ISO 29585:2023

INTERNATIONAL ISO
STANDARD 29585
First edition
2023-06
Health informatics — Framework for
healthcare and related data reporting
Reference number
© ISO 2023
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Published in Switzerland
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Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 4
5 Preparing: Requirements and planning . 4
5.1 Overview . 4
5.2 Prioritization of requirements . 5
5.3 Users . 5
5.4 Data requirements . 6
5.5 Services and non-functional requirements . 6
6 Governance . 6
6.1 Principles . 6
7 Privacy and security of the data . 7
7.1 Overview . 7
7.2 Principles . 7
7.3 Policies . 8
7.4 Processes - Security . 9
7.5 Processes: Pseudonymization and anonymization . 10
7.6 Process: Auditing . 11
8 Data .11
8.1 Overview . 11
8.2 Data definitions.12
8.3 Data models . 12
8.4 Dimensions .13
9 Architecture.14
9.1 Components . . 14
9.2 Data management . 16
9.3 Metadata . 16
10 Data loading .17
10.1 Principles . 17
10.2 Data acquisition . 18
10.3 Data requirements . 19
10.4 Data quality . 19
10.5 Data loading . 20
10.6 Data management . 21
11 Reporting .21
11.1 Principles . 21
11.2 Policies . 21
11.3 Data marts .23
11.4 Indicators . 24
11.5 Performance . 25
12 Operation and service delivery .25
12.1 Service specification .25
12.2 Service management . 27
Annex A (informative) Potential benefits, uses and services .30
Annex B (informative) Privacy impact assessment .32
iii
Annex C (informative) Data types .33
Annex D (informative) Dimensional modelling .35
Annex E (informative) Analytics .38
Bibliography .39
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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electrotechnical standardization.
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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).
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This first edition of ISO 29585 cancels and replaces ISO/TR 22221:2006 and ISO/TS 29585:2010, which
have been technically revised.
The main changes are as follows:
— consideration of the impact of developments such as the availability of big-data and federation of
services;
— each requirement has an identified actor responsible for its delivery and each requirement is
intended to be clear and unambiguous.
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.
v
Introduction
0.1 Background
A considerable amount of data is collected during the provision of care and treatment, some of it spec
...