摘要
目的:梳理人工智能医疗器械的伦理现状与面临的问题,探讨医疗器械领域可遵循的人工智能伦理准则和发展原则。方法:查阅国内外已发布的人工智能伦理准则,国内外监管、医学伦理相关规范要求文件。结果与结论:人工智能医疗器械在发展与应用过程中仍面临着社会影响、个人数据保护、人工智能算法和医学伦理等问题。人工智能医疗器械在沿着推动医学人工智能伦理标准化、保持数据完整性方向发展的同时,还要保障数据隐私。
Objective:To summarize the current ethical status and problems of artificial intelligence(AI)medical devices,and discuss the ethical guidelines and development principles to be followed in the field of artificial intelligence medical devices.Methods:Published ethical guidelines of AI at home and abroad,relevant regulations and requirements of medical ethics were retrieved and reviewed.Results and Conclusion:There are some problems in aspects such as social influence,personal data protection,artificial intelligence algorithm and medical ethics during the development and application of AI medical devices.AI medical devices should protect data privacy during the development in the direction of promoting standardization of medical AI ethics and maintaining data integrity.
作者
唐桥虹
王浩
任海萍
Tang Qiaohong;Wang Hao;Ren Haiping(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国药事》
CAS
2019年第9期1004-1008,共5页
Chinese Pharmaceutical Affairs
基金
中国食品药品检定研究院中青年发展研究基金课题“人工智能医疗器械软件性能评价方法研究”(编号2018C5)
关键词
人工智能
伦理
医疗器械
artificial intelligence
ethical issues
medical devices