National Cybersecurity Strategy
Italy has developed a structured cybersecurity strategy aimed at strengthening national resilience against cyberthreats, protecting critical infrastructures and ensuring the security of digital services. The strategy aligns with Directive (EU) 2022/2555, known as the NIS2 Directive, and is implemented through Legislative Decree Number 138 of 2024, which transposes the Directive into Italian law.
The Agency for National Cybersecurity, or ACN, is the principal authority overseeing cybersecurity at the national level. Established in 2021, it co-ordinates national and European cybersecurity policies, enhances co-operation between public and private entities, and ensures compliance with regulatory requirements.
The objectives of cybersecurity regulation are as follows:
Cybersecurity regulation in Italy is continuously evolving to address emerging threats and align with EU and international best practices. It is paramount to consider that Italy has implemented the Perimetro di Sicurezza Cibernetica (PSNC), which includes all the above-mentioned principles. The legal framework reinforces proactive risk management, fosters digital trust, and ensures the resilience of national infrastructures in the face of increasingly sophisticated cyberthreats.
Italy’s cybersecurity legal framework is based on a combination of EU regulations and national laws that govern critical infrastructure protection, digital resilience, data protection, and cybersecurity obligations for public and private entities. The primary legislative instruments include:
The National Cybersecurity Perimeter Law (Legislative Decree No 105/2019):
DORA (Regulation (EU) 2022/2554):
The NIS2 Directive (Directive (EU) 2022/2555 and Legislative Decree No 138/2024):
The GDPR (Regulation (EU) 2016/679):
Italy’s cybersecurity regulatory framework is designed to ensure digital resilience, protect national security and safeguard personal data. The combined effect of NIS2, DORA, the Cybersecurity Perimeter Law and the GDPR establishes strict obligations for organisations across multiple sectors, reinforcing the country’s defence against cyberthreats and data breaches.
Main Cybersecurity Regulators in Italy
Italy’s cybersecurity regulatory landscape is structured around several key authorities responsible for cybersecurity governance, critical infrastructure protection, financial sector resilience and data protection. The main regulatory bodies are:
ACN
Role and functions:
Scope of authority:
CSIRT Italia
Role and functions:
Scope of authority:
Bank of Italy and Financial Supervisory Authorities
Role and functions:
Scope of authority:
GPDP
Role and functions:
Scope of authority:
Conclusion
Italy’s cybersecurity regulatory framework is based on a multi-agency approach, ensuring comprehensive oversight of cybersecurity risks across different sectors:
Together, these regulatory bodies ensure that Italy’s digital infrastructure remains resilient, cyber-risks are effectively mitigated and organisations comply with strict security standards.
Scope of Application Under the NIS2 Directive
The NIS2 Directive establishes a harmonised cybersecurity framework across the EU, imposing strict security and incident reporting requirements on a broad set of critical and essential entities.
Entities covered:
Key obligations:
Scope of Application Under the U.S. Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA, 2022)
The Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA, 2022), enacted in the United States, establishes mandatory cybersecurity incident-reporting obligations for critical infrastructure operators under the oversight of the Cybersecurity and Infrastructure Security Agency (CISA).
Entities covered:
Key obligations:
Uncertainties in the Interpretation of the Scope
Despite the clear intent to improve cybersecurity resilience, both NIS2 and CIRCIA face interpretational uncertainties that could impact on their practical enforcement.
Defining “Significant” Incidents
NIS2 requires entities to report “significant incidents” but leaves room for interpretation in defining what qualifies as significant. The regulation considers impact on operations, users and the economy, but lacks precise thresholds.
CIRCIA mandates reporting for “substantial” cyber incidents but does not clearly define how severity and material impact should be assessed, leading to potential underreporting or overreporting.
Inclusion of SMEs and Supply Chain Entities
NIS2 explicitly covers only medium and large enterprises, but allows member states to extend regulations to smaller entities based on risk. This could lead to fragmentation across EU jurisdictions, where some countries impose stricter obligations than others.
