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healthcare · Federal Select Agent Program · NIH Guidelines · DURC Policy
Synthetic Biology / Biosecurity
Screening AI failure = criminal liability under Select Agent regulations
—Federal Select Agent Program + DURC
Regulatory exposure — commonly overlooked:
Cloud lab orders sequence — lab owns biosecurity violation, screening vendor owns API uptime SLA. · Korea AI Basic Act emerging — early movers on receipt infrastructure win Samsung/LG supply chain.
DURC policy
Dual use research of concern — AI screening decision must be documented for IBC review.
Sequence orders
Every synthesis order needs screening receipt — HHS 2010 framework now AI-accelerated.
Insurance exclusion
Biotech policies excluding unscreened AI sequence design.
[South Korea] Chip + AI
Samsung, SK Hynix AI in manufacturing — safety-critical receipt requirements.
[South Korea] K-pop platform AI
Content moderation AI for global platforms headquartered in KR.
[Text / Chat] Modality hook
Baseline — all frameworks apply to text decisions.
7 mandate layers (live)
Regulatory Clock
Countdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition.
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Domain Classifier
Industry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping.
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Exhibit / Filing Pack
Regulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11.
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Mandate Registry
Enroll deployers/insureds under vertical-specific governance mandate.
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Bind / Action Gate
ALLOW/BLOCK before consequential action — bind policy, sell loan, deactivate worker.
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Compliance Certificate
Deployer-facing downloadable cert — forward to counsel, auditor, regulator.
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Actuarial / Risk Feed
Anonymized asymmetry signals for pricing, reserving, reinsurance correlation.
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