ISO 17523
(Main)Health informatics — Requirements for electronic prescriptions
Health informatics — Requirements for electronic prescriptions
ISO 17523:2016 specifies the requirements that apply to electronic prescriptions. It describes generic principles that are considered important for all electronic prescriptions. ISO 17523:2016 is constrained to the content of the electronic prescription itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are out of scope of this International Standard, because they are more or less country or region specific, due to differences in culture and in legislation of healthcare. However, requirements and content of electronic prescriptions within the context of jurisdictions have a relationship with these scenarios. The way in which electronic prescriptions are made available or exchanged also fall outside the scope of this International Standard. ISO 17523:2016 is applicable to electronic prescriptions of medicinal products. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an electronic prescription, the requirements in this International Standard are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. An electronic prescription is an information object that authorizes a healthcare professional to legally dispense a medicinal product. ISO 17523:2016 specifies a list of data elements that can be considered as essential for electronic prescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.).
Informatique de santé — Exigences applicables aux prescriptions électroniques
ISO 17523 :2016 spécifie les exigences qui s'appliquent aux prescriptions électroniques. Elle décrit les principes génériques qui sont considérés comme importants pour l'ensemble des prescriptions électroniques. Le domaine d'application de l'ISO 17523 :2016 se limite au contenu de la prescription électronique elle-même, c'est-à-dire du document numérique qui est émis par un professionnel de santé prescripteur et reçu par un professionnel de santé dispensateur. Le produit médicamenteux prescrit doit être délivré par l'intermédiaire d'un professionnel de santé autorisé, dans le but d'être administré à un patient humain. Les autres messages, rôles et scénarios (par exemple, la validation d'une prescription, l'administration, les tableaux d'administration de médicaments, le DIS du patient ou le remboursement des soins et des produits délivrés) ne relèvent pas du domaine d'application de la présente Norme internationale, car ils sont plus ou moins spécifiques à un pays ou à une région, en raison des différences culturelles et législatives en matière de soins de santé. Toutefois, les exigences et le contenu des prescriptions électroniques, tout en tenant compte des différents pays, ont une relation avec ces scénarios. Les modes de transmission et d'échange des prescriptions électroniques ne relèvent pas non plus du domaine d'application de la présente Norme internationale. ISO 17523 :2016 s'applique aux prescriptions électroniques de produits médicamenteux. Bien qu'il soit possible de commander d'autres types de produits (par exemple, des dispositifs médicaux ou des produits de soins des plaies) au moyen d'une prescription électronique, les exigences de la présente Norme internationale concernent les produits médicamenteux ayant une autorisation de mise sur le marché et les préparations pharmaceutiques réalisées dans une pharmacie. Une prescription électronique est un objet d'information qui autorise un professionnel de santé à délivrer légalement un produit médicamenteux. ISO 17523 :2016 spécifie une liste d'éléments de données qui peuvent être considérés comme essentiels pour les prescriptions électroniques, dépendant du pays ou du milieu clinique (soins de santé primaires, hôpital, etc.).
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ISO/FDIS 17523
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Health informatics — Requirements
Secretariat: ANSI
for electronic prescriptions
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Informatique de santé — Exigences applicables aux prescriptions 2025-03-31
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ISO/FDIS 17523:2025(en) © ISO 2025
FINAL DRAFT
ISO/FDIS 17523:2025(en)
International
Standard
ISO/FDIS 17523
ISO/TC 215
Health informatics — Requirements
Secretariat: ANSI
for electronic prescriptions
Voting begins on:
Informatique de santé — Exigences applicables aux prescriptions
électroniques
Voting terminates on:
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.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 17523:2025(en) © ISO 2025
ii
ISO/FDIS 17523:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Conformance . 3
4.1 Generic conformance .3
4.2 Data element conformance .4
5 General information . 4
5.1 Structure of this document .4
5.2 Usage of this document .4
5.3 Use cases, actors, processes .4
5.4 Information objects .5
5.4.1 Prescription .5
5.4.2 Related information objects .5
6 Requirements for electronic prescriptions . 6
6.1 General requirements for prescriptions .6
6.2 Identification of the patient .6
6.3 Identification of the prescribing healthcare professional .6
6.4 Identification of the prescribed product .7
6.5 Dispense information .7
6.6 Usage instructions.7
6.7 Authentication of the electronic prescription .7
6.8 Data elements .7
Annex A (normative) Data elements . 8
Annex B (informative) Examples of elements and implementations of electronic prescription.18
Bibliography .24
iii
ISO/FDIS 17523:2025(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 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 17523:2016), of which it constitutes a minor
revision. The changes are as follows:
— introduction of a data model;
— reshuffling of requirements into clauses in line with the data model;
— rephrasing the requirements in well-defined capability statements;
— updating the relationship between other ISO standards and this document such as IDMP.
