Appendix H — Appendix H: Clinical AI Policy Templates

H.1 Hospital AI Governance Policy Templates

H.1.1 Executive Summary

This appendix provides ready-to-customize policy templates for implementing AI in clinical settings. These templates are based on policies successfully deployed at major academic medical centers and community hospitals.

ImportantLegal Notice

These templates are starting points only. Have your legal team and medical staff review and adapt them to your institution’s specific needs, state regulations, and organizational structure.

H.2 Template 1: Clinical AI Governance Policy

H.2.1 POLICY: Clinical Artificial Intelligence Governance

Effective Date: [Date] Policy Number: [XXX-XXX] Approved By: [Chief Medical Officer] [Date]

H.2.1.1 I. PURPOSE

To establish governance structures and processes for the safe, effective, and ethical implementation of artificial intelligence (AI) technologies in clinical care at [Institution Name].

H.2.1.2 II. SCOPE

This policy applies to all AI/ML systems used for: - Clinical decision support - Diagnostic assistance - Risk prediction - Treatment recommendations - Clinical documentation - Resource allocation - Any system that directly or indirectly affects patient care

H.2.1.3 III. DEFINITIONS

Artificial Intelligence (AI): Computer systems performing tasks that typically require human intelligence.

Clinical AI System: Any AI/ML technology used in patient care delivery, diagnosis, treatment planning, or clinical operations.

Algorithm Steward: Designated clinical leader responsible for specific AI system oversight.

Model Drift: Degradation of AI model performance over time due to changes in data or clinical practice.

H.2.1.4 IV. GOVERNANCE STRUCTURE

H.2.1.4.1 A. AI Governance Committee

Composition: - Chief Medical Officer (Chair) - Chief Information Officer - Chief Medical Information Officer - Department Chair Representatives (minimum 3) - Nursing Leadership - Quality & Safety Officer - Legal Counsel - Patient Representative - Medical Ethics Representative - Health Equity Officer

Responsibilities: 1. Review and approve all clinical AI implementations 2. Establish evaluation criteria for AI systems 3. Monitor ongoing AI performance and safety 4. Address ethical concerns and bias issues 5. Ensure regulatory compliance 6. Review adverse events related to AI use

Meeting Frequency: Monthly, with emergency sessions as needed

H.2.1.4.2 B. Algorithm Stewardship

Each approved AI system must have: - Clinical Algorithm Steward: Senior clinician responsible for clinical oversight - Technical Algorithm Steward: IT/informatics lead for technical maintenance - Quality Monitor: QI professional tracking performance metrics

H.2.1.5 V. IMPLEMENTATION REQUIREMENTS

H.2.1.5.1 A. Pre-Implementation

Required documentation before any clinical AI deployment:

H.2.1.5.2 B. Pilot Requirements

All AI systems must undergo pilot testing: - Minimum 30-day pilot period - Parallel workflow (not replacing standard care) - Daily monitoring and issue tracking - Go/no-go decision based on predefined metrics

H.2.1.5.3 C. Training Requirements

Before using any clinical AI system, users must: 1. Complete system-specific training 2. Demonstrate competency 3. Understand limitations and failure modes 4. Know escalation procedures

H.2.1.6 VI. ONGOING MONITORING

H.2.1.6.1 A. Performance Monitoring

Required Metrics: - Clinical accuracy/agreement rates - Alert fatigue measures - System uptime and response times - User adoption and satisfaction - Patient safety events - Disparate impact analysis

Review Frequency: - Weekly for first month post-implementation - Monthly for months 2-6 - Quarterly thereafter

H.2.1.6.2 B. Model Performance Surveillance
  • Continuous monitoring for model drift
  • Quarterly performance audits
  • Annual bias and fairness assessments
  • Immediate investigation of unexpected outcomes

H.2.1.7 VII. CLINICAL DECISION RIGHTS

  1. Physicians retain ultimate decision-making authority
  2. AI recommendations are decision support only
  3. Physicians may override AI recommendations with documentation
  4. AI cannot make autonomous clinical decisions
  5. Patients must be informed when AI assists in their care (see Template 3)

H.2.1.8 VIII. DATA GOVERNANCE

  • Patient data used for AI must comply with HIPAA
  • Data cannot be shared with vendors without explicit agreements
  • De-identification required for any external use
  • Patients may opt-out of AI-assisted care (see Template 4)

H.2.1.9 IX. QUALITY ASSURANCE

H.2.1.9.1 A. Adverse Event Reporting

AI-related adverse events must be: 1. Reported within 24 hours to Risk Management 2. Investigated by Algorithm Stewards 3. Reviewed by AI Governance Committee 4. Reported to FDA if device-related

