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.
Medizinische Informatik - Portfolio von Referenzstandards (RPS) - Klinische Bildgebung (ISO 21860:2020)
Informatique de santé - Portefeuille de normes de référence - 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
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
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 Initiative Council (JIC) work on the Patient Summary Standards Set .
This work reflects the experience and learning of the international community in developing
interoperability standards in the clinical imaging domain, including representatives of:
1)
— DICOM® (Digital Imaging and Communication in Medicine)
— IHE Radiology (Integrating the Healthcare Enterprise)
— ISO/TC215, Health Informatics.
1) DICOM® is the registered trademark of the National Electrical Manufacturers Association for its standards
publications relating to digital communications of medical information. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO.
INTERNATIONAL STANDARD ISO 21860:2020(E)
Health Informatics — Reference standards portfolio (RSP)
— Clinical imaging
1 Scope
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.
ISO 21860:2020(E)
Figure 1 — RSP Organization
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
DICOM PS3, Digital Imaging and Communication in Medicine, Parts 1-22, National Electrical
Manufacturers Association
HL7 V2.3.1, HL7 Messaging Standard Version 2.3.1 - An Application Protocol for Electronic Data
Exchange in Healthcare Environments, HL7 International
HL7 V2.5.1, HL7 Messaging Standard Version 2.5.1 - An Application Protocol for Electronic Data
Exchange in Healthcare Environments, HL7 International
HL7 CDA R2, HL7 Version 3 Standard: Clinical Document Architecture Framework, Release 2, HL7
International
IHE Cardiology Technical Framework, Volumes 1-2 and associated supplements, Integrating the
Healthcare Enterprise
IHE IT Infrastructure Technical Framework, Volumes 1-4 and associated supplements, Integrating the
Healthcare Enterprise
IHE Radiology Technical Framework, Volumes 1-4 and associated supplements, Integrating the
Healthcare Enterprise
ICD-9, International Classification of Diseases revision 9, World Health Organization
2 © ISO 2020 – All rights reserved
ISO 21860:2020(E)
ICD-10, International Classification of Diseases revision 10, World Health Organization
ICD-11, International Classification of Diseases revision 11, World Health Organization
LOINC, Logical Observation Identifier Names and Codes, Regenstrief Institute
RadLex, A Lexicon for Uniform Indexing and Retrieval of Radiology Information Resources, Radiological
Society of North America
RSNA Radiology Reporting Templates, Radiological Society of North America
SNOMED CT, Systematized Nomenclature of Medicine - Clinical Terms, SNOMED International
UCUM, Unified Code for Units of Measure, Regenstrief Institute
UDI, Unique Device Identification System, US Food and Drug Administration
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/
3.1
clinical imaging
medical imaging
production of visual representations of body parts, tissues, or organs, for use in clinical diagnosis;
encompassing x-ray methods, magnetic resonance imaging, single-photon-emission and positron-
emission tomography, and ultrasound
3.2
imaging modality
class of medical device that utilizes a certain physical mechanism, such as x-rays, magnetic fields,
ultrasound, or visible light, to detect patient signals that reflect either anatomical structures or
physiological events
Note 1 to entry: Imaging modalities include Conventional radiography, Fluoroscopy, Angiography, Mammography,
Computed Tomography (CT), Ultrasound and Ultrasound/Doppler, Magnetic Resonance Imaging (MRI) and
Nuclear Medicine.
