在医疗保健领域的合作:欧盟二次用途数据共享的影响
1Faculty of Law, University of Groningen Oude Boteringestraat 18, 9712GHGroningen The Netherlands.
European journal of health law
|September 5, 2024
概括
欧洲健康数据空间 (EHDS) 条例在二次健康数据使用方面面临法律障碍. 解决GDPR兼容性,数据共享障碍和知识产权问题对于欧盟医疗保健创新至关重要.
科学领域:
- 卫生政策 卫生政策
- 数据治理数据治理
- 欧盟法律 欧盟法律
背景情况:
- 欧洲的医疗保健正在向以患者为中心和以价值为基础的模式转变.
- 欧洲健康数据空间 (EHDS) 旨在为健康数据的初级和次级使用创造一个统一的市场.
- 释放健康数据的潜力是推动医疗保健提供和研究的关键.
研究的目的:
- 分析阻碍在EHDS框架内对健康数据的二次使用的法律挑战.
- 确定与GDPR合规,跨境数据共享和知识产权相关的具体问题.
- 为克服这些法律障碍并促进数据利用提出建议.
主要方法:
- 对EHDS法规的法律分析及其与现有数据保护法律的相互作用.
- 检查跨境健康数据交换所发现的障碍.
- 在健康数据二次使用的背景下对知识产权考虑的审查.
主要成果:
- 在EHDS条款和通用数据保护条例 (GDPR) 之间的不兼容性问题带来了重大挑战.
- 无跨境数据共享的障碍阻碍了实现统一的欧洲健康数据市场.
- 对知识产权的担忧带来了关于数据所有权和使用权的复杂法律问题.
结论:
- 解决已识别的法律挑战对于成功实施EHDS至关重要.
- 解决GDPR兼容性和跨境数据共享障碍将促进更多的医疗保健研究和创新.
- 有效地管理知识产权对于最大限度地利用健康数据在欧盟内的二次使用的好处至关重要.
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