Legal challenges hamper the sharing of health data with researchers outside the European Economic Area (EEA), a new report by European academy networks concludes. The authors call for solutions to overcome these barriers to ensure timely and straightforward research collaboration in the public sector and maximise health benefits for European citizens.
In the report published at the European Federation of Academies of Sciences and Humanities (ALLEA), the European Academies’ Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) call on EU policymakers and legislators for a commitment to overcome the barriers in sharing pseudonymised health data with researchers outside the European Economic Area, including the ones from the public sector, preferably under article 46 of the General Data Protection Regulation (GDPR).
‘EEA citizens strongly benefit from international sharing of health data by allowing researchers to make the best use of limited resources and to ensure that research conducted elsewhere is also relevant for patients in Europe. This must be encouraged and facilitated to maximise the individual and societal benefits to be obtained from the contribution of research participants,’ emphasises George Griffin, co-author of the report.
The GDPR was implemented before options for transferring data to countries outside of the EU were operational. In particular, statutory conflicts between other countries’ legislation and EU fundamental rights have been the main challenge. This affects the direct transfer of public sector health data to foreign institutions and allows external researchers to access data at its original location remotely.
When institutions in other countries have statutory conflicts that prevent them from signing the required contracts under the GDPR, there is currently no workable legal mechanism for sharing health data for public sector research. It has been estimated that in 2019 more than 5,000 collaborative projects were affected between EEA countries and the US National Institutes of Health alone.
The authors stress that a solution is urgently needed, both for ongoing research collaborations and new studies. ‘Collecting and combining health data is fundamental for advancing medical research and improving disease diagnosis and treatment. For research to thrive, pseudonymised personal data often needs to be shared internationally between research groups in a straightforward and timely fashion, whilst securing the protection of personal data.’ says Volker ter Meulen, co-author of the report.
In the joint report, the three European academy networks focus on how global sharing of health data benefits public research, describes the challenges imposed by data protection regulations and provides possible solutions by adapting or expanding the existing legal framework.