On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act, which entered into force on 26 June 2022. The new rules will become fully operational once the Ministry of Health sets up the public database where companies will have to disclose their data. In practice, this means the new
German Supervisory Authorities Publish Paper on Scientific Research and Data Protection
The German Conference of Independent Supervisory Authorities (“DSK”) published on March 23, 2022 a statement on scientific research and data protection (see here, in German). The DSK published the statement in response to the German Government’s initiative on a general law on research data as part of its Open Data Strategy, announced on July 6, 2021. The DSK also refers to the Government’s intention to introduce a law on the use of health data, including the storage of data in electronic health records.
Continue Reading German Supervisory Authorities Publish Paper on Scientific Research and Data Protection
Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes
On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.
One of the main objectives of the…
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.
According to the DSK, broad consent…
European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation
The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”). The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health. The Directorate General decided to create this Q&A…