演算法介入下的醫療告知義務

Informed Consent in Medical Practice under Algorithmic Intervention

隨著人工智慧與大數據技術快速發展，智慧醫療系統已廣泛應用於影像判讀、疾病風險預測與臨床決策支援，並逐步對醫療決策形成產生實質影響。此一發展雖有助於提升醫療效率與精準度，卻也使傳統以醫師個人專業判斷為核心所建構的醫療責任架構，面臨調整壓力。尤其在刑法層次上，醫療行為之正當性高度仰賴病人之有效同意，而智慧醫療介入後，告知義務是否仍得以原有模式履行，遂成為關鍵問題。
本文以「告知義務」為分析核心，從刑法責任風險的角度出發，探討智慧醫療情境下告知義務之內涵轉型，並分析告知義務違反對病人同意有效性、違法性判斷及過失歸責所產生之影響。在醫療決策逐漸由人類專業與演算法分析共同形成的情境下，告知義務應由傳統的治療內容告知，擴張為涵蓋決策形成過程及病人資料利用之「實質告知」。透過告知義務的實質化，不僅有助於落實病人自主權，亦可作為智慧醫療時代中醫師刑事責任合理化與風險調和的重要制度樞紐。

With the rapid development of artificial intelligence (AI) and big data technologies, intelligent medical systems have been widely adopted in areas such as medical imaging interpretation, disease risk prediction, and clinical decision support, and have gradually come to exert a substantive influence on medical decision-making. While these developments contribute to improved efficiency and accuracy in healthcare, they also place significant pressure on the traditional framework of medical liability, which has been constructed around the physician’s individual professional judgment. At the level of criminal law, the legitimacy of medical interventions relies heavily on the patient’s valid consent, raising a critical question as to whether the conventional model of informed consent can still be adequately fulfilled once algorithmic systems intervene in medical decision-making.
Taking informed consent as its analytical core, this article examines the transformation of the physician’s duty of disclosure in the context of intelligent healthcare from the perspective of criminal liability risk. It analyzes how breaches of the duty of disclosure may affect the validity of patient consent, the assessment of unlawfulness, and the attribution of negligence under criminal law. This article argues that, as medical decisions are increasingly formed through a combination of human professional judgment and algorithmic analysis, the duty of disclosure should expand beyond the traditional explanation of treatment content to encompass a form of“substantive disclosure”that includes the decision-making process and the use of patient data. Such a substantive approach to informed consent not only strengthens patient autonomy but also serves as a key institutional mechanism for rationalizing physicians’criminal liability and balancing risk in the era of intelligent healthcare.