EN ISO 17523:2016
(Main)Health informatics - Requirements for electronic prescriptions (ISO 17523:2016)
Health informatics - Requirements for electronic prescriptions (ISO 17523:2016)
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 (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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 17523:2016(E)
© 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
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ii © ISO 2016 – All rights reserved
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 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
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
...
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