HIPAA Security & Compliance
Integrity architecture from wearable signal through FHIR R4 audit-trails.
Field-Proven in Challenging Deployments
Stable capture on consumer devices, validated with licensed clinicians.
Regulatory Posture
Evaluating regulatory classification for composite arousal scoring with independent counsel. Evidence infrastructure only. Partners own patient-facing FDA strategy and compliance.
Medicare Audit Verification
All documentation analysis outputs align with CMS evidentiary requirements. Under review by licensed Medicare compliance consultants.
HIPAA + 42 CFR Part 2
End-to-end encryption, role-scoped access, and 42 CFR Part 2 readiness. Written consent enforced at the API layer before billing or biological data is shared.
The direction of travel is set at the top of the system. The 2025 UN High-Level Political Declaration on NCDs and Mental Health treats behavioral and physical health as one intertwined problem; the WHO’s Global Strategy on Digital Health asks platforms to turn biological evidence into clinical action; WHO Europe pushes mental health into general care. SeroState’s architecture is built to serve that integration: objective session physiology, delivered through the systems clinicians already use. See also WHO ethics and governance of AI for health.
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