隨著數位科技與大數據應用之迅速發展，健康資料已成為推動醫療創新與公共衛生政策的重要資源。全民健康保險制度長期累積之健保資料庫，具備高度完整性與代表性，其二次利用對疾病研究、精準醫療與政策規劃具有重大價值。然而，在資料利用價值日益提升之同時，個人資訊隱私權與資訊自決權之保障亦臨前所未有之挑戰。如何在促 進公共利益與維護基本權利之間取得制度性平衡，已成為當代資料治理之核心課題。於憲法法庭 111 年憲判字第 13 號判決指出，我國現行《個人資料保護法》對於去識別化之規範標準欠缺明確性，且在資料主體事後控制權與監督機制設計上存在結構性不足，凸顯健保資料二次利用法制之缺陷。本文以健保資料庫二次利用為研究核心，從憲法保障資訊隱私權之理論出發，分析去識別化作為合法性基礎之制度界線，並檢視現行法制在目的外利用、合法事由與監督機制上的不足。在比較法層，本文以歐盟《一般資料保護規則》及美國去識別化制度為參照，分析其在合法性基礎體系、資料主體權利保障、風險治理架構與跨境資料傳輸制度之設計邏輯，並與我國法制進行對照。研究發現，GDPR 所強調之目的限制原則、資料最少化原則與可責性原則，形成一套以風險治理與 制度問責為核心之資料保護架構，而我國現行制度則較偏重形式合規與事後救濟，尚未建構完整之風險分級與獨立監督機制。基於上述分析，本文提出健保資料法制建構之方向，包括明確界定去識別化與匿名化之法律效果、建立風險評估與資料保護評估制度、提升資料之可責性義務、構造具實質獨立性之監督機關，以及設計符合國際標準之跨境資料治理框架。本文主張，健保資料二次利用不應僅依賴去識別化作為限制權利之正當化工具，而應透過制度化透明與問責機制，實現資料利用與基本權保障之動態平衡。本研究期望，透過系統性法律分析與比較法觀察，為我國健保資料治理法制之完善提供理論基礎與制度建議，使資料利用在保障資訊隱私權之前提下，成為促進公共福祉與醫療創新之正當制度安排。;With the rapid development of digital technology and big data applications， health data has become a crucial resource for driving medical innovation and shaping public health policies. The database accumulated over time by Taiwan′s National Health Insurance (NHI) system possesses high levels of completeness and representativeness. Its secondary use holds significant value for disease research， precision medicine， and policy planning. However， as the value of data utilization increases， the protection of individual informational privacy rights and the right to informational self-determination faces unprecedented challenges. Striking an institutional balance between promoting public interest and safeguarding fundamental rights has become a core issue in contemporary data governance. Constitutional Court Judgment No. 13 of 2022 (111) points out that Taiwan′s current Personal Data Protection Act lacks clarity in its regulatory standards for de-identification and exhibits structural deficiencies in the design of data subjects′ ex-post control rights and oversight mechanisms. This highlights the flaws in the legal framework governing the secondary use of NHI data. Using the secondary use of the NHI database as its focal point， this paper begins from the constitutional theory protecting informational privacy rights. It analyzes the institutional boundaries of de-identification as a legal basis and examines the shortcomings of the current legal system regarding purpose limitation， legitimate grounds for processing， and oversight mechanisms. From a comparative law perspective， this paper references the EU′s General Data Protection Regulation (GDPR) and the U.S. de-identification regime. It analyzes their underlying design logic concerning the system of legal bases， protection of data subject rights， risk governance frameworks， and cross-border data transfer mechanisms， contrasting them with Taiwan′s legal system. The research finds that the GDPR′s emphasis on principles such as purpose limitation， data minimization， and accountability forms a data protection framework centered on risk governance and institutional accountability. In contrast， Taiwan′s current system leans more towards formal compliance and ex-post remedies， lacking a comprehensive risk-tiering mechanism and an independent supervisory authority. Based on the above analysis， this paper proposes directions for constructing a legal framework for NHI data. These include clearly defining the legal effects of de-identification versus anonymization， establishing risk assessment and data protection impact assessment systems， enhancing data accountability obligations， constructing a supervisory authority with substantive independence， and designing a cross-border data governance framework that aligns with international standards. This paper argues that the secondary use of NHI data should not rely solely on de-identification as a tool to justify the restriction of rights. Instead， it should achieve a dynamic balance between data utilization and the protection of fundamental rights through institutionalized transparency and accountability mechanisms. This study aims to provide a theoretical foundation and institutional recommendations for improving Taiwan′s legal framework for NHI data governance through systematic legal analysis and comparative law observations. The goal is to ensure that data utilization， under the premise of protecting informational privacy rights， becomes a legitimate institutional arrangement that promotes public welfare and medical innovation.
