ISO/TS 9321:2024

FINAL DRAFT
Technical
Specification
ISO/DTS 9321
ISO/TC 215
Health informatics — General
Secretariat: ANSI
requirements of multi-centre
Voting begins on:
medical data collaborative analysis
2024-03-22
Voting terminates on:
2024-05-17
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/DTS 9321:2024(en) © ISO 2024

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FINAL DRAFT
ISO/DTS 9321:2024(en)
Technical
Specification
ISO/DTS 9321
ISO/TC 215
Health informatics — General
Secretariat: ANSI
requirements of multi-centre
Voting begins on:
medical data collaborative analysis
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/DTS 9321:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
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ISO/DTS 9321:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviate terms . 2
5 General requirements . 2
5.1 General .2
5.2 D ata isolation .2
5.3 Terminology standardization .2
5.4 Data standardization .2
5.5 Data incremental expansion.
...

© ISO #### – All rights reserved
ISO/DTS 9321
ISO/TC 215
Secretariat: ANSI
Date: 2024-03-07
Health informatics — General requirementrequirements of multi-
centercentre medical data collaborative analysis
DTS stage

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ISO/DTS 9321:(en)
© ISO 20202024
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
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
© ISO/DTS 9321 2024 – All rights reserved

ii

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ISO/DTS 9321:(en)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviate terms . 2
5 General requirements . 2
5.1 General . 2
5.2 Data isolation . 3
5.3 Terminology standardization . 3
5.4 Data standardization . 3
5.5 Data incremental expansion . 3
5.6 Distributed network framework . 3
5.7 Network scalability . 3
5.8 System modularization . 3
5.9 Security . 3
6 Architecture and workflow . 4
6.1 Architecture . 4
6.2 Workflow . 7
6.2.1 Multi-centre collaborative research initiation workflow . 7
6.2.2 Multi-centre collaborative research implementation workflow .
...