SIST EN ISO 21549-7:2024

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: +41 22 749 01 11
Email: copyright@iso.org
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 different types
of ISO document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 21549-7:2016), of which it constitutes a
minor revision.
The changes are as follows:
— update normative references;
— editorial update;
— correct errors in tables.
A list of all parts in the ISO 21549 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 21549-7:2024(en)
Introduction
With a more mobile population, greater healthcare delivery in the community and at patients’ homes,
together with a growing demand for improved quality of ambulatory care, portable information systems
and stores have increasingly been developed and used. Such devices are used for tasks ranging from
identification, through portable medical record files, and on to patient-transportable monitoring systems.
The functions of such devices are to carry and to transmit person-identifiable information between
themselves and other systems; therefore, during their operational lifetime they may share information with
many technologically different systems which differ greatly in their functions and capabilities.
Healthcare administration increasingly relies upon similar automated identification systems. For
instance, prescriptions may be automated and data exchange carried out at a number of sites using patient
transportable computer readable devices. Healthcare funding institutions and providers are increasingly
involved in cross-region care, where reimbursement may require automated data exchange between
dissimilar healthcare systems. Administrative data objects may require linkage to external parties
responsible for their own domains which are not within the scope of this document. For instance, cross-
border reimbursement of healthcare services is usually regulated by law and intergovernmental agreements.
The advent of remotely accessible databases and support systems has led to the development and use of
“Healthcare Person” identification devices that are also able to perform security functions and transmit
digital signatures to remote systems via networks.
With the growing use of data cards for practical everyday healthcare delivery, the need has arisen for a
standardized data format for interchange.
The person-related data carried by a data card can be categorized in three broad types: identification (of
the device itself and the individual to whom the data it carries relates), administrative and clinical. It is
important to realize that a given healthcare data card “de facto” contains device data and identification data
and may in addition contain administrative, clinical, medication and linkage data.
Device data are defined to include:
— identification of the device itself, and
— identification of the functions and functioning capabilities of the device.
Identification data may include unique identification of the device holder or of all other persons to whom the
data carried by the device are related.
Administrative data may include the following:
— complementary person(s) related data;
— identification of the funding of healthcare, whether public or private, and their relationships, i.e.
insurer(s), contract(s) and policy(ies) or types of benefits;
— other data (distinguishable from clinical data) that are necessary for the purpose of healthcare delivery.
Clinical data may include
— items that provide information about health and health events;
— their appraisal and labelling by a healthcare provider (HCP), and
— related actions planned requested or performed.
Medication data may include
— a record of medications purchased by the patient for self-administration,
— copies of prescriptions including the authority to dispense records of dispensed medications,

v
ISO 21549-7:2024(en)
— records of medications dispensed by a pharmacist to the patient, and
— pointers to other systems that contain information that hold medication data, either medication history
or prescribed medicines, (or both) and in the case of prescribed medicines, the authority to dispense.
Because a data card essentially provides specific answers to definite queries while having at the same time
a need to optimize the use of memory by avoiding redundancies, “high level” Object Modelling Technique
(OMT) has been applied with respect to the definition of healthcare data card data structures
Patient Data Cards may offer facilities to
— communicate prescription information from one healthcare professional to another healthcare
professional such as to a healthcare agent or healthcare organization, and
— provide indexes and/or authority to access prescription information held other than on the patient data
card.
vi
International Standard ISO 21549-7:2024(en)
Health informatics — Patient healthcard data —
Part 7:
Medication data
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.

