 13606-2:2019)

Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von

santé informatisé - Partie 2: Spécification d'échange Patientendaten in elektronischer Form - Teil 2:

d'archétype (ISO 13606-2:2019) Spezifikation für den Austausch von Archetypen (ISO

13606-2:2019)
This European Standard was approved by CEN on 2 July 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-2:2019 E

worldwide for CEN national Members.
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SIST EN ISO 13606-2:2019
EN ISO 13606-2:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 13606-2:2019
EN ISO 13606-2:2019 (E)
European foreword

This document (EN ISO 13606-2:2019) has been prepared by Technical Committee ISO/TC 215 "Health

informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the

secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by January 2020, and conflicting national standards shall

be withdrawn at the latest by January 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN 13606-2:2007.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 13606-2:2019 has been approved by CEN as EN ISO 13606-2:2019 without any

modification.
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SIST EN ISO 13606-2:2019
INTERNATIONAL ISO
STANDARD 13606-2
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 2:
Archetype interchange specification
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 2: Spécification d'échange d'archétype
Reference number
ISO 13606-2:2019(E)
ISO 2019
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ISO 13606-2:2019(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
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Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Abbreviations........................................................................................................................................................................................................... 2

5 Conformance ............................................................................................................................................................................................................. 2

6 Archetype representation requirements .................................................................................................................................... 3

6.1 General ........................................................................................................................................................................................................... 3

6.2 Archetype definition, description and publication information .................................................................. 3

6.3 Archetype node constraints ......................................................................................................................................................... 6

6.4 Data value constraints ...................................................................................................................................................................... 8

7 Archetype object model .............................................................................................................................................................................10

7.1 Preface .........................................................................................................................................................................................................10

7.1.1 Purpose .................................................................................................................................................................................10

7.1.2 Nomenclature ..................................................................................................................................................................10

7.2 Model overview ...................................................................................................................................................................................10

7.2.1 Package structure .........................................................................................................................................................10

7.2.2 Definition and utility classes ..............................................................................................................................11

7.3 The archetype package .................................................................................................................................................................13

7.3.1 Overview ..............................................................................................................................................................................13

7.3.2 Archetype identification .........................................................................................................................................15

7.3.3 Top-level meta-data ........................................................................................................................................... .........16

7.3.4 Governance meta-data .............................................................................................................................................16

7.3.5 Structural definition...................................................................................................................................................18

7.3.6 Class descriptions ........................................................................................................................................................22

7.3.7 Validity rules .....................................................................................................................................................................29

7.4 Constraint model package ..........................................................................................................................................................30

7.4.1 Overview ..............................................................................................................................................................................30

7.4.2 Semantics ............................................................................................................................................................................32

7.4.3 Second order constraints.......................................................................................................................................38

7.4.4 AOM type substitutions ...........................................................................................................................................39

7.4.5 Class definitions.............................................................................................................................................................41

7.5 The rules package ..............................................................................................................................................................................56

7.5.1 Overview ..............................................................................................................................................................................56

7.5.2 Semantics ............................................................................................................................................................................57

7.5.3 Class descriptions ........................................................................................................................................................57

7.6 Terminology package .....................................................................................................................................................................62

7.6.1 Overview ..............................................................................................................................................................................62

7.6.2 Semantics ............................................................................................................................................................................64

7.6.3 Class descriptions ........................................................................................................................................................65

7.7 Templates..................................................................................................................................................................................................67

Annex A (informative) Archetype Definition Language .................................................................................................................69

Annex B (informative) Example Representation ..................................................................................................................................70

Bibliography .............................................................................................................................................................................................................................71

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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 of 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 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 13606-2:2008), which has been

technically revised. The main changes compared to the previous edition are as follows:

— Introduction of new internal coding scheme, consisting of id-codes, at-codes and ac-codes.

— Replace string archetype identifier with multi-part, namespace identifier.

— Addition of explicit value-sets replacing in-line value sets in the terms and definitions.

— Renaming archetype ontology section to terminology.
— Expression of all external term bindings as URIs following IHTSDO format.

— Introduction of ‘tuple’ constraints for co-varying attributes within Quantity, Ordinal structures.

— Re-engineering of all primitive constrainer types, i.e. C_STRING, C_DATE etc.
— Removal of the Archetype Profile specification.

— Full specialisation support: the addition of an attribute to the C_ATTRIBUTE class, allowing the

inclusion of a path that enables specialised archetype redefinitions deep within a structure.

