European Health Regulations Reduce Registry-Based Research

ABSTRACT The European Health Data Space regulation (EHDS) 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. Between 2020 and 2023, a median of 5.5% fewer data permits were approved annually by Finnish university hospitals. Based on linear regression modelling, we estimated a reduction of 46.9% in new data permits nationally in 2023 compared to the expected count. Similar changes were not observed in other medical research types highlighting the consequences of excessive data privacy laws on registry-based medical research.