ISO/TR 17791:2013 provides guidance to National Member Bodies (NMBs) and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software. The framework presented in ISO/TR 17991:2013, together with the mapping of standards to the framework, illustrate relevant standards and how they can optimally be applied. The mapping works to clearly demonstrate where standards gaps and overlaps exist. Specifically, ISO/TR 17791:2013:
- identifies a coherent set of international standards that promote the patient-safe (or safer) development, implementation and use of health software,
- provides guidance on the applicability of these standards towards enabling optimal safety in health software within overall risk management and quality management approaches, as well as within the lifecycle steps and processes of health software development,
- addresses the health software safety issues that remain, either as gaps or overlaps between or among the identified standards, and
- discusses how those gaps and overlaps could be addressed?in the short or long term?through revision of the current standards or the development of new ones.
Harm to the operators of health software, should any such risk exist, is outside the scope of ISO/TR 17791:2013.