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.
Does This Apply to You?
- You are a HIPAA-covered entity or business associate — hospital, clinic, health plan, or health tech company
- You use AI in clinical decisions, patient intake, diagnostics, or health administration
- You collect or process health data from children under 13 (COPPA amended rule in effect April 22, 2026)
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
What Happens Without 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
Preview Your Documents
See what your compliance package includes — sample shown with example data
See Inside Your Documents
Sample page using demo data. Your documents will include your company name, AI systems, and compliance details.
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
Purchase now, customize your documents after checkout
vs. thousands at a law firm
Verified against enacted statute text
Source: HIPAA + FDA AI/ML + COPPAQuestions before purchasing? Email us
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