On September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic
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European Commission Issues Updated Q&A on Interplay between the GDPR and the Clinical Trials Regulation
By Kristof Van Quathem & Dan Cooper on
Posted in European Union, Health Privacy
On April 10, 2019, European Commission Directorate-General for Health and Food Safety issued a revised Q&A analyzing the interplay between the EU Clinical Trials Regulation (“CTR”) and the EU General Data Protection Regulation (“GDPR”). The revised Q&A takes into account the opinion of the European Data Protection Board (“EDPB”) issued…
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Association of German Supervisory Authorities issues paper on broad consent for research
On April 3, 2019, the Association of German Supervisory Authorities (“Datenschutzkonferenz” or “DSK”) issued a paper (available here in German) on the interpretation of “broad consent” for scientific research in Recital 33 of the GDPR and the interplay with the definition of consent and the principle of purpose limitation.