SIST EN ISO 12967-2:2021

Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO 12967- 2:2020)

This document specifies the fundamental characteristics of the information model implemented by
a specific architectural layer (i.e. the service architecture) of the information system to provide a
comprehensive and integrated storage of the common enterprise data and to support the fundamental
business processes of the healthcare organization, as defined in ISO 12967-1.
The information model is specified in this document without any explicit or implicit assumption on the
physical technologies, tools or solutions to adopt for its physical implementation in the various target
scenarios. The specification is nevertheless formal, complete and non-ambiguous enough to allow
implementers to derive an efficient design of the system in the specific technological environment that
will be selected for the physical implementation.
This document does not aim at representing a fixed, complete, specification of all possible data that can
be necessary for any requirement of any healthcare enterprise. It specifies only a set of characteristics,
in terms of overall organization and individual information objects, identified as fundamental and
common to all healthcare organizations, and that is satisfied by the information model implemented by
the service architecture.
Preserving consistency with the provisions of this document, physical implementations are allowed
extensions to the standard information model in order to support additional and local requirements.
Extensions include both the definition of additional attributes in the objects of the standard model, and
the implementation of entirely new objects.
Also, this document specification is extensible over time according to the evolution of the applicable
standardization initiatives.
The specification of extensions is carried out according to the methodology defined in ISO 12967-1:2020,
Clause 7.

Medizinische Informatik - Servicearchitektur - Teil 2: Informationssicht (ISO 12967- 2:2020)

Informatique de santé - Architecture de service - Partie 2: Point de vue d'information (ISO 12967- 2:2020)

Le présent document spécifie les caractéristiques fondamentales du modèle d'information mis en place par une couche architecturale spécifique (c'est-à-dire l'architecture de service) du système d'information pour assurer le stockage cohérent et intégré des données d'entreprise communes et prendre en charge les processus métier fondamentaux de l'organisme de santé, tel que défini dans l'ISO 12967-1.
Le modèle d'information est spécifié dans le présent document sans émettre d'hypothèse (explicite ou implicite) sur les technologies physiques, les outils ou les solutions à adopter pour sa mise en œuvre physique dans le cadre des différents scénarios cible. La spécification n'en est pas moins formelle, exhaustive et sans ambiguïté, afin de permettre aux implémenteurs de prévoir une conception efficace du système dans l'environnement technologique spécifique sélectionné pour sa mise en place physique.
Le présent document n'a pas pour objet de spécifier, de manière fixe et exhaustive, toutes les données possibles susceptibles d'être nécessaires aux exigences d'une entreprise de santé. Elle spécifie simplement un ensemble de caractéristiques (en termes d'objets d'informations organisationnelles globales et individuelles) identifiées comme étant essentielles et communes à tous les organismes de santé, et que le modèle d'information mis en place par l'architecture de service doit satisfaire.
Tout en préservant la cohérence avec les dispositions du présent document, les mises en place physiques sont autorisées à étendre le modèle d'information standard afin de répondre à des exigences supplémentaires et locales. Les extensions incluent la définition d'attributs supplémentaires dans les objets du modèle standard et la mise en place d'objets totalement nouveaux.
De même, la spécification que constitue le présent document doit être extensible dans le temps en fonction de l'évolution des initiatives de normalisation applicables.
La spécification des extensions doit être réalisée conformément à la méthodologie définie dans l'ISO 12967-1:2020, Article 7.

Zdravstvena informatika - Arhitektura storitve - 2. del: Informacijski vidik (ISO 12967-2:2020)

General Information

• Status: Published
• Public Enquiry End Date: 19-Dec-2019
• Publication Date: 06-Dec-2020
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Dec-2020
• Due Date: 05-Feb-2021
• Completion Date: 07-Dec-2020
• Ref Project: EN ISO 12967-2:2020 - Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO 12967-2:2020)

