本文探討大數據運用於醫學研究之進展與倫理考量，首先介紹大數據研究在台灣醫療健康領域之發展現況、當前所遭遇之倫理法律挑戰，包括電子病歷的適用法規、資料加值服務應用之同意、業務上資料保密義務的範圍，並從個人資訊的隱私保護與知情同意、資料管理與使用、建立社會信任三方面來探討大數據研究之倫理議題，並介紹我國相關之人類受試者保護規範，以及美國 SACHRP 對大數據研究管理之建議。作者期望經由本文之倫理反思，能有助於大數據應用於醫學研究之相關倫理治理與法規制度建置，促進研究順利發展並保障個人權益。

This paper explores the application of big data to medical research and its ethical considerations. We introduce the current development of big data health researches in Taiwan and the relevant ethical legal challenges including legal regulation on electronic medical record, consent for using health data, and the scope of administrative responsibilities. The issues of privacy protection of personal information and informed consent, data management and usage, and building social trust were discussed. The governmental regulations of human subject protection which apply to big data health research in Taiwan and the US SACHRP regulatory suggestions were introduced too. It is hoped that through the ethical reflection of this paper, the ethical governance and legal regulation for big data health research can be promoted, and therefore contribute to better big data health research as well as individual protection.