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/FDIS 17523:2025(en)
Introduction
Modern healthcare is rapidly advancing and relying on electronic communications. Many countries
already have or are in the process of developing electronic systems to contain and distribute personal data
regarding healthcare, including the exchange of electronic prescriptions (ePrescriptions). Therefore, it
becomes increasingly important to set up a document that can facilitate safe and reliable dispensing and
administration of the prescribed product to the patient. Also, since international travelling has become
integrated into daily life, it is important that electronic communications regarding prescriptions can
somehow be synchronized between prescribers and dispensers in different jurisdictions.
The most important question regarding ePrescriptions is which information is required to be included in the
ePrescriptions in order to have exactly the intended medicine dispensed to the patient, including all relevant
information with regard to its correct and safe use. This document provides the basic set of information
requirements for ePrescriptions.
While the organization of healthcare is national, the development and production of medicinal products on
the other hand is truly international. For the identification of medicinal products (IDentification of Medicinal
Products, IDMP), five ISO standards are available. This document on ePrescriptions is based on these
standards. In addition, the market authorization is strictly legislated in jurisdictional specific directives and
laws. Part of this legislation regulates prescribing and dispensing of medicinal products. Information systems
in healthcare must be designed so that end-users comply with this legislation (preferably without needing
to pay too much attention). An International Standard on ePrescriptions can support the implementation of
(international) legislation on medicinal products in health informatics.
The prescription written on paper has a deeply rooted cultural history for both healthcare professionals
and patients. Using an ePrescription instead of paper is a change that should be guided to ensure society’s
trust in healthcare professionals. Requirements for the processing of ePrescriptions can fulfil this need. An
example of use in practice of this specification is the following: a general practitioner prescribes a medicinal
product for a patient with the aid of an information system and sends the ePrescription to the local pharmacy
where the patient picks up the medication a short while thereafter.
The benefit of an International Standard on the requirements of ePrescription is that it can serve as a
starting point and reference for all kinds of records and messages related to ePrescriptions, facilitating the
communication between stakeholders and information systems.
The intended audience for this document is made up of the developers of standards and information systems,
so that, in using their products, end-users (healthcare professionals) comply with legislation, regulations and
expectations of society relating to the prescribing and dispensing of medicinal products. Specifically, this
document provides a basis for a common understanding of the data elements contained in an ePrescription
across legislations.
v
FINAL DRAFT International Standard ISO/FDIS 17523:2025(en)
Health informatics — Requirements for electronic
prescriptions
1 Scope
The scope of this document is constrained to the content of the electronic prescription (ePrescription) itself,
the digital document which is issued by a prescribi
...
2025-01-31
ISO/FDIS 17523:2024(en)
ISO/TC 215
Secretariat: ANSI
Date: 2025-03-15
Health informatics — Requirements for electronic prescriptions
Informatique de santé — Exigences applicables aux prescriptions électroniques
FDIS stage
ISO/FDIS 17523:2025(en)
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
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/FDIS 17523:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Conformance . 4
5 General information . 4
6 Requirements for electronic prescriptions . 6
Annex A (normative) Data elements . 9
Annex B (informative) Examples of elements and implementations of electronic prescription . 20
Bibliography . 31
iii
ISO/FDIS 17523:2025(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 documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part two2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that this
may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation onof 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.htmlthe following URL: .
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 17523:2016), of which it constitutes a minor
revision. The changes are as follows:
— Introductionintroduction of a data model;
— Reshufflingreshuffling of requirements into clauses in line with the data model;
— Rephrasingrephrasing the requirements in well-defined capability statements;
— Updatingupdating the relationship between other ISO standards and this document such as IDMP.
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/FDIS 17523:2025(en)
Introduction
Modern healthcare is rapidly advancing and relying on electronic communications. Many countries already
have or are in the process of developing electronic systems to contain and distribute personal data regarding
healthcare, among which isincluding the exchange of electronic prescriptions. (ePrescriptions). Therefore, it
becomes increasingly important to set up a document that can facilitate safe and reliable dispensing (3.2) and
administration of the prescribed product to the patient. Also, since international travelling has become
integrated into daily life, it is important that electronic communications regarding prescriptions can somehow
be synchronized between prescribers and dispensers in different jurisdictions.
