IEC TR 80001-2-4:2012
(Main)Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
IEC/TR 80001-2-4:2012(E), which is a technical report, provides guidance to help a healthcare delivery organization fulfilling its obligations as a responsible organization in the application of IEC 80001-1. A healthcare delivery organization includes hospitals, doctors' offices, community care homes and clinics. Specifically, this guide helps the healthcare delivery organization assess the impact of IEC 80001-1 on the organization and establish a series of business as usual processes to manage RISK in the creation, maintenance and upkeep of its medical IT-networks. This technical report will be useful to those responsible for establishing an IEC 80001-1 compliant risk management framework within a healthcare delivery organization that is expecting to establish one or more medical IT-networks. It provides help through the key decisions and steps required to establish a risk management framework, before the organization embarks on a detailed risk assessment of an individual instance of a medical IT-network. The steps are supported by a series of decision points to steer the responsible organization through the process of understanding the medical IT-network context and identifying any organizational changes required to execute the responsibilities of top management.
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IEC/TR 80001-2-4
Edition 1.0 2012-11
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-4: Application guidance – General implementation guidance for healthcare
delivery organizations
IEC/TR 80001-2-4:2012(E)
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IEC/TR 80001-2-4
Edition 1.0 2012-11
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-4: Application guidance – General implementation guidance for healthcare
delivery organizations
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
T
ICS 11.040.01; 35.240.80 ISBN 978-2-83220-525-9
Warning! Make sure that you obtained this publication from an authorized distributor.
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– 2 – TR 80001-2-4 © IEC:2012(E)
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 7
1.1 Purpose. 7
1.2 HEALTHCARE DELIVERY ORGANIZATION . 7
1.3 Field of application . 7
1.4 Prerequisites . 7
2 Normative references . 8
3 Terms and definitions . 8
4 RESPONSIBLE ORGANIZATION . 12
4.1 TOP MANAGEMENT responsibilities . 12
4.2 Small RESPONSIBLE ORGANIZATION – points to consider . 13
4.3 Large RESPONSIBLE ORGANIZATION – points to consider .
...
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