Health informatics -- Service architecture (HISA)

This document specifies the fundamental characteristics of the computational model implemented by a specific architectural layer of the information system (i.e. the service architecture) to provide a comprehensive and integrated interface to the common enterprise information and to support the fundamental business processes of the healthcare organization, as defined in ISO 12967‑1. The computational model is specified without any explicit or implicit assumption about 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 which will be selected for the physical implementation. The computational model specified in this document provides the basis for ensuring consistency between different engineering and technology specifications (including programming languages and communication mechanisms) since they are intended to be consistent with the same computational object model. This consistency allows open inter-working and portability of components in the resulting implementation. This document does not aim at representing a fixed, complete, specification of all possible interfaces that might be necessary for any requirement of any healthcare enterprise. It specifies only a set of characteristics — in terms of overall organization and individual computational objects, identified as fundamental and common to all healthcare organizations, and that are satisfied by the computational model implemented by the service architecture. Preserving consistency with the provisions of this document, physical implementations of the computational model specified in this document can allow extensions in order to support additional and local requirements. Extensions can include both the definition of additional properties of the objects of the computational model specified in this document and the implementation of entirely new objects. Also, the computational model specified in this document can be extendable over time according to the evolution of the applicable standardization initiatives, in accordance to the methodology defined in ISO 12967‑1:2020, Clause 7, which identifies a set of healthcare common information services, describing the requirements behind them and the methodology through which they will be used. The information services specified in this document are only the minimal set identifiable according to the identified requirements of the healthcare enterprise, and constituting the service architecture (i.e. the integration platform) to serve as the basis for healthcare applications, e.g. EHR or patient administration.

Informatique de santé -- Architecture de service

Le présent document spécifie les caractéristiques fondamentales du modčle de traitement mis en place par une couche architecturale spécifique du systčme d'informations (c'est-ŕ-dire l'architecture de service) pour assurer une interface cohérente et intégrée aux 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 de traitement est spécifié 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 œuvre physique. Le modčle de traitement spécifié dans le présent document fournit la base permettant de garantir la cohérence des différentes spécifications d'ingénierie et de technologie (notamment des langages de programmation et des mécanismes de communication) étant donné qu'elles sont censées ętre conformes au męme modčle d'objet de traitement. Cette cohérence permet de garantir l'interfonctionnement ouvert et la portabilité des composants dans la mise en place finale. Le présent document n'a pas pour objet d'ętre une représentation fixe et exhaustive de toutes les interfaces possibles susceptibles d'ętre nécessaires aux exigences d'une entreprise de santé. Il spécifie simplement un ensemble de caractéristiques (en termes d'objets organisationnels globaux et de traitement individuels) identifiées comme étant essentielles et communes ŕ tous les organismes de santé et que le modčle de traitement 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 du modčle de traitement spécifié dans le présent document peuvent permettre des extensions afin de répondre ŕ des exigences supplémentaires et locales. Les extensions peuvent inclure aussi bien la définition de propriétés supplémentaires d'objets du modčle de traitement spécifié dans le présent document que la mise en œuvre d'objets totalement nouveaux. De męme, le modčle de traitement spécifié dans le présent document peut ętre étendu dans le temps en fonction de l'évolution des initiatives de normalisation applicables, conformément ŕ la méthodologie définie dans l'ISO 12967-1:2020, Article 7, qui identifie un ensemble de services d'informations communs au domaine de la santé, en décrivant les exigences sous-jacentes et la méthodologie en fonction de laquelle ils seront utilisés. Les services d'informations spécifiés dans le présent document ne correspondent qu'au plus petit ensemble de services d'informations identifiable en fonction des exigences identifiées de l'entreprise de santé et constituant l'architecture de service (c'est-ŕ-dire la plateforme d'intégration) servant de base aux applications de santé, par exemple DIS ou administration des patients.

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Status
Published
Publication Date
05-Nov-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
06-Aug-2020
Completion Date
06-Aug-2020
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INTERNATIONAL ISO
STANDARD 12967-3
Second edition
2020-11
Health informatics — Service
architecture (HISA) —
Part 3:
Computational viewpoint
Informatique de santé — Architecture de service —
Partie 3: Point de vue informatique
Reference number
ISO 12967-3:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 12967-3:2020(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
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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 12967-3:2020(E)
Contents Page

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

Introduction ..................................................................................................................................................................................................................................v

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Abbreviated terms .............................................................................................................................................................................................. 2

5 Methodological principles .......................................................................................................................................................................... 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Clusters of objects ................................................................................................................................................................................ 2

5.3 Computational language ................................................................................................................................................................. 3

5.4 The computational objects and interfaces ...................................................................................................................... 4

5.5 Interactions ................................................................................................................................................................................................ 5

6 General characteristics of the model ............................................................................................................................................... 6

6.1 The two types of computational objects for handling the information ................................................. 6

6.2 The ‘basic’ information services .............................................................................................................................................. 6

6.2.1 General requirements .................................................................................................................................................. 6

6.2.2 ‘Add’ basic information services ......................................................................................................................... 7

6.2.3 "Update" basic information services .............................................................................................................. 8

6.2.4 "Delete" basic information services .............................................................................................................10

6.2.5 "Detail" basic information services ..............................................................................................................12

6.2.6 "List" basic information services ....................................................................................................................13

6.3 General-purpose interface .........................................................................................................................................................15

6.3.1 General...................................................................................................................................................................................15

6.3.2 List of information services .................................................................................................................................16

6.3.3 Behavioural specifications ...................................................................................................................................16

6.4 The eHealth business-related interfaces supporting the workflow computational

objects .................. ........................................................................................................................................................................................17

6.4.1 General...................................................................................................................................................................................17

6.4.2 eHealth business-related services managing healthcare workflows ..............................17

6.4.3 Interfaces supporting the “Subject of care workflow” .................................................................17

