Health informatics -- Service architecture (HISA)

This document provides guidance and requirements 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 middleware), distinct from individual applications and accessible throughout the whole information system through services, as shown in Figure 2.

Informatique de santé -- Architecture de service

Le présent document fournit des recommandations et des exigences pour la description, la planification et le développement de nouveaux systčmes ainsi que pour l'intégration des systčmes d'information existants, tant dans le cadre d'une entreprise qu'entre organismes de santé, grâce ŕ la mise en place d'une architecture intégrant les données communes et la logique applicative dans une couche architecturale spécifique (ŕ savoir la couche interstitielle), distincte des applications individuelles et accessible par tous les systčmes d'information grâce ŕ des services (voir Figure 2).

General Information

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

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

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Published in Switzerland
ii © ISO 2020 – All rights reserved
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ISO 12967-1:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

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

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

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

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

3.1 Healthcare ................................................................................................................................................................................................... 2

3.2 System concepts ..................................................................................................................................................................................... 3

3.3 Concepts relating to organization .......................................................................................................................................... 4

3.4 Community concepts ......................................................................................................................................................................... 4

3.5 Behaviour concepts ............................................................................................................................................................................. 5

3.6 Policy concepts ....................................................................................................................................................................................... 7

3.7 Accountability, responsibility and time concepts ..................................................................................................... 7

3.8 Information management .............................................................................................................................................................. 9

4 Symbols and abbreviations ....................................................................................................................................................................10

5 Methodology for the specification of the architecture ...............................................................................................10

5.1 General ........................................................................................................................................................................................................10

5.2 Viewpoints for the specification of the architecture ...........................................................................................10

5.3 The HISA specification procedure .......................................................................................................................................11

5.3.1 The strategic paradigm............................................................................................................................................11

5.3.2 Specification of the enterprise viewpoint ...............................................................................................12

5.3.3 Specification of the information viewpoint ...........................................................................................12

5.3.4 Specification of the computational viewpoint.....................................................................................13

5.4 Iterative specification .....................................................................................................................................................................13

5.5 Viewpoints specification languages, notations and levels of abstraction .........................................14

6 HISA overview.......................................................................................................................................................................................................15

6.1 General requirement .......................................................................................................................................................................15

6.2 Enterprise viewpoint ......................................................................................................................................................................16

6.3 Information viewpoint ..................................................................................................................................................................17

6.4 Computational viewpoint ...........................................................................................................................................................18

7 Methodology for extensions ..................................................................................................................................................................19

8 Conformance criteria ....................................................................................................................................................................................19

8.1 General ........................................................................................................................................................................................................19

8.2 Conformance of specification documents to the HISA methodology ....................................................20

8.3 Conformance of middleware products to the HISA architectural requirements ........................20

9 The HISA Enterprise viewpoint ..........................................................................................................................................................21

9.1 Overview ...................................................................................................................................................................................................21

9.1.1 General...................................................................................................................................................................................21

9.1.2 The regional, inter-enterprise perspective ............................................................................................21

9.1.3 The medical/clinical perspective ...................................................................................................................22

9.1.4 The operational/clinical and organizational process model perspective ...................24

9.1.5 The information services and their complexity .................................................................................28

9.2 The fundamental workflows and groups of users’ activities to be supported by the

middleware .............................................................................................................................................................................................28

9.3 General information requirements for all users’ activities ............................................................................30

9.3.1 General...................................................................................................................................................................................30

9.3.2 Common attributes .....................................................................................................................................................30

9.3.3 Extensibility ......................................................................................................................................................................30

9.3.4 Versioning ...........................................................................................................................................................................31

9.3.5 Auditing ................................................................................................................................................................................31

9.3.6 Handling of life cycle..................................................................................................................................................31

9.4 Subject of care workflow .............................................................................................................................................................31

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ISO 12967-1:2020(E)

9.4.1 Textual description of requirements ...........................................................................................................31

9.4.2 Use-case examples .......................................................................................................................................................33

9.5 Healthcare information workflow .......................................................................................................................................38

9.5.1 Textual specification of requirements ........................................................................................................38

9.5.2 Use-case examples .......................................................................................................................................................39

9.6 Healthcare activity management workflow ................................................................................................................40

9.6.1 Textual description of requirements ...........................................................................................................40

9.6.2 Use-case examples .......................................................................................................................................................43

9.6.3 Examples of functions from ISO/HL7 10781 supporting the use case ..........................46

9.7 Resources management activities .......................................................................................................................................47

9.8 Management activities for users and authorizations .........................................................................................47

9.9 Classifications, coding and dictionaries management activities ...............................................................49

9.9.1 General description of requirements ..........................................................................................................49

9.9.2 Examples of functions from ISO/HL7 10781 providing support ........................................51

Annex A (informative) Highlights of ODP .....................................................................................................................................................52

Annex B (informative) Rationale for the federative structure of the health informatics

service architecture........................................................................................................................................................................................55

Annex C (informative) Cross-Domain Interoperability ..................................................................................................................58

Bibliography .............................................................................................................................................................................................................................65

iv © ISO 2020 – All rights reserved
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ISO 12967-1:2020(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 12967-1:2009), which has been technically

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

— use of terms, definitions and concepts from ISO 13940:2015 (Contsys), with textual alignment

throughout the document including figures, to the extent possible and beneficial;

— reference to further standards, such as HL7® and FHIR®;
— addition of abstraction layers supplementing the viewpoint descriptions;

— introduction of example functions from ISO/HL7 10781 supporting the use case examples of this

document;

— addition of Annex C, Cross-Domain Interoperability, in line with the current (2020) ongoing

ISO Interoperability and Integration Reference Architecture standardization initiative;

— updates to the Bibliography.
A list of all parts in the ISO 12967 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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ISO 12967-1:2020(E)
Introduction

