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)

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.

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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

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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.
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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

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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)
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