healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Radiology AI (SaMD)
Radiology AI 510(k) — per-read decision receipt for malpractice
—Colorado AI Act high-risk deployment
Regulatory exposure — commonly overlooked:
Hospital owns read — AI vendor owns cleared device label only · First comprehensive US state AI law — impact assessments require documentation Velaru generates.
TAM / Exposure
$2B AI radiology
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
Colorado AI Act Pack — Radiology AI (SaMD) External Validation Pack
Global leaders
Aidoc · Google Health · FDA · CO AG · Counterpart · Colorado Division of Insurance
Missed finding
AI flagged then dismissed — who owns miss? Receipt settles.
FDA PCCP
Model update without receipt = off-label use inference
[Colorado] Developer vs deployer
Colorado splits obligations — receipt chain clarifies who documented what when.
[Colorado] Insurance nexus
Colorado insurers using AI in underwriting must comply while selling AI EPL.
[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 →