6.4.4 Interfaces supporting the “Healthcare information workflow” ...........................................19

6.4.5 Interfaces supporting the “Activity management workflow” .................................................21

6.4.6 Behavioural specifications, common to the eHealth business-related services ....23

6.5 Common requirements of the interfaces .......................................................................................................................24

6.5.1 Interface documentation and organization ...........................................................................................24

6.5.2 Naming criteria ..............................................................................................................................................................24

6.5.3 Data types ...........................................................................................................................................................................25

6.5.4 Structure and organization of the interfaces ........................................................................................25

Annex A (informative) Example of services................................................................................................................................................27

Annex B (informative) HISA and FHIR® ........................................................................................................................................................29

Bibliography .............................................................................................................................................................................................................................33

© ISO 2020 – All rights reserved iii
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ISO 12967-3:2020(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 12967-3:2009), 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);
— reference to further standards, such as HL7® and FHIR®;
— 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.
iv © ISO 2020 – All rights reserved
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ISO 12967-3:2020(E)
Introduction

The ISO 12967 series specifies fundamental requirements for 'information infrastructure' and 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 healthcare specific 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 ISO 12967 series information 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

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 this document.
© ISO 2020 – All rights reserved v
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ISO 12967-3:2020(E)

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 12967-3:2020(E)
Health informatics — Service architecture (HISA) —
Part 3:
Computational viewpoint
1 Scope

This document specifies the fundamental characteristics of the computational model implemented

by a specific architectural layer of the information system (i.e. the service architecture) to provide

a comprehensive and integrated interface to the common enterprise information and to support

the fundamental business processes of the healthcare organization, as defined in ISO 12967-1. The

computational model is specified without any explicit or implicit assumption about 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 which will be selected

for the physical implementation.

The computational model specified in this document provides the basis for ensuring consistency

between different engineering and technology specifications (including programming languages and

communication mechanisms) since they are intended to be consistent with the same computational

object model. This consistency allows open inter-working and portability of components in the resulting

implementation.

This document does not aim at representing a fixed, complete, specification of all possible interfaces

that might be necessary for any requirement of any healthcare enterprise. It specifies only a set of

characteristics — in terms of overall organization and individual computational objects, identified as

fundamental and common to all healthcare organizations, and that are satisfied by the computational

model implemented by the service architecture.

Preserving consistency with the provisions of this document, physical implementations of the

computational model specified in this document can allow extensions in order to support additional and

local requirements. Extensions can include both the definition of additional properties of the objects of

the computational model specified in this document and the implementation of entirely new objects.

Also, the computational model specified in this document can be extendable over time according to

the evolution of the applicable standardization initiatives, in accordance to the methodology defined

in ISO 12967-1:2020, Clause 7, which identifies a set of healthcare common information services,

describing the requirements behind them and the methodology through which they will be used.

The information services specified in this document are only the minimal set identifiable according

to the identified requirements of the healthcare enterprise, and constituting the service architecture

(i.e. the integration platform) to serve as the basis for healthcare applications, e.g. EHR or patient

administration.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 12967-1:2020, Health informatics — Service architecture — Part 1: Enterprise viewpoint

ISO 12967-2:2020, Health informatics — Service architecture — Part 2: Information viewpoint

© ISO 2020 – All rights reserved 1
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ISO 12967-3:2020(E)
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/
3.1
interface

abstraction of the behaviour of an object which consists of a subset of the possible interaction

mechanisms of that object, together with the set of constraints when that interaction occurs

3.2
computational object

object as seen in a computational viewpoint representing the functional decomposition of a system

showing a state and behaviour as well as interactions through interfaces with other computational objects

3.3
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
EHR Electronic Health Record
HISA Health Informatics — Service Architecture
ODP Open Distributed Processing
UML Unified Modeling Language
5 Methodological principles
5.1 General

This document encompasses the computational viewpoint, which is concerned in answering HISA

design aspects through the functional decomposition of the system into a set of computational objects

that interact at interfaces, also enabling distribution. HISA will thus be further specified in terms of

computational objects, which manage information and provide services, and their interfaces, starting

from the clusters of objects identified in ISO 12967-1 and further detailed in ISO 12967-2.

5.2 Clusters of objects

ISO 12967-1 has identified the scope, need for, and use of the ISO 12967 series by both developers

and end users. It has described the scope of the business objects from the organization's viewpoint,

by summarizing the related user activities and requirements through natural language. During this

process the main healthcare common clusters of objects have been identified in ISO 12967-1:

a) Subject of care objects

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

identified in the “Subject of care workflow”.
2 © ISO 2020 – All rights reserved
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ISO 12967-3:2020(E)
b) Activity management objects

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

identified in the “Activity Management workflow”.
c) Healthcare information objects

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

identified in the “Healthcare Information workflow”.
d) Users and authorization objects

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

management of users and authorizations.
e) Resources objects

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

management of resources.
f) Classification objects

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

management of classifications, coding criteria and dictionaries.
g) Messaging objects

These objects handle the information necessary for supporting the structuring of data and the

communications with other systems through messaging mechanisms.

ISO 12967-2 has formalized the conceptual model of the information being manipulated by the

information services, derived from the textual descriptions contained in ISO 12967-1. For each of

the clusters of objects, an information model composed of information objects has been identified in

ISO 12967-2.

This document defines the computational model, composed of computational objects, capable of meeting

the requirements described in ISO 12967-1. It is necessary in this document to identify its relationship

to the information model, and the interfaces or access mechanisms it provides to access and manipulate

the information handled by the system, which are also referred to as ‘methods’ but more appropriately

they are in the following referred to as ‘information services’.

The individual information services provided by the computational objects are described illustrating

how they allow actual access to the information handled by the system (identifying the interfaces, the

constraints, as well as which information of the underlying overall information model is accessed), and

eventual parallel actions to be taken.
5.3 Computational language

This document is directly concerned with the distribution of processing but not with the interaction

mechanisms that enable distribution to occur. The computational specification decomposes the system

into objects performing individual functions and interacting at well-defined interfaces.

