healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Tattoo / Body Art AI
AI design tool on minor — consent documentation required
—Health dept + minor consent AI
Regulatory exposure — commonly overlooked:
GlossGenius-style platforms own booking AI — studio owns health violation · Annex III high-risk list covers 8 domains — one vertical per domain minimum for compliance.
TAM / Exposure
$3B US tattoo industry
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
EU AI Act Conformity Pack — Tattoo / Body Art AI External Validation Pack
Global leaders
GlossGenius · Square Appointments · EU AI Office · EDPB · European Parliament
Infection control
AI aftercare advice wrong — cellulitis liability on studio.
Minor protection
KOSA-adjacent — AI booking without age verify
[European Union] FRIA requirement
Fundamental rights impact assessment for public/high-risk — exhibit pack maps to FRIA.
[European Union] PLD strict liability
Dec 2026 product liability directive — software and AI explicitly included.
[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 →