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Personal health data provide a vital resource for research to save and improve lives, reduce health inequalities and benefit society. Research data should be regarded as a global public good. Sharing of data is an essential part of public sector medical research for improved health care and disease prevention, for example to ensure sufficiently large sample sizes, identify complex pathways, and compare the determinants and outcomes of disease in different settings, thereby making the most of the contribution by patients and volunteers to research. It is important for EU citizens that their data are shared for health research, to ascertain whether research results from elsewhere are relevant to their particular genetic makeup and risk factors.
At the same time, it is essential to provide appropriate protections for personal data privacy. The General Data Protection Regulation (GDPR) addresses the protection of personal data in the European Union (EU) and European Economic Area (EEA) and the international transfer of data to areas outside the region. It has become apparent that the implementation of the GDPR has introduced impediments to this international transfer of data to outside the EU/EEA, creating problems for academic researchers, healthcare professionals and others in the public sector. These problems affect patients and all citizens who are the ultimate beneficiaries of public sector health research.