SIST-TS CEN ISO/TS 5499:2024
(Main)Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024)
Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024)
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
Medizinische Informatik - Klinische Besonderheiten - Grundprinzipien für die Harmonisierung von Indikationsbegriffen und -bezeichnungen (ISO/TS 5499:2024)
Informatique de santé - Spécificités cliniques - Principes fondamentaux pour l'harmonisation des termes et identifiants des indications thérapeutiques (ISO/TS 5499:2024)
Zdravstvena informatika - Klinični podatki - Temeljna načela za uskladitev izrazov in identifikatorjev terapevtskih indikacij (ISO/TS 5499:2024)
Cilj tega dokumenta je določiti skupna načela za ustvarjanje, ocenjevanje, izbiro in vzdrževanje preslikav med terminološkimi viri, ki se uporabljajo za opisovanje in šifriranje terapevtskih indikacij za identifikacijo medicinskih izdelkov (IDMP) za izdelke v postopku preiskave in medicinske izdelke, medicinske pripomočke, kombinirane izdelke ter biološko in dopolnilno diagnostiko. Obravnavana so tudi osnovna načela vzdrževanja, kot so zanesljivost, ponovljivost in zagotavljanje kakovosti preslikav za prihodnjo uporabo indikacijske terminologije. Ta dokument je namenjen:
a) globalnim regulatorjem, farmacevtskim/biofarmacevtskim podjetjem, organizacijam za klinične raziskave (CRO) in univerzam/znanstvenim inštitutom, vključenim v razvoj, odobritev in trženje medicinskih izdelkov;
b) izvajalcem identifikacije medicinskih izdelkov, ki iščejo dodatne informacije o šifriranju terapevtskih indikacij;
c) izvajalcem zdravstvenih storitev;
d) organizacijam za standardizacijo;
e) izvajalcem in prodajalcem programske opreme, ki razvijajo in izvajajo sklope terminoloških preiskav;
f) pacientom.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Zdravstvena informatika - Klinični podatki - Temeljna načela za uskladitev izrazov
in identifikatorjev terapevtskih indikacij (ISO/TS 5499:2024)
Health informatics - Clinical particulars - Core principles for the harmonization of
therapeutic indications terms and identifiers (ISO/TS 5499:2024)
Medizinische Informatik - Klinische Besonderheiten - Grundprinzipien für die
Harmonisierung von Indikationsbegriffen und -bezeichnungen (ISO/TS 5499:2024)
Informatique de santé - Spécificités cliniques - Principes fondamentaux pour
l'harmonisation des termes et identifiants des indications thérapeutiques (ISO/TS
5499:2024)
Ta slovenski standard je istoveten z: CEN ISO/TS 5499:2024
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.
CEN ISO/TS 5499
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
February 2024
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Clinical particulars - Core principles
for the harmonization of therapeutic indications terms and
identifiers (ISO/TS 5499:2024)
Informatique de santé - Spécificités cliniques - Medizinische Informatik - Klinische Besonderheiten -
Principes fondamentaux pour l'harmonisation des Grundprinzipien für die Harmonisierung von
termes et identifiants des indications thérapeutiques Indikationsbegriffen und -bezeichnungen (ISO/TS
(ISO/TS 5499:2024) 5499:2024)
This Technical Specification (CEN/TS) was approved by CEN on 28 January 2024 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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. CEN ISO/TS 5499:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/TS 5499:2024) has been prepared by Technical Committee ISO/TC 215
"Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
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/national committee. 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 announce this Technical Specification: 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/TS 5499:2024 has been approved by CEN as CEN ISO/TS 5499:2024 without any
modification.
Technical
Specification
ISO/TS 5499
First edition
Health informatics — Clinical
2024-01
particulars — Core principles for
the harmonization of therapeutic
indications terms and identifiers
Informatique de santé — Spécificités cliniques — Principes
fondamentaux pour l'harmonisation des termes et identifiants
des indications thérapeutiques
Reference number
ISO/TS 5499:2024(en) © ISO 2024
ISO/TS 5499:2024(en)
© ISO 2024
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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/TS 5499:2024(en)
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 .3
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 .4
4.5 MeSH .5
5 Use Cases for Coding of Therapeutic Indications . 5
5.1 General .5
5.2 IDMP data exchange between global regulators and bio/pharmaceutical companies
during regulatory processes .6
5.2.1 Clinical Trials (Medicinal Product Development Lifecycle) .6
5.2.2 Regulatory Submission and Coded Labelling Information .6
5.2.3 Clinical protocol .8
5.2.4 Risk Management.8
5.3 Pharmacovigilance .9
5.3.1 General .9
5.3.2 Clinical information in the EHR supporting regulation for Pharmacovigilance .9
5.3.3 Identify potentially inappropriate prescribing/off-label use .10
5.4 Registries.10
6 Mapping principles specific to therapeutic indications .10
6.1 Maps between Terminologies .10
6.1.1 General .10
6.1.2 Mapping Prerequisites .10
6.1.3 Required Processes . .11
6.2 Therapeutic Indications - Mapping best practice principles and conventions .11
6.3 General mapping guidance . 13
6.3.1 General . 13
6.3.2 Mapping of national and regional terms . 13
6.3.3 Regulatory agencies . 13
Annex A (informative) Implementations of the IDMP Therapeutic Indications Data Model .16
Bibliography .22
iii
ISO/TS 5499:2024(en)
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 document 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).
ISO draws attention to the possibility that the
...
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