Biomedical research relies on the patients’ participation and on the use and reuse of special categories of personal data, such as data concerning health. The fight against COVID-19 caused several official bodies to emphasise that the General Data Protection Regulation (GDPR) is not intended to hinder the secondary use of personal data for the purpose of scientific research. However, variation in national interpretation of the GDPR have led to a fragmented approach, which brings uncertainty for researchers and potentially stifles innovation. Questions remain as regards to the interplay of the GDPR with the intricate legal framework applicable to biomedical research. Moreover, several future legislative acts – such as the Data Governance Act and the European Health Data Space – despite their promise to foster the use and reuse of data, could all potentially present novel challenges as regard the protection and use of personal data.
• Individual autonomy versus public interest. Is it database ownership that spurs the discussion in the field of (biomedical) research? Are controversies triggered through the debate on patients’ ownership of data?
• When personal data are re-used for scientific research, which safeguards are needed? Do these safeguards depend on the type of controller? Do you consider the same safeguards when the data are sensitive data, e.g. relating to health or genomic data?
• On the interplay of other legal frameworks with the GDPR we ask our speakers to zoom in on one specific framework and discuss the challenges and future considerations. Such frameworks could include the Clinical Trials Regulation, as well as the proposal for a Data Governance Act, and the future European Health Data Space regulation.