ISO/TS 5499:2024

Health informatics — Clinical particulars — Core principles for the harmonization of therapeutic indications terms and identifiers

The objective of this document is to establish common principles for the creation, assessment, selection and maintenance of maps between terminological resources used to describe and code IDMP therapeutic indications for investigational and medicinal products, medical devices, combination products, biologics and companion diagnostics. Core maintenance principles, such as reliability, reproducibility and quality assurance of the maps for future indication terminology use, are also discussed. The intended audience for this document includes: a) Global regulators, pharmaceutical/biopharmaceutical companies, Clinical Research Organizations (CROs) and universities/scientific institutes involved in the development, authorization and marketing of medicinal products b) Implementers of IDMP seeking more information about coding of Therapeutic Indications c) Healthcare providers d) Standards Organizations e) Implementers and software vendors developing and implementing terminology map sets f) Patients

Informatique de santé — Spécificités cliniques — Principes fondamentaux pour l'harmonisation des termes et identifiants des indications thérapeutiques

General Information

• Status: Published
• Publication Date: 30-Jan-2024
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 31-Jan-2024
• Due Date: 01-Sep-2023
• Completion Date: 31-Jan-2024

Relations

• Consolidates: ISO/IEC 10373-6:2020 - Cards and security devices for personal identification — Test methods — Part 6: Contactless proximity objects
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 5499
ISO/TC 215
Health informatics — Clinical
Secretariat: ANSI
particulars — Core principles for
Voting begins on:
2023-10-04 the harmonization of therapeutic
indications terms and identifiers
Voting terminates on:
2023-12-27
ISO/CEN PARALLEL PROCESSING
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/DTS 5499:2023(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 2023

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ISO/DTS 5499:2023(E)
FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 5499
ISO/TC 215
Health informatics — Clinical
Secretariat: ANSI
particulars — Core principles for
Voting begins on:
the harmonization of therapeutic
indications terms and identifiers
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
ISO/CEN PARALLEL PROCESSING
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/DTS 5499:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/DTS 5499:2023(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 . 4
4 Terminologies used for the coding of Therapeutic Indications . 4
4.1 General . 4
4.2 SNOMED CT . 4
4.3 MedDRA . 4
4.4 ICD .
...

© ISO 2022 – All rights reserved Formatted: Font: Bold
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ISO/DTS 5499
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ISO/TC 215/WG 6
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Secretariat: ANSI
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Date: 2023-09-18
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Health informatics — — Clinical Particulars –particulars — Core
Formatted: Cover Title_A1
Principlesprinciples for the Harmonisationharmonization of
Formatted
...
Therapeutic Indications Termstherapeutic indications terms and
Identifiersidentifiers

DTS ballot

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ISO #####-#:####(X)
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2 © ISO #### – All rights reserved

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ISO/DTS 5499:2022(E)
1 © ISO 20202023
Formatted: Indent: Left: 0 pt, Right: 0 pt, Space
Before: 0 pt, No page break before, Adjust space
2 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
between Latin and Asian text, Adjust space between
3 publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
Asian text and numbers, Border: Top: (No border)
4 including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
5 be requested from either ISO at the address below or ISO’s member body in the country of the requester.
6 ISO copyright office
7 CP 401 • Ch. de Blandonnet 8
8 CH-1214 Vernier, Geneva
9 Phone: + 41 22 749 01 11
Formatted: French (Switzerland)
10 EmailE-mail: [e-mail]
Formatted: French (Switzerland)
11 Website: www.iso.orgwww.iso.org
Formatted: French (Switzerland)
12 Published in Switzerland
Formatted: English (United Kingdom)
Formatted: English (United Kingdom)
© ISO 2022 – All rights reserved iii

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ISO/DTS 5499:2022(E)
13 Contents
14 Foreword . vi
15 Introduction . vii
16 1 Scope . 1
17 2 Normative references . 1
18 3 Terms, definitions and abbreviated terms. 1
19 3.1 Terms and definitions . 1
20 3.2 Abbreviated terms . 5
21 4 Terminologies used for the coding of Therapeutic Indications . 5
22 4.1 General . 5
23 4.2 SNOMED CT . 5
24 4.3 MedDRA . 5
25 4.4 ICD . 6
26 4.5 MeSH . 6
27 5 Use Cases for Coding of Therapeutic Indications . 6
28 5.1 General . 6
29 5.2 IDMP data exchan
...