SIST EN ISO 21549-5:2024

• Abstract:

  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 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 document).; Therefore, this document does not cover:; — 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.

• Status: Published
• Public Enquiry End Date: 13-Jul-2023
• Publication Date: 28-Feb-2024
• ICS: 35.240.15 - Identification cards. Chip cards. Biometrics
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-Feb-2024
• Due Date: 19-Apr-2024
• Completion Date: 29-Feb-2024
• Ref Project: EN ISO 21549-5:2023 - Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2023)

• Replaces: SIST EN ISO 21549-5:2016 - Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2015)
• Effective Date: 01-Apr-2024

Overview

SIST EN ISO 21549-5:2024 specifies the basic structure of identification data objects stored on healthcare data cards, ensuring consistency and interoperability in health informatics. Developed by the Slovenski inštitut za standardizacijo (SIST) and aligned with ISO 21549-5:2023, this standard focuses on the foundational data structures necessary for uniquely identifying patients via healthcards. Adoption of this standard supports more efficient healthcare data exchange, improved patient safety, and accurate identification across varied health information systems.

Key Topics

• Healthcare Data Card Structure: Defines how identification data should be organized and represented on healthcare data cards.
• Identification Data Objects: Details the components required to uniquely identify an individual, including person name, date of birth, identifier, sex, nationality, place of birth, address, and telephone number.
• International Interoperability: Supports use of standardized data object definitions and coding schemes to facilitate compatibility across regional and national borders.
• Data Encoding: Specifies the use of international character encodings (UTF8), enabling multilingual support and flexible data representation.
• Exclusions: Does not address security mechanisms, access control, or device initialization and personalization processes. Also, it does not specify the appearance or representation of data outside the data card itself.

Applications

The application of SIST EN ISO 21549-5:2024 plays a vital role in the digital transformation of health services and healthcare administration:

• Patient Identification in Healthcare IT Systems: Enables consistent, reliable identification of individuals across clinics, hospitals, and pharmacies, enhancing patient safety and care continuity.
• Cross-Border Health Data Exchange: Facilitates secure and accurate patient identification for international healthcare provision, including insurance claims and reimbursement.
• Integration with Health Information Management (HIM): Supports seamless data transfer between patient healthcards and electronic health record (EHR) systems.
• Personalized Medicine and Mobile Healthcare: Forms the basis for portable and secure patient identification in emerging eHealth and telehealth applications.
• Regulatory Compliance and Standardization: Helps healthcare organizations comply with local and international regulations on patient data management and interoperability.

Related Standards

For a holistic approach to healthcare data card standardization, consider these related standards:

• ISO 21549-1: Health informatics – Patient healthcard data – Part 1: General structure
  Provides general requirements and an overview of the data structure for patient healthcards.

• ISO 21549-2: Health informatics – Patient healthcard data – Part 2: Common objects
  Defines shared data objects used across multiple parts of the standard.

• ISO 21549-6: Health informatics – Patient healthcard data – Part 6: Administrative data
  Focuses on additional administrative data objects that can be stored on healthcare cards.

• ISO/IEC 7816-6: Identification cards – Integrated circuit cards – Interindustry data elements for interchange
  Details essential data elements for chip card applications in different domains.

• ISO/IEC 5218: Information technology – Codes for the representation of human sexes
  Used for encoding gender information as part of patient identification data.

• ISO/IEC 10646: Universal Coded Character Set (UCS)
  Specifies character encoding standards underlying international name and address fields.

By adhering to SIST EN ISO 21549-5:2024, healthcare providers, IT system developers, and card issuers benefit from a robust and consistent patient identification framework. This supports safer care delivery, smoother data exchange, and compliance with recognized international health informatics practices.

SLOVENSKI STANDARD
01-april-2024
Nadomešča:
SIST EN ISO 21549-5:2016
Zdravstvena informatika - Podatki o pacientu na zdravstveni kartici - 5. del:
Identifikacijski podatki (ISO 21549-5:2023)
Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-
5:2023)
Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 5:
Identifikationsdaten (ISO 21549-5:2023)
Informatique de santé - Données relatives aux cartes de santé des patients Partie 5:
Données d'identification (ISO 21549-5:2023)
Ta slovenski standard je istoveten z: EN ISO 21549-5:2023
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 21549-5
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 21549-5:2016
English Version
Health informatics - Patient healthcard data - Part 5:
Identification data (ISO 21549-5:2023)
Informatique de santé - Données relatives aux cartes Medizinische Informatik - Patientendaten auf Karten
de santé des patients ¿ Partie 5: Données im Gesundheitswesen - Teil 5: Identifikationsdaten
d'identification (ISO 21549-5:2023) (ISO 21549-5:2023)
This European Standard was approved by CEN on 1 October 2023.

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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21549-5:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21549-5:2023) 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 May 2024, and conflicting national standards shall be
withdrawn at the latest by May 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 21549-5:2016.
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 21549-5:2023 has been approved by CEN as EN ISO 21549-5:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 21549-5
Third edition
2023-10
Health informatics — Patient
healthcard data —
Part 5:
Identification data
Informatique de santé — Données relatives aux cartes de santé des
patients —
Partie 5: Données d'identification
Reference number
ISO 21549-5:2023(E)
ISO 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’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 21549-5:2023(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 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 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 can 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 can 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 can 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 can 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 (distingu
...