The Federal Trade Commission has sounded warnings on matters of digital health. It has highlighted personal health data privacy concerns with connected devices and taken action against digital health companies over marketing claims such as those from Luminosity and Carrot Neurotechnology. So the FTC is trying a new approach with the U.S. Food and Drug Administration, Office of National Coordinator and Office of Civil Rights in the form of an interactive guide for digital health developers.
Its digital health developer engagement approach is intended to help developers to school themselves on the rules that determine the difference between devices that need to go down a regulatory path and those that don’t.
Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, said in a statement:
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“As the number of mobile health products available today continues to rise, it’s important to clarify for developers how FDA and other agencies’ regulations would apply to their app…This effort is part of the FDA’s continued commitment to protecting patient safety while encouraging innovation in digital health.”
It comes across a bit like a chutes and ladders of medical app development. 
The question is, how effective will this interactive approach be? It lacks the dry approach of previous education efforts and could help those entrepreneurs with a desire to be informed. But the aggressive marketing approaches by digital health companies keen to build up the health attributes of their products while avoiding the additional cost of obtaining regulatory approval will continue to test the boundaries no matter how compelling FDA and FTC’s strategies are.
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Pharma Guy’s assessment of the FTC’s action last week against Carrot Neurotechnology over its Ultimeyes marketing pitch, which included a $150,000 fine, seems fitting.
Is there a secret pact between #FDA and #FTC about who regulates low-risk mHealth apps? @richmeyer
— Pharma Guy (@pharmaguy) March 30, 2016
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