医疗人工智能产品研发的伦理审查与法律考量

Ethical Review and Legal Considerations on Development of Medical Artificial Intelligence Products

国内医疗人工智能研究日益增多,具有多学科合作,并以数据驱动的特点。走访深圳开展健康领域人工智能研发的企业、医疗机构以及研究机构的开发者,了解到存在监管不足、数据收集及处理过程欠缺标准化、责任不清等挑战。并且,面临应该如何遵循医学科研伦理审查原则,如何合法合规收集、利用、共享数据并界定责任等问题。从医院进行伦理审查实践层面探讨医疗人工智能的研究价值、科学有效性、风险受益等的审查要点;医疗人工智能研究的法律考量主要包括个人信息收集和利用的边界,以及侵权责任主体的认定。

More and more projects of the medical artificial intelligence(AI)products with multidisciplinary cooperation and data-driven features are under development.Based on the interviews with the developers from local industry,hospitals and research institutions in Shenzhen,this paper discusses the challenges of medical AI research,such as insufficient supervision,lack of standardization of data collection and processing,and unclear responsibility.Specifically,how should we comply with the principles of ethical review?How to legally collect,use and share data,as well as sharing the responsibility?This paper discusses the research value,scientific validity,risk and benefit of medical AI research from the perspective of ethical review practice in hospitals.The legal consideration of medical AI research mainly includes the boundary of personal information collection and utilization,and the identification of the subject of tort liability.