善用前沿科技以促進我國健康資料之治理──以桃園市擴大肺癌篩檢計畫為例

Utilizing Advanced Technologies to Enhance the Governance of Health Data in Taiwan: A Case Study of the Taoyuan City Expanded Lung Cancer Screening Program

本文以「桃園市擴大肺癌篩檢計畫」為例，透過「低劑量電腦斷層篩檢」的給付行政措施來蒐集、處理並利用民眾的個人健康資料。藉助動態同意DAPP的應用，取得資料目的外使用的同意，並將當事人的同意內容記錄於區塊鏈上，以實現去中心化、透明性及安全性的目標，且提供當事人退出及接收相關訊息的機制。
本文從技術、法律、倫理和社會等層面分析了資料蒐集及整合的過程中，可能面臨的困境以及對應的解決方案，提出了一個全面的策略框架。從技術角度來看，動態同意和區塊鏈技術能有效取得民眾的同意並保障其隱私；跨資料庫的串聯能增強人工智慧在醫療影像分析中的效能，使其更精確地學習和提取關鍵特徵，從而改進疾病預測模型，提高診斷和治療的準確性。從法律、倫理及社會層面來看，本文從111年憲判字第13號判決有關隱私權保障的觀點出發，強調建立公眾對健康資料處理的信任機制的重要性。信任機制的建立則是透過多項驗證措施來加以實現，包括資料去識別化的嚴格流程、資料使用的透明度、民眾退出權的行使、以及對資料使用目的和範圍的清晰界定。這些措施可以有效增加公眾對個人資料安全和隱私保護的信心，從而獲得廣泛的社會支持和參與。
最後，在建議方面，強調必須依據法律規劃組織和流程，以確保資料的合法使用。這包括設立倫理治理和監督機制，引入倫理、法律和社會風險評估（Ethical, legal and socialimplications, ELSI）框架，以及建立獨立的監督和諮詢機構。地方政府應將政策和法規變動納入行政考慮，以適應快速變化的技術和市場環境，這包括與其他生物資料庫、研究機構、產業合作夥伴及政府部門的合作，以共同推動生物醫學研究的進展和健康資料的應用，並建立公眾對資料目的外利用的信任和支持。

This paper uses the ’’Taoyuan City Expanded Lung Cancer Screening Program’’ as an example to illustrate how low-dose computed tomography (LDCT) screening is employed as an administrative measure to collect, process, and use personal health data. Through the application of dynamic consent DAPP, consent for the use of data beyond its original purpose is obtained, and the consent details are recorded on a blockchain to achieve the goals of decentralization, transparency, and security. Additionally, the mechanism allows participants to withdraw consent and receive relevant updates.
From a technical perspective, dynamic consent and blockchain technology can effectively obtain public consent and ensure privacy protection. Cross-database integration can enhance the performance of Artificial Intelligence (AI) in medical image analysis, enabling more precise learning and extraction of key features, thereby improving disease prediction models and increasing the accuracy of diagnosis and treatment. From legal, ethical, and social perspectives, this paper starts from the standpoint of the Constitutional Court Judgment No. 111-Hsien-Pan-13 regarding privacy protection, emphasizing the importance of establishing a public trust mechanism in the handling of health data. The establishment of this trust mechanism is realized through multiple verification measures, including strict de-identification processes, transparency of data use, the exercise of the right to opt-out by individuals, and clear definition of the purposes and scope of data use. These measures can effectively increase public confidence in the security and privacy protection of personal data, thereby gaining broad social support and participation.
Finally, it is emphasized that organizations and processes must be planned according to legal requirements to ensure the lawful use of data. This includes establishing ethical governance and oversight mechanisms, introducing an Ethical, Legal, and Social Implications (ELSI) framework, and setting up independent oversight and advisory bodies. Local governments should incorporate policy and regulatory changes into their administrative considerations to adapt to the rapidly changing technological and market environments. This includes collaborating with other biobanks, research institutions, industry partners, and government departments to jointly promote the advancement of biomedical research and the application of health data, and to build public trust and support for the use of data beyond its original purposes.