AI/ML Medical Device Documentation Requirements in California (AB 3030)
Starting in 2026, your AI/ML medical device documentation must include specific California transparency disclosures. Here is how to comply. 🤖
Who Needs to Comply?
AB 3030 applies broadly to any "generative artificial intelligence" system that interacts with a person. In the context of medical devices, this includes:
- Chatbots: Any conversational agent used for triage, scheduling, or mental health support.
- Generated Reports: Summaries of patient data, lab results, or imaging reports created by GenAI.
- Virtual Assistants: Avatars or voice assistants that guide patients through therapy or medication adherence.
If your device generates text, images, video, or audio that simulates human communication, you are likely covered.
The Checklist
Compliance isn't complicated, but it must be precise. Use this checklist to audit your device:
- Prominent Disclosure: Is there a clear statement at the start of the interaction? It cannot be hidden in a "More Info" menu.
- Clear Language: Do you use plain English? Avoid technical jargon. Say "I am an AI assistant," not "I am a large language model based on transformer architecture."
- Instructions: Do you tell the patient how to reach a human? The law requires a clear path to human escalation if the AI cannot resolve the issue.
- Visual Cues: If using an avatar, ensure it does not look deceptively human (see AB 489).
🚀 Pro-Tip: Automate Your Compliance
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Don't bury the disclosure in the Terms of Service. It must be visible in the UI. For chat interfaces, it should be the very first message bubble. For voice interfaces, it should be the first sentence spoken.
Conclusion
Transparency builds trust. Patients are more likely to engage with an AI tool if they know exactly what it is and what its limitations are. Make sure your device is honest about its nature.
Frequently Asked Questions (FAQ)
Does a simple "AI" badge count as disclosure?
Likely not. The law requires a "clear and prominent" disclosure. A small icon might be missed. A text statement like "Generated by AI" is safer.
What if my device is only used by doctors, not patients?
AB 3030 is primarily focused on consumer/patient protection. However, if the output of your device (e.g., a report) is eventually shown to the patient, it is best practice to include the disclosure to prevent downstream liability.
Do I need to repeat the disclosure in every message?
No. The disclosure must be made at the start of the interaction. However, if the session times out or a new conversation begins, the disclosure should be repeated.