3.3
interoperability
ability to capture, communicate, and exchange data accurately, effectively, securely, and consistently
with different information technology systems, software applications, and networks in various settings,
and exchange data such that clinical or operational purpose and meaning of the data are preserved and
unaltered
[39]
[SOURCE: HL7, Coming to Terms: Scoping Interoperability for Health Care. White Paper, 2007 ]
3.4
semantic interoperability
category of interoperability based on standardizing content, where content includes vocabularies, code
sets, terminologies, identifiers, information models, composite data structures, data object definitions,
and templates
ISO 21860:2020(E)
3.5
technical interoperability
category of interoperability based on standardizing infrastructure, including messaging and transport
protocols, message sets and sequencing, encryption, certificates, access controls, digital worklists, and
status tracking
3.6
functional interoperability
category of interoperability based on standardizing legal and organizational rules, including definitions
of business processes, practice guidelines, clinical treatment pathways, business rules, information
governance, and safety/risk classification and mitigation
2)
Note 1 to entry: Also referred to by HITSP and HL7® as Process Interoperability.
3.7
reference information model
RIM
single information model that covers the domain of activity being addressed by a standards developing
organization using this methodology
[SOURCE: ISO/TS 27790:2009, 3.62]
3.8
reference standard
standard selected as being mature, fit for purpose, and most appropriate to address use cases related to
a given domain
4 Clinical imaging domain
The clinical imaging domain spans the systems, data and activities involved in planning, acquiring,
processing, managing, distributing, displaying and interpreting imaging data in a clinical context.
The clinical context for imaging can include screening for disease or risk factors, documentation
of observations or procedures, diagnosis, treatment (directly image-guided or simply informed or
planned from imaging), monitoring of disease progression or response to treatment, palliative care,
and research into the causes and treatments of disease.
The operational context for imaging can include administration, operations, and research.
Clinical imaging, also referred to as medical imaging, or diagnostic imaging, is a domain that includes
various clinical specialties:
— Radiology (including interventional radiology)
— Cardiology
— Oncology
— Obstetrics/Gynecology
— Orthopedics
— Surgery
— Dermatology
— Dentistry
— Ophthalmology
2) HL7® is the registered trademark of Health Level Seven International. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO.
4 © ISO 2020 – All rights reserved
ISO 21860:2020(E)
— Anatomic Pathology
— Emergency Medicine
Clinical imaging encompasses x-ray methods (CT, CR/DR, angiography/fluoroscopy, mammography,
etc.), magnetic resonance imaging (MRI), single-photon-emission (SPECT) and positron-emission
tomography (PET), ultrasound, visible light (endoscopy, digital microscopy, medical photography,
etc.) and optical coherence tomography. The scanners used to acquire these images are referred to as
Acquisition Modality Devices or simply "modalities".
Imaging data refers primarily to the images produced by imaging procedures, but also includes
associated data such as measurements, and other processing results. Images include single frame
images (such as a conventional chest x-ray or a dermatological photograph), volumetric image sets
(such as a CT series), "cine" video images (such as from an angiography or ultrasound procedure),
multi-dimensional image sets (such as functional MRI volume data over time and different stimuli or a
multi-focal multi-filter pathology slide scan). Images might be monochrome, true color or pseudocolor.
Measurements include such things as cardiac flow metrics, fetal growth values, tissue perfusion
indices, tumor sizes, Computer Aided Detection/Diagnosis findings, and the output of clinical analysis
applications. Processing results include spatial registrations of datasets, segmentations, extracted
surfaces, implant models, etc. Data might also include associated audio or ECG waveforms and scanned
documents such as procedure requisitions.
Clinical imaging information content include test orders, images and test results reports, which have to
be generated/shared across various technical actors for use by business actors.
Humans involved in clinical imaging include:
— patients and/or their legal representatives
— referring physicians
— imaging specialty technologists
— imaging specialty physicians
Devices and systems involved in clinical imaging include:
— acquisition modality devices (CT, MR, Ultrasound, Angiography, Mammography, Xray, retinal
cameras, slide scanners, etc.)
— data analysis systems (clinical application SW, dose analysis, protocol management, departmental
analytics)
— data management systems (PACS - Picture Archive and Communication Systems, VNA - Vendor
Neutral Archives, Enterprise Imaging Systems)
— reporting systems (Reading Workstations, Image Display Systems, Report Management Systems)
— departmental systems (RIS – Radiology Information Systems, Cardiology Information Systems,
Practice Management Systems, etc.)