CIRCIA applies to all entities supporting critical infrastructure, regardless of size, but does not clarify the thresholds for third-party ICT providers, leaving uncertainty for vendors and subcontractors.
Cross-Border Enforcement and Jurisdictional Overlaps
NIS2 faces challenges in cross-border enforcement, especially for multinational companies operating in multiple EU member states. National cybersecurity authorities may interpret enforcement differently, leading to inconsistent compliance burdens.
CIRCIA’s reporting obligations may conflict with state-level cybersecurity laws, particularly in California and New York, which have separate breach notification requirements. This creates regulatory duplication and compliance complexity.
Interaction with Other Regulations (GDPR, DORA and National Laws)
In the EU, NIS2 overlaps with GDPR and DORA, raising questions about regulatory precedence.
If a cyber incident involves both personal data breaches and operational disruptions, organisations must report separately to the Data Protection Authority and the Cybersecurity Authority, increasing compliance complexity.
In the USA, CIRCIA intersects with sector-specific regulations, such as:
Conclusion
While NIS2 and CIRCIA mark significant steps in enhancing critical infrastructure cybersecurity, interpretational uncertainties remain, particularly in defining reportable incidents, scope of covered entities and enforcement across jurisdictions:
Future regulatory clarifications, sector-specific guidance and international co-operation will be critical to ensuring uniform enforcement and effective cybersecurity protections.
Italy has adopted a comprehensive regulatory framework to ensure the cybersecurity resilience of critical infrastructure, aligning with EU legislation such as the NIS2 Directive and DORA, as well as national cybersecurity laws. The main legal instruments governing cybersecurity for critical infrastructure include:
These laws impose strict cybersecurity obligations on critical infrastructure operators across energy, telecommunications, financial services, healthcare, transportation and public administration.
Key Cybersecurity Requirements
Risk management and security measures are as follows.
Cyber Incident Reporting Obligations
Entities covered under the NIS2 Directive must report significant cybersecurity incidents to the Agency for National Cybersecurity (ACN) within 24 hours of detection.
Financial institutions regulated under DORA must report major ICT disruptions or cyber incidents to supervisory authorities within 72 hours.
Organisations must provide a detailed incident analysis, including the impact, response measures and mitigation strategies.
Business Continuity and Resilience Planning
Operators must maintain cyber-resilience plans, ensuring their ability to continue operations during cyber disruptions.
Companies must conduct regular stress tests and resilience exercises to evaluate their preparedness against cyber-attacks.
The use of back-up systems, redundancy mechanisms and disaster recovery protocols is mandatory for ensuring operational continuity.
Supply Chain Security and Third-Party Risk Management
Organisations must assess and monitor cybersecurity risks posed by third-party ICT service providers.
Under DORA, financial entities must implement contractual cybersecurity requirements for ICT suppliers, including incident-reporting clauses and security audit rights.
Critical infrastructure operators are required to verify the security posture of external vendors before integrating their services.
Compliance and Supervision
The ACN conducts regular inspections and audits to verify compliance with cybersecurity laws.
Non-compliance with cybersecurity obligations can result in severe penalties, including fines of up to 2% of global turnover.
Authorities have the power to impose remediation measures or restrict ICT operations if security risks are not properly managed.
Conclusion
Italy’s cybersecurity regulations establish a robust legal framework to protect critical infrastructure from cyberthreats. These requirements focus on risk management, incident reporting, resilience planning, supply chain security and regulatory supervision. Organisations operating in critical sectors must adhere to strict security standards to ensure national security, economic stability and public safety.
Italy imposes strict cybersecurity incident notification obligations on critical infrastructure owners and operators under the NIS2 Implementation Law, the National Cybersecurity Perimeter Law and DORA. These laws establish mandatory reporting frameworks to ensure rapid response to cyber incidents, minimise disruptions and enhance national cybersecurity resilience.
Notification Requirements Under NIS2 (Legislative Decree No 138/2024)
The NIS2 Directive introduces a harmonised cyber incident reporting framework for critical and essential service providers operating in sectors such as energy, transport, banking, healthcare and public administration.