Relations

• Replaces: SIST EN ISO 12967-2:2011 - Health informatics - Service architecture - Part 2: Information viewpoint (ISO 12967-2:2009)
• Effective Date: 01-Jan-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 12967-2:2021
01-januar-2021
Nadomešča:
SIST EN ISO 12967-2:2011
Zdravstvena informatika - Arhitektura storitve - 2. del: Informacijski vidik (ISO
12967-2:2020)
Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO
12967- 2:2020)
Medizinische Informatik - Servicearchitektur - Teil 2: Informationssicht (ISO 12967-
2:2020)
Informatique de santé - Architecture de service - Partie 2: Point de vue d'information
(ISO 12967- 2:2020)
Ta slovenski standard je istoveten z: EN ISO 12967-2:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 12967-2:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 12967-2:2021

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SIST EN ISO 12967-2:2021


EN ISO 12967-2
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2020
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 12967-2:2011
English Version

Health informatics - Service Architecture (HISA) - Part 2:
Information viewpoint (ISO 12967-2:2020)
Informatique de santé - Architecture de service - Partie Medizinische Informatik - Servicearchitektur - Teil 2:
2: Point de vue d'information (ISO 12967-2:2020) Informationssicht (ISO 12967-2:2020)
This European Standard was approved by CEN on 11 June 2020.

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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12967-2:2020 E
worldwide for CEN national Members.

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SIST EN ISO 12967-2:2021
EN ISO 12967-2:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 12967-2:2021
EN ISO 12967-2:2020 (E)
European foreword
This document (EN ISO 12967-2:2020) 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 May 2021, and conflicting national standards shall be
withdrawn at the latest by May 2021.
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 ISO 12967-2:2011.
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 12967-2:2020 has been approved by CEN as EN ISO 12967-2:2020 without any
modification.


3

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SIST EN ISO 12967-2:2021

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SIST EN ISO 12967-2:2021
INTERNATIONAL ISO
STANDARD 12967-2
Second edition
2020-11
Health informatics — Service
architecture (HISA) —
Part 2:
Information viewpoint
Informatique de santé — Architecture de service —
Partie 2: Point de vue de l'information
Reference number
ISO 12967-2:2020(E)
©
ISO 2020

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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Methodological principles . 2
5.1 Language and notation adopted for the specification of the model. 2
5.2 UML class diagram notation guidelines and profile . 3
5.3 Clusters of objects in the information model . 4
5.4 Operational and descriptive information: classifications, knowledge and its instantiation 5
5.5 Data types . 7
5.6 General characteristics of the model . 8
6 General characteristics of the model . 8
6.1 Common structure of each information object: the GenericHisaClass . 8
6.2 UML diagram . 9
6.3 Specification of Generic HISA Class .10
6.3.1 Generic meta-class .10
6.3.2 Class: Set of structure attributes .11
6.3.3 Class: Set of class specific attributes .11
6.3.4 Class: Set of common attributes .11
6.3.5 Class: Set of system attributes .11
6.3.6 Class: Set of version attributes.12
6.3.7 Class: Extended attributes .12
6.3.8 Class: State changes .13
6.3.9 Class: Business rules .13
6.3.10 Class: Classification criteria.14
7 The reference information models .14
7.1 Classification objects .14
7.1.1 Aim .14
7.1.2 UML information model .14
7.1.3 Specification of the individual classes .15
7.2 Subject of care objects .18
7.2.1 Aim .18
7.2.2 UML information model .18
7.2.3 Specification of the individual classes .19
7.3 Activity management objects .23
7.3.1 Aim .23
7.3.2 UML information model .24
7.3.3 Specification of the individual classes .24
7.4 Clinical and health information objects .31
7.4.1 Aim .31
7.4.2 UML information model .31
7.4.3 Specification on the individual classes .32
7.5 Resource management objects .37
7.5.1 Aim .37
7.5.2 UML information model .37
7.5.3 Specification of the individual classes .37
7.6 User and authorization objects .43
7.6.1 Aim .43
7.6.2 UML information model .43
7.6.3 Specification of the individual classes .44
© ISO 2020 – All rights reserved iii

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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

7.7 Messaging objects .49
7.7.1 Aim .49
7.7.2 UML information model .50
7.7.3 Specification of the individual classes .50
Bibliography .54
iv © ISO 2020 – All rights reserved

