卫生法学

随着AI技术在医疗领域的融合创新，医疗人工智能产品被广泛应用于术前诊疗、临床手术以及术后护理等阶段。然而在推动现代医疗技术革新的同时，也引发了新的法律问题。对于人工智能医疗产品在医疗活动中因自身缺陷导致医疗事故的责任归属问题，成为了当前热议的焦点。鉴于其与传统医疗器械不同的独特属性，法学界对此类事故的责任承担主体存在不同观点，司法实践也面临着举证责任困难等挑战。我国现行法规将人工智能医疗产品归类至医疗器械当中，认为其本身并不具备法律责任主体资格，其侵权责任也应由生产企业来承担。同时作为其数据库的提供方，若数据存在质量瑕疵而导致患者受损，也应承担相应的不合格产品责任。针对司法实践中举证困难的问题，建议采取举证责任倒置原则，由生产方承担举证责任，并呼吁加快完善人工智能医疗领域的立法建设，优化法律责任分配，以应对这一新兴领域的法律挑战。

With the integration of AI technology in the medical field, medical artificial intelligence products are widely used in the pre-operative diagnosis and treatment, clinical surgery, and post-operative care stages. However, while driving modern medical technological innovation, it has also led to new legal issues. The issue of liability attribution for medical accidents caused by the defects of AI medical products in medical activities has become a hot topic. Due to its unique attributes different from traditional medical devices, the legal community has different views on the responsibility bearer of such accidents, and the judicial practice is facing challenges such as difficulty in proving. The current laws in China classify AI medical products as medical devices and believe that they do not have legal liability subject qualifications. Their tort liability should also be borne by the manufacturers. At the same time, as the provider of the database, if the data has quality defects and causes harm to patients, it should also bear the corresponding liability for defective products. In response to the problem of difficulty in proving in judicial practice, the principle of shifting the burden of proof should be adopted, with the manufacturers bearing the burden of proof. It is also proposed to accelerate the legislative construction in the field of artificial intelligence medical treatment and optimize the allocation of legal responsibilities to meet the legal challenges of this emerging field.