Regulatory & Compliance

    LifeBot supports HIPAA‑aligned deployments and GDPR‑ready data flows, integrates with FDA/CE‑cleared medical devices, and implements security controls for clinical safety and data protection.

    HIPAA

    GDPR

    FDA Devices

    CE Devices

    AES-256

    Audit Logs

    Data Protection Controls

    Security

    • AES‑256 encryption in transit and at rest
    • Role‑based access control (RBAC)
    • Device & session management with timeouts
    • Signed audit logs & immutable event trails

    Privacy & Residency

    • Minimum necessary PHI handling
    • Configurable data retention policies
    • Regional data routing options for GDPR
    • BAA support with covered entities

    Clinical Safety & Quality

    Clinical Workflows

    • Protocol checklists & decision support
    • Video + vitals + device telemetry in one view
    • Handoff packets & documentation exports

    Quality Assurance

    • Session review & QA audit features
    • Event markers for training & debriefs
    • Configurable consent & notification prompts

    Interoperability & Devices

    Standards

    • HL7 • FHIR • DICOM interfaces
    • PDF/CCD exports to EHRs
    • Directory & SSO (SAML/OIDC) options

    Medical Devices

    • Integrates with FDA/CE‑cleared devices (e.g., monitors/defib, ultrasound, scopes, i‑STAT)
    • Device telemetry and alarms surfaced in UI
    • Calibration & model tracking fields

    Need Documentation?

    We provide security overviews, DPIA/DPA templates, integration guides, and validation test plans on request.

    Request Compliance Pack