AI Compliance Checklist - Healthcare Edition

Overview

Healthcare AI compliance isn't just about avoiding fines—it's about patient safety. FDA regulations ensure AI medical devices are safe and effective. HIPAA protects patient privacy when AI processes health information. Clinical documentation requirements ensure AI decisions can be explained and defended. Getting compliance wrong puts patients at risk.

This comprehensive checklist provides healthcare organizations with actionable compliance requirements across all major regulatory frameworks. It covers the full regulatory lifecycle: pre-market approval, operational compliance, incident reporting, and audit preparation.

What's Inside

• Healthcare AI Regulatory Overview: Map of which regulations apply to different healthcare AI use cases (clinical decision support, imaging, predictive analytics, administrative)
• FDA Compliance Checklist: Software as Medical Device (SaMD) classification, 510(k) and De Novo pathways, Quality Management System requirements, post-market surveillance, and clinical decision support exemptions
• HIPAA Compliance Checklist: Privacy Rule requirements for AI (minimum necessary, de-identification, patient rights), Security Rule requirements (administrative, physical, technical safeguards), and Breach Notification preparation
• State Law Compliance: State-specific healthcare AI requirements including transparency laws, consent requirements, and anti-discrimination provisions
• Clinical Documentation Requirements: What documentation regulators and auditors expect for healthcare AI including model validation, clinical workflow integration, and outcome monitoring
• Audit Preparation Guide: How to prepare for FDA inspections, HIPAA audits, and state regulatory examinations
• Incident Reporting Requirements: When and how to report AI-related adverse events, device malfunctions, and security incidents
• Vendor Compliance Management: Managing compliance obligations when using third-party AI services including BAA requirements and vendor due diligence
• 90-Day Healthcare AI Compliance Roadmap: Phased approach to achieving compliance prioritized by patient safety and regulatory risk

Who This Is For

• Chief Medical Information Officers responsible for clinical AI
• Regulatory Affairs managing FDA compliance
• Privacy/Compliance Officers ensuring HIPAA compliance
• Health IT Leaders deploying AI systems
• Medical Device Companies developing healthcare AI products

Why This Resource

Healthcare AI compliance requires understanding multiple overlapping regulatory frameworks: FDA medical device regulations, HIPAA privacy and security rules, state laws, and clinical standards. This checklist integrates all frameworks into a unified compliance approach, showing how requirements interact and how to satisfy multiple regulators efficiently.

The 90-day roadmap prioritizes patient safety first—ensuring high-risk clinical AI is compliant before lower-risk administrative applications.

FAQ

Q: How do we know if FDA regulates our AI?

A: The FDA section includes detailed classification guidance. AI that informs clinical decisions may be regulated as a medical device. The checklist helps you assess whether your AI falls under FDA jurisdiction and what pathway (510(k), De Novo, exempt) applies.

Q: What about AI that uses PHI but isn't clinical?

A: HIPAA applies to all AI that creates, receives, maintains, or transmits PHI—whether clinical or administrative. The HIPAA section covers requirements for all healthcare AI use cases.

Q: How do we handle AI vendor compliance?

A: The vendor compliance section covers Business Associate Agreement requirements specific to AI vendors, due diligence questions to ask, and ongoing monitoring requirements.