ISO 21549-7:2024(en)
ISO 21549-2, Health informatics — Patient healthcard data — Part 2: Common objects
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
attribute
characteristic of an object or entity
3.2
batch
amount of material which is uniform in character and quantity as shown by compliance with production and
quality assurance test requirements and produced during a defined validated process of manufacture
3.3
coding scheme
collection of rules that maps the elements of one set onto the elements of a second set
[SOURCE: ISO/TS 21089:2018, 3.33]
3.4
data object
instance of some information object class (3.10), being composed of a set of fields which conform to the field
specifications of the class
3.5
dispenser
healthcare professional (3.9) which is a representation of an individual, professionally responsible for filling/
dispensing the prescription (3.21)
Note 1 to entry: This is usually the pharmacist but it can be other individuals according to local jurisdictions.
3.6
healthcare
care
activities, services or supplies related to the health of an individual
Note 1 to entry: This includes more than performing procedures for subjects of care. It includes, for example, the
management of information about patients, health status and relations within the healthcare framework.
[SOURCE: ISO 13940:2015, 3.1.1, modified — The preferred term “care” has been added; “care activities” has
been replaced by “activities”, “management or supplies” has been replaced by “supplies”; in Note 1 to entry
“healthcare delivery framework and may also include the management of clinical knowledge” has been
replaced by “healthcare framework”.]
3.7
healthcare data card
machine-readable card conformant to specific requirements intended for use within the healthcare domain
Note 1 to entry: The requirements are given in ISO/IEC 7810.
3.8
healthcare party
organization (3.15) or person involved in the direct or indirect provision of healthcare services to an
individual or to a population
ISO 21549-7:2024(en)
3.9
healthcare professional
person entrusted with the direct or indirect provision of defined healthcare services to a subject of care
(3.24) or a population of subjects of care
EXAMPLE Qualified medical practitioner, pharmacist, nurse, social worker, radiographer, medical secretary or
clerk.
3.10
information object class
set of fields, forming a template for the definition of a potentially unbounded collection of information
objects, the instances of the class
[SOURCE: ISO/IEC 8824-2:2021, 3.4.10, modified — Note 1 to entry has been removed.]
3.11
ingredient
substance (3.25) included as a component in a product
Note 1 to entry: In this context, product refers to pharmaceutical product (3.18).
3.12
magistral medicinal product
extemporaneous medicinal product
medicinal product (3.13) manufactured in a pharmacy or pharmacy department, which is based on a recipe
and intended to be used for one and only one subject of care (3.24)
Note 1 to entry: A magistral/extemporaneous medicinal product is also a pharmaceutical product (3.18).
3.13
medicinal product
substance (3.25) or combination of substances, which can be administered to human beings or animals for
treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify
physiological functions
Note 1 to entry: A medicinal product may contain one or more manufactured items and one or more pharmaceutical
products (3.18).
Note 2 to entry: In certain jurisdictions, a medicinal product is be defined as any substance or combination of
substances which can be used to make a medical diagnosis.
3.14
medicinal product package
delivery unit of a medicinal product (3.13) in an outer container (3.16)
3.15
organization
unique framework of authority within which a person or persons act, or are designated to act towards some
purpose
Note 1 to entry: Groupings or subdivisions of an organization may also be considered as organizations where there is
a need to identify them for information interchange.
3.16
outer container
container that serves as an external layer of a package
3.17
payment guarantor
organization (3.15) responsible for the total or partial reimbursement or payment of the price of the
medicinal product (3.13)
ISO 21549-7:2024(en)
3.18
pharmaceutical product
qualitative and quantitative composition of a medicinal product (3.13) in the dose form approved for
administration in line with the regulated product information
Note 1 to entry: A medicinal product may contain one or more pharmaceutical products.
Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item. However, there are
instances where the manufactured item must undergo a transformation before being administered to the patient (as
the pharmaceutical product) and the two are not equal.
[SOURCE: ISO 11616:2017, 3.1.24, modified — “administration” has been replaced by “administration in line
with the regulated product information”; a new note 1 to entry has been added, the original note 1 to entry
has become note 2 to entry.]
3.19
prescriber
healthcare professional (3.9) authorized to issue prescriptions (3.21)
3.20
prescribing
process of creating a prescription (3.21)
3.21
prescription
direction created by an authorized healthcare professional (3.9), to instruct a dispensing agent regarding the
preparation and use of a medicinal product (3.13) or medicinal appliance to be taken or used by a subject of
care (3.24)
3.22
prescription item
specification created by an authorized healthcare professional (3.9), to instruct a dispensing agent regarding
the preparation and use of single medicinal product (3.13)/medicinal appliance or to inform other parties
following dispensing regarding the preparation and use of a single dispensed medicinal product/medicinal
appliance
Note 1 to entry: A prescription item may contain administrative details needed for dispensing or derived from
dispensing, but does not contain information about the prescriber (3.19) or the subject of care (3.24) for whom the
prescription item is prescribed or to whom it has been dispensed.
3.23
prescription set
collection of one or more prescription item(s) (3.22) prescribed and/or dispensed as a unit
3.24
subject of care
person or defined group of persons receiving or registered as eligible to receive healthcare services or
having received healthcare services
3.25
substance
matter of defined composition that has discrete existence, whose origin may be biological, mineral or
chemical
Note 1 to entry: Substances can be either single substances mixture substances or one of a group of specified
substances. Single substances shall be defined using a minimally sufficient set of data elements divided into five types:
chemical, protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free
bases, mixtures of related compounds that are either isolated or synthesized together. Pharmacopoeial terminology
and defining characteristics will be used when available and appropriate. Defining elements are dependent on the
type of substance.
ISO 21549-7:2024(en)
Note 2 to entry: Discrete existence refers to the ability of a substance to exist independently of any other substance.
Substances can either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric
mixtures) or naturally-occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite molecular
structures or materials derived from plants, animals, microorganisms or inorganic matrices for which the chemical
structure may be unknown or difficult to define. Substances may be salts, solvates, free acids, free bases, mixtures of
related compounds that are either isolated or synthesized together.
[SOURCE: ISO 11238:2018, 3.84, modified — The original Note 1 to entry has been deleted, Notes 2 and 3 to
entry have been adapted.]
4 Abbreviated terms
ATC Anatomical Therapeutic Chemical Classification System
DEA Drug Enforcement Administration Registration Number
NCDCP National Council for Prescription Drug Programs
UML Unified Modelling Language
5 Basic data object model for a healthcare data card
5.1 Patient healthcard data object structure
A set of basic data objects have been designed to facilitate the storage of clinical data in a flexible structure,
allowing for future application specific enhancements. These tools should help the implementation of
common accessory characteristics of stored data in a way that allows efficient use of memory, an important
feature for many types of data cards.
The tools consist of a generic data structure based on an object-oriented model represented as an UML class
diagram as shown in Figure 1.
Figure 1 — Patient healthcard data — Overall structure
The content of this object-oriented structure is described both below and intrinsically will also require the
use of data objects not defined within this document.
It is recognized that medication data is semantically a type of “clinical data”. However, to enable more flexible
implementation approaches, it is modelled as a direct child of the PatientHealthcardData object allowing a
simpler and reduced model implementation where the full clinical data is not required.
NOTE It is possible to take the data objects and recombine them while preserving their context specific tags, and
to define new objects, while still preserving interoperability.

