Abstract: Artificial intelligence (AI) medical devices are more and more widely used in stroke diagnosis and treatment. On the one hand, it can help improve the efficiency of stroke diagnosis and treatment; on the other hand, there are some potential ethical problems, including informed consent of stroke patients, privacy security, data comprehensiveness, scientific algorithm, diagnostic accuracy and developers responsibility, etc. The countermeasures to deal with the ethical problems of AI medical devices in stroke diagnosis and treatment include two aspects: firstly, to construct perfect ethical review norms in ethical review procedure, clarify the identity and responsibilities of informed agents, and hire independent consultants in computer science; secondly, to establish an accountability system of AI medical devices in clinical application, and strengthen the professional training and ethics education for AI medical devices users.

Key words: Artificial intelligence; Medical device; Ethics; Stroke

摘要： 人工智能（artificial intelligence，AI）医疗器械在卒中诊疗中的应用越来越广泛，一方面可以辅助提高卒中诊疗的效率，另一方面也存在一些潜在的伦理问题，包括卒中患者的知情同意、隐私安全性、数据全面性、算法科学性、诊断准确性和主体责任划分等。AI医疗器械在卒中诊疗中的伦理问题对策包括以下2个方面：①伦理审查阶段构建完善的伦理审查规范、明确知情代理人身份和职责、聘请计算机科学独立顾问等；②临床应用阶段建立AI医疗器械问责机制，加强对应用者的专业培训与伦理教育。

关键词: 人工智能; 医疗器械; 伦理; 卒中