For almost a decade, the scientific research provisions of the General Data Protection Regulation (GDPR) have lacked authoritative, European Union (EU)-wide interpretation, leaving sponsors of clinical trials and research institutions alike to navigate a patchwork of national implementing laws. A 2019 study commissioned by the European Data Protection Board (EDPB) — the body comprising EU national data protection authorities — confirmed significant divergence among EU Member States, and interim guidance published in 2021 by the EDPB highlighted — but left unresolved — several key GDPR compliance issues facing organisations in the life sciences industry. In the years since, the COVID-19 pandemic and the United Kingdom’s post-Brexit departure from the EU framework have only sharpened the need for more specific guidance. Ropes & Gray attorneys co-authored an article published in Science magazine in October 2020 that provided a summary of the complexity in this space and potential solutions.

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