Entities covered:
Incident reporting timeline:
Criteria for Reporting
An incident must be reported if it:
Penalties for Non-Compliance
Failure to report cyber incidents may result in fines of up to 2% of an entity’s global turnover.
The ACN can impose corrective measures, audits or operational restrictions if an organisation fails to comply.
Notification Requirements Under the National Cybersecurity Perimeter Law (Legislative Decree No 105/2019)
This law applies to operators of critical infrastructure and strategic national entities, such as those in defence, telecommunications, energy and public administration.
Incident reporting timeline:
Key obligations:
Enforcement and penalties:
Notification Requirements Under DORA for Financial Entities
DORA imposes specific cybersecurity reporting requirements on banks, insurance companies, investment firms and financial service providers.
Incident reporting timeline:
Criteria for Reporting
Incidents must be reported if they:
Regulatory Oversight
The Bank of Italy, Consob and IVASS oversee DORA compliance in Italy.
Financial institutions failing to report incidents face regulatory sanctions and potential suspension of operations.
Conclusion
Italy’s cybersecurity notification framework is one of the most stringent in the EU, requiring rapid incident reporting, real-time threat monitoring and co-ordinated response mechanisms.
These laws ensure that Italy’s critical infrastructure remains resilient, cyberthreats are swiftly addressed and government agencies can co-ordinate effective cyber crisis responses.
Italy has established a national cybersecurity framework that assigns clear responsibilities to state authorities for resilience building and cyberthreat identification. These responsibilities are defined under the NIS2 Implementation Law, the National Cybersecurity Perimeter Law and DORA.
National Cyber-Resilience Responsibilities
The Italian state is responsible for strengthening the cybersecurity resilience of critical infrastructure, essential service providers and public sector entities. These responsibilities include the following.
Developing and enforcing cybersecurity policies
The ACN is tasked with defining and implementing the National Cybersecurity Strategy, aligning with EU Regulations and international best practices.
The government establishes sector-specific cybersecurity regulations, ensuring that energy, telecommunications, healthcare, finance and public administration sectors comply with risk management requirements.
Supervising critical infrastructure cybersecurity compliance
The ACN conducts regular cybersecurity audits and risk assessments for national critical infrastructure operators.
Operators of essential services must submit cyber-risk management plans to demonstrate resilience preparedness.
The ACN can impose corrective measures and penalties if an entity fails to implement required cybersecurity measures.
Establishing cyber incident response capabilities
CSIRT Italia (the National Cybersecurity Incident Response Team) co-ordinates real-time threat response and mitigation for national security threats.
The State facilitates public-private collaboration on cybersecurity best practices, ensuring that private sector entities share threat intelligence with national authorities.
Italy participates in EU-wide cybersecurity initiatives, including the EU Cyber Crisis Liaison Organisation Network (EU-CyCLONe) for rapid cyber crisis management.
National Cyberthreat Identification and Intelligence-Sharing Responsibilities
The Italian government plays a proactive role in identifying, analysing and mitigating cyberthreats at the national level.
Cyberthreat monitoring and detection
The ACN and CSIRT Italia continuously monitor cyberthreats, vulnerabilities and attack vectors targeting critical infrastructure.
The State mandates that essential service providers implement advanced threat-detection systems, including intrusion detection, behavioural analytics and automated monitoring tools.
The National Cyber Threat Intelligence Platform collects, analyses and distributes real-time cyberthreat intelligence to government agencies and private entities.
Cybersecurity incident reporting and analysis
Entities covered under NIS2 and the National Cybersecurity Perimeter Law must report significant cybersecurity incidents to the ACN within 24 hours.
The State analyses cyber incident reports to assess risk trends, identify attack patterns and develop national defence strategies.
Italy collaborates with EU cybersecurity agencies (ENISA, Europol and NATO cyber defence units) to exchange threat intelligence and co-ordinate international cyber response actions.