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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(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, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251,
Health informatics, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 12967-2:2009), which has been technically
revised. The main changes compared to the previous edition are as follows:
— use of terms, definitions and concepts from ISO 13940:2015 (Contsys), with textual alignment
throughout the document including figures, to the extent possible and beneficial;
— reference to further standards, such HL7®;
— updates to the Bibliography.
A list of all parts in the ISO 12967 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 2020 – All rights reserved v

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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

Introduction
The ISO 12967 series provides guidance for the description, planning and development of new
systems as well as for the integration of existing information systems, both within one enterprise and
across different healthcare organizations through an architecture integrating the common data and
business logic into a specific architectural layer (i.e. the service architecture), distinct from individual
applications and accessible throughout the whole information system through information services, as
shown in Figure 1.
Figure 1 — Scope of the ISO 12967 series
The overall architecture is formalized according to ISO/IEC 10746 (all parts) and is therefore structured
through the following three viewpoints.
a) Enterprise viewpoint: specifies a set of fundamental common requirements at enterprise level
with respect to the organizational purposes, scopes and policies that should be supported by
the information and functionality of the service architecture. It also provides guidance on how
one individual enterprise (e.g. a regional healthcare authority, a large hospital or any other
organization where this model is applicable) can specify and document additional specific business
requirements, with a view to achieving a complete specification, adequate for the characteristics of
that enterprise.
Enterprise viewpoint is specified in ISO 12967-1.
b) Information viewpoint: specifies the fundamental semantics of the information model to be
implemented by the service architecture to integrate the enterprise’s common data and to support
the enterprise requirements formalized in ISO 12967-1. It also provides guidance on how one
individual enterprise can extend the standard model with additional concepts needed to support
local requirements in terms of information to be put in common.
Information viewpoint is specified in this document.
c) Computational viewpoint: specifies the scope and characteristics of the information services that
should be provided by the service architecture for allowing access to the common data as well as for
the execution of the business logic supporting the enterprise processes identified in the information
viewpoint and in ISO 12967-1. It also provides guidance on how one individual enterprise can
specify additional information services needed to support local specific requirements in terms of
common business logic to be implemented.
Computational viewpoint is specified in ISO 12967-3.
1)
ISO 12967-1:2020, Annex C includes an explanation of ISO 23903:— and its relevance in regard to the
ISO 12967 series, for integration with other International Standards such as ISO 13940.
1) Under preparation. Stage at the time of publication: ISO/DIS 23903:2020.
vi © ISO 2020 – All rights reserved

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SIST EN ISO 12967-2:2021
INTERNATIONAL STANDARD ISO 12967-2:2020(E)
Health informatics — Service architecture (HISA) —
Part 2:
Information viewpoint
1 Scope
This document specifies the fundamental characteristics of the information model implemented by
a specific architectural layer (i.e. the service architecture) of the information system to provide a
comprehensive and integrated storage of the common enterprise data and to support the fundamental
business processes of the healthcare organization, as defined in ISO 12967-1.
The information model is specified in this document without any explicit or implicit assumption on the
physical technologies, tools or solutions to adopt for its physical implementation in the various target
scenarios. The specification is nevertheless formal, complete and non-ambiguous enough to allow
implementers to derive an efficient design of the system in the specific technological environment that
will be selected for the physical implementation.
This document does not aim at representing a fixed, complete, specification of all possible data that can
be necessary for any requirement of any healthcare enterprise. It specifies only a set of characteristics,
in terms of overall organization and individual information objects, identified as fundamental and
common to all healthcare organizations, and that is satisfied by the information model implemented by
the service architecture.
Preserving consistency with the provisions of this document, physical implementations are allowed
extensions to the standard information model in order to support additional and local requirements.
Extensions include both the definition of additional attributes in the objects of the standard model, and
the implementation of entirely new objects.
Also, this document specification is extensible over time according to the evolution of the applicable
standardization initiatives.
The specification of extensions is carried out according to the methodology defined in ISO 12967-1:2020,
Clause 7.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1

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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

