Healthcare marketing compliance terms, in plain language

Substantiation

The evidence you must hold before you make an objective claim. The FTC expects competent and reliable evidence, and for health claims that usually means well-designed human studies.

Structure/function claim

A claim about how a product affects the body's normal structure or function, as opposed to a claim about an illness. Dietary supplement claims of this kind need an FDA disclaimer and notice.

Disease claim

A statement tying a product to a named illness or its symptoms. For products without drug approval, FDA can treat such a claim as turning the product into an unapproved drug.

Typical results disclosure

A clear statement of what most people can expect when an ad shows an unusual outcome. The FTC's Endorsement Guides expect this when an endorsement does not reflect typical results.

Endorsement disclosure

A clear and conspicuous statement that a speaker was paid or has a connection to the advertiser. It applies to influencers, patients and clinicians alike.

Protected health information (PHI)

Individually identifiable health information held by a covered entity or its business associate. Using it in marketing generally needs the individual's written authorization.

Covered entity

A health plan, a clearinghouse, or a provider that bills electronically. HIPAA's marketing rules apply to covered entities and their business associates.

Tracking technology

Pixels, tags and scripts on health pages that can send visit data to ad platforms. When the data identifies a patient, it can count as PHI.

Fair balance

The requirement that promotion of a prescription drug present risk information with comparable prominence to benefit claims.

Off-label promotion

Marketing a drug or device for a use FDA has not approved. Manufacturers face strict limits here.

Anti-Kickback Statute

A federal law that makes it a crime to offer or pay anything of value to induce referrals of items or services paid by federal health programs. Payments or gifts tied to patient referrals can raise this issue.

Clear and conspicuous

A disclosure that a reasonable consumer will notice and understand, given its size, placement, contrast and wording. A footnote that most people skip does not meet the standard.

See the rules and coverage for how each term shows up in the rule-set, and the limitations for what the checker misses.