The heart of the computational language is the computational object model, which constrains the

computational specification by defining:
— the form of interface that an object can have;

— the way the interfaces can be bound and the forms of interaction which can take place at them;

— actions an object can perform, in particular the creation of new objects and interfaces.

© ISO 2020 – All rights reserved 3
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ISO 12967-3:2020(E)
5.4 The computational objects and interfaces

The computational objects provide the interfaces through which it is possible to access and manipulate

the information managed by the information objects described in the information viewpoint. Each

cluster itself can be seen as a computational object, providing several interfaces that comprise all

interfaces of the information objects belonging to such cluster. The computational objects are defined

at the level of the HISA object.

For each cluster of objects, there will be a set of computational objects providing interfaces allowing

the management of the common information and business logic relevant to the organization. Two types

of computational object are foreseen per cluster:

— ‘basic’ computational objects deriving directly from the corresponding information object (i.e. one

computational object per information object);

— higher-level eHealth-business related computational objects providing interfaces achieving higher-

level business logic.

Thus, the majority of the computational objects will be derived directly from the corresponding

information objects. The further higher-level computational objects also envisaged provide interfaces

achieving higher-level eHealth business logic on possibly multiple information objects within the same

operation. Such eHealth business logic is described in ISO 12967-1 and has to do with the main workflow

processes (i.e. patient management, activity management, etc.).

The basic computational objects, corresponding one-to-one to the information objects, will be equipped

with standardized lower-level basic interfaces having the scope of creating, reading, updating and

deleting — in short maintaining, listing, and getting one instance of — the main classes described in

the information viewpoint.

These basic information services allow the access to and the manipulation of each element of the

underlying model. Their availability secure the openness of the system.
Figure 2 shows an example.
Figure 2 — Example of "basic services"
NOTE 1 The basic services are detailed in 6.2.

The higher-level computational objects implement eHealth business-related transactions on the objects

of the information model, simplifying and ensuring consistency of developments and allowing the

building up of common fundamental procedures of the organization.

Figure 3 shows an example of the possible information handled by an "eHealth business-related

information service"
EXAMPLES

— Patient/person area: registering a person, patient administration, merging patient identifiers, period of

care, etc.;
— Activity management and life cycle: requests, planning, booking, etc.;
— Clinical and EHR: terminologies, classifications, problem-orientation, etc.;
4 © ISO 2020 – All rights reserved
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ISO 12967-3:2020(E)
— Resource management: standard usages, etc.

Figure 3 — Example of the information handled by an "eHealth business-related information

service"
NOTE 2 The eHealth business-related information services are detailed in 6.4.

The HISA service architecture also provides a set of interfaces relating to functionalities of general utility

for the management of the overall system, with respect to the execution of particular functionalities.

These services do not pertain to any specific cluster of objects, and are related to general-purpose

issues like session management (e.g. when consumer programs and services are communicating back

and forth, logging in and out of the system, etc.), transaction management, setting system variables, etc.

These information services will be provided by at least a further computational object equipped with

appropriate services, namely the general-purpose interface.
5.5 Interactions

Three types of interaction are envisaged in ODP: signals, operations and flows. Signals are single

actions conveying data from one object to another, while operations can be seen as “client-server”

interactions between objects in which the server object elaborates the data provided by the client or

better ‘consumer’, sending back a result. Flows can be considered as a sequence of interactions (i.e.

information exchanges) between objects pertaining to a specific domain.

The interaction type is part of the interface signature. In HISA the focus is on the interaction type

operation. For this reason, it will not be explicitly referred to in this specification. Such interaction

type implies the need to identify for each computational object the role it plays in the client-server

interaction. However, HISA prescribes the general external characteristics through which each

identified computational object provides interfaces, while the interaction amongst the computational

objects is not part of this document. Thus, the role is always “server”.

NOTE Of the three types of interaction, operations are the ones that present the service-oriented call/return,

or client-server pattern required in the service architecture. The other interaction types can, when necessary, be

described as particular type of operations.
© ISO 2020 – All rights reserved 5
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ISO 12967-3:2020(E)
6 General characteristics of the model
6.1 The two types of computational objects for handling the information

The computational objects provide the interfaces through which it is possible to access and manipulate

the information managed by the information objects described in the information viewpoint. An

example of the two types of computational objects is displayed in Figure 4 and shall be referred to in the

following as ‘basic’ and eHealth business-related’ computational objects according to the terminology

adopted in 5.4. The information services that these will expose shall also be referred to in the following

as ‘basic’ and business-related’.
Figure 4 — types of computational object
6.2 The ‘basic’ information services
6.2.1 General requirements

For each class belonging to the seven clusters of objects defined in ISO 12967-1 and specified in the

information viewpoint, the service architecture shall be equipped with a computational object each of

which is in turn equipped with a set of information services allowing to access and to manipulate every

concept (i.e. objects and properties) of the class. The generic structure is displayed in Figure 5.

Figure 5 — Generic structure of the computational objects
6 © ISO 2020 – All rights reserved
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ISO 12967-3
...

NORME ISO
INTERNATIONALE 12967-3
Deuxième édition
2020-11
Informatique de santé — Architecture
de service —
Partie 3:
Point de vue informatique
Health informatics — Service architecture (HISA) —
Part 3: Computational viewpoint
Numéro de référence
ISO 12967-3:2020(F)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 12967-3:2020(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

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Publié en Suisse
ii © ISO 2020 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 12967-3:2020(F)
Sommaire Page

Avant-propos ..............................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

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

3 Termes et définitions ....................................................................................................................................................................................... 2

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

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

5.1 Généralités .................................................................................................................................................................................................. 2

5.2 Groupes d'objets .................................................................................................................................................................................... 3

5.3 Langage de traitement ...................................................................................................................................................................... 4

5.4 Objets de traitement et interfaces .......................................................................................................................................... 4

5.5 Interactions ................................................................................................................................................................................................ 6

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

6.1 Deux types d'objets de traitement pour la gestion des informations ...................................................... 6

