Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO 12967- 2:2020)

This document specifies the fundamental characteristics of the information model implemented by
a specific architectural layer (i.e. the service architecture) of the information system to provide a
comprehensive and integrated storage of the common enterprise data and to support the fundamental
business processes of the healthcare organization, as defined in ISO 12967-1.
The information model is specified in this document without any explicit or implicit assumption on the
physical technologies, tools or solutions to adopt for its physical implementation in the various target
scenarios. The specification is nevertheless formal, complete and non-ambiguous enough to allow
implementers to derive an efficient design of the system in the specific technological environment that
will be selected for the physical implementation.
This document does not aim at representing a fixed, complete, specification of all possible data that can
be necessary for any requirement of any healthcare enterprise. It specifies only a set of characteristics,
in terms of overall organization and individual information objects, identified as fundamental and
common to all healthcare organizations, and that is satisfied by the information model implemented by
the service architecture.
Preserving consistency with the provisions of this document, physical implementations are allowed
extensions to the standard information model in order to support additional and local requirements.
Extensions include both the definition of additional attributes in the objects of the standard model, and
the implementation of entirely new objects.
Also, this document specification is extensible over time according to the evolution of the applicable
standardization initiatives.
The specification of extensions is carried out according to the methodology defined in ISO 12967-1:2020,
Clause 7.

Medizinische Informatik - Servicearchitektur - Teil 2: Informationssicht (ISO 12967- 2:2020)

Informatique de santé - Architecture de service - Partie 2: Point de vue d'information (ISO 12967- 2:2020)

Zdravstvena informatika - Arhitektura storitve - 2. del: Informacijski vidik (ISO 12967-2:2020)

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 12967-2:2021
01-januar-2021
Nadomešča:
SIST EN ISO 12967-2:2011

Zdravstvena informatika - Arhitektura storitve - 2. del: Informacijski vidik (ISO

12967-2:2020)

Health informatics - Service Architecture (HISA) - Part 2: Information viewpoint (ISO

12967- 2:2020)

Medizinische Informatik - Servicearchitektur - Teil 2: Informationssicht (ISO 12967-

2:2020)

Informatique de santé - Architecture de service - Partie 2: Point de vue d'information

(ISO 12967- 2:2020)
Ta slovenski standard je istoveten z: EN ISO 12967-2:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 12967-2:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 12967-2:2021
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SIST EN ISO 12967-2:2021
EN ISO 12967-2
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 12967-2:2011
English Version
Health informatics - Service Architecture (HISA) - Part 2:
Information viewpoint (ISO 12967-2:2020)

Informatique de santé - Architecture de service - Partie Medizinische Informatik - Servicearchitektur - Teil 2:

2: Point de vue d'information (ISO 12967-2:2020) Informationssicht (ISO 12967-2:2020)

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 12967-2:2020 E

worldwide for CEN national Members.
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SIST EN ISO 12967-2:2021
EN ISO 12967-2:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 12967-2:2021
EN ISO 12967-2:2020 (E)
European foreword

This document (EN ISO 12967-2:2020) 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 12967-2:2011.

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 12967-2:2020 has been approved by CEN as EN ISO 12967-2:2020 without any

modification.
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SIST EN ISO 12967-2:2021
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SIST EN ISO 12967-2:2021
INTERNATIONAL ISO
STANDARD 12967-2
Second edition
2020-11
Health informatics — Service
architecture (HISA) —
Part 2:
Information viewpoint
Informatique de santé — Architecture de service —
Partie 2: Point de vue de l'information
Reference number
ISO 12967-2:2020(E)
ISO 2020
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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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

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

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

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)
Contents Page

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

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

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

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

3 Terms and definitions ..................................................................................................................................................................................... 1

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

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

5.1 Language and notation adopted for the specification of the model.......................................................... 2

5.2 UML class diagram notation guidelines and profile ............................................................................................... 3

5.3 Clusters of objects in the information model ............................................................................................................... 4

5.4 Operational and descriptive information: classifications, knowledge and its instantiation 5

5.5 Data types .................................................................................................................................................................................................... 7

5.6 General characteristics of the model ................................................................................................................................... 8

6 General characteristics of the model ............................................................................................................................................... 8

6.1 Common structure of each information object: the GenericHisaClass ................................................... 8

6.2 UML diagram ............................................................................................................................................................................................ 9

6.3 Specification of Generic HISA Class ....................................................................................................................................10

