Jinrun Jia, Shiqiao Zhao

School of Law, Xi’an Jiaotong University, Xi’an, Shaanxi Province, People’s Republic of China

Correspondence: Jinrun Jia, School of Law, Xi’an Jiaotong University, Xi’an, Shaanxi Province, People’s Republic of China, Email jinrun@stu.xjtu.edu.cn

Abstract: The application of generative artificial intelligence (AI) technology in the healthcare sector can significantly enhance the efficiency of China’s healthcare services. However, risks persist in terms of accuracy, transparency, data privacy, ethics, and bias. These risks are manifested in three key areas: first, the potential erosion of human agency; second, issues of fairness and justice; and third, questions of liability and responsibility. This study reviews and analyzes the legal and regulatory frameworks established in China for the application of generative AI in healthcare, as well as relevant academic literature. Our research findings indicate that while China is actively constructing an ethical and legal governance framework in this field, the regulatory system remains inadequate and faces numerous challenges. These challenges include lagging regulatory rules; an unclear legal status of AI in laws such as the Civil Code; immature standards and regulatory schemes for medical AI training data; and the lack of a coordinated regulatory mechanism among different government departments. In response, this study attempts to establish a governance framework for generative AI in the medical field in China from both legal and ethical perspectives, yielding relevant research findings. Given the latest developments in generative AI in China, it is necessary to address the challenges of its application in the medical field from both ethical and legal perspectives. This includes enhancing algorithm transparency, standardizing medical data management, and promoting AI legislation. As AI technology continues to evolve, more diverse technical models will emerge in the future. This study also proposes that to address potential risks associated with medical AI, efforts should be made to establish a global AI ethics review committee to promote the formation of internationally unified ethical and legal review mechanisms.

Keywords: generative artificial intelligence, healthcare, policy, law, ethics