European Union (EU)

On 20 January 2026, the European Commission published a proposal for a Regulation to update and replace the Cybersecurity Act (Regulation 2019/881). The proposal—known as the Cybersecurity Act 2 (CSA2)—forms part of a wider package aimed at modernizing and streamlining the EU’s cybersecurity framework and is closely linked to the…

Continue Reading European Commission Proposes Cybersecurity Act 2: New EU Supply Chain Rules and Certification Reforms

On December 16, 2025, the EU Commission unveiled its proposal for the Biotech Act.  The proposal, which is only the first part of a bigger initiative for regulating biotechnologies, focuses primarily on the health sector.  The Commission took the opportunity to broadly revise the Clinical Trial Regulation (“CTR”) – see our blog post here.  In particular, it sought to better align the CTR requirements with those of the General Data Protection Regulation (“GDPR”).  This blog post provides an overview of those revisions relating to the processing of personal data during clinical trials.Continue Reading EU Biotech Act Suggests Clarifying Data Protection Rules For Clinical Trials

The European Commission (“Commission”) recently launched two stakeholder consultations under the EU AI Act. The first (see here), closing on 9 January 2026, relates to the copyright-related obligations for General Purpose AI (“GPAI”) providers under the AI Act and GPAI Code of Practice. The second (see here)…

Continue Reading European Commission Launches Consultations on the EU AI Act’s Copyright Provisions and AI Regulatory Sandboxes

On November 19, 2025, the European Commission (“Commission”) officially presented its Digital Omnibus Package (see here and here). In our previous blog post (see here), we explained that this initiative, which represents a comprehensive update to the EU’s digital regulatory landscape, consisted of two proposed regulations: a “Digital…

Continue Reading Digital Omnibus Package Series: European Commission’s Proposal to Revise the EU’s AI Rules

On 19 November 2025, the European Commission (“Commission”) officially presented its Digital Omnibus Package (see here and here). The initiative represents a comprehensive update to the EU’s digital regulatory landscape, which the Commission frames as a competitiveness and simplification initiative aimed at reducing administrative burdens and enhancing legal certainty for businesses. Although the final text is likely to evolve during negotiations with the European Parliament and the Council of the EU (“Council”), the package, if adopted in its present form, would introduce significant changes to data protection obligations, cookie rules, cybersecurity regulations and the EU AI Act.

The Digital Omnibus Package consists of two proposed regulations: a “Digital Omnibus” that would amend, amongst other legislation, the General Data Protection Regulation (GDPR), ePrivacy Directive, NIS2 Directive and Data Act, and a “Digital Omnibus on AI” that would amend the EU AI Act. We outline below key proposals from the Digital Omnibus that have particular significance for organizations operating in the EU.

A summary of amendments affecting the Data Act and the key proposals in the Digital Omnibus on AI will be addressed in subsequent blog posts.Continue Reading European Commission Proposes Revisions to GDPR and Other Digital Rules Under Digital Omnibus Package

On September 23, 2025, the Italian law on artificial intelligence (hereinafter, “Italian AI Law”) was signed into law, after receiving final approval by the Italian Senate on September 17, 2025. 

The law consists of varied provisions, including general principles and targeted sectoral rules in certain areas not covered by the EU AI Act.  The Italian AI Law will enter into force on October 10, 2025. We provide below an overview of key aspects of the final text of the Italian AI Law.  For full detail, please see our previous blogpost here.Continue Reading Italy Adopts Artificial Intelligence Law

On September 4, 2025, the Court of Justice of the EU (“Court”) handed down its judgment in case EDPS v SRB C-413/23 P, setting aside the General Court of the European Union’s (“General Court”) judgment of April 26, 2023 in case SRB v EDPS T‑557/20.  In particular, the Court clarified that whether pseudonymized data can be considered as personal data depends on the specific circumstances of the case, such as whether a third party to whom data is transferred by a data controller can reasonably identify the data subject.

We provide below an overview of the Court’s key findings.Continue Reading EU Court of Justice Clarifies the Concept of Personal Data in the Context of a Transfer of Pseudonymized Data to Third Parties

On June 26, 2025, the European Parliament’s Committee on Employment and Social Affairs published a draft report (“Draft Report”) recommending that the Commission initiate the legislative process for an EU Directive on algorithmic management in the workplace.  The Draft Report defines algorithmic management as the use of automated systems—including those involving artificial intelligence—to monitor, assess, or make decisions affecting workers and solo self-employed persons.

This Draft Report follows a Commission study published in March 2025 (“Commission Study”), which found that while existing EU legislation, such as the GDPR, addresses some risks to workers from algorithmic management, others remain.  The Commission Study also recognizes that the AI Act does not establish specific rights for workers in the context of AI use, which is noted as a concern.

The Draft Report encloses the proposed text for a new Directive on algorithmic management in the workplace (“Proposed Directive”).  The Draft Report has not yet been endorsed by the European Parliament.Continue Reading European Parliament Committee Recommends Commission to Propose EU Directive on Algorithmic Management

On May 7, 2025, the European Commission published a Q&A on the AI literacy obligation under Article 4 of the AI Act (the “Q&A”).  The Q&A builds upon the Commission’s guidance on AI literacy provided in its webinar in February 2025, covered in our earlier blog here.  Among other things, the Commission clarifies that the AI literacy obligation started to apply from February 2, 2025, but that the national market surveillance authorities tasked with supervising and enforcing the obligation will start doing so from August 3, 2026 onwards.Continue Reading European Commission Publishes Q&A on AI Literacy

On April 29, 2025, the Italian data protection authority (“Garante”) launched a public consultation to collect feedback from stakeholders about the so-called “Pay or Ok” model. 

“Pay or Ok” refers to the concept of making access to a website’s content or service conditional on the website visitor performing one of…

Continue Reading Italian Garante Launches Public Consultation on the Implementation of “Pay or Ok” Models