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How Artificial Intelligence is Revolutionizing Medical Devices Following the EU AI Act

Artificial intelligence is rapidly transforming the life sciences sector — and its impact on the medical devices industry is particularly significant, especially after the coming into force of the EU AI Act. From diagnostics to patient monitoring and personalized treatments, AI-powered medical technologies are reshaping the future of healthcare in Italy, Europe, and globally. But as innovation accelerates, so does the need for a robust legal framework — especially under the recently adopted AI Act.

ByNicola LandolfiJuly 8, 20250Comments 7 minRead time

Gaming

New Italian Guidelines for Certification in Online Gambling: Key Changes and Open Questions

The final version of the Italian guidelines on certification for online gambling systems introduce a stricter and more comprehensive regulatory framework, setting new technical and procedural standards for platform compliance.

ByGiulio CoraggioJune 26, 20250Comments 4 minRead time

Data Protection & Cybersecurity

Ransomware and Crime – A Proposal to Tackle Cyber Extortion in Italy

The potential classification of activities associated with ransomware cyberattacks, including ransom payments by victims, as a crime has long been an unresolved issue, also in Italy. This concern has now led Italy to introduce a groundbreaking legislative proposal aimed at enhancing cybersecurity and mitigating threats posed by digital extortionists.

ByGiulio CoraggioJune 23, 20250Comments 5 minRead time

Technology

AI Act Compliance Deadline Approaching: Are You Ready?

In less than 50 days, relevant provisions of the EU AI Act will become applicable making even more paramount for businesses to ensure compliance in the exploitation of artificial intelligence systems.

ByGiulio CoraggioJune 17, 20250Comments 6 minRead time

Technology

Defining High-Risk AI Systems Under the AI Act – Consultation Now Open!

The European Commission has launched a consultation on high-risk AI systems to support the adoption of the implementing act under Article 6(2) of the AI Act which is a crucial step for any sort of business.

ByGiulio CoraggioJune 10, 20250Comments 6 minRead time

Data Protection & Cybersecurity

NIS 2 – Personal Liability of Directors For Lack of Compliance

The NIS 2 Directive has issued a significant warning to companies within the European Union: the personal liability of directors for lack of compliance is now a critical issue that cannot be ignored and the responsible directors must be notified by the end of May 2025.

ByGiulio CoraggioMay 26, 20250Comments 6 minRead time

Gaming

Italian Tender for Remote Gambling Licenses – Final Days to Apply

The countdown has begun: just a few days remain before the submission deadline for the Italian tender for remote gambling licenses.

ByGiulio CoraggioMay 15, 20250Comments 6 minRead time

Gaming

NIS 2 Gambling Obligations – What Changes for Operators and Suppliers

Gambling operators and their suppliers must address the NIS 2 obligations, which impose stringent cybersecurity requirements across the European Union.

ByGiulio CoraggioMay 8, 20250Comments 7 minRead time

Data Protection & Cybersecurity

NIS 2 in Italy – Deadlines and Obligations

This infographic summarizes, in legal design style, the main deadlines and obligations imposed by Legislative Decree No. 138/2004 (the NIS2 Decree), which transposed in Italy the provisions of Directive (EU) 2022/2555 on measures for a high common level of cybersecurity (the NIS2 Directive).

ByGiulia ZappaterraMay 7, 20250Comments 1 minRead time

Gaming

Gambling operators shall deal with the implementation of NIS 2 in Malta

The implementation in Malta of the NIS 2 Directive has substantial impact on gambling operators and suppliers.

ByGiulio CoraggioApril 28, 20250Comments 11 minRead time