Health informatics - Requirements for electronic prescriptions (ISO 17523:2016)

The goal is an international standard and European standard on electronic prescriptions. This standard describes the
requirements that apply to existing and future electronic prescriptions which are part of health informatics systems
throughout the world.
This standard specifies the general principles for electronic prescriptions and the content that facilitates the exchange and
processing of an electronic prescription. The standard applies to healthcare outside hospitals as well as within.
The scope is constrained to the content of the prescription itself, to the roles of prescriber and dispensing pharmacist and to
the scenario of prescribing medicinal products to be dispensed to human patients. Other messages, roles and scenario’s are
out of scope of an international standard, because they are more or less country or region specific, due to differences in
culture and in legislation of healthcare and reimbursement of care.
The way in which electronic prescriptions and dispensing messages are actually exchanged or made available falls outside
the scope of this standard.

Medizinische Informatik - Anforderungen an elektronische Verschreibungen (ISO 17523:2016)

Diese Internationale Norm legt die Anforderungen an elektronische Verschreibungen fest. Sie beschreibt generische Grundsätze, die als für alle elektronischen Verschreibungen wichtig betrachtet werden.
Der Anwendungsbereich dieser Internationalen Norm ist auf den Inhalt der elektronischen Verschreibung selbst begrenzt, das digitale Dokument, das durch eine die Verschreibung vornehmende im Gesundheitswesen tätige, qualifizierte Person ausgestellt und durch eine die Abgabe vornehmende im Gesundheitswesen tätige, qualifizierte Person entgegengenommen wird. Das verschriebene Arzneimittel ist über eine befugte im Gesundheitswesen tätige, qualifizierte Person abzugeben, um einem menschlichen Patienten verabreicht zu werden. Weitere Meldungen, Rollen und Szenarios (z. B. Validierung einer Verschreibung, Verabreichung, Medikamenten¬tabellen, ELGA des Patienten, Erstattung der Pflegekosten und abgegebenen Produkte) liegen außerhalb des Anwendungsbereichs dieser Internationalen Norm, da sie aufgrund der kulturellen und gesetzgeberischen Unterschiede in Bezug auf das Gesundheitswesen mehr oder weniger länder- oder regionsspezifisch sind. Die Anforderungen an die und der Inhalt der elektronische(n) Verschreibungen im Kontext der Rechtsprechungen stehen jedoch mit diesen Szenarios im Zusammenhang. Die Art und Weise, auf die elektronische Verschreibungen zur Verfügung gestellt oder ausgetauscht werden, liegt außerhalb des Anwendungs¬bereichs dieser Internationalen Norm.
Die vorliegende Internationale Norm gilt für elektronische Verschreibungen von Arzneimitteln. Obwohl auch andere Arten von Produkten (z. B. Medizinprodukte, Wundpflegeprodukte) mithilfe von elektronischen Verschreibungen bestellt werden können, beziehen sich die Anforderungen in dieser Internationalen Norm auf Arzneimittel mit Marktzulassung und pharmazeutische Präparate, die in einer Apotheke zubereitet werden. Bei einer elektronischen Verschreibung handelt es sich um ein Informationsobjekt, das eine im Gesundheitswesen tätige, qualifizierte Person zur legalen Abgabe eines Arzneimittels befugt.
Diese Internationale Norm legt eine Auflistung von Datenelementen fest, die teilweise als wesentlich für alle elektronischen Verschreibungen oder für elektronische Verschreibungen in bestimmten Rechtsprechungen oder bestimmten klinischen Umgebungen (z. B. medizinische Grundversorgung, Krankenhaus usw.) angesehen werden können.

