Is there a HIPAA compliant AI? Why the answer is a contract, not a product
No AI product is HIPAA compliant on its own. When HIPAA reaches your firm, which AI vendors become business associates, and what a BAA has to say.
At a glance
- No AI tool is HIPAA compliant by itself, because HIPAA’s rules apply to covered entities and business associates, and HHS does not certify products.
- An AI vendor that creates, receives, maintains or transmits protected health information for you is a business associate, and using one without a business associate agreement (BAA) violates the HIPAA Rules.
- A BAA has required contents: what the vendor may do with the data, Security Rule safeguards, breach and incident reporting, rules for subcontractors, and return or destruction of the data at the end.
- Whether you can get a BAA depends on the vendor and the plan: OpenAI offers one for its API, for sales-managed ChatGPT Enterprise and Edu accounts and, through a separate flow, for eligible clinicians on ChatGPT for Clinicians, and says it does not offer one for ChatGPT Business.
- Data that has been de-identified to HIPAA’s standard is outside the Privacy Rule, so a vendor that only ever receives de-identified data is not a business associate.
- Running the model on your own premises takes the AI company out of the picture, but whoever administers the machine may still be your business associate.
No AI product is HIPAA compliant on its own, whatever its website says. HIPAA regulates organizations and the contracts between them, so three questions decide which AI tool may touch patient data: does HIPAA reach your firm at all, which vendors would handle the data, and has each one signed the agreement the rules require. For a CRO, sponsor or medtech firm, the first question often settles more than the other two.
No tool is compliant on its own
HIPAA’s standards apply to health plans, health care clearinghouses and health care providers who transmit health information electronically in connection with a covered transaction. Where the rules provide, they also apply to business associates. A software product is neither of those. What can meet the rules is your use of a product: the contract you sign, the plan you buy, how you configure it and what your staff put into it.
HHS says so directly. Asked which cloud providers offer HIPAA-compliant services, its Office for Civil Rights answers that it “does not endorse, certify, or recommend specific technology or products.” OpenAI states that accepting its BAA and enabling HIPAA support do not, by themselves, make your application HIPAA compliant, and that you remain responsible for evaluating your use and meeting your obligations.
Does HIPAA apply to your firm?
Settle this first, because many CROs, medtech firms and health-adjacent consultancies are not covered entities, and some are not business associates either.
A covered entity is a health plan, a health care clearinghouse, or a health care provider who transmits health information in electronic form in connection with a transaction covered by HIPAA. A business associate is a person who, on behalf of a covered entity and other than as a member of its workforce, creates, receives, maintains or transmits protected health information for a function or activity HIPAA regulates. A subcontractor that creates, receives, maintains or transmits protected health information on behalf of a business associate is itself a business associate.
| Your situation | Where HIPAA puts you |
|---|---|
| You are a clinic, hospital, health plan or billing clearinghouse that transacts electronically | Covered entity |
| You handle patient data for one of them under contract, for example data management for a hospital registry or analysis of a health plan’s claims | Business associate |
| You hand part of that work to another firm, including an AI vendor | That firm is your subcontractor and a business associate in its own right |
| You receive patient data from a covered entity for your own study, as a sponsor | The covered entity’s disclosure needs the patient’s authorization or an approved waiver. Your own obligations depend on your role and contracts, so ask counsel |
| You only ever receive data de-identified to HIPAA’s standard | Outside the Privacy Rule for that data |
When an AI vendor becomes your business associate
When someone pastes a patient summary into a chatbot, the vendor receives it, processes it and, if the product keeps history, stores it. If you are a covered entity or business associate, that vendor is creating, receiving, maintaining or transmitting protected health information on your behalf, which is the business associate test.
HHS’s cloud computing guidance closes the usual escape routes:
- A provider that stores only encrypted health data and holds no decryption key is still a business associate, because it maintains the data.
- The “conduit” exception covers transmission-only services with no more than temporary storage incident to the transmission, and a service that maintains data to store or process it is not a conduit.
- A covered entity or business associate that uses a cloud provider to maintain electronic protected health information without a BAA is in violation of the HIPAA Rules.
