Health informatics -- Service architecture (HISA)

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.

Informatique de santé -- Architecture de service

Le présent document spécifie les caractéristiques fondamentales du modčle d'information mis en place par une couche architecturale spécifique (c'est-ŕ-dire l'architecture de service) du systčme 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 modčle d'information est spécifié dans le présent document sans émettre d'hypothčse (explicite ou implicite) sur les technologies physiques, les outils ou les solutions ŕ 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 ambiguďté, afin de permettre aux implémenteurs de prévoir une conception efficace du systčme dans l'environnement technologique spécifique sélectionné pour sa mise en place physique. Le présent document n'a pas pour objet de spécifier, de maničre fixe et exhaustive, toutes les données possibles susceptibles d'ętre 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 ŕ tous les organismes de santé, et que le modčle 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 ŕ étendre le modčle d'information standard afin de répondre ŕ des exigences supplémentaires et locales. Les extensions incluent la définition d'attributs supplémentaires dans les objets du modčle standard et la mise en place d'objets totalement nouveaux. De męme, la spécification que constitue le présent document doit ętre extensible dans le temps en fonction de l'évolution des initiatives de normalisation applicables. La spécification des extensions doit ętre réalisée conformément ŕ la méthodologie définie dans l'ISO 12967-1:2020, Article 7.

General Information

Status
Published
Publication Date
05-Nov-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
31-Aug-2020
Completion Date
31-Aug-2020
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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
---------------------- Page: 1 ----------------------
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
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

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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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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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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.

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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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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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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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 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.

— Association labels indicate a property, or a verb phrase; in the latter case, an arrow is 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.
© ISO 2020 – All rights reserved 3
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ISO 12967-2:2020(E)
— 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 models. In the related class descriptions, these instances of simplified modeling 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 correspondences between the related entities that appear in the

different viewpoints, also allowing the treatment of the consistency among the viewpoints.

In particular, this information specification incorporates the information handled by the system as

described in ISO 12967-1:2020, 6.2 to 6.4.

According to the methodology identified in the enterprise viewpoint, seven clusters of objects have

been identified, each of which is responsible for organizing and storing the information necessary for

supporting the users’ activities identified in the related areas of ISO 12967-1, as follows.

a) Classification objects

These objects handle the information necessary for supporting the users’ activities related to the

management of classifications, coding criteria and dictionaries.
b) Subject of care objects

These objects handle the information necessary for supporting the users’ activities that are

identified in the “subject of care workflow”.
c) Activity management objects

These objects handle the information necessary for supporting the users’ activities identified in

the “activity management workflow”.
d) Healthcare information objects

These objects handle the information necessary for supporting the users’ activities identified in

the “healthcare information workflow”.
e) Resources objects
4 © ISO 2020 – All rights reserved
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ISO 12967-2:2020(E)

These objects handle the information necessary for supporting the users’ activities related to the

management of resources.
f) Users and authorization objects

These objects handle the information necessary for supporting the users’ activities related to the

management of users and authorizations.
g) Messaging objects
These objects handle the information necessary for
...

NORME ISO
INTERNATIONALE 12967-2
Deuxième édition
2020-11
Informatique de santé — Architecture
de service —
Partie 2:
Point de vue de l'information
Health informatics — Service architecture (HISA) —
Part 2: Information viewpoint
Numéro de référence
ISO 12967-2:2020(F)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 12967-2:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

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Publié en Suisse
ii © ISO 2020 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 12967-2:2020(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

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

1 Domaine d'application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Termes abrégés ...................................................................................................................................................................................................... 2

5 Principes méthodologiques ...................................................................................................................................................................... 2

5.1 Langage et notation adoptés pour la spécification du modèle ...................................................................... 2

5.2 Principes de notation et profil du diagramme de classes UML ..................................................................... 3

5.3 Groupes d'objets du modèle d'information ................................................................................................................... 4

5.4 Informations opérationnelles et descriptives: classifications, connaissances et

instanciation.............................................................................................................................................................................................. 6

5.5 Types de données ................................................................................................................................................................................. 7

5.6 Caractéristiques générales du modèle ............................................................................................................................... 8