Informatique de santé - Exigences applicables aux prescriptions électroniques (ISO 17523:2016)

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 17523:2016)

Cilj je mednarodni standard in evropski standard o elektronskih receptih. Ta standard opisuje zahteve, ki veljajo za obstoječe in prihodnje elektronske recepte, ki so del zdravstvenega informacijskega sistema po vsem svetu. Ta standard določa splošna načela za elektronske recepte in vsebino, ki omogoča lažjo izmenjavo in obdelavo elektronskih receptov. Standard se uporablja v bolnicah in zunaj njih. Področje uporabe je omejeno na vsebino samega recepta, na vloge predpisovalca in farmacevta ter scenarij predpisovanja medicinskih proizvodov bolnikom. Druga sporočila, vloge in scenariji niso zajeti v mednarodnem standardu, ker so bolj ali manj specifični za državo ali regijo zaradi kulturnih razlik in različne zakonodaje o zdravstvu in povračilu stroškov oskrbe. Način izmenjave ali razpoložljivosti elektronskih receptov in sporočil o predpisovanju ne spada na področje uporabe tega standarda.

General Information

Status
Published
Public Enquiry End Date
29-Nov-2014
Publication Date
06-Nov-2016
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Jul-2016
Due Date
15-Sep-2016
Completion Date
07-Nov-2016

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SLOVENSKI STANDARD
SIST EN ISO 17523:2016
01-december-2016
Zdravstvena informatika - Zahteve za elektronske recepte (ISO 17523:2016)
Health informatics - Requirements for electronic prescriptions (ISO 17523:2016)
Medizinische Informatik - Anforderungen an elektronische Verschreibungen (ISO
17523:2016)
Informatique de santé - Exigences applicables aux prescriptions électroniques (ISO
17523:2016)
Ta slovenski standard je istoveten z: EN ISO 17523:2016
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 17523:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 17523:2016

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SIST EN ISO 17523:2016


EN ISO 17523
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2016
EUROPÄISCHE NORM
ICS 35.240.80
English Version

Health informatics - Requirements for electronic
prescriptions (ISO 17523:2016)
Informatique de santé - Exigences applicables aux Medizinische Informatik - Anforderungen an
prescriptions électroniques (ISO 17523:2016) elektronische Verschreibungen (ISO 17523:2016)
This European Standard was approved by CEN on 15 April 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17523:2016 E
worldwide for CEN national Members.

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SIST EN ISO 17523:2016
EN ISO 17523:2016 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 17523:2016
EN ISO 17523:2016 (E)
European foreword
This document (EN ISO 17523:2016) 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 December 2016, and conflicting national standards
shall be withdrawn at the latest by December 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 17523:2016 has been approved by CEN as EN ISO 17523:2016 without any modification.
3

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SIST EN ISO 17523:2016

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SIST EN ISO 17523:2016
INTERNATIONAL ISO
STANDARD 17523
First edition
2016-06-01
Health informatics — Requirements
for electronic prescriptions
Informatique de santé — Exigences applicables aux prescriptions
électroniques
Reference number
ISO 17523:2016(E)
©
ISO 2016

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SIST EN ISO 17523:2016
ISO 17523:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 17523:2016
ISO 17523:2016(E)

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 International Standard . 4
5.2 Usage of this International Standard . 4
5.3 Use cases, actors, processes . 4
5.4 Information objects . 6
5.4.1 Prescription . 6
5.4.2 Related information objects . 6
6 Requirements for electronic prescriptions . 6
6.1 Identification of the patient . 6
6.2 Identity information of the prescribing healthcare professional . 6
6.3 Identification of the prescribed medicinal product . 7
6.4 Compliance to medicinal product dictionaries . 7
6.5 Product use information . 7
6.6 Authentication of the electronic prescription . 7
6.7 Data elements . 7
Annex A (normative) Data elements. 8
Annex B (informative) Examples of elements and implementations of electronic prescription .14
Bibliography .18
© ISO 2016 – All rights reserved iii

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SIST EN ISO 17523:2016
ISO 17523:2016(E)

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).
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 2016 – All rights reserved

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SIST EN ISO 17523:2016
ISO 17523:2016(E)

