Expert Consensus on Ethical Governance for Clinical Applications of Generative Medical Artificial Intelligence(2025 Edition).

Abstract

The research and innovative applications of generative medical artificial intelligence(GMAI)are rapidly advancing in the healthcare field.Significant breakthroughs of GMAI have been achieved in areas such as generating diagnostic suggestions,optimizing treatment plans,and assisting doctor-patient communication,profoundly reshaping the paradigm of clinical diagnosis and treatment.However,the open-ended nature of GMAI's generation raises novel ethical challenges,including algorithmic bias,ambiguous accountability,data privacy breaches,and insufficient cultural adaptability.Current ethical governance lags behind technological implementation,necessitating the establishment of a standardized governance framework.Our research team assembled a multidisciplinary panel of experts spanning medical ethics,clinical medicine,medical artificial intelligence,hospital management,public health,and law.According to the governance logic of "prevention-control-remediation" and integrating international norms with domestic policies,this consensus was developed through two rounds of expert consultation to unify opinions and perspectives.It aims to provide a reference for the specific practice of clinical ethical review in the research and clinical application of GMAI and to establish an authoritative guidance framework for the clinical ethical governance of GMAI,tailored to China's cultural context and national requirements.