HIPAA Compliance for AI/ML Companies | Complete Guide
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Key Compliance Highlights
Protected Health Information (PHI) safeguards
Administrative, physical, and technical security controls
Business Associate Agreement (BAA) requirements
Breach notification and incident response procedures
Privacy Rule and Security Rule compliance mapping
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Establish Your Audit Baseline
Get your readiness score, identify critical gaps, and unblock enterprise deal velocity in under 2 minutes.
Frequently Asked Questions
Can we use PHI for AI model training?
Yes, with proper safeguards. Options include de-identification per Safe Harbor/Expert Determination, obtaining authorization, or using the research exception with IRB approval.
What security controls are needed for healthcare AI?
Controls include encrypted model training environments, access restrictions to PHI datasets, audit logging of data access, secure model serving, and protection against model inversion attacks.
How do we handle AI-generated insights from PHI?
AI outputs derived from PHI may still be PHI if individually identifiable. Apply minimum necessary principle, document data flows, and ensure downstream uses comply with HIPAA.
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Disclaimer: Compliance costs and timelines are estimates based on market benchmarks (AICPA fee surveys, vendor pricing indices 2025). Actual auditor fees and internal effort will vary based on your specific control environment, system complexity, and auditor selection. Consult with a qualified CPA for a formal statement of work.