ISO/TS 8376:2023

Genomics informatics — Requirements for interoperable systems for genomic surveillance

This document outlines the design principles and the service and standards requirements to enable an interoperable system for genomic surveillance (herein referred to as “federated surveillance system”), including data representation, discovery and analysis, and data linkage. Using select profiles this document applies to genomics digital systems, networks and platforms that enable a federated approach for researchers, clinicians, and patients in both the private and public sector at the local, regional, and international levels.

Titre manque

General Information

• Status: Published
• Publication Date: 14-Dec-2023
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215/SC 1 - Genomics Informatics
• Drafting Committee: ISO/TC 215/SC 1 - Genomics Informatics
• Current Stage: 6060 - International Standard published
• Start Date: 15-Dec-2023
• Due Date: 20-May-2024
• Completion Date: 15-Dec-2023

Standards Content (Sample)

Technical
Specification
ISO/TS 8376
First edition
Genomics informatics —
2023-12
Requirements for interoperable
systems for genomic surveillance
Reference number
ISO/TS 8376:2023(en) © ISO 2023

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ISO/TS 8376:2023(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland

© ISO 2023 – All rights reserved
ii

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ISO/TS 8376:2023(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 3
5 Design principles . 4
5.1 Overview .4
5.2 Explicitness .4
5.3 Scalability .4
5.4 Transparency .5
5.5 Extensibility .5
5.6 Trust and cooperation . .5
6 Service and standards requirements and recommendations . 6
6.1 Overview .6
6.2 Data representation .6
6.2.1 Data identifiers .6
6.2.2 Platform/vendor agnostic data access and retrieval .6
6.2.3 Standard data models and
...

FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 8376
ISO/TC 215/SC 1
Genomics informatics —
Secretariat: KATS
Requirements for interoperable
Voting begins on:
2023-09-15 systems for genomic surveillance
Voting terminates on:
2023-11-10
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTS 8376:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT 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. © ISO 2023

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ISO/DTS 8376:2023(E)
FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 8376
ISO/TC 215/SC 1
Genomics informatics —
Secretariat: KATS
Requirements for interoperable
Voting begins on:
systems for genomic surveillance
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/DTS 8376:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/DTS 8376:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 3
5 Design principles . 4
5.1 Overview . 4
5.2 Explicitness . 4
5.3 Scalability . 4
5.4 Transparency . 5
5.5 Extensibility .
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                                                                         ISO TS
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8376:####(X)
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ISO/DTS 8376
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ISO /TC 215/SC 1/WG 1
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Secretariat: KATS .
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Date: 2023-08-0831
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Genomics informatics - — Requirements for interoperable systems for
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genomic surveillance
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Warning for WDs and CDs
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This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change Style Definition
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without notice and may not be referred to as an International Standard.
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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. Style Definition
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© ISO 8376 – All rights reserved Formatted
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ISO #####-#:####(X)
A model manuscript of a draft International Standard (known as “The Rice Model”) is available at
https://www.iso.org/iso/model_document-rice_model.pdf
2 © ISO #### – All rights reserved

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CP 401 • Ch. de Blandonnet 8
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Phone: + 41 22 749 01 11
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Website: www.iso.orgwww.iso.org
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ISO 8376-#:####(X)

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ISO 8376-#:####(X)
Contents
Foreword . iv
Introduction . ix
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 4
5 Design principles .
...