6 Caractéristiques générales du modèle .......................................................................................................................................... 9

6.1 Structure commune de chaque objet d'information: ClasseHISAGénérique ..................................... 9

6.2 Diagramme UML .................................................................................................................................................................................10

6.3 Spécification de la classe HISA générique ....................................................................................................................10

6.3.1 Métaclasse générique ...............................................................................................................................................10

6.3.2 Classe: Ensemble d'attributs de structure ..............................................................................................11

6.3.3 Classe: Ensemble d'attributs spécifiques de la classe ..................................................................11

6.3.4 Classe: Ensemble d'attributs communs ....................................................................................................11

6.3.5 Classe: Ensemble d'attributs système ........................................................................................................11

6.3.6 Classe: Ensemble d'attributs de version ..................................................................................................12

6.3.7 Classe: Attributs étendus .......................................................................................................................................12

6.3.8 Classe: Changements d'état .................................................................................................................................13

6.3.9 Classe: Règles métier .................................................................................................................................................14

6.3.10 Classe: Critères de classification .....................................................................................................................14

7 Modèles d'information de référence ............................................................................................................................................14

7.1 Objets classification .........................................................................................................................................................................14

7.1.1 But .............................................................................................................................................................................................14

7.1.2 Modèle d'information UML ..................................................................................................................................15

7.1.3 Spécification des classes individuelles ......................................................................................................15

7.2 Objets sujet de soins ........................................................................................................................................................................18

7.2.1 But .............................................................................................................................................................................................18

7.2.2 Modèle d'information UML ..................................................................................................................................18

7.2.3 Spécification des classes individuelles ......................................................................................................19

7.3 Objets gestion d'activité ...............................................................................................................................................................24

7.3.1 But .............................................................................................................................................................................................24

7.3.2 Modèle d'information UML ..................................................................................................................................24

7.3.3 Spécification des classes individuelles ......................................................................................................25

7.4 Objets informations cliniques et de santé ....................................................................................................................32

7.4.1 But .............................................................................................................................................................................................32

7.4.2 Modèle d'information UML ..................................................................................................................................32

7.4.3 Spécification des classes individuelles ......................................................................................................32

7.5 Objets gestion des ressources .................................................................................................................................................38

7.5.1 But .............................................................................................................................................................................................38

7.5.2 Modèle d'information UML ..................................................................................................................................38

7.5.3 Spécification des classes individuelles ......................................................................................................38

7.6 Objets utilisateurs et autorisations ....................................................................................................................................44

7.6.1 But .............................................................................................................................................................................................44

7.6.2 Modèle d'information UML ..................................................................................................................................44

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ISO 12967-2:2020(F)

7.6.3 Spécification des classes individuelles ......................................................................................................45

7.7 Objets messagerie .............................................................................................................................................................................50

7.7.1 But .............................................................................................................................................................................................50

7.7.2 Modèle d'information UML ..................................................................................................................................50

7.7.3 Spécification des classes individuelles ......................................................................................................51

Bibliographie ...........................................................................................................................................................................................................................55

iv © ISO 2020 – Tous droits réservés
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ISO 12967-2:2020(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

Le présent document a été élaboré par le comité technique ISO/TC 215, Informatique de santé, en

collaboration avec le comité technique CEN/TC 251, Informatique de santé, du Comité européen de

normalisation (CEN) conformément à l’Accord de coopération technique entre l’ISO et le CEN (Accord

de Vienne).

Cette deuxième édition annule et remplace la première édition (ISO 12967-2:2009), qui a fait l'objet

d'une révision technique.

Les principales modifications par rapport à l'édition précédente sont les suivantes:

— utilisation des termes, définitions et concepts de l'ISO 13940:2015 (Contsys), avec alignement

textuel tout au long du document, y compris pour les figures, si cela est possible et utile;

— référence à d'autres normes, telles que HL7®;
— mises à jour de la Bibliographie.

