Health informatics. Framework of event data and reporting definitions for the safety of health software
Health informatics. Framework of event data and reporting definitions for the safety of health software
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1 Scope This document provides a model framework for improving the surveillance and reporting of events with respect to the safety of health software . This document defines those data elements needed for identification of particular events including incidents , near-misses and unsafe conditions , as well as outlining good principles, relevant concepts and a process model for the recording, analysis and reporting of event-specific information related to the safety of health software .
Другие стандарты PD