The most important question regarding electronic prescriptionsePrescriptions is which information is
required to be included in the electronic prescription (3.7)ePrescriptions in order to have exactly the intended
medicine dispensed to the patient, including all relevant information with regard to its correct and safe use.
This document provides the basic set of information requirements for electronic prescription
(3.7).ePrescriptions.
While the organization of healthcare is national, the development and production of medicinal products on
the other hand is truly international. For the identification (3.12) of medicinal products (IDentification of
Medicinal Products, IDMP), five ISO standards are available. This document on e-PrescriptionePrescriptions
is based on these standards. In addition, the market authorization (3.11) is strictly legislated in jurisdictional
specific directives and laws. Part of this legislation regulates prescribing (3.6) and dispensing (3.2) of
medicinal products. Information systems in healthcare must be designed so that end-users comply with this
legislation (preferably without needing to pay too much attention). An International Standard on electronic
prescriptionsePrescriptions can support the implementation of (international) legislation on medicinal
products in health informatics.
The prescription (3.7) written on paper has a deeply rooted cultural history for both healthcare professionals
and patients. Using an electronic prescription (3.7)ePrescription instead of paper is a change that should be
guided to ensure society’s trust in healthcare professionals. Requirements for the processing of electronic
prescriptionsePrescriptions can fulfil this need. An example of use in practice of this specification is the
following: a general practitioner prescribes a medicinal product (3.8) for a patient with the aid of an
information system and sends the electronic prescription (3.7)ePrescription to the local pharmacy where the
patient picks up the medication a short while thereafter.
The benefit of an International Standard on the requirements of an electronic prescription (3.7)ePrescription
is that it can serve as a starting point and reference for all kinds of records and messages related to electronic
prescriptionsePrescriptions, facilitating the communication between stakeholders and information systems.
The intended audience for this document is made up of the developers of standards and information systems,
so that, in using their products, end-users (healthcare professionals) comply with legislation, regulations and
expectations of society relating to the prescribing (3.6) and dispensing (3.2) of medicinal products.
Specifically, this document provides a basis for a common understanding of the data elements contained in an
electronic prescription (3.7)ePrescription across legislations.
v
ISO/FDIS 17523:2025(en)
Health informatics — Requirements for electronic prescriptions
1 Scope
The scope of this document is constrained to the content of the electronic prescription (3.7ePrescription)
itself, the digital document which is issued by a prescribing (3.6) healthcare professional and received by a
dispensing (3.2) healthcare professional. The prescribed medicinal product (3.8) is to be dispensed through
an authorized healthcare professional with the aim of being administered to a human patient. The electronic
prescriptionePrescription in the administrative workflow of reimbursement is not part ofcovered in this
scopedocument.
This document specifies the requirements that apply to electronic prescriptions.ePrescriptions. It describes
generic principles that are considered important for all electronic prescriptionsePrescriptions.
This document is applicable to electronic prescriptionsePrescriptions of medicinal products for human use.
Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an
electronic prescription (3.7),ePrescription, the requirements in this document are aimed at medicinal products
that have a market authorization (3.11) and at pharmaceutical preparations which are compounded in a
pharmacy.
This document does not limit the scope to any setting (community, institutional) and leaves it to the National
bodies to decide on this matter.
This document specifies a list of data elements that can be considered as essential for electronic
prescriptionsePrescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.).
Ensuring the authenticity of these data elements is in scope and will have impact on the requirements of
information systems.
Other messages, roles and scenarios (e.g. validation of a prescription (3.7),, administration, medication charts,
EHR of the patient, reimbursement of care and dispensed products) are not covered in this document, because
they are country-specific or region-specific, due to differences in culture and in legislation of healthcare.
However, requirements and content of electronic prescriptionsePrescriptions within the context of
jurisdictions have a relationship with these scenarios. This document also does not cover the way in which
electronic prescriptionsePrescriptions are made available or exchanged, and the process of prescribing itself.
The logistic process of prescribing (3.6) itself is not part of the scope. A prescription (3.7) can either be sent
(pushed) to a dispenser (3.1) or either be retrieved (pulled) at the dispenser (3.1). The requirements.
