by MedNex Labs
by MedNex Labs
There are zero production-ready audit standards for agentic AI in regulated healthcare. VMARAS is the accountability infrastructure that changes that — AI agents that execute compliance workflows with cryptographically verifiable proof of every decision and action.
Agentic AI is entering regulated healthcare — automating clinical workflows, managing supply chains, executing compliance actions. But there are zero production-ready standards for proving what an AI agent did, why it did it, and whether it followed policy. Every regulatory framework assumes a human made the decision.
"The question is not whether AI will automate healthcare compliance — it's who provides the accountability infrastructure when it does."
AI agents execute compliance workflows autonomously — triage, matching, quarantine, notification, escalation — following configurable policy playbooks.
Every agent action produces an Ed25519-signed receipt in an append-only SHA-256 hash chain. Tamper-evident, mathematically verifiable, litigation-ready.
Compliance rules enforced before agents can act. Human-in-the-loop authorization for high-risk decisions. No autonomous action without policy clearance.
Continuous polling of FDA enforcement data. New recalls detected, classified by severity, and matched against organizational inventory within minutes.
FDA Form 3911, quarantine notices, chain-of-custody reports, DSCSA transaction records — generated automatically from the evidence chain.
Enterprise-grade data isolation, role-based access control, AES-256-GCM encryption, and 7-year immutable retention — built for regulated industries.
VMARAS continuously monitors regulatory data sources — starting with FDA recall databases. Events are ingested, classified by severity, and routed to the agent orchestrator.
AI agents execute compliance workflows — matching regulatory events against organizational data, identifying impact across locations, supply chains, and patient records.
Agents act within policy gates: quarantine inventory, notify stakeholders, generate compliance documents. High-risk actions require human authorization. Every step is sealed to the evidence ledger.
A cryptographically signed integrity manifest lets any auditor, regulator, or attorney verify the complete chain of agent actions — with mathematical certainty that nothing was altered.
FDA Class II recall — ingested, orchestrated, executed, and sealed with cryptographic proof
VMARAS is built for organizations where AI-driven compliance must be provable — not just promised.
Not another alert tool. Not another dashboard. The verifiable layer that makes agentic AI auditable.
The live demo runs a real FDA recall through the full infrastructure — ingestion, agent orchestration, policy-gated quarantine, and cryptographic proof chain. No signup required.
Or talk to us about how VMARAS applies to your compliance environment.