6.3.1 Generic meta-class ......................................................................................................................................................10

6.3.2 Class: Set of structure attributes .....................................................................................................................11

6.3.3 Class: Set of class specific attributes ............................................................................................................11

6.3.4 Class: Set of common attributes ......................................................................................................................11

6.3.5 Class: Set of system attributes ...........................................................................................................................11

6.3.6 Class: Set of version attributes..........................................................................................................................12

6.3.7 Class: Extended attributes ....................................................................................................................................12

6.3.8 Class: State changes ....................................................................................................................................................13

6.3.9 Class: Business rules ..................................................................................................................................................13

6.3.10 Class: Classification criteria.................................................................................................................................14

7 The reference information models ................................................................................................................................................14

7.1 Classification objects ......................................................................................................................................................................14

7.1.1 Aim ............................................................................................................................................................................................14

7.1.2 UML information model .........................................................................................................................................14

7.1.3 Specification of the individual classes ........................................................................................................15

7.2 Subject of care objects ...................................................................................................................................................................18

7.2.1 Aim ............................................................................................................................................................................................18

7.2.2 UML information model .........................................................................................................................................18

7.2.3 Specification of the individual classes ........................................................................................................19

7.3 Activity management objects ..................................................................................................................................................23

7.3.1 Aim ............................................................................................................................................................................................23

7.3.2 UML information model .........................................................................................................................................24

7.3.3 Specification of the individual classes ........................................................................................................24

7.4 Clinical and health information objects ..........................................................................................................................31

7.4.1 Aim ............................................................................................................................................................................................31

7.4.2 UML information model .........................................................................................................................................31

7.4.3 Specification on the individual classes ......................................................................................................32

7.5 Resource management objects ..............................................................................................................................................37

7.5.1 Aim ............................................................................................................................................................................................37

7.5.2 UML information model .........................................................................................................................................37

7.5.3 Specification of the individual classes ........................................................................................................37

7.6 User and authorization objects ..............................................................................................................................................43

7.6.1 Aim ............................................................................................................................................................................................43

7.6.2 UML information model .........................................................................................................................................43

7.6.3 Specification of the individual classes ........................................................................................................44

© ISO 2020 – All rights reserved iii
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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

7.7 Messaging objects ..............................................................................................................................................................................49

7.7.1 Aim ............................................................................................................................................................................................49

7.7.2 UML information model .........................................................................................................................................50

7.7.3 Specification of the individual classes ........................................................................................................50

Bibliography .............................................................................................................................................................................................................................54

iv © ISO 2020 – All rights reserved
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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)
Foreword

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

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

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

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

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

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

electrotechnical standardization.

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

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

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

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

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

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

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

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

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

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration

with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251,

Health informatics, in accordance with the Agreement on technical cooperation between ISO and CEN

(Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 12967-2:2009), which has been technically

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

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

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

— reference to further standards, such HL7®;
— updates to the Bibliography.
A list of all parts in the ISO 12967 series can be found on the ISO website.

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

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)
Introduction

The ISO 12967 series provides guidance for the description, planning and development of new

systems as well as for the integration of existing information systems, both within one enterprise and

across different healthcare organizations through an architecture integrating the common data and

business logic into a specific architectural layer (i.e. the service architecture), distinct from individual

applications and accessible throughout the whole information system through information services, as

shown in Figure 1.
Figure 1 — Scope of the ISO 12967 series

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

through the following three viewpoints.

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

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

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

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

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

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

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

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

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

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

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

local requirements in terms of information to be put in common.
Information viewpoint is specified in this document.

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

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

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

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

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

common business logic to be implemented.
Computational viewpoint is specified in ISO 12967-3.

ISO 12967-1:2020, Annex C includes an explanation of ISO 23903:— and its relevance in regard to the

ISO 12967 series, for integration with other International Standards such as ISO 13940.

1) Under preparation. Stage at the time of publication: ISO/DIS 23903:2020.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 12967-2:2021
INTERNATIONAL STANDARD ISO 12967-2:2020(E)
Health informatics — Service architecture (HISA) —
Part 2:
Information viewpoint
1 Scope

This document specifies the fundamental characteristics of the information model implemented by

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

comprehensive and integrated storage of the common enterprise data and to support the fundamental

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

The information model is specified in this document without any explicit or implicit assumption on the

physical technologies, tools or solutions to adopt for its physical implementation in the various target

scenarios. The specification is nevertheless formal, complete and non-ambiguous enough to allow

implementers to derive an efficient design of the system in the specific technological environment that

will be selected for the physical implementation.