3.1
information object
information held by the system about entities of the real world
Note 1 to entry: Entities including the ODP system itself can be represented in an information specification in
terms of information objects, their relationships and behaviour.
3.2
package
cluster of information objects (3.1)
3.3
middleware
enabling technology of enterprise application integration (3.4) describing a piece of software that
connects two or more software applications so that they can exchange data
3.4
enterprise application integration
EAI
use of software and computer systems architectural principles to integrate a set of enterprise computer
applications
3.5
subject of care
patient
subject of healthcare
healthcare actor with a person role; who seeks to receive, is receiving, or has received healthcare
[SOURCE: ISO 13940:2015, 5.2.1, modified — Note and Examples omitted.]
4 Abbreviated terms
ODP Open Distributed Processing
HISA Health Informatics Service Architecture
UML Unified Modeling Language
5 Methodological principles
5.1 Language and notation adopted for the specification of the model
The objective of the information viewpoint specification is to describe the information relevant for the
enterprise to be handled by the service architecture. It consists of a formal information model detailing
the semantic and syntactic aspects of all data to be managed.
The specification is based on an object model, derived from the enterprise viewpoint by properly
structuring and aggregating the information that has been identified as relevant in the specification of
the business processes, tasks and activities.
The general approach of the ODP standard [i.e. ISO/IEC 10746 (all parts)] is also used in ISO 12967-1,
the modeling language used in this document is UML.
The information viewpoint is concerned with information modeling (i.e. the kinds of information
handled by the system). It focuses on the semantics of information and information processing in the
system. It is fundamental that the individual components of a distributed system share a common
understanding of the information they communicate when they interact, or the system will not behave
as expected. Some of these items of information are handled, in one way or another, by many of the
objects in the system. To ensure that the interpretation of these items is consistent, the information
2 © ISO 2020 – All rights reserved

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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

language defines concepts for the specification of the meaning of information stored within, and
manipulated by, an ODP system, independently of the way the information processing functions
themselves are to be implemented.
Thus, information held by the ODP system about entities in the real world, including the ODP system
itself, is represented in an information specification in terms of information objects, and their
associations and behaviour. Atomic information objects represent basic information elements. More
complex information is represented as composite information objects, each expressing associations
over a set of constituent information objects.
Some elements visible from the enterprise viewpoint will be visible from the information viewpoint
and vice versa. For example, an activity seen from the enterprise viewpoint will be in the information
viewpoint as the specification of some processing which causes a state transition of an information entity.
Different notations for information specifications model the properties of information in different
ways. It is possible to place emphasis on classification and reclassification of information types, or on
the states and behaviour of information objects. In some specification languages, atomic information
objects are represented as values. The approach to be taken will depend on the modeling technique and
notation being used.
Assessment of conformance to the information specification of a system involves relating the
requirements expressed in the specification to sets of observations of the behaviour of the system
at conformance points identified in the engineering and technology specification, and assessing the
degree of consistency between the requirements and the observations.
5.2 UML class diagram notation guidelines and profile
For each cluster of objects identified in the enterprise viewpoint, the information objects will be
illustrated according to the following rationale.
— Information objects (i.e. classes) grouped in the packages will be not be coloured.
— Classes not expressly grouped in the package will also be represented if there are associations from
classes belonging to the package to these classes. These classes, however, will be coloured in yellow.
— The names of classes will be meaningful and start with a capital letter (e.g. Person). If the name is
composed of more than one word the blank spaces between
...

SLOVENSKI STANDARD
oSIST prEN ISO 12967-2:2019
01-december-2019
Zdravstvena informatika - Arhitektura storitve - 2. del: Informacijski vidik (ISO/DIS
12967-2:2019)
Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO/DIS
12967-2: 2019)
Medizinische Informatik - Servicearchitektur - Teil 2: Informationssicht (ISO/DIS 12967-
2:2019)
Informatique de santé - Architecture de service - Partie 2: Point de vue d'information
(ISO/DIS 12967-2: 2019)
Ta slovenski standard je istoveten z: prEN ISO 12967-2
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 12967-2:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 12967-2:2019

