MVP Preview — Week 2 Build
Healthcare AI Compliance Risk Scorer
Score your clinical AI system against all 7 constitutional pillars mapped to HIPAA, FDA, EU AI Act, and Joint Commission requirements in under 5 minutes.
Section 1 of 50%
SECTION 01
Organization & System Information
SECTION 02
Risk Classification
Your answers determine your compliance exposure
⚠
High Risk
Annex III systems
◈
Limited Risk
Transparency obligations
◎
Minimal Risk
Voluntary codes
HIPAA breach penalties up to $1.9M per violation category
Yes
No
Unsure
SaMD requires 510(k) clearance or De Novo classification
Yes
No
Unsure
◷
Pilot
Testing phase
▶
Production
Live deployment
◌
Planning
Not yet deployed
SECTION 03
Governance Readiness Assessment
Check all that apply to your organization across the 7 constitutional pillars.
Named individual accountable for AI governance
AI governance policy document exists and is current
Vendor due diligence process for AI procurement
Staff training on AI governance procedures
Data processing locations documented and declared
PHI encryption at rest and in transit verified
Data retention policy for AI outputs exists
Training data composition documented (CA SB 1001)
Cross border data transfer documentation complete
Data subject access and deletion procedures defined
Patients informed when interacting with AI systems
AI system outputs labeled as AI generated
Domain and contact information verified and public
AI system limitations disclosed to clinical users
Audit logs retained for minimum 12 months
Human oversight mechanisms documented
Escalation paths for AI failures defined
Override procedures for clinical AI decisions
Bias testing and fairness audit conducted
Performance monitoring dashboard in place
Documented AI system revocation procedure
Incident response plan for AI failures
Breach notification process for AI related PHI exposure
Vendor termination and data return procedures
AI system integrates with EHR via standardized APIs (FHIR/HL7)
USCDI data elements mapped for AI inputs and outputs
Model cards or system documentation published
Interoperability testing completed with existing systems
Public transparency report on AI usage published
Patient complaint or appeal process for AI decisions
External audit or third party certification obtained
Ethics committee review for AI system deployment
Your Compliance Risk Score
0
out of 100
85%
Industry Pilot Rate
5%
In Production
42
Avg Score
Compliance Gaps Identified
Sorted by severity. Each gap includes the specific regulation it violates and recommended remediation timeline.
Regulatory Requirements Applicable to Your System
30 Day Remediation Roadmap
Prioritized action plan based on your assessment results.