This document does not aim at representing a fixed, complete, specification of all possible data that can

be necessary for any requirement of any healthcare enterprise. It specifies only a set of characteristics,

in terms of overall organization and individual information objects, identified as fundamental and

common to all healthcare organizations, and that is satisfied by the information model implemented by

the service architecture.

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

extensions to the standard information model in order to support additional and local requirements.

Extensions include both the definition of additional attributes in the objects of the standard model, and

the implementation of entirely new objects.

Also, this document specification is extensible over time according to the evolution of the applicable

standardization initiatives.

The specification of extensions is carried out according to the methodology defined in ISO 12967-1:2020,

Clause 7.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)
3.1
information object
information held by the system about entities of the real world

Note 1 to entry: Entities including the ODP system itself can be represented in an information specification in

terms of information objects, their relationships and behaviour.
3.2
package
cluster of information objects (3.1)
3.3
middleware

enabling technology of enterprise application integration (3.4) describing a piece of software that

connects two or more software applications so that they can exchange data
3.4
enterprise application integration
EAI

use of software and computer systems architectural principles to integrate a set of enterprise computer

applications
3.5
subject of care
patient
subject of healthcare

healthcare actor with a person role; who seeks to receive, is receiving, or has received healthcare

[SOURCE: ISO 13940:2015, 5.2.1, modified — Note and Examples omitted.]
4 Abbreviated terms
ODP Open Distributed Processing
HISA Health Informatics Service Architecture
UML Unified Modeling Language
5 Methodological principles
5.1 Language and notation adopted for the specification of the model

The objective of the information viewpoint specification is to describe the information relevant for the

enterprise to be handled by the service architecture. It consists of a formal information model detailing

the semantic and syntactic aspects of all data to be managed.

The specification is based on an object model, derived from the enterprise viewpoint by properly

structuring and aggregating the information that has been identified as relevant in the specification of

the business processes, tasks and activities.

The general approach of the ODP standard [i.e. ISO/IEC 10746 (all parts)] is also used in ISO 12967-1,

the modeling language used in this document is UML.

The information viewpoint is concerned with information modeling (i.e. the kinds of information

handled by the system). It focuses on the semantics of information and information processing in the

system. It is fundamental that the individual components of a distributed system share a common

understanding of the information they communicate when they interact, or the system will not behave

as expected. Some of these items of information are handled, in one way or another, by many of the

objects in the system. To ensure that the interpretation of these items is consistent, the information

2 © ISO 2020 – All rights reserved
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SIST EN ISO 12967-2:2021
ISO 12967-2:2020(E)

language defines concepts for the specification of the meaning of information stored within, and

manipulated by, an ODP system, independently of the way the information processing functions

themselves are to be implemented.

Thus, information held by the ODP system about entities in the real world, including the ODP system

itself, is represented in an information specification in terms of information objects, and their

associations and behaviour. Atomic information objects represent basic information elements. More

complex information is represented as composite information objects, each expressing associations

over a set of constituent information objects.

Some elements visible from the enterprise viewpoint will be visible from the information viewpoint

and vice versa. For example, an activity seen from the enterprise viewpoint will be in the information

viewpoint as the specification of some processing which causes a state transition of an information entity.

Different notations for information specifications model the properties of information in different

ways. It is possible to place emphasis on classification and reclassification of information types, or on

the states and behaviour of information objects. In some specification languages, atomic information

objects are represented as values. The approach to be taken will depend on the modeling technique and

notation being used.

Assessment of conformance to the information specification of a system involves relating the

requirements expressed in the specification to sets of observations of the behaviour of the system

at conformance points identified in the engineering and technology specification, and assessing the

degree of consistency between the requirements and the observations.
5.2 UML class diagram notation guidelines and profile

For each cluster of objects identified in the enterprise viewpoint, the information objects will be

illustrated according to the following rationale.

— Information objects (i.e. classes) grouped in the packages will be not be coloured.

— Classes not expressly grouped in the package will also be represented if there are associations from

classes belonging to the package to these classes. These classes, however, will be coloured in yellow.

— The names of classes will be meaningful and start with a capital letter (e.g. Person). If the name is

composed of more than one word the blank spaces between
...

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