病歷與健康資料研究應用之倫理與法律

The Ethical and Legal Implication of Using Medical Record and Health Data in Research

應用大數據於生物醫學及人工智慧領域之研發，使得病歷及健康資料使用於研究之重要性與日俱增。建立病歷與健康資料庫供醫學研究，並與生物及基因資料庫進行串連，成為國際生醫研究新趨勢，其所涉研究倫理與法律問題亦帶來新的挑戰。本文首先闡明健康資料之定義及應受保護之特殊性、探討病歷所有權歸屬、民眾對健康資料使用之態度、臺灣健保資料庫訴訟案、去識別化與事後退出權、參與研究之道德義務、最後提出對我國健康資料研究與治理之主張，期能提供未來相關法規與政策制訂之參考。

Using big data in biomedicine and artificial intelligence research have developed rapidly in recent years which makes the importance of medical record and health database for research also increased. Establishing health databases for research and linking them to biobank or genetic bank is current research trend which brings novel ethical legal challenges. This paper firstly examines the definitions of health data and the necessity of data protection, then explores the ownership of medical record, public attitude toward using data for research, the lawsuits of the Taiwanese Health Insurance Database research, anonymization and right to opt-out, the moral obligation to participate in research, and proposes justification and recommendation for ethical health data research.