AI Compliance Checklist for Medical Clinics: What You Need to Know Before You Deploy
By: Empathia Editorial Team
July 16, 2025
As AI tools like medical scribes and charting assistants become more common, compliance isn’t optional — it’s foundational. Whether you operate in the U.S. or Canada, you need to ensure that any AI assistant used in your clinic aligns with legal, ethical, and clinical safety standards. Use this checklist to verify your clinic is AI-compliant from day one.
✅ AI Compliance Checklist for Clinics
🔐 1. Privacy & Data Protection
☐ The AI vendor is compliant with HIPAA (U.S.) and/or PHIPA/PIPEDA (Canada).
☐ Patient data is encrypted in transit and at rest.
☐ Data is not stored or used for training without explicit consent.
📝 2. Informed Consent
☐ Patients are informed when AI is used in their care or documentation.
☐ Consent processes are documented and updated to include AI usage.
☐ You’ve reviewed local college or regulatory body guidance on digital tools.
🧑⚕️ 3. Clinical Governance & Accountability
☐ AI-generated content (e.g., notes, referrals) is reviewed by a licensed provider.
☐ Final clinical decisions are always made by a human clinician.
☐ Your clinic has policies on how AI output is used, reviewed, and corrected.
🧾 4. Auditability & Transparency
☐ The AI tool provides a clear audit trail of inputs and outputs.
☐ Notes include metadata or labels indicating AI involvement (as required).
☐ You have access to logs or data reports in the event of an audit or complaint.
🖥️ 5. Technical Safeguards
☐ AI systems are hosted on secure, reputable cloud providers (e.g., SOC 2, ISO 27001 certified).
☐ Role-based access control is in place to restrict who can view/edit records.
☐ Backups and failovers are in place to prevent data loss or service interruption.
📄 6. Vendor Assessment & Due Diligence
☐ You’ve received documentation on the vendor’s security, uptime, and data handling.
☐ The vendor has a defined incident response plan and contact protocols.
☐ Your clinic’s legal or compliance team has reviewed the vendor agreement.
🔄 7. Ongoing Monitoring & Review
☐ AI performance is regularly reviewed for accuracy, bias, and utility.
☐ There is a process for clinicians to provide feedback or flag issues.
☐ Your clinic has scheduled a review of AI usage every 6–12 months.
✅ Bonus: Empathia AI’s Approach to Compliance
At Empathia AI, we take compliance seriously. Our platform is:
Built to meet HIPAA, PHIPA, and PIPEDA standards
Hosted on secure, compliant infrastructure
Designed for clinician oversight, not decision replacement
Fully auditable with clear records and data exportability
Want a compliant AI assistant from day one?
Empathia AI was built with clinical safety and privacy at its core. Start your free trial and explore our compliance-first approach to medical documentation.
About Empathia AI
Empathia AI delivers reliable AI solutions for specialty medicine through intelligent medical scribing and clinical decision support. Built on unwavering reliability, partnership-driven support, and specialty excellence, our platform helps specialists focus on remarkable patient care.
