医疗人工智能应用的法律挑战及其治理

Legal Governance of Medical Artificial Intelligence

医疗人工智能的高效性和先进性对公共卫生和医疗保健领域的技术创新产生了深刻影响。医疗人工智能有望使公民更好地享有健康权,并对整个公共卫生领域带来裨益,但同时也需注意医疗人工智能的发展速度远超对其监管框架的部署规划,会对个人权利和公共健康构成严重挑战,亟需法律作出相应回应。从相关当事人的尊严和自主性的保护、健康数据处理中的隐私和个人信息保护、医疗人工智能应用的公平性和透明度、问责制度和归责原则等方面分析了医疗人工智能应用的法律挑战,并从明确医疗人工智能的治理原则,建立包含硬法和软法在内的初步立法框架,构建科学、合理、高效的监管体制等角度构思了我国医疗人工智能的治理框架。

The efficiency and sophistication of medical AI has made a profound impact on the technological innovation in public health and healthcare industry.It is widely acknowledged that medical AI can provide patients with more efficient healthcare services,allow people to enjoy right to health in a better way,and benefit the public health sector.However,it should be noted that the technological development speed of medical AI is much faster than its regulatory frameworks,posing considerable challenges to individual rights and public health,which requires urgent legal and ethical response.This paper describes the legal challenges of medical AI in terms of the protection of the dignity and autonomy of relevant parties,the issue with privacy and personal information protection in the processing of health data,the issue with fairness and transparency in the application of medical AI,as well as the construction of an accountability system with its principles of responsibility’s attribution.The paper also demonstrates the governance principles of medical AI and discusses how to establish a preliminary legislative framework that includes hard laws and soft laws.Establishing a scientific,reasonable,and efficient regulatory system is also of vital significance to conceptualize the governance framework of medical AI in China.