SIST EN ISO 21860:2024
(Main)Health Informatics - Reference standards portfolio (RSP) - Clinical imaging (ISO 21860:2020)
Health Informatics - Reference standards portfolio (RSP) - Clinical imaging (ISO 21860:2020)
This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as
defined in Clause 4).
An RSP lists the principle health information technology (HIT) standards that form the basis of
implementing and deploying interoperable applications in the target domain.
An RSP includes a description of the domain, a normative list of standards, and an informative
framework for mapping the standards to example deployment use cases.
The lists do not include standards that are specifically national in scope.
The primary target audience for this document is policy makers (governmental or organizational),
regulators, project planners and HIT managers. This document will also be of interest to other
stakeholders such as equipment and HIT vendors, clinical and health information management (HIM)
professionals and standards developers.
The intended usage of this document is to inform decisions about selecting the standards that will form
the basis of integration projects in geographic regions or healthcare organizations. For example:
— What standards to use for capturing/encoding/exchanging certain types of information
— What standards to use for interfaces between the devices and information systems that support
information capture, management, exchange, processing and use
— What standards to use for specific use cases/deployment scenarios
The selected standards, and/or corresponding RSP clauses, might be useful when drafting project
specifications.
Figure 1 shows the conceptual organization of this document. The top part represents individual HIT
standards grouped under semantic, technical and functional interoperability categories. The bottom
part shows use cases for example implementation projects with a selected list of standards.
See the figure in the ISO standard
Medizinische Informatik - Portfolio von Referenzstandards (RPS) - Klinische Bildgebung (ISO 21860:2020)
Informatique de santé - Normes de référence du portefeuille (REEECI) - Imagerie clinique (ISO 21860:2020)
Le présent document établit le portefeuille de normes de référence (RSP) pour le domaine de l'imagerie clinique (comme défini à l'Article 4).
Un RSP répertorie les principales normes des technologies de l'information pour la santé (TIS) qui constituent la base d'implémentation et de déploiement d'applications interopérables dans le domaine cible.
Une instance de RSP comprend une description du domaine, une liste normative de normes et une infrastructure informative pour la mise en correspondance des normes avec des exemples de cas d'utilisation de déploiement.
Les listes ne comprennent pas de normes de portée spécifiquement nationale.
Le public essentiellement visé par le présent document inclut les décideurs politiques (gouvernementaux ou organisationnels), les législateurs, les planificateurs de projet et les gestionnaires en technologies de l'information pour la santé (TIS). Le présent document est également destiné à d'autres parties prenantes telles que les fournisseurs d'équipement et de TIS, les professionnels de gestion de l'information clinique et de santé et les rédacteurs de normes.
Le présent document a pour but d'éclairer les décisions relatives à la sélection des normes qui constitueront la base des projets d'intégration dans les régions géographiques ou les organismes de soins de santé. Par exemple:
— les normes à utiliser pour capturer/coder/échanger certains types d'informations;
— les normes à utiliser pour les interfaces entre les dispositifs et les systèmes d'information permettant la capture, la gestion, l'échange, le traitement et l'utilisation des informations;
— les normes à utiliser pour des cas d'utilisation/des scénarios de déploiement particuliers.
Les normes sélectionnées et/ou les articles des RSP correspondants peuvent être utiles lors de l'élaboration des spécifications de projet.
Zdravstvena informatika - Portfelj referenčnih standardov (RSP) - Klinično slikanje (ISO 21860:2020)
Ta dokument vzpostavlja portfelj referenčnih standardov (RSP) za področje kliničnega slikanja (kot
je opredeljeno v točki 4).
Portfelj referenčnih standardov navaja glavne standarde za zdravstveno informacijsko tehnologijo (HIT), ki so osnova za implementacijo in uporabo interoperabilnih aplikacij v ciljni domeni.
Portfelj referenčnih standardov vključuje opis domene, normativni seznam standardov in informativni okvir za preslikavo standardov v primere uporabe.
Seznami ne vključujejo standardov, ki so posebej namenjeni za nacionalno uporabo.
Ta dokument je namenjen predvsem oblikovalcem politik (vladnih ali organizacijskih), regulatorjem, načrtovalcem projektov in upravljavcem zdravstvene informacijske tehnologije. Ta dokument bo zanimiv tudi za druge deležnike, kot so prodajalci opreme in zdravstvene informacijske tehnologije, strokovnjaki za upravljanje kliničnih in zdravstvenih podatkov (HIM)
ter razvijalci standardov.
