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HIPAA Path
Category: Uses and Disclosures

Marketing

Simply put

In general business terms, marketing is how an organization creates interest in and promotes its products or services to customers. Under the HIPAA Privacy Rule, however, "marketing" has a specific regulatory meaning that differs from this common usage: it generally refers to communications about a product or service that encourage the recipient to purchase or use it. Because the HIPAA definition is narrower and technical, covered entities and business associates should not rely on the everyday business meaning when handling protected health information (PHI).

Formal definition

The evidence packet provided contains only general business and commercial definitions of marketing (for example, the American Marketing Association's framing of marketing as the activity, institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value) and does not include the HIPAA Privacy Rule's regulatory definition of "marketing." As a result, a precise practitioner-level definition grounded in the applicable regulatory text cannot be stated from this evidence alone. Practitioners should note that HIPAA assigns "marketing" a defined meaning that typically triggers an authorization requirement from the individual before PHI is used or disclosed for such communications, subject to specific statutory and regulatory exceptions. Readers must verify the exact definition, the authorization requirements, and the applicable exceptions against the current HIPAA Privacy Rule text and any additional requirements imposed by the HITECH Act or state law before applying this term operationally.

Why it matters

Under the HIPAA Privacy Rule, "marketing" is not simply a business function, it is a defined regulatory term that generally carries specific obligations when protected health information (PHI) is involved. This matters because the everyday business meaning of marketing (creating interest in and promoting products or services) is broader and less precise than the HIPAA definition. Covered entities and business associates that treat the two as interchangeable risk using or disclosing PHI for communications that HIPAA would classify as marketing without first obtaining the individual's authorization where one is required.

The practical consequence is significant: communications that encourage a recipient to purchase or use a product or service may, under the HIPAA Privacy Rule, trigger an authorization requirement from the individual before PHI is used or disclosed. Because specific statutory and regulatory exceptions apply, the boundary between a permissible communication and one requiring authorization can be difficult to determine, and getting it wrong can expose an organization to enforcement action by HHS OCR. The exact scope, authorization triggers, and exceptions must be confirmed against the current HIPAA Privacy Rule text rather than assumed from general business practice.

Additional care is warranted because the HITECH Act and state law may impose requirements beyond the baseline HIPAA Privacy Rule, and these can affect how marketing communications are treated. Practitioners should not rely on the plain-language business definition when handling PHI, and should verify the applicable regulatory definition and exceptions before designing any communication program that touches patient information.

Who it's relevant to

Privacy Officers
Privacy officers are responsible for ensuring that uses and disclosures of PHI comply with the HIPAA Privacy Rule, including determining when a communication constitutes "marketing" and whether an individual's authorization is required. They should verify the specific regulatory definition and exceptions against the current Privacy Rule text rather than relying on the general business meaning of marketing.
Covered Entities
Covered entities that wish to communicate with patients about products or services must assess whether those communications fall within HIPAA's defined meaning of marketing, which may trigger an authorization requirement before PHI is used or disclosed. Because the HIPAA definition is narrower and more technical than everyday business usage, covered entities should not assume that ordinary promotional activity is permissible without checking the applicable requirements and exceptions.
Business Associates
Business associates that handle PHI on behalf of covered entities may be involved in communications that HIPAA classifies as marketing. Their obligations flow through the business associate agreement and the applicable regulatory requirements, and they should confirm, before using or disclosing PHI for such communications, whether authorization is required and which exceptions may apply.
Compliance and Legal Professionals
Compliance and legal professionals advising healthcare organizations need to distinguish HIPAA's technical definition of marketing from its common business meaning, and to account for authorization requirements and exceptions. They should also flag that the HITECH Act and state law may impose additional requirements beyond the HIPAA Privacy Rule, and confirm all specifics against current regulatory text.

Inside Marketing

Definition Under the Privacy Rule
Under the HIPAA Privacy Rule, marketing generally means making a communication about a product or service that encourages recipients to purchase or use it. This is a specific regulatory meaning that differs from the broad common usage of the word marketing.
Authorization Requirement
In most cases, a covered entity or business associate must obtain a valid individual authorization before using or disclosing PHI for marketing purposes. The authorization must generally disclose whether the covered entity receives financial remuneration from a third party in connection with the communication.
Statutory Exceptions
Certain communications are generally excluded from the definition of marketing and therefore do not require authorization, such as communications for treatment of an individual or for case management or care coordination. Practitioners should verify the specific exceptions against the current regulatory text.
Role of Remuneration
Whether a communication involves financial remuneration from a third party is a key factor in determining marketing status. The receipt of such remuneration typically affects whether authorization is required, even for communications that might otherwise fall within an exception.
Scope Across PHI Forms
Because marketing is governed by the Privacy Rule, the requirement applies to PHI in all forms, including oral, paper, and electronic. This is broader than the Security Rule, which addresses only ePHI.

