ISO/TS 20405:2018

Health informatics — Framework of event data and reporting definitions for the safety of health software

Publication date: May 18, 2018

General information

Current stage: 90.93 Effective date: Feb 16, 2022

Originator: ISO

Owner: ISO/TC 215

Type: Technical Specification

ICS: 35.240.80

Languages: English

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Status: Published

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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.

Life cycle

NOW

PUBLISHED
ISO/TS 20405:2018
90.93 Standard confirmed
Feb 16, 2022

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