EN ISO 21549-7:2016

Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2016)

ISO 21549-7:2016 applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
ISO 21549-7:2016 specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
-      medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
-      medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
-      medication dispensed: the records of medications dispensed for the patient;
-      medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
-      physical or logical solutions for the practical functioning of particular types of data cards;
-      how the message is processed further "downstream" of the interface between two systems;
-      the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE          Not only does the definition of "medicinal products" differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
ISO 21549-7:2016 describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
ISO 21549-7:2016 does not describe nor define the common objects defined within ISO 21549-2, even though they are referenced and utilized within this document.

Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 7: Medikationsdaten (ISO 21549-7:2016)

Informatique de santé - Données relatives aux cartes de santé des patients - Partie 7: Données de médication (ISO 21549-7:2016)

L'ISO 21549-7 :2016 s'applique aux situations dans lesquelles des données sont enregistrées sur ou transportées par des cartes de santé des patients conformes aux dimensions physiques des cartes ID-1 définies par l'ISO/IEC 7810.
L'ISO 21549-7 :2016 spécifie la structure de base des données contenues dans l'objet de données de médication, sans toutefois spécifier ou recommander des ensembles de données particuliers destinés à être stockés sur des dispositifs.
L'ISO 21549-7 :2016 a pour objet de définir des cartes qui fournissent des informations aux autres professionnels de santé et au patient ou à son soignant non professionnel.
Il peut également être utilisé pour transporter une nouvelle prescription du prescripteur à l'agent délivrant/pharmacien dans le cadre de la définition de ses ensembles.

Zdravstvena informatika - Podatki o pacientu na zdravstveni kartici - 7. del: Podatki o zdravilih (ISO 21549-7:2016)

Ta dokument se uporablja za situacije, kjer se takšni podatki zapišejo na zdravstvene kartice pacientov, skladne s fizičnimi merami kartic ID-1, kot jih določa ISO/IEC 7810, oziroma se podatki prenašajo na tak način.
Ta dokument navaja osnovne strukture podatkov, ki so vsebovani v objektu podatkov o zdravilih,
vendar ne navaja ali določa specifičnih naborov podatkov za shranjevanje v napravah.
Namen tega dokumenta je zagotoviti, da se s karticami posredujejo informacije drugim zdravstvenim delavcem in pacientu ali njegovemu nepoklicnemu negovalcu.
Uporablja se lahko tudi za prenos novega recepta od osebe, ki ga je predpisala, do ustrezne osebe/lekarne pri oblikovanju njegovih nizov.
Podatki o zdravilih vključujejo štiri komponente:
– opombe glede zdravil: dodatne informacije v zvezi z zdravili in njihovo varno uporabo s strani
bolnika, kot so zgodovina predpisanih zdravil, občutljivosti in alergije;
– recepti za zdravila: za prenos novega recepta od osebe, ki ga je predpisala, do ustrezne osebe/lekarne;
– posredovanje zdravil: zapisi o zdravilih, posredovanih pacientu;
– reference za zdravila: kazalniki proti drugim sistemom, ki vsebujejo informacije za določitev recepta za zdravila in organa za posredovanje zdravil.
Naslednje teme ne spadajo na področje uporabe tega dokumenta:
– fizične in logične rešitve za praktično delovanje določenih vrst podatkovnih kartic;
– način nadaljnje obdelave sporočila pod vmesnikom med dvema sistemoma;
– oblika, v kateri so podatki za uporabo zunaj podatkovne kartice, ali način, kako so ti podatki vidno predstavljeni na podatkovni kartici ali drugje.
OPOMBA: Poleg tega, da se definicija izraza »medicinski proizvodi« razlikuje med posameznimi državami, se lahko isti izraz v nekaterih državah nanaša na povsem različne proizvode. Zaradi tega je pri uporabi kartice v drugih državah pomembno upoštevati varnost pacienta.
Ta dokument opisuje in opredeljuje objekte podatkov o zdravilih, ki se uporabljajo na podatkovnih karticah pacientov ali so na njih in uporabljajo označevanje UML, navadno besedilo ali abstraktno skladnjo (ASN.1).
Ta dokument ne opisuje in ne določa običajnih objektov, opredeljenih v standardu ISO 21549-2,
čeprav so navedeni in uporabljeni v tem dokumentu.

