In 2018, the General Data Protection Regulation (GDPR) became a binding law in the EU and led to uncertainty in the research community. A recent study, to which the European Kidney Health Alliance (EKHA) contributed, assesses the main principles of GDPR in relation to biomedical research. It reviews the practical problems of data and bio-sample sharing, provides interpretations of the GDPR in biomedical research, and suggestions to amend the Regulation to overcome challenges in this area.
In principle, GDPR should lead to the regulatory harmonisation of data usage and sharing. However, because a large part of decision-making remains under the scope of Member States, it leads to confusion and bureaucratic complexity. This is particularly true for international collaborative projects, which are dependent on data and bio-sample sharing.
GDPR has created challenges for the exchange of data and bio-samples in the research community as scientists fear violating the legislation. Nonetheless, COVID-19 has shown the need to enable quick and secure data sharing without legal delays.
The paper provides suggestions to improve the harmonisation of data usage and sharing, with the aim to create a better roadmap for secondary use of data and bio-samples at the European level.
The authors suggest to involve all major stakeholders in the optimisation of GDPR.
Read the full paper here.