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 Data Protection
EDPB Issues Draft Guidelines on the Calculation of Administrative Fines
On May 16, 2022, the European Data Protection Board (‘EDPB’) published draft regulatory guidelines (‘draft guidance’) on the calculation of administrative fines for infringements of the EU General Data Protection Regulation (‘GDPR’). In the draft guidance, the EDPB sets out its methodology, consisting of five steps, for calculating administrative fines. The EDPB adopted these guidelines […]
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 […]
Major Overhaul of EU Clinical Trial Rules Kicks In on 31 January 2022
On 31 January 2022, the EU Clinical Trial Regulation (CTR) will come into application, almost 8 years after its adoption by the European Parliament and the Council of the EU. The CTR will radically change the regulatory framework for conducting clinical trials in the EU Member States as well as European Economic Area (EEA) countries […]
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 […]