The healthcare organizational structure consists of networks of centres (hospitals of different

types and sizes and outpatient clinics for primary and secondary care within a geographical area)

distributed over the territory, characterized by a high degree of heterogeneity and diversity, from

organizational, logistic, clinical, technological and even cultural perspectives. The structure of

individual centres evolves from a vertical, aggregated organization towards the integration of a set

of specialized functional areas (e.g. unit of laboratory analyses, unit of surgery), with specific needs

and characteristics, nevertheless needing to share common information and to operate according to

integrated workflows. Such a situation determines two main needs which conflict with each other

in a certain way. On the one hand, it is necessary to effectively support the specific requirements of

each unit or user in the most appropriate and cost-effective way whilst, on the other hand, it is vital to

ensure the consistency and integration of the overall organization, at local and territorial levels. This

integration requirement is not only related to the need for improving clinical treatments to the subject

of care but is also demanded by the urgent necessity of all countries to control and optimize the current

level of expenditure for health, whilst ensuring the necessary qualitative level of services to all subjects

of care.

The large number of databases and applications, mutually isolated and incompatible, which are already

available on the market and operational in healthcare organizations to support specific needs of users,

cannot be underestimated. Even within the same centre, healthcare information systems are frequently

fragmented across a number of applications, data and functionalities, isolated and scarcely consistent

with each other.

In the present circumstances, the main need for care delivery organizations is to integrate and to make

available the existing information assets, and to make possible the integration and interoperability

of existing applications, thereby protecting investments. During integration activities, continuity

of service needs to be achieved whilst gradual migration of existing proprietary, monolithic systems

towards the new concepts of openness and modularity occurs. The cost-effectiveness of the solutions,

especially when projected on the scale of the whole healthcare organization, represents another crucial

aspect to be evaluated carefully.

A further aspect is related to quality management (see bibliography), where information management

is an integrated part of quality management and the strategic and operative approaches for these two

managerial aspects need to be co-ordinated to be effective. Clinical processes are comprehensive.

Systematic and structured information management including medical knowledge management is

required for high-level quality in effective healthcare systems.

The aims can be achieved through a unified, open architecture based on middleware independent from

specific applications and capable of integrating common data and business logic and of making them

available to diverse, multi-vendor applications through many types of deployment. According to the

integration objectives at organizational level, all aspects (i.e. clinical, organizational and managerial)

of the healthcare structure should be supported by the architecture, which should therefore be able to

comprise all relevant information and all business workflows, structuring them according to criteria

and paradigms independent from specific sectorial aspects, temporary requirements or technological

solutions.

Standards and technological solutions already exist and will continue to be defined for supporting

specific requirements, both in terms of in situ user operations and with respect to the movement of

information. The architecture should be able to accommodate such requirements by allowing the

specific models to be integrated with the complete information assets of the healthcare organization

and e.g. communication messages to be “services” extracting or importing data from/to the common

information shown in Figure 1.

On the basis of these considerations, the purpose of the ISO 12967 series is twofold:

— identify a methodology to describe healthcare information systems through a language, notation

and paradigms suitable to facilitate the planning, design and comparison of systems;

vi © ISO 2020 – All rights reserved
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ISO 12967-1:2020(E)

— identify the fundamental architectural aspects enabling the openness, integration and

interoperability of healthcare information systems.

The architecture is therefore intended as a basis both for working with existing systems and for the

planning and construction of new systems.
Key

1 specific models and communication interfaces (e.g. CDA, FHIR, ISO 13606, DICOM)

2 common, neutral, organisation-wide HISA model

3 integrated and consistent heritage of all common enterprise data and common business logic

Figure 1 — Complementarity and positioning of the architecture with other standards and

models

It is pointed out that the ISO 12967 series does not aim to define a unique model for clinical,

organizational, managerial or administrative activities, but rather defines a set of workflows,

information and services common to all healthcare information systems, relevant for any healthcare

sector and usable by any application also for facilitating the mutual interworking.

Similarly, the ISO 12967 series does not aim to represent a final, complete set of specifications. On the

contrary, it formalizes only fundamental aspects, identified as common in all countries and considered

to be currently essential in any advanced healthcare information system. Specifications are formalized,

avoiding any dependency on specific technological products and/or solutions.

In line with the above, HISA neither explicitly addresses major trends within healthcare in 2020 such as

"Patient Engagement" or "Patient Registries/Patient Data Hubs". HISA nevertheless also supports these

trends and might very well be used in connection herewith, providing further support for information

exchange, to the benefit of the patient, or for structured and systematic information management

regarding research, clinical databases, knowledge application and quality improvement.

The ISO 12967 series, therefore, is an open framework that, according to the specification methodology

and preserving the compatibility with previous versions, can be extended during time according to

the evolution of the healthcare organization both in the individual (national and local) contexts and

through international standardization initiatives.

A European pre-standard, ENV 12967, developed according to such rationale during 1993 to 1997

and published in 1998, was the basis for implementations of middleware products and implemented

integrations in healthcare regions in several countries. In 2000, the CEN/TC 251 Short Strategic Study

on Health Information Infrastructure identified a number of other new architectures and health

infrastructure initiatives, as well as the requirements and possibilities for alignment with the large

body of information model standards developed by CEN for various communication purposes. European

standardization initiatives have delivered a number of object-oriented domain models and message

descriptions that include an architecture for the Electronic Health Record [ISO 13606 (all parts)], and a

concept model of healthcare (ISO 13940:2015). In the last ten years ISO, HL7 and CEN have increasingly

collaborated and both the ISO 13606 (all parts) and ISO 13940:2015 have undergone major systematic

© ISO 2020 – All rights reserved vii
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ISO 12967-1:2020(E)

reviews as ISO standards. Besides these ISO standards, HL7 Service-Aware Interoperability Framework

(SAIF) has served as a source of inspiration, the Australian E-health Interoperability Framework (eHIF,

see bibliography) and a conference paper from 2016 "Digital Health Interoperability Frameworks: Use

of RM-ODP Standards" as sources of input for this revision (see bibliography).

