It's time to clear the murky regulatory waters of mHealth oversight
A federal regulatory agency fired awarning shot against false marketing of an mHealth app's capabilities this past week, and while the intention is clearly to protect the U.S. consumer, it also illustrates there is still a great deal of murkiness regarding government oversight when it comes to mHealth tools.
The Federal Trade Commission (FTC) is fining vision app maker Carrot Neurotechnology Inc. $150,000 for false claims. The agency is demanding the company stop advertising that claims the app can improve a person's vision. However, Carrot Neurotechnology co-owner Aaron Seitz says the FTC decision will have a great impact on innovation, especially for scientists looking to grow their research, according to Bloomberg BNA. Seitz is a professor of psychology at the University of California Riverside.
The FTC decision once again puts a spotlight on mHealth app regulation and raises questions about which agency, the FTC or the Food and Drug Administration (FDA), should be playing a role in mHealth tool oversight.
The problem I see with this latest FTC action is that it can and will, as Seitz says, stifle innovation and shut down developers who are legitimately striving to help consumers deal with health-related issues.
It's already happening, according to a former FDA official, who in late 2015 wrote that the current regulatory approach needs a good look. The "we'll know when we see it," strategy, Scott Gottlieb, M.D., said, has already stymied the potential of the Apple Watch.
The latest FTC action also clearly reveals that neither agency has spent much time talking with one another. In addition, neither seems focused on determining what each agency's responsibility is with regard to emerging mHealth technology. That is not good given the rapid advancement and growth of new mHealth tools.
It's time the FTC and FDA come together and map out their responsibilities in this space--deciding what specific actions require fines and what specific actions require pulling apps or devices off the market.
Consumer protection can't remain in such a murky state; it puts the health and safety of consumers at risk and creates confusion within the industry.