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R0044/2026-04-01/Q001/S03

WebSearch — Sector-specific AI requirements (healthcare/FDA, financial/FINRA, aviation/FAA)

Summary

Field Value
Source/Database WebSearch
Query terms "FDA AI clinical decision support automation bias requirements" + "financial services AI regulatory requirements overreliance automation bias SEC FINRA" + "aviation FAA AI automation bias EASA machine learning certification requirements"
Filters None
Results returned 30
Results selected 3
Results rejected 27

Selected Results

Result Title URL Rationale
S03-R01 Automation Bias and Clinical Practice: FDA CDS Guidance (Cooley LLP) https://www.cooley.com/news/insight/2026/2026-01-20-automation-bias-and-clinical-practice-fda-makes-incremental-updates-to-clinical-decision-support-software-guidance Most detailed analysis of FDA's automation bias treatment in CDS guidance
S03-R02 FINRA Key Challenges and Regulatory Considerations https://www.finra.org/rules-guidance/key-topics/fintech/report/artificial-intelligence-in-the-securities-industry/key-challenges Primary FINRA guidance on AI governance in financial services
S03-R03 FAA Roadmap for AI Safety Assurance https://www.faa.gov/aircraft/air_cert/step/roadmap_for_AI_safety_assurance Primary FAA document on AI safety assurance including automation bias considerations

Rejected Results

Result Title URL Rationale
S03-R04 Various FDA AI/ML device guides (6 results) Various Focus on data bias and model performance, not behavioral output constraints
S03-R05 Various financial regulatory articles (7 results) Various General AI procurement/governance; no system behavioral constraints
S03-R06 Various aviation AI articles (7 results) Various Certification process focus; no output behavioral constraints
S03-R07 GAO AI Financial Services Report https://www.gao.gov/assets/gao-25-107197.pdf Relevant but PDF inaccessible; key findings captured from search summary

Notes

Sector-specific searches consistently confirmed the pattern: all four target sectors (defense via CaTE in Q004, healthcare via FDA, finance via FINRA, aviation via FAA/EASA) address automation bias through human oversight requirements, not through AI output behavioral constraints. The FDA search was most revealing — its January 2026 CDS guidance update actually relaxed a system-side mechanism (multiple alternatives requirement) while maintaining human-side requirements.