Health informatics — A case study on establishing standardized measurement data in cardiac examination reports

This document reposts a case study on how to establish and maintain standardized cardiac examination export measurement data (CE-EMD), especially for enabling its secondary use for medical research. The document includes information for CE-EMD on: — Building a representative coalition of stakeholders to identify and establish specifications; — Standardizing both the content and format in reports; — Maintaining and extending the specifications over time. Out-of-scope for this document are any requirements for specific CE-EMD content or formatting. Also, this document is limited to cardiac examination reporting, and does not encompass other clinical care areas or reporting that have been standardized.

Informatique de santé — Étude de cas sur l'établissement de données de mesure normalisées dans les rapports d'examens cardiaques

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Status
Published
Publication Date
13-Nov-2022
Current Stage
6060 - International Standard published
Completion Date
14-Nov-2022
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ISO/TR 23358:2022 - Health informatics — A case study on establishing standardized measurement data in cardiac examination reports Released:14. 11. 2022
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TECHNICAL ISO/TR
REPORT 23358
First edition
2022-11
Health informatics — A case study
on establishing standardized
measurement data in cardiac
examination reports
Informatique de santé — Étude de cas sur l'établissement de données
de mesure normalisées dans les rapports d'examens cardiaques
Reference number
ISO/TR 23358:2022(E)
© ISO 2022
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ISO/TR 23358:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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

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© ISO 2022 – All rights reserved
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ISO/TR 23358:2022(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

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

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

3 Terms, definitions and abbreviated terms .............................................................................................................................. 1

3.1 Terms and definitions ...................................................................................................................................................................... 1

3.2 Abbreviated terms .............................................................................................................................................................................. 2

4 Establishing and maintaining export measurement data standards .........................................................2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Stakeholder coalition establishment, roles and responsibilities ............................................................... 2

4.2.1 Coalition establishment method .......................................................................................................................... 2

4.2.2 Roles and responsibilities of coalition committee members ...................................................... 3

4.3 Semantic content standardization ........................................................................................................................................ 3

4.3.1 Unification of name .......................................................................................................................................................... 3

4.3.2 Standardized data element coding ..................................................................................................................... 3

4.3.3 Report formatting ............................................................................................................................................................. 3

4.3.4 Additional considerations .......................................................................................................................................... 4

4.4 Specification maintenance ........................................................................................................................................................... 4

5 Governance policy establishment .....................................................................................................................................................4

Annex A (informative) Japan SEAMAT program case study ....................................................................................................... 6

Bibliography .............................................................................................................................................................................................................................11

iii
© ISO 2022 – All rights reserved
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ISO/TR 23358:2022(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.
© ISO 2022 – All rights reserved
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ISO/TR 23358:2022(E)
Introduction

Various clinical examinations, such as ultrasonic echocardiography (UCG), electrocardiogram (ECG)

and coronary angiogram (CAG) are used for diagnosis and treatment of cardiovascular diseases.

Cardiologists not only use imaging during those examinations but also numerical measurement data

obtained from clinician observation and the various medical device systems used in daily clinical

examination routines. They also consider information such as the patient's symptoms and the

examination procedure(s) performed. These data are stored with images and waveforms in standard

1)[1] [2]

formats such as DICOM® and MFER , or are stored as non-interoperable, manufacturer-specific

data formats.

In cardiac examinations, multiple devices are used simultaneously for diagnostic and therapeutic

purposes, and corresponding reports are produced by each device and system. This includes “cath labs”

(Cardiac Catheterization Lab) where multiple device modalities (e.g. haemodynamic monitoring and

imaging) are utilized and reports generated; however, as pointed out above there is little consistency in

the resulting reports, especially with respect to parametric data.

The contents of data required for these cardiac examination reports is generally different for

each medical facility, as well as clinicians performing the procedures. In addition to these general

interoperability challenges, medical researchers want to utilize such data for secondary purposes

utilizing a clinical database or registry to support, for example, nation-wide” big data” analytics

research programs. In order to support this secondary use, one must both collect the data generated

from devices and reporting systems and then register that data used in the cardiovascular division in a

clinical information database. However, since the contents and formats of the examination data are not

standardized and consistent, special conversion is required. The cost of machine conversion is typically

high, and there are increased risks of human error when an operator re-enters data manually.

