“With broad extraterritorial reach, significant penalties of up to seven percent of worldwide annual turnover, and an emphasis on risk-based governance, the EU AI Act will have a profound impact on U.S. businesses that develop, use, and distribute AI systems.”
Why this is important: The EU AI Act, effective August 1, 2024, marks a major shift in AI regulation, impacting businesses globally, particularly in the U.S. The Act introduces a risk-based governance system with penalties up to 7 percent of global revenue, and focuses on high-risk AI systems, such as those used in critical sectors like biometric identification, education, law enforcement, and healthcare. The Act applies to U.S. companies operating AI systems in the EU, requiring compliance with strict regulations on risk management, transparency, and data governance.
The Act defines an AI System as “a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that…infers from the input it receives how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.”
The Act then classifies AI systems into four risk categories: prohibited, high-risk, limited-risk, and minimal-risk, with most attention on high-risk systems. Companies must implement measures to ensure the accuracy, security, and transparency of AI systems, especially those used in regulated products like medical devices or vehicles. High-risk AI providers must register their systems in an EU database and complete conformity assessments.
The legislation applies to U.S. companies across the AI value chain, even if they only develop or use AI systems with outputs used in the EU. Most rules for high-risk AI will take effect in August 2026, while additional regulations for certain products will come into force in 2027.
U.S. companies are advised to assess their AI use, review data quality, and prepare for evolving AI compliance laws to avoid significant fines and ensure smooth market operations.
If your business needs assistance understanding and complying with the new EU AI Act, attorneys at Spilman Thomas & Battle are ready to help. Please reach out today to schedule a consultation to answer your questions. --- Shane P. Riley