Une liste de toutes les parties de la série ISO 12967 se trouve sur le site web de l'ISO.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
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ISO 12967-2:2020(F)
Introduction

La série ISO 12967 propose des recommandations pour la description, la planification et le

développement de nouveaux systèmes ainsi que pour l'intégration des systèmes d'information existants,

tant dans le cadre d'une entreprise que dans différents organismes de santé, grâce à la mise en place

d'une architecture intégrant les données communes et la logique métier dans une couche architecturale

spécifique (à savoir, l’architecture de service), distincte des applications individuelles et accessible par

tout le système d'information grâce à des services d’informations (voir Figure 1).

Figure 1 — Domaine d'application de la série ISO 12967

L'architecture générale est formalisée conformément à l'ISO/IEC 10746 (toutes les parties) et est, par

conséquent, structurée par l'intermédiaire des trois points de vue suivants.

a) Point de vue de l'entreprise: il spécifie un ensemble d'exigences communes fondamentales au

niveau d'une entreprise par rapport aux objectifs, aux domaines d'application et aux politiques

organisationnels qu'il convient d'appuyer grâce aux informations et aux fonctionnalités de

l'architecture de service. Il fournit également des recommandations relatives à la manière dont une

entreprise individuelle (par exemple, un système de santé régional, un grand hôpital ou tout autre

établissement dans lequel ce modèle peut s'appliquer) peut spécifier et justifier des exigences de

fonctionnement spécifiques supplémentaires, dans le but d'obtenir une spécification complète et

adaptée aux caractéristiques de cette entreprise.
Le point de vue de l'entreprise est spécifié dans l'ISO 12967-1.

b) Point de vue de l'information: il spécifie les aspects sémantiques fondamentaux du modèle

d'information à mettre en œuvre par l’architecture de service afin d'intégrer les données communes

de l'entreprise et de prendre en charge les exigences de l'entreprise formalisées dans l'ISO 12967-1.

Il fournit également des recommandations relatives à la manière dont une entreprise individuelle

peut étendre le modèle standard en ajoutant des concepts supplémentaires nécessaires à la prise

en charge des exigences locales en termes de mise en commun des informations.
Le point de vue de l'information est spécifié dans le présent document.

c) Point de vue informatique: il spécifie le domaine d'application et les caractéristiques des services

d’informations qu'il convient de fournir via l’architecture de service pour accéder aux données

communes et exécuter la logique applicative prenant en charge les processus d'entreprise

identifiés dans le point de vue de l'information et dans l’ISO 12967-1. Il fournit également des

recommandations relatives à la manière dont une entreprise individuelle peut spécifier des services

d’informations supplémentaires nécessaires à la prise en charge d'exigences spécifiques locales en

termes de mise en œuvre de la logique applicative commune.
Le point de vue informatique est spécifié dans l'ISO 12967-3.
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ISO 12967-2:2020(F)

L'ISO 12967-1:2020, Annexe C, comporte une présentation de l'ISO 23903:— et de sa pertinence par

rapport à la série ISO 12967, en ce qui concerne son intégration à d'autres normes internationales, telles

que l'ISO 13940.
1) En cours d'élaboration. Stade à la date de publication: ISO/DIS 23903:2020.
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NORME INTERNATIONALE ISO 12967-2:2020(F)
Informatique de santé — Architecture de service —
Partie 2:
Point de vue de l'information
1 Domaine d'application

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.
2 Références normatives
Le présent document ne contient aucune référence normative.
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions suivants s'appliquent.

L'ISO et l'IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:
— IEC Electropedia: disponible à l'adresse http:// www .electropedia .org/

— ISO Online browsing platform: disponible à l'adresse https:// www .iso .org/ obp.

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ISO 12967-2:2020(F)
3.1
objet d'information
informations détenues par le système sur des entités du monde réel

Note 1 à l'article: Les entités, y compris le système ODP lui-même, peuvent être représentées dans une

spécification d'informations en termes d'objets d'informations, de relations et de comportements.