National defence against cyberthreats
The government strengthens national cyber defence capabilities by investing in cybersecurity research, innovation and workforce development.
Italy enforces strict cybersecurity standards for ICT suppliers, ensuring that critical infrastructure operators use secure, vetted technologies.
The Ministry of Defence and intelligence agencies monitor cyberthreats linked to foreign actors, cyber-espionage and State-sponsored attacks.
Conclusion
Italy’s State responsibilities on resilience and threat identification ensure a structured and proactive approach to national cybersecurity:
Through policy enforcement, risk monitoring and cyber intelligence operations, Italy upholds a robust cybersecurity framework that safeguards national security, economic stability and public trust.
Italy’s financial sector’s operational resilience is regulated primarily under DORA, which establishes a harmonised cybersecurity framework for financial entities across the EU. DORA applies directly in Italy without requiring national transposition, ensuring uniform ICT risk management and cyber-resilience measures for financial institutions.
Material Scope of Application
DORA applies to a broad range of financial entities and their third-party ICT service providers, ensuring that digital resilience measures extend throughout the financial supply chain.
Financial entities covered:
Third-party ICT providers covered:
Key regulatory requirements:
Territorial Scope of Application
DORA applies to all financial entities operating within the EU, including:
The Bank of Italy, Consob and IVASS are responsible for DORA’s enforcement in Italy, ensuring that financial institutions meet digital resilience obligations and remain operationally secure against cyberthreats.
Under DORA, Italy enforces strict contractual obligations for ICT service providers that support financial sector operations. These requirements aim to ensure resilience, security and accountability in the supply chain of banks, investment firms, insurance companies and other financial entities.
Definition of ICT Service Providers in Italy
DORA defines ICT service providers as third-party entities offering digital, information technology or cybersecurity services to financial institutions. This includes:
If an ICT provider delivers essential digital services to financial entities, it falls under DORA’s oversight framework, requiring compliance with contractual and risk management obligations.
Contractual Requirements for ICT Service Providers Under DORA
Financial institutions in Italy must ensure that contracts with ICT service providers include specific provisions on risk management, security and resilience.
Mandatory Contractual Clauses
Security and risk management standards:
Business continuity and incident response obligations:
Incident reporting and notification requirements:
Audit rights and compliance monitoring:
Exit and termination strategy:
Classification of Critical ICT Services Under DORA
DORA mandates additional oversight for “critical ICT service providers”, which are entities indispensable for the stability of financial markets.
Critical ICT services include:
These critical ICT providers are subject to direct regulatory oversight from the European Supervisory Authorities (ESAs), including:
Will Every Cloud Service Provider Be Classified as Critical?
A cloud service provider will not necessarily be classified as critical. DORA applies additional scrutiny only to cloud providers whose services are fundamental to financial stability:
However, even non-critical cloud providers must comply with DORA’s contractual obligations, ensuring cybersecurity, resilience and transparency in financial ICT supply chains.
Conclusion
DORA imposes strict contractual requirements on ICT service providers, ensuring cybersecurity resilience, incident reporting and regulatory compliance for financial sector digital infrastructure:
DORA establishes a uniform legal framework for digital operational resilience in the EU financial sector, applying directly to Italy. The Regulation ensures that financial institutions and their ICT service providers can withstand, respond to and recover from cyberthreats and ICT disruptions.
Objectives of DORA
The primary goals of DORA are to:
Key Obligations Under DORA
DORA applies to banks, insurance companies, investment firms, crypto-asset service providers and ICT vendors supporting financial institutions. Its requirements include the following.
ICT risk management:
ICT third-party risk management:
Digital resilience testing:
Governance and compliance:
Incident and Reporting Obligations Under DORA
DORA introduces strict cybersecurity incident reporting requirements to prevent systemic financial risks.
Incident classification:
The reporting timeline and process is as follows.