H.2.1.9.2 B. Regular Audits
  • Quarterly clinical outcome audits
  • Semi-annual algorithm performance reviews
  • Annual comprehensive system evaluation

H.2.1.10 X. VENDOR MANAGEMENT

For vendor-supplied AI systems: - Service Level Agreements (SLAs) required - Regular performance reviews - Liability and indemnification clauses - Data ownership clearly defined - Exit strategy documented

H.2.1.11 XI. COMPLIANCE

This policy aligns with: - FDA guidance on AI/ML medical devices - Joint Commission standards - CMS Conditions of Participation - State medical practice regulations - Professional liability requirements

H.2.1.12 XII. POLICY VIOLATIONS

Violations may result in: - Immediate system suspension - Remedial training requirements - Disciplinary action per medical staff bylaws - Reporting to appropriate regulatory bodies

H.3 Template 2: Clinical AI Implementation Checklist

H.3.1 PRE-IMPLEMENTATION CHECKLIST

System Name: ____________________ Vendor/Developer: ____________________ Implementation Date: ____________________

H.3.1.1 Clinical Validation

H.3.1.2 Technical Requirements

H.3.1.3 Workflow Integration

H.3.1.5 Quality Metrics

H.3.1.6 Training & Competency

Approval Signatures:

CMO: ____________________ Date: ____________________ CIO: ____________________ Date: ____________________ Department Chair: ____________________ Date: ____________________

H.4 Template 3: Patient Notification Template

H.4.1 PATIENT INFORMATION: AI-Assisted Care

Dear Patient,

[Hospital Name] uses advanced artificial intelligence (AI) technology to assist your healthcare team in providing the best possible care. This notice explains how AI may be used in your treatment.

H.4.1.1 How We Use AI

AI helps your doctors by: - Analyzing medical images (X-rays, CT scans, MRIs) - Identifying potential health risks early - Suggesting treatment options based on current medical evidence - Helping document your visit accurately

H.4.1.2 Important Things to Know

✓ Your doctor makes all final decisions - AI only provides suggestions ✓ You can opt-out - You have the right to receive care without AI assistance ✓ Your data is protected - We follow all privacy laws (HIPAA) ✓ AI has limitations - Your doctor understands when AI should not be used

H.4.1.3 Your Rights

You have the right to: - Know when AI is used in your care - Ask questions about AI recommendations - Request care without AI assistance - Receive a second opinion - File concerns about AI use

H.4.1.4 Questions?

Please ask your healthcare provider or contact: - Patient Relations: [Phone] - Email: [Email] - Website: [URL]

H.5 Template 4: AI Opt-Out Form

H.5.1 PATIENT OPT-OUT: AI-Assisted Clinical Care

Patient Name: ____________________ Medical Record #: ____________________ Date: ____________________

H.5.1.1 Patient Declaration

I understand that [Hospital Name] uses AI technology to assist in clinical care. After discussing with my healthcare provider, I choose to:

H.5.1.2 Acknowledgments

I understand that opting out: - May affect care efficiency but not quality - Does not affect my right to treatment - Can be reversed at any time - Applies only to AI assistance, not to human clinical judgment

Patient Signature: ____________________ Date: ____________________ Witness: ____________________ Date: ____________________

H.6 Template 5: AI Incident Report Form

H.6.1 CLINICAL AI INCIDENT REPORT

Report Date: ____________________ Reporter Name: ____________________ Department: ____________________

H.6.1.1 System Information

  • AI System Name: ____________________
  • Vendor: ____________________
  • Version: ____________________

H.6.1.2 Incident Details

Date/Time of Incident: ____________________ Patient Affected (MRN): ____________________

Incident Type: - [ ] Incorrect recommendation - [ ] System failure/downtime - [ ] Integration error - [ ] User interface issue - [ ] Alert fatigue - [ ] Bias/discrimination concern - [ ] Other: ____________________

Description: [Detailed description of incident]

Clinical Impact: - [ ] No impact on patient care - [ ] Delayed care - [ ] Incorrect treatment - [ ] Near miss - [ ] Adverse event - [ ] Other: ____________________

Immediate Actions Taken: [List actions]

Root Cause (if known): [Description]

Recommendations: [Suggested improvements]

Report Submitted to: - [ ] Department Chair - [ ] Risk Management - [ ] AI Governance Committee - [ ] Vendor (if applicable) - [ ] FDA (if required)

H.7 Template 6: Monthly AI Performance Report

H.7.1 CLINICAL AI MONTHLY PERFORMANCE REPORT

System: ____________________ Month/Year: ____________________ Algorithm Steward: ____________________