The obligation to get the agreement sits with you. A covered entity may let a business associate create, receive, maintain or transmit protected health information on its behalf only if it obtains satisfactory assurance that the business associate will safeguard it, documented in a written contract that meets 45 CFR 164.504(e). A business associate that hands work to a subcontractor must obtain the same assurances from the subcontractor.
What a BAA must say
The contract between a covered entity and a business associate must establish what the business associate is permitted and required to do with the information, and it may not authorize anything the covered entity itself could not do. Under 45 CFR 164.504(e)(2), it must also require the business associate to:
- not use or further disclose the information other than as the contract permits or the law requires
- use appropriate safeguards and comply with the Security Rule for electronic protected health information
- report any use or disclosure the contract does not provide for, including breaches of unsecured protected health information
- make sure any subcontractor that handles the information agrees to the same restrictions and conditions
- make the information available for patients’ access, amendment and accounting of disclosures
- make its internal practices, books and records available to HHS for compliance reviews
- return or destroy the information at termination if feasible, or extend the contract’s protections to whatever it must keep
For an AI vendor, read the BAA against how the product works. OpenAI’s API BAA page tells you to review which API services are eligible for protected health information before you process any, and features outside that list are outside the agreement. Ask which data the vendor keeps and for how long (history, uploaded files, logs, backups), which subcontractors receive it, and how it comes back or is destroyed when you leave.
A BAA moves only part of the work to the vendor. You and the vendor must each carry out an accurate and thorough risk analysis of the risks to the data each holds. On your side of an AI tool, that means at least unique user identification and access control, audit controls that record activity in systems holding the data, procedures to verify that a person seeking access is who they claim to be, and a security awareness and training program for your workforce.
The options compared
| Option | BAA available? | Who is your business associate | What to watch |
|---|---|---|---|
| Personal or consumer chatbot accounts | Not on OpenAI’s list, which names only the API, sales-managed ChatGPT Enterprise and Edu, and ChatGPT for Clinicians | Nobody under contract, so there is no BAA | Staff using their own accounts for work |
| Small-business or team plans | Varies by vendor. OpenAI says it does not offer a BAA for ChatGPT Business | The vendor, without a BAA | A paid business plan is not the same as a BAA plan |
| Enterprise plans with a BAA | Yes, by contract. OpenAI arranges BAAs for ChatGPT Enterprise and Edu through sales | The vendor and its subcontractors | Exactly which features the BAA covers |
| An API with a BAA, behind a tool a developer builds for you | OpenAI offers a self-serve BAA for API organizations with an established usage history | The model provider, plus whoever builds and hosts your tool | Only eligible services may receive the data, and the hosting company is another business associate |
| Healthcare-specific AI tools (note-takers, coding assistants) | Ask for one. A product built for clinics still needs the contract | The tool’s vendor, plus the model provider behind it as a subcontractor | The subcontractor chain |
| De-identify first, then use any tool | Not needed for data that is truly de-identified | Nobody, for that data | The de-identification step itself, see below |
| A model on your own premises | Depends on who administers the machine | Whoever maintains or has access to the system | See the on-premise section |
Microsoft’s privacy page for its Copilot assistant lists HIPAA among the service’s compliance offerings (Microsoft Learn, “Data, Privacy, and Security for Microsoft Copilot”, last updated 18 August 2026, read 20 October 2026). That tells you the vendor is prepared for the question. Your answer still comes from the agreement you sign.
Free tools are not forbidden, they just come without the contract. None of the routes to an OpenAI BAA in the table above is a free tier. If the data is protected health information, you need a vendor that will sign, or data with the identifiers removed.
De-identified data: when HIPAA stops applying
HIPAA’s Privacy Rule requirements do not apply to information that has been de-identified in line with 45 CFR 164.514. HHS’s cloud guidance draws the consequence for vendors: a provider that receives and maintains only information de-identified under the Privacy Rule’s process is not a business associate.
There are two methods. Under expert determination, a person with appropriate knowledge of statistical and scientific methods documents that the risk of identifying anyone is very small. Under safe harbor, you remove 18 kinds of identifiers for the individual and for their relatives, employers and household members, and you have no actual knowledge that what remains could identify anyone. The list covers names, small geographic units, all date elements except the year, contact details, record and account numbers, device identifiers, IP addresses, biometrics and full-face photos.