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 International Standards that in the end will 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 electronic prescriptions is which information is required to
accompany the electronic prescription 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 International
Standard provides the basic set of information requirements to support electronic prescription.
While the organization of healthcare is national, the development and production of medicinal products
on the other hand is truly international. 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
electronic prescriptions may support the implementation of (international) legislation on medicinal
products in health informatics. For instance, the definition of the term “electronic prescription” has to
comply with that of national legislations and multinational directives.
The prescription written on paper has a deeply rooted cultural history for both healthcare professionals
and patients. Using an electronic prescription 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 medicinal product for a patient with the aid of an information system
and sends the electronic prescription 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 is that it
can serve as a starting point and reference for all kinds of records and messages related to electronic
prescriptions, facilitating the communication between stakeholders and information systems.
The intended audience for this International Standard 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 International Standard provides a basis for a common
understanding of the data elements contained in an electronic prescription across legislations.
© ISO 2016 – All rights reserved v

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SIST EN ISO 17523:2016

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SIST EN ISO 17523:2016
INTERNATIONAL STANDARD ISO 17523:2016(E)
Health informatics — Requirements for electronic
prescriptions
1 Scope
This International Standard specifies the requirements that apply to electronic prescriptions. It
describes generic principles that are considered important for all electronic prescriptions.
The scope of this International Standard 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.
This International Standard 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.
This International Standard 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.).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated information on substances
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 11615, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information
ISO 11616, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated pharmaceutical product information
© ISO 2016 – All rights reserved 1

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SIST EN ISO 17523:2016
ISO 17523:2016(E)

ISO 17090-1, Health informatics — Public key infrastructure — Part 1: Overview of digital certificate
services
ISO/TS 16791, Health informatics — Requirements for international machine-readable coding of medicinal
product package identifiers
ISO/TS 22220, Health informatics — Identification of subjects of health care
ISO/TS 27527, Health informatics — Provider identification
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
dispenser
healthcare professional authorized to dispense medicinal products
3.2
dispensing
process of validation of the electronic prescription, preparation of the medicinal product, labelling,
informing and handing the medication to the patient or administering healthcare professional
3.3
electronic prescription
e-prescription
prescription (issued by electronic means) that complies with this International Standard
3.4
digital signature
signature based upon cryptographic methods of originator authentication, 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
verified
Note 1 to entry: Digital signatures employ a type of asymmetric cryptography. For messages sent through an
insecure channel, a properly implemented digital signature gives the receiver reason to believe the message was
sent by the claimed sender.
3.5
prescriber
healthcare professional authorized to issue electronic prescriptions
3.6
prescribing
process in which an authorized healthcare professional, the prescriber, issues a prescription
information object
Note 1 to entry: Typically, the healthcare professional is a medical specialist or a general practitioner but this
differs across legislations. In some countries, pharmacists or nurse practitioners are also authorized to prescribe.
3.7
prescription
set of values of attributes that is produced as the output of a prescription act
Note 1 to entry: A prescription is a set of instructions written by a prescriber that authorizes a medicinal product
or treatment to be given to a patient. It is a) an instruction by an authorized healthcare professional, b) a request
to dispense by an authorized healthcare professional and c) advice to a patient on his/her medication treatment
or d) an instruction to administer by an authorized healthcare professional.
2 © ISO 2016 – All rights reserved

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ISO 17523:2016(E)

Note 2 to entry: The word “prescription” is sometimes used when referring to the act of prescribing, “prescription
process”. To avoid confusion with the term “prescription” as an information object, throughout this International
Standard, the word “prescription” is reserved for the information object. For the act of prescribing, the term
“prescribing” is used.
3.8
medicinal product
substance or combination of substances, which can be administered to human beings for treating or
preventing disease, making a medical diagnosis or to restore, correct or modify physiological functions
3.9
authentication
formalized process of verification that, if successful, results in an authenticated identity for an entity
Note 1 to entry: The authentication process involves tests by a verifier of one or more identity attributes provided
by an entity to determine, with the required level of assurance, their correctness.
Note 2 to entry: Authentication typically involves the use of a policy to specify a required level of assurance for
the result of a successful completion.
Note 3 to entry: Identification is usually done as authentication to obtain a specific level of assurance in the result.
[SOURCE: ISO/IEC 24760-1:2011, 3.3.1, modified]
3.10
authorization
granting of rights, which includes the granting of access based on access rights
[SOURCE: ISO 7498-2:1989, 3.3.10]
3.11
identification
process of recognizing an entity in a particular domain as distinct from other entities
Note 1 to entry: The process of identification applies verification to claimed or observed attributes.
Note 2 to entry: Identification typically is part of the interactions between an entity and the services in a domain
and to access resources. Identification can occur multiple times while the entity is known in the domain.
[SOURCE: ISO/IEC 24760-1:2011, 3.2.1, modified]
3.12
identity information
set of values of attributes that differentiate one entity from others
Note 1 to entry: In an information and communication technology system, an identity is present as identity
information.
[SOURCE: ISO/IEC 24760-1:2011, 3.2.4, modified]
4 Conformance
4.1 Generic conformance
An electronic prescription is conformant to this International Standard when it fulfils all detailed
requirements in Clause 6.
© ISO 2016 – All rights reserved 3

