FDA Publishes Draft Guidelines on Mobile Health App Regulations

The FDA is seeking feedback on new guidelines that inform cell phone manufacturers and software developers on what mobile medical applications will require its approval.

The U.S. Food and Drug Administration has released guidance on mobile medical applications to inform manufacturers and distributors which applications would require review and approval by the agency. It seeks public comment on the document through Oct. 19.

According to its draft guidelines made public on July 19, the agency would regulate a small group of medical apps for smartphones that directly affect a patient's health. The FDA will not regulate the sale of mobile devices themselves, however.

A separate FDA rule regarding medical device data systems took effect on April 18 requiring IT companies to register health care hardware and software that transfers, stores, converts or displays health care data.

The FDA's Center for Devices and Radiological Health oversees regulations for companies manufacturing, repacking, relabeling or importing medical devices in the United States.

The Federal Communications Commission governs smartphone airwave signals, while the FDA regulates medical devices that provide treatment or therapy.

The smartphone platforms for which medical apps would be regulated under the draft guidelines include Android, BlackBerry and iPhone. Mobile apps in question would reside directly on a smartphone or on the Web.

"Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

The apps that will require regulations are those that work as an accessory to an FDA-regulated device and those that turn a smartphone into a medical device to monitor health conditions. Apps that could turn phones into a stethoscope or ECG machine to look for abnormal heart rhythms will fall under the regulations.

An app that allows a physician to monitor a heartbeat or other vital signs such as blood glucose readings would also need FDA approval. Other medical apps that would be regulated might generate signals to check a patient's hearing or use a smartphone's light to treat skin conditions.

Apps that connect to medical imaging servers to allow doctors to view X-rays on smartphones to make diagnoses would also fall under the guidelines. In addition, screen size, contract ratio or inadequate ambient lighting could affect the quality of medical images and impact patients' health, the FDA reports.

The agency's guidelines would not include medical reference, physician-managed EHR (electronic health record) and patients' PHR (personal health record) applications.

Practice-management applications that allow doctors' offices to track billing, inventory and appointments would also be unaffected by the regulations.

"If it is marketed as a medical solution, the FDA has jurisdiction, and these guidelines are actually a bit late," Rob Enderle, principal analyst at the Enderle Group, wrote in an email to eWEEK.

At UnitedHealth Group's Mobile Health and Technology panel discussion attended by eWEEK on June 10 in New York City, Tom Marchioro, solutions architect, fitness, for GPS manufacturer Garmin, mentioned that the company is working on wellness apps for smartphones, but won't be developing those that require FDA approval.

"We're probably going to draw the line for the foreseeable future on things that require FDA approval," Marchioro said, noting the long procurement and approval cycles. "FDA approval slows everything down," he explained.

FDA spokesman Dick Thompson had told eWEEK back in September that the FDA would seek public input before issuing a final document. The agency will issue an updated guidance following the end of the comments period on Oct. 19.