Health Informatics -- Reference standards portfolio (RSP) -- Clinical imaging

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.

Informatique de santé -- Normes de référence du portefeuille (REEECI) -- Imagerie clinique

General Information

Status
Published
Publication Date
23-Nov-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
14-Oct-2020
Completion Date
13-Oct-2020
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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
---------------------- Page: 1 ----------------------
ISO 21860:2020(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
---------------------- Page: 2 ----------------------
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 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
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
---------------------- Page: 4 ----------------------
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:

— 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.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
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 2020 – All rights reserved 1
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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
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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 2020 – All rights reserved 3
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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
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
---------------------- Page: 9 ----------------------
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 2020 – All rights reserved 5
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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
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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 2020 – All rights reserved 7
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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.
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.
High in US and Canada, Low elsewhere.

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
---------------------- Page: 13 ----------------------
ISO 21860:2020(E)
Table 1 (continued)
Standard Product Site
Brief name Formal name and scope Tooling
Maturity Adoption Deployment
DICO
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21860
ISO/TC 215
Health Informatics — Reference
Secretariat: ANSI
standards portfolio (RSP) — Clinical
Voting begins on:
2020­08­18 imaging
Voting terminates on:
Informatique de santé — Normes de référence du portefeuille
2020­10­13
(REEECI) — Imagerie clinique
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 21860:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 21860:2020(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
CH­1214 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
---------------------- Page: 2 ----------------------
ISO/FDIS 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 .......................................................................................................................................................35

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 cross­enterprise integration ..................................................................................................................40

Annex A (informative) Process for RSP population and maintenance ...........................................................................43

Bibliography .............................................................................................................................................................................................................................50

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 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 non­governmental, 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
---------------------- Page: 4 ----------------------
ISO/FDIS 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:

— 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. This information is given for the convenience of users of this

document and does not constitute an endorsement by ISO.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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.

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ISO/FDIS 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 1­22

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 1­4 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

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ISO/FDIS 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, U.S. 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
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ISO/FDIS 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
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.

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ISO/FDIS 21860:2020(E)
— Anatomic Pathology
— Emergency Medicine

Clinical imaging encompasses x-ray methods (CT, CR/DR, angiography/fluoroscopy, mammography,

etc.), magnetic resonance imaging (MRI), single­photon­emission (SPECT) and positron­emission

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),

multi­dimensional 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 practice­level 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
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ISO/FDIS 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
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ISO/FDIS 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, well­established and well­supported.

— 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.
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ISO/FDIS 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.
ICD­10 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.
High in U.S. and Canada, Low elsewhere.
Since SNOMED
...

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