Marketing Claims in Healthcare: Building Compliance Into Messaging from Day One

When healthcare startups and innovators market their services, they often assume legal risk lies primarily in clinical care, data sharing, or reimbursement—not promotional messaging. But poorly substantiated claims, endorsements, or data-driven outreach can quickly attract regulatory scrutiny, erode trust, or even complicate an exit. This post outlines the core filters a sophisticated product or marketing compliance process should use to spot risk early—and why they matter.

Substantiation: Proof-Backed Promotion

Substantiation is the cornerstone of healthcare advertising compliance. While pharmaceutical and device companies navigate this through FDA premarket approvals, many digital health or service startups overlook the fact that the FTC and state attorneys general also enforce general consumer protection laws against unsubstantiated health claims.

The FTC expects health-related claims to be supported by “competent and reliable scientific evidence.” What qualifies depends on the type of product and claim, but may include:

• Nationally recognized clinical guidelines (e.g., HEDIS measures)

• Peer-reviewed studies or professional standards in the relevant domain

• Laboratory or diagnostic validation standards, such as those required under CLIA or CAP

Fictional personas can be used in healthcare marketing if the presentation is clearly labeled (e.g., “actor portrayal”) and represents a typical consumer experience. However, if the persona makes a clinical claim (e.g., “this cured my diabetes”), the claim must be independently substantiated to the applicable evidentiary standard.

For products or services tied to federal healthcare program reimbursement, substantiation plays a role in supporting truthful claims under fraud, waste, and abuse (FWA) laws. In this context, unsubstantiated marketing claims may pose risk not only under consumer protection statutes, but also under the False Claims Act and the Civil Monetary Penalties Law.

Endorsements: Real Opinions, Real Transparency

Endorsements from physicians, influencers, or customers can build trust—but also introduce compliance exposure. Under the FTC Endorsement Guides, any material connection between the endorser and the company (e.g., payments, ownership, incentives) must be clearly and conspicuously disclosed.

In healthcare, payment streams may also raise anti-kickback concerns, particularly if compensation relates to the volume or value of reimbursable services. Compliance professionals should evaluate:

• Whether any compensation complies with applicable regulatory safe harbors

• Whether the endorsement could be construed as remuneration in exchange for patient referrals or product promotion

Customer reviews also qualify as endorsements, especially when used in advertising. Key considerations include:

• Reviews should not be edited in a way that distorts the original opinion

• Positive reviews should not be selectively published while negative ones are suppressed

• Incentives for reviews must be clearly disclosed and cannot be contingent on a positive outcome.

Data-Driven Marketing: Consent and Context

Many healthcare organizations use audience segmentation or outreach tools—SMS, email, programmatic ads—without fully mapping the data sources involved or the legal regimes that apply. There’s no single “health marketing law,” but rather a patchwork of overlapping restrictions:

• TCPA: Regulates mobile, residential, and even fax outreach. Healthcare-related exceptions exist, but they are narrow and context-specific.

• HIPAA and State Analogs: Under HIPAA (applicable to covered entities and business associates), marketing communications using protected health information (PHI) generally require written authorization—not just a click-through or checkbox. HIPAA’s definition of “marketing” is also broader than many assume.

• FTC and State Consumer Data Laws (e.g., CPRA): These may require affirmative express consent for the use of personal data in targeted advertising—even in B2B settings—especially where sensitive or health-related inference data is involved.

Understanding what constitutes “marketing,” what counts as sensitive data, and what kind of consent is legally valid is essential to managing risk in modern digital outreach.

Final Thought: Don’t Just Ask Legal—Build a Process

Ad hoc lawyer review provides a measure of protection, but it has important limits. Reviews are often unstructured, and organizations may lack a reliable record of what content was reviewed, for what purpose, and under which regulatory framework. Moreover, a lawyer’s professional judgment is generally not a suitable substitute for the evidentiary standards governing health-related claims.

However, companies are well positioned to introduce scalable Promotional Content Review (PCR or MLR) processes that:

• Flag unsubstantiated health claims early

• Screen for endorsement and payment conflicts

• Classify data sources and assess required consents

Getting these workflows in place early doesn’t just reduce red flags—it demonstrates credibility with regulators, payers, partners, and acquirers.

This blog is for general informational purposes only and does not constitute legal advice. If you have specific questions about your organization’s marketing practices, consult with qualified counsel.