EU AI Act

The EU AI Act is comprehensive legislation that regulates AI systems based on risk, applying to providers and deployers of AI systems in the European Union market. Adopted in 2024, it establishes a horizontal regulatory framework covering all sectors and use cases.The regulation addresses:

  • Risk-Based Classification: Different requirements based on AI system risk levels
  • Prohibited Practices: AI systems that pose unacceptable risks
  • High-Risk Systems: Stringent requirements for AI in critical areas
  • Transparency Obligations: Disclosure requirements for certain AI systems
  • General Purpose AI: Special rules for foundation models and generative AI
  • Governance Framework: EU-wide enforcement and oversight mechanism
Key Compliance Requirements

Governance and Accountability

Organizations must assign clear AI governance roles, including board-level oversight, to ensure responsible deployment of AI systems. This includes establishing internal policies, risk frameworks, and operational procedures while maintaining adequate resources and expertise to oversee safe and compliant AI lifecycle management.

Risk Management

AI systems should be evaluated and classified by their risk level, with continuous risk assessments performed from design through deployment. Documented mitigation strategies and regular reviews ensure risks are proactively identified, monitored, and reduced as systems evolve.

Data Governance

High-quality, relevant, and representative data is essential for trustworthy AI. Organizations must monitor for bias, protect personal data, track data lineage, and document all data sourcing and preprocessing activities to maintain transparency and compliance with privacy standards.

Technical Documentation

Comprehensive documentation is required to explain how AI systems function, their intended use, technical architecture, development methods, and validation metrics. This includes detailed records of risk controls, performance evaluations, and testing methodologies to support auditability and regulatory compliance.

Transparency and Disclosure

Users and impacted individuals should be fully informed about AI system capabilities, limitations, and decision-making involvement. Organizations must label AI-generated content, ensure human oversight, and provide clear communication so individuals understand when and how AI influences outcomes.

Human Oversight

AI systems must be designed to enable meaningful human control. Clear oversight responsibilities, defined intervention processes, and adequate training ensure humans can monitor performance, override outcomes when necessary, and escalate issues effectively.

Why This Framework is Critical

The EU AI Act is the world's first comprehensive legal framework for AI, establishing mandatory requirements based on risk levels. Organizations deploying AI in Europe must comply or face penalties up to €35 million or 7% of global turnover. The regulation impacts any organization with AI systems used by EU persons, regardless of where the organization is headquartered.

Financial Services
  • High-Risk Classification: Credit scoring and loan approval AI require conformity assessments, technical documentation, and bias testing before EU deployment
  • Discrimination Prevention: Must demonstrate AI models don't discriminate based on protected characteristics, maintaining comprehensive training data and performance documentation
  • Severe Penalties: Non-compliance risks €15 million fines plus regulatory enforcement potentially restricting lending operations across EU markets
Healthcare
  • Medical Device Requirements: Diagnostic and treatment AI classified as high-risk requiring CE marking, clinical validation, and post-market surveillance systems
  • Safety Validation: Must demonstrate performance across diverse patient populations and maintain continuous monitoring for model degradation affecting accuracy
  • Liability Exposure: Non-compliant medical AI exposes healthcare organizations to both regulatory penalties and malpractice liability for unsafe systems
Law Enforcement
  • Maximum Penalties: Predictive policing and risk assessment AI face strictest requirements with €35 million penalties for prohibited uses
  • Human Rights Protection: Must ensure systems don't perpetuate bias against marginalized communities and maintain comprehensive oversight and accountability
  • Biometric Restrictions: Real-time biometric identification in public spaces generally prohibited except narrow law enforcement exceptions requiring judicial authorization
Education
  • Student Assessment: AI evaluating student performance or determining educational opportunities classified as high-risk requiring fairness validation
  • Bias Testing: Must demonstrate AI assessment tools are fair across student demographics, disabilities, and socioeconomic backgrounds
  • EdTech Liability: Platform providers face conformity assessment requirements and liability for discriminatory outcomes affecting students' futures
Critical Infrastructure
  • Safety Requirements: AI managing energy, water, transportation classified as high-risk requiring rigorous safety testing and incident response procedures
  • Resilience Obligations: Must ensure human operators can override AI decisions and conduct regular security assessments against adversarial attacks
  • Public Safety Impact: AI failures could trigger regulatory investigations, service disruption penalties, and liability for infrastructure safety incidents
Biometric System
  • Transparency Mandates: Must inform users about AI-based biometric processing, obtain appropriate consent, and provide opt-out mechanisms where feasible
  • GDPR Coordination: Violations risk compounding penalties under both EU AI Act (€35 million) and GDPR (€20 million) requiring coordinated compliance
  • Surveillance Prohibition: Real-time biometric surveillance in public spaces prohibited except specific law enforcement scenarios with strict oversight requirements
AI ASSURANCE PLATFORM
How Trusys Helps You
Comprehensive Security Assessments
Our platform conducts thorough evaluations of your AI applications against the Security Frameworks, identifying vulnerabilities in your application before attackers do.
Real World Attack Simulation
Real-world attack simulations that uncover security weaknesses across all vulnerable categories, providing actionable remediation guidance.
Continous Analysis & Monitoring
Ongoing security monitoring and vulnerability management to ensure your applications remain protected as new threats emerge.
Compliance Support
Navigate regulatory requirements with confidence as we help align your security practices with industry standards and other security frameworks.
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