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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.

"We are developing draft guidance that will help clarify an appropriate policy and role for the FDA regarding the regulation of mobile applications, including those on smartphones," FDA spokesperson Dick Thompson wrote in a Sept. 8 e-mail to eWEEK. "Some mobile applications are very similar to traditional software applications that the FDA has already classified or regulated, but we believe that further clarifications on mobile applications would be helpful."

Thompson added that the FDA plans to seek public input before issuing a final document.

On July 26, the FDA and Federal Communications Commission held public meetings to explore the extent to which wireless medical devices should be regulated. "Innovation in broadband and wireless-enabled medical devices holds significant promise for enhancing health and reducing the costs of health care for all Americans," FCC Chairman Julius Genachowski and FDA Commissioner Margaret Hamburg wrote in a joint statement.

The two officials cited heart rhythm monitors and glucose monitoring systems as examples.