European Union (EU)

On 3 June 2026, the European Commission published several legislative and policy measures wrapped up in one “tech sovereignty” package (see our posts summarising the package as a whole here, and diving deeper into the Cloud and AI Development Act here). But the EU’s tech sovereignty drive has a long history, and is by no means limited to this package.

In this post, we take a closer look at the current and forthcoming EU legislative measures aimed at increasing the resilience of services provided in the EU against external, malicious influence, a key aspect of tech sovereignty. Relevant legislation falls into two broad categories: (1) laws promoting cyber resilience generally, to prevent malicious actors from disrupting services and critical infrastructure; and (2) laws focused on building supply chain resilience and reducing dependencies on certain external actors by building European industrial capacity in key tech sectors.

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Continue Reading Looking beyond the tech sovereignty package: how the EU is moving to ensure tech sector resilience

On July 7, 2026, the Irish National Cyber Security Centre (“NCSC”) published guidance for management boards and senior executives of organizations subject to the EU’s Network and Information Security Directive (“NIS2”). Reflecting a central theme of NIS2, the Guidance makes it clear that cybersecurity is no longer solely a technical issue, but a governance and risk-management matter that requires active oversight at “the highest levels of executive management.”  It is a helpful document for organizations that are likely to be subject to NIS2, expect to be supervised in Ireland, and that are considering their governance structures and board-level oversight mechanisms.

Continue Reading Irish NCSC Issues Cyber Governance Guidance for Management Boards Ahead of NIS2 Implementation

On 19 May 2026, the European Commission published its long-awaited draft, non-binding guidelines on the classification of high-risk AI systems (“HRAIs”) under the EU AI Act (the “Guidelines”). Across three documents—covering general principles, high-risk classification in the context of regulated products (Annex I), and high-risk use cases (Annex III)—the Commission sets out its approach to one of the AI Act’s central questions: when does an AI system fall within the high-risk regime (and, just as importantly, when does it not)?

Rather than restating every aspect of the Guidelines, this post highlights a number of interpretative points likely to matter most in practice.

Continue Reading EU AI Act Update: The European Commission Publishes Draft Guidelines on HRAIs
On 19 March 2026, Advocate-General Capeta issued an opinion in the case of Elisa Eesti AS v Estonian Government Security Committee (C-354/24). This case concerned, among other things, whether a 2022 order from the Estonian Government for Elisa Eesti AS—a 5G network operator—to remove Huawei components from its network for national security reasons was subject to EU law, constituted a lawful restriction on the right to offer an electronic communications network, and amounted to a “deprivation of property” requiring compensation. AG Capeta concluded that the relevant Estonian regime was within scope of EU law—specifically the European Electronic Communications Code (“EECC”)—even though that regime allowed for the imposition of orders on electronic communications network (“ECN”) providers for national security reasons. She also concluded that the requirement to obtain prior authorization from the Estonian government for use of network equipment constituted a restriction on the freedom to provide an ECN, but that this could be justified on national security grounds if the decision was based on a genuine risk assessment that meets the requirements for proportionality under EU law. She stated that this determination should be left to the referring court. Finally, she concluded that the Estonian Government’s order did not amount to a “deprivation” of property for which compensation would be required, as it was instead a mere “restriction” on the use of property. Below, we describe these non-binding conclusions in more detail. The Court’s final ruling in this case will have significant implications for the European Commission’s proposed revisions to the EU Cybersecurity Act, which as drafted would—among other things—allow the Commission to require ECN providers to remove and cease using components from designated high-risk jurisdictions in their networks. See our prior blog post on the proposal for a revised Cybersecurity Act here. … Continue Reading CJEU Advocate-General indicates that communications network operators can lawfully be required to remove Chinese components, and that compensation is not required

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