The reporting of cardiac examination export measurement data (CE-EMD) to clinical databases has not

been standardized for numerous reasons, including the following:

— Requested CE-EMD content varies depending on the medical facility and care providers/clinicians;

— Produced CE-EMD is different for each manufacturer;
— Name and contents (data elements) of CE-EMD are not uniform;

— Format of CE-EMD is often not represented or “coded” according to any standard.

Figure A.1 provides an overview of the use context for this document. Although guidance for the creation

of radiology reports has been developed (e.g. in IHE and DICOM), this is not the case for cardiology

examination reporting.

This document provides an overview of the rules on how to establish and maintain standardized CE-

EMD report content based on the SEAMAT program in Japan as applied to cardiac examination reports,

which has been organized to present the approach that successfully employed in both establishing and

maintaining CE-EMD specifications. This approach could be as a reference for applying in other national

or regional contexts.
Annex A provides a more detailed history of the SEAMAT program.

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 of the product named.

© ISO 2022 – All rights reserved
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TECHNICAL REPORT ISO/TR 23358:2022(E)
Health informatics — A case study on establishing
standardized measurement data in cardiac examination
reports
1 Scope

This document reposts a case study on how to establish and maintain standardized cardiac examination

export measurement data (CE-EMD), especially for enabling its secondary use for medical research.

The document includes information for CE-EMD on:

— Building a representative coalition of stakeholders to identify and establish specifications;

— Standardizing both the content and format in reports;
— Maintaining and extending the specifications over time.

Out-of-scope for this document are any requirements for specific CE-EMD content or formatting. Also,

this document is limited to cardiac examination reporting, and does not encompass other clinical care

areas or reporting that have been standardized.
2 Normative references
There are no normative references in this document.
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

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

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1.1
cardiac examination – export measurement data
CE-EMD

numeric and text data that is exported from medical devices and reporting systems during cardiology

examinations
3.1.2
reporting system

computer system or software application with function to create a report containing CE-EMD for

diagnosis and treatment
3.1.3
secondary use
using data for purposes other than clinical

Note 1 to entry: In this document, cardiac examination data is used for medical research, etc.

© ISO 2022 – All rights reserved
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ISO/TR 23358:2022(E)
3.2 Abbreviated terms
CAG Coronary angiography
CDA Clinical Document Architecture
DICOM® Digital Imaging and Communications in Medicine
ECG Electrocardiogram
HL7® Health Level 7
IHE-J Integrating the Healthcare Enterprise Japan
JAHIS Japanese Association of Healthcare Information Systems Industry
JCS The Japanese Circulation Society
LOINC® Logical observation identifiers names and codes
MFER Medical waveform Format Encoding Rules
PCI Percutaneous coronary intervention

SEAMAT Guideline for Standard export data format by the Japanese Circulation Society

SS-MIX2 Standardized Structured Medical Information Exchange revision 2.

Storage specifications for electronic clinical information exchange used in Japan.

UCG Ultrasonic echocardiography
4 Establishing and maintaining export measurement data standards
4.1 General

There are three key elements for establishing and maintaining a national CE-EMD specifications:

— Stakeholder coalition establishment
— Semantic content standardization
— Specification maintenance

Each element precedes and supports the next element: Semantic content is not standardized until a

representative coalition of stakeholders is convened and able to deliberate, identify and establish

the needed CE-EMD specifications. Similarly, the maintenance process follows the successful

accomplishment of the first two process elements.

The following sections provide general rules for each of these three key elements. Annex A provides

more detailed background information for each of these areas.
4.2 Stakeholder coalition establishment, roles and responsibilities
4.2.1 Coalition establishment method
Establishing stakeholder participation can include the following:

— Establishing a committee to identify and analyse CE-EMD specification requirements;

© ISO 2022 – All rights reserved
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ISO/TR 23358:2022(E)
— Committee
...

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