At the heels of a recent Civil Cyber-Fraud Initiative related to cybersecurity practices and the False Claims Act (FCA), a cybersecurity-related FCA case has survived a motion for summary judgment, teeing up a trial to determine if the defendants’ cybersecurity compliance disclosures were materially incomplete and if any misstatements were knowingly made. On February 1, […]
Data Protection
Belgian Data Protection Authority Fines Bank for DPO’s Conflicting Roles
In a decision of December 16, 2021, the Belgian Data Protection Authority (“DPA”) imposed a EUR 75,000 administrative fine on a bank located in Belgium for failure to comply with the requirement in Article 38.6 of the General Data Protection Regulation (“GDPR”) that the tasks and duties of the Data Protection Officer (“DPO”) must not […]
EDPB Issues Draft Guidelines on Data Subject Access Rights
On January 28, 2022, the European Data Protection Board (“EDPB”) published draft regulatory guidelines (“draft guidance”) on the right of data subjects to have access to their personal data under the EU General Data Protection Regulation (“GDPR”). In the draft guidance, the EDPB explains the aim and components of the right. This analysis is followed […]
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 […]