6.2 Services d'informations «de base» ........................................................................................................................................ 6

6.2.1 Exigences générales ...................................................................................................................................................... 6

6.2.2 Services d'informations de base «ajout» ..................................................................................................... 7

6.2.3 Services d'informations de base «mise_à_jour» .................................................................................... 9

6.2.4 Services d'informations de base «suppression»................................................................................11

6.2.5 Services d'informations de base «détail» ................................................................................................13

6.2.6 Services d'informations de base «liste» ....................................................................................................15

6.3 Interface à usage général ............................................................................................................................................................17

6.3.1 Généralités .........................................................................................................................................................................17

6.3.2 Liste des services d'informations ...................................................................................................................17

6.3.3 Spécifications comportementales ..................................................................................................................18

6.4 Interfaces liées au secteur de l’eSanté prenant en charge les objets de traitement

des workflows .......................................................................................................................................................................................18

6.4.1 Généralités .........................................................................................................................................................................18

6.4.2 Services liés au domaine de l'eSanté gérant les workflows de santé ..............................18

6.4.3 Interfaces prenant en charge le workflow «Sujet des soins» .................................................19

6.4.4 Interfaces prenant en charge le workflow «Informations de soins de santé» .........21

6.4.5 Interfaces prenant en charge le workflow «Gestion d'activité» ...........................................22

6.4.6 Spécifications comportementales communes à tous les services liés

au domaine de l'eSanté ........................................................................................................................................... .25

6.5 Exigences communes des interfaces .................................................................................................................................26

6.5.1 Documentation et organisation de l'interface .....................................................................................26

6.5.2 Critères d'attribution de noms .........................................................................................................................26

6.5.3 Types de données .........................................................................................................................................................27

6.5.4 Structure et organisation des interfaces ..................................................................................................27

Annexe A (informative) Exemples de services ........................................................................................................................................29

Annexe B (informative) Normes HISA et FHIR® ....................................................................................................................................31

Bibliographie ...........................................................................................................................................................................................................................35

© ISO 2020 – Tous droits réservés iii
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ISO 12967-3:2020(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 européen de normalisation (CEN), le comité technique CEN/TC 251,

Informatique de santé, 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 12967-3:2009), 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);
— référence à d'autres normes, telles que HL7® et FHIR®;
— mises à jour de la Bibliographie.

Une liste de toutes les parties de la série ISO 12967 est disponible 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.
iv © ISO 2020 – Tous droits réservés
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ISO 12967-3:2020(F)
Introduction

La série ISO 12967 spécifie les exigences fondamentales d'une «infrastructure d'informations» et établit

les principes généraux de description, de planification et de développement de nouveaux systèmes et

d'intégration des systèmes d'informations existants, tant dans le cadre d'une entreprise qu'à travers

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 propre au domaine de la santé), 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 quant à la manière dont une

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

institution dans laquelle 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 donne également des recommandations quant à la manière dont une entreprise individuelle peut

étendre le modèle d'information de la série ISO 12967 en ajoutant les concepts supplémentaires

nécessaires à la prise en charge des exigences locales en termes d'informations devant être mises

en commun.
Le point de vue de l'information est spécifié dans l'ISO 12967-2.

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 le présent document.
© ISO 2020 – Tous droits réservés v
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ISO 12967-3:2020(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.
vi © ISO 2020 – Tous droits réservés
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE ISO 12967-3:2020(F)
Informatique de santé — Architecture de service —
Partie 3:
Point de vue informatique
1 Domaine d'application

Le présent document spécifie les caractéristiques fondamentales du modèle de traitement mis en

place par une couche architecturale spécifique du système d'informations (c'est-à-dire l’architecture

de service) pour assurer une interface cohérente et intégrée aux 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 de traitement est spécifié 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 œuvre physique.

Le modèle de traitement spécifié dans le présent document fournit la base permettant de garantir la

cohérence des différentes spécifications d'ingénierie et de technologie (notamment des langages de

programmation et des mécanismes de communication) étant donné qu'elles sont censées être conformes

au même modèle d’objet de traitement. Cette cohérence permet de garantir l'interfonctionnement

ouvert et la portabilité des composants dans la mise en place finale.

Le présent document n'a pas pour objet d'être une représentation fixe et exhaustive de toutes les

interfaces possibles susceptibles d'être nécessaires aux exigences d'une entreprise de santé. Il spécifie

simplement un ensemble de caractéristiques (en termes d'objets organisationnels globaux et de

traitement individuels) identifiées comme étant essentielles et communes à tous les organismes de

santé et que le modèle de traitement 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

du modèle de traitement spécifié dans le présent document peuvent permettre des extensions afin

de répondre à des exigences supplémentaires et locales. Les extensions peuvent inclure aussi bien la

définition de propriétés supplémentaires d’objets du modèle de traitement spécifié dans le présent

document que la mise en œuvre d'objets totalement nouveaux.

De même, le modèle de traitement spécifié dans le présent document peut être étendu dans le temps

en fonction de l'évolution des initiatives de normalisation applicables, conformément à la méthodologie

définie dans l’ISO 12967-1:2020, Article 7, qui identifie un ensemble de services d'informations communs

au domaine de la santé, en décrivant les exigences sous-jacentes et la méthodologie en fonction de

laquelle ils seront utilisés.

Les services d'informations spécifiés dans le présent document ne correspondent qu’au plus petit

ensemble de services d’informations identifiable en fonction des exigences identifiées de l'entreprise de

santé et constituant l’architecture de service (c'est-à-dire la plateforme d'intégration) servant de base

aux applications de santé, par exemple DIS ou administration des patients.
2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l'édition citée s'applique.

