What are the boundaries of marketing activities for an entity covered by HIPAA?

by | Feb 28, 2023 | HIPAA News and Advice

Marketing activities for an entity covered by HIPAA are subject to strict boundaries, where patient-specific authorization is generally required before using PHI for marketing purposes, unless the communication falls under certain exceptions like treatment-related communications, healthcare operations, face-to-face communications, and promotional gifts of nominal value, ensuring that patients’ privacy rights are respected and their sensitive health information is not improperly used or disclosed for marketing endeavors. Healthcare professionals and entities must adhere to these boundaries to ensure compliance with the law and maintain the confidentiality of patient information.

Boundaries of Marketing Activities for HIPAA-covered EntitiesExplanation
Authorization RequirementMarketing involving patient PHI generally needs explicit patient authorization.
Definition of MarketingCommunication encouraging product/service use, requiring patient consent.
Authorization ElementsClear, specific form detailing the purpose, types of PHI, recipients, and revocation right.
Treatment-Related CommunicationsMarketing related to current treatment doesn’t require authorization.
Healthcare Operations ExceptionCertain communication-supporting operations are exempt from authorization.
Face-to-Face CommunicationsIn-person interactions are exempt from the marketing authorization requirement.
Promotional Gifts of Nominal ValueLow-value gifts can be given without explicit patient authorization.
Opt-Out OptionsPatients can opt out of marketing communications, even exempt ones.
Authorization ClarityAuthorization forms should be clear, not buried, and avoid complex language.
Revocation RightsPatients can revoke authorization anytime, stopping PHI use for marketing.
Third-Party CommunicationsBusiness associates must follow the same marketing rules as covered entities.
Educational InformationSharing general health info doesn’t require patient authorization.
Privacy NoticesMarketing practices and PHI use must be in privacy notices.
De-Identified DataProperly de-identified PHI isn’t subject to marketing restrictions.
HIPAA Compliance TrainingStaff involved in marketing need training on HIPAA’s marketing rules.
Penalties for Non-ComplianceNon-compliance can lead to financial penalties and legal consequences.
Ethical ConsiderationsAdhere to ethical principles to preserve patient trust and medical integrity.
Balancing Marketing and PrivacyMaintain a balance between marketing efforts and patient privacy rights.
Table: Key Boundaries that HIPAA-Covered Entities Must Observe in Their Marketing Activities

Under HIPAA, marketing refers to any communication about a product or service that encourages recipients to purchase or use that product or service. This includes communications made by the covered entity, as well as by business associates on their behalf. Marketing communication under HIPAA does not include communications that are intended for treatment, healthcare operations, and other specific purposes outlined in the law. The primary principle guiding marketing activities under HIPAA is that a covered entity must obtain an individual’s valid and explicit authorization before using their PHI for marketing purposes. Authorization is an important concept within HIPAA’s marketing regulations. Authorization for marketing communication must be obtained in a manner that is clear, specific, and unambiguous. The authorization form must clearly state the purpose for which the PHI will be used, the types of PHI that will be disclosed, the individuals or entities that will receive the PHI, and the individual’s right to revoke the authorization at any time. The authorization must not be buried within other documents or written in complex language that might obscure its intent.

However, there are certain exceptions to the requirement for patient authorization for marketing activities. One exception is for communication that is part of a healthcare provider’s treatment activities. If a healthcare professional wishes to communicate information about a product or service that is directly related to a patient’s current treatment regimen, patient authorization is not required. This exception recognizes that timely and relevant treatment-related communications can contribute to the patient’s well-being and overall healthcare experience. Communications that support healthcare operations also do not require patient authorization. Healthcare operations encompass a wide range of activities necessary for the proper functioning of a healthcare entity. These activities may include quality assessment and improvement, case management, patient satisfaction surveys, and other administrative functions that aim to enhance the efficiency and effectiveness of healthcare delivery. However, even within the scope of healthcare operations, the communication must be relevant and beneficial to the patient, and patients must have the ability to opt out of such communications.

Face-to-face communications between a healthcare provider and a patient also fall outside the realm of requiring patient authorization. This recognizes that direct interactions between healthcare professionals and patients are an essential part of delivering care, and they do not constitute the kind of unsolicited communication that HIPAA aims to regulate. For instance, if a physician discusses treatment options with a patient during an appointment, this conversation does not necessitate patient authorization under HIPAA’s marketing rules. The provision of promotional gifts of nominal value is another exception to the authorization requirement. Covered entities are allowed to provide patients with gifts that are inexpensive, such as pens or notepads, without obtaining explicit authorization. These gifts are seen as a means of promoting goodwill and building positive patient relationships, rather than as marketing strategies aimed at generating revenue.


Marketing activities for entities covered by HIPAA must adhere to specific boundaries to protect the privacy and confidentiality of patients’ PHI. Patient authorization is generally required for using PHI for marketing purposes, with exceptions including treatment-related communication, healthcare operations, face-to-face interactions, and promotional gifts of nominal value. Healthcare professionals and entities must carefully navigate these regulations to ensure HIPAA compliance while maintaining effective communication and patient engagement. By upholding the principles of HIPAA, healthcare providers can balance their marketing efforts with their commitment to patient privacy and ethical medical practices.

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