SilicoHealth AI · GovernAI Platform
GovernAI
The Purpose-Built AI Governance Platform for Healthcare
Trusted · Transparent · Accountable
• The Urgency
Why Healthcare AI Governance And Why Now
The regulatory window is compressing. Health systems that act now build governance infrastructure once those that wait will face emergency remediation at 3× the cost.
1
Regulatory Pressure is Real
47 states introduced 250+ health AI bills in 2025 alone. 33 became law across 21 states. The compliance surface is three dimensional: FDA, CMS, and state law simultaneously.
2
Health Systems Are Unprepared
Most hospitals manage 30+ AI models on ad-hoc spreadsheets. Standing up proper governance costs $1–2M per health system. The vast majority of medical AI has never been reviewed by any regulator.
3
The Stakes Are Existential
A misdiagnosis, a biased triage algorithm, or a data breach can destroy a health system’s reputation and finances. AI governance is now a patient safety, legal liability, and accreditation issue.
The GovernAI Architecture
A 4-Layer Governance Framework
GovernAI maps every regulation, standard, and accreditation requirement into a single unified compliance architecture so your team governs once, not four times.
Layer 01
Hard Compliance Federal Regulatory
- FDA SaMD / AI-ML Framework + PCCPs
- ONC HTI-1 Final Rule (algorithm transparency)
- CMS Prior Authorization AI Guardrails
- Washington SB 5395 (PA denial reporting)
Layer 02
Accreditation-Linked Industry Self-Governance
- Joint Commission + CHAI RUAIH (7 elements)
- CHAI Best Practice Guides for PA & Medicaid
- No Fully Automated Denials standard
- Voluntary AI Certification Program (2026)
Layer 03
Operational Layer Technical Standards
- NIST AI RMF (Govern / Map / Measure / Manage)
- ISO/IEC 42001 — AI Management System
- Good Machine Learning Practices (GMLP)
- 3-year certification cycle support
Layer 04
The Baseline — Data & Privacy Compliance
- HIPAA / HITECH — PHI in AI pipelines
- HITRUST CSF — security certification layer
- HHS 2025 AI Strategic Plan
- FHIR-aligned data provenance
Healthcare AI Transformation Journey
We help healthcare organizations streamline operations, improve compliance and accelerate decision-making through a structured AI implementation framework.
Assessment & Discovery
Understand healthcare needs, challenges and opportunities.
Data & Clinical Intelligence
Collect and structure healthcare data for AI readiness.
Workflow & Compliance
Analyze workflows, regulations and compliance requirements.
Monitoring & Optimization
Continuously monitor and improve AI performance.
• The Urgency
Why Healthcare AI Governance And Why Now
The regulatory window is compressing. Health systems that act now build governance infrastructure once those that wait will face emergency remediation at 3× the cost.
AI Model Registry
Catalogue every AI system with risk tier, FDA status, PCCP scope, clinical domain, and responsible owner — one source of truth.
Bias & Fairness Auditing
Demographic parity, equalized odds, and calibration with healthcare-specific fairness benchmarks calibrated to known disparities.
Drift & Performance Monitor
Subgroup-level drift detection with clinical outcome feedback loops — not just aggregate accuracy. Real alerts, not vanity metrics.
Regulatory Compliance Mapper
Auto-map controls to FDA, ONC HTI-1, CMS, Joint Commission RUAIH, NIST RMF, and ISO 42001 maintained as regulations evolve.
Data Lineage & Governance
PHI flow tracking, consent documentation, FHIR-aligned data provenance, and jurisdiction mapping fully HIPAA/HITECH.
Human Oversight Framework
Escalation pathways, confidence thresholds, clinician override capture enforcing that AI assists humans, never replaces them on high-stakes determinations.
Incident Management
Structured adverse event capture, root-cause workflows, and FDA post-market surveillance reporting built on PSO-channel.
Impact Assessment Workflows
Templated bias, fairness, and clinical safety assessments version-controlled to model versions audit-ready at any time.
Transparency Reporting
Model cards for regulators, plain-language AI notices for patients and clinical staff satisfying ONC HTI-1 disclosure mandates automatically.
• Compliance Coverage
State-Level Regulatory Landscape
GovernAI’s regulatory mapper tracks and auto-updates to each state’s evolving requirements so your compliance posture moves with the law, not behind it.
| STATE | LAW / EFFECTIVE DATE | SCOPE | PRIORITY |
|---|---|---|---|
| Texas | TRAIGA (eff. Jan 2026) | Broad AI governance, mental health chatbot protocols, adversarial testing defense | HIGH |
| California | TFAIA (eff. Jan 2026) | Transparency in frontier AI, chatbot disclosure, prohibition on AI impersonating licensed professionals | HIGH |
| Washington | SB 5395 (2026) | Prohibits AI-only PA denials; requires licensed clinician for adverse determinations; AI denial reporting | HIGH |
| Maryland | HB 1563 (eff. Jun 2026) | Novel disclosure requirements for health insurers using AI in coverage determinations | MED |
| Colorado | ADAI (eff. Jun 2026) | Reasonable care to prevent algorithmic discrimination in high-risk AI affecting healthcare access | MED |
| Utah | AI Disclosure Law | Clear disclosure required when licensed professionals use AI during patient-facing services | MED |
•Competitive Moat
Why GovernAI Wins Against Horizontal Tools
FDA SaMD risk tiers, EU AI Act Annex III, and clinical domain classification — out of the box on day one. Horizontal tools require weeks of custom configuration.
Auto-mapping to FDA, ONC, CMS, CHAI, NIST, and ISO maintained as regulations evolve. No manual update cycle, no compliance drift.
Calibrated to known clinical disparities: pulse oximetry bias, pain assessment inequity, maternal mortality gaps. No generic fairness proxies.
FDA post-market reports, Joint Commission evidence packages, and ISO 42001 audit-ready documentation generated automatically from governance activities.
Tracks PHI provenance through AI pipelines using healthcare interoperability standards — the only governance platform built natively on healthcare data infrastructure.