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In The Lancet regional health. Europe

The COVID-19 pandemic saw a massive investment into collaborative research projects with a focus on producing data to support public health decisions. We relay our direct experience of four projects funded under the Horizon2020 programme, namely ReCoDID, ORCHESTRA, unCoVer and SYNCHROS. The projects provide insight into the complexities of sharing patient level data from observational cohorts. We focus on compliance with the General Data Protection Regulation (GDPR) and ethics approvals when sharing data across national borders. We discuss procedures for data mapping; submission of new international codes to standards organisation; federated approach; and centralised data curation. Finally, we put forward recommendations for the development of guidelines for the application of GDPR in case of major public health threats; mandatory standards for data collection in funding frameworks; training and capacity building for data owners; cataloguing of international use of metadata standards; and dedicated funding for identified critical areas.

Tacconelli Evelina, Gorska Anna, Carrara Elena, Davis Ruth Joanna, Bonten Marc, Friedrich Alex W, Glasner Corinna, Goossens Herman, Hasenauer Jan, Abad Josep Maria Haro, Peñalvo José L, Sanchez-Niubo Albert, Sialm Anastassja, Scipione Gabriella, Soriano Gloria, Yazdanpanah Yazdan, Vorstenbosch Ellen, Jaenisch Thomas


Cohort study, Data sharing, General Data Protection Regulation, Machine learning, Pandemic, Preparedeness, SARS-CoV-2