European health regulations reduce registry-based research.

IF 3.6 2区医学 Q1 HEALTH POLICY & SERVICES

Health Research Policy and Systems Pub Date : 2024-09-30 DOI:10.1186/s12961-024-01228-1

Oscar Brück, Enni Sanmark, Ville Ponkilainen, Alexander Bützow, Aleksi Reito, Joonas H Kauppila, Ilari Kuitunen

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引用次数: 0

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: This study highlights concerns related to data privacy laws for registry-based medical research and future patient care.

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欧洲卫生法规减少了以登记册为基础的研究。

背景：欧洲健康数据空间（EHDS）法规的提出是为了统一健康数据的处理。鉴于该法规与芬兰 2020 年实施的《健康和社会数据二次使用法》（二次使用法）相似，本研究探讨了隐私限制加强对基于登记册的医学研究的影响：我们收集了 2014-2023 年芬兰大学医院和数据机构 Findata 批准的研究许可证数量。我们分析了《通用数据保护条例》（GDPR）和《二次使用法》实施前后研究许可数量的变化。通过拟合线性回归模型，我们估算了《二次使用法》实施后研究许可数量的赤字：2020年至2023年期间，芬兰大学医院每年批准的数据许可中位数减少了5.5%。根据线性回归模型，我们估计 2023 年全国新数据许可数量比预期数量减少了 46.9%。GDPR实施后，其他医学研究类型的许可证数量也没有出现类似变化，这证实了《二次使用法》造成的数据赤字：本研究强调了数据隐私法对基于登记册的医学研究和未来患者护理的影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Health Research Policy and Systems HEALTH POLICY & SERVICES-

CiteScore

7.50

自引率

7.50%

发文量

124

审稿时长

27 weeks

期刊介绍： Health Research Policy and Systems is an Open Access, peer-reviewed, online journal that aims to provide a platform for the global research community to share their views, findings, insights and successes. Health Research Policy and Systems considers manuscripts that investigate the role of evidence-based health policy and health research systems in ensuring the efficient utilization and application of knowledge to improve health and health equity, especially in developing countries. Research is the foundation for improvements in public health. The problem is that people involved in different areas of research, together with managers and administrators in charge of research entities, do not communicate sufficiently with each other.