ISO 21549-7:2024(en)
In addition to the capability of building complex aggregate data objects from simpler building blocks, this
document allows for associations between certain objects, so that information can be shared. This feature
is mainly used to allow, for example, a set of accessory attributes to be used as services to several stored
information objects.
5.2 Basic data objects for referencing
5.2.1 Overview
A series of generally useful data type definitions have been made that have no underlying meaning in
themselves, but which are used to define other objects within this document. Operations may be performed
with these objects in association with other information objects to add usability or business purpose. These
objects have formal definitions within ISO 21549-2.
5.2.2 Coded data
Coded values are understood by reference to the coding system to which they apply. The general principle
in this document is that it is not mandatory to use a particular coding system, unless specified within this
document, when such codes act as parameters. One example is the use of the ISO 3166 series for country
codes.
When a coding scheme is exclusively specified within this document, no alternative coding scheme shall
be allowed. Any references to coding schemes not so specified may however be modified in the future
independent of the rest of this document.
The data object “CodedData” shall be constructed according to the definition contained in ISO 21549-2.
5.3 Device and data security attributes
Data stored in data cards used in health care may be personally sensitive. For this reason, this document
utilizes a series of security attributes, defined in ISO 21549-2. The actual data content (value) is not within
the scope of this document, nor are the mechanisms that make use of these data elements. It is emphasized
that the security attributes cannot satisfy given security requirements without the implementation of the
appropriate security functions and mechanisms within the data card.
Such rights of “access” are attributable to specific individuals with respect to discrete data items. These
rights will be defined by local jurisdictions, organizational policies and local legal frameworks and
implemented by application developers and can be controlled by automated systems such as health care
professional cards. The rights may be defined at the application level, thereby providing application and
potential country specificity.
The “SecurityServices” data object provides for the storage of data required to deliver these security
functions and mechanisms. This data can be “attached” to individual data elements, thereby preserving the
original author's security requirements when the data object is transferred between different forms of data
card. This mechanism may therefore ensure that in the process of transferring data from active to passive
media and then back to active media, the original security requirements are re-generated. This ability also
allows exact replication of a data card such as on regeneration after failure.
5.4 Accessory attributes
The data object “AccessoryAttributes” shall consist of an ordered set of data that is essential to record of the
resources which were accessed and/or used by whom regarding both the originator of the information and
the means via which it arrives to the recipient as defined in ISO 21549-2.

