PD IEC TS 81001-2-2:2025 PDF
Health software and health IT systems safety, effectiveness and security - Coordination. Guidance for the implementation, disclosure and communication of security needs, risks and controls
Название (английский):
Health software and health IT systems safety, effectiveness and security - Coordination. Guidance for the implementation, disclosure and communication of security needs, risks and controls
Health software and health IT systems safety, effectiveness and security - Coordination. Guidance for the implementation, disclosure and communication of security needs, risks and controls
1 Scope This document presents an informative set of common, high-level security-related capabilities and additional considerations to be used across the life cycle of health software and health IT systems , for the information exchange between the health software manufacturers (including medical device manufacturers) , healthcare delivery organizations ( HDOs ) and other stakeholders. It is applicable to health software running on any platform and in any environment such as cloud, on premise or hybrid. Figure 1 provides a graphical representation of the health software which fully includes medical device software. While important security topics, the following are outside the scope of this document:
the security policies of the HDO , the product and services security policies of the manufacturer , determinations of
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