However, the requirement for the prescription (3.7) however is described, that it will be able to function in
both environments.
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.
ISO 11239, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation,
routes of administration and packaging
ISO 11240, Health informatics — Identification of medicinal products — Data elements and structures for the
unique identification and exchange of units of measurement
ISO/FDIS 17523:2025(en)
ISO 8601-1, Data elementsDate and time — Representations for information interchange formats —
Information interchange — Representation of dates and times— Part 1: Basic rules
ISO/TS 22220, Health informatics — Identification of subjects of health care
3 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 3.1
dispenser
healthcare professional authorized to dispense medicinal products
3.2 3.2
dispensing
process of validation of the electronicprescription (3.3electronic prescription (3.7),), preparation of the
medicinal product (3.8(3.8),), labelling, informing and handing the medication to the patient or administering
healthcare professional
3.3 3.3
electronic prescription
ePrescription
prescription (3.7(3.7)) (issued by electronic means) that is conforms with this International
Standarddocument
3.4 3.4
digital signature
signature based upon cryptographic methods of originator authentication (3.10(3.10),), computed by using a
set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be
verif
...
PROJET FINAL
Norme
internationale
ISO/FDIS 17523
ISO/TC 215
Informatique de santé — Exigences
Secrétariat: ANSI
applicables aux prescriptions
Début de vote:
électroniques
2025-03-31
Health informatics — Requirements for electronic prescriptions
Vote clos le:
2025-05-26
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO/FDIS 17523:2025(fr) © ISO 2025
PROJET FINAL
ISO/FDIS 17523:2025(fr)
Norme
internationale
ISO/FDIS 17523
ISO/TC 215
Informatique de santé — Exigences
Secrétariat: ANSI
applicables aux prescriptions
Début de vote:
électroniques
2025-03-31
Health informatics — Requirements for electronic prescriptions
Vote clos le:
2025-05-26
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2025 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO/FDIS 17523:2025(fr) © ISO 2025
ii
ISO/FDIS 17523:2025(fr)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Champ d'application . 1
2 Références normatives . 1
3 Termes et définitions . 2
4 Conformité . 4
4.1 Conformité générique . .4
4.2 Conformité des éléments de données . .4
5 Informations générales. 4
5.1 Structure du présent document .4
5.2 Utilisation de ce document .4
5.3 Cas d'utilisation, acteurs, processus .4
5.4 Objets d'information.5
5.4.1 Prescription .5
5.4.2 Objets d'information connexes .5
6 Exigences relatives aux prescriptions électroniques . 6
6.1 Exigences générales pour les prescriptions .6
6.2 Identification du patient .6
6.3 Identification du professionnel de santé prescripteur .6
6.4 Identification du produit prescrit .7
6.5 Informations sur la distribution .7
6.6 Instructions d'utilisation.7
6.7 Authentification de la prescription électronique .7
6.8 Éléments de données.8
Annexe A (normative) Éléments de données . 9
Annexe B (informative) Exemples d'éléments et d'implémentations de la prescription
électronique . 19
Bibliographie .25
iii
ISO/FDIS 17523:2025(fr)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux
de normalisation (organismes membres de l'ISO). Les travaux d'élaboration des normes internationales sont
normalement menés par les comités techniques de l'ISO. Chaque organisme membre intéressé par un sujet
pour lequel un comité technique a été créé a le droit d'être représenté au sein de ce comité. Des organisations
internationales, gouvernementales et non gouvernementales, en liaison avec l'ISO, participent également aux
travaux. L'ISO collabore étroitement avec la Commission électrotechnique internationale (CEI) sur toutes les
questions de normalisation électrotechnique.
Les procédures utilisées pour l'élaboration de ce document et celles destinées à sa mise à jour ultérieure
sont décrites dans les Directives ISO/CEI, Partie 1. En particulier, il convient de noter les différents
critères d'approbation nécessaires pour les différents types de documents ISO. Ce document a été rédigé
conformément aux règles éditoriales des Directives ISO/CEI, Partie 2 (voir www.iso.org/directives).
