prEN ISO 17523
(Main)Health informatics - Requirements for electronic prescriptions (ISO/DIS 17523:2024)
Health informatics - Requirements for electronic prescriptions (ISO/DIS 17523:2024)
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.).
Medizinische Informatik - Anforderungen an elektronische Verschreibungen
Informatique de santé - Exigences applicables aux prescriptions électroniques (ISO/DIS 17523:2024)
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.).
Zdravstvena informatika - Zahteve za elektronske recepte (ISO/DIS 17523:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2024
Zdravstvena informatika - Zahteve za elektronske recepte (ISO/DIS 17523:2024)
Health informatics - Requirements for electronic prescriptions (ISO/DIS 17523:2024)
Medizinische Informatik - Anforderungen an elektronische Verschreibungen
Informatique de santé - Exigences applicables aux prescriptions électroniques (ISO/DIS
17523:2024)
Ta slovenski standard je istoveten z: prEN ISO 17523
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.
DRAFT
International
Standard
ISO/DIS 17523
ISO/TC 215
Health informatics — Requirements
Secretariat: ANSI
for electronic prescriptions
Voting begins on:
Informatique de santé — Exigences applicables aux prescriptions
2024-07-29
électroniques
Voting terminates on:
ICS: 35.240.80 2024-10-21
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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NATIONAL REGULATIONS.
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Reference number
ISO/DIS 17523:2024(en)
DRAFT
ISO/DIS 17523:2024(en)
International
Standard
ISO/DIS 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:
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 17523:2024(en)
ii
ISO/DIS 17523:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
1.1 In scope .1
1.2 Out of scope .1
2 Normative references . 1
3 Terms and definitions . 2
4 Conformance . 4
4.1 Generic conformance .4
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 (3.6) healthcare professional .7
6.4 Identification of the prescribed medicinal product (3.8) .7
6.5 Dispense information .7
6.6 Usage instructions.7
6.7 Authentication of the electronic prescription (3.7) .7
6.8 Data elements .7
Annex A (normative) Data elements . 8
Annex B (informative) Examples of elements and implementations of electronic prescription
(3.7) .18
Bibliography .24
iii
ISO/DIS 17523:2024(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 documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part two (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT)
see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 215, Health informatics.
iv
ISO/DIS 17523:2024(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 is exchange of electronic prescriptions. Therefore, it becomes
increasingly important to set up a document that in the end will 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 prescriptions is which information is required to be
included in the electronic prescription (3.7) 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).
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, a suit of five
ISO Standards (IDentification of Medicinal Products, IDMP) is available. This document on e-Prescription 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
prescriptions may support the implementation of (international) legislation on medicinal products in health
informatics. For instance, the definition of the term “electronic prescription (3.7)” has to comply with that of
national legislations and multinational directives.
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) instead of paper is a change that must be guided to ensure
society’s trust in healthcare professionals. Requirements for the processing of electronic prescriptions can
fulfil this need. An example of use in practice of this specification is the following: a general practitioner
prescribes a
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