大數據應用於醫學研究之法律議題

The Legal Issues of the Applications of Big Data on Medical Research

醫療大數據應用於醫學研究，對於促進人類健康福祉具有其重要性，因此關於醫療大數據之利用，具有公共利益之性質，但因為個人醫療健康資料所具有的特殊敏感性，也需在法制上對所涉及的個人資料隱私權加以保護，這是重要的法律討論議題。本文主要是討論目前我國法制上對醫療大數據應用於醫學研究的議題，包括：個人醫療資訊隱私權的保護法制、可識別醫療資料的蒐集與利用、及去識別化醫療資訊的蒐集與利用等，並輔以美國、英國及日本的法律規範概念，作為我國法解釋之參考。

Health Big data in medical research is important to the promotion of human well-being. Thus, the use of health big data is associated with public interests. However, since there are particular issues associated with personal medical data, it is essential to discuss the legal issues associated with the protection of individuals' information privacy rights when health big data is used. This study mainly discusses the regulations of health big data in medical research in Taiwanese legal system with a comparison with those in the US, England, and Japan. These issues include the legal protection of privacy and the collection and use of identifiable as well as de-identifiable medical information.