联影智能首席科学家高耀宗：医疗AI大模型面临新的监管挑战

Core Viewpoint - The interview highlights the transformative impact of AI technology on the medical imaging market, emphasizing its current role in clinical decision support and the regulatory challenges faced in the industry [2] Industry Overview - AI in healthcare is primarily applied in decision support scenarios, with most products classified as high-risk and managed under Class III medical devices, which have distinct approval and clinical evaluation requirements compared to traditional medical products [2] - Over 100 AI Class III products have been approved by the National Medical Products Administration, predominantly featuring single-model and single-scenario applications [2] Regulatory Environment - The medical field's seriousness, complexity, and low tolerance for error necessitate caution in defining the intended use of medical AI products, with applications limited to specific disease areas such as lung cancer or prostate cancer for auxiliary detection and diagnosis [2] - The company is actively involved in shaping regulatory guidelines and industry standards alongside the National Medical Products Administration, aiming to contribute practical experience to support the industry's normative development [2] Technological Development - The rapid advancement of AI technology, particularly large models, presents new challenges and transformations for the industry [2] - Currently, AI products based on large models have not yet been implemented in complex clinical scenarios, both domestically and internationally [2]