SIST EN ISO 17523:2025

Health informatics - Requirements for electronic prescriptions (ISO 17523:2025)

The scope of this document is constrained to the content of the electronic prescription (ePrescription) 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. The ePrescription in the administrative workflow of reimbursement is not covered in this document.
This document specifies the requirements that apply to ePrescriptions. It describes generic principles that are considered important for all ePrescriptions.
This document is applicable to ePrescriptions 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 ePrescription, the requirements in this document are aimed at medicinal products that have a market authorization 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 ePrescriptions, 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, 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 ePrescriptions within the context of jurisdictions have a relationship with these scenarios. This document also does not cover the way in which ePrescriptions are made available or exchanged, and the process of prescribing itself.
The logistic process of prescribing itself is not part of the scope. A prescription can either be sent (pushed) to a dispenser or either be retrieved (pulled) at the dispenser. However, the requirement for the prescription is described, that it will be able to function in both environments.

Medizinische Informatik - Anforderungen an elektronische Verschreibungen (ISO 17523:2025)

Informatique de santé - Exigences applicables aux prescriptions électroniques (ISO 17523:2025)

Le domaine d'application du présent document 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 médicament prescrit doit être délivré par l'intermédiaire d'un professionnel de santé autorisé, dans le but d'être administré à un patient humain. La prescription électronique dans le flux administratif du remboursement n'est pas couverte dans le présent document.
Le présent document spécifie les exigences qui s'appliquent aux e-prescriptions. Il décrit les principes génériques qui sont considérés comme importants pour l'ensemble des e-prescriptions.
Le présent document s'applique aux e-prescriptions de médicaments à usage humain. 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 e-prescription, les exigences du présent document concernent les médicaments ayant une autorisation de mise sur le marché et les préparations pharmaceutiques réalisées dans une pharmacie.
Le présent document ne limite pas le domaine d'application à un quelconque contexte (communautaire, institutionnel) et laisse aux organismes nationaux le soin de se prononcer sur cette question.
Le présent document spécifie une liste d'éléments de données qui peuvent être considérés comme essentiels pour les e-prescriptions, en fonction du pays ou du milieu clinique (soins de santé primaires, hôpital, etc.). La garantie de l'authenticité de ces éléments de données relève du domaine d'application et aura une incidence sur les exigences des systèmes d'information.
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 sont pas couvert dans le présent document, car ils sont 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 e-prescriptions, tout en tenant compte des différents pays, ont une relation avec ces scénarios. Le présent document ne couvre également pas la manière dont les e‑prescriptions sont mises à disposition ou échangées, ni le processus de prescription lui-même.
Le processus logistique de prescription en lui-même ne relève pas du domaine d'application. Une prescription peut être soit envoyée (transmise) à un dispensateur ou être récupérée (obtenue) auprès du dispensateur. Cependant, les exigences applicables à la prescription sont décrites, à savoir être capable de fonctionner dans les deux environnements.

Zdravstvena informatika - Zahteve za elektronske recepte (ISO 17523:2025)

General Information

• Status: Published
• Public Enquiry End Date: 17-Oct-2024
• Publication Date: 23-Sep-2025
• 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: 21-Aug-2025
• Due Date: 26-Oct-2025
• Completion Date: 24-Sep-2025
• Ref Project: EN ISO 17523:2025 - Health informatics - Requirements for electronic prescriptions (ISO 17523:2025)

Relations

• Replaces: SIST EN ISO 17523:2016 - Health informatics - Requirements for electronic prescriptions (ISO 17523:2016)
• Effective Date: 01-Oct-2025

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2025
Nadomešča:
SIST EN ISO 17523:2016
Zdravstvena informatika - Zahteve za elektronske recepte (ISO 17523:2025)
Health informatics - Requirements for electronic prescriptions (ISO 17523:2025)
Medizinische Informatik - Anforderungen an elektronische Verschreibungen (ISO
17523:2025)
Informatique de santé - Exigences applicables aux prescriptions électroniques (ISO
17523:2025)
Ta slovenski standard je istoveten z: EN ISO 17523:2025
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.

EN ISO 17523
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 17523:2016
English Version
Health informatics - Requirements for electronic
prescriptions (ISO 17523:2025)
Informatique de santé - Exigences applicables aux Medizinische Informatik - Anforderungen an
prescriptions électroniques (ISO 17523:2025) elektronische Verschreibungen (ISO 17523:2025)
This European Standard was approved by CEN on 27 June 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17523:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 17523:2025) 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.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
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.
This document supersedes EN ISO 17523:2016.
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 implement this European Standard: 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 17523:2025 has been approved by CEN as EN ISO 17523:2025 without any modification.

International
Standard
ISO 17523
Second edition
Health informatics — Requirements
2025-07
for electronic prescriptions
Informatique de santé — Exigences applicables aux prescriptions
électroniques
Reference number
ISO 17523:2025(en) © ISO 2025
ISO 17523:2025(en)
© ISO 2025
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 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 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 17523:2025(en)
Introduction
Modern healthcare is rapidly advancing and relying on electronic
...