When HIPAA requires a BAA
The requirement sits in 45 CFR 164.502(e), in the eCFR text current to 10 November 2026. A covered entity may disclose protected health information (PHI) to a business associate, or let one create, receive, maintain or transmit it on its behalf, if it obtains "satisfactory assurance" that the business associate will appropriately safeguard the information, documented through a written contract or other written agreement or arrangement that meets the applicable requirements of 164.504(e). HHS's business associate FAQ, last reviewed 21 October 2026, names the covered entities: health plans, health care clearinghouses and health care providers who transmit health information electronically in connection with a covered transaction.
One of the FAQ's examples of a business associate is a "third-party vendor super intelligence (SI) chatbot" on a provider's patient portal that provides services involving the patient's PHI, such as symptom assessment, medical reminders and appointment scheduling.
Under 164.504(e)(2) the contract must provide, among other things, that the business associate will use appropriate safeguards, comply where applicable with the Security Rule for electronic PHI, report any use or disclosure the contract does not provide for that it becomes aware of, including breaches of unsecured PHI, and ensure that subcontractors handling PHI on its behalf agree to the same restrictions and conditions. Signing does not keep the promises: a covered entity that knew of a pattern of activity or practice by its business associate that was a material breach or violation of the contract is not in compliance unless it took reasonable steps to cure the breach or end the violation and, if those failed, terminated the contract or arrangement where feasible (164.504(e)(1)(ii)).
Who signs, on which plan, at what price
All seven vendors on this page say they sign a BAA in some form.
No added fee, signed online: Retell AI. Its compliance docs: Yes, self-signed online. No fee to sign the BAA. The pricing table checks "HIPAA / BAA" under both Pay-as-you-go and Enterprise and keeps "Custom BAA" for Enterprise. Terms: Retell is not a business associate unless a BAA is agreed.
A fixed monthly fee: Vapi. Yes, as a $2,000 per month add-on, on any package including Usage only, charged per organization. Signing: BAA emailed on enabling HIPAA in the Dashboard.
On an Enterprise plan: Bland, ElevenLabs and Ultravox. Bland: BAA on Enterprise; price custom. ElevenLabs: Enterprise plan only; price not published. Ultravox: BAA on an Enterprise plan, while its trust center lists HIPAA: in progress. Its FAQ sends BAA requests to an inworld.ai address; the terms name the other party: The contract is with Theai, Inc. dba Inworld AI (terms effective October 1, 2026).
Conditions, and pages that disagree: Synthflow and Telnyx. Synthflow: Yes, for customers using the HIPAA Setting. The BAA is executed at contract signing; no price or plan requirement for it is published. Synthflow's own pages disagree on self-serve. The pricing page: Enterprise contract for every new deployment. Its support pages describe self-serve plans alongside Enterprise, and none of them says whether new self-serve sign-ups are accepted today.
Telnyx: BAA offered; who qualifies differs by page. Its contact-center page says a BAA is available on every plan. A help-center article sets two conditions: meeting Telnyx's commercial thresholds and architecting use of the platform in line with its HIPAA architecture guide. A page on SOC 2 says Telnyx does not publish those thresholds and signs the BAA through sales. The Voice AI pricing page: Regulated-industry readiness on every plan, including pay as you go.
What vendors call their own HIPAA status
This is how the vendors describe themselves. Retell's compliance docs: HIPAA compliant; a signed BAA is required before sending health data. Vapi's home page: States SOC 2, HIPAA and PCI compliance. ElevenLabs picks a different word: ElevenLabs Agents is a HIPAA-eligible service. Synthflow's pricing page gives its Trust Center's list as SOC 2 Type 2 plus the following, with HIPAA marked self-attested. Trust Center list, as given on the pricing page: SOC 2 Type 2, ISO/IEC 27001, GDPR, HIPAA (self-attested), PCI DSS v4.0.1; ISO/IEC 42001, DORA and the EU AI Act shown as in progress.
