Dentists: Does Your AI Tool Have a Medical Device License?

Dentists Leading AI Adoption

So you’re excited about the promise of artificial intelligence (AI) to make you a better, more efficient, and profitable dentist, but should you blindly accept the sales pitch? The world of dentistry is being transformed by artificial intelligence (AI). From analyzing radiographs to suggesting treatment plans, AI tools promise improved efficiency and accuracy. But not all tools are created equal—or legally compliant. If you’re using or considering an AI tool in your practice, the most critical question to ask is: Does it need a Medical Device License and does it have one?

Does Your AI Tool Actually Need an MDL?

Not all AI tools used in dental practices require a Medical Device License. The requirement depends on what the tool is designed to do. According to Health Canada:

• If the AI tool makes diagnostic or treatment-related claims, it is classified as a medical device and must have an MDL. For example, AI software that analyzes radiographs to identify caries or periodontal disease falls into this category.
• If the tool is purely administrative or operational, such as scheduling software or patient communication tools, it likely does not require an MDL. However, it is important to note that privacy laws and cybersecurity best practices must still be addressed. We will cover this in our next blog post.

Key Tip: If the tool influences clinical decisions, it likely needs a license. Always verify the claims made by the vendor and ensure they align with Health Canada’s regulations.

Why Medical Device Licensing Matters

In Canada, any tool that makes diagnostic or treatment-related claims is regulated as a medical device by Health Canada. This means it must meet strict safety, efficacy, and quality standards. Using an unlicensed AI tool puts your practice at risk—both legally and ethically.

How to Check if Your AI Tool Is Licensed

1. Search the Health Canada Medical Devices Database
   • Health Canada maintains a public database of licensed medical devices. You can search for your tool on the Health Canada Medical Devices Active Licences Search.
   • If the tool doesn’t appear, it likely hasn’t received the necessary approval.
2. Consult the Manufacturer
   • Reputable AI vendors will prominently display their regulatory credentials, including their Health Canada Medical Device License number. If you can’t find this information, contact the company directly.
3. Ask Your Distributor
   • Dental distributors like Henry Schein or Patterson Dental often work with licensed products and can verify whether an AI tool has proper approval.
4. Check with Professional Associations

The Risks of Using Unlicensed AI Tools

1. Legal and Compliance Issues
   • Using unlicensed tools can lead to violations of privacy laws like PIPEDA or provincial healthcare regulations.
   • You may also face scrutiny if the tool’s diagnostic or treatment suggestions lead to patient harm.
2. Patient Safety
   • Without proper testing and approval, there’s no guarantee the AI tool’s recommendations are accurate or reliable.
3. Reputation Damage
   • If your patients or regulatory bodies discover that you’re using unlicensed software, it could harm your practice’s reputation.

How to Stay Compliant

• Choose Reputable Vendors
  Ensure the AI tools you use are backed by evidence, research, and proper licensing. Tools like VideaHealth’s Videa Caries Assist and Overjet are examples of licensed products.
• Perform Regular Audits
  Review your technology regularly to ensure compliance with evolving regulations.
• Get Educated
  Stay informed about AI regulations and best practices through webinars, courses, and industry publications.

Red Flags to Watch Out For

• Lack of transparency about licensing or regulatory approval.
• Tools making bold diagnostic claims without evidence or credentials.
• Vendors that can’t provide documentation of compliance with Health Canada or other regulatory bodies.

Moving Forward
AI can revolutionize dental care—but only when it’s used responsibly. By ensuring the tools you use have a valid Medical Device License, you protect your patients, your practice, and your reputation. Take the time to verify your AI tools today and be confident that your practice is on the right side of innovation and regulation.

Would you like help verifying your AI tools or staying compliant with privacy and cybersecurity regulations? Contact us for expert guidance!