欧洲卫生法规减少了基于注册表的研究
Oscar Brück1, Enni Sanmark2, Ville Ponkilainen3
1Hematoscope Lab, Comprehensive Cancer Center & Department of Clinical Chemistry, Diagnostic Center, Helsinki University Hospital & University of Helsinki, Biomedicum I, Haartmaninkatu 8, P.O. Box 700, 00290, Helsinki, Finland. oscar.bruck@hus.fi.
Health research policy and systems
|September 30, 2024
概括
芬兰的2020年二次使用法大大减少了医疗研究的健康数据许可. 这项隐私法导致到2023年,新数据许可的缺口为46.9%,影响了研究和患者护理.
科学领域:
- 医疗信息学 医疗信息学
- 医学研究政策 医学研究政策
- 数据隐私法 数据隐私法
背景情况:
- 欧洲健康数据空间 (EHDS) 条例旨在标准化健康数据处理.
- 芬兰2020年关于健康和社会数据的二次使用法 (二次使用法) 引入了更严格的隐私限制.
- 这项研究调查了这些强化隐私法规对基于登记册的医学研究的影响.
研究的目的:
- 分析二次使用法对研究卫生数据可用性的影响.
- 量化该法案实施后研究许可批准的减少.
- 评估对未来医学研究和患者护理的影响.
主要方法:
- 收集了芬兰大学医院 (2014-2023) 和Findata (2020-2023) 的学习许可数.
- 分析了GDPR和二次使用法之前和之后许可数量的变化.
- 使用线性回归建模来估计归因于二次使用法研究许可证的缺口.
主要成果:
- 芬兰大学医院在2020-2023年期间数据许可的年平均下降率为5.5%.
- 线性回归估计,在2023年,新数据许可的全国减少率为46.9%.
- 在GDPR后或其他类型的医学研究中没有观察到类似的赤字,从而孤立了二次使用法的影响.
结论:
- 像芬兰的二次使用法 (Secondary Use Act) 这样的强化数据隐私法规,对基于注册表的医学研究构成重大挑战.
- 观察到的数据许可证缺口引发了对医疗研究和患者护理未来的担忧.
- 强调了平衡数据隐私与研究需求的政策影响.
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