Medical Device Legal News with Sam Bernstein: Episode 11
On April 14 2025, the European Data Protection Board (EDPB) announced the outcomes of its plenary session that took place on April 8 2025, during which the EDPB adopted draft Guidelines on processing of personal data through...more
On December 2 – 3 2024, the European Data Protection Board (EDPB) met for its 99th plenary session. It subsequently issued several documents, one of which calls for the need for greater alignment between the GDPR and EU...more
The draft guidelines provide further clarification to the EDPB’s interpretation of legitimate interests, and suggest a potential divergence with the UK ICO....more
On 9 October 2024, the European Data Protection Board (EDPB) published its draft Guidelines on the processing of personal data based on legitimate interest for public consultation. The draft Guidelines, adopted on 8 October...more
The updated guidelines (05/2021) from the European Data Protection Board (“EDPB”) issued on 14 February 2023 (the “New Guidelines”) look at the interplay of two fundamental, protective mechanisms contained in the EU GDPR....more
MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more
Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more
On January 18, 2022, the European Data Protection Board (the "EDPB") issued the Guidelines 01/2022 on data subject rights - Right of access (the "Draft Guidelines"), laying out its interpretation of Article 15 GDPR on the...more
On January 28, 2022, the European Data Protection Board (“EDPB”) published draft regulatory guidelines (“draft guidance”) on the right of data subjects to have access to their personal data under the EU General Data...more
On 2 September 2020, the European Data Protection Board (“EDPB”) published draft guidelines on the concepts of controller, joint controllers and processor, which – as explained below - play a crucial role within GDPR...more
On February 7, 2020, the European Data Protection Board (EDPB) published draft guidelines on the processing of personal data in the context of connected vehicles and mobility related applications. If adopted in their current...more
The European Data Protection Board has published draft guidelines for public comment on the data protection aspects of connected vehicles. Key takeaways: The Relevant Players- Non exhaustive list of stakeholders: vehicle...more
The European Data Protection Board (EDPB) has issued draft guidelines on the GDPR legal basis of “necessary for the performance of a contract”....more
Much has happened since the European Union (EU) General Data Protection Regulation (GDPR) went into effect on May 25, 2018. Many EU countries have enacted national legislation to implement and expand the requirements of the...more
The Situation: The General Data Protection Regulation has a broad territorial scope and can apply to businesses based outside the European Union. The Result: The European Data Protection Board has provided important...more
Does the EU General Data Protection Regulation (GDPR) apply to me? This is a question with which many U.S.-based companies have been grappling since the GDPR took effect on May 25. Six months later, the European Data...more
One of the most striking changes to EU privacy law under the EU’s General Data Protection Regulation (which goes into effect May 25, 2018) is the very strict approach to user consent. For many years, companies operating in...more
One of the key components of the General Data Protection Regulation (Regulation (EU) 2016/679) (“GDPR”) is its stronger enforcement mechanisms. Administrative fines are one of the most powerful parts of the enforcement...more
On October 18, the Article 29 Working Party released its draft of “ Guidelines on Automated individual decision-making and Profiling for the Purpose of Regulation 2016/679” (“Guidelines on Automated individual decision-making...more
Many companies have started the potentially lengthy process of auditing their service provider contracts to make sure that they comply with the requirements of the General Data Protection Regulation, which comes into force on...more