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 · Federal agencies disagree on AI approach — but examiners agree internal logs are insufficient.
TAM / Exposure
$3B US tattoo industry
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
US Federal Exhibit — Tattoo / Body Art AI External Validation Pack