Synthflow's HIPAA switch is off by default. HIPAA Setting: protected health information not logged, recorded or stored persistently. For PHI, ElevenLabs requires a BAA and Zero Retention Mode: no PII logged or stored after a call. Vapi goes the other way: HIPAA mode and Zero Data Retention cannot be on together.
Who else handles the call
The subcontractor clause, 164.504(e)(2)(ii)(D), covers subcontractors that create, receive, maintain or transmit PHI on the business associate's behalf. In a voice agent call the AI model, speech-to-text, the voice and the phone line can each come from a different company. Vapi's hosting fee includes: None: speech, model, voice, transport extra. The keys can also be the buyer's own: Bring your own provider keys; that provider then bills you directly.
At ElevenLabs the AI model can come from a third party, and on the Free to Business plans the phone line comes from the buyer. Model: Passed through at provider rates, no markup. Phone line: No ElevenLabs rate; your carrier bills you. Retell: Bring your own AI model (custom LLM over WebSocket); Bring your own carrier and numbers via SIP. For the providers it uses itself: Zero data retention agreements with model, speech and voice providers.
Telnyx's HIPAA architecture page sets a rule: Under a BAA, AI features handling PHI must use Telnyx-hosted models. Its Voice AI price list also offers models and voices from other companies: Anthropic, OpenAI: at provider list rates; ElevenLabs voices with your own API key.
Other platforms take a carrier the buyer already has: Bland (Your own Twilio account or SIP trunks), Synthflow (Bring your own Twilio numbers) and Ultravox (Bring your own telephony: SIP trunking, Twilio or other providers).
Among the situations in which HHS's FAQ says a BAA is not required is transmitting PHI through a person that acts only as a conduit for it, for example the US Postal Service, certain private couriers and their electronic equivalents. The FAQ limits this conduit exception to entities that only provide transmission services for PHI, including any temporary storage of PHI. Entities that access PHI on a regular or frequent basis to perform a service on behalf of a covered entity are not conduits.
Often confused with
- Data processing agreement (DPA). A contract on how a vendor processes personal data in general. The BAA is the written arrangement HIPAA requires for protected health information handled by a business associate.
- SOC 2 report. An independent auditor's report on a company's security controls. It is a separate thing from a signed BAA: Ultravox's trust center lists SOC 2 Type I: compliant beside HIPAA: in progress.
- Zero data retention. A promise or setting about whether call data is kept after it is processed. A BAA governs how PHI may be used, disclosed and protected while the vendor holds it.
What each compared vendor publishes about a BAA
| Bland AI | |
|---|---|
| Cartesia Managed Agents | |
| ElevenLabs Agents (ElevenAgents) | |
| LiveKit Cloud | |
| Pipecat Cloud | |
| PolyAI | |
| Retell AI | |
| Smallest.ai Atoms | |
| Synthflow AI | |
| Telnyx Voice AI Agents | |
| Ultravox | |
| Vapi |
The monthly bill on each vendor's BAA plan, with any HIPAA charge the plan adds.
Vendors cited on this page
Bland AI, ElevenLabs Agents (ElevenAgents), Retell AI, Synthflow AI, Telnyx Voice AI Agents, Ultravox, Vapi. Each profile lists everything that vendor publishes, with its sources. All of them are side by side in the comparison.
Sources
- HHS, Business Associates Frequently Asked Questions (content last reviewed 21 October 2026) read 14 Nov 2026
- HHS, Business Associate Contracts: Sample Business Associate Agreement Provisions (published 25 January 2013) read 14 Nov 2026
- eCFR, 45 CFR 164.502, paragraph (e): disclosures to business associates (up to date as of 10 November 2026) read 14 Nov 2026
- eCFR, 45 CFR 164.504, paragraph (e): business associate contracts (up to date as of 10 November 2026) read 14 Nov 2026
Checked against its sources on 14 Nov 2026. Vendor figures on this page open their source when clicked. Lexicost has no commercial relationship with any vendor named on this site.