Do you need opt-in for fundraising emails?

Fundraising emails occupy a unique space in healthcare communications. While HIPAA regulations are strict about marketing emails, particularly those promoting services or products, they allow for certain exceptions when it comes to fundraising. Specifically, healthcare organizations do not require explicit opt-in consent to send fundraising emails. Instead, HIPAA permits an opt-out approach, provided the organization respects patient privacy and offers recipients a clear method to unsubscribe.

Marketing vs. Fundraising

The Health Insurance Portability and Accountability Act (HIPAA) defines marketing as “making “a communication about a product or service that encourages recipients of the communication to purchase or use the product or service.” Generally, if the communication is “marketing,” then the communication can occur only if the covered entity first obtains an individual’s “authorization.” Marketing is also “An arrangement between a covered entity and any other entity whereby the covered entity discloses protected health information to the other entity, in exchange for direct or indirect remuneration, for the other entity or its affiliate to make a communication about its own product or service that encourages recipients of the communication to purchase or use that product or service.”

The Association of American Medical Colleges (AAMC) defines fundraising as “A communication by or on behalf of a Covered Entity for the purpose of raising funds for a Covered Entity, including, donations, appeals, or sponsorship of events, but not royalties or remittances for sale of products.”

The distinction is important because fundraising is viewed as directly tied to the mission of nonprofit healthcare providers. As a result, HIPAA permits covered entities to use limited patient information for fundraising without obtaining explicit opt-in consent.

Related: What are the opt-in exceptions?

HIPAA and fundraising

HIPAA’s Privacy Rule balances patient privacy and permissible uses of protected health information (PHI). As the Department of Health and Human Services (HHS) puts it in its summary, the Rule aims to protect individuals' health information while “allowing the flow of health information needed to provide and promote high quality health care.”

Specifically on fundraising, a key clarifier comes from the AAMC, which states that: “All Covered Entity’s fundraising communications must include, in a clear and conspicuous manner, the opportunity for the recipient to opt-out of receiving any future fundraising communications.” 

Moreover, the AAMC guidance emphasizes that the opt-out method must be “simple, quick and inexpensive,” meaning that requiring patients to send a letter is burdensome and not compliant, whereas options like an email, toll-free number, or pre-paid postcard are acceptable. 

Further clarity comes from the legal analysis in Bricker Graydon: The Privacy Rule mandates that communications must contain a description of how the individual may opt out of future fundraising messages (§ 164.514(f)(2)(ii)), and the methods must “not impose an undue burden or more than a nominal cost.” 

These guidelines clarify that while HIPAA doesn’t require explicit consent (opt-in) for fundraising emails, compliance depends on providing a clear, user-friendly opt-out option, and treating that opt-out as final unless the patient explicitly opts back in.

What are the requirements for the opt-out mechanism?

For the opt-out exception to align with HIPAA's principles, covered entities must prioritize patient preferences and privacy. In every fundraising email, the opt-out mechanism should be prominently displayed. Recipients should have no difficulty finding and using the opt-out option, ensuring a seamless and respectful experience. Organizations must promptly honor opt-out requests to maintain compliance with HIPAA. 

Furthermore, an opt-out mechanism is necessary under the CAN-Spam Act, which states that “Recipients of emails from a sender that runs a subscription service or membership program still have the right to opt out of marketing messages from you.” Furthermore, the Act states that “Any opt-out mechanism you offer must be able to process opt-out requests for at least 30 days after you send your message. You must honor a recipient’s opt-out request within 10 business days. You can’t charge a fee, require the recipient to give you any personally identifying information beyond an email address, or make the recipient take any step other than sending a reply email or visiting a single page on an Internet website as a condition for honoring an opt-out request.”

