運用人工智慧技術於醫療的法律風險與隱憂──利弊互現

Legal Risks and Concerns of Applying Artificial Intelligence Technology to Medical Treatment- Merits and Drawbacks

運用AI技術於醫療的應用包括診斷、治療和醫療管理等方面，但也引發了一系列倫理問題，尤其是病人的自主權、個人隱私權保護和資訊安全至關重要。人工智慧醫療倫理準則是應用AI技術須遵守的倫理原則和指導方針，以確保運行過程中尊重人性尊嚴、隱私性和公平性。世界衛生組織於2021年確立了六項最適切的倫理原則，因應人工智慧運用於醫療衛生領域。目前AI監管模式之規範，歐盟率先完成人工智慧法案（Artificial Intelligence Act；簡稱AI Act）立法。我國則由國家科學暨技術研究會研擬人工智慧基本法草案（2024年7月15日公告)等。本文試圖透過現行規範及醫療實務進行AI醫療責任之界定與釐清，區分輔助地位及全自動執行地位，融合醫療法過失責任及消保法無過失責任，調和開發設計人員及臨床醫事人員責任。

Applications of AI in the medical field include diagnosis, treatment, and medical management, but it also raises a series of ethical issues, especially patient autonomy, privacy protection, and personal information security. The rule of medical ethics for Artificial Intelligence is the ethical principles and guidelines that ensure respect for human dignity, privacy, and fairness during operation. The World Health Organization established the six most appropriate ethical principles in 2021 in response to the application of artificial intelligence in the medical and health field. To establish AI regulatory model, the European Union took the lead in Artificial Intelligence Act (AI Act) legislation. In our country, the National Science and Technology Research Association has drafted of the Basic Law of Artificial Intelligence (2024). This article attempts to define and clarify AI medical liability through the current legal system and medical practice, distinguish between auxiliary status and fully automatic execution status, integrate negligence liability under medical law and no-fault liability under consumer protection law, and reconcile the responsibilities of developers and clinical medical personnel.