Skip to the main content.
Talk to sales Start for free
Talk to sales Start for free

2 min read

Does HIPAA require opt in for healthcare emails?

Does HIPAA require opt in for healthcare emails?

For communications categorized as marketing, obtaining opt-in consent is a requirement under HIPAA to protect patient privacy and uphold the principles of transparency and patient privacy.


Does HIPAA require opt-in for healthcare emails?

Yes, according to the HIPAA Privacy Rule, opt-in consent is generally required for healthcare organizations to use or disclose an individual's protected health information (PHI) for marketing purposes. In most cases, healthcare entities must obtain explicit, informed consent—referred to as "authorization"—from individuals before using their PHI for marketing. This authorization ensures that patients have control over their health information and understand how it will be used for marketing purposes. 

See alsoHIPAA compliant email best practices


What is considered marketing?

Marketing under the HIPAA Privacy Rule refers to communication about a product or service that encourages recipients to purchase or use that product or service. It involves promoting goods or services to patients using their PHI. Examples of what is considered marketing include:

  1. Promoting external services: Communications encouraging patients to use external services or products, such as informing former patients about a cardiac facility not affiliated with the hospital.
  2. Selling PHI for communication: Disclosing PHI to another entity in exchange for payment, with the intention that the entity will make communications encouraging recipients to purchase its own product or service. For instance, selling a list of health plan members to a company that wants to send brochures about blood glucose monitors to those members.
  3. Direct-to-patient communications: Sending communications, such as discount coupons or information, directly to patients based on their medical records or prescription history to encourage them to purchase or use specific products.


When is opt-in consent not necessary?

  1. Face-to-face communications: Authorization is not required if the marketing communication is conducted face-to-face between a covered entity and an individual. For instance, a healthcare provider directly communicates with a patient in person to promote a product or service.
  2. Promotional gifts of nominal value: If a covered entity provides a promotional gift of little value to an individual, authorization is unnecessary for subsequent marketing communications. An example is a hospital giving new mothers a free package of baby products upon discharge.

Note that in these scenarios, explicit authorization is not required due to the nature or context of communication. However, all other instances of marketing communication require individual authorization as defined by Health and Human Services.  

See also: What are the opt-in exceptions?


Implementing effective opt-in consent for healthcare marketing

  1. Develop authorization forms: Draft comprehensive authorization forms covering the elements outlined in 45 CFR 164.508. Include clear language about the purpose of the communications, how PHI will be used, and the individual's right to withdraw consent.
  2. Educate recipients: Create informative content explaining the benefits of subscribing to your email list, the type of content they'll receive, and how frequently they can expect emails.
  3. Maintain Records: Keep detailed records of each individual's opt-in consent. Document the date, time, method of consent, and the information provided to patients. This documentation is necessary to demonstrate compliance during audits or investigations.
  4. Informed decision making: Ensure the opt-in consent process includes a clear explanation of the purpose of the emails, what type of information will be shared, and how their data will be used.
  5. Obtain explicit consent: Use a double opt-in process. After a user signs up, send a confirmation email requiring them to click a link to confirm their subscription. This ensures that the individual agrees to receive emails.
  6. Customize consent options: Offer recipients the option to choose the frequency of emails or the specific topics they are interested in. This respects their preferences and aligns with the Individual Choice Principle.
  7. Revocation of consent: Clearly state how recipients can unsubscribe from emails. Make sure that unsubscribing is clear.

See also: HIPAA Compliant Email: The Definitive Guide

Subscribe to Paubox Weekly

Every Friday we'll bring you the most important news from Paubox. Our aim is to make you smarter, faster.