AI Compliance Monitoring for Healthcare
HIPAA-aligned monitoring, clinical decision support auditing, and health equity compliance for health systems, payers, and health tech.
Built for Healthcare
Purpose-built compliance monitoring features for your industry's unique challenges.
Clinical AI Auditing
Monitor clinical decision support algorithms for accuracy, bias, and drift. Catch degradation before it impacts patient outcomes.
HIPAA AI Governance
Ensure AI systems handling PHI meet HIPAA Security Rule requirements. Automated access logging and risk assessments.
Health Equity Monitoring
Detect and alert on disparities in AI outputs across race, gender, age, and socioeconomic factors.
FDA AI/ML Compliance
Track your AI/ML software against FDA's predetermined change control plan framework and 21 CFR Part 11.
CMS AI Reporting
Generate reports aligned with CMS guidelines for AI use in Medicare Advantage, prior authorization, and claims processing.
De-Identification Verification
Continuously verify that AI training data and model outputs maintain HIPAA de-identification standards.
Regulatory Landscape
Healthcare AI faces a rapidly evolving regulatory landscape spanning federal, state, and international requirements. SpectrumAI keeps you ahead of every change.
HIPAA Security Rule
AI systems processing PHI must meet administrative, physical, and technical safeguard requirements. SpectrumAI automates compliance documentation and risk analysis.
FDA AI/ML Framework
FDA's evolving framework for AI/ML-based Software as a Medical Device (SaMD) requires continuous monitoring and predetermined change control plans.
CMS AI Guidelines
Centers for Medicare & Medicaid Services guidance on AI use in coverage determinations, prior authorization, and claims adjudication.
EU AI Act (Health)
Clinical AI classified as high-risk under the EU AI Act. SpectrumAI provides conformity assessments and ongoing risk monitoring for EU market access.
Healthcare Pricing
Transparent pricing built for healthcare compliance needs.
Growth
- 10 monitored models
- HIPAA governance templates
- Bias & drift detection
- Health equity alerts
- Email notifications
- Standard support
Professional
- 50 monitored models
- All Growth features
- FDA AI/ML templates
- CMS reporting
- API integrations
- Priority support (8h SLA)
Enterprise
- Unlimited models
- All Professional features
- Custom frameworks
- Dedicated advisor
- SSO & RBAC
- 24/7 SLA + BAA
Ready to automate healthcare compliance?
Join leading healthcare organizations using SpectrumAI to stay compliant, reduce risk, and build trust.
Get Early Access