人工智能医疗器械可信赖性研究  

Research on Trustworthiness of Artificial Intelligence-Based Medical Devices

作　　者：郝烨[1] 王浩[1] HAO Ye;WANG Hao(Institute for Medical Device Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院医疗器械检定所,北京102629

出　　处：《中国医疗设备》2023年第3期56-60,共5页China Medical Devices

基　　金：工信部“面向医疗健康行业的人工智能筛查和辅助诊断公共服务平台”项目(2020-0103-3-1)。

摘　　要：目的分析人工智能(Artificial Intelligence,AI)医疗器械的可信赖性定义及特点,研究具体要求、内容及评价方式,为此类产品质控提供技术支撑。方法调研国内外AI医疗器械领域相关监管文件、法规及标准,结合实际检验经验,从质量评价层面分析可信赖层面存在的主要风险及预防措施,对可信赖性的具体内涵及具体评价方法进行研究。结果AI医疗器械可信赖性的评价是系统性评价,涉及产品界面、功能及文档等,需要从可控性、鲁棒性、隐私保护等多个角度综合评价。结论可信赖性是AI医疗器械的重要特性之一,本研究结果可为今后的可信赖性评价提供技术参考。Objective To provide technical support for the quality control of artificial intelligent(AI)-based medical devices by analyzing the definition and characteristics of the trustworthiness of such products,and studying the specific requirements,contents,and evaluation methods.Methods The relevant regulatory documents,regulations,and standards in the field of AI-based medical devices at home and abroad were investigated.Combined with the experience of actual inspection,the main risks and preventive measures at the trustworthiness level were analyzed from the perspective of quality evaluation,and the specific connotation and evaluation methods of trustworthiness were studied.Results The trustworthiness evaluation of AI-based medical devices was a systematic evaluation involving product interface,functions and documents,which needed to be comprehensively evaluated from multiple perspectives of controllability,robustness and privacy protection.Conclusion Trustworthiness is one of the important characteristics of AI-based medical devices.The results of this study provide technical reference for the trustworthiness evaluation in the future.

关 键 词：人工智能 医疗器械 可信赖性 质量评价 

分 类 号：R197.39[医药卫生—卫生事业管理]