HIPAA-Compliant AI: Which Tools Sign a BAA

What the BAA Leaves Out

A signed BAA covers features, not a brand. Inside the same workspace, one button can be covered and the one next to it not. These are the exclusions practices miss most often, straight from each vendor's scope page. The fix is the same everywhere: switch the feature off for anyone who handles PHI, or keep PHI out of it by written policy.

Practice Use Cases: BAA or Not

The question is never “is this AI tool allowed?” It is “does this task put PHI into it?” Here is how the tasks we see most at small practices sort out.

The last row is the one to plan for, because it happens without anyone asking first. A disclosure to an AI vendor with no BAA is not a permitted use, so the breach notification rules apply: you run the four-factor risk assessment in 45 CFR 164.402 and notify unless it shows a low probability of compromise. That incident belongs on your incident report form, and the pattern usually shows up on any list of common HIPAA violations.

De-Identify First: The No-BAA Route

Information that meets HIPAA's de-identification standard is not PHI, so it can go into any tool. There are two ways to get there (45 CFR 164.514(b)): Expert Determination, where a qualified statistician documents that the re-identification risk is very small, and Safe Harbor, where you strip the identifiers below from the patient and from relatives, employers and household members, and have no actual knowledge that what remains could identify someone.

On paper it is a checklist. In a chat box it fails quietly, because free-text notes hide identifiers in prose: “her son drives for the county,” a visit date in the middle of a sentence, a scanned page with the MRN in its header. The rule strips even dates and ages over 89 for a reason: next to a rare diagnosis, they point to one person.

7 Steps Before PHI Goes In

The order matters: contract, then risk analysis, then configuration, then people. A practice that trains staff on a tool it has not configured yet has trained them on the wrong tool.

1. 1

   Confirm the exact product, then sign

   164.308(b)(3)

   Match the plan on your invoice to the vendor's eligible list, word for word. “Enterprise” on a sales call is not “Enterprise with Regulated Workspace” on the contract. The assurances must be in a written contract; file it with a dated copy of the scope page.

2. 2

   Add the tool to your risk analysis

   164.308(a)(1)(ii)(A)

   Record where prompts, uploads, outputs and logs live, and for how long (some of Anthropic's covered models need 30-day retention, for example). Our risk assessment tool has a row for each system that touches ePHI.

3. 3

   Switch off what the BAA excludes

   Vendor scope page

   Memory, connectors, plug-ins, web fetch, browser agents: off for every role that handles PHI. Re-check after each product update.

4. 4

   One workspace, company sign-in only

   164.312(a)(1)

   SSO with MFA, no personal accounts, departing staff removed the same day. A BAA covers the organization that signed it, not a doctor's home login.

5. 5

   Paste the minimum

   164.502(b)

   A covered tool still gets only what the task needs. Apply the minimum necessary rule to prompts: the denial reason and the codes, not the whole chart.

6. 6

   Write the AI rule and train on it

   164.308(a)(1)(ii)(C)

   List approved tools, ban personal chatbots for patient work, and name the sanction. Add it to your HIPAA policies and to the annual session in your HIPAA training.

7. 7

   A human signs what goes in the chart

   Practice policy

   An AI draft that lands in the record is the signer's note. Read it against the source before it is saved, and keep the audit log turned on.

Section 1557 and Clinical AI

HIPAA covers the data. A separate rule covers what the tool decides. Under the Affordable Care Act's nondiscrimination rule, a covered entity must not discriminate on the basis of race, color, national origin, sex, age or disability “through the use of patient care decision support tools” (45 CFR 92.210). The definition is broad: any automated or non-automated tool used to support clinical decision-making, from a risk score in the EHR to a triage chatbot.