L'ISO attire l'attention sur le fait que la mise en œuvre du présent document peut impliquer l'utilisation d'un
ou de plusieurs brevets. L'ISO ne prend pas position concernant la preuve, la validité ou l'applicabilité de
tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l'ISO n'a pas reçu
d'avis concernant un ou plusieurs brevets qui pourraient être nécessaires à la mise en œuvre du présent
document. Toutefois, les personnes chargées de la mise en œuvre sont averties que ce document peut ne pas
représenter l'information la plus récente, qui peut être obtenue à partir de la base de données des brevets
disponible à l'adressewww.iso.org/patents . L'ISO ne peut être tenue responsable de l'identification de tout
ou partie de ces droits de brevet.
Tout nom de marque utilisé dans ce document est une information donnée pour la commodité des utilisateurs
et ne constitue pas une approbation.
Pour une explication de la nature volontaire des normes, de la signification des termes et expressions
spécifiques à l'ISO relatifs à l'évaluation de la conformité, ainsi que pour des informations sur l'adhésion
de l'ISO aux principes de l'Organisation mondiale du commerce (OMC) dans le domaine des Obstacles
techniques au commerce (OTC), voir www.iso.org/iso/foreword.html.
Ce document a été préparé par le comité technique ISO/TC 215, Informatique de santé, en collaboration
avec le comité technique CEN/TC 251, Informatique de santé, du Comité européen de normalisation (CEN),
conformément à l'accord de coopération technique entre l'ISO et le CEN (accord de Vienne).
Cette deuxième édition annule et remplace la première édition (ISO 17523:2016), dont elle constitue une
révision mineure. Les modifications sont les suivantes:
— l'introduction d'un modèle de données;
— le remaniement des exigences en clauses conformément au modèle de données;
— reformuler les exigences dans des énoncés de capacités bien définis;
— mettre à jour les relations entre d'autres normes ISO et le présent document, telles que l'IDMP.
Tout commentaire ou question sur ce document doit être adressé à l'organisme national de
normalisation de l'utilisateur. Une liste complète de ces organismes est disponible à l'adresse
suivante:www.iso.org/members.html .
iv
ISO/FDIS 17523:2025(fr)
Introduction
Les soins de santé modernes progressent rapidement et s'appuient sur les communications électroniques. De
nombreux pays ont déjà mis en place, ou sont en train de le faire, des systèmes électroniques pour contenir
et distribuer des données personnelles concernant les soins de santé, y compris l'échange de prescriptions
électroniques (ePrescriptions). Il devient donc de plus en plus important de mettre en place un document qui
puisse faciliter la délivrance et l'administration sûres et fiables du produit prescrit au patient. En outre, les
voyages internationaux faisant désormais partie intégrante de la vie quotidienne, il est important que les
communications électroniques concernant les prescriptions puissent être synchronisées d'une manière ou
d'une autre entre les prescripteurs et les dispensateurs dans différentes juridictions.
La question la plus importante concernant les prescriptions électroniques est de savoir quelles informations
doivent être incluses dans les prescriptions électroniques afin que le médicament prévu soit délivré au
patient, y compris toutes les informations pertinentes concernant son utilisation correcte et sûre. Ce
document présente l'ensemble des informations de base requises pour les prescriptions électroniques.
Si l'organisation des soins de santé est nationale, le développement et la production de médicaments sont en
revanche véritablement internationaux. Pour l'identification des médicaments (IDentification of Medicinal
Products, IDMP), il existe cinq normes ISO. Le présent document sur les prescriptions électroniques est
basé sur ces normes. En outre, l'autorisation de mise sur le marché est strictement réglementée par des
directives et des lois spécifiques à chaque juridiction. Une partie de cette législation régit la prescription et
la délivrance de médicaments. Les systèmes d'information dans le domaine des soins de santé doivent être
conçus de manière à ce que les utilisateurs finaux se conforment à cette législation (de préférence sans avoir
à y prêter trop d'attention). Une norme internationale sur les prescriptions électroniques peut faciliter la
mise en œuvre de la législation (internationale) sur les médicaments dans l'informatique de santé.
La prescription écrite sur papier a une histoire culturelle profondément enracinée, tant pour les
professionnels de la santé que pour les patients. L'utilisation d'une ordonnance électronique au lieu du
papier est un changement qui doit être guidé pour garantir la confiance de la société dans les professionnels
de la santé. Les exigences relatives au traitement des prescriptions électroniques peuvent répondre à ce
besoin. Voici un exemple d'utilisation pratique de la présente spécification: un médecin généraliste prescrit
un médicament à un patient à l'aide d'un système d'information et envoie l'ordonnance électronique à la
pharmacie locale
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