Responsible AI Implementation in Clinical Practice

Guidance for FDA-Compliant Medical AI Deployment

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Key Regulatory Requirement

AI tools providing diagnostic/treatment recommendations typically qualify as SaMD and require FDA clearance.
Non-SaMD tools may include Clinical Decision Support software that meet FDA Guidelines.

SaMD Classification Guide

Regulated SaMD	Non-Regulated Tools
! Diagnostic recommendations	✓ Administrative workflows
! Treatment-specific advice	✓ General health information
! Automated risk stratification	✓ Reference calculators

FDA SaMD Resources

Chatbot Implementation Standards

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Permitted Use: "This tool provides general health information - always consult your physician for medical advice"

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Prohibited: "Based on your symptoms, you likely have [condition] - follow this specific treatment plan"

🛡️ Use only FDA-cleared diagnostic chatbots

📋 Document all AI interactions in patient records

☑️ Implement mandatory clinician review

Implementation Checklist

Verified FDA status via GUDID database

Obtained vendor 510(k)/PMA documentation

Reviewed SaMD labeling for intended use

Ongoing Compliance

📊 Quarterly accuracy audits

🎓 Annual staff training updates

🤝 Biannual vendor compliance reviews

Regulatory Resources

📄 2022 CDS Software Guidance

📜 HTI-1 Final Rule Summary

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