Depending on a HealthTech companies product or service, certain rules regulating the advertising of the product or service may apply. This section discusses three federal agencies that enforce certain advertising and labeling rules. There are Federal guidelines which outline how to commercially advertise and how to make sure your company is in compliance with all regulations. It is best to consult with a qualified HealthTech attorney.
Commercial Regulations
The Federal Trade Commission (the FTC) enforces regulations pertaining to commercial advertising generally, which centers on unfair or deceptive practices. The FTC has established a three-part standard for the determination of a deceptive practice: (i) the representation must mislead or be likely to mislead the consumer, (ii) the consumers interpretation must be reasonable under the circumstances and (iii) the misleading misrepresentation, omission or practice must be material. FTC regulations is no less applicable in the digital sphere than in traditional media.
Much of healthcare marketing involves claims regarding healthcare treatments and outcomes. The FTC has made it clear that the advertiser must substantiate all health claims express and implied that the ad conveys to reasonable consumers. A healthcare technology company advertising treatment results must be able to substantiate any claims and must be clear when making comparison claims to regional or national averages. Further, advertisers should not make claims regarding success rates if there is a statistical anomaly behind the data being presented in the advertisement.
Digital Marketing
The FTC has issued additional guidance for digital marketing. If the necessary disclaimers cannot fit into the digital medium, then the ad should not run. Disclosures can be difficult in the reduced footprint of digital spaces, such as Twitter or other platforms where the post is structurally limited.
Further, influencer marketing (social media marketing involving endorsements by people or organizations who possess a purported level of knowledge or social influence in their respective fields) is gaining prominence in the digital arena. When an endorsement is being made for compensation, the relationship (known as a material connection) must be clearly disclosed.
The Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003 (CAN-SPAM) established national standards for the sending of commercial emails and granted the FTC authority to enforce its provisions. Healthcare marketers who rely on an email strategy must comply with CAN-SPAM. Some of the substantive rules include: avoiding deceptive subject lines or misleading headers, identifying the message as an advertisement, giving recipients the business location, giving recipients an option to stop receiving emails, and honoring all requests to stop receiving emails.
Matthew DeNoncour, Esq. is the principal attorney and owner of Magis Law Firm, a boutique law firm based in Boston, with offices in Providence, Miami, and Fort Myers, where he provides legal services to the healthcare, life science, and technology industries. You can reach Matt at magislawfirm.com, by phone at 866-277-8680 or by email at mdenoncour@magislawfirm.com. This post is not meant to be legal advice: learn more here.
