The European Union’s (EU) General Data Protection Regulation (GDPR) became effective in 2018, and it puts restrictions on the processing and use of health data in clinical research. Besides limiting cross-border data exchange between EU and non-EU-based researchers, obtaining informed consent with regard to data privacy became more challenging.
The impact on clinical research is studied looking at case reports, a timely format for clinical research results. Using a regression discontinuity design taking into account that not all case reports are affected by the policy change, it is found that there was a decline in publishing clinical case reports by EU-based authors in the order of around 12 percent following the GDPR introduction. This decline is robust for various alternative model specifications and data subsets.
Follow-on analyses show heterogeneity among EU member states in terms of publication output, seemingly rooted in different institutionalized contexts, implying that clinical researchers in some countries struggle more than in others, which raises questions on equal opportunities for clinical research following a policy change that aims at standardizing data privacy in Europe. It is also found that rare and non-rare cases are affected alike.
Overall, the GDPR introduction may negatively affect knowledge diffusion, negatively impacting patient health.
Contact person: Michael E. Rose
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