The formal major revision of the pre-standard to a European standard was started in 2003 and in 2007

this led to the publication of the EN 12967-1 to EN 12967-3 series on which the ISO 12967 series is

based, currently serving as the basis for this revision.

The following characteristics of the ISO 12967 series can be highlighted as follows.

— The architecture is described according to the methodology of ISO/IEC 10746 (all parts), to provide

a formal, comprehensive and non-ambiguous specification suitable to serve as a reference in the

planning, design and implementation of healthcare information systems. (Annex A provides short

informative background information regarding the ISO/IEC 10746 (all parts) and Open Distributed

Processing).

— The scope of the architecture comprises the support to the activities of the healthcare organization

as a whole, from the clinical, organizational and managerial point of view. It therefore does not detail

specificities of different subdomains, but provides an overarching comprehensive information and

services framework to accommodate requirements.

— The architecture is intrinsically compatible, complementary and synergistic with other models

and standards, such as HL7 CDA, HL7 FHIR, ISO 13940:2015 (Contsys) and ISO 13606 (all parts).

A separate mapping document between ISO 12967-2 and HL7 RIM was produced during the

process for the first version of this ISO 12967 series. Specific information objects and services are

explicitly foreseen in the architecture to facilitate the implementation of views and communication

mechanisms based on such standards.

— Many of the concepts and principles shared with ISO 13606 (all parts), ISO 13940:2015 (Contsys)

and the ISO 12967 series are aligned, originally stemming from CEN. But as the standards also

reflect different, although complementary, scopes, purposes and objectives, as investigated during

a joint "concurrent use" initiative, differences do exist.

Each part in the ISO 12967 series is self-consistent and is also independently utilizable for the intended

purposes by different types of users (this document being more oriented to the managerial level,

Parts 2 and 3 being more dedicated to the design activities). Nevertheless, it should be understood

that they represent three aspects of the same architecture. Mutual references therefore exist between

the different parts and evolutions of the individual documents should be carried out according to the

defined methodology to reserve the overall integrity and consistency of the specification.

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 middleware. 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 this document.

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

implemented by the middleware to integrate the common enterprise data and to support the

enterprise requirements formalized in this document. 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.
viii © ISO 2020 – All rights reserved
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ISO 12967-1:2020(E)

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

provided by the middleware for allowing access to the common data as well as the execution of the

business logic supporting the enterprise processes identified in the information viewpoint and in

this document. It also provides guidance on how one individual enterprise can specify additional

services needed to support local specific requirements in terms of common business logic to be

implemented.
Computational viewpoint is specified in ISO 12967-3.

Annex C includes an explanation of ISO 23903:— and its relevance in regard to the ISO 12967 series,

for integration with
...

NORME ISO
INTERNATIONALE 12967-1
Deuxième édition
2020-11
Informatique de santé — Architecture
de service —
Partie 1:
Point de vue de l'entreprise
Health informatics — Service architecture (HISA) —
Part 1: Enterprise viewpoint
Numéro de référence
ISO 12967-1:2020(F)
ISO 2020
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ISO 12967-1:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
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ii © ISO 2020 – Tous droits réservés
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ISO 12967-1:2020(F)
Sommaire Page

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

Introduction ..............................................................................................................................................................................................................................vii

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

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

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

3.1 Soins de santé........................................................................................................................................................................................... 2

3.2 Concepts liés au système ................................................................................................................................................................ 3

3.3 Concepts liés à l'organisme .......................................................................................................................................................... 4

3.4 Concepts liés à la communauté ................................................................................................................................................. 5

3.5 Concepts liés au comportement ............................................................................................................................................... 5

3.6 Concepts de politique ........................................................................................................................................................................ 7

3.7 Concepts liés à l'imputabilité, à la responsabilité et au temps ...................................................................... 8

3.8 Gestion de l'information ..............................................................................................................................................................10

4 Symboles et abréviations ..........................................................................................................................................................................10

5 Méthodologie pour la spécification de l'architecture .................................................................................................11

5.1 Généralités ...............................................................................................................................................................................................11

5.2 Points de vue pour la spécification de l'architecture ..........................................................................................11

5.3 Procédure de spécification de l'HISA ................................................................................................................................12

5.3.1 Paradigme stratégique .............................................................................................................................................12

5.3.2 Spécification du point de vue de l'entreprise.......................................................................................13

5.3.3 Spécification du point de vue de l'information ...................................................................................13

5.3.4 Spécification du point de vue informatique ..........................................................................................14

5.4 Spécification itérative .....................................................................................................................................................................14

5.5 Langages, notations et niveaux d'abstraction de la spécification des points de vue ...............15

6 Présentation de l'HISA .................................................................................................................................................................................16

6.1 Exigences générales .........................................................................................................................................................................16

6.2 Point de vue de l'entreprise ......................................................................................................................................................17

6.3 Point de vue de l'information ..................................................................................................................................................18

6.4 Point de vue informatique ..........................................................................................................................................................19

7 Méthodologie des extensions ...............................................................................................................................................................20

8 Critères de conformité .................................................................................................................................................................................21

8.1 Généralités ...............................................................................................................................................................................................21

8.2 Conformité des documents de spécification à la méthodologie de l'HISA .......................................21

8.3 Conformité des produits de couche interstitielle aux exigences de l'HISA ......................................21

9 Point de vue de l'entreprise de l'HISA .........................................................................................................................................22

9.1 Vue d'ensemble ....................................................................................................................................................................................22

9.1.1 Généralités .........................................................................................................................................................................22

