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R0021/2026-03-25/Q004

Query: How do regulated industries such as financial services, healthcare, and aviation currently test and validate AI systems before deployment in production environments?

BLUF: All three regulated industries have established validation frameworks for AI, but all acknowledge these frameworks were designed for traditional systems and need adaptation. Aviation (FAA) released an AI Safety Assurance Roadmap. Healthcare (FDA) requires Good Machine Learning Practice principles and change control plans. Finance (Fed/OCC) applies SR 11-7 model risk management. NIST provides a voluntary cross-industry AI risk framework.

Answer: H3 (Frameworks exist but adapting) · Confidence: High


Summary

Entity Description
Query Definition Question as received, clarified, ambiguities, sub-questions
Assessment Full analytical product
ACH Matrix Evidence × hypotheses diagnosticity analysis
Self-Audit ROBIS-adapted 4-domain process audit

Hypotheses

ID Statement Status
H1 Rigorous, specific AI validation requirements Partially supported
H2 Minimal or vague requirements Eliminated
H3 Frameworks exist but adapting with gaps Supported

Regulatory Framework Comparison

Industry Framework Year Status Key Gap
Aviation FAA AI Safety Assurance Roadmap v1 2024 Foundational "Methods must be developed"
Healthcare FDA GMLP + PCCP for SaMD 2021-2025 Active Traditional paradigm not designed for adaptive AI
Finance SR 11-7 Model Risk Management 2011 (extended) Active "May lose effectiveness" for self-adapting models
Cross-industry NIST AI RMF 1.0 2023 Voluntary No enforcement mechanism

Searches

ID Target Type Outcome
S01 FAA AI roadmap WebSearch 2 selected, 8 rejected
S02 FDA SaMD guidance WebSearch 2 selected, 8 rejected
S03 SR 11-7 AI validation WebSearch 2 selected, 8 rejected

Sources

Source Description Reliability Relevance Evidence
SRC01 FAA AI Roadmap High High 1 extract
SRC02 FDA SaMD High High 1 extract
SRC03 SR 11-7 High High 1 extract
SRC04 NIST AI RMF High High 1 extract

Revisit Triggers

  • FAA releases AI certification standards beyond the roadmap
  • FDA finalizes adaptive AI device guidance
  • Federal Reserve updates SR 11-7 for AI/ML specifically