Pour les références non datées, la dernière édition du document de référence s'applique (y compris les

éventuels amendements).
© ISO 2020 – Tous droits réservés 1
---------------------- Page: 7 ----------------------
ISO 12967-3:2020(F)

ISO 12967-1:2020, Informatique de santé — Architecture de service — Partie 1: Point de vue de l’entreprise

ISO 12967-2:2020, Informatique de santé — Architecture de service — Partie 2: Point de vue de l’information

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:

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

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
interface

abstraction du comportement d'un objet composée d'un sous-ensemble des mécanismes d'interaction

possibles dudit objet, avec l'ensemble de contraintes lorsque cette interaction a lieu

3.2
objet de traitement

objet perçu du point de vue informatique représentant la décomposition fonctionnelle d'un système et

montrant un état, un comportement et des interactions par l'intermédiaire d'interfaces avec d'autres

objets de traitement
3.3
sujet des soins
patient
sujet des soins de santé

acteur 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
DIS Dossier informatisé de santé

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

ODP Open Distributed Processing (traitement réparti ouvert)
UML Unified Modeling Language (langage de modélisation unifié)
5 Principes méthodologiques
5.1 Généralités

Le présent document porte sur le point de vue informatique, qui vise à répondre aux aspects liés à

la conception de l’architecture HISA par la décomposition fonctionnelle du système en un ensemble

d'objets de traitement qui interagissent au niveau des interfaces, tout en permettant la répartition. Par

conséquent, le système HISA sera approfondi en termes d'objets de traitement (permettant de gérer les

informations et de fournir des services) et de leurs interfaces. Il s'agira en premier lieu de décrire les

groupes d'objets identifiés dans l'ISO 12967-1 et détaillés dans l’ISO 12967-2.
2 © ISO 2020 – Tous droits réservés
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ISO 12967-3:2020(F)
5.2 Groupes d'objets

L’ISO 12967-1 a identifié le domaine d'application, la nécessité de la série ISO 12967 et son utilisation tant

par les développeurs et que par les utilisateurs. Elle a décrit le domaine d'application des objets métier

du point de vue de l'organisme, en résumant les activités et les exigences associées de l'utilisateur, au

moyen d'un langage naturel. Lors de ce processus, les groupes d'objets principaux communs au domaine

de la santé ont été identifiés dans l'ISO 12967-1.
a) Objets Sujet des soins

Ces objets traitent les informations nécessaires à la prise en charge des activités des utilisateurs

identifiées dans le «workflow Sujet des soins».
b) Objets Gestion d'activité

Ces objets traitent les informations nécessaires à la prise en charge des activités des utilisateurs

identifiées dans le «workflow Gestion d'activité».
c) Objets Informations de soins de santé

Ces objets traitent les informations nécessaires à la prise en charge des activités des utilisateurs

identifiées dans le «workflow Informations de soins de santé».
d) Objets Utilisateurs et autorisations

Ces objets traitent les informations nécessaires à la prise en charge des activités des utilisateurs

liées à la gestion des utilisateurs et des autorisations.
e) Objets Ressources

Ces objets traitent les informations nécessaires à la prise en charge des activités des utilisateurs

liées à la gestion des ressources.
f) Objets Classification

Ces objets traitent les informations nécessaires à la prise en charge des activités des utilisateurs

liées à la gestion des classifications, des critères de codage et des dictionnaires.

g) Objets Messagerie

Ces objets traitent les informations nécessaires à la prise en charge de la structuration des données

et des communications avec d'autres systèmes par des mécanismes de messagerie.

L'ISO 12967-2 a formalisé le modèle conceptuel des informations manipulées par les services

d’informations, lequel est dérivé des descriptions textuelles contenues dans l'ISO 12967-1. Pour chacun

des groupes d'objets, un modèle d'information composé d'objets informations a été identifié dans

l'ISO 12967-2.

Le présent document définit le modèle de traitement (composé d'objets de traitement) permettant

de répondre aux exigences décrites dans l'ISO 12967-1. Il est nécessaire, dans le présent document,

d'identifier ses relations avec le modèle d'information, ainsi que les interfaces ou les mécanismes

d’accès qu'il propose pour pouvoir manipuler et accéder aux informations traitées par le système, qui

sont également appelées «méthodes», mais qui, de manière plus appropriée, sont ci-après appelées

«services d'informations».

Les services d'informations individuels proposés par les objets de traitement doivent être décrits en

illustrant la manière dont ils accèdent réellement aux informations traitées par le système (en identifiant

les interfaces et les contraintes, ainsi que les informations accessibles du modèle d'information global

sous-jacent) et les actions parallèles éventuelles à réaliser.
© ISO 2020 – Tous droits réservés 3
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ISO 12967-3:2020(F)
5.3 Langage de traitement

Le présent document est directement concerné par la répartition du traitement, mais sans les

mécanismes d'interaction à l'origine de cette répartition. La spécification de traitement décompose

le système en objets exécutant des fonctions individuelles et interagissant au niveau d'interfaces bien

définies.

Le cœur du langage de traitement est le modèle d'objet de traitement, qui délimite la spécification de

traitement en définissant:
— la forme de l'interface dont peut disposer un objet;

— la manière dont les interfaces peuvent être liées et les formes d'interaction qui peuvent prendre

place à leur niveau;

— les actions qu'un objet peut réaliser, en particulier la création de nouveaux objets et interfaces.

5.4 Objets de traitement et interfaces

Les objets de traitement offrent les interfaces permettant d'accéder aux informations gérées par les

objets d'informations décrits dans le point de vue de l'information, et de les manipuler. Chaque groupe

peut être perçu comme un objet de traitement, offrant des interfaces composées de toutes les interfaces

des objets d’informations appartenant audit groupe. Les objets de traitement sont définis au niveau de

l'objet HISA.

À chaque groupe d'objets correspond un ensemble d'objets de traitement offrant des interfaces de

gestion des informations communes et de la logique métier pertinentes pour l'organisme. Deux types

d'objets de traitement sont prévus par groupe:

— les objets de traitement de base dérivés directement de l'objet d'information correspondant (en

d'autres termes, il existe un objet de traitement par objet d'information);

— les objets de traitement de haut niveau liés au secteur de l’eSanté, offrant des interfaces permettant

d'atteindre un degré élevé de logique métier.

