PD ISO/TS 20405:2018

This standard PD ISO/TS 20405:2018 Health informatics. Framework of event data and reporting definitions for the safety of health software is classified in these ICS categories:

• 35.240.80 IT applications in health care technology

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.