Ta dokument se predvidoma uporablja za pravilno odločanje o izbiri standardov, ki bodo osnova za integracijske projekte v geografskih regijah ali zdravstvenih organizacijah. Na primer:
– katere standarde uporabiti za zajem/kodiranje/izmenjavo določenih vrst informacij; – katere standarde uporabiti za vmesnike med napravami in informacijskimi sistemi, ki podpirajo zajem, upravljanje, izmenjavo, obdelavo in uporabo informacij;
– katere standarde uporabiti za posebne primere uporabe/scenarije uvajanja.
Izbrani standardi in/ali ustrezne točke o portfelju referenčnih standardov so lahko uporabni za pripravo projektnih specifikacij.
Slika 1 prikazuje konceptualno ureditev tega dokumenta. Zgornji del predstavlja posamezne standarde HIT, združene v kategorije semantične, tehnične in funkcionalne interoperabilnosti. Spodnji del prikazuje primere uporabe, na primer implementacijske projekte z izbranim seznamom standardov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Zdravstvena informatika - Portfelj referenčnih standardov (RSP) - Klinično slikanje
(ISO 21860:2020)
Health Informatics - Reference standards portfolio (RSP) - Clinical imaging (ISO
21860:2020)
Medizinische Informatik - Portfolio von Referenzstandards (RPS) - Klinische Bildgebung
(ISO 21860:2020)
Informatique de santé - Normes de référence du portefeuille (REEECI) - Imagerie
clinique (ISO 21860:2020)
Ta slovenski standard je istoveten z: EN ISO 21860:2024
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 21860
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2024
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health Informatics - Reference standards portfolio (RSP) -
Clinical imaging (ISO 21860:2020)
Informatique de santé - Portefeuille de normes de Medizinische Informatik - Portfolio von
référence - Imagerie clinique (ISO 21860:2020) Referenzstandards (RPS) - Klinische Bildgebung (ISO
21860:2020)
This European Standard was approved by CEN on 12 February 2024.
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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21860:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 21860:2020 has been prepared by Technical Committee ISO/TC 215 "Health
informatics” of the International Organization for Standardization (ISO) and has been taken over as
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 August 2024, and conflicting national standards shall
be withdrawn at the latest by August 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 21860:2020 has been approved by CEN as EN ISO 21860:2024 without any modification.
INTERNATIONAL ISO
STANDARD 21860
First edition
2020-11
Health Informatics — Reference
standards portfolio (RSP) — Clinical
imaging
Informatique de santé — Normes de référence du portefeuille
(REEECI) — Imagerie clinique
Reference number
ISO 21860:2020(E)
©
ISO 2020
ISO 21860:2020(E)
© 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
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ii © ISO 2020 – All rights reserved
ISO 21860:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Clinical imaging domain . 4
5 Portfolio of reference standards . 6
5.1 Usage. 6
5.2 Portfolio structure . 6
5.2.1 Standard categories . 6
5.2.2 Standard assessment. 7
5.3 Semantic interoperability . 8
5.3.1 Data standards . 8
5.3.2 Content standards.11
5.4 Technical interoperability .22
5.4.1 Information exchange standards .22
5.4.2 Privacy and security standards .27
5.4.3 Technical workflow standards .29
5.5 Functional interoperability .36
6 Implementation use case guidance .36
6.1 Overview .36
6.2 Device to department integration .37
6.3 Department to enterprise integration .39
6.4 Enterprise to cross-enterprise integration .41
Annex A (informative) Process for RSP population and maintenance .43
Bibliography .50
ISO 21860:2020(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.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
ISO 21860:2020(E)
Introduction
Modern healthcare is supported by medical devices and information systems that capture, manage,
exchange, process and present clinical, operational, research and public health data. This occurs at
scales from individual clinics and hospital departments, up to networks of hospitals and regional or
national healthcare systems. Adopting standards and using them consistently would make it easier to
install, operate and, over time, update and replace these devices and information systems.
This document presents a portfolio of standards that have been selected as being mature, fit for purpose
and most appropriate to address use cases related to the clinical imaging domain. Clinical imaging is
considered throughout the enterprise.
It should be noted, however, that achieving full interoperability within a given environment or set of
systems is a large endeavor of which the selection of underlying standards is an important component,
but just one component. Additional guidance can be found in the Process clause of the TR on IHE Global
[1]
Standards Adoption .
This document was developed based on concepts and methodology described in the Healthcare
Informatics – Reference Standards Portfolio (RSP): Development framework. RSPs are an evolution
of past work, such as that done by the Board of Directors of the American Medical Informatics
[2] [28]
Association and the Joint In
...
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