生醫個資利用之倫理與法遵考量

Ethical and Legal Aspects in the Use of Biomedical Data

桃園市政府自2023年3月起實施「桃園市擴大肺癌篩檢計畫」、提供40歲以上有肺癌風險因子者，免費的低劑量電腦斷層篩檢，至2023年底，近2萬名市民完成篩檢。由於該計畫涉及大量個人資料的收集、長期儲存與後續利用，如何運用這些資料，提供地方及國家公衛政策及精準醫學研究，並避免在使用個人資料時有違憲違法之虞，本文本諸111年憲判字13號判決所揭示憲法保障資訊隱私權之意旨，就該計畫涉及個人資料收集、儲存與利用，進行倫理合規與法遵之研析；包括有無適當的概括同意、完整的參與者事前告知及事後退出機制、篩檢結果或意外發現是否適當的回饋參與者，以及有無獨立監督機制等，藉以提出適於地方衛生局施政參考，並用於後續建置生物資料庫的推動。

The Taoyuan City Government has implemented the“Taoyuan early Lung Cancer Screening Program”from March 2023, providing free low-dose computed tomography lung cancer screening (LDCT) services to citizens over 40 years old with lung cancer risk factors. By the end of 2023, nearly 20,000 people have been screened. Since the screening program involves the collection, storage and subsequent use of a large amount of personal health data, how to use this data to provide public health policy and precision medicine research, and avoid constitutional violations when using personal data is a concern. This article examines the part of the Taiwan Constitutional Court's Judgment No. 13 of 2022 regarding the constitutional protection of the right to privacy of personal information, and examines whether the collection, storage and use of personal data in this screening program complies with ethical and legal considerations, such as whether there are complete participants in advance notification and subsequent withdrawal mechanisms, whether screening results or incidental findings are reported back to participants, and whether there is an independent supervisory authority. This article will serve as important references for the public health department in planning and building a biobank in the future.