ISO/FDIS 21549-5
(Main)Health informatics — Patient healthcard data — Part 5: Identification data
Health informatics — Patient healthcard data — Part 5: Identification data
ISO 21549-5:2015 describes and defines the basic structure of the identification data objects held on healthcare data cards, but does not specify particular data sets for storage on devices. The detailed functions and mechanisms of the following services are not within the scope of this part of ISO 21549 (although its structures can accommodate suitable data objects elsewhere specified): - security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions; - access control services; - the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this part of ISO 21549). The following topics are therefore beyond the scope of this part of ISO 21549: - physical or logical solutions for the practical functioning of particular types of data card; - the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.
Informatique de santé — Données relatives aux cartes de santé des patients — Partie 5: Données d'identification
L'ISO 21549-5:2015 définit et décrit la structure de base des objets associés aux données d'identification se trouvant sur les cartes de santé, mais ne spécifie pas de jeu de données particulier pour le stockage sur la carte. Les fonctions et les mécanismes détaillés des services ci-après ne relèvent pas du domaine d'application de la présente partie de l'ISO 21549 (bien que ces structures puissent prendre en charge des objets de cette nature, spécifiés par ailleurs): ? les fonctions de sécurité et les services associés susceptibles d'être spécifiés par les utilisateurs de cartes de données selon leurs applications spécifiques, par exemple la protection des données confidentielles, la protection de l'intégrité des données et l'authentification des personnes et les dispositifs liés à ces fonctions; ? les services de contrôle de l'accès; ? l'initialisation et le processus qui en découle (qui débute la durée de vie d'une carte individuelle et par lequel la carte de données est préparée pour les données qui seront communiquées ultérieurement, conformément à la présente partie de l'ISO 21549). Les sujets suivants sont donc en dehors du domaine d'application de la présente partie de l'ISO 21549: ? les solutions physiques ou logiques pour le fonctionnement de type de cartes particulières; ? la forme que prennent les données pour leur utilisation en dehors de la carte ou la manière de représenter visuellement ces données sur la carte ou ailleurs.
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ISO/FDIS 21549-5:202x(X2023(E)
ISO TC 215/ WG 4
Date: 2023-04-10
Secretariat: ANSI
Health informatics — Patient healthcard data — Part 5: Identification data
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This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
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Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
A model manuscript of a draft International Standard (known as “The Rice Model”) is available at
© ISO #### – All rights reserved
---------------------- Page: 1 ----------------------
© ISO 20XX
Third edition
Date: 2023-05-24
---------------------- Page: 2 ----------------------
ISO/FDIS 21549-5:2023(E)
© ISO 2023
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’sISO'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 copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/FDIS 21549-5:2023(E)
Contents
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 2
5 Identification data objects . 2
5.1 Identification objects and data structure . 2
5.2 Definition of the identification data set . 2
Annex A (normative) ASN.1 Data definitions . 5
Bibliography . 7
© ISO 2023 – All rights reserved iii
---------------------- Page: 4 ----------------------
ISO/FDIS 21549-5:2023(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 documentsdocument 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 drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse 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. 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 ).
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, Medical
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 21549-5:2015), of which has been
technically revised.
it constitutes a minor revision. The main changes are as follows:
— updated normative references have been updated;
— errors have been corrected errors in Annex A.
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 2023 – All rights reserved
---------------------- Page: 5 ----------------------
ISO/FDIS 21549-5:2023(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 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 maycan require linkage to external
parties responsible for their own domains which are not within the scope of this part of ISO
21549.document. For instance, cross-border reimbursement of healthcare services are usually regulated
by law and intergovernmental agreements which are not subject to standardization.
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 categorised 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;
— identification of the functions and functioning capabilities of the device.
Identification data are defined to include:
— unique identification of the device holder (and not information of other persons).
Administrative data can include:
— 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;
— identification of other persons as a part of the insurance contract (e.g. a family contract);
— 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;
© ISO 2023 – All rights reserved v
---------------------- Page: 6 ----------------------
ISO/FDIS 21549-5:2023(E)
— their appraisal and labelling by a healthcare provider;
— related actions planned requested or performed.
Medication data maycan include:
— a record of medications received or taken by the patient;
— copies of prescriptions including the authority to dispense records of dispensed medication;
— records of medication bought by the patient;
— pointers to other systems that contain information that makes up an electronic prescription and the
authority to dispense.
BecauseAs 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
Modelingmodelling technique (OMT) has been applied with respect to the definition of healthcare data
card data structures.