— Addition of node-level annotations.
— Structural simplification of archetype ontology section.

— The name of the invariant section has been changed to rules, to better reflect its purpose.

— A template is now just an archetype.
A list of all parts in the ISO 13606 series can be found on the ISO website.
iv © ISO 2019 – All rights reserved
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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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Introduction

This document is part of a five-part standard series, published jointly by CEN and ISO through the

Vienna Agreement. In this document dependency upon any of the other parts of this series is explicitly

stated where it applies.

Comprehensive, multi-enterprise and longitudinal electronic health records will often in practice be

achieved through the joining up of multiple clinical applications, databases (and increasingly devices)

that are each tailored to the needs of individual conditions, specialties or enterprises.

This requires that Electronic Health Record (EHR) data from diverse systems be capable of being

mapped to and from a single comprehensive representation, which is used to underpin interfaces

and messages within a distributed network (federation) of EHR systems and services. This common

representation has to be sufficiently generic and rich to represent any conceivable health record data,

comprising part or all of an EHR (or a set of EHRs) being communicated.

The approach adopted in the ISO 13606 standards series, underpinned by international research on the

EHR, has been to define a rigorous and generic Reference Model that is suitable for all kinds of data and

data structures within an EHR, and in which all labelling and context information is an integral part of

each construct. An EHR Extract (as defined in ISO 13606-1) will contain all of the names, structure and

context required for it to be interpreted faithfully on receipt even if its organisation and the nature of

the clinical content have not been “agreed” in advance.

However, the wide-scale sharing of health records, and their meaningful analysis across distributed

sites, also requires that a consistent approach is used for the clinical (semantic) data structures that

will be communicated via the Reference Model, so that equivalent clinical information is represented

consistently. This is necessary in order for clinical applications and analysis tools safely to process EHR

data that have come from heterogeneous sources.
0.1 Archetypes

The challenge for EHR interoperability is therefore to devise a generalised approach to representing

every conceivable kind of health record data structure in a consistent way. This needs to cater for

records arising from any profession, speciality or service, whilst recognising that the clinical data sets,

value sets, templates etc. required by different health care domains will be diverse, complex and will

change frequently as clinical practice and medical knowledge advance. This requirement is part of the

widely acknowledged health informatics challenge of semantic interoperability.

The approach adopted by this standard series distinguishes a Reference Model, used to represent the

generic properties of health record information, and Archetypes (conforming to an Archetype Model),

which are meta-data used to define patterns for the specific characteristics of the clinical data that

represent the requirements of each particular profession, speciality or service.

The Reference Model is specified as an Open Distributed Processing (ODP) Information Viewpoint

model, representing the global characteristics of health record components, how they are aggregated,

and the context information required to meet ethical, legal and provenance requirements. In the 13606

standards series, the Reference Model is defined in Part 1. This model defines the set of classes that

form the generic building blocks of the EHR. It reflects the stable characteristics of an electronic health

record, and would be embedded in a distributed (federated) EHR environment as specific messages or

interfaces (as specified in Part 5 of this standard series).

Archetypes are effectively pre-coordinated combinations of named RECORD_COMPONENT hierarchies

that are agreed within a community in order to ensure semantic interoperability, data consistency and

data quality.

For an EHR_EXTRACT, as defined in ISO 13606-1, an archetype specifies (and effectively constrains)

a particular hierarchy of RECORD_COMPONENT sub-classes, defining or constraining their names

and other relevant attribute values, optionality and multiplicity at any point in the hierarchy, the

datatypes and value ranges that ELEMENT data values can take, and might include other dependency

constraints. Archetype instances themselves conform to a formal model, known as an Archetype Model

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(which is a constraint model, also specified as an ODP Information Viewpoint Model). Although the

Archetype Model is stable, individual archetype instances can be revised or succeeded by others as

clinical practice evolves. Version control ensures that new revisions do not invalidate data created with

previous revisions.

Archetypes can be used within EHR systems to govern the EHR data committed to a repository.

However, for the purposes of this interoperability standard series, no assumption is made about the

use of archetypes within the EHR Provider system whenever this standard series is used for EHR

communication. It is assumed that the original EHR data, if not already archetyped, can be mapped to a

set of archetypes, if desired, when generating the EHR_EXTRACT.