Cross-border co-ordination:
Conclusion
DORA sets out comprehensive digital resilience standards for Italy’s financial sector, ensuring strict cybersecurity measures, third-party risk controls and mandatory cyber incident reporting:
These measures enhance cyber-resilience, protect financial markets and ensure regulatory oversight in an increasingly digital financial ecosystem.
Under DORA, regulatory authorities in Italy and the EU enforce strict operational resilience obligations on critical ICT service providers that support the financial sector. These providers – such as cloud computing firms, cybersecurity vendors and data-processing centres – are subject to direct regulatory oversight due to their essential role in financial stability.
Regulatory Authorities Responsible for Enforcement
The enforcement of operational resilience obligations is managed by both national and EU-level regulators, including:
For critical ICT providers, DORA establishes a direct regulatory oversight framework, allowing EU financial authorities to intervene in ICT service delivery, mandate corrective actions and impose sanctions.
Compliance Obligations for Critical ICT Service Providers
Critical ICT service providers must comply with specific operational resilience obligations, including:
Enforcement Measures and Sanctions
Regulatory bodies enforce compliance through audits, inspections and corrective actions. If a critical ICT provider fails to meet operational resilience standards, the following enforcement measures apply.
Supervisory audits and on-site inspections
Regulatory authorities audit ICT providers to verify compliance with DORA and cybersecurity best practices.
On-site inspections and forensic reviews are conducted if vulnerabilities or past incidents indicate a high cyber risk.
Corrective measures and compliance orders
If deficiencies are found, regulators can issue binding corrective measures, including:
Financial penalties for non-compliance
ICT service providers failing to meet regulatory obligations may face severe financial penalties:
Termination of ICT service contracts
If a critical ICT provider poses an unacceptable risk to financial stability, regulators can order financial institutions to terminate service contracts with the non-compliant provider.
The ESAs maintain a register of high-risk ICT service providers, restricting their access to EU financial markets.
Regulatory intervention in ICT service operations
In extreme cases, regulators may impose operational restrictions, requiring ICT providers to suspend or restructure critical services that threaten financial stability.
National authorities can mandate emergency cybersecurity measures if a major cyber event impacts on financial institutions.
Cross-Border Enforcement and Co-ordination
Because many critical ICT service providers operate across multiple jurisdictions, enforcement requires EU-wide co-ordination:
Conclusion
Enforcement of operational resilience obligations for critical ICT providers under DORA is strict and proactive, ensuring financial market stability and cybersecurity resilience:
Through these measures, Italy and the EU maintain a secure, resilient and stable financial digital infrastructure, protecting against cyberthreats and ICT disruptions.
Italy’s legal framework for cybersecurity and financial resilience includes multiple provisions that directly or indirectly regulate international data transfers. These rules stem from EU regulations such as the GDPR, DORA and NIS2, as well as national cybersecurity laws.
The impact on international data transfers arises through:
Direct Provisions Impacting on International Data Transfers
GDPR:
DORA:
NIS2:
The National Cybersecurity Perimeter Law:
Indirect Provisions Affecting International Data Transfers
Cloud service and ICT provider oversight:
Supply chain cybersecurity and data flow restrictions:
Cyber incident notification and international data flows:
Conclusion
Italy’s regulatory framework restricts and regulates international data transfers through the GDPR, DORA, NIS2 and national cybersecurity laws:
These legal provisions ensure that international data transfers do not expose Italy’s financial and critical sectors to cyberthreats, unauthorised access or geopolitical risks.
In Italy, threat-led penetration testing (TLPT) is mandated under DORA, which directly applies to banks, investment firms, insurance companies and other financial sector entities. The Bank of Italy, Consob and IVASS oversee TLPT compliance for financial institutions.
Scope of TLPT Requirements
TLPT is a high-level cybersecurity testing framework designed to simulate real-world cyber-attacks on financial institutions and their critical ICT infrastructure:
Key TLPT Obligations Under DORA
Risk-based TLPT execution:
Regulatory oversight and reporting:
Cross-border testing and EU co-ordination:
Enforcement and Non-Compliance Penalties
Failure to conduct TLPT or address identified vulnerabilities can lead to regulatory sanctions, including fines and operational restrictions.