Par conséquent, la majorité des objets de traitement dérivera directement des objets d'informations

correspondants. Les objets de traitement de haut niveau supplémentaires également envisagés

permettent aux interfaces d'atteindre un degré plus élevé de logique métier propre à l’eSanté, bâti

éventuellement sur plusieurs objets d'informations dans le cadre d’une même opération. Une telle

logique métier propre à l’eSanté est décrite dans l'ISO 12967-1 et concerne les principaux processus de

workflow (c'est-à-dire la gestion des patients, la gestion d'activité, etc.).

Les objets de traitement de base, qui correspondent de manière biunivoque à des objets d'informations,

seront associés à des interfaces de base normalisées de bas niveau visant à créer, lire, mettre à jour

et supprimer (en bref, conserver, répertorier et extraire) une instance des classes principales décrites

dans le point de vue de l'information.

Ces services d'informations de base permettent d'accéder à chaque élément du modèle sous-jacent et de

les manipuler. Leur disponibilité garantit l'ouverture du système.
La Figure 2 en est un exemple.
4 © ISO 2020 – Tous droits réservés
---------------------- Page: 10 ----------------------
ISO 12967-3:2020(F)
Figure 2 — Exemple de «services de base»
NOTE 1 Les services de base sont détaillés en 6.2.

Les objets de traitement de haut niveau permettent de mettre en place des transactions liées au

domaine de l'eSanté sur les objets du modèle d'information, ce qui simplifie et garantit la cohérence

des développements et permet la mise en place de procédures fondamentales communes au sein de

l'organisme.

La Figure 3 donne un exemple d'informations possibles traitées par un «service d'information lié au

domaine de l'eSanté».
EXEMPLES

— le domaine patient/personne, notamment l'enregistrement d'une personne, l'administration des patients, la

fusion des identifiants patient, la période de soins, etc.;

— la gestion d'activité et le cycle de vie, notamment les demandes, la planification, les rendez-vous, etc.;

— les données cliniques et le dossier informatisé de santé du patient, notamment les terminologies, les

classifications, l'orientation en fonction du problème, etc.;
— la gestion des ressources, notamment les usages standard, etc.

Figure 3 — Exemple d'informations traitées par un «service d'information lié au domaine

de l'eSanté»

NOTE 2 Les services d'informations liés au domaine de l'eSanté sont détaillés en 6.4.

L’architecture de service HISA fournit également un ensemble d'interfaces portant sur les fonctionnalités

d'utilité générale pour la gestion de l'ensemble du système, et tenant compte de l'exécution de

fonctionnalités particulières.
© ISO 2020 – Tous droits réservés 5
---------------------- Page: 11 ----------------------
ISO 12967-3:2020(F)

Ces services ne dépendent pas d'un groupe d'objets particulier. Ils portent sur des questions d'ordre

général comme la gestion de session (par exemple, lorsque des programmes et services destinés aux

consommateurs communiquent entre eux, la connexion au système/déconnexion du système, etc.),

la gestion des transactions, la définition des variables système, etc. Ces services d'informations sont

fournis par au moins un autre objet de traitement disposant des services appropriés, à savoir l'interface

à usage général.
5.5 Interactions
Trois typ
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 12967-3
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-11-01 2020-01-24
Health informatics — Service Architecture (HISA) —
Part 3:
Computational viewpoint
Informatique de santé — Architecture de service —
Partie 3: Point de vue informatique
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 12967-3:2019(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
---------------------- Page: 1 ----------------------
ISO/DIS 12967-3:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
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ii © ISO 2019 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 12967-3:2019(E)
Contents Page

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

Introduction ..................................................................................................................................................................................................................................v

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

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

5 Methodological principles .......................................................................................................................................................................... 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Clusters of objects ................................................................................................................................................................................ 2

5.3 Computational language ................................................................................................................................................................. 3

5.4 The computational objects and interfaces ...................................................................................................................... 3

5.5 Interactions ................................................................................................................................................................................................ 5

6 General characteristics of the model ............................................................................................................................................... 5

6.1 The two types of computational objects for handling the information ................................................. 5

6.2 The ‘basic’ information services .............................................................................................................................................. 6

6.2.1 General requirements .................................................................................................................................................. 6

6.2.2 ‘Add’ basic information services ......................................................................................................................... 7

6.2.3 "Update" basic information services .............................................................................................................. 8

6.2.4 "Delete" basic information services .............................................................................................................10

6.2.5 "Detail" basic information services ..............................................................................................................12

6.2.6 "List" basic information services ....................................................................................................................13

6.3 General-purpose interface .........................................................................................................................................................15

6.3.1 General...................................................................................................................................................................................15

6.3.2 List of information services .................................................................................................................................15

6.3.3 Behavioural specifications ...................................................................................................................................16

6.4 The eHealth business-related interfaces supporting the workflow computational

objects .................. ........................................................................................................................................................................................17

6.4.1 General...................................................................................................................................................................................17

6.4.2 eHealth business-related services managing healthcare workflows ..............................17

6.4.3 Interfaces supporting the “Subject of care workflow” .................................................................17

6.4.4 Interfaces supporting the “Healthcare information workflow” ...........................................19

6.4.5 Interfaces supporting the “Activity management workflow” .................................................21

6.4.6 Behavioural specifications, common to the eHealth business-related services ....23

6.5 Common requirements of the interfaces .......................................................................................................................24

6.5.1 Interface documentation and organization ...........................................................................................24

6.5.2 Naming criteria ..............................................................................................................................................................24

6.5.3 Data types ...........................................................................................................................................................................25

6.5.4 Structure and organization of the interfaces ........................................................................................25

Annex A (informative) Example of services................................................................................................................................................26

Annex B (informative) HISA and FHIR..............................................................................................................................................................28

Bibliography .............................................................................................................................................................................................................................32

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ISO/DIS 12967-3:2019(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

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

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the 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 12967-3:2009), which

was based on the European Standard EN 12967-3:2007.

