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 […]
EU Privacy
European Commission Takes Significant Step Towards New Solution for Transatlantic Transfers of Personal Data
What Happened? On December 13, 2022, the European Commission (the “Commission”) took a significant step towards the adoption of the EU-U.S. Data Privacy Framework (“DPF”). The DPF is a new framework designed to replace the EU-U.S. Privacy Shield (“Privacy Shield”), which was struck down by Court of Justice of the European Union in the Schrems […]
Heavier Breach Notification Obligations for U.S. Companies Subject to the EU GDPR According to Proposed Regulatory Guidance from the EDPB
On October 18, 2022, the European Data Protection Board (“EDPB”) published a proposed updated version of its regulatory guidance on personal data breaches under the EU GDPR (the “Proposed Updated Guidance”). The Proposed Updated Guidance seeks to place heavier personal data breach notification obligations on controllers established in the U.S. (and other non-EU countries) but […]
EU and U.S. Reach Agreement In Principle on a Replacement for the EU-U.S. Privacy Shield
On March 25, 2022, the European Commission and the United States announced that they have reached an “agreement in principle” on a replacement for the EU-U.S. Privacy Shield, which was invalidated by the Court of Justice of the European Union in 2020. The new framework will be designed to allow personal data to flow freely […]
EDPB Issues New Guidance for Assessing Personal Data Breaches under the EU GDPR
On Monday, 3 January 2022, the European Data Protection Board (“EDPB”) published the finalized version of its regulatory guidance entitled “Examples regarding Personal Data Breach Notification” (the “Guidelines”), following a public consultation on a draft set of guidelines in 2021. The finalized Guidelines are a practice-oriented, and case-based set of examples that leverage the experiences […]