EN ISO 21549-7:2016

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
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

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 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 World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO 21549-7:2007), which has been
technically revised with the following changes:
— medication notes definition in Clause 1 is modified;
— the list of definitions in Clause 3 is shortened and several definitions are corrected and clarified;
— the list of abbreviation in Clause 4 is shortened;
— an explanation is added in 5.1 why MedicationData is modelled as a direct child of the
PatientHealthcardData;
— “healthcare person” in 6.2.3 is replaced by “healthcare professional”;
— “factor of the quantity” in 6.2.4 is replaced by “quantity units”;
— “medication history” in 6.4 is changed to “medication notes” in the title and an explanation of a
major use is modified;
— in Clause 7, all the names of attributes in the tables are harmonized with the class diagrams. The
term “data object” is replaced by “class”. Additional comments are included in the tables. For
implementer’s convenience, the fragments of ASN.1 definitions are gathered together in the new
Annex A;
— explanation of MedicationNotes in 7.2.1 is modified;
— comments in Table 3 are modified;
— comments in Table 4 are modified;
— comments in Table 5 are modified;
— Example in 7.2.5 is moved to informative Annex B;
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ISO 21549-7:2016(E)
— Figures 7 and 8 are merged. Class “Prescriber” is defined as an attribute. The attribute
“qualification” is replaced by the attribute “qualifier” having datatype “CodedData”. The attribute
“medicinalProduct” is renamed as “prescribedMedicinalProduct”. The class “MedicinalProduct”
is renamed as “PrescribedMedicinalProduct”. The class “ManufacturedMedicinalProduct” is
renamed as “PrescribedManufacturedMedicinalProduct”. The class “MagistralMedicinalProduct”
is renamed as “PrescribedMagistralMedicinalProduct”. Datatype of the attribute “strength”
is replaced by “Strength”, the definition of this new datatype is added. Datatype of the
attribute “quantityOfMedicinalProduct” is replaced by “Quantity”. Datatype of the attribute
“amountOfIngredient” is replaced by “Amount”. The class “AmountOfIngredient” is replaced by the
class “Amount”;
— Figures 17 and 18 are merged. Class “Dispenser” is defined as an attribute. The attribute
“dispensedMedicinalCode” is replaced by the attribute “dispensedMedicinalProduct” having
new datatype “DispensedMedicinalProduct”. This new datatype is a generalization of the classes
“DispensedManufacturedMedicinalProduct” and “DispensedMagistralMedicinalProduct”. The
attributes “strength”, “form”, manufacturerOfMedicinalProduct” are moved from the class
“ActualDispensedItem” to the class “DispensedManufacturedMedicinalProduct”. The attributes
“batchIdentifier”, “genericSubstitution” are moved from the class “DispensingInformation” to the
class “DispensedManufacturedMedicinalProduct”. Datatype of the attribute “quantityDispensed”
is replaced by “QuantityToDispense”, so the class “QuantityDispensed” becomes unused and is
deleted. The attributes “magistralMedicinalProductName” and “dispensedQuantity” are added
to the class “DispensedMagistralMedicinalProduct”. The attribute “nameOfIngredient” is deleted
from the class “DispensedIngredient”. Datatype of the attribute “quantityOfIngredient” is
replaced by “Amount”. The attribute “nameOfContainerOrApplicationAid” is deleted from the class
“DispensedContainerOrApplicationAid”;
— Figures 26 and 27 are merged;
— new ASN.1 definition is added in Annex A.
A list of all parts in the ISO 21549 series can be found on the ISO website.
ISO 21549-7:2016(E)
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 insurers and providers are increasingly
involved in cross-region care, where reimbursement may require automated data exchange between
dissimilar healthcare systems.
The advent of remotely accessible databases and support systems has led to the development and use
of “Healthcare Professional” 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” has to contain device data and
identification data and may, in addition, contain administrative, clinical, medication and linkage data.
Device data is 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 health care, 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,
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ISO 21549-7:2016(E)
— 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.
INTERNATIONAL STANDARD ISO 21549-7:2016(E)
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, even
though they are referenced and utilized within this document.
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 21549-7:2016(E)
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 terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp/
NOTE There are many different terms used to describe the basic concepts in healthcare for different
purposes available from ISO, CEN, HL7 and various national organizations. The following definitions are not
meant to be universal in ISO work in health informatics, only to facilitate the understanding of this document.
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
[SOURCE: EN 375:1992 E, EN 376:1992 E]
3.3
coding scheme
collection of rules that maps the elements of one set onto the elements of a second set
[SOURCE: ISO 21089:2004, 3.25]
3.4
data object
information object
instance of some information object class (3.11), being composed of a set of fields which conform to the
field specifications of the class