— enterprise or practice-level electronic health record infrastructure (EHR – Electronic Health Record
Systems, CPOE – Computerized Physician Order Entry Systems for imaging procedures).
The following activities generate data elements that appear in clinical imaging information content but
are not inherently clinical imaging data and will be considered in other domains, not in the clinical
imaging domain:
— Patient registration and account administration
— Order entry for non-imaging procedures
— Lab test result reporting
ISO 21860:2020(E)
The following specialties also use clinical imaging but will also be considered in a separate domain
from the clinical imaging domain:
— Radiation Therapy
— Biological Research
5 Portfolio of reference standards
5.1 Usage
Interoperability projects shall use standards listed as preferred or legacy in Table 1 to Table 5 when the
scope of that standard applies to the integration project except when alternate standards are locally
mandated. Such exceptions shall be described by the project documentation.
Interoperability projects should give due consideration to standards listed as emerging in the tables in
this portfolio.
5.2 Portfolio structure
5.2.1 Standard categories
Within this portfolio of reference standards, individual standards are first divided into semantic
[4]
interoperability, technical interoperability, and functional interoperability , and then organized into
categories as follows:
Semantic interoperability
— Data standards
— Define encoding for individual data elements
— E.g. vocabularies, code sets, terminologies and identifiers
— Content standards
— Define how content is encoded, e.g. assembled from multiple data elements
— E.g. reference information models (RIMs), data object definitions, document structures,
templates
Technical interoperability
— Information exchange standards
— Define how content is transferred from one system to another
— E.g. messaging and transport protocols
— Privacy and security standards
— Define how content is protected when transferred from one system to another
— E.g. encryption, certificates, access controls, consent directives, de-identification and
pseudonymization
— Technical workflow standards
— Define sets of transactions between systems and associated data requirements to achieve
particular technical tasks
6 © ISO 2020 – All rights reserved
ISO 21860:2020(E)
— E.g. digital worklists, status tracking and notifications, and data flow
Functional interoperability
— Functional standards
— Define procedures for business actors to achieve particular goals
— E.g. functional requirements (procedures, checklists, organizational rules) that an actor would
follow to capture, manage, exchange, analyze, present information for a specific use case
— Workflow standards
— Define interactions between business actors to achieve particular tasks
— E.g. functional requirement analysis, evaluation of human users needs in the context of specific
use cases
— Business process standards
— Define process interactions between business and technical systems to achieve particular tasks,
— E.g. practice standards, clinical pathways built from guidelines, worklists.
— Safety standards
— Define methods for addressing risks when using HIT products. E.g. criteria for classification
and prioritization of risks and best practices for risk mitigation
Many standards do not fit neatly into just one of the above categories. Standards that address multiple
categories are listed under their primary category. For example, the DICOM CT Image Storage SOP Class
includes the Storage Service (transport protocol), the CT Image IOD ("document"/content), and to a
3) 4)
lesser degree defines code sets that include specific SNOMED® and LOINC® codes and introduce a
few DICOM codes as needed, but the primary content is the CT image, so it and the other DICOM “Core”
IODs are placed in the “Content Standards” category.
5.2.2 Standard assessment
In each category, standards have been assessed and are listed in one table with three groups (See A.4):
— Preferred standards are considered to be stable, well-established and well-supported.
— Legacy standards are widely implemented and deployed but have been superseded by another
Preferred standard and no longer represent the long-term direction of the industry. Support in
future products might diminish over time.
— Emerging standards are promising and stable but have not yet been widely implemented and
deployed. Note that adoption of standards sometimes moves faster than this document is updated.
The factors assessed (See A.3) are:
— Standard maturity – publication, stability, and maintenance status: published draft, trial use,
final, retired
3) SNOMED® and SNOMED CT® are the registered trademarks of International Health Terminology Standards
Development Organization. This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO.
