Conformità normativa

Regulatory compliance refers to the comprehensive set of processes, controls, and governance structures that organisations implement to ensure conformity with applicable laws and regulations. In the European Union context, the regulatory landscape has expanded significantly in recent years, creating a complex web of overlapping obligations that companies must navigate.

The current EU regulatory environment includes several major frameworks that interact with each other: the EU AI Act governing artificial intelligence systems, the General Data Protection Regulation (GDPR) for personal data protection, the Digital Operational Resilience Act (DORA) for financial sector cybersecurity, the NIS2 Directive for network and information systems security, the Corporate Sustainability Reporting Directive (CSRD) for sustainability disclosures, and the Markets in Crypto-Assets Regulation (MiCA) for the crypto industry. Each framework carries its own compliance requirements, reporting obligations, and penalty regimes.

Effective regulatory compliance requires a systematic approach encompassing several key elements: regulatory monitoring to identify applicable requirements and track changes, gap analysis to assess current compliance status, implementation of policies, procedures, and technical controls, ongoing monitoring and testing, documentation and record-keeping, training and awareness programmes, incident management and reporting, and regular internal and external audits.

The challenge for modern organisations lies in the interconnected nature of these regulations. A single business activity may trigger compliance obligations under multiple frameworks simultaneously. For example, deploying an AI-powered fraud detection system in a bank implicates the EU AI Act (as a high-risk AI system), GDPR (processing personal data), and DORA (ICT risk management). This regulatory convergence demands an integrated compliance approach rather than siloed management of individual regulations, making specialised regulatory technology (RegTech) solutions increasingly essential for efficient compliance management.

• Regolamento UE sull’IA
• DORA
• NIS2
• CSRD/ESG
• MiCA
• GDPR