ISO/PRF 29585

Health informatics — Framework for healthcare and related data reporting

Titre manque

General Information

• Status: Not Published
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Completion Date: 27-Apr-2023

Relations

• Revises: ISO/TR 22221:2006 - Health informatics - Good principles and practices for a clinical data warehouse
• Effective Date: 06-Jun-2022
• Revises: ISO/TS 29585:2010 - Health informatics — Deployment of a clinical data warehouse
• Effective Date: 06-Jun-2022

Standards Content (Sample)

DRAFT INTERNATIONAL STANDARD
ISO/DIS 29585
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-09-21 2022-12-14
Health informatics – Framework for healthcare and related
data reporting
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 29585:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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ISO/DIS 29585:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 29585
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
Health informatics – Framework for healthcare and related
data reporting
ICS: 35.240.80
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

NOT BE REFERRED TO AS AN INTERNATIONAL

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

IN ADDITION TO THEIR EVALUATION AS

or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,

TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
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WHICH REFERENCE MAY BE MADE IN
Reference number
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 29585:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
---------------------- Page: 2 ----------------------
ISO/DIS 29585:2022(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

0 Introduction ......................................................................................................................................................................................................................... vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Abbreviations .......................................................................................................................................................................................................... 4

5 Preparing: Requirements and Planning ..................................................................................................................................... 5

5.1 Overview ...................................................................................................................................................................................................... 5

5.2 Prioritisation of requirements ................................................................................................................................................. 5

5.3 Users ................................................................................................................................................................................................................ 6

5.4 Data requirements .............................................................................................................................................................................. 6

5.5 Services and non-functional requirements .................................................................................................................. 6

6 Governance ................................................................................................................................................................................................................ 7

6.1 Principles ..................................................................................................................................................................................................... 7

7 Privacy and security of the data ......................................................................................................................................................... 8

7.1 Overview ...................................................................................................................................................................................................... 8

7.2 Principles ..................................................................................................................................................................................................... 8

7.3 Policies ........................................................................................................................................................................................................... 9

7.4 Processes - Security ........................................................................................................................................................................ 10

7.5 Processes: Pseudonymisation and Anonymisation ............................................................................................ 11

7.6 Process: Auditing ...............................................................................................................................................................................12

8 Data .................................................................................................................................................................................................................................12

8.1 Overview ...................................................................................................................................................................................................12

8.2 Data definitions................................................................................................................................................................................... 13

8.3 Data models ............................................................................................................................................................................................ 14

8.4 Dimensions ............................................................................................................................................................................................. 14

9 architecture ...........................................................................................................................................................................................................15

9.1 Components ........................................................................................................................................... ................................................. 15

9.2 Standards Conformance .............................................................................................................................................................. 18

9.3 Metadata ................................................................................................................................................................................................... 18

10 Data Loading ...................................................................... ....................................................................................................................................19

10.1 Principles .................................................................................................................................................................................................. 19

10.2 Data acquisition .................................................................................................................................................................................. 19

10.3 Data requirements ........................................................................................................................................................................... 20

10.4 Data quality ............................................................................................................................................................................................ 20

10.5 Data Loading ........................................................................................................................................... ............................................... 21

10.6 Data management ............................................................................................................................................................................. 22

11 Reporting ..................................................................................................................................................................................................................22

11.1 Principles ..................................................................................................................................................................................................22

11.2 Policies ........................................................................................................................................................................................................ 23

11.3 Data marts ............................................................................................................................................................................................... 25

11.4 Indicators ................................................................................................................................................................................................. 26

11.5 Performance .......................................................................................................................................................................................... 27

12 Operation and Service Delivery ........................................................................................................................................................27

12.1 Service Specification ...................................................................................................................................................................... 27

12.2 Service Management ......................................................................................................................................................................29

Annex A (informative) Potential benefits, uses and services ................................................................................................31

Annex B (informative) Privacy impact assessment ..........................................................................................................................33

iii
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ISO/DIS 29585:2022(E)

Annex C (informative) Data types........................................................................................................................................................................34

Annex D (informative) Dimensional modelling ....................................................................................................................................36

Annex E (informative) Analytics ...........................................................................................................................................................................39

Bibliography .............................................................................................................................................................................................................................40

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ISO/DIS 29585:2022(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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

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.

This second edition cancels and replaces the first edition (ISO/TS 29585:2010), which has been

technically revised.
The main changes are as follows:

— inclusion of ISO/TR 22221:2006 Health informatics - Good principles and practices for a clinical

data warehouse

— Consideration of the impact of developments such as the availability of big-data and federation of

services

— Following comments in the CD ballot, 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.
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ISO/DIS 29585:2022(E)
0 Introduction
0.1 Background

The scope of this document is the effective delivery of healthcare information to service a wide range of

decision-making and research questions.

