A drug company pays a clinic to mail its patients ads for a new product. What does the clinic need?

Each patient's authorization, saying payment is involved.

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  1. Each patient's written authorization ✔
  2. Nothing, it counts as operations
  3. Only an opt-out notice in the mailer

Why: Using PHI for marketing needs the patient's authorization. When a third party pays the covered entity, the authorization must say so.

Huh, didn't know that: A covered entity's own face-to-face conversation with a patient about a product needs no authorization.

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What did the mailbox say to the letter? Nice to meet you, I'll be in touch.
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References

Answer: Each patient's written authorization. Using PHI for marketing needs the patient's authorization. When a third party pays the covered entity, the authorization must say so.

  1. 45 CFR 164.508 (eCFR) www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.508
    a covered entity must obtain an authorization for any use or disclosure of protected health information for marketing
    Checked 2026-10-10.
  2. 45 CFR 164.508 (eCFR) www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-E/section-164.508
    A face-to-face communication made by a covered entity to an individual; or (B) A promotional gift of nominal value
    Checked 2026-10-10.

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