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IEC

ISO 81001-1:2021

(Main)

Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts

Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts

This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning, as represented in Figure 1. It also identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points. This document also establishes a coherent concepts and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.
This document is applicable to all parties involved in the health software and health IT systems life cycle including the following:
a) Organizations, health informatics professionals and clinical leaders designing, developing, integrating, implementing and operating health software and health IT systems – for example health software developers and medical device manufacturers, system integrators, system administrators (including cloud and other IT service providers);
b) Healthcare service delivery organizations, healthcare providers and others who use health software and health IT systems in providing health services;
c) Governments, health system funders, monitoring agencies, professional organizations and customers seeking confidence in an organization’s ability to consistently provide safe, effective and secure health software, health IT systems and services;
d) Organizations and interested parties seeking to improve communication in managing safety, effectiveness and security risks through a common understanding of the concepts and terminology used in safety, effectiveness and security management;
e) Providers of training, assessment or advice in safety, effectiveness and security risk management for health software and health IT systems;
f) Developers of related safety, effectiveness and security standards.

General Information

Status
Published
Publication Date
30-Mar-2021
ICS
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
07-Jun-2021
Completion Date
06-Apr-2021
Ref Project

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ISO 81001-1:2021 - Health software and health IT systems safety, effectiveness and security - Part 1: Principles and conceptsISO 81001-1:2021 - Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts
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ISO 81001-1:2021 - Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts
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61 pages
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 81001-1
First edition
2021-03
Health software and health IT systems
safety, effectiveness and security —
Part 1:
Principles and concepts
Sécurité, efficacité et sûreté des logiciels de santé et des systèmes TI
de santé —
Partie 1: Principes et concepts
Reference number
ISO 81001-1:2021(E)
©
ISO 2021

---------------------- Page: 1 ----------------------
ISO 81001-1:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 81001-1:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Organizations, people, and roles . 2
3.2 Key properties and processes . 3
3.3 Health information and technology . 5
3.4 Risk management . 8
4 Core themes .11
4.1 General .11
4.2 Sociotechnical ecosystem .12
4.3 System of systems .13
4.4 Life cycle of health software and health IT systems .14
4.5 Roles and responsibilities .17
4.6 Communication .18
4.7 Interdependence of safety, effectiveness and security .20
5 Foundational elements .21
5.1 General .21
5.2 Gover
...

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