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oSIST prEN ISO 12967-2:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 12967-2
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-11-01 2020-01-24
Health informatics — Service Architecture (HISA) —
Part 2:
Information viewpoint
Informatique de santé — Architecture de service —
Partie 2: Point de vue d'information
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 12967-2:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019

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oSIST prEN ISO 12967-2:2019
ISO/DIS 12967-2:2019(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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

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oSIST prEN ISO 12967-2:2019
ISO/DIS 12967-2:2019(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 2
5 Methodological principles . 2
5.1 Language and notation adopted for the specification of the model (informative) . 2
5.2 UML Class Diagram notation guidelines and profile (informative) . 3
5.3 Clusters of objects in the information model . 4
5.4 Operational and descriptive information: classifications, knowledge and its instantiation 5
5.5 Data types . 7
5.6 General characteristics of the model . 8
6 General characteristics of the model . 8
6.1 Common structure of each information object: the GenericHisaClass . 8
6.2 UML diagram . 9
6.3 Specification of Generic HISA Class .10
6.3.1 General.10
6.3.2 Class: Set of structure attributes .10
6.3.3 Class: Set of class specific attributes .11
6.3.4 Class: Set of common attributes .11
6.3.5 Class: Set of system attributes .11
6.3.6 Class: Set of version attributes.12
6.3.7 Class: Extended attributes .12
6.3.8 Class: State changes .13
6.3.9 Class: Business rules .13
6.3.10 Class: Classification criteria.14
7 The reference information models .14
7.1 Classification objects .14
7.1.1 Scope .14
7.1.2 UML information model .15
7.1.3 Specification of the individual classes .15
7.2 Subject of care objects .18
7.2.1 Scope .18
7.2.2 UML information model .18
7.2.3 Specification of the individual classes .19
7.3 Activity management objects .24
7.3.1 Scope .24
7.3.2 UML information model .24
7.3.3 Specification of the individual classes .25
7.4 Clinical and health information objects .32
7.4.1 Scope .32
7.4.2 UML information model .32
7.4.3 Specification on the individual classes .32
7.5 Resource management objects .37
7.5.1 Scope .37
7.5.2 UML information model .37
7.5.3 Specification of the individual classes .38
7.6 User and authorization objects .44
7.6.1 Scope .44
7.6.2 UML information model .44
7.6.3 Specification of the individual classes .45
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7.7 Messaging Objects .50
7.7.1 Scope .50
7.7.2 UML information model .50
7.7.3 Specification of the individual classes .51
Bibliography .55
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the 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.
The committee responsible for this document is ISO/TC 215, Health informatics.
This second edition is a revision of, cancels and replaces the first edition (ISO 12967-2:2009), which
was based on the European Standard EN 12967-2:2007.
ISO 12967 consists of the following parts, under the general title Health informatics — Service
architecture:
— Part 1: Enterprise viewpoint
— Part 2: Information viewpoint
— Part 3: Computational viewpoint
The main changes compared to the previous edition of this part (part 2, information viewpoint) are as
follows:
— Use of terms, definitions and concepts from part 1 of ISO 12967, in turn aligned with ISO 13490:2016
(Contsys)
— Reference to further standards, such as HL7
— Updating regarding text and figures related to the UML diagrams based on the revision of part 1 of
this 3-part standard, aligned in turn with ISO 13940:2016 Contsys
— Updates to the Bibliography
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Introduction
ISO 12967 is a multi-part standard that provides guidance for the description, planning and
development of new systems as well as for the integration of existing information systems, both within
one enterprise and across different healthcare organizations through an architecture integrating
the common data and business logic into a specific architectural layer (i.e. the service architecture),
distinct from individual applications and accessible throughout the whole information system through
information services, as shown in Figure 1.
Figure 1 — Scope of this International Standard
[10][11][12][13]
The overall architecture is formalized according to ISO/IEC 10746 (all parts) and is
therefore structured through the following three viewpoints.
a) Enterprise viewpoint: specifies a set of fundamental common requirements at enterprise level
with respect to the organizational purposes, scopes and policies that must be supported by the
information and functionality of the service architecture. It also provides guidance on how
one individual enterprise (e.g. a regional healthcare authority, a large hospital or any other
organization where this model is applicable) can specify and document additional specific business
requirements, with a view to achieving a complete specification, adequate for the characteristics of
that enterprise.
Enterprise viewpoint is specified in ISO 12967-1.
b) Information viewpoint: specifies the fundamental semantics of the information model to be
implemented by the service architecture to integrate the enterprise’s common data and to support
