Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more
Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more
On 9 October 2024, the European Data Protection Board (EDPB) published its Opinion 22/2024, clarifying the responsibilities of controllers when relying on processors and sub-processors. This guidance emphasizes the importance...more
The EU AI Act is on the verge of becoming the first law to specifically govern the use of artificial intelligence at a European level. In light of the extensive set of new obligations imposed on companies, and considering the...more
In December 2023, political agreement was reached by EU policy makers on all substantive aspects of the EU Artificial Intelligence Act. Since then, the close-to-final text of this transformational piece of European...more
Following the political agreement between the EU Parliament and Council in December 2023, the EU AI Act is set to become the new key pillar of the EU’s AI strategy. The AI Act is widely expected to be at the forefront of AI...more
On 8 December 2023, after marathon “trilogue” negotiations, the Council of the EU, the European Parliament and European Commission reached a groundbreaking agreement on the forthcoming AI Act. Although the final text is still...more
In the first fine issued by a German data protection authority under the European General Data Protection Regulation (“GDPR”), on 21 November 2018 the authority of the German state of Baden-Württemberg (“LfDI”) imposed a fine...more
11/26/2018
/ BDSG ,
Corporate Counsel ,
Data Breach ,
Data Protection Authority ,
Encryption ,
Enforcement Actions ,
EU ,
General Data Protection Regulation (GDPR) ,
Germany ,
Hackers ,
Information Technology ,
Personal Data ,
Personally Identifiable Information ,
Security Standards ,
Social Media