Closed-Loop AI Assurance Platform

Transform healthcare AI compliance from barrier to advantage through automated bias auditing and continuous monitoring.

Assess

FDA‑style bias audit with report in under 24 hours.

Harden

Privacy‑safe synthetic EHR to close coverage gaps identified in audits.

Continuous Monitor

Production drift & bias monitoring with actionable alerts.

Core Capabilities

Assess — Audit Container

Drop-in Docker image for comprehensive bias and robustness auditing

  • Model Agnostic: Works with ONNX, sklearn, PyTorch, TensorFlow via converters
  • Bias Detection: Statistical analysis across demographic groups including equal-opportunity, demographic-parity, equalized-odds, and treatment-equality metrics
  • Synthetic Cohorts: ICD-10 conditioned test cohorts stratified by demographics and comorbidities
  • Perturbation Testing: Demographic flips, value jitter, and missingness injection for robustness

Key Features:

  • Under 24 hours to report
  • FDA‑style PDF + machine‑readable JSON
  • Runs entirely in your VPC for security
  • Enterprise-ready with Cosign signing and SBOM

Harden — SynthData Service

Privacy‑preserving synthetic EHR generation to address coverage gaps

  • Gap-Driven Sampling: Automatically identifies under‑represented strata from audit results
  • Foundation EHR Model: Conditional diffusion/GAN hybrid trained on de‑identified records
  • Differential Privacy: DP-SGD targeting ε≤3 with k‑anonymity >20
  • Stratified Output: Deterministic oversampling while preserving marginal correlations

Key Features:

  • Addresses specific gaps found in audits
  • Multiple output formats (Parquet/CSV/Feather)
  • Hash‑signed manifests for data integrity
  • Maintains statistical fidelity

Continuous Monitor — MLS Platform

Production drift & bias monitoring with actionable alerts and compliance‑ready evidence

  • Continuous Bias Monitoring: Track fairness metrics in production
  • Drift Detection: Statistical drift monitoring with configurable thresholds
  • Compliance Evidence: Exportable artifacts suitable for audits
  • Alert System: Webhook and email notifications

Key Features:

  • Embedded container architecture
  • Hospital‑ready compliance reporting
  • Configurable alert thresholds
  • Historical trend analysis

Integration & Operations

  • Runs entirely in your VPC or secure on‑prem (air‑gap optional)
  • Cosign‑signed containers and SBOM included
  • Exports PDF (FDA‑style) and JSON for downstream automation

Compliance & Regulatory Support

  • FDA Good ML Practice: Generate required bias and robustness evidence
  • EU AI Act: High‑risk healthcare AI documentation support
  • Joint Commission: Ongoing monitoring evidence for governance programs

Investor‑pitch language and forward‑looking claims have been removed. For a demo, contact our team.