医疗人工智能在医学影像、辅助诊断、手术治疗、医院护理、药物研发、健康管理、疾病预测等领域被广泛应用，并发挥着重要的作用。但是“算法黑箱”“算法歧视”“深度学习”可能会导致医疗人工智能产品在应用时存在巨大的风险，同时出现了一系列法律和伦理方面的挑战，因此我国需要从医疗人工智能法律规制的基本原则、主体地位、法律行为、法律责任、核心算法、数据保护与隐私、风险防范、知识产权等方面构建系统化的医疗人工智能法律规制体系。本文的研究目的在于，一方面，通过对医疗人工智能的主体地位的研究以及医疗人工智能的诊疗行为的规范研究，我国可明确医疗人工智能应用的责任承担与风险防范，促使医疗人工智更好地为人类服务；另一方面，本文通过对医疗人工智能法律规制的体系化研究以及国内外医疗人工智能立法的比较研究，为我国医疗人工智能的立法提出合理化建议。
Medical artificial intelligence is widely used and playing an important role in medical imaging，auxiliary diagnosis，surgical treatment，hospital nursing，drug research and development，health management，disease prediction and other fields. However，the “black box of algorithm”，“algorithm discrimination” and “deep learning” could lead to enormous risks in medical artificial intelligence，along with a series of legal and ethical challenges. Therefore it is necessary to construct a legal system of medical artificial intelligence，by regulating the basic principles，subject status，legal actions，legal liability，core algorithm，data privacy，risk prevention，intellectual property etc. On the one hand，clarifying the responsibility and risk prevention of medical artificial intelligence for a better service through the research on subject status and diagnosis and treatment behavior of medical artificial intelligence. On the other hand，with the purpose of providing rationalization proposals about the regulating of medical artificial intelligence，this article focuses on the research of systematic legal regulation and comparative study of the legislation of medical artificial intelligence between China and foreign countries.
