健康信息学——健康软件安全标准指南

[中文适用范围]： 本技术报告为国家成员机构（NMB）和读者提供指导，识别与健康软件安全开发、实施和使用相关的国际标准。报告中提出的框架以及对标准与框架的映射，展示了相关标准及其如何能够最佳地应用。该映射工作清楚地表明了现有标准之间的差距和重叠。具体来说，本技术报告：- 识别了一组促进患者安全（或更安全）开发、实施和使用健康软件的国际标准；- 提供指导，说明这些标准在整体风险管理方法中如何应用于确保健康软件的安全；- 在健康软件开发周期步骤和过程中实现优化安全；- 解决了现有标准之间的差距和重叠问题；以及讨论了如何通过修订现行标准或制定新标准在短期或长期内解决这些问题。 [外文原描述]： ISO/TR 17791:2013 provides guidance to National Member Bodies (NMBs) and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software. The framework presented in ISO/TR 17991:2013, together with the mapping of standards to the framework, illustrate relevant standards and how they can optimally be applied. The mapping works to clearly demonstrate where standards gaps and overlaps exist. Specifically, ISO/TR 17791:2013: - identifies a coherent set of international standards that promote the patient-safe (or safer) development, implementation and use of health software, - provides guidance on the applicability of these standards towards enabling optimal safety in health software within overall risk management and quality management approaches, as well as within the lifecycle steps and processes of health software development, - addresses the health software safety issues that remain, either as gaps or overlaps between or among the identified standards, and - discusses how those gaps and overlaps could be addressed?in the short or long term?through revision of the current standards or the development of new ones. Harm to the operators of health software, should any such risk exist, is outside the scope of ISO/TR 17791:2013.