The digital health ecosystem has swelled to encompass a broad range of products over the years.
On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time worrying about oversight from the Federal Trade Commission than the health regulator. [Read more…] about Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA
Federal Trade Commission
“The company behind the LearningRX “brain training” program has agreed to pay a $200,000 settlement and to stop making claims that its system is clinically proven to treat serious health conditions, or that it can [Read more…] about Brain training franchisor LearningRx settles FTC complaint about its marketing claims
Lumosity’s Stumble Reveals How We Think About Thinking (BuzzFeed News):
“The ads were pervasive, popping up on CNN, Fox News, NPR, and Google searches. And they were persuasive: Playing Lumosity games would do your brain good…But these claims sounded a little too rosy to the Federal Trade Commission, which [Read more…] about Under new CEO, Lumosity to expand brain training platform with focus on applied skills and broader social, wellness factors
“Federal enforcement action against the makers of a mobile app that claims to improve users’ vision will have a chilling effect on scientists hoping to commercialize their research, the app’s inventor told Bloomberg BNA Feb. 24. [Read more…] about Important conversation: Who knows more about improving vision, a) the Federal Trade Commission or b) 60+ vision scientists
Despite all the noise around brain training, we must be careful not to confuse commerce with science. It is important to remember that the Federal Trade Commission (FTC), which regulates marketing claims and communications in the United States, issues legal rulings against specific commercial behaviors. [Read more…] about The Federal Trade Commission vs Lumosity: What does it mean for the brain training market?
“UC Riverside professor of psychology Aaron Seitz had an idea for a mobile health app based on his area of research.…Seitz is the academic behind UltimEyes, the vision improvement app that got dinged by the Federal Trade Commission (FTC) for $150,000 last week for making deceptive claims about the app’s efficacy. [Read more…] about Next: How to best civilize the mobile brain health and brain training Wild West (Tip: Consumer education may help more than pure regulation)