病歷與健康資料研究應用之倫理與法律

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。

關鍵字

病歷資料；健康資料研究； HIPAA ； GDPR ；健保資料庫訴訟；參與研究義務

並列摘要

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.

並列關鍵字

medical record ； health data research ； HIPPA ； GDPR ； national health insurance database lawsuit ； duty to participate research

參考文獻

蔡甫昌、邱泰源：世界醫師會台北宣言：健康資料庫與生物資料庫之倫理考量。臺灣醫學 2016;20:620-4。

莊宇真、蔡甫昌：健康資料與生物資料庫研究之倫理議題。臺灣醫學 2018;22:181-91。

Persaud N. A national electronic health record for primary care. CMAJ 2019;191:E28-9.

Burke T. The health information technology provisions in the American Recovery and Reinvestment Act of 2009: implications for public health policy and practice. Public Health Rep 2010;125:141-5.

Kish LJ, Topol EJ. Unpatients-why patients should own their medical data. Nat Biotechnol 2015;33:921-4.

國際替代計量

病歷與健康資料研究應用之倫理與法律

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