人工智慧醫療傷害之損害賠償責任

Liabilities for Medical Injuries Caused by Artificial Intelligence

「人工智慧」正如火如荼地改變吾人由檢查、診斷到治療之所有醫療流程。人工智慧之醫療應用，初期將先作為輔助醫師作成醫療決策之工具，其後則可能逐漸取代醫師，而成為真正的醫療決策者。在此一演進過程中，醫師及醫療機構之注意標準及注意義務內容亦將隨之變動。在人工智慧之輔助下，醫師在臨床決策上犯錯之機率將大幅減少，進而降低其所暴露之法律風險；但亦由於醫師將可運用人工智慧輕易取得大量醫學資訊，法院於認定醫療過失時，或將提高醫師所應具備之注意標準。而隨著人工智慧之功能愈加強大，醫師及醫療機構就其醫療決策錯誤所須負之法律責任將更限縮，取而代之者，則係醫師及醫療機構對於人工智慧醫療軟體之評估及驗證義務。
另一方面，人工智慧醫療軟體無論係以單純軟體程式之形式、抑或係以軟硬體結合之形式進入醫療市場，皆屬我國消費者保護法所涵蓋之客體，病人如因產品安全性欠缺受有損害，得依法向研發廠商主張產品責任，應無疑義。惟就醫師、醫療機構及軟體研發廠商三者之間的責任如何分配，以及如何設計適當之責任保險以分散人工智慧醫療之風險，則係未來吾人必須面對及處理之課題。

Artificial intelligence (AI) is dynamically revolutionizing the whole medical process from examination, diagnosis to treatment. Artificial intelligence will initially be used as a tool to assist physicians in making medical decisions, and later, it may gradually replace physicians and become the authentic decision-maker in clinical practice. In this process of evolution, the standard of care and the duty of care for physicians and medical institutions will also change accordingly. With the assistance of artificial intelligence, the probability of physicians making mistakes will be greatly reduced, thereby reducing their exposure to legal risks; but also because physicians will be able to use artificial intelligence to easily access a large amount of medical information, the court may raise the standard of care that the defendant physician need to have while finding negligence in medical malpractice lawsuits. As the black-box artificial intelligence medicine becomes more and more powerful and dominant in various clinical scenarios, the legal responsibility of physicians and medical institutions for their decision-making errors will shrink. Instead, physicians and medical institutions will be obliged to assess and validate the safety of medical artificial intelligence software before and when such software is applied to clinical practice.
On the other hand, whether medical artificial intelligence enters the market in the form of a pure software program or a combination of software and hardware, it is covered and regulated by the Consumer Protection Act of Taiwan. In case of damage which is attributable to product defects, the product liability can be claimed to the developer of medical artificial intelligence according to the Consumer Protection Act of Taiwan. However, how to allocate the legal responsibilities among physicians, medical institutions, and software developers, and how to design appropriate liability insurance to distribute the risks of medical artificial intelligence are issues that we must face and deal with in the future.