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Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts
This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning, as represented in Figure 1.
It also identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points.
This document also establishes a coherent concepts and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.
This document is applicable to all parties involved in the health software and health IT systems life cycle including the following:
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