Non-compliance with TLPT obligations may result in penalties up to 2% of global turnover under DORA.
Regulators may impose mandatory audits, security patches or temporary suspension of ICT services if critical risks are found.
Conclusion
Italy enforces strict TLPT requirements for major financial institutions and their critical ICT providers, ensuring proactive cybersecurity resilience:
These measures strengthen digital operational resilience, protecting Italy’s financial sector from advanced cyberthreats and systemic disruptions.
Italy has established a comprehensive cybersecurity and cyber-resilience regulatory framework, aligning with EU Directives and Regulations. The country enforces strict cyber-resilience obligations for critical infrastructure, financial institutions, public administration and private entities handling sensitive data.
The legislative framework is built on:
Core Cyber-Resilience Laws in Italy
The GDPR:
NIS2:
DORA:
The National Cybersecurity Perimeter Law:
Cybercrime and national security regulations:
Enforcement and Supervision of Cyber-Resilience
The ACN enforces NIS2, supervises critical infrastructure security, and co-ordinates cyber crisis response.
The Bank of Italy, IVASS and Consob regulate financial sector cyber-resilience under DORA, ensuring compliance with ICT risk management and testing requirements.
The Italian Data Protection Authority (Garante per la Protezione dei Dati Personali – GPDP) ensures GDPR compliance, personal data security and breach-reporting enforcement.
Future Legislative Developments in Cyber-Resilience
National AI and cybersecurity regulations
The EU AI Act and upcoming EU cybersecurity certification schemes will impose new compliance obligations for AI-driven cybersecurity solutions and critical infrastructure technologies.
Strengthened supply chain security rules
Italy is expected to introduce additional controls on ICT vendors and foreign technology providers, especially in critical sectors such as telecommunications and defence.
Expanded cybercrime enforcement
New measures will increase penalties for cyber-attacks targeting government systems and essential services.
Conclusion
Italy’s cyber-resilience legal framework is one of the most robust in the EU, incorporating the GDPR, NIS2, DORA and national cybersecurity laws;
These measures ensure that Italy’s digital infrastructure remains resilient against cyberthreats, safeguarding economic stability and national security.
Italy enforces strict cyber-resilience obligations across critical infrastructure, financial institutions and data-driven enterprises under EU Regulations (DORA, NIS2, GDPR) and national cybersecurity laws. These obligations ensure ICT risk management, incident reporting, business continuity and regulatory oversight to mitigate cyberthreats and enhance digital resilience.
Cyber-Resilience Obligations Under Existing Legislation
GDPR:
NIS2:
DORA:
The National Cybersecurity Perimeter Law:
Cyber-Resilience Obligations Under Draft Legislation and Future Regulations
EU AI Act (Draft):
Cyber-Resilience Act (Draft – Proposed by the European Commission):
Strengthened supply chain cybersecurity rules (upcoming national reforms):
Key enforcement mechanisms and penalties are as follows.
Conclusion
Italy’s cyber-resilience obligations are among the most stringent in the EU, covering critical infrastructure, financial institutions and digital service providers:
These measures fortify national cybersecurity resilience, protect critical services from cyberthreats and ensure compliance with evolving EU Regulations.
Italy’s cybersecurity and cyber-resilience legal framework is shaped by EU Regulations, national laws and sector-specific rules that govern data protection, critical infrastructure security, financial sector resilience and cybercrime prevention.
The GDPR:
NIS2:
DORA:
The National Cybersecurity Perimeter Law:
Cybercrime and digital security laws:
Upcoming and draft legislation:
Conclusion
Italy enforces a multi-layered cybersecurity legal framework, ensuring:
Future laws will further enhance cyber-resilience, AI security and supply chain protection, reinforcing Italy’s national and EU-wide cybersecurity defences.
Italy enforces strict cybersecurity obligations under the GDPR and national data protection laws. These rules require organisations processing personal data to implement technical and organisational security measures to prevent data breaches, unauthorised access and cyberthreats.
