March 2019
By: Andrew Neiman
“The number of mobile medical applications (“mHealth apps”) available on the market has more than doubled in recent years with incredible potential for expanding access to healthcare. However, it is difficult for the FDA to regulate mHealth apps under its traditional medical device regulations because these apps have rapid commercial cycles that respond to technological innovation.”
“The FDA has therefore chosen to employ a Software PreCertification Pilot Program (“PreCert Program”), where it plans to regulate mHealth apps by preapproving the developer rather than the product. This Note argues that the PreCert Program is an effective policy to sidestep regulatory issues for mHealth apps, so long as the FDA adopts certain measures to protect consumers and encourage innovation.”
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