ISO/TS 20405:2018 健康信息 健康软件安全事件数据和报告定义的框架

标准编号：ISO/TS 20405:2018

中文名称：健康信息 健康软件安全事件数据和报告定义的框架

英文名称：Health informatics — Framework of event data and reporting definitions for the safety of health software

发布日期：2018-05

标准范围

本文件提供了一个模型框架，用于改进与健康软件安全相关的事件监控和报告。本文件定义了识别特定事件所需的数据元素，包括事件、未遂事件和不安全条件，并概述了记录、分析和报告与健康软件安全相关的事件特定信息的良好原则、相关概念和过程模型。

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.

标准预览图