A 2025 Compliance Guide for U.S. Healthcare Calls

AI-powered voice calls are transforming patient outreach—but they also trigger complex legal obligations. This guide explains when and how healthcare providers must disclose AI involvement in phone calls, what federal and state laws apply, and how to stay compliant without over-disclosing.

Understanding the Federal Baseline

Under U.S. law, any AI-generated voice is treated as an “artificial or prerecorded voice” under the Telephone Consumer Protection Act (TCPA). That means:

• You do not have to say “this is AI.”

• You must comply with all TCPA requirements for artificial or prerecorded calls.

According to 47 C.F.R. §64.1200, these calls must:

• Identify the caller at the beginning.

• Provide a callback number.

• Include an opt-out mechanism for telemarketing or promotional content.

In short: treat every AI-voice call like a prerecorded call. Lead with your identity, provide a callback number, and add an opt-out option for any marketing content.

Why This Matters

For most providers, the compliance risk isn’t about saying “this is AI.” It’s about meeting existing prerecorded-call rules—disclosure, consent, and opt-out. In 2024, the FCC confirmed that AI voices fall under the same TCPA category as other artificial or prerecorded messages.

California: The Only State with AI-Specific Rules

California adds two extra requirements on top of federal law:

1. GenAI-Generated Clinical Content (AB 3030)

• Applies when clinical information is generated by AI (e.g., follow-up instructions).

• Requires a verbal disclaimer at the start and end of the call.

• Must provide instructions for reaching a human.

• If a licensed clinician reviews and reads the message before delivery, the disclaimer is not required.

• Administrative messages like scheduling or billing are exempt.
  Effective January 1, 2025.

2. Prerecorded or ADAD Calls Using AI Voices

• California Public Utilities Code §2874 requires a live, natural-voice preamble before any automated message.

• Pending updates may require that preamble to explicitly disclose AI use.

• Even now, human preambles are mandatory for prerecorded or automated AI calls.

Other States: New York, New Jersey, and Florida

These states have no AI-specific disclosure laws yet—but they do enforce strict caller identification and consent standards:

• New York: Must identify caller and purpose early; limits prerecorded telemarketing.

• New Jersey: Within 30 seconds, identify yourself, your organization, and purpose.

• Florida: Requires prior express written consent for prerecorded or AI-assisted sales calls and restricts call times and frequency.

Bottom line: Follow each state’s telemarketing rules and the federal TCPA standard for any artificial or prerecorded voice.

Patients vs. Pharmacies

Patients:

• AI voice = artificial/prerecorded call.

• Begin with identity and callback number.

• Add California disclaimers for AI-generated clinical content.

Pharmacies:

• Still subject to identification and consent requirements, especially for wireless numbers.

• California’s ADAD rules apply to prerecorded messages using AI voices.

Model Scripts for Compliance

Federal-Compliant Minimum Script:

“Hi, this is [Provider/Clinic Name] calling about [reason]. You can reach us at [callback number].”
(Add automated opt-out for telemarketing only.)

Future-Proof Script (covers AI and human escalation):

“Hi, this is [Provider/Clinic Name] using an automated assistant about [reason]. You can reach a person at [human number].”

California AB 3030 (Clinical AI-Generated Content):
Start: “This message was generated using automated tools on behalf of [Provider] regarding your care. You can reach a human at [number].”
End: “Reminder: this message was generated using automated tools. For a person at [Provider], call [number].”

California ADAD (Prerecorded AI Message):

“Hello, this is [Agent Name] with [Company]. We have a prerecorded message for you that uses an AI-generated voice. May we play it now?”

Common Compliance Pitfalls

• Mixing sales and care content: Sales elements trigger higher consent standards. When in doubt, classify as telemarketing.

• Wireless numbers: Sales or marketing calls to mobile phones using AI voices require prior express written consent.

• Consent recordkeeping: Keep full audit trails—text of consent, timestamp, number type, and campaign linkage.

Compliance Checklist

• Identify the caller and purpose at the start of every AI-assisted call.

• Provide a callback number.

• Include an opt-out option for sales or promotional calls.

• Add California disclaimers if clinical content is AI-generated.

• Use a live preamble for prerecorded messages in California.

• Maintain clear consent records with timestamps and consent language.

FAQ

Q1: Do I have to say “I’m an AI” on patient calls outside California?
No. Federal law doesn’t require that. You only need to follow TCPA identification and opt-out rules.

Q2: What about New York, New Jersey, or Florida?
They require early caller identification and consent for prerecorded or automated calls but no AI-specific statements.

Q3: Is the FCC planning an AI-disclosure rule?
Not yet. The FCC has confirmed AI voices count as prerecorded under TCPA, but labeling requirements are still under review.

Conclusion

You don’t have to say, “This is AI.”
You do have to say who you are, give a callback number, and offer an opt-out for sales.

In California, add AI disclaimers for GenAI-generated clinical content and live preambles for prerecorded AI messages. Future-proofing your scripts and consent text now ensures compliance as regulations evolve.