the enterprise requirements formalized in ISO 12967-1. It also provides guidance on how one
individual enterprise can extend the standard model with additional concepts needed to support
local requirements in terms of information to be put in common.
Information viewpoint is specified in ISO 12967-2.
c) Computational viewpoint: specifies the scope and characteristics of the information services that
must be provided by the service architecture for allowing access to the common data as well as for
the execution of the business logic supporting the enterprise processes identified in the information
viewpoint and in ISO 12967-1. It also provides guidance on how one individual enterprise can
specify additional information services needed to support local specific requirements in terms of
common business logic to be implemented.
Computational viewpoint is specified in this part of ISO 12967-3.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 12967-2:2019(E)
Health informatics — Service Architecture (HISA) —
Part 2:
Information viewpoint
1 Scope
This part of ISO 12967 specifies the fundamental characteristics of the information model to be
implemented by a specific architectural layer (i.e. the service architecture) of the information system
to provide a comprehensive and integrated storage of the common enterprise data and to support the
fundamental business processes of the healthcare organization, as defined in ISO 12967-1.
The information model is specified without any explicit or implicit assumption on the physical
technologies, tools or solutions to be adopted for its physical implementation in the various target
scenarios. The specification is nevertheless formal, complete and non-ambiguous enough to allow
implementers to derive an efficient design of the system in the specific technological environment that
will be selected for the physical implementation.
This specification does not aim at representing a fixed, complete, specification of all possible data
that can be necessary for any requirement of any healthcare enterprise. It specifies only a set of
characteristics, in terms of overall organization and individual information objects, identified as
fundamental and common to all healthcare organizations, and that is satisfied by the information
model implemented by the service architecture.
Preserving consistency with the provisions of this part of ISO 12967, physical implementations allow
extensions to the standard information model in order to support additional and local requirements.
Extensions include both the definition of additional attributes in the objects of the standard model, and
the implementation of entirely new objects.
Also, this standard specification is extensible over time according to the evolution of the applicable
standardization initiatives.
The specification of extensions is carried out according to the methodology defined in ISO 12967-1:2019,
Clause 7, “Methodology for extensions”.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 12967-1:2019, Health informatics — Service architecture — Part 1: Enterprise viewpoint
ISO 12967-3:2019, Health informatics — Service architecture — Part 3: Computational viewpoint
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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3.1 information object
information held by the system about entities of the real world, including the ODP system itself, is
represented in an information specification in terms of information objects, their relationships and
behaviour
3.2 package
cluster of information objects
3.3 middleware
enabling technology of enterprise application integration (EAI) describing a piece of software that
connects two or more software applications so that they can exchange data
3.4 enterprise application integration EAI
use of software and computer systems architectural principles to integrate a set of enterprise computer
applications
4 Abbreviations
ODP Open Distributed Processing
HISA Health Informatics Service Architecture
UML Unified Modelling Language
GPIC General Purpose Information Component
5 Methodological principles
5.1 Language and notation adopted for the specification of the model (informative)
The objective of the information viewpoint specification is to describe the information relevant for the
enterprise to be handled by the service architecture. It consists of a formal information model detailing
the semantic and syntactic aspects of all data to be managed.
The specification is based on an object model, derived from the enterprise viewpoint by properly
structuring and aggregating the information that has been identified as relevant in the specification of
the business processes, tasks and activities.
While the general approach of the ODP standard is also used for ISO 12967-1, the modelling language to
be used is UML, which was not available at the time of the first edition of the ODP standard.
The information viewpoint is concerned with information modelling (i.e. the kinds of information
handled by the system). It focuses on the semantics of information and information processing in the
system. The individual components of a distributed system must share a common understanding of the
information they communicate when they interact, or the system will not behave as expected. Some of
these items of information are handled, in one way or another, by many of the objects in the system. To
ensure that the interpretation of these items is consistent, the information language defines concepts
for the specification of the meaning of information stored within, and manipulated by, an ODP system,