ISO 21549-7:2024(en)
6 Functional requirements on card information for prescriptions
6.1 Overview of supported uses
Healthcards may be considered useful in many different functions in relation to medicine prescriptions.
Two functions are for the identification of the patient and of the prescribing health professional toward the
prescribing system. These two uses are considered to be outside of this document.
The major consideration in this document is for cards to provide information to other health professionals
and to the patient or its non-professional care giver. However, the use for carrying a new prescription from
the prescriber to the dispenser/pharmacy are also considered in the design of its data sets.
6.2 Carry a prescription from prescriber to the dispenser
6.2.1 General
A healthcard designed to carry a prescription between a prescriber and dispenser has, within its data set,
to incorporate several different objects such as identifiers relating to the prescriber, dispensing agent,
subject of care and the actual information in relation to the prescribed item/items. Information relating to
the subject of care is considered to be static and provided/defined by other parts of the ISO 21549 series.
Similarly are Prescriber and Dispensing agent, while there may be several different iterations of the same,
these are essentially static and as such are covered by other parts of the ISO 21549 series.
6.2.2 Prescription set
A prescription issued for one patient by one prescriber at one occasion may contain several prescription
items for individual medicinal products. The collection of items with some additional information relevant
for all items is referred to as a prescription set.
6.2.3 Who
This is data relevant for the whole prescription set and has a series of specialisations of healthcare party.
Patient
This is the subject of care who is the intended recipient of a prescribed item.
NOTE For healthcards, only single patients are considered, not animals, nor groups of patients.
Prescriber
This is a specialization of a more generic concept that may be called a healthcare professional and is the
healthcare professional who takes legal responsibility for the creation of the prescription and for providing
the authority to dispense.
Payment guarantor
This is a specialization of healthcare party. These may be one or more insurance companies or other entity
that, in one way or another, is involved with financial aspects of the prescription.
NOTE This can include the patient as guarantor.
Dispenser
This is a specialization of a healthcare professional which is a representation of an individual who has a
pharmacist status who is filling/dispensing the prescription.

ISO 21549-7:2024(en)
6.2.4 What
These are the data relevant for a prescription item.
a) Name of the medicinal product:
— identified by brand name, generic name or code values for these (with reference to identification of code
set, if used);
— this may include also medicinal appliance whereas magistral (extemporaneous) medicinal products are
treated separately.
b) Strength;
c) Drug form;
d) Quantity;
e) Quantity units;
f) Manufacturer;
g) Code in respect to all above except possibly quantity units;
h) Magistral medicinal product.
6.2.5 Times
The followings are the points of time and intervals relevant for prescription and dispense:
a) time/date when a prescription is authorized;
b) time/date when a prescription is dispensed;
c) validity time (length of validity of prescription can be defined by legal framework of medicine supply
regulations);
d) specified interval between multiple supplies of the same medication (for example, “not less than 21 d
between supplies”).
6.2.6 How
The following information relates to a prescription item:
a) dosage instruction (plain text, CODED + numeric perhaps structure with time separate from amount);
b) comments of prescriber (to one item or the whole prescription);
c) special prescriptions (narcotics);
d) special license prescription;
e) substitution rules (if applicable in the local jurisdiction);
f) repeat prescription (no + possible time interval);
g) preferred language of the patient;
h) language of the prescription (these two refers to the prescription set).
6.3 Card information on dispensed prescriptions
Information on cards contains data on dispensed items. This information may be used at a future dispensing
occasion by a health professional, in particular when considering new prescriptions. It is worth noting

ISO 21549-7:2024(en)
that this information remains as confidential as other clinical data in that patients do not always fill their
prescriptions.
6.4 Medication notes
A major use of healthcards containing prescription information has been to create an accumulated list of
all medication for a patient and information relating to the safe use of medicines by the patient such as
sensitivities and allergies. This may result from the recording of dispensed prescription items, but it may
also be of interest to record medication when medicines are directly purchased/acquired by the patient.
There are many issues to consider here when a system is designed such as a history of prescriptions as
opposed to a list of current total medication from one or several prescribers and whether or not to remove
from the list what is not currently taken.
The users of this data are health professionals involved with a patient’s medication management or who
have a requirement to understand the medical history of the patient.
Finally, this information could be accessed by patients or their non-health professional caregivers and
thereby both be able to be used to inform but also aid them in decisions they may take.
7 Medication data
7.1 General
The MedicationData class is divided into four separate subclasses (see Figure 2):
— MedicationNotes;
— MedicationPrescriptions;
— MedicationsDispensed;
— MedicationReferences;
— MedicationDataStructureEdition.
Because of their groupings, each of these may have differing security settings including access rights as
determined by the provisions contained within their attached attributes.
Figure 2 — Structure of MedicationData
Individual entities within MedicationData are specified in Table 1.

ISO 21549-7:2024(en)
Table 1 — Specification of individual entities within MedicationData
Name Data type Multiplicity Comments
MedicationNotes Class 0.
...