Informatique de santé — Cadre des données relatives aux événements et de compte-rendu des définitions pour la sécurité des logiciels de santé

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.