A considerable amount of data is collected during the provision of care and treatment, some of it specific

to the patient being treated, and some of it not. The primary purpose of this information is to support

and improve individual patient care and much of it is held under professional and legal obligations of

confidentiality. However, this information, often in conjunction with other records, is of value for many

other purposes to support healthcare for groups of patients or for populations.

Healthcare data reporting provides many benefits. The health and well-being of the population are

improved by activities such as disease surveillance, screening, needs assessment and preventative

activities such as identifying the relationship between infected water and cholera resulting in better

sewers. Research has led to major benefits in health practice such as the cure of duodenal ulcers,

prevention of spina bifida, effective treatment of breast cancer and the carrying out of hip replacements.

Research has also reduced risks through a greater understanding of HIV prevention, the relationship

between smoking and lung cancer and the ill effects of the use of aspirin for children. The regulation of

new medicines and other treatments relies on evidence of safety and efficacy from clinical trials.

Providing appropriate conditions are met, these data can legitimately be used to support these other

purposes. In practice, such healthcare data reporting covers a wide spectrum including:

— Protecting the health of the public through surveillance and immediate response to infectious

disease and other environmental threats to health, monitoring adverse effects of therapeutic

interventions and informing and evaluating screening;
— Providing better information to the general public about healthy lifestyles;

— Improving the quality and safety of care or reducing the impact of new risks to population;

— Improving the management of the health system, for example by supporting the more efficient

commissioning of services and value-based care

— Improving the quality of clinical care within an institution, for example through the audit of clinical

practice;

— Identifying patients who interact with multiple parts of the health system in order to monitor equity

of access and provision;

— ensuring consistent care for people who interact with multiple parts of the system, and

— monitoring equity of access and provision

— Ensuring that health policy is evidence-based through carrying out empirical research.

0.2 Healthcare Data Reporting

The scope of this document has not changed, in that the purposes remain largely the same. However,

where the term CDW implied a specific, bounded, repository of data, with specific functions, recent

developments have greatly increased the ways of addressing potential applications. For instance:

— The era of “big data“ offering new sources and modes of data, with a massive increase in data

capture and use, including structured, unstructured, text, images, near real-time, combination of

data sources e.g. personal device data, also social determinant of health data to inform population

health and a wide range of presentation and visualisation tools

— The establishment of federated services that can link data sources which previously could not be

combined and, hence, supporting distributed queries. These federated approaches can support:

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ISO/DIS 29585:2022(E)

moving from hierarchical views of data to multi-layered and multi-dimensional approaches,

the separation of data sources and data consumers, distributed queries and moving from data

warehouses / data marts to data lakes and data labs.

— The potential for analysing data on a much wider scale, particularly for areas such as rare diseases

where federated big data enables studies requiring this population size

— The push for transparency of data has further reinforced the opportunities and responsibilities of

sharing the value of such analysis with a wider public

In view of these developments, this document provides a framework for healthcare and data reporting,

addressing both the opportunities and the responsibilities of the handling of the data. Figure 1

summarises the stages, products and actors through the lifecycle. The following clauses describe these

activities with principles, processes, standards and activities.
Figure 1 — Lifecycle for healthcare data reporting services

Clauses 5-12 specify requirements, each of which is allocated to one actor. Requirements are

individually referenced by actor (e.g. SPnnn for sponsor, DCnnn for data controller, ANnnn for business

analyst, ARnnn for architect, DVnnn for developer and PRnnn for service provider).

vii
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DRAFT INTERNATIONAL STANDARD ISO/DIS 29585:2022(E)
Health informatics – Framework for healthcare and related
data reporting
1 Scope

The scope of this document is the reporting of data to support improved public health, more effective

health care and better health outcomes.

This document provides guidance for those wishing to develop or deploy a healthcare data reporting

service, addressing data capture, processing, aggregation and data modelling and architecture and

technology approaches.

The role of a healthcare data reporting service is to enable data analyses in support of effective policies

and decision making, to improve quality of care, to improve health services organizations and to

influence learning and research. This document has relevance both to developing and more established

health systems. It enables meaningful comparison of programs and outcomes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
actor

person, organization, or system that has one or more roles that initiates or interacts with activities

[SOURCE: TOGAF 9.2, 3.2, modified]
3.2
analyst

member of the technical community who is skilled and trained to define problems and to analyze,

develop, and express algorithms
EXAMPLE systems engineer, business analyst
3.3
architect

person, team, or organization responsible for the process of defining a collection of hardware and

software components and their interfaces to establish the framework for the development of a computer

system

[SOURCE: ISO/IEC/IEEE 24765:2017, modified by combining definitions of architect (3.209) and

architectural design (3.211)]
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ISO/DIS 29585:2022(E)
3.4
business analyst

person who bridges the gap of understanding between business and technology to accurately define

software requirements and carefully control scope
3.5
clinical data warehouse
CDW

grouping of data accessible by a single data management system, possibly of diverse sources, pertaining

to a health system or sub-system and enabling secondary data analysis for questions relevant to

understanding the functioning of that health system, and hence supporting proper maintenance and

improvement of that health system, e.g., public health services

Note 1 to entry: A CDW tends not to be used in real time. However, depending on the rapidity of transfer of data to

the data warehouse, and data integrity, near real-time applications are not excluded.

