European Union (EU)

On February 27, 2025, the Court of Justice of the European Union (“CJEU”) issued a significant decision on the right of data subjects to request access to their personal data under Article 15 GDPR, specifically as it relates to automated decision-making and striking an appropriate balance between informing data subjects and protecting trade secrets (Case C‑203/22).Continue Reading CJEU Clarifies GDPR Rights on Automated Decision-Making and Trade Secrets

On February 20, 2025, the European Commission’s AI Office held a webinar explaining the AI literacy obligation under Article 4 of the EU’s AI Act.  This obligation started to apply on February 2, 2025.  At this webinar, the Commission highlighted the recently published repository of AI literacy practices.  This repository compiles the practices that some AI Pact companies have adopted to ensure a sufficient level of AI literacy in their workforce.  Continue Reading European Commission Provides Guidance on AI Literacy Requirement under the EU AI Act

On February 6, 2025, Advocate General Spielmann released his opinion in the EDPS vs. SRB case (Case C‑413/23 P).  In this case, the European Data Protection Supervisor appealed a decision from the General Court (see our blog post here).

In essence, the case turns on the question of whether…

Continue Reading CJEU Advocate General Supports Pragmatic Definition of Personal Data

On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers

In the final quarter of 2024, there have been significant developments in the EU cybersecurity legal landscape. Most prominently, the EU institutions adopted the Cyber Resilience Act and mid-October marked the deadline for Member States to transpose the NIS2 Directive into national law. Most Member States failed to meet the NIS2 transposition deadline, which resulted in the European Commission sending a formal notice to 23 Member States, urging them to transpose the Directive. These 23 Member States have been given two months to respond. (For more information on the Cyber Resilience Act and NIS2 Directive, see our blog posts here and here.)Continue Reading Three Recent Developments in the EU Cyber Landscape

On 2 December 2024, the European Data Protection Board (“EDPB”) adopted its draft guidelines on Article 48 GDPR (the “Draft Guidelines”). The Draft Guidelines are intended to provide guidance on the GDPR requirements applicable to private companies in the EU that receive requests or binding demands for personal data from public authorities (e.g., law enforcement or national security agencies, as well as other regulators) located outside the EU.Continue Reading EDPB adopts draft guidelines on requirements when responding to requests from non-EU public authorities

On May 30, 2024, the Court of Justice of the EU (“CJEU”) handed down its rulings in several cases (C-665/22, Joined Cases C‑664/22 and C‑666/22, C‑663/22, and Joined Cases C‑662/22 and C‑667/22) concerning the compatibility with EU law of certain Italian measures imposing obligations on providers of online platforms and search engines.  In doing so, the CJEU upheld the so-called “country-of-origin” principle, established in the EU’s e-Commerce Directive and based on the EU Treaties principle of free movement of services.  The country-of-origin principle gives the Member State where an online service provider is established exclusive authority (“competence”) to regulate access to, and exercise of, the provider’s services and prevents other Member States from imposing additional requirements.

We provide below an overview of Court’s key findings.Continue Reading CJEU Upholds Country-of-Origin Principle for Online Service Providers in the EU

On May 20, 2024, a proposal for a law on artificial intelligence (“AI”) was laid before the Italian Senate.

The proposed law sets out (1) general principles for the development and use of AI systems and models; (2) sectorial provisions, particularly in the healthcare sector and for scientific research for healthcare; (3) rules on the national strategy on AI and governance, including designating the national competent authorities in accordance with the EU AI Act; and (4) amendments to copyright law. 

We provide below an overview of the proposal’s key provisions.Continue Reading Italy Proposes New Artificial Intelligence Law

On May 9, 2024, the Italian data protection authority (“Garante”) published a decision identifying the safeguards that controllers must put in place when processing health data for medical research purposes, in cases where data subjects’ consent cannot be obtained for ethical or organizational reasons.

The Garante’s decision follows a recent legislative development, enacted by Law n. 56 of April 29, 2024, and effective as of May 1, 2024, which amended, among other things, Article 110 of the Italian Privacy Code.  The amendment removes the obligation to submit a research program and related data protection impact assessment (“DPIA”) for prior consultation to the Garante, in cases where it is impossible or disproportionately burdensome to contact the concerned individuals.  

We provide below an overview of the legal framework and the safeguards identified by the Garante.Continue Reading Italian Legislator and Regulator Update Rules on Processing of Health Data for Medical Research