European Union (EU)

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data holders; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective

On February 13, 2024, the European Data Protection Board (“EDPB”) adopted an opinion on the notion of “main establishment” of a controller in the context of Article 4(16)(a) of GDPR.  The opinion aims to clarify (i) the relevant conditions for the determination of whether a controller has a “main establishment” in the EU, for controllers that have more than one establishment in the EU; and (ii) the application of the so-called “one-stop-shop” mechanism in these scenarios.  

We provide below an overview of the EDPB’s opinion.Continue Reading EDPB Clarifies the Notion of “Main Establishment” under the GDPR

On January 24, 2024, the European Commission (“Commission”) announced that, following the political agreement reached in December 2023 on the EU AI Act (“AI Act”) (see our previous blog here), the Commission intends to proceed with a package of measures (“AI Innovation Strategy”) to support AI startups and small and medium-size enterprises (“SMEs”) in the EU.

Alongside these measures, the Commission also announced the creation of the European AI Office (“AI Office”), which is due to begin formal operations on February 21, 2024.

This blog post provides a high-level summary of these two announcements, in addition to some takeaways to bear in mind as we draw closer to the adoption of the AI Act.Continue Reading European Commission Announces New Package of AI Measures

In December 2023, the Dutch SA fined a credit card company €150,000 for failure to perform a proper data protection impact assessment (“DPIA”) in accordance with Art. 35 GDPR for its “identification and verification process”.Continue Reading Dutch SA Sanctions Credit Card Company for Failure to Perform Data Protection Impact Assessment

On January 15, 2024, the European Commission released its report on the first review of the functioning of the existing eleven adequacy decisions adopted under the pre-GDPR framework.  

The Commission concluded that personal data transferred from the European Economic Area to any of Andorra, Argentina, Canada (for PIPEDA-regulated entities), the Faroe Islands, Guernsey, Isle of Man, Israel, Jersey, New Zealand, Switzerland and Uruguay continue to receive an adequate level of protection.Continue Reading European Commission Retains Adequacy Decisions for Data Transfers to Eleven Countries

On November 27, 2023, the Council of the EU formally adopted the Data Act, following the European Parliament’s endorsement of November 9, which concludes the EU legislative process.  As noted below, the Data Act will shortly be published in the Official Journal and become enforceable in 2025.

The Data Act is designed to require entities to make data, including non-personal data, accessible to other parties, so that it can be re-used for new purposes.  The Data Act’s obligations are broad  and may require significant engineering work to re-design products to ensure compliance.  

We provide below a brief overview of key takeaways and timelines.Continue Reading Data Act Becomes Law: What Next?

On December 9, 2023, the European Parliament, the Council of the European Union and the European Commission reached a political agreement on the EU Artificial Intelligence Act (“AI Act”) (see here for the Parliament’s press statement, here for the Council’s statement, and here for the Commission’s statement). Following three days of intense negotiations, during the fifth “trilogue” discussions amongst the EU institutions, negotiators reached an agreement on key topics, including: (i) the scope of the AI Act; (ii) AI systems classified as “high-risk” under the Act; and (iii) law enforcement exemptions.

As described in our previous blog posts on the AI Act (see here, here, and here), the Act will establish a comprehensive and horizontal law governing the development, import, deployment and use of AI systems in the EU. In this blog post, we provide a high-level summary of the main points EU legislators appear to have agreed upon, based on the press releases linked above and a further Q&A published by the Commission. However, the text of the political agreement is not yet publicly available. Further, although a political agreement has been reached, a number of details remain to be finalized in follow-up technical working meetings over the coming weeks.Continue Reading EU Artificial Intelligence Act: Nearing the Finish Line

The recently agreed Cyber Resilience Act isn’t the only new EU cybersecurity rule set to be published this December: by the end of the year, the European Commission is expected to adopt its draft regulations to establish a European cybersecurity certification scheme (“ECCS”). Continue Reading EU cyber regulation wave quietly rolls on – Commission set to finalize new cyber standards

Yesterday, the European Commission, Council and Parliament announced that they had reached an agreement on the text of the Cyber Resilience Act (“CRA”). As a result, the CRA now looks set to finish its journey through the EU legislative process early next year. As we explained in our prior post about the Commission proposal, the CRA will introduce new cybersecurity obligations for a range of digital products sold in Europe. We’ll provide a more detailed summary of the agreed text once it is finalized and published but in this post we set out a brief summary of key provisions. In terms of timing, the CRA will come into force over a phased transition period starting in late 2025.
Continue Reading The EU’s Cyber Resilience Act Has Now Been Agreed