Key Cybersecurity Obligations Under the GDPR
Risk-based security measures (Article 32, GDPR)
Organisations must implement appropriate technical and organisational security measures based on data sensitivity and processing risks.
Required measures include:
Data breach notification (Articles 33 & 34, GDPR)
Organisations must report personal data breaches to the GPDP within 72 hours.
If the breach poses a high risk to individuals, the organisation must also notify affected data subjects without delay.
Security of processing (Article 25, GDPR – Privacy by Design and by Default)
Organisations must integrate cybersecurity protections from the outset of data-processing activities.
Systems must be configured to minimise data collection, restrict access and ensure secure storage.
Third-party risk management
Companies using cloud services, external data processors or ICT vendors must ensure contractual compliance with GDPR security requirements.
Data-processing agreements (DPAs) must include security guarantees, incident-reporting procedures and compliance obligations.
Enforcement and Penalties for Non-Compliance
Severe GDPR fines apply for cybersecurity failures:
The GPDP conducts security audits, issues compliance orders and enforces corrective measures.
Conclusion
Italy’s data protection cybersecurity obligations require organisations to implement strong security controls, monitor risks and report breaches. Failure to comply can result in significant financial penalties and regulatory actions, reinforcing the importance of robust cybersecurity practices in data-processing activities.
Italy follows EU-wide regulations on AI security and cybersecurity obligations, with upcoming AI-specific laws under the Artificial Intelligence Act (AI Act - EU Draft). Currently, AI systems must comply with GDPR, NIS2, and cybersecurity best practices, ensuring data protection, algorithmic security, and resilience against cyberthreats.
AI Security and Risk Management Obligations
General cybersecurity requirements (the GDPR and NIS2):
Upcoming AI Act cybersecurity obligations (EU Draft):
AI Supply Chain and Third-Party Security Obligations
Cloud AI services and external AI vendors must meet cybersecurity certification standards before integration.
Financial and critical sectors using AI for fraud detection or automated decision-making must comply with DORA and NIS2 security controls.
AI Cybersecurity Enforcement and Compliance
The GPDP enforces AI security compliance under the GDPR.
The ACN will oversee AI-related cyber-risks under NIS2.
Violations of AI cybersecurity standards could lead to penalties similar to GDPR fines (up to 4% of global turnover).
Conclusion
Italy’s AI cybersecurity obligations focus on risk management, data security and adversarial resilience. Future EU AI Act regulations will further tighten cybersecurity requirements for high-risk AI systems, ensuring robust security frameworks and regulatory enforcement.
Italy enforces strict cybersecurity obligations for the healthcare sector under GDPR, NIS2, and national health data protection laws. These regulations ensure secure processing, storage, and transmission of sensitive health data, protecting medical institutions from cyberthreats, data breaches, and unauthorised access.
Key Cybersecurity Obligations Under Healthcare Regulations
GDPR:
NIS2:
Electronic Health Record (EHR) and telemedicine regulations:
Cybersecurity Compliance and Enforcement
The Italian Ministry of Health and GPDP oversee compliance with health data security regulations.
Non-compliance with healthcare cybersecurity laws can result in fines of up to EUR20 million or 4% of global turnover under the GDPR.
The ACN enforces cybersecurity resilience for hospitals and digital health providers under NIS2.
Conclusion
Italy’s healthcare cybersecurity laws impose strict data protection, network security and incident-reporting requirements. Hospitals, medical institutions and digital health services must comply with the GDPR and NIS2 to ensure patient data confidentiality, system resilience and regulatory compliance.
Via Borgonuovo 12
20121 Milan
Italy
+39 028 424 7194
+39 0270 0512 101
info@ictlc.com www.ictlc.comCybersecurity and digital resilience are critical priorities in Italy, shaped by new EU Regulations, evolving cyberthreats and increasing digital transformation across industries. Businesses operating in Italy must adapt to a rapidly changing regulatory and risk landscape, ensuring compliance with stringent cybersecurity obligations while mitigating emerging cyber-risks.