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ISO 17523:2016(E)

4.2 Data element conformance
An electronic prescription is conformant to Annex A when it fulfils the requirements described in
Clause 6 by using data elements from Annex A.
NOTE Data element conformance implies generic conformance.
5 General information
5.1 Structure of this International Standard
This International Standard provides the requirements for electronic prescriptions. Clause 6 describes
the generic requirements considered important for any electronic prescription, regardless of the data
elements presented in the electronic prescription. Annex A lists a selection of data elements and their
definition that should be used to fulfil the requirements as specified in Clause 6. Annex B has three
parts: B.1 lists examples of electronic prescription implementations in other countries; B.2 provides an
overview of data structures and standards; B.3 lists examples and code snippets belonging to either the
core or optional elements.
5.2 Usage of this International Standard
This International Standard provides a basis for a common understanding of the data elements
contained in an electronic prescription within and across jurisdictions to achieve interoperability. This
International Standard is therefore intended to be used in the process of development of standards and
information systems handling electronic prescription information. Healthcare system designers should
specify which data elements are supported by their implementation. The chosen subset may vary based
on their intended use, regulatory background, and other aspects that condition the local requirements.
However, data elements used have to fulfil the requirements of Annex A.
5.3 Use cases, actors, processes
This International Standard intends to specify the requirements for the information object that is to
be created when a system issues a prescription. While an electronic prescription can appear in a wide
range of processes, the intended scope of this International Standard is for a simple use case:
A physician enters prescription information for medication. The prescription information may then be
reviewed by another professional before dispensing and the medication is then dispensed. After the
dispense, the medication is expected to be administered.
NOTE 1 In a cross-border setting, the use case can be described as follows: A physician enters prescription
information for medication in country A. The prescription information may then be reviewed by another
professional before dispensing, and the medication is then dispensed in country B. After the dispense, the
medication is expected to be administered. Extended information on cross-border requirements of electronic
prescriptions can, e.g. be found in the Directive 2011/24/EU of the European Parliament and of the Council of 9
[7]
March 2011 on the application of patients’ rights in cross-border healthcare. Article 11 (2-b) of the Directive
defines the need for supporting the Member States in developing the interoperability of electronic prescriptions.
[8]
The “Guidelines on eprescriptions dataset for electronic exchange under cross-border directive 2011/24/EU”
is aiming to facilitate this.
NOTE 2 Review, dispense, and administration processes use the prescription information. These processes
might lead to the creation of new additional information possibly including parts of the prescription information
or referring to it. The review, dispense and administration processes are considered only in so far as they impose
additional requirements on the prescription information. The information created by those processes is not
subject of this International Standard.
This International Standard only addresses the requirements that are necessary for the electronic
prescription. However, this use case may trigger the following acts.
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ISO 17523:2016(E)

Prescribing: the intellectual process of deciding on a medication, related to medication treatment
plans, decision support, etc. All considerations that lead to defining the information to be entered are
considered to be prior to the prescription entry.
Prescription review: to check prescription information against pharmaceutical knowledge and
regulations, e.g. drug interaction checking.
In order to fulfil this task, the reviewer should have access to information concerning the current
treatment of the patient and medication already dispensed. For a prescription to be validated, a
prescription review (or several) may be needed. The conditions for this are not relevant for this
International Standard.
During the review process, there can arise a need to contact the prescriber.
NOTE 3 Prescription review is also known as medication order review or pharmaceutical review.
Dispense of medication:
...

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