HEALTHCARE AI COMPLIANCE MONITOR

Know Which AI Tools
Are Out of Compliance.
Before an Auditor Does.

ClinicalGuard monitors every AI system across your organization against FDA, CMS, and HIPAA requirements — and generates the audit report in one click.

3
Compliance Frameworks
10
Built-in Rule Codes
<1hr
Time to First Scan
6yr
Audit Trail Retention
FDA AI/ML SaMD Compliance CMS Billing Requirements HIPAA BAA Tracking iCare EHR Integration Real-Time Risk Scoring Immutable Audit Trail One-Click Regulatory Reports Joint Commission Ready FDA AI/ML SaMD Compliance CMS Billing Requirements HIPAA BAA Tracking iCare EHR Integration Real-Time Risk Scoring Immutable Audit Trail One-Click Regulatory Reports Joint Commission Ready
Five MVP Modules
Everything Your CCO Needs.
Nothing They Don't.

Every module works out of the box — no configuration, no weeks of setup. Register your AI systems and your first scan runs in under an hour.

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MODULE 01
AI System Registry
Centralized inventory of every AI/ML tool deployed across your organization. FDA clearance, HIPAA BAA, CMS approval — tracked per system, updated in real time.
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MODULE 02
Compliance Monitor
Real-time findings across FDA, CMS, and HIPAA frameworks. Every finding tagged with rule code, severity, and the system that triggered it. One-click remediation.
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MODULE 03
Audit Trail Generator
Immutable, append-only log of every compliance event. 6-year retention. Every entry timestamped and tied to the system, user, and iCare encounter where applicable.
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MODULE 04
Regulatory Reports
One-click generation of audit-ready reports for FDA, CMS, HIPAA, Joint Commission, and internal audit. If an auditor walks in tomorrow — you're ready today.
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MODULE 05
Risk Scoring Engine
Automated 0–100 risk score per AI system, recomputed in real time on every change. Sub-scores by framework. Your CCO knows which systems need attention — right now.
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INTEGRATION
iCare EHR Live Scan
Direct read connection to the iCare EHR database. Scans for unsigned AI-generated documents and auto-generates CMS-AI-001 critical findings. 3 seconds. No other platform has this.
Compliance Coverage
Three Frameworks.
Ten Rule Codes. All Built In.

No configuration required. ClinicalGuard ships with every current FDA, CMS, and HIPAA AI rule code — and we update them when regulations change.

FDA
AI/ML Software as a Medical Device
  • AI/ML SaMD deployed without 510(k) clearance — Critical
  • Missing Algorithm Change Protocol documentation — High
  • Post-market surveillance plan not established — High
  • Performance monitoring metrics not defined — Medium
CMS
Medicare/Medicaid AI Billing
  • AI documentation submitted without provider co-signature — Critical
  • AI-assisted diagnosis not reviewed before billing — High
  • AI tool usage not disclosed in claim — Medium
HIPAA
Privacy & Security
  • AI vendor processing PHI without signed BAA — Critical
  • AI system accessing PHI beyond minimum necessary — High
  • AI model training data audit trail not maintained — Medium
iCare Integration
The Only Compliance Monitor
That Talks to Your EHR.
EXCLUSIVE — ICARE EHR
Find CMS Violations Before Your Billing Team Does
ClinicalGuard maintains a live read connection to the iCare EHR database. One click scans every AI-generated document for missing provider co-signatures — a CMS-AI-001 critical violation that triggers Medicare billing rejections and fines.
  • 1Click Run iCare Scan in the dashboard
  • 2ClinicalGuard scans your iCare document database in 2–3 seconds
  • 3Unsigned AI documents surface as Critical findings instantly
  • 4Remediate, log, and generate a CMS report — before submission
clinicalguard.apmedicalsystems.com
3
AI Systems
5
Open Findings
2
Critical
20
Risk Score
RECENT FINDINGS
Unsigned AI Doc: Enc-4821CRITICAL
No FDA Clearance: RadAICRITICAL
Missing BAA: ClaimsPilotHIGH
iTranscriberCLEAN
▶ iCare Scan: 12 docs · 1 new finding
Pricing
Priced for Hospitals.
Not Enterprise Budgets.

Start with a 30-day free trial. No credit card required. Cancel anytime.

Starter
$2,500/mo
$25,000/yr — save $5K
  • Up to 5 AI systems
  • 2 platform users
  • All 5 compliance modules
  • FDA / CMS / HIPAA
  • 6-year audit trail
  • Email support
Professional
$8,000/mo
$80,000/yr — save $16K
  • Up to 20 AI systems
  • 10 platform users
  • All 5 compliance modules
  • iCare EHR live integration
  • Priority support
  • Automated iCare scanning
Enterprise
Custom
Starting $200K/yr
  • Unlimited AI systems
  • Unlimited users
  • All 5 compliance modules
  • iCare integration
  • Dedicated onboarding
  • 99.9% SLA
APMS Add-On
$1,500/mo
$15,000/yr — for iCare clients
  • Existing iCare clients only
  • Up to 10 AI systems
  • 5 platform users
  • Full iCare integration
  • Billed with APMS suite
Your CCO deserves to sleep at night.
Start your free 30-day trial. No credit card. No setup fees. First scan in under an hour.