Healthcare AI Accreditation & Compliance
Building trust through transparent, governed AI that meets the highest healthcare standards
Our approach
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Deterministic Safety Layer
Popper: 7-gate pipeline, no LLMs in the safety-critical path
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Glass Box Transparency
Every AI decision is auditable and explainable
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Clinician-in-the-Loop
Human oversight built into the system, not bolted on
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Open-Source Contracts
Hermes protocol: typed, versioned supervision contracts (Apache 2.0)
Standards alignment
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IAC AI Accreditation Framework
Eight governance categories across all IAC program areas
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URAC Health Plan Accreditation
Organizational governance layer compliance
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Joint Commission / CHAI
Health AI trustworthiness and safety standards
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FDA Software as Medical Device
Pre-submission strategy for De Novo classification
Deutsch-Popper-Hermes Architecture
Three independent systems: clinical reasoning (Deutsch), safety supervision (Popper), and typed contracts (Hermes). Every clinical output is gated by a deterministic 7-gate pipeline in 47ms.
AI Safety Architecture
Popper agent ensures every recommendation passes safety checks. Deterministic 7-gate pipeline with no LLMs in the safety-critical path.
Glass Box Transparency
Every AI decision is auditable and explainable. Full epistemic metadata, confidence scoring, and evidence traceability on every output.
Clinician-in-the-Loop
Human oversight is built into the system, not bolted on. HARD_STOP and ROUTE_TO_CLINICIAN verdicts ensure safety escalation by design.
Standards Alignment
Working with IAC on AI accreditation, following URAC, Joint Commission, and CHAI frameworks for healthcare AI governance.
What Sets Us Apart
| Typical Healthcare AI | Regain Approach |
|---|---|
| Black-box AI decisions | Glass box: full epistemic metadata and evidence traceability |
| ML model watching ML model | Deterministic safety DSL. No LLMs in the safety-critical path |
| Compliance as afterthought | Governance built into the architecture from day one |
| Vendor-specific, closed systems | Open-source Hermes protocol: interoperable supervision contracts |
AI Governance
Eight governance categories for healthcare AI accreditation.
Explore frameworkSafety Architecture
Deutsch-Popper-Hermes: three-system deterministic safety.
View architectureEvidence
Pre-clinical evaluation: 68 vignettes, 6 scoring layers.
Review evidenceRegulatory Strategy
FDA De Novo pathway, IAC alignment, and compliance roadmap.
Read strategyContact us about accreditation and compliance
We work with healthcare facilities, accreditation bodies, and regulators
