HIPAA Security & Compliance
Integrity architecture from wearable signal through FHIR R4 audit trails.
- In production
- Pilot-ready
- In validation
- Partner-owned
Statuses below separate what is architected and pilot-ready from what remains in validation or partner-owned. Click a stage on the integrity path.
Wearable signal
Continuous heart rate and motion on consumer devices. Consent before capture. Stable session logging validated with licensed clinicians.
Synthesis
Fusion engine with end-to-end encryption and role-scoped access. Processing is for evidence production, not silent data warehousing.
FHIR R4 audit trail
Structured evidence with flags, confidence, and signal quality. Written consent enforced at the API before billing or biological data is shared.
Regulatory posture In validation Partner-owned
Evaluating regulatory classification for composite arousal scoring with independent counsel. Not a completed certification or FDA clearance.
Evidence infrastructure only — not a diagnostic device. Partners own patient-facing FDA strategy and compliance.
HIPAA + 42 CFR Part 2 Pilot-ready
Architected for HIPAA-aligned deployments with end-to-end encryption, role-scoped access, and 42 CFR Part 2 readiness. BAAs available for pilot partners. Written consent enforced at the API layer before billing or biological data is shared. Not a third-party certification badge.
Medicare audit verification In validation
Documentation analysis outputs are designed to align with CMS evidentiary requirements. Under review by licensed Medicare compliance consultants — not a completed CMS approval or endorsement.
Built for the same direction as WHO digital health strategy and WHO AI ethics guidance: objective session physiology through systems clinicians already use.
Clinician Validation
"An elegant, streamlined solution to measure quality biomarkers of stress. By transforming voice into time-locked events, it lets us link context with stress responses, finally making it possible to create and track actionable patient strategies."
On the measurement engine
"This platform's innovative analytics have been a game-changer at our hospital. We strongly recommend it for the objective monitoring of integrated mental health services and verifying patient outcomes."
On the measurement engine