Questions to ask an AI chatbot vendor
Use this list before signing with any chatbot or AI vendor for a clinic. Each question maps to a HIPAA requirement or an FDA or FTC rule explained elsewhere on this site.
Last reviewed against the HHS, FDA, FTC, and eCFR pages linked on this page on .
Privacy and contracts
- Will you sign a business associate agreement?Required before PHI is shared.
- Which subcontractors (hosting, AI model providers) will see the data, and do they sign BAAs?
- Is our data used to train or improve your models?And can we opt out in the contract?
- Where is data stored, and how long are transcripts kept?
- How do we get our data back, or have it destroyed, when we leave?
Security
- How is data encrypted in transit and at rest?
- How is staff access controlled and logged?
- How fast will you tell us about a security incident?We need time to meet our own breach-notification deadline.
Safety and scope
- What does the bot do with emergency language?It should route to 911 or 988 immediately.
- Does it give medical advice or suggest diagnoses?If so, how has it been assessed under FDA’s rules?
- Does it tell patients they are talking to software, and how do they reach a person?
Common questions
- Is a vendor’s “HIPAA-compliant” badge enough?
- No. HHS does not certify products. Ask for the BAA and the specific safeguards, and include the tool in your own risk analysis.
Sources
- Business Associates (FAQs and guidance) (opens in a new tab) — HHS Office for Civil Rights
- Guidance on HIPAA & Cloud Computing (opens in a new tab) — HHS Office for Civil Rights
- Summary of the HIPAA Security Rule (opens in a new tab) — HHS Office for Civil Rights
- Clinical Decision Support Software (guidance) (opens in a new tab) — U.S. Food and Drug Administration
- Guidance Regarding Methods for De-identification of PHI (opens in a new tab) — HHS Office for Civil Rights
Questions about this domain
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Last reviewed against the HHS, FDA, FTC, and eCFR pages linked on this page on .
Every rule described here is linked to the agency that publishes it. If one has changed, tell us.