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R0021/2026-03-25/Q004 — Query Definition

Query as Received

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

Query as Clarified

  • Subject: Testing and validation frameworks for AI systems in safety-critical regulated industries
  • Scope: Financial services (banking/insurance), healthcare (medical devices), and aviation
  • Evidence basis: Regulatory guidance, frameworks, standards, and published requirements from FDA, FAA, Federal Reserve/OCC, NIST, and EASA

Ambiguities Identified

  1. "Test and validate" could mean pre-deployment testing only, or ongoing monitoring. This research covers both.
  2. "AI systems" encompasses ML models, LLMs, and traditional algorithmic systems — regulatory frameworks may treat these differently.
  3. "Currently" implies 2024-2026 practices, which are rapidly evolving.

Sub-Questions

  1. What does the FAA require for AI safety assurance in aviation?
  2. What does the FDA require for AI/ML in medical devices (SaMD)?
  3. What do banking regulators (Fed/OCC) require under SR 11-7 for AI model validation?
  4. What framework does NIST provide for AI risk management?
  5. Are there common elements across all three industries?

Hypotheses

ID Hypothesis Description
H1 Regulated industries have rigorous, specific AI validation requirements Each industry has detailed, enforceable testing and validation standards for AI systems
H2 Validation requirements are minimal or vague Regulators have not kept pace with AI and requirements are insufficient
H3 Requirements exist but are adapting and incomplete Frameworks exist and are being applied, but they were designed for traditional systems and are being extended (sometimes awkwardly) to cover AI