Health informatics - Service architecture (HISA) - Part 1: Enterprise viewpoint (ISO 12967-1:2020)

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.This document is also independent from, and does not imply either explicitly or implicitly, any specific
technological solution or product for its deployment. Accordingly, the formalization of the architecture
according to two lower levels of the ODP reference model, the engineering and technology viewpoints,
is outside the scope of this document.
The language and notations used here for specifying the architecture are based on UML (Unified
Modeling Language) complemented by case studies and other paradigms widely utilized by other
standards in health informatics. The level of the specification is complete and non-ambiguous enough to
allow its implementation into the specific physical and technological scenarios adopted by the various
healthcare organizations and vendors. Accordingly, methodology formalized by the Engineering and
Technology viewpoints of the RM ODP Reference Model can be followed for the implementation.

Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht (ISO 12967-1:2020)

Informatique de santé - Architecture de service - Partie 1: Point de vue d'entreprise (ISO 12967-1:2020)

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

Zdravstvena informatika - Arhitektura storitve - 1. del: Podjetniški vidik (ISO 12967-1:2020)

General Information

Status
Published
Public Enquiry End Date
19-Dec-2019
Publication Date
06-Dec-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Dec-2020
Due Date
05-Feb-2021
Completion Date
07-Dec-2020

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SLOVENSKI STANDARD
SIST EN ISO 12967-1:2021
01-januar-2021
Nadomešča:
SIST EN ISO 12967-1:2011
Zdravstvena informatika - Arhitektura storitve - 1. del: Podjetniški vidik (ISO 12967-
1:2020)
Health informatics - Service architecture (HISA) - Part 1: Enterprise viewpoint (ISO
12967-1:2020)
Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht (ISO 12967-
1:2020)
Informatique de santé - Architecture de service - Partie 1: Point de vue d'entreprise (ISO
12967-1:2020)
Ta slovenski standard je istoveten z: EN ISO 12967-1:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 12967-1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 12967-1:2021

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SIST EN ISO 12967-1:2021


EN ISO 12967-1
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2020
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 12967-1:2011
English Version

Health informatics - Service architecture (HISA) - Part 1:
Enterprise viewpoint (ISO 12967-1:2020)
Informatique de santé - Architecture de service - Partie Medizinische Informatik - Servicearchitektur - Teil 1:
1: Point de vue d'entreprise (ISO 12967-1:2020) Unternehmenssicht (ISO 12967-1:2020)
This European Standard was approved by CEN on 11 June 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12967-1:2020 E
worldwide for CEN national Members.

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SIST EN ISO 12967-1:2021
EN ISO 12967-1:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 12967-1:2021
EN ISO 12967-1:2020 (E)
European foreword
This document (EN ISO 12967-1:2020) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2021, and conflicting national standards shall be
withdrawn at the latest by May 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 12967-1:2011.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 12967-1:2020 has been approved by CEN as EN ISO 12967-1:2020 without any
modification.


3

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SIST EN ISO 12967-1:2021

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SIST EN ISO 12967-1:2021
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

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SIST EN ISO 12967-1:2021
ISO 12967-1:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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SIST EN ISO 12967-1:2021
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
© ISO 2020 – All rights reserved iii

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SIST EN ISO 12967-1:2021
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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SIST EN ISO 12967-1:2021
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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SIST EN ISO 12967-1:2021
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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SIST EN ISO 12967-1:2021
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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SIST EN ISO 12967-1:2021
ISO 12967-1:2020(E)

review
...

SLOVENSKI STANDARD
oSIST prEN ISO 12967-1:2019
01-december-2019
Zdravstvena informatika - Arhitektura storitve - 1. del: Podjetniški vidik (ISO/DIS
12967-1:2019)
Health informatics - Service architecture (HISA) - Part 1: Enterprise viewpoint (ISO/DIS
12967-1:2019)
Medizinische Informatik - Servicearchitektur - Teil 1: Unternehmenssicht (ISO/DIS 12967
-1:2019)
Informatique de santé - Architecture de service - Partie 1: Point de vue d'entreprise
(ISO/DIS 12967-1:2019)
Ta slovenski standard je istoveten z: prEN ISO 12967-1
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 12967-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 12967-1:2019

---------------------- Page: 2 ----------------------
oSIST prEN ISO 12967-1:2019
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

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oSIST prEN ISO 12967-1:2019
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 12967-1:2019
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
© ISO 2019 – All rights reserved iii

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oSIST prEN ISO 12967-1:2019
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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oSIST prEN ISO 12967-1:2019
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
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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
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— 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 d
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