9.1.2 Point de vue régional, interentreprise .......................................................................................................22

9.1.3 Point de vue médical/clinique ..........................................................................................................................23

9.1.4 Point de vue du modèle de processus opérationnel/clinique et organisationnel 25

9.1.5 Les services d'informations et leur complexité .................................................................................29

9.2 Workflows fondamentaux et groupes d'activités des utilisateurs pris en charge par

la couche interstitielle ...................................................................................................................................................................30

9.3 Exigences en matière d'informations générales pour toutes les activités des utilisateurs 32

9.3.1 Généralités .........................................................................................................................................................................32

9.3.2 Attributs communs .....................................................................................................................................................32

9.3.3 Extensibilité ......................................................................................................................................................................32

9.3.4 Gestion des versions ..................................................................................................................................................33

9.3.5 Audit ........................................................................................................................................................................................33

9.3.6 Traitement du cycle de vie .................. ..................................................................................................................33

9.4 Workflow du sujet de soins .......................................................................................................................................................34

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ISO 12967-1:2020(F)

9.4.1 Description textuelle des exigences .............................................................................................................34

9.4.2 Exemples de cas d'utilisation .............................................................................................................................36

9.5 Workflow des informations de soins de santé ..........................................................................................................42

9.5.1 Spécification textuelle des exigences ..........................................................................................................42

9.5.2 Exemples de cas d'utilisation .............................................................................................................................42

9.6 Workflow de gestion des activités de soins de santé ..........................................................................................44

9.6.1 Description textuelle des exigences .............................................................................................................44

9.6.2 Exemples de cas d'utilisation .............................................................................................................................47

9.6.3 Exemples de fonctions extraits de l'ISO/HL7 10781 venant à l'appui du

cas d'utilisation ..............................................................................................................................................................50

9.7 Activités de gestion des ressources ....................................................................................................................................51

9.8 Activités de gestion des utilisateurs et des autorisations ...............................................................................52

9.9 Activités de gestion des classifications, du codage et des dictionnaires ............................................54

9.9.1 Description générale des exigences .............................................................................................................54

9.9.2 Exemples de fonctions extraits de l'ISO/HL7 10781 fournissant un support .........56

Annexe A (informative) Présentation du traitement réparti ouvert (ODP) ..............................................................57

Annexe B (informative) Logique de la structure fédérative de l'architecture des services

informatiques de santé (HISA) ...........................................................................................................................................................60

Annexe C (informative) Interopérabilité interdomaine ................................................................................................................63

Bibliographie ...........................................................................................................................................................................................................................70

iv © ISO 2020 – Tous droits réservés
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ISO 12967-1:2020(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 le lien suivant: www .iso .org/ iso/ fr/ 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 12967-1:2009), qui a fait l'objet

d'une révision technique.

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

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

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

— référence à d'autres normes, telles que HL7® et FHIR®;
— ajout de couches d'abstraction complétant les descriptions des points de vue;

— introduction d'exemples de fonctions extraits de l'ISO/HL7 10781 prenant en charge les exemples de

cas d'utilisation du présent document;

— ajout de l'Annexe C, Interopérabilité interdomaine, dans la droite ligne de l'initiative actuelle (2020)

de normalisation de l'architecture de référence de l'interopérabilité et de l'intégration de l'ISO;

— mises à jour de la Bibliographie.

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

© ISO 2020 – Tous droits réservés v
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ISO 12967-1:2020(F)

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.
vi © ISO 2020 – Tous droits réservés
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ISO 12967-1:2020(F)
Introduction

Le système de santé se compose de réseaux d'organisations de santé (hôpitaux de différents types et

tailles, cliniques pour soins ambulatoires primaires et secondaires dans une zone géographique donnée)

répartis sur tout le territoire, caractérisés par un degré élevé d'hétérogénéité et de diversité, au niveau

organisationnel, logistique, clinique, technologique, voire culturel. La structure des organismes de santé

évolue d'une organisation globale verticale à l'intégration d'un ensemble de domaines fonctionnels

spécialisés (par exemple analyses en laboratoire, chirurgie) ayant des besoins et des caractéristiques

spécifiques, mais ressentant néanmoins le besoin de partager des informations communes et d'agir

en fonction de workflows intégrés. D'une telle situation découlent deux nécessités principales qui

s'opposent l'une à l'autre d'une certaine façon. D'une part, il est nécessaire de soutenir efficacement

les besoins spécifiques de chaque unité ou de chaque utilisateur de la manière la plus appropriée et la

plus efficiente, alors que, d'autre part, il est vital d'assurer la cohérence et l'intégration de l'ensemble

de l'organisme, tant au niveau local que territorial. Les exigences en matière d'intégration ne sont pas

uniquement liées à la nécessité d'améliorer les traitements médicaux apportés aux patients. Ils sont

aussi exigés par la demande urgente de tous les pays de contrôler et d'optimiser le niveau actuel des

dépenses de santé tout en assurant le niveau nécessaire de qualité des services à tous les patients.

Le grand nombre de bases de données et d'applications isolées et mutuellement incompatibles déjà

disponibles sur le marché, installées et opérationnelles dans les organismes de santé, afin de supporter

efficacement les besoins spécifiques des utilisateurs, ne peut pas être sous-estimé. Il arrive souvent

que, dans le même organisme, le système d'information de santé soit fréquemment fragmenté en un

certain nombre d'applications, de données et de fonctionnalités, isolées et très peu cohérentes les unes

avec les autres.

Dans la situation actuelle, la nécessité principale des organismes de santé est d'intégrer et de rendre

disponibles les informations existantes, de rendre possible l'intégration et l'interopérabilité des

applications déjà existantes et de protéger ainsi les investissements. Lors des activités d'intégration,

la continuité du service doit être maintenue, tout en facilitant une migration progressive des systèmes

propriétaires et monolithiques existants vers les nouveaux concepts d'ouverture et de modularité.

