The European Union is moving closer to adopting the first major legislation to horizontally regulate artificial intelligence. Today, the European Parliament (Parliament) reached a provisional agreement on its internal position […]
In March 2021, the European Commission released a proposal for the creation of a “Digital Green Certificate,” which will allow EU citizens to travel easier throughout the EU during the […]
On February 12, 2021, the European Commission (Commission) published an “Assessment of the EU Member States’ rules on health data in the light of GDPR” (the Assessment). The Assessment concludes, […]
On February 17, 2021 the European Medicines Agency (EMA) published an updated version of its good clinical practice questions and answers (GCP Q&A). The updated section relates to access to […]
Taking a step into the digital age, the European Commission announced that the 2020s shall become the EU’s Digital Decade. The EU’s digitalization, including in the area of health, is […]
On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data […]
A recent opinion from the European Data Protection Supervisor (EDPS) on data protection and scientific research builds on an opinion from January 2019 from the European Data Protection Board on […]
New European medical device guidance will require manufacturers to carefully review cybersecurity and IT security requirements in relation to their devices and in their product literature. This new guidance comes […]
The European Commission’s Medical Devices Coordination Group (MDCG) has published a much-anticipated guidance on the qualification and classification of software devices as medical devices (MDSW)1 under the new Medical Devices […]