EN ISO 21549-5:2023
(Main)Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2023)
Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2023)
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.
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)
Le présent document 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.
Le présent document ne s'applique pas aux fonctions et mécanismes détaillés des services ci-après (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 au présent document).
Par conséquent, le présent document ne relève pas:
— les solutions physiques ou logiques pour le fonctionnement pratique de types de cartes particuliers;
— 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.
Zdravstvena informatika - Podatki o pacientu na zdravstveni kartici - 5. del: Identifikacijski podatki (ISO 21549-5:2023)
Standard ISO 21549-5:2015 opisuje in določa osnovno strukturo identifikacijskih podatkov na zdravstvenih karticah, vendar ne navaja specifičnih naborov podatkov za shranjevanje v napravah.
Podrobno delovanje in mehanizmi naslednjih storitev niso del obsega tega dela standarda ISO 21549 (čeprav njihove strukture omogočajo prilagajanje primernih podatkovnih predmetov drugje):
– varnostne funkcije in povezane storitve, za katere obstaja verjetnost, da jih bodo uporabniki navedli za podatkovne kartice, glede na specifično uporabo, npr. varovanje zaupnosti, varovanje integritete podatkov ter preverjanje pristnosti oseb in naprav, povezanih s temi funkcijami;
– storitve nadzora dostopa;
– postopek inicializacije in izdaje (s katerim se začne življenjska doba uporabe posamezne podatkovne kartice in s katerim se podatkovna kartica pripravi za podatke, ki ji bodo posledično sporočeni v skladu s tem delom standarda ISO 21549).
Naslednje teme ne spadajo na področje uporabe tega dela standarda ISO 21549:
– fizične in logične rešitve za praktično delovanje določenih vrst podatkovnih kartic;
– oblika, v kateri so podatki za uporabo zunaj podatkovne kartice, ali način, kako so ti podatki vidno predstavljeni na podatkovni kartici ali drugje.
General Information
Relations
Standards Content (Sample)
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
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or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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 (distinguishable from clinical data) that are necessary for the purpose of
...
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