International Sharing of Personal Health Data for Research
Data sharing is an essential part of modern international research. In medical research, pooled data on individuals are often needed to obtain sufficiently large study numbers and to ensure that research conducted elsewhere is also relevant for patients in Europe. Ultimately, global sharing of health data is key to maximise the individual and societal benefits to be obtained from the contribution of research participants.
Currently, the transfer of personal health data to non-EU/European Economic Area (EAA, which comprises EU member states plus Iceland, Liechtenstein, and Norway) countries is being hampered by the EU’s General Data Protection Regulation 2016/679 (GDPR). When institutions in other countries have statutory conflicts that prevent them from signing the required contracts under the GDPR, there is presently no workable legal mechanism for sharing pseudonymised health data for public sector research.
On 8 April 2021, ALLEA, the European Academies’ Science Advisory Council (EASAC), and the Federation of European Academies of Medicine (FEAM) published the joint report “International sharing of personal health data for research”. The report discusses how global sharing of health data benefits public research, describes the challenges imposed by the GDPR, and provides possible solutions through adapting or expanding the existing legal framework.
This is the first report published by the tripartite collaboration between ALLEA, EASAC, and FEAM and benefits from the complementary expertise joined in these networks. EASAC has a history of interest in optimising the use of health research data, and worked together with FEAM in providing evidence on the value of research and the need for collaborative activity, in previous discussions with the European Commission and Parliament (e.g. ‘’Protecting health and scientific research in the Data Protection Regulation’’). FEAM has collaborated with numerous health stakeholders to issue recommendations in view of the discussions preceding the GDPR (e.g. “Ensuring a healthy future for scientific research through the Data Protection Regulation”). ALLEA has significant interest in the benefits and challenges of collecting, sharing and using data (see our activities on “Data Governance”) and provides the project with a broad and interdisciplinary perspective.
Previously, ALLEA, FEAM and EASAC published a joint open letter to the EU Health Commissioner on the Implications of the ECJ decision on the “Shrems II” for international sharing of health data for research.