Active standard | Published: 18/05/2018

ISO/TS 20405:2018

Health informatics — Framework of event data and reporting definitions for the safety of health software
(Informatique de santé — Cadre des données relatives aux événements et de compte-rendu des définitions pour la sécurité des logiciels de santé)

Available languages: English

Available design: electronic design (pdf), Print design

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Detail information

Designation: ISO/TS 20405:2018

Publication date: 18/05/2018

Pages: 16

Country: International technical standard

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Anotation

Description / Abstract: 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.

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