General Information

• Status: Withdrawn
• Publication Date: 13-Dec-2016
• Withdrawal Date: 20-Feb-2024
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 2 - Terminology and knowledge representation
• Mandate: M/255 - Standardization mandate to CEN, CENELEC and ETSI in the field of health care informatics
• Ref Project: SIST EN ISO 21549-7:2017 - Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2016)

Relations

• Replaces: EN ISO 21549-7:2007 - Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2007)
• Effective Date: 21-Dec-2016
• Replaced By: EN ISO 21549-7:2024 - Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2024)
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2017
1DGRPHãþD
SIST EN ISO 21549-7:2008
Zdravstvena informatika - Podatki o pacientu na zdravstveni kartici - 7. del:
Podatki o zdravilih (ISO 21549-7:2016)
Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-
7:2016)
Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 7:
Medikationsdaten (ISO 21549-7:2016)
Informatique de santé - Données relatives aux cartes de santé des patients - Partie 7:
Données de médication (ISO 21549-7:2016)
Ta slovenski standard je istoveten z: EN ISO 21549-7:2016
ICS:
35.240.15 ,GHQWLILNDFLMVNHNDUWLFHýLSQH Identification cards. Chip
NDUWLFH%LRPHWULMD cards. Biometrics
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 21549-7
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2016
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 21549-7:2007
English Version
Health informatics - Patient healthcard data - Part 7:
Medication data (ISO 21549-7:2016)
Informatique de santé - Données relatives aux cartes Medizinische Informatik - Patientendaten auf Karten
de santé des patients - Partie 7: Données de médication im Gesundheitswesen - Teil 7: Medikationsdaten (ISO
(ISO 21549-7:2016) 21549-7:2016)
This European Standard was approved by CEN on 12 December 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 21549-7:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21549-7:2016) 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 June 2017, and conflicting national standards shall be
withdrawn at the latest by June 2017.
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.
This document supersedes EN ISO 21549-7:2007.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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 21549-7:2016 has been approved by CEN as EN ISO 21549-7:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 21549-7
Second edition
2016-12-01
Health informatics — Patient
healthcard data —
Part 7:
Medication data
Informatique de santé — Données relatives aux cartes de santé des
patients —
Partie 7: Données de médication
Reference number
ISO 21549-7:2016(E)
©
ISO 2016
ISO 21549-7:2016(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
the requester.
ISO copyright office
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Tel. [phone]
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ii © ISO 2016 – All rights reserved

ISO 21549-7:2016(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviated terms . 5
5 Basic data object model for a healthcare data card . 6
5.1 Patient healthcard data object structure . 6
5.2 Basic data objects for referencing . 6
5.2.1 Overview . 6
5.2.2 Coded data . 6
5.3 Device and data security attributes . 7
5.4 Accessory attributes . 7
6 Functional requirements on card information for prescriptions .7
6.1 Overview of supported uses . 7
6.2 Carry a prescription from prescriber to the dispenser . 7
6.2.1 General. 7
6.2.2 Prescription set . 8
6.2.3 Who . 8
6.2.4 What . 8
6.2.5 Times . . 9
6.2.6 How . 9
6.3 Card information on dispensed prescriptions . 9
6.4 Medication notes . 9
7 Medication data .10
7.1 General .10
7.2 “MedicationNotes” class.11
7.2.1 General.11
7.2.2 “MedicationHistory” class .12
7.2.3 “MedicationRelevantCharacteristics” class .13
7.2.4 “KnownMedicationRisks” class .14
7.3 “MedicationPrescriptions” class .15
7.4 “MedicationsDispensed” data object .23
7.5 MedicationReferences .30
Annex A (normative) ASN.1 data definitions .32
Annex B (informative) Example of medication notes .48
Bibliography .50
ISO 21549-7:2016(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 declar
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