La rentabilité des solutions, surtout lorsqu'elle est projetée à l'échelle de tout l'organisme de santé,

représente un autre aspect crucial qui doit être évalué soigneusement.

Un autre aspect est lié au management de la qualité (voir Bibliographie), où la gestion de l'information

fait partie intégrante du management de la qualité et où les approches stratégiques et opérationnelles

de ces deux aspects doivent être coordonnées pour être efficaces. Les processus cliniques sont globaux.

La gestion systématique et structurée de l'information, y compris la gestion des connaissances

médicales, est nécessaire pour assurer un haut niveau de qualité et d'efficacité dans des systèmes de

soins de santé.

Les objectifs peuvent être atteints grâce à une architecture unifiée ouverte reposant sur une

couche interstitielle indépendante des applications spécifiques et en mesure d'intégrer des données

communes et des logiques applicatives et de les mettre à la disposition des différentes applications

multiprestataires par un déploiement adapté à chacune des situations. Conformément aux objectifs

d'intégration au niveau organisationnel, il convient que l'architecture soit en mesure de prendre en

charge tous les aspects, qu'ils soient cliniques, organisationnels ou managériaux. Par conséquent, il

convient qu'elle puisse inclure toutes les informations pertinentes et tous les workflows métier, en les

structurant en fonction de critères et de paradigmes indépendants des aspects sectoriels particuliers,

des besoins temporaires ou des solutions technologiques.

Des normes et des solutions technologiques existent déjà. Leur définition se poursuivra de façon à

prendre en charge les exigences spécifiques, tant en termes de besoins de l'utilisateur in situ que par

rapport au mouvement des informations. Il convient que l'architecture soit en mesure de s'adapter à

ces exigences en facilitant l'intégration de modèles propres aux informations existantes de l'organisme

de santé et, par exemple, en permettant à des messages de communication de faire office de «services»

extrayant ou important des données depuis/vers les informations mises en commun (voir Figure 1).

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ISO 12967-1:2020(F)
Sur la base de ces considérations, l'objectif de la série ISO 12967 est double:

— identifier une méthodologie afin de décrire les systèmes d'information de santé au moyen d'un

langage, d'une notation et de paradigmes pertinents facilitant la planification, la conception et la

comparaison des systèmes;

— identifier les aspects fondamentaux de l'architecture assurant l'ouverture, l'intégration et

l'interopérabilité des systèmes d'information de santé.

Par conséquent, l'architecture est prévue pour servir de base à la gestion des systèmes existants. Elle

est également utile à la planification et à la construction de nouveaux systèmes.

Légende

1 modèles spécifiques et interfaces de communication (par exemple CDA, FHIR, ISO 13606, DICOM)

2 modèle HISA commun, neutre à l'échelle de l'organisme

3 héritage intégré et cohérent de toutes les données communes de l'entreprise et de la logique métier commune

Figure 1 — Complémentarité et positionnement de l'architecture avec d'autres normes et modèles

Il convient de souligner que la série ISO 12967 n'a pas pour objet de définir un modèle unique pour

les activités médicales, organisationnelles, managériales ou administratives. Son objectif est plutôt

de définir un ensemble de workflows, d'informations et de services spécifiques de santé, communs à

tous les systèmes d'information de santé, adapté à tous les secteurs de santé et utilisables par toute

application pour faciliter leur interopérabilité.

De même, la série ISO 12967 n'a pas pour objet de représenter un ensemble de spécifications définitif

et exhaustif. Au contraire, elle formalise uniquement les aspects fondamentaux, communs à tous les

pays européens et considérés actuellement comme essentiels dans un système d'information de santé

avancé. Les spécifications sont formalisées, ce qui permet d'éviter toute dépendance vis-à-vis de

produits et/ou de solutions technologiques spécifiques.

Conformément à ce qui précède, l'HISA ne traite pas explicitement des grandes tendances 2020 du

domaine des soins de santé, telles que la «participation du patient» ou les «registres de patients/

concentrateurs de données patient», même si elle va dans le même sens et pourrait fort bien être utilisée

dans ce contexte, en apportant un soutien supplémentaire à l'échange d'informations, au bénéfice du

patient, ou à la gestion structurée et systématique des informations concernant la recherche, les bases

de données cliniques, l'application des connaissances et l'amélioration de la qualité.

Par conséquent, la série ISO 12967 se situe dans un cadre ouvert qui, conformément à la méthodologie

de spécification et en préservant la compatibilité avec les versions précédentes, peut être étendu en

fonction de l'évolution de l'organisme de santé, tant du point de vue des contextes individuels (nationaux

et locaux) que des initiatives de normalisation internationales.

Un projet de Norme européenne, l'ENV 12967, a été élaboré conformément à cette logique entre 1993

et 1997 et a été publié en 1998. Il a servi de base à la mise en œuvre de produits d'infrastructure

viii © ISO 2020 – Tous droits réservés
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ISO 12967-1:2020(F)

d'intégration dans le domaine de la santé dans plusieurs pays. En 2000, la courte étude stratégique sur

l'infrastructure de l'information en matière de santé du CEN/TC 251 a identifié un certain nombre de

nouvelles architectures et d'initiatives d'infrastructure de santé ainsi que des exigences et possibilités

d'alignement sur un large éventail de normes relatives au modèle d'information développées par le

CEN pour différents besoins de communication. En outre, des initiatives de normalisation européenne

ont permis de proposer un certain nombre de modèles de domaine orientés objet et de descriptions de

message comprenant une architecture de dossiers santé informatisés [ISO 13606 (toutes les parties)]

et un modèle de concept de soins de santé (ISO 13940:2015). Au cours des dix dernières années, l'ISO, le

HL7 et le CEN ont intensifié leur collaboration, ce qui a mené à des refontes systématiques majeures des

normes ISO 13606 (toutes les parties) et ISO 13940:2015 en tant que normes ISO. Outre ces normes ISO,

le Service-Aware Interoperability Framework (SAIF) du HL7 a servi de source d'inspiration, l'Australian

E-health Interoperability Framework (eHIF, voir Bibliographie) et un document de conférence de 2016

«Digital Health Interoperability Frameworks: Use of RM-ODP Standards» ont servi de sources de

contribution pour la présente révision (voir Bibliographie).