[SOURCE: ISO/IEC 8824-2:2015, 3.4.9]
3.5
dispenser
healthcare professional (3.9) which is a representation of an individual, professionally responsible for
filling/dispensing the prescription (3.22)
Note 1 to entry: This is usually the pharmacist, but may be other individuals according to local jurisdiction.
3.6
healthcare
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 healthcare framework.
Note 2 to entry: In this document, the term “care” is to be understood as a synonym for “healthcare”.
[SOURCE: ISO 13940:2015, 3.1.1, modified]
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ISO 21549-7:2016(E)
3.7
healthcare data card
machine-readable card conformant to ISO/IEC 7810 intended for use within the healthcare domain
3.8
healthcare party
organization (3.16) or person involved in the direct or indirect provision of healthcare services to an
individual or to a population
[SOURCE: ENV 13607]
3.9
healthcare professional
person entrusted with the direct or indirect provision of defined healthcare services to a subject of care
(3.25) or a population of subjects of care
EXAMPLE Qualified medical practitioner, pharmacist, nurse, social worker, radiographer, medical secretary
or clerk.
[SOURCE: ENV 1613]
3.10
immediate container
container that is in direct contact with the pharmaceutical product (3.19)
[SOURCE: ENV 12610]
3.11
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 8824-2:2015, 3.4.10]
3.12
ingredient
substance (3.26) included as a component in a product
Note 1 to entry: In this context, product refers to pharmaceutical product (3.19).
[SOURCE: ENV 13607]
3.13
magistral medicinal product
extemporaneous medicinal product
medicinal product (3.14) 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 (3.25)
Note 1 to entry: A magistral/extemporaneous medicinal product is also a pharmaceutical product (3.19).
[SOURCE: ENV 12610, ENV 13607, modified]
3.14
medicinal product
substance (3.26) or combination of substances, which may 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 (3.19).
Note 2 to entry: In certain jurisdictions, a medicinal product may also be defined as any substance or combination
of substances which may be used to make a medical diagnosis.
ISO 21549-7:2016(E)
[SOURCE: ENV 13607, ENV 12610]
3.15
medicinal product package
delivery unit of a medicinal product (3.14) in an outer container (3.17)
[SOURCE: ENV 12610]
3.16
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.
3.17
outer container
container that serves as an external layer of a package
[SOURCE: ENV 12610]
3.18
payment guarantor
organization (3.16) responsible for the total or partial reimbursement or payment of the price of the
medicinal product (3.14)
[SOURCE: ENV 13607]
3.19
pharmaceutical product
qualitative and quantitative composition of a medicinal product (3.14) 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 11616:2012, 3.1.20, modified]
3.20
prescriber
healthcare professional (3.9) authorized to issue prescriptions (3.22)
[SOURCE: ENV 13607]
3.21
prescribing
process of creating a prescription (3.22)
[SOURCE: ENV 13607]
3.22
prescription
direction created by an authorized healthcare professional (3.9), to instruct a dispensing agent regarding
the preparation and use of a medicinal product (3.14) or medicinal appliance to be taken or used by a
subject of care (3.25)
[SOURCE: ENV 13607]
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ISO 21549-7:2016(E)
3.23
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 (3.14)/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 (3.20) or the subject of care (3.25) for whom
the prescription item is prescribed or to whom it has been dispensed.
[SOURCE: ENV 13607]
3.24
prescription set
collection of one or more prescription item(s) (3.23) prescribed and/or dispensed as a unit
[SOURCE: ENV 13607]
3.25
subject of care
person or defined group of persons receiving or registered as eligible to receive healthcare services or
having received healthcare services
[SOURCE: ENV 12443]
3.26
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.
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 synthesised together.
[SOURCE: ISO 11238:2012, 2.1.58]
4 Abbreviated terms
ATC Anatomical Therapeutic Chemical Classification System
DEA Drug Enforcement Administration Registration Number
ENV European Prestandard
NCDCP National Council for Prescription Drug Programs
UML Unified Modelling Language
ISO 21549-7:2016(E)
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.
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 ISO 3166 for
country codes.
6 © ISO 2016 – All rights reserved

ISO 21549-7:2016(E)
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 emphasised 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.
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 ISO 21549.
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 ISO 21549.
ISO 21549-7:2016(E)
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, we are only considering one person, not animals, nor groups of patients.
Prescriber
This is a specialization of a more generic concept that may be called a healthcare professional (see
Clause 3) 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 (see Clause 3).
6.2.4 What
These are the data relevant for a prescription item.
a) Name of the medicinal product (see Clause 3):
— 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 (synonym: “extemporaneous product”)
8 © ISO 2016 – All rights reserved

ISO 21549-7:2016(E)
6.2.5 Times
The followingh 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 may 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
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