Health informatics — Guidance on standards for enabling safety in health software
ISO/TR 17791:2013 provides guidance to National Member Bodies (NMBs) and readers by identifying a coherent set of international StandardDetails relevant to the development, implementation and use of safer health software. The framework presented in ISO/TR 17991:2013, together with the mapping of StandardDetails to the framework, illustrate relevant StandardDetails and how they can optimally be applied. The mapping works to clearly demonstrate where StandardDetails gaps and overlaps exist. Specifically, ISO/TR 17791:2013:
Harm to the operators of health software, should any such risk exist, is outside the scope of ISO/TR 17791:2013.
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