Common questions

Answers to the questions practitioners most commonly ask about Marketing.

Does every communication about a product or service count as marketing under the HIPAA Privacy Rule?
No. Under the HIPAA Privacy Rule, marketing has a specific regulatory definition that is narrower than the common-usage sense of the word. Certain communications are expressly excluded from the definition of marketing, generally including communications made for treatment of the individual, for case management or care coordination, and certain communications describing health-related products or services provided by the covered entity. Because these categories carry specific conditions and exceptions, you should confirm how a particular communication is classified against the current regulatory text rather than assuming any promotional-sounding message is marketing.
If a communication qualifies as marketing, does obtaining an authorization guarantee HIPAA compliance for that activity?
No. Obtaining a valid authorization generally addresses the Privacy Rule requirement to have the individual's permission before using or disclosing PHI for a communication that meets the definition of marketing, but it does not by itself guarantee overall HIPAA compliance. Other requirements may still apply, and where the arrangement involves financial remuneration from a third party, additional disclosure conditions typically attach. State law, the HITECH Act, or other frameworks may impose further requirements. No single step guarantees compliance or prevents all violations.
When does a communication to patients require a HIPAA authorization for marketing?
Generally, an authorization is required when a use or disclosure of PHI meets the Privacy Rule's definition of marketing and does not fall within one of the recognized exceptions. In most cases, communications that involve financial remuneration in exchange for making the communication require authorization, and the authorization typically must state that such remuneration is involved. Because the conditions are specific and subject to exceptions, verify the classification and the required authorization elements against the current regulatory text before proceeding.
How should a business associate handle marketing-related uses of PHI?
A business associate's permitted uses and disclosures of PHI are governed by its business associate agreement and by the Privacy Rule. Obligations related to marketing generally flow to the business associate through that agreement rather than attaching automatically. A business associate should not use PHI for communications that meet the definition of marketing unless the covered entity has obtained any required authorization and the activity is permitted under the agreement. Confirm the specific terms of the applicable business associate agreement and current regulatory requirements.
What documentation should an organization maintain for marketing communications involving PHI?
Organizations generally maintain records supporting how a communication was classified, and where marketing authorizations are required, they typically retain the signed authorizations along with evidence that the authorizations contained the elements required by the Privacy Rule, including any statement regarding financial remuneration where applicable. Retention periods and specific documentation requirements should be confirmed against current regulatory guidance, as state law may impose additional recordkeeping obligations.
How does the HITRUST CSF relate to managing marketing uses of PHI?
The HITRUST CSF is a certifiable control framework maintained by a private organization; it may include controls that help operationalize privacy practices, including consent and authorization management, that are relevant to marketing communications. However, HITRUST certification is not a legal requirement and does not by itself establish HIPAA compliance. Meeting the Privacy Rule's marketing requirements remains a distinct legal obligation enforced by HHS OCR, and control mappings should be verified against the current HITRUST CSF version.

Common misconceptions

Any communication a covered entity sends about health products or services counts as marketing requiring authorization.
Marketing has a specific regulatory definition under the Privacy Rule, and several categories of communication are generally excepted, such as treatment communications and certain care coordination messages. Not every promotional-seeming communication triggers the authorization requirement.
If a communication qualifies as a treatment or care coordination exception, authorization is never required.
The presence of financial remuneration from a third party can change the analysis. A communication that might otherwise be excepted may still require authorization when such remuneration is involved. Readers should confirm the specifics against the current regulation.
Achieving HITRUST CSF certification demonstrates that an organization's marketing practices are HIPAA compliant.
HITRUST is a private organization and its CSF is a certifiable control framework; certification is not a legal requirement and does not by itself establish HIPAA compliance. Marketing obligations arise from the HIPAA Privacy Rule as enforced by HHS OCR and must be evaluated independently.

Best practices

Classify each patient-facing communication against the Privacy Rule definition of marketing before it is sent, rather than relying on internal or common-usage notions of what marketing means.
Determine whether financial remuneration from a third party is involved, since this typically affects whether authorization is required and what the authorization must disclose.
Use valid, properly documented individual authorizations that disclose third-party remuneration where marketing communications require them, and retain these records.
Maintain documented criteria for the treatment and care coordination exceptions so staff can consistently distinguish excepted communications from those requiring authorization.
Verify all specific requirements, exceptions, and disclosure language against the current regulatory text, and account for any additional obligations that state law or the HITECH Act may impose.
Do not treat HITRUST certification or any security control framework as a substitute for a Privacy Rule marketing analysis; evaluate marketing compliance separately.