La principale révision formelle du projet de norme en vue d'en faire une Norme européenne a commencé

en 2003 et a abouti, en 2007, à la publication de la série de normes EN 12967-1 à EN 12967-3, sur laquelle

se fonde la série ISO 12967 et qui sert actuellement de base à la présente révision.

Les caractéristiques suivantes de la série ISO 12967 peuvent être présentées comme suit.

— L'architecture est décrite conformément à la méthodologie de l'ISO/IEC 10746 (toutes les parties),

de façon à fournir une spécification formelle, exhaustive et sans ambiguïté apte à faire office de

référence dans le cadre de la planification, de la conception et de la mise en place de systèmes

d'information de santé. (L'Annexe A présente, de manière succincte, l'ISO/IEC 10746 (toutes les

parties) ainsi que le traitement réparti ouvert.)

— Le domaine d'application de l'architecture intègre la prise en charge de toutes les activités liées à

l'ensemble de l'organisme de santé, des points de vue clinique, organisationnel et managérial. Par

conséquent, il ne détaille pas les particularités des différents sous-domaines, mais offre un cadre

d'informations et de services exhaustifs pour répondre à ces exigences.

— L'architecture est intrinsèquement compatible, complémentaire et en totale synergie avec d'autres

modèles et normes, comme le format CDA de HL7, la norme FHIR de HL7, le système Contsys de

l'ISO 13940:2015 et la norme ISO 13606 (toutes les parties). Un document distinct de mise en

correspondance entre l'ISO 12967-2 et le modèle HL7 RIM a été réalisé au cours de l'élaboration

de la première version de la présente série ISO 12967. Pour faciliter la mise en place des vues et

mécanismes de communication reposant sur de telles normes, des objets et services d'informations

spécifiques sont explicitement prévus dans l'architecture.

— De nombreux concepts et principes provenant à l'origine du CEN, communs à l'ISO 13606 (toutes

les parties), à l'ISO 13940:2015 (Contsys) et à la série ISO 12967 sont alignés. Mais, comme les

normes reflètent également des domaines d'application, des buts et des objectifs différents, même

si complémentaires, il existe des différences, comme l'a révélé une étude menée dans le cadre d'une

initiative conjointe d'«utilisation en parallèle».

Chaque partie de la série ISO 12967 est autocohérente et peut être également utilisée indépendamment,

pour les objectifs visés par différents types d'utilisateurs (le présent document étant davantage orienté

vers le niveau de gestion, les Parties 2 et 3 étant davantage dédiées aux activités de conception).

Néanmoins, il convient de comprendre qu'elles représentent trois aspects de la même architecture.

Il existe, par conséquent, des références mutuelles entre les différentes parties et il convient de faire

évoluer les documents individuels conformément à la méthodologie définie, afin de préserver l'intégrité

et la cohérence globale de la spécification.
© ISO 2020 – Tous droits réservés ix
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 12967-1
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-11-01 2020-01-24
Health informatics — Service architecture (HISA) —
Part 1:
Enterprise viewpoint
Informatique de santé — Architecture de service —
Partie 1: Point de vue d'entreprise
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 12967-1:2019(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 12967-1:2019(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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Published in Switzerland
ii © ISO 2019 – All rights reserved
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ISO/DIS 12967-1:2019(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

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

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

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

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

3.1 Healthcare ................................................................................................................................................................................................... 2

3.2 System concepts ..................................................................................................................................................................................... 3

3.3 Concepts relating to organization .......................................................................................................................................... 4

3.4 Community concepts ......................................................................................................................................................................... 5

3.5 Behaviour concepts ............................................................................................................................................................................. 5

3.6 Policy concepts ....................................................................................................................................................................................... 8

3.7 Accountability, responsibility and time concepts ..................................................................................................... 8

3.8 Information Management ...........................................................................................................................................................10

4 Symbols and abbreviations ....................................................................................................................................................................11

5 Methodology for the specification of the architecture ...............................................................................................11

5.1 Viewpoints for the specification of the architecture ...........................................................................................12

5.2 The HISA specification procedure .......................................................................................................................................13

5.2.1 The Strategic Paradigm ...........................................................................................................................................13

5.2.2 Specification of the enterprise viewpoint ...............................................................................................13

5.2.3 Specification of the information viewpoint ...........................................................................................14

5.2.4 Specification of the computational viewpoint.....................................................................................14

5.3 Iterative specification .....................................................................................................................................................................15

5.4 Viewpoints specification languages, notations and levels of abstraction .........................................15

6 HISA overview.......................................................................................................................................................................................................17

6.1 General requirement .......................................................................................................................................................................17

6.2 Enterprise viewpoint ......................................................................................................................................................................17

6.3 Information viewpoint ..................................................................................................................................................................19

6.4 Computational viewpoint ...........................................................................................................................................................19

7 Methodology for extensions ..................................................................................................................................................................20

8 Conformance criteria ....................................................................................................................................................................................21

8.1 Conformance of specification documents to the HISA methodology ....................................................21

8.2 Conformance of middleware products to the HISA architectural requirements ........................21

9 The HISA Enterprise viewpoint ..........................................................................................................................................................22

9.1 Introduction(informative) .........................................................................................................................................................22

