Medical Smartphone Apps May Need New Federal Regulation

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"We are developing draft guidance that will help clarify an appropriate policy and role for the FDA regarding the regulation of mobile applications, including those on smartphones," FDA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.

"Developing and integrating wireless and broadband communications technology with medical devices and applications requires agencies to assure that such devices operate in a safe, reliable and secure manner," Genachowski and Hamburg added.

At the joint meeting, Genachowski and Hamburg signed a Joint Statement of Principles and Memorandum of Understanding on the agencies' commitment to both innovation and patient safety.

Wireless medical devices allow patients to transmit vital information to patients over the Web to allow doctors to make decisions on care remotely.

Devices include glucose monitors, insulin pumps and heart monitors as well as patch fetal sensors for pregnant women, according to a joint statement by the FDA and FCC.

The FCC regulates smartphone airwave signals, while the FDA regulates medical devices that provide treatment or therapy, according to the two agencies. Meanwhile, software companies may be hesitant to enter the medical app market due to fear of FDA regulation.

"That degree of fear of the FDA regulations is putting established companies off from coming into that market," U.K.-based wireless technology analyst Nick Hunn told DOTmed. "It's causing concern for startups, and perhaps most worrying of all, it's making investors wary of putting money in a company if they have to go through a protracted approval process."

Editor's Note: This article has been updated to include additional information from an FDA spokesman.