人工智能医疗器械的伦理审查要点

人工智能医疗器械分为具备辅助识别的二类和辅助诊断的三类医疗器械,我国三类人工智能医疗器械刚进入注册申报阶段。很多人工智能医疗器械以科研方式进入医疗机构,为受试者免费试用以获取临床试验数据,这给伦理审查带来极大挑战。伦理委员会审查三类人工智能医疗器械的核心问题包括风险评估、数据库、数据安全及软件更新。除关注医疗器械产品与试验操作外,更要从适用范围、研究要求与资料、研究方案、风险控制、数据库、数据安全和软件更新等方面仔细把关,不断总结经验,切实保护受试者权益,也助推我国人工智能医疗器械的健康快速发展。

Elements for Ethical Review of Artificial Intelligence Medical Device

Artificial intelligence medical devices are classified as the third category of medical devices with assisted detection and the second category of medical devices with assisted diagnosis.The third category of artificial intelligence medical devices have started to enter registration application stage.Many artificial intelligence medical devices enter the medical institutions through scientific research,and they can be used for free to obtain clinical trial data,which brings great challenges to ethical review.It is proposed that the core issues of ethical review of the third category of artificial intelligence medical devices include risk assessment,databases,data security,and software updates.In addition to focusing on medical device products and testing operations,it is also necessary to carefully check the scope of application,research requirements and data,research protocol,risk control,database,data security and software update,and keep summarizing experience,effectively protect the rights and interests of subjects,and promote the healthy and rapid development of artificial intelligence medical devices in China.