When considering marketing a new HealthTech device or platform, there are many federal agencies that have jurisdiction over proper advertising, branding, and marketing communications with consumers and businesses alike. This post is dedicated to sharing three quick tips to consider when marketing in the HealthTech field.
Patient Endorsements and TestimonialsÂ
Much like brands seeking testimonials from their consumer base to prove the validity of their service or product, doctors often seek testimonials from impressed patients to prove the validity of their services. However, these claims, under HIPAA (Health Insurance Portability and Accountability Act of 1996) may breach the security offered to patients under the Act. It is best to consult with a qualified HealthTech attorney who can determine how to prevent a breach of patient information.Â
Just as treatment claims must be substantiated as typical, patient endorsements and testimonials also must reflect typical outcomes. Because a patient endorsement or testimonial advertised by a covered entity or business associate will most likely constitute a breach of HIPAA, it is important to seek the written authorization of the patient to disclose and use the endorsement or testimonial in accordance with the Privacy Rule.
The FTC has further stated that patient endorsements and testimonials must speak to the kind of result that the average patient would reasonably expect to experience. If the endorsement does not present the typical result, then the advertisement must disclose the typical result. Qualifying statements, such as results not typical do not adequately reduce the advertisement to depict experiences as generally representative.
Labeling
The FDA enforces rules pertaining to the labeling of medical devices. In determining whether the labeling or advertising is misleading, the following is taken into account: representations that have been made or suggested; the extent to which the labeling or advertising fails to reveal material facts in the light of such representations; and material with respect to consequences which may result from the use of the device under the conditions of use prescribed in the labeling or advertising or under usual or customary use.
Premarket Notification Representations
Misbranding can also occur if the device creates a representation that creates an impression of official approval because of complying with premarket notification regulations. Violations of these misbranding rules can result in judicial injunction, criminal penalties fines, and seizure of property.
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.
