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Medical Smartphone Apps May Need New Federal Regulation

Health Care IT - eWeek, September 9, 2010

The Food and Drug Administration is looking into whether smartphone apps that allow patients to monitor their vital signs wirelessly should earn FDA approval before implementation.

Bradley Merrill Thompson, an attorney with law firm Epstein, Becker & Green, who studies health care issues, told GigaOM that the FDA is keeping an eye on app stores to see which medical applications for smartphones might require regulation. "The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement," Thompson told GigaOM for an Aug. 31 report. "Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval."

GigaOM notes that the iStethoscope iPhone application and the Instant Heart Rate tool for Android could warrant FDA regulation.