健康資料二次利用治理再平衡—芬蘭《健康與社會資料二次利用法》之修法制度評析【月旦時論】 試閱
Rebalancing the Governance of Secondary Use of Health Data: An Institutional Analysisof Finland’s 2026 Amendments to the Act on the Secondary Use of Health and Social Data
芬蘭於2019年施行《健康與社會資料二次利用法》（Act on the Secondary Use of Health and Social Data），建立以集中式資料許可機關Findata為核心之健康資料二次利用治理架構。然而，近年制度運作逐漸浮現若干瓶頸，包括許可程序繁複、行政成本偏高，以及對跨國研究合作之限制。為回應上述挑戰，芬蘭政府已啟動修法程序，並預計於2026年實施重要修正。本文從資料治理之視角出發，分析此次修法如何透過調整集中化資料審查機制、釐清臨床研究之適用範圍、放寬國際資料使用限制，以及簡化許可程序並提升制度透明度，以改善既有制度之運作。本文指出，此次修法可視為芬蘭健康資料二次利用治理架構之再平衡：在維持資料保護與公共信任之前提下，回應研究效率與創新發展之需求，並因應歐洲健康資料空間（European Health Data Space, EHDS）法制發展所帶來之制度壓力，進而為相關制度設計提供重要之比較法與政策啟示。
Finland enacted the Act on the Secondary Use of Health and Social Data in 2019, establishing a governance framework for the secondary use of health data centered on the centralized data permit authority, Findata. However, practical implementation has gradually revealed several institutional bottlenecks, including complex authorization procedures, relatively high administrative costs, and limitations on international research collaboration. In response to these challenges, the Finnish government initiated a legislative amendment process and plans to implement significant revisions in 2026. From a data governance perspective, this article examines how the reform seeks to improve the existing system by adjusting the centralized data permit mechanism, clarifying the applicability of the Act to clinical research, relaxing restrictions on international data use, and simplifying authorization procedures while enhancing transparency. This article argues that the reform can be understood as an attempt to rebalance the governance of secondary use of health data. While maintaining data protection and public trust, the amendments aim to respond to pressures arising from research efficiency, innovation needs, and the evolving legal framework of the European Health Data Space (EHDS). The Finnish experience thus provides important insights for comparative legal analysis and policy development.
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