Three traps matter for AI use:
- Free text is hard to clean. A clinical note or a narrative in a safety report carries dates, places and names in the prose, and every element of a date except the year has to go.
- A re-identification code stays sensitive. Disclosing a code or key that lets de-identified data be re-identified counts as disclosing protected health information.
- The tool that does the cleaning sees the raw data. A covered entity may disclose protected health information to a business associate to create de-identified information, so a service that strips identifiers before passing data on is a business associate for that step.
On-premise AI: what it changes and what it does not
A model that runs on a machine in your own office changes one part of the analysis. If no prompt, document or answer leaves the building, the AI company that trained the model never receives your data, and that link drops out of the business associate chain. We cover the wider trade-offs in our guide to on-premise AI.
It does not change the rest:
- The machine holds electronic protected health information, in the documents it reads and the conversations it keeps, so your Security Rule duties apply to it like any other system.
- Somebody administers the machine. If that is an outside firm that sets it up, patches it, monitors it and backs it up, that firm may be your business associate. HHS’s guidance is clear that an entity maintaining electronic protected health information on your behalf is a business associate even if it cannot view the data.
IntraMuros is one such setup. Mayet delivers the machine, configures it remotely in a few hours, connects it to your documents, email and software, and patches, monitors and backs it up. Prompts and documents don’t go to an AI company and are never used to train any AI model. Staff sign in with their Microsoft or Google work account, and the assistant reads only what each person can already open. Mayet connects to the machine to update, monitor and back it up, and sees system health, not your prompts, documents or conversations.
That narrows the HIPAA question to one vendor. Whether that makes Mayet your business associate, and whether Mayet signs a BAA, is settled case by case, so raise it with Mayet before any protected health information goes onto the machine. Pricing is per year, by how many people use it at once: Standard £8,900 for one or two at a time, Advanced £21,900 for about five to ten, Enterprise quoted (pricing). It is the wrong fit if you want a cloud product whose maker will sign a BAA for it.
A checklist before staff put PHI into any AI tool
- Decide whether HIPAA reaches your firm, and for which data.
- List every party that will handle the data: the AI vendor, the model provider behind it, whoever hosts or administers the system.
- Get a BAA with each, check it against the required contents above, and confirm which features it covers.
- Update your risk analysis and set up user accounts, audit logs and retention before go-live.
- Ask whether de-identified data would do the job instead.
- Tell staff which accounts they may use for this work, and train them on it.
FAQ
Is ChatGPT HIPAA compliant?
No plan is compliant on its own. OpenAI arranges BAAs for sales-managed ChatGPT Enterprise and Edu accounts, has a separate in-product BAA flow for eligible clinicians using ChatGPT for Clinicians, and says it does not offer a BAA for ChatGPT Business. Everything outside a signed BAA is outside it.
Can you get a BAA with ChatGPT?
For ChatGPT Enterprise or Edu, yes, through OpenAI’s sales team. For the API, eligible organizations can accept a standard BAA in the API Platform. For ChatGPT Business, OpenAI says no.
Is a local or on-premise AI automatically HIPAA compliant?
No. It removes the AI company from the chain, but your Security Rule duties apply to the machine, and a vendor that administers it may be your business associate.
Does HIPAA apply to a CRO, medtech firm or consultancy?
Only if you are a covered entity, or you handle protected health information on behalf of a covered entity or one of its business associates. Use the table above, and take the research case to counsel. Firms in the EU and UK face a separate test under GDPR, which this guide does not cover.
Sources
- 45 CFR Part 160, HIPAA General Administrative Requirements (CFR edition of 1 October 2025)
- 45 CFR Part 164, HIPAA Security and Privacy (CFR edition of 1 October 2025)
- HHS OCR, Guidance on HIPAA & Cloud Computing (last reviewed 23 December 2022)
- OpenAI Help Center, Getting a Business Associate Agreement for the OpenAI API (as read 20 October 2026)