IEC 80001-1:2021规定了在健康IT基础设施内连接健康IT系统之前、期间和之后，通过解决安全、有效性和安全性的关键属性，同时雇佣适当的利益相关者，对组织应用风险管理的一般要求
IEC 80001-1:2021取消并取代了2010年发布的第一版。本版为技术修订版
与上一版本相比，本版本包括以下重大技术更改:
a） 结构改变，以更好地与ISO 31000保持一致
b） 制定组织在风险管理应用中的要求
c） 通过支持在实施和使用互联健康软件和/或健康IT系统期间保护关键财产的原则，传达风险管理的价值、意图和目的。

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.