independently of the way the information processing functions themselves are to be implemented.
Thus, information held by the ODP system about entities in the real world, including the ODP system
itself, is represented in an information specification in terms of information objects, and their
associations and behaviour. Atomic information objects represent basic information elements. More
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complex information is represented as composite information objects, each expressing associations
over a set of constituent information objects.
Some elements visible from the enterprise viewpoint will be visible from the information viewpoint and
vice versa. For example, an activity seen from the enterprise viewpoint may appear in the information
viewpoint as the specification of some processing which causes a state transition of an information entity.
Different notations for information specifications model the properties of information in different ways.
Emphasis may be placed on classification and reclassification of information types, or on the states
and behaviour of information objects. In some specification languages, atomic information objects are
represented as values. The approach to be taken will depend on the modelling technique and notation
being used.
Assessment of conformance to the information specification of a system involves relating the
requirements expressed in the specification to sets of observations of the behaviour of the system
at conformance points identified in the engineering and technology specification, and assessing the
degree of consistency between the requirements and the observations.
5.2 UML Class Diagram notation guidelines and profile (informative)
For each cluster of objects identified in the enterprise viewpoint, the information objects will be
illustrated according to the following rationale.
— Information objects (i.e. classes) grouped in the packages will be not be coloured.
— Classes not expressly grouped in the package will also be represented if there are associations from
classes belonging to the package to these classes. These classes, however, will be coloured in yellow.
— The names of classes will be meaningful and start with a capital letter (e.g. Person). If the name is
composed of more than one word the blank spaces between the words present in the diagrams will
be instead omitted in the section of the tables containing the class identifiers (e.g. “Subject of care
will have as class identifier “SubjectOfCare”). Blank spaces are left in the class names and diagrams
also with the scope of supporting readability.
— Associations will be labelled when the label adds value to the diagram.
— Associations may be labelled through a property, or through a verb phrase; in the latter case, an
arrow will be added to the association label to avoid ambiguity.
— Labels are always in lower case and, if a label is a verb phrase (with arrow), it will have one blank
space in between words.
— Navigability is not relevant when using UML for an information specification and will not be
represented.
— In general, in order to support readability, the classes should only contain the name of the class.
Properties should be described in the tables; however, if properties are displayed in the diagrams,
the following two points hold.
— Notation for visibility of properties is not used, as it is not pertinent for the conceptual models
used in the information viewpoint. Although visibility symbols could be used to indicate access
control, this is not done as all healthcare-related information should be accessed through
careful authorization.
— Data types of the properties should be displayed in the class in the diagram.
— For some classes, associations to other classes could be modelled (in the UML diagrams) as attributes
to the class. This reflects that the association has value rather than reference semantics, in addition
to the resulting simplification of the model. In other cases, the same method might be used in the
UML diagrams even though the association has reference semantics. This is done just to simplify the
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models. In the related class descriptions, these instances of simplified modelling are described as
associations rather than attributes.
— Properties (attributes) of classes start with a lower-case letter (e.g. name). If the property is
composed of more than one word, the blank spaces in between words are omitted (e.g. familyName,
birthDate).
— Current ISO and low-level data types will preferably be used. These will allow mapping to CEN or
ISO (in the future) when possible.
— Many-to-many binary associations named “related to” may be implemented as a set of specific
associations or association classes of specific multiplicities.
— Cardinalities of properties are used in case of associations, especially to distinguish between
optional and mandatory properties.
— Cardinality ‘*’ is never used, as the reader might be confused as to whether a 0.* or 1.* was intended.
— When the composition symbol is used, the non-displayed cardinality will always be ‘1’.
5.3 Clusters of objects in the information model
The information specification is built by considering the elements of the enterprise viewpoint
specification. ODP does not impose any methodology for the definition and use of the viewpoints. Thus,
the enterprise specification has been used here for building the UML specification. This approach
greatly facilitates the definition of the corresponde
...