ISO/TS 14265:2024
(Main)Health informatics — Classification of purposes for processing personal health information
Health informatics — Classification of purposes for processing personal health information
This document defines a set of high-level categories of purposes for which personal health information can be processed: collected, used, stored, accessed, analysed, created, linked, communicated, disclosed or retained. This is in order to provide a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organisation, regional health authority, jurisdiction, country) as an aid to the consistent management of information in the delivery of health care services and for the communication of electronic health records across organisational and jurisdictional boundaries. Health data that have been irreversibly de-identified are outside the scope of this document, but since de-identification processes often includes some degree of reversibility, this document can also be used for disclosures of de-identified and/or pseudonymised health data whenever practicable. This classification, whilst not defining an exhaustive set of purposes categories, provides a common mapping target to bridge between differing national lists of purpose and thereby supports authorised automated cross-border flows of EHR data.
Informatique de santé — Classification des besoins pour le traitement des informations de santé personnelles
General Information
Relations
Standards Content (Sample)
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 2024
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ii
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
Foreword
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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
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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.
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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 considered still to be personal even if it has had many explicit identifiers removed.
In large distributed health data ecosystems, and even for point-to-point data sharing and access, it
is important that personal data processing activities (collection, storage, access, analysis, linkage,
communication, disclosure and retention) are compliant with the applicable permissions. For these data
accesses and processing activities, policies need to be examined and the permissions they contain may need
to be compared (brokered) between parties and systems. Ideally these policy negotiations should be capable
of computable negotiation as often as possible, which can require the permissions including permitted
purposes of use to be compared between a data provider and an intended data user.
Data protection legislation usually requires that permissions such as consent are granted for an intended
purpose that often has to be quite precisely specified, such as when obtaining informed consent. When
determining compatibility of purpose, either to arrive at a formal access/processing decision or to guide
people who will make the final decision, it can be helpful to map a specific purpose to a more coarse-grained
category.
0.3 Using purpose categories when communicating with the public
Many members of the public recognise the need to scale up the use and re-use of health data to improve the
quality, connectivity and safety of healthcare to individuals, to improve the effectiveness of care pathways,
to generate evidence to inform health service planning, public health and policy-making, for research by
public and private organisations including the development of drugs, devices, algorithms and personalised
health services. However, a significant barrier to scaling up learning from health data is public concern
about the uses made of their health data and their not understanding why their data might be used by
different actors. It is important that the range of possible purposes can be communicated to the public in
v
a manageable and understandable way. This set of purpose categories can serve as a useful framework for
raising awareness and education for the public about the different ways in which health data might be used,
and the same framework might serve as a basis for expressing public or patient preferences in a realistic
way, if these can be exercised.
0.4 Alignment with other ISO standards
ISO 22600 (PMAC) defines an architectural approach for policy services, and a generic framework for
defining policies in a formal way. However, like any generic architecture, a structural framework to
support policy interoperability has to be instantiated for use. Policy domains need also to specify which
information properties each takes into account when making processing decisions. They need to specify
a high level policy model containing those properties, to which all instances of that kind of policy must
conform. ISO/EN 13606-4 defines such a policy model for requesting and providing EHR Extracts, i.e. for one
particular use case.
Even if instances of policies conforming to the models defined in ISO 22600 or ISO/EN 13606-4 specify
precise purposes of processing, mapping this to a standardised category of purpose provides a basic level
of semantic interoperability and might support policy negotiations. It can also help to computably identify
incompatibilities of purpose, even if the formal confirmation of compatibility requires the precise purposes
to be compared by a decision maker.
This categorisation in accordance with this document can be used in conjunction with functional roles and
data sensitivity classifications to complement and populate portions of a policy. Categories of purpose can
also assist when developing role-based access models.
No particular technical approach for implementing policy services or policy bridging is implied in this
document.
vi
Technical Specification ISO/TS 14265:2024(en)
Health informatics — Classification of purposes for
processing personal health information
1 Scope
This document defines a set of high-level categories of purposes for which personal health information can be
processed: collected, used, stored, accessed, analysed, created, linked, communicated, disclosed or retained.
This is in order to provide a framework for classifying the various specific purposes that can be defined
and used by individual policy domains (e.g. healthcare organisation, regional health authority, jurisdiction,
country) as an aid to the consistent management of information in the delivery of health care services and
for the communication of electronic health records across organisational and jurisdictional boundaries.
Health data that have been irreversibly de-identified are outside the scope of this document, but since de-
identification processes often includes some degree of reversibility, this document can also be used for
disclosures of
...
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