Companies with mobile medical applications can now look to guidance from the Federal Trade Commission (FTC) to inform their marketing efforts and keep them in line with federal law.
Mobile applications, more commonly referred to as "apps," are stand-alone programs that operate on mobile devices, including smartphones and tablets. While they have become a ubiquitous presence on many technology platforms, regulators, and in particular the US Food and Drug Administration (FDA) and FTC, have been wary of some of the regulatory gray areas surrounding the technology.
In July 2011, FDA went as far as to release guidance to mobile application developers of healthcare-focused apps, noting that if their application instructed people to seek the care of a physician or take a particular product, the app would need to be cleared or approved by FDA before being allowed on the market. Specifically exempt from the requirements were any applications simply relaying information or those used to log or track data or general wellness.
FTC's General Guidance
Unlike FDA's guidance, FTC's 5 September guidance speaks in more general terms regarding marketing claims that may be made for all applications, and not just those marketed for medical purposes.
Developers of applications should be truthful in describing what their application is capable of doing, writes FTC. "Once you start distributing your app, you become an advertiser," it explains. "Under the law, an ad isn't just a multimillion-dollar TV campaign. It's pretty much anything a company tells a prospective buyer or user - expressly or by implication - about what a product can do."
Companies are still required to back up claims using "competent and reliable evidence" regardless of whether it is an application or a physical product, explains FTC.
Key information about a product should also be maintained in a clear and conspicuous location so that end users can easily find the information, continued FTC. For a medical application that provides general information, this might include a disclaimer that the information should not be used to substitute for the opinion of a medical professional, for instance.
In addition, applications will need to protect consumer information, including honoring the privacy promises made to users in agreements, protect the privacy of children using the applications, collecting sensitive information from consumers only after obtaining their consent and keeping all data secure. This is particularly important if the application involving financial or medical data about an end user. Failure to secure either type of data could place the manufacturer in violation of numerous federal laws.