AI GOVERNANCE, RISK & COMPLIANCE (GRC) FOR HEALTHCARE
Patient‑Safe GenAI for Healthcare.
PHI‑Aware Guardrails. Audit‑Grade Evidence.
TestSavant.ai unifies adversarial red‑teaming, runtime guardrails, and AI governance for clinical and operational assistants. Prevent PHI leakage and unsafe medical statements, prove controls to auditors, and evolve defenses safely.
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Reduction in PHI Exposure
Entity detection + field‑level redaction before any external model call, with zero‑retention options.
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Improvement in Model Fairness
Continuous tests for demographic performance disparities and reviewer‑approved mitigations.
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Faster Audit Readiness
One‑click evidence packs mapped to HIPAA, FDA AI/ML SaMD, ISO/IEC 42001, ISO/IEC 23894, and NIST AI RMF.
Solution Bundles for Healthcare
Start where impact is highest. Each bundle includes guardrails, tests, governance, and exportable evidence.
Clinical Scribe & Summarization
- PHI redaction at ingress and storage minimization
- Unsafe medical statement filters + disclaimers
- Lineage with citations for clinician review
Prior‑Auth & Payer Policy Assistant
- Controlled RAG over payer policies & medical necessity criteria
- Tenant‑scoped retrieval and zero‑retention modes
- Approval gates for pre‑filled forms/messages
Patient Education & Safety
- Plain‑language explanations with required disclaimers
- Topic/age appropriateness and safety filters
- Escalation to human for ambiguous/critical queries
Rev-Cycle & Ops Automation
- Minimum-necessary PHI for medical coding suggestions
- Reviewer gates for automated billing and code submissions
- Tool-use approvals for any task touching financial records
From Threat Model to Enforced Control
How our platform translates specific healthcare AI risks into automated, auditable defenses.
| Threat / Failure Mode | Guardrail Decision (UGM + Nero) | Test Methodology (Coliseum) | Result |
|---|---|---|---|
| Unsafe medical guidance | Policy block/transform; mandatory disclaimers; route to clinician review | Prompt suites forcing contraindicated advice | No unreviewed guidance; reviewer trail |
| PHI spill to external models | Entity detection → redact/tokenize; zero‑retention; residency routing | Adversarial PHI in notes/scans; verify masking + evidence logs | Lower leakage; redaction proofs |
| Prompt injection via attachments | Multi‑model injection detection; sanitize/deny; quarantine suspicious content | Hidden instructions in PDFs/images; indirect injection chains | Blocked takeovers; documented events |
| Drift & robustness regressions | Drift SLOs; alerts; Auto‑Tune retraining gates | Periodic regression packs; challenger comparisons | Faster detection; controlled updates |
Evidence‑Based Compliance for Healthcare Regulators
Produce concrete artifacts mapped to the clauses auditors scrutinize.
HIPAA Privacy & Security Rules
- ✓Minimum necessary & PHI redaction: Field‑level masking before model calls; zero‑retention and encryption options; residency routing.
- ✓Access controls & audit trails: Role/tenant scoping for assistants; immutable lineage of PHI access with timestamps and purposes.
FDA AI/ML‑Based SaMD Guidance
- ✓Predetermined Change Control Plan (PCCP): Versioned policies and tests; approval gates; rollback history with rationale.
- ✓Real‑world performance monitoring: Drift dashboards; safety/efficacy metrics; trigger‑based mitigation and revalidation.
NIST AI RMF 1.0
- ✓Govern · Map · Measure · Manage: Risk registers, test results (injection/leakage/fairness), monitoring alerts, incident retrospectives.
ISO/IEC 42001 (AIMS)
- ✓PDCA governance (Clauses 4–10): AI policy & scope, SoA, RACI, risk appetite, management reviews, control KPIs.
ISO/IEC 23894:2023 (AI Risk Management)
- ✓Risk lifecycle: Identification → analysis → treatment → monitoring/review for harms incl. privacy and fairness, with residual‑risk acceptance.
Architecture & Controls
How TestSavant enforces safe behavior in healthcare flows—protecting PHI, preventing unsafe guidance, and producing audit-grade evidence.
UGM (Unified Guardrail Model)
- Medical-safety policies (contraindications, diagnosis disclaimers, age/topic fit)
- “Minimum necessary” PHI rules for prompts, RAG, and tool use
- Scoped tool permissions (EHR writes/orders) with pre-approval
Nero (Runtime Orchestrator)
- Context-aware block / transform / route-to-clinician decisions
- Role/specialty/acuity signals to gate high-risk outputs
- Mandatory disclaimers and “do-not-answer” on unsafe topics
Coliseum (Adversarial Safety Testing)
- Attack suites for unsafe medical guidance, PHI exfiltration, and prompt injection
- Tests across notes, PDFs/images (indirect injection chains)
- Release gates with findings, mitigations, and residual-risk evidence
Auto-Tune (Adaptive Defenses)
- Adjust thresholds from drift, incidents, and clinician feedback
- Change-controlled updates compatible with SaMD PCCP
- Fairness monitoring and reviewer-approved mitigations
PHI Gateway & Lineage
- Entity detection → redact/pseudonymize before external model calls
- Zero-retention options and data-residency routing
- Immutable conversation lineage: sources, tools, policies, timestamps
Clinical Registry & Model Cards
- Inventory with owners, intended use, limitations/contraindications
- Dataset provenance, validation status, and explainability excerpts
- Links to HIPAA artifacts and (if SaMD) PCCP/validation packages
Frequently Asked Questions
How do you prevent unsafe medical guidance?
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UGM enforces medical‑safety policies with mandatory disclaimers; Nero blocks or routes high‑risk statements to clinician review. Coliseum tests prompt sets that force contraindicated advice to prove coverage.
How is PHI handled in prompts, RAG, and logs?
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PHI entities are detected and redacted before external model calls; tenant‑scoped retrieval applies “minimum necessary.” Optional no‑retention modes and data residency routing are available; lineage records every scope decision.
Can we run on‑prem/VPC with customer‑managed keys?
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Yes. Private VPC patterns with KMS/HSM; evidence mirroring to your trust portal; integration with SIEM/GRC tools.
Upgrade Your AI Governance from a Liability to a Life‑Saving Asset
Schedule a confidential briefing to see PHI‑aware guardrails, adversarial testing, and audit evidence in action—mapped to HIPAA and SaMD.
