Healthcare AI Compliance Package
If you're a healthcare organization using AI — whether for clinical decisions, patient intake, diagnostics, or administration — you're navigating HIPAA, FDA guidance, and state requirements simultaneously. This package addresses all three frameworks in one set of documents.
Penalties for Non-Compliance
HIPAA penalties up to $2.1M per violation category per year. COPPA penalties up to $50,120 per violation. FDA enforcement for medical devices.
Maximum: $2.1M per HIPAA violation category
Who Must Comply
Hospitals, clinics, health tech companies, health plan administrators, and any HIPAA-covered entity using AI.
What's Included (8 Documents)
HIPAA AI Risk Assessment
BAA Addendum for AI Vendors
Minimum Necessary Standard AI Policy
Patient AI Disclosure Notice
AI-Generated Output Review Protocol
De-Identification Protocol for AI
COPPA Compliance Checklist
FDA Pre-Submission AI Checklist
All documents include electronic signature blocks compliant with the ESIGN Act (15 U.S.C. § 7001) and UETA.
What Happens After You Purchase
Your documents generate instantly as fillable PDFs, packaged in a single zip file.
Download directly to your device or email to up to 3 team members.
Fill in the highlighted form fields with your company-specific information. Each document includes clear instructions.
Sign using the electronic signature blocks — ESIGN Act compliant, no printing required.
Have your legal team review the completed documents before deployment.
Statutory Authority
Citation: HIPAA + FDA AI/ML + COPPA
View official source(opens in new tab)Complete Package
$597
One-time purchase. Instant download.
- 8 customized documents
- Instant digital download
- Based on HIPAA + FDA AI/ML + COPPA
- Secure checkout via Stripe
vs. $5,000–$25,000 at a law firm
Verified against enacted statute text
Source: HIPAA + FDA AI/ML + COPPAQuestions before purchasing? Email us
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