4) LOINC® is the registered trademark of Regenstrief Institute. This information is given for the convenience of
users of this document and does not constitute an endorsement by ISO.
ISO 21860:2020(E)
— Product adoption – international availability in clinical imaging domain products (See Clause 4):
none, pilot, low, moderate, high, universal
Product adoption demonstrates Vendor endorsement of this standard
— Site deployment –installation and clinical use at imaging sites: none, pilot, low, moderate, high,
universal
Site deployment demonstrates User endorsement of this standard
— Tooling – supported by readily available tools: none, low, moderate, high
Tools might include browsers, viewers, editors, validators, reference implementations, sample data,
libraries/toolkits, etc.
Adoption and deployment levels are broad estimates for the combined North American, European, and
Japanese regions, based on the subject matter expertise of the contributors to this document. Where
uptake is known to differ geographically, this is noted in footnotes.
The specific version/release/edition of the standard that was assessed is usually not listed. Generally,
the recommendation applies to recent versions of the standard.
This document does not track the terms for licensing the standards listed here. Those who adopt and/
or deploy a standard are encouraged to consult the website of that standard.
5.3 Semantic interoperability
5.3.1 Data standards
Data standards define how to encode data elements or individual pieces of information. This might
include vocabularies, code sets, terminologies and identifiers. Such standards commonly restrict
themselves to a particular scope or purpose.
Table 1 lists the portfolio of preferred, legacy, and emerging data standards for clinical imaging.
Table 1 — Preferred, legacy, and emerging data standards
Standard Product Site
Brief name Formal name and scope Tooling
Maturity Adoption Deployment
Preferred data standards
LOINC Logical Observation Identifiers Names and Codes Final Moderate Moderate Moderate
Identifiers, names, and codes for identifying health meas-
urements, observations, and documents.
UCUM Unified Code for Units of Measure Final High High Moderate
A system to encode units of measure, e.g. for associated
quantities.
a
ICD-10 International Classification of Diseases Final Moderate Moderate
A system of codes for representing medical encounter
diagnoses.
DICOM Codes DICOM Controlled Terminology Definitions Final High High Moderate
Codes and definitions for DICOM concepts.
a
High in US and Canada, Low elsewhere.
b
Since SNOMED has announced that it will no longer license the use of the RT Identifiers, that standard has been moved to the Legacy
group and the SNOMED CT Numeric Identifiers have been listed in the Emerging group even though the adoption and deployment of the
Numeric Identifiers have not yet reached the criteria normally required (See A.4).
See A.3 for terms.
8 © ISO 2020 – All rights reserved
ISO 21860:2020(E)
Table 1 (continued)
Standard Product Site
Brief name Formal name and scope Tooling
Maturity Adoption Deployment
DICOM Context DICOM DCMR Context Groups Final High High Moderate
Groups
Sets of codes relevant to coding values for particular
DICOM attributes or concepts.
Legacy data standards
SNOMED CT Systematized Nomenclature of Medicine - Clinical Terms – Retired High High Low
b
(RT Identifiers) RT Style Codes
Superseded by SNOMED-CT (Numerical Identifiers)
ICD-9 International Classification of Diseases Final High High Moderate
Superseded by ICD-10
Emerging data standards
b
SNOMED CT Systematized Nomenclature of Medicine - Clinical Terms Final Pilot Pilot Moderate
(Numeric Iden-
Codes, descriptions, synonyms and relationships for
tifiers)
findings, symptoms, diagnoses, procedures, body struc-
tures, organisms, substances, pharmaceuticals, devices
and specimens.
RadLex Play- Radiology Lexicon – Procedure Playbook Final Low Low Low
book
Names and codes for radiology procedures.