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 3, computational viewpoint) are

as follows:

— Use of terms, definitions and concepts from parts 1 and 2 of ISO 12967, in turn aligned with

ISO 13490:2016 (Contsys)

— Reference to further standards, such as HL7 and FHIR, the latter of which is treated in new Annex B

with respect to the HISA service architecture

— Updating regarding text, tables, etc. related based on the revision of parts 1 and 2 of this 3-part

standard, aligned in turn with ISO 13940:2016 Contsys
— Updates to the Bibliography
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Introduction

ISO 12967 is a multi-part standard that provides guidance for the description, planning and

development of new systems as well as for the integration of existing information systems, both within

one enterprise and across different healthcare organizations through an architecture integrating

the common data and business logic into a specific architectural layer (i.e. the service architecture),

distinct from individual applications and accessible throughout the whole information system through

information services, as shown in Figure 1.
Figure 1 — Scope of this International Standard
[10][11][12][13]

The overall architecture is formalized according to ISO/IEC 10746 (all parts) and is

therefore structured through the following three viewpoints.

a) Enterprise viewpoint: specifies a set of fundamental common requirements at enterprise level

with respect to the organizational purposes, scopes and policies that must be supported by the

information and functionality of the service architecture. It also provides guidance on how

one individual enterprise (e.g. a regional healthcare authority, a large hospital or any other

organization where this model is applicable) can specify and document additional specific business

requirements, with a view to achieving a complete specification, adequate for the characteristics of

that enterprise.
Enterprise viewpoint is specified in ISO 12967-1.

b) Information viewpoint: specifies the fundamental semantics of the information model to be

implemented by the service architecture to integrate the enterprise’s common data and to support

the enterprise requirements formalized in ISO 12967-1. It also provides guidance on how one

individual enterprise can extend the standard model with additional concepts needed to support

local requirements in terms of information to be put in common.
Information viewpoint is specified in ISO 12967-2.

c) Computational viewpoint: specifies the scope and characteristics of the information services that

must be provided by the service architecture for allowing access to the common data as well as for

the execution of the business logic supporting the enterprise processes identified in the information

viewpoint and in ISO 12967-1. It also provides guidance on how one individual enterprise can

specify additional information services needed to support local specific requirements in terms of

common business logic to be implemented.
Computational viewpoint is specified in this part of ISO 12967.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 12967-3:2019(E)
Health informatics — Service Architecture (HISA) —
Part 3:
Computational viewpoint
1 Scope

HISA specifies fundamental requirements for 'information infrastructure' and healthcare specific

‘service architecture’.

This part of ISO 12967 specifies the fundamental characteristics of the computational model to be

implemented by a specific architectural layer of the information system (i.e. the service architecture)

to provide a comprehensive and integrated interface to the common enterprise information and to

support the fundamental business processes of the healthcare organization, as defined in ISO 12967-1.

The computational model is specified without any explicit or implicit assumption about 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

which will be selected for the physical implementation.

The computational model provides the basis for ensuring consistency between different engineering

and technology specifications (including programming languages and communication mechanisms)

since they must be consistent with the same computational object model. This consistency allows open

inter-working and portability of components in the resulting implementation.

This specification does not aim at representing a fixed, complete, specification of all possible interfaces

that may be necessary for any requirement of any healthcare enterprise. It specifies only a set of

characteristics – in terms of overall organization and individual computational objects, identified as

fundamental and common to all healthcare organizations, and that are satisfied by the computational

model implemented by the service architecture.

Preserving consistency with the provisions of this part of ISO 12967, physical implementations

shall allow extensions to the standard computational model in order to support additional and local

requirements. Extensions shall include both the definition of additional properties in the objects of the

standard model and the implementation of entirely new objects.

Also, this standard specification shall be extendable over time according to the evolution of the

applicable standardization initiatives. The specification of extensions shall be carried out according to

the methodology defined in Clause 7 of ISO 12967-1:2019, which identifies a set of healthcare common

information services, describing their need and the methodology through which they will be used.

These information services are only the minimal set identifiable according to the needs of the healthcare

enterprise, and constituting the service architecture (i.e. the integration platform) to serve as the basis

for healthcare applications, e.g. EHR or patient administration.
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 12967-2:2019, Health informatics — Service architecture — Part 2: Information viewpoint

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3 Terms and definitions
For the purposes of this document the following terms and definitions apply.
3.1 interface

abstraction of the behaviour of an object which consists of a subset of the possible interaction

mechanisms of that object, together with the set of constraints when that interaction occurs

3.2 computational object

object as seen in a computational viewpoint representing the functional decomposition of a system

showing a state and behaviour as well as interactions through interfaces with other computational objects

4 Abbreviations
EHR Electronic Health Record
HISA Health Informatics - Service Architecture
ODP Open Distributed Processing
UML Unified Modelling Language
5 Methodological principles
5.1 General

This part of ISO 12967 encompasses the computational viewpoint, which is concerned in answering HISA

design aspects through the functional decomposition of the system into a set of computational objects

that interact at interfaces, also enabling distribution. The ‘Health Informatics - Service Architecture’

will thus be further specified in terms of computational objects, which manage information and provide

services, and their interfaces, starting from the clusters of objects identified in ISO 12967-1 and further

detailed in ISO 12967-2.
5.2 Clusters of objects

ISO 12967-1 has identified the scope, need for, and use of the HISA standard by both developers and

end users. It has described the scope of the business objects from the organization's viewpoint, by

summarising the related user activities and requirements through natural language. During this

process the main healthcare common clusters of objects have been identified:
1) Subject of care objects

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

“Subject of Care workflow” of ISO 12967-1.
2) Activity management objects

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

“Activity Management workflow” of ISO 12967-1.
3) Healthcare information objects

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

“Healthcare Information workflow” of ISO 12967-1.
4) Users and authorization objects
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ISO/DIS 12967-3:2019(E)

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

management of users and authorizations, as identified in ISO 12967-1.
5) Resources objects

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

management of resources, as identified in ISO 12967-1.
6) Classification objects

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

management of classifications, coding criteria and dictionaries, as identified in ISO 12967-1.

