HIPAA + 21 CFR Part 11 access receipts for every PHI event.
HIPAA §164.312(b) requires audit controls over PHI access. 21 CFR Part 11 demands trustworthy electronic records for FDA-regulated trials. OCR breach settlements in 2025–2026 averaged $1.3M, frequently citing missing or unverifiable audit logs. Hospitals carry the exposure when systems log to mutable databases.
Patent USPTO #64/081,419 applied to the workflow that matters in your industry. Same substrate that powers our banking, healthcare, and energy attestation stacks.
Every PHI read, write, or export creates a cryptographic receipt at the workstation
Chain-of-custody hash links each event, making silent log edits mathematically detectable
Audit export hands OCR or sponsors a verifier-ready bundle in under five minutes
Designed to land below the SaaS incumbents while preserving on-prem hardware economics.
Multi-site clinics, regional hospital systems, and CROs running 21 CFR Part 11 workflows. Reference customer: Dr Silva (Virtual Healing Solutions, live). Pipeline target: Ponce Health Sciences.
See a live PHI receipt demo. We will walk you through the architecture, the verifier flow, and the deployment options for your industry.
See a live PHI receipt demo →