Hematoscope 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.
Department of Otorhinolaryngology and Phoniatrics-Head and Neck Surgery, Helsinki University Hospital, Finland and Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Health Res Policy Syst. 2024 Sep 30;22(1):135. doi: 10.1186/s12961-024-01228-1.
The European Health Data Space (EHDS) regulation has been proposed to harmonize health data processing. Given its parallels with the Act on Secondary Use of Health and Social Data (Secondary Use Act) implemented in Finland in 2020, this study examines the consequences of heightened privacy constraints on registry-based medical research.
We collected study permit counts approved by university hospitals in Finland in 2014-2023 and the data authority Findata in 2020‒2023. The changes in the study permit counts were analysed before and after the implementation of the General Data Protection Regulation (GDPR) and the Secondary Use Act. By fitting a linear regression model, we estimated the deficit in study counts following the Secondary Use Act.
Between 2020 and 2023, a median of 5.5% fewer data permits were approved annually by Finnish university hospitals. On the basis of linear regression modelling, we estimated a reduction of 46.9% in new data permits nationally in 2023 compared with the expected count. Similar changes were neither observed after the implementation of the GDPR nor in permit counts of other medical research types, confirming that the deficit was caused by the Secondary Use Act.
This study highlights concerns related to data privacy laws for registry-based medical research and future patient care.
欧盟健康数据空间（EHDS）法规的提出旨在协调健康数据处理。鉴于其与 2020 年在芬兰实施的《健康和社会数据二次利用法》（Secondary Use Act）有相似之处，本研究探讨了隐私限制加强对基于注册的医学研究的影响。
我们收集了芬兰大学附属医院在 2014-2023 年期间获得的研究许可数量以及 Findata 数据管理局在 2020-2023 年期间的数据。在实施《通用数据保护条例》（GDPR）和《二次利用法》前后，我们分析了研究许可数量的变化。通过拟合线性回归模型，我们估计了《二次利用法》实施后的研究数量缺口。
2020 年至 2023 年间，芬兰大学附属医院每年平均批准的数据集许可减少了 5.5%。基于线性回归模型，我们估计 2023 年全国新的数据许可数量比预期减少了 46.9%。类似的变化既没有在 GDPR 实施后出现，也没有出现在其他类型的医学研究许可数量中，这证实了这种缺口是由《二次利用法》造成的。
本研究强调了数据隐私法对基于注册的医学研究和未来患者护理的关注。
