调和生物医学数据公众和GDPR:来自EUCAN ELSI合作机构的三个教训
Alexander Bernier1,2,3, Fruzsina Molnár-Gábor4,5, Bartha M Knoppers4,6,7
1EUCANCan: European-Canadian Cancer Network, Barcelona, Spain. alexander.bernier@mcgill.ca.
European journal of human genetics : EJHG
|June 15, 2023
概括
欧盟通用数据保护条例 (GDPR) 给生物医学数据共享带来了挑战. 拟议的法律澄清可以促进国际数据交换用于研究和临床目的.
科学领域:
- 生物医学数据治理 生物医学数据治理
- 欧盟法律 欧盟法律
- 医疗信息学 医疗信息学
背景情况:
- 欧盟通用数据保护条例 (GDPR) 确立了信息自决权.
- 快速发展的数据保护法对生物医学数据共享网络和已建立的监督机构构成挑战.
- 跨国临床和研究网络在欧洲经济区 (EEA) 的国际数据传输方面面临着高的合规负担.
研究的目的:
- 确定对GDPR进行必要的法律修改.
- 为了促进临床医生和研究人员之间的生物医学数据交换.
- 为应对GDPR对跨国数据共享所带来的挑战.
主要方法:
- 对GDPR条款的法律分析.
- 检查生物医学研究中现有的数据共享实践.
- 关于具体立法和监管修正案的建议.
主要成果:
- 责任的合同分配可以澄清数据共享网络中的参与者角色.
- 使用安全的数据处理环境不应触发GDPR国际转移规则.
- 产生不可识别数据的联合数据分析不应导致联合控制人或处理者身份.
结论:
- 澄清关于数据传输和控制权的GDPR条款至关重要.
- 实施拟议的法律变更将简化生物医学数据交换.
- 这些修改支持跨境敏感健康数据的道德和有效使用.
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