H.7.1.1 Performance Metrics

Metric Target Actual Status
Clinical Agreement Rate >90% ___% ⚫⚫⚫
System Uptime 99.5% ___% ⚫⚫⚫
Response Time <3 sec ___ sec ⚫⚫⚫
User Adoption >80% ___% ⚫⚫⚫
Alert Override Rate <20% ___% ⚫⚫⚫

Status: 🟢 Meeting 🟡 Caution 🔴 Below Target

H.7.1.2 Clinical Outcomes

  • Cases processed: ____
  • Clinical interventions influenced: ____
  • Estimated time saved: ____ hours
  • Patient satisfaction score: ____

H.7.1.3 Issues & Resolutions

Issue Date Resolution Status

H.7.1.4 Bias Monitoring

  • Demographic performance variation: ____
  • Disparate impact identified: Yes/No
  • Mitigation actions: ____

H.7.1.5 User Feedback Summary

[Key themes from user feedback]

H.7.1.6 Recommendations

Report Prepared By: ____________________ Date: ____________________ Reviewed By: ____________________ Date: ____________________

H.8 Template 7: Vendor Contract Addendum

H.8.1 AI VENDOR CONTRACT ADDENDUM

This addendum supplements the Master Service Agreement between [Hospital] and [Vendor] dated ____.

H.8.1.1 Performance Guarantees

Vendor warrants: 1. Clinical accuracy of >% as measured by _ 2. System uptime of 99.5% measured monthly 3. Response time <3 seconds for 95% of queries 4. FDA clearance maintained throughout contract term

H.8.1.2 Liability & Indemnification

  1. Vendor maintains professional liability insurance minimum $5M per occurrence
  2. Vendor indemnifies Hospital for algorithm errors not caused by Hospital misuse
  3. Liability cap excluded for: patient harm, data breaches, willful misconduct

H.8.1.3 Data Rights & Privacy

  1. Hospital retains ownership of all patient data
  2. Vendor cannot use Hospital data for model training without written consent
  3. Data must be returned/destroyed at contract termination
  4. HIPAA Business Associate Agreement attached as Exhibit A

H.8.1.4 Clinical Validation

  1. Vendor provides quarterly performance reports
  2. Hospital may conduct independent validation studies
  3. Performance degradation >10% triggers remediation plan
  4. Persistent underperformance allows termination without penalty

H.8.1.5 Transparency Requirements

Vendor must provide: - Algorithm update notifications 30 days in advance - Access to validation studies and FDA submissions - Adverse event reports from other clients (de-identified) - Annual fairness and bias assessment results

H.8.1.6 Termination Rights

Hospital may terminate without penalty for: - FDA recall or warning letter - Failure to meet performance guarantees - Data breach attributed to Vendor - Material change in algorithm without notification - Acquisition by competitor

H.9 Implementation Guide

H.9.1 How to Use These Templates

  1. Customize for Your Institution
    • Replace [bracketed] text with your specifics
    • Adjust committee structures to match your organization
    • Align with existing policies
  2. Legal Review Required
    • Have legal counsel review all templates
    • Ensure compliance with state regulations
    • Verify alignment with medical staff bylaws
  3. Stakeholder Engagement
    • Present to medical staff for input
    • Review with nursing leadership
    • Obtain board approval where required
  4. Pilot Before Full Implementation
    • Test policies with one AI system first
    • Gather feedback and refine
    • Roll out institution-wide
  5. Regular Updates
    • Review policies annually
    • Update based on regulatory changes
    • Incorporate lessons learned

H.9.2 Common Implementation Mistakes

❌ Avoid These Pitfalls: - Implementing AI without formal policies - Copying policies without customization - Excluding frontline clinicians from governance - Focusing only on technology, not clinical impact - Ignoring equity and bias considerations - Underestimating training requirements

✅ Best Practices: - Start with governance before implementation - Include diverse stakeholders - Plan for continuous monitoring - Document everything - Prepare for failures - Maintain human oversight always

H.10 Additional Resources

H.10.1 Regulatory Guidance

H.10.2 Professional Organizations

H.10.3 Sample Policies from Leading Institutions

  • Mayo Clinic AI Governance Framework
  • Stanford Health AI Implementation Guidelines
  • Mass General Brigham AI Governance

H.11 The Bottom Line

Tip🎯 Key Takeaway

Good AI governance policies: - Protect patients while enabling innovation - Maintain physician autonomy - Ensure transparency and accountability - Address bias and equity - Plan for both success and failure

Remember: Policies are living documents. Start with these templates, but continuously refine based on your experience.

These templates are adapted from policies successfully implemented at major medical centers. They represent current best practices as of January 2025.