Regulatory Evolution: Strengthening Cybersecurity Laws
Implementation of NIS2 and national cybersecurity reforms
Italy has adopted Legislative Decree No 138/2024, implementing the NIS2 Directive (Directive (EU) 2022/2555) and significantly expanding cybersecurity compliance obligations for essential and important entities. Key regulatory shifts include:
Italy’s National Cybersecurity Perimeter Law (Legislative Decree No 105/2019) also enforces data localisation requirements, requiring critical infrastructure operators to store and process security-sensitive data within the EU or in trusted jurisdictions.
DORA and financial sector digital resilience
The Digital Operational Resilience Act (DORA – Regulation (EU) 2022/2554) directly applies to Italy’s financial sector, introducing strict cyber-resilience and ICT risk management standards:
These regulations signal a shift from reactive cybersecurity measures to proactive resilience strategies, requiring financial institutions and ICT vendors to enhance cyber defences.
Emerging Cyberthreats and Risk Landscape
Rise in ransomware and cyber-extortion attacks
Italy has seen a surge in ransomware incidents, targeting public institutions, healthcare providers and large corporations. Cybercriminals exploit vulnerabilities in outdated IT systems and third-party supply chains, demanding ransom payments in cryptocurrency to avoid data leaks.
Businesses must implement advanced endpoint protection, secure back-up solutions and real-time threat intelligence-monitoring to mitigate ransomware risks.
Supply chain attacks and third-party risk
Cybercriminals increasingly target ICT vendors, cloud service providers and managed security services to infiltrate large enterprises and government networks:
AI-powered cyberthreats
The adoption of artificial intelligence (AI) and automation in cybersecurity presents both opportunities and risks. While AI enhances threat detection and anomaly identification, cybercriminals are leveraging AI-driven attacks, including deepfake fraud and automated phishing campaigns.
With the EU AI Act in development, companies deploying AI-based security tools must comply with transparency, accountability and risk mitigation requirements.
Compliance Challenges and Business Adaptation
Increased regulatory complexity
The overlap of cybersecurity laws (the GDPR, NIS2, DORA and national regulations) creates compliance challenges for businesses, particularly multinational corporations operating in Italy.
To navigate regulatory complexities, organisations must:
Operational and financial burden on SMEs
While large corporations can invest in cybersecurity infrastructure and compliance programmes, small and medium-sized enterprises (SMEs) face financial and technical challenges in meeting regulatory standards:
Future Outlook: Strengthening Cyber-Resilience in Italy
Cybersecurity investment and public-private collaboration
Italy is expanding investment in cybersecurity innovation, fostering collaboration between government agencies, private enterprises and academia to strengthen national cyber defence capabilities:
Focus on AI and quantum-resistant cybersecurity
AI-powered cybersecurity solutions will play a key role in automating threat detection, response and risk analysis.
Quantum-resistant cryptography is emerging as a critical area of research, ensuring long-term protection against quantum computing threats.
Harmonisation of cybersecurity standards across the EU
The EU Cyber-Resilience Act (expected in 2025) will introduce mandatory cybersecurity certification for ICT products, further harmonising cyber-risk management across sectors.
Italy will need to adapt national regulations to align with new EU cybersecurity frameworks, ensuring interoperability and compliance efficiency.
Conclusion
Italy’s cybersecurity landscape is rapidly evolving, driven by regulatory reforms, emerging cyberthreats and technological advancements. Businesses must proactively enhance cyber-resilience, adopting risk-based security strategies, compliance automation and advanced threat intelligence to navigate the growing complexity of cybersecurity obligations.
As digital transformation accelerates, organisations that prioritise cybersecurity investments, strengthen regulatory compliance and adopt cutting-edge security technologies will gain a competitive advantage in the Italian market.
Via Borgonuovo 12
20121 Milan
Italy
+39 028 424 7194
+39 0270 0512 101
info@ictlc.com www.ictlc.com