3.6
dashboard

user interface based on predetermined reports, indicators and data fields, upon which the end user can

apply filters and graphical display methods to answer predetermined business questions and which is

suited to regular use with minimal training
3.7
data controller
organization that determines what information will be processed and why,

Note 1 to entry: The data processor is the one that does the actual processing. Controllers are responsible for

creating privacy notices, implementing mechanisms to ensure that individuals can exercise their data subject

rights and adopting measures to ensure the data processing meets the GDPR’s principle of privacy by design and

by default.
3.8
data custodian
role within the processing entity (IT department) that handles the data daily
3.9
data processor

entity that works under the direction of the owner/controller, such as an IT department

Note 1 to entry: Data processors are responsible for meeting the instructions set by the controller, therefore

mitigating the risk that data is processed excessively or without a lawful basis, providing whatever information is

necessary to help the controller complete a DSAR (data subject access request) and informing data subjects in

advance if personal data is being transferred between jurisdictions.
3.10
data dictionary

database used for data that refer to the use and structure of other data, i.e. a database for the storage of

metadata
3.11
data element

variable, clinical elements are considered synonyms in a clinical information model unit of data that is

considered, in context, to be indivisible

[SOURCE: ISO/IEC 14957:2010, 3.1, modified — "variable, clinical elements are considered synonyms in

a clinical information model" added.]
3.12
data mart
subject area of interest within or standalone from the data warehouse dimension
EXAMPLE An inpatient data mart.
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ISO/DIS 29585:2022(E)

Note 1 to entry: Data marts can also exist as a standalone database tuned for query and analysis, independent of

a data warehouse.

Note 2 to entry: Data marts are typically suitable to adhere to localised requirements such as GDPR in Europe,

via clear specification of purpose for analysis, permissions of data subjects, and data minimalization procedures

3.13
data warehouse dimension
subject-oriented, often hierarchical business relevant grouping of data
3.14
developer

individual or organization that performs development activities (including requirements analysis,

design, testing through acceptance) during the system or software life-cycle process

[SOURCE: ISO/IEC 25000:2014, 4.6]
3.15
drill down

exploration of multidimensional data which makes it possible to move down from one level of detail to a

more detailed level depending on the granularity of data
EXAMPLE Number of patients by departments and/or by services.
3.16
episode of care

identifiable grouping of healthcare-related activities characterized by the entity relationship between

the subject of care and a healthcare provider, such grouping determined by the healthcare provider

3.17
health indicator

single summary measure, most often expressed in quantitative terms, that represents a key dimension

of health status, the healthcare system, or related factors

Note 1 to entry: A health indicator is informative and also sensitive to variations over time and across

jurisdictions.
[SOURCE: ISO/TS 21667:2010, 2.2]
3.18
healthcare data reporting service

managed service to provide reporting of data to support improved public health, more effective health

care and better health outcomes
3.19
metadata

information stored in the data dictionary which describes the content of a document

3.20
master data management

enablement of a program that provides for an organization’s data definitions, source locations,

ownership and maintenance rules
3.21
organization

unique framework of authority within which a person or persons act, or are designated to act towards

some purpose
[SOURCE: ISO/IEC 6523-1:1998, 3.1]
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ISO/DIS 29585:2022(E)
3.22
performance indicator

measure that supports evaluation of an aspect of performance and its change over time

3.23
person
human being regarded as an individual
3.24
role

usual or expected function of an actor or the part somebody or something plays in an action or event

Note 1 to entry: It is also defined as a part an individual plays in an organization and the contribution they make

through the application of their skills, knowledge, experience, and abilities.
Note 2 to entry: An Actor may have several roles.
[SOURCE: TOGAF 9.2, 3.31]
3.25
service provider

organization or part of an organization that manages and delivers a service or services to the customer

Note 1 to entry: A customer can be internal or external to the service provider's organization.

3.26
sponsor

person or group who provides resources and support for the project, program, or portfolio and is

accountable for enabling success
[SOURCE: ISO/IEC TR 24587:2021, 3.15]
3.27
star schema

dimensional modelling concept that refers to a collection of fact and dimension tables

4 Abbreviations
DICOM Digital Imaging and Communications in Medicine
AES Advanced Encryption Standard
API Application Programming Interface
CDW Clinical Data Warehouse
CIM Clinical
...