AI Regulatory Landscape

EU AI Act

Europe In Force 2024 High-Risk AI

The world's first comprehensive AI regulation. Classifies AI systems by risk level and imposes strict requirements on high-risk applications in healthcare, finance, employment, and critical infrastructure.

Key Requirements:

• Risk management systems throughout AI lifecycle
• Data governance and quality requirements
• Technical documentation and logging
• Transparency to users
• Human oversight capabilities
• Accuracy, robustness, and cybersecurity

How Reality Fidelity Helps:

Completeness gates ensure AI systems cannot emit outputs without verified required state, satisfying risk management and data quality requirements. Provenance tracking creates the technical documentation and logging required for compliance.

FDA AI/ML Guidance

United States Healthcare SaMD

FDA guidance for Software as a Medical Device (SaMD) incorporating AI/ML. Focuses on ensuring AI-based medical devices are safe and effective throughout their lifecycle.

Key Requirements:

• Good Machine Learning Practice (GMLP)
• Algorithm change protocol documentation
• Real-world performance monitoring
• Predetermined change control plans
• Clinical validation requirements

How Reality Fidelity Helps:

Required state registries ensure diagnostic AI systems verify patient context and calibration before emitting classifications. Audit trails document every decision point for FDA review.

NIST AI Risk Management Framework

United States Framework Voluntary

Voluntary framework providing guidance for managing AI risks. Structured around four core functions: Govern, Map, Measure, and Manage.

Core Functions:

• Govern — Establish AI risk management culture and accountability
• Map — Identify and categorize AI risks
• Measure — Analyze and assess AI risks
• Manage — Prioritize and act on AI risks

How Reality Fidelity Helps:

Reality Fidelity architecture directly implements the "Measure" and "Manage" functions by quantifying completeness of required state and preventing outputs when risks are unacceptable.

SEC AI Guidance

United States Finance Proposed

Proposed SEC rules addressing AI use by investment advisers and broker-dealers, focusing on conflicts of interest and investor protection.

Key Concerns:

• Predictive data analytics in investment advice
• Conflicts of interest from AI optimization
• Explainability of AI-driven recommendations
• Fairness in algorithmic trading