On December 3, 2025, the European Commission published its first set of technical FAQs on the EU Cyber Resilience Act (‘CRA’). The CRA is an EU-wide law which lays down cybersecurity requirements for ‘products with digital elements’ (‘PDEs’), including IoT devices, hardware components, and certain software. It becomes fully applicable on December 11, 2027, with […]
EU Privacy
The EU Digital Omnibus: A European Data Law Shake-Up May Be Coming
On November 19, the European Commission (EC) released its EU Digital Omnibus proposal – a 153-page document accompanied by an explanatory memorandum and a Staff Working Document. This proposal introduces amendments, deletions, and replacements to several cornerstone EU digital laws, including: The GDPR. The Data Act. The AI Act. The ePrivacy Directive. Other instruments such […]
European Commission Moves to Extend Free Flows of Personal Data to the UK
On March 18, 2025, the European Commission proposed to extend its adequacy decision in favor of the United Kingdom (‘UK’) for an additional six-month period. This would allow free flows of personal data from the EU to the UK to continue until December 2025. The existing adequacy decision – which was adopted in 2021 in […]
EDPB Adopts Opinion on the Use of Processors and Sub-processors
On October 7, 2024, the European Data Protection Board (“EDPB”) adopted an opinion on obligations following from the use of processors and sub-processors (the “Opinion”). The EDPB is the body that seeks to ensure harmonised application of the EU GDPR across the European Economic Area (“EEA”) and is comprised of the heads of the data […]
Why the New EU-U.S. Data Privacy Framework May Be Good News for Life Sciences Companies in the U.S.
BACKGROUND U.S.-based life sciences companies can be subject to the European Union (‘EU’) General Data Protection Regulation (‘GDPR’), even if they do not have any subsidiary, affiliate or other physical presence in the EU. This can be the case if, for example, a pharmaceutical or medical device company in the U.S. acts as a sponsor […]