ICD-11 International Classification of Diseases Final Low Low Low
Will Supersede ICD-10
UDI Unique Device Identifier Final Low Low Low
Globally unique identifiers for "all implantable, life-saving
or life sustaining devices".
a
High in US and Canada, Low elsewhere.
b
Since SNOMED has announced that it will no longer license the use of the RT Identifiers, that standard has been moved to the Legacy
group and the SNOMED CT Numeric Identifiers have been listed in the Emerging group even though the adoption and deployment of the
Numeric Identifiers have not yet reached the criteria normally required (See A.4).
See A.3 for terms.
5.3.1.1 SNOMED CT®
[5]
SDO: SNOMED International
3)
SNOMED CT® codes are used to populate coded data elements in DICOM instances, in particular for
anatomy and materials. For example, (81745001, SCT, "Eye") as the coded value for the Anatomic Region
Sequence (0008,2218) data element of an ophthalmic image. SNOMED CT codes are also used in HL7 CDA
and CCD documents. SNOMED CT also includes a model of the relationships between the codes. Although
DICOM only references the nodes, applications might find uses for the graph that connects the nodes.
SNOMED CT is available in multiple languages.
SNOMED has been licensed nationally by a number of countries. The SNOMED CT terms used in the
DICOM Standard (the SNOMED CT DICOM Subset) are the subject of a licensing agreement between
NEMA and SNOMED International that allows the use of this defined subset in DICOM conformant
applications without further license or payment of fee. Any use of SNOMED CT beyond the terms
published in the DICOM Standard is subject to SNOMED CT licensing rules, which might include a fee.
For definitive information about SNOMED CT licensing, see http:// www .snomed .org/ snomed -ct/ get
-snomed or contact SNOMED International at info@ snomed .org.
Implementations making use of these codes shall conform to SNOMED CT.
Tooling: Tools for browsing terms, mapping codes, translating meanings, etc.:
— https:// confluence .ihtsdotools .org/ tools
ISO 21860:2020(E)
— https:// ihtsdo .github .io/
Until 2018, SNOMED codes used in the DICOM Standard followed the older RT Identifiers which
used alphanumeric code values. Since 2019, the DICOM Standard uses the newer ConceptID numeric
identifiers, however significant numbers of older products and data objects might be encountered that
use the older codes. Mappings to the new codes can be found in DICOM PS3.16.
5.3.1.2 LOINC
[6]
SDO: Regenstrief Institute
LOINC codes are incorporated in many data elements in DICOM instances, HL7v2 messages and CDA
documents to encode the measurement concepts. For example, (2160-0, LN, "Serum Creatinine") to
indicate that the subsequent numeric value represents an observation of serum creatinine.
Implementations making use of these codes shall conform to LOINC.
Tooling: Tools for browsing terms, mapping codes, translating meanings, etc.:
— https:// loinc .org/ downloads/
5.3.1.3 UCUM
[7]
SDO: Regenstrief Institute
UCUM codes are incorporated in many numerical data elements in DICOM instances to encode the unit
of measure of the value. For example, mg/dl for a serum creatinine value.
[8]
UCUM codes are based on ISO 80000:2009 .
Implementations making use of these codes shall conform to UCUM.
Tooling: Tools for finding and validating codes:
— https:// ucum .nlm .nih .gov/
5.3.1.4 DICOM Codes
[9]
SDO: DICOM , See PS3.16, Annex D
DICOM Codes are used to encode a variety of concepts inside DICOM instances. DICOM Codes are
typically defined for concepts that do not clearly belong in one of the other Data Standards listed here.
Implementations making use of these codes shall conform to DICOM PS3.
Tooling: Code tables downloadable in XML or OWL. Also available through BioPortal in OWL, CSV, and
RDF/XML.
5.3.1.5 DICOM Context Groups
[9]
SDO: DICOM , See PS3.16, Annex B
DICOM Context Groups provide selected sets of codes appropriate for coding values of associated
DICOM attributes or DICOM SR Template concepts. The codes are typically drawn from coding schemes
like SNOMED, LOINC, UCUM, DICOM, and ICD-10. Many Context Groups include equivalent codes from
several coding schemes.
