歐盟健康資料空間（EHDS）之立法初探：以健康資料二次利用為核心【月旦時論】 試閱
The European Health Data Space: Exploring the Secondary Use of Health Data
健康資料已成為醫療照護、研究與公共衛生決策的重要基石，但在保障個資隱私與促進資料「二次利用」間如何取得平衡，仍是全球資料治理的核心議題。歐盟於2025年正式施行「歐洲健康資料空間」（EHDS），旨在回應「一般資料保護規則」（GDPR）於目的外利用上的限制，並藉由跨境共享強化健康資料的公共性。本文以EHDS之立法架構為核心，分析其促進健康資料二次利用的制度設計，並探討其在規範與技術實踐上的挑戰。除揭示EHDS在資料治理上的制度創新，本文亦對歐盟健康資料利用體系的未來發展提出評析。
Health data has become an essential resource for healthcare, biomedical research, and public health decision-making. However, balancing privacy protection with the promotion of its secondary use remains a central challenge in global data governance. In 2025, the European Union implemented the European Health Data Space (EHDS), designed to address the limitations of the GDPR on secondary use and to enhance the public value of health data through secure cross-border sharing. This paper examines the EHDS legislative framework, focusing on its mechanisms for enabling secondary use of health data, while analyzing the legal and technical challenges it entails. By highlighting the EHDS’s institutional innovations, the study offers insights into the evolving governance of health data and the future development of the EU’s health data utilization system.
113-128
