ISO/TS 11633-1:2019 卫生信息学 医疗设备和医疗信息系统远程维护的信息安全管理 第1部分：要求和风险分析

标准编号：ISO/TS 11633-1:2019

中文名称：卫生信息学 医疗设备和医疗信息系统远程维护的信息安全管理 第1部分：要求和风险分析

英文名称：Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis

发布日期：2019-08

标准范围

本文档重点介绍医疗设备和健康信息系统供应商为医疗设施（HCF）中的信息系统提供的远程维护服务（RMS）。本文件规定了保护远程维护活动所需的风险评估，并考虑了医疗领域的特殊特征，如患者安全、法规和隐私保护。本文件提供了风险分析的实例，以安全高效（即经济）的方式保护HCF和RMS提供商信息资产。这些资产主要是信息系统本身和信息系统中保存的个人健康数据。

This document focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems.This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections.This document provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient (i.e. economical) manner. These assets are primarily the information system itself and personal health data held in the information system.

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