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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)

General Information

Status
Published
Publication Date
15-Apr-2024
ICS
35.240.80 - IT applications in health care technology
Technical Committee
ITC - Information technology
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
20-Mar-2024
Due Date
25-May-2024
Completion Date
16-Apr-2024
Ref Project
CEN ISO/TS 5499:2024 - Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024)

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 5499:2024
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
SIST-TS CEN ISO/TS 5499:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 5499:2024

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SIST-TS CEN ISO/TS 5499:2024


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.

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SIST-TS CEN ISO/TS 5499:2024
CEN ISO/TS 5499:2024 (E)
Contents Page
European foreword . 3

2

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SIST-TS CEN ISO/TS 5499:2024
CEN ISO/TS 5499:2024 (E)
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.


3

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