9.1.1 General...................................................................................................................................................................................22

9.1.2 The regional, inter-enterprise perspective ............................................................................................22

9.1.3 The medical/clinical perspective ...................................................................................................................23

9.1.4 The operational/clinical and organizational process model perspective ...................25

9.1.5 The information services and their complexity .................................................................................28

9.2 The fundamental workflows and groups of users’ activities to be supported by the

middleware .............................................................................................................................................................................................29

9.3 General information requirements for all users’ activities ............................................................................30

9.3.1 Introduction ......................................................................................................................................................................30

9.3.2 Common attributes .....................................................................................................................................................30

9.3.3 Extensibility ......................................................................................................................................................................31

9.3.4 Versioning ...........................................................................................................................................................................31

9.3.5 Auditing ................................................................................................................................................................................31

9.3.6 Handling of life cycle..................................................................................................................................................32

9.4 Subject of care workflow .............................................................................................................................................................32

9.4.1 Textual description of requirements ...........................................................................................................32

9.4.2 Use-case examples (informative) ...................................................................................................................34

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ISO/DIS 12967-1:2019(E)

9.5 Healthcare information workflow .......................................................................................................................................39

9.5.1 Textual specification of requirements ........................................................................................................39

9.5.2 Use-case examples (informative) ...................................................................................................................40

9.6 Healthcare activity management workflow ................................................................................................................41

9.6.1 Textual description of requirements ...........................................................................................................41

9.6.2 Use-case examples (informative) ...................................................................................................................44

9.7 Resources management activities/Textual description of requirements .........................................47

9.8 Management activities for users and authorizations / textual description of

requirements .........................................................................................................................................................................................48

9.9 Classifications, coding and dictionaries management activities / textual

description of requirements .................. ...................................................................................................................................49

9.9.1 Examples of Functions from ISO 10781 Health Informatics – HL7
Electronic Health Records-System Functional Model, Release 2 (EHR FM),

providing support ........................................................................................................................................................51

Annex A (informative) Highlights of Open Distributed Processing (ODP) .................................................................53

Annex B (informative) Rationale for the federative structure of the Health Informatics

Service Architecture ......................................................................................................................................................................................56

Annex C (informative) Cross-Domain Interoperability ..................................................................................................................59

Bibliography .............................................................................................................................................................................................................................67

iv © ISO 2019 – All rights reserved
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ISO/DIS 12967-1:2019(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 12967-1:2009), which was

based on the European Standard EN 12967-1:2007.

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 1, enterprise viewpoint) are as

follows:

— Use of terms, definitions and concepts from ISO 1390:2016 (Contsys), with textual alignment

throughout the document including figures, to the extent possible and beneficial
— Reference to further standards, such as HL7 and FHIR
— Addition of abstraction layers supplementing the viewpoint descriptions

— Substantial updating (based on ISO 13940:2016 Contsys) regarding text and figures related to the

clinical process, modelling of healthcare and the strategic paradigm of HISA

— Introduction of example Functions from ISO 10781 Health Informatics – HL7 Electronic Health

Records-System Functional Model, supporting the use case examples of the EV

— Addition of Annex C, Cross-Domain Interoperability, in line with the current (2019) ongoing ISO

Interoperability Reference Architecture standardization initiative
— Updates to the Bibliography
© ISO 2019 – All rights reserved v
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ISO/DIS 12967-1:2019(E)
Introduction

The healthcare organizational structure consists of networks of centres (hospitals of different

types and sizes and outpatient clinics for primary and secondary care within a geographical area)

distributed over the territory, characterized by a high degree of heterogeneity and diversity, from

organizational, logistic, clinical, technological and even cultural perspectives. The structure of

individual centres evolves from a vertical, aggregated organization towards the integration of a set

of specialized functional areas (e.g. unit of laboratory analyses, unit of surgery), with specific needs

and characteristics, nevertheless needing to share common information and to operate according to

integrated workflows. Such a situation determines two main needs which conflict with each other in a

certain way. On the one hand it is necessary to effectively support the specific requirements of each unit

or user in the most appropriate and cost-effective way whilst, on the other hand, it is vital to ensure the

consistency and integration of the overall organization, at local and territorial levels. This integration

requirement is not only related to the need for improving clinical treatments to the subject of care but

is also demanded by the urgent necessity of all countries to control and optimize the current level of

expenditure for health, whilst ensuring the necessary qualitative level of services to all subjects of care.

The large number of databases and applications, mutually isolated and incompatible, which are already

available on the market and operational in healthcare organizations to support specific needs of users,

cannot be underestimated. Even within the same centre, healthcare information systems are frequently

fragmented across a number of applications, data and functionalities, isolated and scarcely consistent

with each other.

In the present circumstances, the main need for care delivery organizations is to integrate and to make

available the existing information assets, and to make possible the integration and interoperability

of existing applications, thereby protecting investments. During integration activities, continuity

of service needs to be achieved whilst gradual migration of existing proprietary, monolithic systems

towards the new concepts of openness and modularity occurs. The cost-effectiveness of the solutions,

especially when projected on the scale of the whole healthcare organization, represents another crucial

aspect to be evaluated carefully.

A further aspect is related to quality management (see bibliography), where information management

is an integrated part of quality management and the strategic and operative approaches for these two

managerial aspects need to be co-ordinated to be effective. Clinical processes are comprehensive.

Systematic and structured information management including medical knowledge management is

required for high-level quality in effective healthcare systems.

The aims can be achieved through a unified, open architecture based on middleware independent from

specific applications and capable of integrating common data and business logic and of making them

available to diverse, multi-vendor applications through many types of deployment. According to the

integration objectives at organizational level, all aspects (i.e. clinical, organizational and managerial)

of the healthcare structure must be supported by the architecture, which must therefore be able to

comprise all relevant information and all business workflows, structuring them according to criteria

and paradigms independent from specific sectorial aspects, temporary requirements or technological

solutions.

