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| 題 名 | 健保資料庫案後的健康資料再利用法制--歐盟法制及英國經驗對我國之啟發=Legal Framework for Judgement Health Data Re-use after the Case on NHI Research Database: Lessons from EU Regulations and the British Experience |
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| 作 者 | 翁逸泓; | 書刊名 | 中研院法學期刊 |
| 卷 期 | 37 2025.09[民114.09] |
| 頁 次 | 頁99-183 |
| 分類號 | 584.111 |
| 關鍵詞 | 資料治理; 個人資料保護; 健保資料庫; 歐盟一般資料保護規則; 隱私權; 可信任研究環境; Data governance; Personal data protection; National health insurance research database; NHIRD; GDPR; Right to privacy; Trusted research environment; TRE; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 本文之目的在於理解健康資料治理法制上應當蘊含之論理,並 分析為何我國不應該揚棄現行所繼受之歐盟個資保護與資料法制模 式。 歐盟資料法制模式以貌似複雜,但實質上友善的管制方式,在 綿密的體系架構包括以資料治理法與健康資料空間規則提案等,處 理在健康資料研究的權利衡平問題。就英國法而言,實際問題之癥 結在於政府與民眾間就資訊隱私和安全性與資料利用透明度和可控 性等議題,未能建立足夠之「信任」關係,因此嘗試提出TRE作為 解方。 本文認為,我國現行法律僅透過傳統上區分不同學術研究和不 同公益重要性的方式來衡平個人資料權利與公共利益,無法真正地 反映人民個資權利可能受到的風險,也難以符合比例原則的實質判 斷。最後,就臺灣未來資料治理法制而言,則須有關機關與資料控制人能承擔信任擔保責任、有效監督管理個資應用行為,並有更佳 之公眾溝通。 |
| 英文摘要 | This article examines the principles and implications underlying health data governance laws, and advises against abandoning Taiwan’s current implementations that adopt the European Union (EU) framework for data protection and governance. The EU framework, which is widely implemented and has had a large influence in shaping international practice, provides a sound balance between safeguarding health data and enabling scientific research. While often perceived as overly complex, it provides a coherent and robust regulatory approach for balancing the rights and interests of diverse stakeholders in health data research within a comprehensive legal framework. In contrast, the United Kingdom’s (UK) efforts to enable the reuse of health data for scientific research has been fraught with challenges. The main problem lies in the lack of sufficient trust between the government and the public, particularly regarding issues on information privacy and security, data utilisation transparency, and data control. To address this, the UK has proposed Trusted Research Environments (TREs) as a solution. This approach emphasizes the need to establish “provable and trustworthy” methods for protecting privacy and data utilisation, with one of the prerequisites being that those who use data and regulate such sharing behavior are trustworthy. In the case of Taiwan’s National Health Insurance Research Database, this article argues that current laws rely on outdated distinctions between academic research and public welfare to balance personal data rights and public interest. This approach fails to truly reflect the risks to personal data rights and make a substantive judgment based on the proportionality principle. Looking ahead, Taiwan’s approach to data governance must promote institutional accountability and trust, strengthen the ability of relevant agencies to effectively supervise and manage oversight of personal data applications, and foster communication with the public. |
本系統中英文摘要資訊取自各篇刊載內容。