3.2
module
regroupement d'objets d'informations (3.1)
3.3
couche interstitielle

technologie d'activation du système d'intégration d'applications d'entreprise (3.4) décrivant une partie

de logiciel associant plusieurs applications logicielles de façon à leur permettre d'échanger des données

3.4
intégration d'applications d'entreprise
IAE

utilisation de principes d'architecture de logiciels et systèmes informatiques pour intégrer un ensemble

d'applications informatiques d'entreprise
3.5
sujet des soins
patient

sujet des soins de santéacteur de soins de santé avec un rôle de personne, qui cherche à recevoir, reçoit

ou a reçu des soins de santé

[SOURCE: ISO 13940:2015, 5.2.1, modifiée — La Note et les Exemples n'ont pas été inclus.]

4 Termes abrégés

HISA Health Informatics Service Architecture (architecture des services d'informations de santé)

ODP Open Distributed Processing (traitement réparti ouvert)
UML Unified Modeling Language (langage de modélisation unifié)
5 Principes méthodologiques
5.1 Langage et notation adoptés pour la spécification du modèle

L'objectif de la spécification du point de vue de l'information consiste à décrire les informations

pertinentes pour l'entreprise que l’architecture de service doit intégrer. Il doit être composé d'un modèle

d'information formel détaillant les aspects sémantiques et syntaxiques de toutes les données à gérer.

La spécification repose sur un modèle objet dérivé du point de vue de l'entreprise. Il s'agit de structurer

et de regrouper correctement les informations identifiées comme pertinentes pour la définition des

processus métier, tâches et activités.

L'approche générale de la norme ODP [c'est-à-dire l'ISO/IEC 10746 (toutes les parties)] est également

utilisée dans l'ISO 12967-1, et le langage de modélisation utilisé dans le présent document est l'UML.

Le point de vue de l'information porte sur la modélisation des informations, c'est-à-dire les types

d'informations traités par le système. Il se concentre sur la sémantique des informations et leur

traitement dans le système. Pour éviter tout comportement aléatoire du système, il est fondamental

que les différents composants d'un système réparti partagent une interprétation commune des

informations qu'ils communiquent lorsqu'ils interagissent. Certains de ces éléments d'informations

sont traités, d'une manière ou d'une autre, par la plupart des objets présents dans le système. Pour

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ISO 12967-2:2020(F)

garantir la cohérence d'interprétation de ces éléments, le langage d'information définit les concepts

de spécification, de la signification des informations reçues et manipulées par un système ODP,

indépendamment de la manière dont les fonctions de traitement des informations elles-mêmes doivent

être mises en œuvre.

Par conséquent, les informations que détient le système ODP relatives aux entités du monde réel, y

compris le système ODP lui-même, sont représentées dans une spécification fondée sur un modèle objets

d'informations, intégrant leurs relations et leur comportement. Les objets d'informations atomiques

représentent la base des éléments d'informations. Les informations plus complexes sont représentées

sous la forme d'objets d'informations composites exprimant chacun les associations parmi un ensemble

d'objets d'informations constitutifs.

Certains éléments visibles du point de vue de l'entreprise le seront du point de vue de l'information et

inversement. Par exemple, une activité considérée du point de vue de l'entreprise sera, du point de vue

de l'information, perçue comme la spécification de certains traitements à l'origine d'un changement

d'état d'une entité informationnelle.

Différentes notations des spécifications d'information permettent de modéliser les propriétés des

informations de diverses manières. Il est possible de privilégier la classification et la reclassification

des types d'informations ou les états et le comportement des objets d'informations. Dans certains

langages de spécification, les objets d'informations atomiques sont représentés sous forme de valeurs.

L'approche dépend de la technique de modélisation et de la notation utilisées.

L'évaluation de la conformité à la spécification des informations d'un système implique de lier les

exigences exprimées dans la spécification à des ensembles d'observations du comportement du système

en certains points de conformité, identifiés dans la spécification de l'ingénierie et de la technologie. Cela

implique également d'évaluer le degré de cohérence entre les exigences et les observations.

