SIST-TS CEN ISO/TS 14265:2024

SLOVENSKI STANDARD
01-junij-2024
Nadomešča:
SIST-TS CEN ISO/TS 14265:2014
Zdravstvena informatika - Klasifikacija namenov za obdelavo osebnih
zdravstvenih informacij (ISO/TS 14265:2024)
Health informatics - Classification of purposes for processing personal health information
(ISO/TS 14265:2024)
Medizinische Informatik - Klassifikation des Zwecks zur Verarbeitung von persönlichen
Gesundheitsinformationen (ISO/TS 14265:2024)
Informatique de santé - Classification des besoins pour le traitement des informations de
santé personnelles (ISO/TS 14265:2024)
Ta slovenski standard je istoveten z: CEN ISO/TS 14265:2024
ICS:
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.

CEN ISO/TS 14265
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
January 2024
TECHNISCHE SPEZIFIKATION
ICS 35.240.80 Supersedes CEN ISO/TS 14265:2013
English Version
Health informatics - Classification of purposes for
processing personal health information (ISO/TS
14265:2024)
Informatique de santé - Classification des besoins pour Medizinische Informatik - Klassifikation des Zwecks
le traitement des informations de santé personnelles zur Verarbeitung von persönlichen
(ISO/TS 14265:2024) Gesundheitsinformationen (ISO/TS 14265:2024)
This Technical Specification (CEN/TS) was approved by CEN on 7 January 2024 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 14265:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 14265:2024) has been prepared by Technical Committee ISO/TC 215
"Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
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 CEN ISO/TS 14265:2013.
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 announce this Technical Specification: 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/TS 14265:2024 has been approved by CEN as CEN ISO/TS 14265:2024 without any
modification.
Technical
Specification
ISO/TS 14265
Second edition
Health informatics — Classification
2024-01
of purposes for processing personal
health information
Informatique de santé — Classification des besoins pour le
traitement des informations de santé personnelles
Reference number
ISO/TS 14265:2024(en) © ISO 2024

ISO/TS 14265:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/TS 14265:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 3
5 Conformance . 3
6 Classification of purposes for processing personal health information . 3
Annex A (informative) Examples . 6
Bibliography .11

iii
ISO/TS 14265:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO/TS 14265:2011), which has been technically
revised.
The main changes are as follows:
— the list of categories has been expanded to include subdivisions of the health service management,
population and public health and research categories;
— other categories have been renamed to make their meaning and distinction from other categories more
explicit;
— the categories have been organised within a hierarchy;
— the informative introduction has been shortened by removing explanatory material about basic data
protection principles which were relatively novel at the time of the previous version but are now well
understood across jurisdictions;
— the retained portions of the introduction have been made more crisp.
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/TS 14265:2024(en)
Introduction
0.1 General
This document defines a set of categories of purpose for processing personal health information, to
which specific purposes can be mapped if it is desirable to compare permitted and intended purposes for
processing personal health data, or to determine if two or more permitted purposes are compatible. This
document does not aim to present a comprehensive list of specific purposes, but that all specific purposes
can be mapped to one or more of these categories. Although any specific purpose will usually map to one
category, at times a purpose can be mapped to more than one category. The categories are not mutually-
exclusive, and the mapping of a specific purpose might not always be unique to one category.
Categories of purpose to which specific purposes are mapped should be standardised to allow for consistent
comparisons to be made, rules and guidelines developed, and people trained. Bodies that make data access
decisions, sometimes known as data access bodies or data permit authorities, often specify rules for certain
categories of purpose and can find this categorisation useful.
0.2 Rationale for this classification
A fundamental principle underlying the use of personal data, often codified in data protection legislation,
is that it is necessary to formally specify the purpose for which data was originally collected and/or is
permitted to be processed. Personal information is normally used only for the purpose or purposes for
which it was collected or created, unless otherwise required or authorised by law, or with the explicit or
implied consent of the data subject. All subsequent processing activities by the original data holder or others
by whom the data is accessed needs to be for the same as, or compatible with, the original purpose.
Interoperability standards and common data models, and their progressive adoption by e-health programmes
and clinical research platforms, are expanding the capacity for organizations to exchange personal health
information, within and between countries. Large scale research and public health intelligence sharing
are amongst the drivers for scaling up investments in these data infrastructures. Whilst it is common and
desirable that much of the processing for analysis and knowledge generation utilises anonymised data
or distributed (federated) querying mechanisms, it is sometimes necessary to use pseudonymised data
if longitudinal or cross-organisational linkage is required; pseudonymised data is considered in some
jurisdictions to be personal data. It can at times be difficult to robustly anonymise health data, for example
in the case of rare disease patients, genetic and personalised medicine research, in which case the data can
be co
...