SHIPPEDAI Voice AgentCompliance AuditRegulated Healthcare

    Regulatory Feasibility Audit — AI Voice Agent

    Client — Confidential · regulated healthcare distributor

    Pre-build regulatory feasibility audit for an autonomous AI voice agent in regulated healthcare outreach — go/no-go delivered with hard compliance boundaries.

    Feasibility audit · build deferred

    What was broken

    The client wanted an autonomous AI voice agent to place outbound calls to physician practices, navigate front-desk gatekeepers, qualify interest, and book doctors onto a specialist's calendar — every call logged to a CRM. On the surface, a standard voice-agent build. Underneath, one of the most heavily regulated sales contexts in the country: federal robocall law (TCPA), state AI-disclosure statutes (FL HB 919, CA AB 1018), FDA/FTC regulation of claims for non-FDA-approved biologics, two-party recording consent, and HIPAA boundaries — simultaneously. A single misconfigured assumption isn't a bug; it's per-call statutory liability of $500–$1,500 with no cap.

    What we built

    Instead of quoting the build and wiring telephony, Trenith ran a structured feasibility audit across every regulatory surface the system would touch: TCPA artificial-voice consent requirements, state AI-disclosure law, the product's federal regulatory status, advertising and claim risk, recording-consent rules, the HIPAA data boundary, and operating liability. The finding: technically feasible, but lawful only under a compliance-first architecture — AI identity, non-FDA-approved status, and recording consent disclosed in the opening seconds of every call; the agent restricted to qualification and booking with all medical and efficacy discussion routed to a licensed physician; build-and-handoff so operating liability stays where it legally belongs; and a capped, supervised pilot with qualified-counsel sign-off before live calling. The client elected not to proceed under those constraints — the engagement working exactly as intended.

    AI & automation layer

    Compliance-first voice-agent architecture (designed, not built)
    Disclosed-by-design call openings: AI identity, product status, recording consent
    Claim-safe routing: AI qualifies and books only — medical discussion goes to the physician

    The stack

    TCPA / FCC AnalysisState AI-Disclosure LawFDA & FTC Claim ReviewHIPAA Boundary Mapping

    Outcomes

    Seven regulatory surfaces audited before any build
    Per-call statutory exposure modeled at target call volume
    Compliance-first architecture and hard boundaries delivered
    Build-and-handoff liability model defined
    Clear go/no-go recommendation — build deferred by client

    What this proves

    Trenith audits before it builds in regulated industries — and would rather stop a project than hand a client a liability with our name on it.

    Sitting with the same problem?

    A 60-minute call. You leave with a one-page scope and a fixed number, or a straight "this isn't for us."