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 […]
European Union (EU)
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 […]
EDPB publishes Guidelines on the Concepts of Controller and Processor in the GDPR
On July 7th, the European Data Protection Board (“EDPB”) adopted its finalized guidelines on the concepts of controller and processor in the General Data Protection Regulation (“GDPR”). While the EDPB’s predecessor – the Article 29 Working Party – had issued guidance on the concepts of controller/processor (Opinion 1/2010, WP169) back in 2010, many practical concerns […]
European Commission Adopts Draft UK Adequacy Decision
On February 19, 2021, the European Commission adopted a draft ‘adequacy decision’ in favor of the UK. The adoption of the draft adequacy decision marks the first step in ensuring the continued free flow of personal data from EEA countries to the UK under the EU GDPR. Once (and if) the final adequacy decision is […]
The EDPB-EDPS Joint Opinion on Data Processing Standard Contractual Clauses: Key Takeaways
When a controller engages a processor, the GDPR requires that the parties enter into a specific contract that contains certain mandatory provisions. This contract is often referred to as a ‘data processing agreement’ or ‘DPA’. To facilitate compliance with this requirement, the GDPR has provided the European Commission with the power to issue standard contractual […]