7) Messaging objects

These objects handle the information necessary for supporting the structuring of data and the

communications with other systems through messaging mechanisms, as identified in ISO 12967-1

ISO 12967-2 has formalized the conceptual model of the information being manipulated by the

information services, derived from the textual descriptions contained in ISO 12967-1. For each of

the clusters of objects, an information model composed of information objects has been identified in

ISO 12967-2.

This part of ISO 12967 defines the computational model, composed of computational objects, capable of

meeting the requirements described in ISO 12967-1. It is necessary here to identify its relationship to

the information model, and the interfaces or access mechanisms it provides to access the information

handled by the system, which may also be referred to as ‘methods’ but more appropriately they are in

the following referred to as ‘information services’.

The individual information services provided by the computational objects are described illustrating

how they allow actual access to the information handled by the system (identifying the interfaces, the

constraints, as well as which information of the underlying overall information model is accessed), and

eventual parallel actions to be taken.
5.3 Computational language

This part of ISO 12967 is directly concerned with the distribution of processing but not with the

interaction mechanisms that enable distribution to occur. The computational specification decomposes

the system into objects performing individual functions and interacting at well-defined interfaces.

The heart of the computational language is the computational object model, which constrains the

computational specification by defining:
— The form of interface that an object can have;

— the way the interfaces can be bound and the forms of interaction which can take place at them;

— actions an object can perform, in particular the creation of new objects and interfaces.

5.4 The computational objects and interfaces

The computational objects provide the interfaces through which it is possible to access and manipulate

the information managed by the information objects described in the information viewpoint. Each

cluster itself can be seen as a computational object, providing several interfaces that comprise all

interfaces of the information objects belonging to such cluster. The computational objects are defined

at the level of the HISA object.
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For each cluster of objects there will be a set of computational objects providing interfaces allowing the

management of the common information and business logic relevant to the organization. Two types of

computational object are foreseen per cluster:

— ‘basic’ computational objects deriving directly from the corresponding information object (i.e. one

computational object per information object);

— higher-level eHealth-business related computational objects providing interfaces achieving higher-

level business logic.

Thus, the majority of the computational objects will be derived directly from the corresponding

information objects. The further higher-level computational objects also envisaged provide interfaces

achieving higher-level eHealth business logic on possibly multiple information objects within the same

operation. Such eHealth business logic is described in ISO 12967-1 and has to do with the main workflow

processes (i.e. patient management, activity management, etc.).

NOTE The term patient is used in this specification as a synonym of subject of care as has been done in the

other parts of ISO 12967.

The basic computational objects, corresponding one-to-one to the information objects, will be equipped

with standard lower-level basic interfaces having the scope of creating, reading, updating and deleting

– in short maintaining, listing, and getting one instance of the main classes described in the information

viewpoint.

These basic information services allow the access to and the manipulation of each element of the

underlying model. Their availability secure the openness of the system.
Figure 2 shows an example.
Figure 2 — Example of "basic services"

NOTE 1 The actual basic services that shall be available for HISA objects are detailed in 6.2.

The higher-level computational objects implement eHealth business-related transactions on the objects

of the information model, simplifying and ensuring consistency of developments and allowing the

building up of common fundamental procedures of the organization.
EXAMPLES

— Patient/person area: registering a person, patient administration, merging patient identifiers, period of

care, etc.;
— Activity management and life cycle: requests, planning, booking, etc.;
— Clinical and EHR: terminologies, classifications, problem-orientation, etc.;
— Resource management: standard usages, etc.
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Figure 3 — Example of an "eHealth business-related information service"

NOTE 2 The actual eHealth business-related information services that shall be available for HISA objects are

detailed in 6.4.

The HISA service architecture also provides a set of interfaces relating to functionalities of general utility

for the management of the overall system, with respect to the execution of particular functionalities.

These services do not pertain to any specific cluster of objects, and are related to general-purpose

issues like session management (e.g. when consumer programs and services are communicating back

and forth, logging in and out of the system, etc.), transaction management, , setting system variables,

etc. These information services will be provided by at least a further computational object equipped

with appropriate services, namely the general-purpose interface.
5.5 Interactions

Three types of interaction are envisaged in ODP: signals, operations and flows. Signals are single

actions conveying data from one object to another, while operations can be seen as “client-server”

interactions between objects in which the server object elaborates the data provided by the client or

better ‘consumer’, sending back a result. Flows can be considered as a sequence of interactions (i.e.

information exchanges) between objects pertaining to a specific domain.

The interaction type is part of the interface signature. In HISA the focus is on the interaction type

operation. For this reason, it will not be explicitly referred to in this specification. Such interaction

type implies the need to identify for each computational object the role it plays in the client-server

interaction. However, HISA prescribes the general external characteristics through which each

identified computational object provides interfaces, while the interaction amongst the computational

objects is not part of this part of ISO 12967. Thus, the role is always “server”.

NOTE Of the three types of interaction, operations are the ones that present the service-oriented call/return,

or client-server pattern required in the service architecture. The other interaction types can, when necessary, be

described as particular type of operations.
6 General characteristics of the model
6.1 The two types of computational objects for handling the information

The computational objects provide the interfaces through which it is possible to access and manipulate

the information managed by the information objects described in the information viewpoint. An

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example of the two types of computational objects is displayed in Figure 4, and shall be referred to in the

following as ‘basic’ and eHealth business-related’ computational objects according to the terminology

adopted in 5.4. The information services that these will expose shall also be referred to in the following

as ‘basic’ and business-related’.
Figure 4 — types of computational object
6.2 The ‘basic’ information services
6.2.1 General requirements

For each class belonging to the seven clusters of objects defined in ISO 12967-1 and specified in the

information viewpoint, the service architecture shall be equipped with a computational object each of

which is in turn equipped w
...

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