Tag: HIPAA

FDA: Regulators Can’t Scale To Police Mobile Health Apps

A senior advisor to the U.S. Food and Drug Administration (FDA) tossed cold water on speculation that the Agency might try to police mobile health and wellness applications, saying the FDA couldn’t possibly scale up to meet the challenge of policing the hundreds of new apps appearing every month. Correction: The article was changed to clarify Mr. Patel’s comments. He was not responding to a direct question about the FDA setting up an office to regulate mobile health applications. He was commenting on the possibility of creating a platform to evaluate and rate mobile health applications.  Also, he said “It’s not do-able,” not “it’s not possible.” We apologize for any confusion created by the article. – PFR July 10, 2014. The sheer pace of innovation in the mobile health application space and the numbers of such applications already available on mobile marketplaces like the iTunes App Store and Google Play mean that many mobile health applications will escape scrutiny by federal […]