Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

IEC 80001-1:2021 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.