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 […]
EU Data Protection
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 issues draft guidelines on the interplay between the GDPR’s provisions on territorial scope and international data transfers
On November 18, the European Data Protection Board (“EDPB”) released draft guidelines on the interplay between Article 3 GDPR – which sets out the GDPR’s territorial scope – and the provisions in Chapter V of the GDPR, which impose restrictions on international data transfers. In this draft guidance, the EDPB clarifies which (cumulative) criteria must […]
UK Unveils Post-Brexit Data Plans with an Emphasis on International Transfers of Personal Data
Today, the UK Department of Digital, Culture, Media and Sport (“DCMS”) has made a series of announcements shedding light on the UK’s post-Brexit data strategy. The announcements – which emphasize the importance of international transfers of personal data to global trade – include as follows: A Press Release, providing an overview of the UK government’s […]
Swiss Data Protection Regulator Is Latest to Outline Framework for Transferring Data to the SEC
Entities registered with the U.S. Securities & Exchange Commission (SEC) must maintain certain books and records and can be subject to the SEC’s examination, inspection, and enforcement authority. Responding to SEC requests can require cross-border transfers of personal data, and this has historically risked non-compliance under foreign data protection law. The SEC has been proactive […]