How to send HIPAA compliant fundraising emails

Sending fundraising emails under HIPAA’s opt-out provision requires more than just adding an unsubscribe link. Healthcare entities need to embed compliance and ethics into every stage of their campaign. Here’s a practical roadmap:

• Identify relevant recipients: Limit your fundraising emails to patients whose current treatment or condition is directly linked to the fundraising initiative. This approach ensures that the opt-out exception is applicable, maintaining patient privacy.
• Transparent subject lines: Clearly articulate the email's purpose in the subject line. Transparency builds trust and helps recipients understand the context of the communication.
• Explain relevance: In the initial lines of the email, elaborate on how the fundraising effort relates to the recipient's healthcare journey.
• Robust opt-out mechanism: Include a prominently displayed, intuitive opt-out link or button. This empowers recipients to effortlessly exercise their choice while respecting their privacy preferences.
• Concise content: Keep the email content brief and focused on the fundraising initiative and its impact. Steer clear of excessive medical details.
• Respectful and ethical tone: Craft the email with a style that exudes respect and empathy. Avoid pressure tactics or language that could cause the recipients discomfort.
• Educate on the opt-out process: Briefly explain the process, detailing how recipients can unsubscribe from further fundraising communications if they desire.
• Rigorous data handling: Ensure the highest standards of data security by employing a secure, HIPAA compliant email marketing platform for sending and managing fundraising emails.
• Regular opt-out review: Consistently review and update your contact lists to honor opt-out preferences. Implement measures to prevent recipients who have opted out from receiving future fundraising emails.
• Periodic compliance assessment: Regularly assess your fundraising email strategy to guarantee ongoing alignment with HIPAA regulations. 

While marketing emails often demand opt-in consent, the opt-out provision for fundraising emails provides a middle ground that respects both organizations' fundraising needs and recipients' preferences.

Best practices beyond compliance

To truly succeed, organizations should aim for strategies that are legal, patient-centered and effective. Here are a few advanced best practices:

• Segment your audience: Tailor emails based on demographics, past engagement, or patient journey stages. A family-centered message for pediatric care may resonate differently than a campaign for oncology research.
• Tell stories responsibly: With proper consent, share patient testimonials that highlight the real-world impact of donations. Stories are powerful motivators.
• Express gratitude: Recognize past contributions and thank supporters. Gratitude fosters long-term relationships.
• Coordinate across channels: Pair fundraising emails with social media posts, direct mail, or events to maximize reach.

Learn more: Best practices for HIPAA compliant email marketing

Using Paubox Marketing for HIPAA compliant fundraising emails

Even with HIPAA’s opt-out exception, healthcare organizations must ensure the platform they use to send fundraising emails is fully compliant. Traditional email marketing tools often fall short because they aren’t designed to safeguard protected health information (PHI). That’s where Paubox Marketing comes in.

Paubox Marketing is a HIPAA compliant email marketing solution that allows healthcare entities to securely send personalized emails, including fundraising campaigns, without sacrificing compliance or patient trust.

Benefits of using Paubox Marketing for fundraising:

• Seamless HIPAA compliance: Every message sent through Paubox is encrypted by default. As Paubox notes, its solution “removes the friction of portals and passwords, delivering HIPAA compliant email directly to the inbox,” making it easier for recipients to engage.
• Personalization with PHI: Unlike most platforms, Paubox Marketing enables you to segment and personalize emails using PHI. For example, you can target patients who have received cardiology care with a fundraising campaign for expanding the heart center. This is done securely, without exposing sensitive data.
• Built-in opt-out mechanisms: Paubox automatically provides unsubscribe links in compliance with HIPAA’s requirement that opt-outs must be “simple, quick and inexpensive.” This ensures you meet regulatory standards without extra steps.
• Audit trails and tracking: The platform logs and tracks communications, making it easier to demonstrate compliance if audited by regulators or questioned by patients.
• Improved engagement: Because patients receive fundraising messages directly in their inbox (without having to log into a portal), open and click-through rates are higher, making campaigns more effective.

FAQS

Can patients opt back in after unsubscribing?

Yes. If a patient changes their mind, they can opt back in by contacting the organization or following re-subscription instructions provided in the opt-out process.

Why do nonprofits rely so much on fundraising emails?

Fundraising helps healthcare organizations cover costs that insurance or government reimbursements don’t fully support, such as new equipment, community programs, and research initiatives. Emails allow organizations to reach donors quickly and efficiently while still protecting privacy.