In 1998, only 7% of American physicians communicated via email with patients due to initial resistance. However, this figure has significantly increased, with up to 72% of physicians in large outpatient settings now using email communication. Healthcare marketing must be HIPAA compliant to legally and ethically protect patient information. Sending a HIPAA compliant marketing email ensures that any electronic protected health information (ePHI) it contains is secure.
Beyond HIPAA, other legislation governs email marketing in healthcare. The CAN-SPAM Act requires marketers to provide accurate sender information, clear subject lines, and an easy opt-out mechanism, with strict penalties for noncompliance. The Federal Trade Commission (FTC) enforces laws against deceptive advertising, ensuring that marketing claims are truthful and endorsements are genuine. Together with HIPAA, this legislation informs the way healthcare organizations handle email communications sent for marketing purposes.
The HIPAA Privacy Rule, any use of PHI for marketing purposes, defined by the HHS as communications that “encourage recipients … to purchase or use” a product or service, as requiring an individual’s prior written authorization. This means typical marketing emails sent to patient lists (even generic newsletters) often contain PHI by implication, making them subject to HIPAA safeguards.
The HHS also noted, “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.”
To lawfully send personalized, marketing-oriented emails, healthcare organizations must either strip PHI entirely or deploy a HIPAA compliant email marketing platform that encrypts messages in transit and at rest.
Email marketing in healthcare crosses into HIPAA’s regulatory domain whenever PHI enters the conversation. Any email that contains or references PHI, even subtly, such as “Reminder: Follow-up X‑ray scheduled at 3 pm” qualifies. A Journal of the California Dental Association article, ‘Regulatory Compliance/Texting Patients? Collecting Patient Information on a Website? Know the Rules’ provides an apt example of marketing in healthcare, “If a dental practice hires a third party to send marketing communications and the recipient list includes patient email addresses, the practice should sign a HIPAA business associate agreement with the third party.” If an email discloses PHI and is used to promote services or products, it is classified as marketing and requires authorization.
Even a generic newsletter can become marketing if it targets individuals with PHI-relevant content, like sending heart-healthy tips to patients known to have heart conditions. The Privacy Rule bans such communication unless pre-authorized. There’s also when a covered entity receives compensation in exchange for the communication, whether direct payment or other incentives, it compounds the legal requirements. HIPAA’s marketing definition tightens in this context, necessitating enhanced written authorization that acknowledges remuneration.
2025 marks a regulatory inflection point. Healthcare marketers must now ensure their email systems are not only explicitly consent‑driven but are built on secure, audited, and identity-verified infrastructures compliant with the updated HIPAA framework.
The Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) aiming to modernize the HIPAA Security Rule. According to the HHS factsheet in the topic, “On December 27, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule to strengthen cybersecurity protections for electronic protected health information (ePHI).”
It proposes precise definitions for “relevant electronic information systems,” and mandates full inventories and network mapping to identify systems that handle PHI, including email servers and marketing platforms, followed by annual, written risk assessments of those systems.
OCR’s intensified enforcement, informed by a dramatic 264% spike in ransomware in 2024 according to Reuters litigation commentary, is putting pressure on covered entities to adopt mandatory encryption and multifactor authentication across all ePHI channels, encompassing email communications. Furthermore, these updates reinforce HIPAA’s “minimum necessary” principle, compelling healthcare organizations to reevaluate how marketing emails are constructed, encrypted, and transmitted, heightening compliance demands for any electronically delivered PHI.
HIPAA’s Privacy Rule carves out an exception allowing covered entities to engage in in-person conversations or distribute promotional items of minimal worth, like pens, notepads, or brochures, without prior patient authorization, even if the communication might encourage use of a service or product. It should be noted that this is different from other exceptions to the definition of marketing as discussed in the Wake Forest Law Review, “The law included a number of health-related exceptions to the definition of “marketing,” including pharmacy reimbursement, patient care management, utilization review by a healthcare provider, and healthcare research.”
This exception is explicitly included in §164.508(a)(3)(i)(A),(B), which clarifies that neither face-to-face marketing nor nominal-value giveaway items are considered marketing under HIPAA. It preserves patient–provider interactions while maintaining trust and compliance. Notably, the exception does not apply to phone, mail, or electronic communication; those channels still require explicit authorization if tied to promotional content with remuneration.
Healthcare marketers in 2025 should prioritize platforms that ensure encryption, BAA commitments, PHI-specific access controls, audit and DLP features, and ease of patient consent management. According to Statista, email marketing delivers a remarkable $42 in ROI for every $1 spent, underscoring the value of secure email marketing systems. Paubox Marketing meets and often exceeds these requirements:
Before signing up with a HIPAA compliant email service, review the below points.
‘HIPAA COMPLIANCE: A Common Sense Approach’ notes that, “No amount of IT resources can prevent breaches involving blatant violations of patient confidentiality.”
Healthcare organizations that use email marketing improperly can violate HIPAA and CAN-SPAM laws. Under HIPAA, misuse or unauthorized disclosure of PHI in emails, like sending marketing messages without patient consent, can result in civil fines ranging from $100 to $50,000 per violation, with maximum annual penalties up to $1.5 million, and criminal penalties including fines up to $250,000 and up to 10 years in prison if PHI is used for commercial gain or malicious purposes
While CAN-SPAM does not govern PHI, it prohibits misleading headers, deceptive subject lines, and lack of opt-out mechanisms—infractions that can trigger federal fines up to $46,517 per email.