Oscar Brück, Enni Sanmark, Ville Ponkilainen, Alexander Bützow, Aleksi Reito, Joonas H Kauppila, Ilari Kuitunen
{"title":"欧洲卫生法规减少了以登记册为基础的研究。","authors":"Oscar Brück, Enni Sanmark, Ville Ponkilainen, Alexander Bützow, Aleksi Reito, Joonas H Kauppila, Ilari Kuitunen","doi":"10.1186/s12961-024-01228-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>This study highlights concerns related to data privacy laws for registry-based medical research and future patient care.</p>","PeriodicalId":12870,"journal":{"name":"Health Research Policy and Systems","volume":null,"pages":null},"PeriodicalIF":3.6000,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443657/pdf/","citationCount":"0","resultStr":"{\"title\":\"European health regulations reduce registry-based research.\",\"authors\":\"Oscar Brück, Enni Sanmark, Ville Ponkilainen, Alexander Bützow, Aleksi Reito, Joonas H Kauppila, Ilari Kuitunen\",\"doi\":\"10.1186/s12961-024-01228-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>This study highlights concerns related to data privacy laws for registry-based medical research and future patient care.</p>\",\"PeriodicalId\":12870,\"journal\":{\"name\":\"Health Research Policy and Systems\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2024-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443657/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Health Research Policy and Systems\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12961-024-01228-1\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH POLICY & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health Research Policy and Systems","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12961-024-01228-1","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
European health regulations reduce registry-based research.
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.
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.
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