Implementations making use of these codes shall conform to DICOM PS3.
Tooling: Context Group code tables are downloadable in HTML, FHIR JSON, FHIR XML, and IHE SVS XML.
10 © ISO 2020 – All rights reserved
ISO 21860:2020(E)
5.3.1.6 ICD-9, ICD-10, ICD-11
[10]
SDO: World Health Organization
th th th
ICD-9, ICD-10 and ICD-11 are, respectively, the 9 , 10 , and 11 revisions of the International Statistical
Classification of Diseases and Related Health Problems. ICD codes are used to encode diagnoses,
symptoms, and findings in structured reports and fields such as admitting diagnosis, etc. Various
countries publish national variants of the ICD codeset, distinguished by a suffix, e.g. ICD-10-GM.
Since diagnosis is a very significant detail for many types of data analysis and population health, some
jurisdictions (e.g. Germany) make the use of ICD codes required for reimbursement.
Implementations making use of these codes shall conform to ICD-9, ICD-10, and/or ICD-11.
Tooling: A variety of free and commercial tools exist for searching, browsing, and mapping ICD codes.
5.3.1.7 RadLex Playbook
[11] [6]
SDO: RSNA and Regenstrief Institute
Playbook codes are used in worklists to encode the ordered imaging procedure to be performed. For
example, (36244-2, LN, “MR Prostate W contrast IV”). The codes might also appear in images and
reports to encode the imaging procedure that was actually performed and reported on. The code
might also be used to drive workflow, e.g. standard procedure at a given site might be to perform a 3D
reconstruction for all cardiac CT studies.
The codes are managed by RSNA and published as part of LOINC in version 2.6 and later.
Implementations making use of these codes shall conform to Radlex.
5.3.1.8 UDI
[12]
SDO: United States Food and Drug Administration (FDA)
The UDI standard is managed by the US FDA in collaboration with other international medical device
regulators for use worldwide. UDI codes are administered by several Issuing Agencies, such as GS1,
HIBCC, or ICCBBA.
UDI codes identify specific instances of a medical device. Each code combines a device id (DI), which
is unique to the manufacturer, make and model, and a production id (PI), which is the serial #, or lot #,
or manufacturing date, or expiration date. Each DI is issued by an FDA accredited Issuing Agency. The
Issuing Agency chooses a format within certain constraints.
The primary purpose of UDI codes is to facilitate traceability and regulatory management of medical
devices, e.g. for postmarket surveillance and recalls. UDI codes of devices used (e.g. scanners,
pacemakers, stents) or consumed (e.g. catheters, drugs) during medical procedures can be recorded in
the data produced during those procedures, such as images, medication records or procedure logs.
Device labelers ubmit information about each device to FDA’s Global Unique Device Identification
Database (GUDID). The public can search and download information from the GUDID at AccessGUDID:
— h t t p s : // w w w . fd a . g o v/ M e d ic a l D e v ic e s / D e v ic eR e g u l a t io n a n d G u id a n c e /
UniqueDeviceIdentification/ GlobalUDIDatabaseGUDID/ ucm444831 .htm
Implementations making use of these codes shall conform to UDI.
5.3.2 Content standards
Content standards define how to encode information content, such as documents, often by assembling
multiple data elements. They describe what data is mandatory in a given content structure, what is
ISO 21860:2020(E)
optional and sometimes what is not to be included. These standards include object definitions, reference
information models (RIMs), document structures, and templates.
Table 2 lists the portfolio of preferred, legacy, and emerging content standards for clinical imaging.
Table 2 — Preferred, legacy, and emerging content standards
Standard Product Site
Brief name Formal name and scope Tooling
Maturity Adoption Deployment
Preferred content standards
DICOM “Core” DICOM Image Information Object Definitions (“Core”) Final Universal Universal High
Image IODs
Data structure for encoding image pixels and key
metadata, including patient id and demographics,
imaging technique, procedure detail
...
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