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¶
- "Test and validate" could mean pre-deployment testing only, or ongoing monitoring. This research covers both.
- "AI systems" encompasses ML models, LLMs, and traditional algorithmic systems — regulatory frameworks may treat these differently.
- "Currently" implies 2024-2026 practices, which are rapidly evolving.
Sub-Questions¶
- What does the FAA require for AI safety assurance in aviation?
- What does the FDA require for AI/ML in medical devices (SaMD)?
- What do banking regulators (Fed/OCC) require under SR 11-7 for AI model validation?
- What framework does NIST provide for AI risk management?
- 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 |