A Study on the Legal Challenges and Countermeasures to the Medical AI in China

leejihaeng; SUN， gaoang; ZHOU， ZI-ANG; MAO， NE-NE

The application of AI in medical field, brings both hope and panic to people. On one hand, it offers more precise diagnosis, more personalized treatment and less unnecessary diagnosis, treatment and health care. On the other hand, it also brings legal challenges to ascertain responsibility to medical misdiagnosis and medical accidents. Different ways to deal with the problems may lead to different effects because solutions are likely to accelerate or hinder the introduction of new technologies. At present, since an applicable quality standard evaluation system for medical AI has not established, it is unable to effectively verify and evaluate medical AI according to the data and algorithm, and the legal framework for the protection and utilization of medical data has not been improved, as a result of which, China is unable to issue relevant laws and regulations to effectively supervise medical AI. China should put forward relevant laws and regulations as soon as possible, establish proper technical standards and legal liability system so as to balance the interests and responsibilities of patients, medical personnel, medical institutions, medical AI designers and producers. Based on the comprehensive measure on the risks and benefits of medical AI, the negligence liability of all parties should be determined combined with relationship among all parties. This paper intends to analyze the situation, problems and challenges of the relevant legal system of AI medical in China by analyzing literature, interviews and statistics.

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* 2021년 이후 발행 논문의 참고문헌은 현재 구축 중입니다.

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