What HIPAA actually requires of an AI vendor (and the marketing copy to ignore)
Before comparing vendors, get the terminology straight. A **Business Associate Agreement (BAA)** is the contract HHS requires between a Covered Entity (your hospital, clinic, payer, or clearinghouse) and any Business Associate that creates, receives, maintains, or transmits Protected Health Information on your behalf. The legal basis is 45 CFR 160 and 164 — full statutory text linked from https://www.hhs.gov/hipaa/. The BAA must contractually obligate the Business Associate to safeguard PHI, report breaches, ensure sub-processors meet the same standards, and return or destroy PHI at contract end. No BAA means the vendor is not legally permitted to process your PHI, full stop.
**Protected Health Information (PHI)** is individually identifiable health information held or transmitted by a Covered Entity or Business Associate in any form — electronic, paper, or oral. The 18 HIPAA identifiers include names, dates, addresses, phone numbers, email, SSN, MRN, account numbers, biometric identifiers, full-face photos, and IP addresses tied to a person. If you pipe any of those into a model prompt without a BAA covering the endpoint, you have just committed a HIPAA violation regardless of how the model behaved. Vendors love to advertise that they are 'HIPAA-ready' or 'HIPAA-friendly' — those phrases are meaningless. The question is binary: do they sign a BAA, and is the specific service you are using on their HIPAA-eligible services list.
**De-identification** is the safe harbor that lets you process former PHI without a BAA. HHS recognizes two methods. **Safe Harbor de-identification** requires removing all 18 specified identifiers and having no actual knowledge that the remaining information could re-identify the individual. **Expert Determination** requires a qualified statistician to certify, in writing, that the risk of re-identification is very small. Both methods are documented at https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/. Google's Cloud Healthcare API ships presets for both methods. AWS Comprehend Medical handles PHI entity detection that maps to the Safe Harbor list. Microsoft's Azure AI Language PII detection includes health-specific entities. OpenAI ships no native de-identification tooling — you must pre-process upstream.
**Audit logging is not optional.** HIPAA Security Rule §164.312(b) requires implementation of 'hardware, software, and procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information.' Translated: every read, write, modify, and delete of PHI must be logged, the logs must be tamper-evident, and they must be retained long enough to support OCR investigation. HHS does not name a specific retention period in §164.312, but the related §164.530(j) document-retention requirement is six years from creation or last effective date. Most health-system CISOs set six-year minimums for AI inference logs that touched PHI. AWS CloudTrail, Azure Monitor, and Google Cloud Audit Logs all support multi-year retention; OpenAI's audit log retention defaults to 30 days and requires export to extend.
**Breach notification under HIPAA is unambiguous.** 45 CFR 164.404 requires Covered Entities to notify affected individuals of a breach of unsecured PHI without unreasonable delay and no later than **60 calendar days** after discovery. Breaches affecting 500 or more individuals also require notice to HHS and to prominent media outlets in the affected state. Your vendor's job under the BAA is to give you prompt notice — typically within hours to days of discovery — so you have time to investigate, contain, and meet the 60-day patient notification deadline. The OCR fines schedule under the HITECH Act ranges from $137 per violation at the lowest culpability tier to $2,067,813 annual maximum per identical violation at the willful-neglect-uncorrected tier (2024 inflation-adjusted figures per 45 CFR 102). The penalty math is what makes the BAA review serious.
Finally, **sub-processor pass-through** is the question that traps most healthcare buyers. When you sign a BAA with Microsoft for Azure OpenAI, you are accepting that Microsoft's sub-processors (Azure infrastructure, data center contractors, security tooling vendors) are also bound to HIPAA terms by Microsoft. AWS, Google, and Microsoft all publish sub-processor lists and warrant pass-through for in-scope services. OpenAI's sub-processor pass-through is more limited and is part of the negotiated enterprise contract, not a standard term. Hippocratic AI markets a single-tenant deployment option specifically to shrink the sub-processor surface area to near zero. Read every sub-processor list before signing — that is where novel infrastructure dependencies hide.