Standards and technological solutions already exist and will continue to be defined for supporting

specific requirements, both in terms of in situ user operations and with respect to the movement of

information. The architecture must be able to accommodate such requirements by allowing the

specific models to be integrated with the complete information assets of the healthcare organization

and e.g. communication messages to be “services” extracting or importing data from/to the common

information shown in Figure 1.
On the basis of these considerations, the purpose of ISO 12967 is twofold:

— identify a methodology to describe healthcare information systems through a language, notation

and paradigms suitable to facilitate the planning, design and comparison of systems

vi © ISO 2019 – All rights reserved
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ISO/DIS 12967-1:2019(E)

— identify the fundamental architectural aspects enabling the openness, integration and

interoperability of healthcare information systems

The architecture is therefore intended as a basis both for working with existing systems and for the

planning and construction of new systems.

Figure 1 — Complementarity and positioning of the architecture with other standards and

models

It is pointed out that ISO 12967 does not aim to define a unique model for clinical, organizational,

managerial or administrative activities, but rather defines a set of workflows, information and services

common to all healthcare information systems, relevant for any healthcare sector and usable by any

application also for facilitating the mutual interworking.

Similarly, ISO 12967 does not aim to represent a final, complete set of specifications. On the contrary,

it formalizes only fundamental aspects, identified as common in all countries and considered to be

currently essential in any advanced healthcare information system. Specifications are formalized,

avoiding any dependency on specific technological products and/or solutions.

In line with the above, HISA neither explicitly addresses major trends within healthcare in 2018

such as "Patient Engagement" or "Patient Registries / Patient Data Hubs". HISA never the less also

supports these trends and might very well be used in connection herewith, providing further support

for information exchange, to the benefit of the patient, or for structured and systematic information

management regarding research, clinical databases, knowledge application and quality improvement.

ISO 12967, therefore, is an open framework that, according to the specification methodology and

preserving the compatibility with previous versions, can be extended during time according to the

evolution of the healthcare organization both in the individual (national and local) contexts and through

international standardization initiatives.

A European pre-standard, ENV12967-1, developed according to such rationale during 1993 to 1997

and published in 1998, was the basis for implementations of middleware products and implemented

integrations in healthcare regions in several countries. In 2000, the CEN/TC 251 Short Strategic

Study on Health Information Infrastructure identified a number of other new architectures and

health infrastructure initiatives, as well as the requirements and possibilities for alignment with the

large body of information model standards developed by CEN for various communication purposes.

European standardization initiatives have delivered a number of object-oriented domain models and

message descriptions that include an architecture for the Electronic Health Record (ISO 13606), and

a concept model of healthcare (ISO 13940). In the last ten years ISO, HL7 and CEN have increasingly

collaborated and both 13606 and 13940 have undergone major systematic reviews as ISO standards.

Besides these ISO standards, HL7 Service-Aware Interoperability Framework (SAIF) has served as a

source of inspiration, the Australian E-health Interoperability Framework (eHIF, see bibliography) and

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a conference paper from 2016 "Digital Health Interoperability Frameworks: Use of RM-ODP Standards"

as sources of input for this revision (see bibliography).

The formal major revision of the pre-standard to a European standard was started in 2003 and in 2007

this led to the publication of the EN 12967 Parts 1 to 3 series on which ISO 12967 is based, currently

serving as the basis for this revision.
The following characteristics of ISO 12967 can be highlighted as follows.

— The architecture is described according to the methodology of ISO/IEC 10746 (all parts), to provide

a formal, comprehensive and non-ambiguous specification suitable to serve as a reference in the

planning, design and implementation of healthcare information systems.

— The scope of the architecture comprises the support to the activities of the healthcare organization

as a whole, from the clinical, organizational and managerial point of view. It therefore does not detail

specificities of different subdomains, but provides an overarching comprehensive information and

services framework to accommodate requirements.

— The architecture is intrinsically compatible, complementary and synergistic with other models

and standards, such as HL7 CDA, FHIR, ISO 13940 (Contsys) and the Electronic Health Record

Architecture ISO 13606. A separate mapping document between this HISA standard and HL7 RIM

was produced during the process for the first version of this ISO standard. Specific information

objects and services are explicitly foreseen in the architecture to facilitate the implementation of

views and communication mechanisms based on such standards.

— Many of the concepts and principles shared with ISO 13606, ISO 13940 (Contsys) and this standard

are aligned, originally stemming from CEN. But as the standards also reflect different, although

complementary, scopes, purposes and objectives, as investigated during a joint "concurrent use"

initiative, differences do exist.
ISO 12967 consists of three parts:

— Part1 (this part) specifies the overall characteristics of the architecture, formalizes the specification

methodology and the conformance criteria, and provides details of the enterprise viewpoint of the

architecture;
— Part 2 specifies the information viewpoint of the architecture;
— Part 3 specifies the computational viewpoint of the architecture.

Each part is self-consistent and is also independently utilizable for the intended purposes by different

types of users (this part being more oriented to the managerial level, Parts 2 and 3 being more dedicated

to the design activities). Nevertheless, it must be understood that they represent three aspects of the

same architecture. Mutual references therefore exist between the different parts and evolutions of the

individual documents must be carried out according to the defined methodology to reserve the overall

integrity and consistency of the specification.

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 middleware. 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 this part of ISO 12967.

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

implemented by the middleware to integrate the common enterprise data and to support the

enterprise requirements formalized in this part of ISO 12967. It also provides guidance on how one

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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 services that must be

provided by the middleware for allowing access to the common data as well as the execution of

the business logic supporting the enterprise processes identified in the information viewpoint and

in this part of IS
...

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