Status : Published

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Abstract

This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.

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General information

  • Status
     : Published
    Publication date
     : 2021-09
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 215
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

10
Reduced Inequalities
12
Responsible Consumption and Production
3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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