The world's first comprehensive AI regulation is here. If your organization builds, deploys, or uses AI systems that touch EU citizens or operations, you're in scope. Non-compliance means fines up to 7% of global revenue. The compliance window is closing.
The EU AI Act introduces a risk-based framework for AI systems. Every organization using AI in EU markets must classify their systems, implement controls, and prove compliance — or face enforcement.
Every AI system must be classified into one of four risk tiers: unacceptable, high-risk, limited, or minimal. Your classification determines your obligations — from outright prohibition to transparency requirements to full conformity assessments.
Social scoring, real-time biometric surveillance, manipulation of vulnerable groups, and predictive policing are banned outright. Organizations must audit existing AI systems to confirm none fall into prohibited categories — violations carry the highest fines.
High-risk AI systems — hiring, credit scoring, healthcare diagnostics, critical infrastructure — require risk management systems, data governance, technical documentation, human oversight, and ongoing monitoring. This is where most compliance work lives.
AI systems that pose clear threats to fundamental rights. Prohibited from February 2025.
AI in critical sectors. Requires conformity assessments, documentation, and ongoing monitoring.
AI systems that interact with people. Must disclose AI nature and meet transparency obligations.
Most AI systems. No mandatory requirements, but encouraged to follow codes of conduct.
The EU AI Act has extraterritorial reach. Like GDPR, it applies to any organization whose AI outputs affect EU citizens — regardless of where the company is headquartered.
AI-assisted diagnostics, clinical decision support, patient triage, and drug discovery tools serving EU patients or providers. Most medical AI qualifies as high-risk under Annex III.
AI credit scoring, fraud detection, algorithmic trading, and robo-advisory serving EU markets. Creditworthiness assessment is explicitly named as high-risk.
AI used in law enforcement, border management, judicial systems, and public administration within EU jurisdictions. Subject to the strictest requirements.
Any AI-powered software product deployed to EU users — from customer service chatbots to AI content generation. Providers and deployers both carry obligations.
AI in safety-critical systems, quality control, predictive maintenance, and industrial automation. AI embedded in machinery falls under existing product safety regulation plus AI Act.
AI-driven admissions, automated grading, hiring tools, and employee monitoring systems. Recruitment and educational AI are explicitly high-risk under Annex III.
Altiri's framework maps directly to EU AI Act obligations — from initial AI inventory and risk classification through technical documentation, conformity assessment preparation, and ongoing governance. We turn 500+ pages of regulation into a clear compliance roadmap.
Catalog every AI system in your organization. Classify each against EU AI Act risk tiers. Identify prohibited uses, high-risk systems, and transparency obligations.
Map current governance posture against EU AI Act requirements. Identify specific gaps in risk management, data governance, documentation, and human oversight. Prioritize by enforcement timeline and risk exposure.
Build conformity assessment packages, technical documentation, risk management systems, and monitoring frameworks. Create the evidence trail regulators expect.
Fractional vCAIO leadership to maintain compliance as the regulatory landscape evolves, new AI systems are deployed, and enforcement guidance matures.
"The EU AI Act isn't just a European problem. If your AI touches EU citizens — patients, customers, employees — you're in scope. The organizations that start their compliance journey now will have a defensible program by enforcement. The ones that wait will be scrambling through August 2026."
Deep expertise mapping between NIST AI RMF, ISO 42001, and EU AI Act requirements. Builds unified governance programs that satisfy multiple regulatory frameworks simultaneously.
Experience preparing organizations for regulatory assessments across healthcare (HIPAA), defense (CMMC), and financial services — the same rigor applied to EU AI Act conformity requirements.
Translates complex regulatory text into operational governance programs. Every deliverable is designed to be used by your teams — not filed in a drawer.
Take the free AI Readiness Assessment to understand your current governance posture, identify high-risk AI systems, and get a prioritized compliance roadmap — before August 2026.
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