EN ISO 21549-7:2024

Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2024)

This document 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.
This document 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.
This document 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).
This document does not describe nor define the common objects defined within ISO 21549-2.

Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 7: Medikationsdaten (ISO 21549-7:2024)

Informatique de santé - Données relatives aux cartes de santé des patients - Partie 7: Données de médication (ISO 21549-7:2024)

Le présent document 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.
Le présent document 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.
Le présent document 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.
Les données de médication comprennent les quatre composants suivants:
—     notes de médication: informations supplémentaires concernant la médication et l'utilisation en toute sécurité des médicaments par le patient, telles que l'historique des médications, les sensibilités et les allergies;
—     prescriptions médicamenteuses: pour transporter une nouvelle prescription du prescripteur à l'agent délivrant/pharmacien;
—     médication délivrée: enregistrements des médications délivrées au patient;
—     références de médication: des liens vers d'autres systèmes contenant les informations constitutives d'une prescription médicamenteuse et l'autorisation de dispensation.
Par conséquent, les sujets suivants ne relèvent pas du domaine d'application du présent document:
—     solutions physiques ou logiques pour le fonctionnement pratique de types particuliers de cartes de données;
—     modalités de traitement du message «en aval» de l'interface entre deux systèmes;
—     forme que prennent les données lorsqu'elles sont utilisées indépendamment de la carte de données ou manière dont ces données sont représentées visuellement sur la carte de données ou ailleurs.
NOTE            Non seulement la définition de «médicaments» diffère d'un pays à l'autre mais également, dans certains pays, la même désignation peut être associée à des produits totalement différents. Par conséquent, il est important de prendre en considération la sécurité du patient lorsque la carte est utilisée à l'étranger.
Le présent document décrit et définit les objets de données de médication utilisés dans le cadre de ou référencés par les cartes de données de santé des patients au moyen du langage UML, de texte en clair et de la Notation Syntaxique Abstraite (ASN.1).
Ce document ne décrit ni ne définit les objets communs définis dans l'ISO 21549-2.

Zdravstvena informatika - Podatki o pacientu na zdravstveni kartici - 7. del: Podatki o zdravilih (ISO 21549-7:2024)

Standard ISO 21549-7:2016 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.
Standard ISO 21549-7:2016 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.
Uporabljati ga je mogoče 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 pacienta, 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 izdelki« med posameznimi državami razlikuje, se lahko isti izraz v nekaterih državah navezuje na povsem različne izdelke. Zaradi tega je pri uporabi kartice v drugih državah pomembno upoštevati varnost pacienta.
Standard ISO 21549-7:2016 opisuje in opredeljuje objekte podatkov o zdravilih, ki se uporabljajo na zdravstvenih podatkovnih karticah v lasti pacientov ali so na njih in uporabljajo označevanje UML, navadno besedilo in abstraktno skladnjo (ASN.1).
Standard ISO 21549-7:2016 ne opisuje in ne določa običajnih objektov, opredeljenih v standardu ISO 21549-2, čeprav so navedeni in uporabljeni v tem dokumentu.

General Information

• Status: Published
• Publication 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
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 21-Feb-2024
• Completion Date: 21-Feb-2024
• Ref Project: SIST EN ISO 21549-7:2024 - Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2024)

Relations

• Replaces: EN ISO 21549-7:2016 - Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2016)
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2024
Nadomešča:
SIST EN ISO 21549-7:2017
Zdravstvena informatika - Podatki o pacientu na zdravstveni kartici - 7. del:
Podatki o zdravilih (ISO 21549-7:2024)
Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-
7:2024)
Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 7:
Medikationsdaten (ISO 21549-7:2024)
Informatique de santé - Données relatives aux cartes de santé des patients - Partie 7:
Données de médication (ISO 21549-7:2024)
Ta slovenski standard je istoveten z: EN ISO 21549-7:2024
ICS:
35.240.15 Identifikacijske kartice. Čipne Identification cards. Chip
kartice. Biometrija 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
February 2024
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 21549-7:2016
English Version
Health informatics - Patient healthcard data - Part 7:
Medication data (ISO 21549-7:2024)
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 21549-7:2024) 21549-7:2024)
This European Standard was approved by CEN on 19 January 2024.

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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21549-7:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21549-7:2024) 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 August 2024, and conflicting national standards shall
be withdrawn at the latest by August 2024.
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 21549-7:2016.
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 21549-7:2024 has been approved by CEN as EN ISO 21549-7:2024 without any
modification.
International
Standard
ISO 21549-7
Third edition
Health informatics — Patient
2024-02
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 21549-7:2024(en) © ISO 2024

ISO 21549-7:2024(en)
© ISO 2024
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 21549-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
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 . 5
5.1 Patient healthcard data object structure .5
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 .6
5.4 Accessory attributes . .6
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 .7
6.2.3 Who .7
6.2.4 What .8
6.2.5 Times.8
6.2.6 How.8
6.3 Card information on dispensed prescriptions .8
6.4 Medication notes .9
7 Medication data. 9
7.1 General .9
7.2 "MedicationNotes" class .10
7.2.1 General .10
7.2.2 “MedicationHistory” class .11
7.2.3 “MedicationRelevantCharacteristics” class . 13
7.2.4 “KnownMedicationRisks” class . 13
7.3 "MedicationPrescriptions" class .14
7.4 "MedicationsDispensed" data object . 23
7.5 MedicationReferences . 29
Annex A (normative) ASN.1 data definitions .31
Annex B (informative) Example of medication notes .40
Bibliography .42

iii
ISO 21549-7:2024(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 d
...