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. · CNIL among most aggressive EU DPAs on AI — French language audit trail required.
TAM / Exposure
Synthetic biology market $80B+ · DNA synthesis screening mandatory
Insurance lines
Biotech E&O · Product liability
Exhibit authority
France CNIL AI Pack — Biosecurity AI Screening Pack
Global leaders
CDC · Ginkgo Bioworks · Twist Bioscience · NIH · WHO · CNIL · Mistral AI · AMF
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.
[France] Sovereign AI
France pushing Mistral/sovereign stack — receipts prove which model decided.
[France] AMF scrutiny
French financial markets AI — AMF expects algorithm documentation.
[Text / Chat] Modality hook
Baseline — all frameworks apply to text decisions.
7 mandate layers (live)
Regulatory ClockCountdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition.Open →
Domain ClassifierIndustry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping.Open →
Exhibit / Filing PackRegulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11.Open →
Mandate RegistryEnroll deployers/insureds under vertical-specific governance mandate.Open →