The reference model defined in ISO 13606-1 has a property that can be used to specify the archetype

to which any RECORD_COMPONENT within an EHR_EXTRACT conforms. The class RECORD_

COMPONENT includes an attribute archetype_id to identify the archetype and node to which that

RECORD_COMPONENT conforms.

Part 3 of this standard series includes a set of Reference Archetypes: which are base archetypes that

are likely to be specialised further before they are used. Those archetypes are example instances of

this Archetype Model.

The Archetype Model specified in this document was originally developed by the openEHR Foundation,

which publishes its archetypes using Archetype Definition Language, conforming to this Archetype

Model, referenced within Annex A. The Archetype Model has been the subject of collaborative updating

to incorporate the requirements and modelling inputs from the Clinical Information Modeling Initiative

(CIMI). CIMI is in the process of submitting a modelling language (Archetype Modeling Language, AML)

to the Object Management Group. AML also aligns to this Archetype Model.
0.2 Archetype datatypes

It should be noted that ISO 13606-1 and ISO 13606-2 use datatypes for different purposes.

Part 1 defines datatypes to represent the properties of the Reference Model, as a profile of ISO 21090,

in 5.3. It separately defines in Clause 7 the data types that can be the values of Element, also a subset

of ISO 21090. All these datatypes are finally expressed in terms of the so-called “primitive” datatypes

(Integer, Real, String, Boolean, Date/Time/Datetime).

Part 2 uses the same set of primitive datatypes to represent the properties of the Archetype Object

Model. Additionally, Part 2 defines a set of classes that allow defining constraints over primitive

datatypes of Part 1. These constraining classes are shown in Figure 9 of Part 2, as descendants of the

C_PRIMITIVE_OBJECT class.

A single Part 1 complex datatype (e.g. PHYSICAL_QUANTITY) can be constrained by a combination of

the constraining classes of the Archetype Object Model, defining constraints on both the complex and

primitive datatypes it contains. Thus, Part 1 complex datatypes are treated as classes when defining

constraints with Part 2, while Part 1 primitive data types are constrained by the C_PRIMITIVE_OBJECT

hierarchy.

An example of a PHYSICAL_QUANTITY archetype can be seen in the example below. In this example,

the value on a PHYSICAL_QUANTITY shall be between 0.0 and 1000.0 and their units shall be UCUM

‘mm[Hg]’ code.
PHYSICAL_QUANTITY matches {
value matches {|0.0..<1000.0|}
units matches {
CODED_SIMPLE matches {
value matches {"mm[Hg]"}
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}
}
}

This example archetype, expressed in terms of the Archetype Object Model, would have the structure

shown in Table 1.
Table 1 — Example structure for representing physical quantity
Reference Model class, attribute or primitive
Archetype Model constraining class
value
PHYSICAL_QUANTITY C_COMPLEX_OBJECT
value C_ATTRIBUTE
Real C_REAL
units C_ATTRIBUTE
CODED_SIMPLE C_COMPLEX_OBJECT

value C_ATTRIBUTE

String C_STRING

Since the Archetype Object Model is also used to constrain other reference models, as for example

the openEHR Reference Model, there will be a need to transform openEHR archetypes to ISO 13606

archetypes, and vice versa. The openEHR Reference Model also uses the same primitive datatypes, but

includes a different set of complex datatypes, such as DV_ORDINAL, or DV_TEXT . When transforming

an openEHR archetype constraint to an ISO 13606 archetype, it might be necessary to introduce an

additional CLUSTER structure to represent the equivalent openEHR sub-components as ELEMENTs.

For example, a representation of an openEHR DV_ORDINAL in ISO 13606 would have the structure

shown in Table 2.
Table 2 — Example structure for representing an ordinal data value
openEHR ISO 13606
DV_ORDINAL CLUSTER matches { -- DV_ORDINAL
parts matches {
symbol ELEMENT matches { -- symbol
value matches {

DV_CODED_TEXT CODED_VALUE matches {*}

}
}
value ELEMENT matches { -- value
value matches {
Integer INTEGER matches {*}
}
}
}

An example of how the LINK class defined in Part 1 of this standard series can be represented using the

Archetype Object Model defined in this document is given in Annex B.

1) Please see http: //www .openehr .org/releases/RM/latest/docs/data _types/data _types .html # _text _package for

the specification of this datatype.
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0.3 Archetype repositories
The range of archetypes required within a sha
...

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