5.2 Principes de notation et profil du diagramme de classes UML

Pour chaque groupe d'objets identifiés dans le point de vue de l'entreprise, les objets d'informations

sont illustrés conformément à la logique suivante:

— les objets d'informations (c'est-à-dire les classes) groupés dans les modules ne sont pas colorés;

— les classes qui ne sont pas formellement groupées dans le module sont également représentées s'il

existe des liens entre elles et les classes appartenant au module. Toutefois, elles doivent s'afficher

en jaune;

— les noms de classe doivent être significatifs et commencer par une lettre majuscule (par exemple,

Personne). Si le nom est composé de plusieurs mots, les espaces entre chacun d'eux dans les

diagrammes doivent être supprimés dans la section des tableaux contenant les identificateurs de

classe (par exemple, «sujet de soins» aura comme identificateur de classe «SujetDeSoins»). Les

espaces (ou blancs) sont maintenus dans les noms de classe et les diagrammes, par souci de lisibilité;

— les associations sont libellées lorsque cela permet d'ajouter une valeur au diagramme;

— les libellés d'associations désignent une propriété ou une phrase verbale. Dans ce dernier cas, une

flèche est ajoutée au libellé de l'association pour éviter toute ambiguïté;

— le libellé doit toujours être rédigé en lettres minuscules. Les mots composant une phrase verbale

(avec une flèche) seront séparés par un espace;

— la navigabilité n'est pas pertinente, en cas d’utilisation du langage UML pour une spécification

d'informations, et ne sera pas représentée;
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ISO 12967-2:2020(F)

— d'une manière générale, pour des raisons de lisibilité, il convient que les classes ne contiennent

que le nom de la classe. Il est recommandé que les propriétés soient décrites dans les tableaux.

Cependant, si les propriétés sont affichées dans les diagrammes, il y a lieu d’appliquer ce qui suit:

— la notation de la visibilité des propriétés n'est pas utilisée, cela n'étant pas adapté aux modèles

conceptuels utilisés dans le point de vue de l'information. Bien que des symboles de visibilité

puissent être utilisés pour indiquer le contrôle d'accès, cela ne doit pas être le cas étant donné

qu'il est recommandé de n'accéder aux informations relatives à la santé qu'en y étant dûment

autorisé;

— il convient que les types de données des propriétés s'affichent dans la classe du diagramme;

— pour certaines classes, les associations à d'autres classes peuvent être modélisées (dans les

diagrammes UML) sous la forme d'attributs liés à la classe. Il s'agit de souligner que l'association

repose sur une sémantique de valeur plutôt que de référence, en plus de la simplification du modèle

qui en résulte. Dans d'autres cas, la même méthode peut être utilisée dans les diagrammes UML,

même si l'association repose sur une sémantique de référence. Il s'agit ici de simplifier les modèles.

Dans les descriptions de classe associées, ces instances de modélisation simplifiée sont présentées

comme des associations plutôt que comme des attributs;

— les propriétés (attributs) des classes commencent par une lettre minuscule (par exemple, nom). Si

la propriété est composée de plusieurs mots, les espaces entre chacun d'eux sont supprimés (par

exemple nomFamille, dateNaissance);

— la norme ISO en cours et les types de données de niveau inférieur sont de préférence utilisés. Cela

permet d'établir une correspondance vers l
...

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
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STANDARDS MAY ON OCCASION HAVE TO
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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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ISO/DIS 12967-2:2019(E)
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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ii © ISO 2019 – All rights reserved
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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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ISO/DIS 12967-2:2019(E)

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

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 correspondences between the related entities that appear in the

different viewpoints, also allowing the treatment of the consistency among the viewpoints.

In particular, this information specification incorporates the information handled by the system as

described in clauses 6.2 to 6.4 of ISO 12967-1:2009.

According to the methodology identified in the enterprise viewpoint, seven clusters of objects have

been identified, each of which is responsible for organizing and storing the information necessary for

supporting the users’ activities identified in the related areas of the enterprise viewpoint.

1) Classification objects

These objects shall organize and store the information necessary for supporting the users’ activities

related to the management of classifications, coding criteria and dictionaries, as identified in

ISO 12967-1.
2) Subject of care objects

These objects shall organize and store the information necessary for supporting the users’

activities identified in the “Subject of Care workflow” of ISO 12967-1.
3) Activity management objects

These objects shall organize and store the information necessary for supporting the users’

activities identified in the “Activity Management workflow”
...

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