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ISO TR 17791:2013

(Main)

Health informatics -- Guidance on standards for enabling safety in health software

Health informatics -- Guidance on standards for enabling safety in health software

ISO/TR 17791:2013 provides guidance to National Member Bodies (NMBs) and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software. The framework presented in ISO/TR 17991:2013, together with the mapping of standards to the framework, illustrate relevant standards and how they can optimally be applied. The mapping works to clearly demonstrate where standards gaps and overlaps exist. Specifically, ISO/TR 17791:2013: - identifies a coherent set of international standards that promote the patient-safe (or safer) development, implementation and use of health software, - provides guidance on the applicability of these standards towards enabling optimal safety in health software within overall risk management and quality management approaches, as well as within the lifecycle steps and processes of health software development, - addresses the health software safety issues that remain, either as gaps or overlaps between or among the identified standards, and - discusses how those gaps and overlaps could be addressed?in the short or long term?through revision of the current standards or the development of new ones. Harm to the operators of health software, should any such risk exist, is outside the scope of ISO/TR 17791:2013.

General Information

Status
Published
Publication Date
04-Dec-2013
ICS
01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
35.240.80 - IT applications in health care technology
Technical Committee
SC 62A - Common aspects of medical equipment, software, and systems
Drafting Committee
JWG 7 - TC 62/SC 62A/JWG 7
Current Stage
PPUB - Publication issued
Start Date
31-Dec-2013
Completion Date
28-Feb-2014
Ref Project

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ISO TR 17791:2013 - Health informatics -- Guidance on standards for enabling safety in health softwareISO TR 17791:2013 - Health informatics -- Guidance on standards for enabling safety in health software
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ISO TR 17791:2013 - Health informatics -- Guidance on standards for enabling safety in health software
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TECHNICAL ISO/TR
REPORT 17791
First edition
2013-12-15
Health informatics — Guidance on
standards for enabling safety in health
software
Informatique de la santé — Conseils sur les normes de sécurité des
logiciels de la santé
Reference number
ISO/TR 17791:2013(E)
©
ISO 2013

---------------------- Page: 1 ----------------------
ISO/TR 17791:2013(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TR 17791:2013(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Abbreviated terms . 6
4 Health software safety . 6
4.1 Health software safety incidents . 6
4.2 Health software definitions . 7
4.3 Towards safer health software . 9
4.4 Health software lifecycle . 9
4.5 How standards were selected for assessment .12
4.6 Standards assessed in this Technical Report .13
4.7 Risk management basis .15
4.8 Human factors basis .16
4.9 Granularity .17
5 Standards assessment and guidance .17
5.1 Standards assessment .17
5.2 Standards assessed by lifecycle applicability and software granularity .31
5.3 Standards assessment overlap and gap analysis .33
5.4 Standards for enabling safety in health software — Implementation and use guidance .36
Annex A (informative) Patient safety benefits arising from eHealth investments .39
Annex B (informative) Standards
...

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