This part of ISO 21549document describes and defines the basic structure of the identification data
objects held on healthcare data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
This part of ISO 21549document does not describe and defineestablish the common objects defined
within ISO 21549-2 even though they are referenced and utilized within this part of ISO 21549document.
vi © ISO 2023 – All rights reserved
---------------------- Page: 7 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 21549-5:2023(E)
Health informatics — Patient healthcard — Part 5: Identification
data)
1 Scope
This part of ISO 21549document describes and defines the basic structure of the identification data
objects held on healthcare data cards, but it does not specify particular data sets for storage on devices.
This document does not apply to the detailed functions and mechanisms of the following services are not
within the scope of this part of ISO 21549 (although its structures can accommodate suitable data objects
elsewhere specified):
— security functions and related services that are likely to be specified by users for data cards
depending on their specific application, e.g. confidentiality protection, data integrity protection and
authentication of persons and devices related to these functions;
— access control services;
— the initialization and issuing process (which begins the operating lifetime of an individual data card,
and by which the data card is prepared for the data to be subsequently communicated to it according
to this part of ISO 21549document).
The following topics are therefore beyond the scope of this part of ISO 21549document:
— physical or logical solutions for the practical functioning of particular types of data card;
— the forms that data take for use outside the data card, or the way in which such data are visibly
represented on the data card or elsewhere.
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 3166-1,/IEC 5218, Information technology — Codes for the representation of names of countries and
their subdivisions — Part 1: Country codeshuman sexes
ISO 8601, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 21549--1, Health informatics — Patient healthcard data — Part 1: General structure
ISO 21549-2, Health informatics — Patient healthcard data — Part 2: Common objects
ISO/IEC 5218, Information technology — Codes for the representation of human sexes
ISO/IEC 8824-1, Information technology — Abstract Syntax Notation One (ASN.1) — Part 1: Specification
of basic notation
© ISO 2023 – All rights reserved 1
---------------------- Page: 8 ----------------------
ISO/FDIS 21549-5:2023(E)
ISO/IEC 8825-1, Information technology — ASN.1 encoding rules — Part 1: Specification of Basic
Encoding Rules (BER), Canonical Encoding Rules (CER) and Distinguished Encoding Rules (DER)
ISO/IEC 10646, Information technology — Universal Coded Character Set (UCS)
83 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 21549-1 and the following
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.o
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21549-5
ISO/TC 215
Health informatics — Patient
Secretariat: ANSI
healthcard data —
Voting begins on:
2023-06-07
Part 5:
Voting terminates on:
Identification data
2023-08-30
Informatique de santé — Données relatives aux cartes de santé des
patients —
Partie 5: Données d'identification
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 21549-5:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 21549-5:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 21549-5
ISO/TC 215
Health informatics — Patient
Secretariat: ANSI
healthcard data —
Voting begins on:
Part 5:
Voting terminates on:
Identification data
Informatique de santé — Données relatives aux cartes de santé des
patients —
Partie 5: Données d'identification
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
ISO/CEN PARALLEL PROCESSING
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 21549-5:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
ISO/FDIS 21549-5:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms.2
5 Identification data objects . 2
5.1 Identification objects and data structure. 2
5.2 Definition of the identification data set . 2
Annex A (normative) ASN.1 Data definitions . 5
Bibliography . 8
iii
© ISO 2023 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/FDIS 21549-5:2023(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 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, Medical
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 21549-5:2015), of which it constitutes a
minor revision. The changes are as follows:
— normative references have been updated;
— errors have been corrected in Annex A.
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 2023 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 21549-5:2023(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 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 can 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 are usually regulated by law and
intergovernmental agreements which are not subject to standardization.
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 categorised 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;
— identification of the functions and functioning capabilities of the device.
Identification data are defined to include:
— unique identification of the device holder (and not information of other persons).
Administrative data can include:
— 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;
— identification of other persons as a part of the insurance contract (e.g. a family contract);
— 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;
— related actions planned requested or performed.
v
© ISO 2023 – All rights reserved
---------------------- Page: 5 ----------------------
ISO/FDIS 21549-5:2023(E)
Medication data can include:
— a record of medications received or taken by the patient;
— copies of prescriptions including the authority to dispense records of dispensed medication;
— records of medication bought by the patient;
— pointers to other systems that contain information that makes up an electronic prescription and the
authority to dispense.
As 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.
This document describes and defines the basic structure of the identification data objects held on
healthcare data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
This document does not establish the common objects defined within ISO 21549-2 even though they
are referenced and utilized within this document.
vi
© ISO 2023 – All rights reserved
---------------------- Page: 6 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 21549-5:2023(E)
Health informatics — Patient healthcard data —
Part 5:
Identification data
1 Scope
This document describes and defines the basic structure of the identification data objects held on
healthcare data cards, but it does not specify particular data sets for storage on devices.
This document does not apply to the detailed functions and mechanisms of the following services
(although its structur
...
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