FDA Crafting Regs for Mobile Medical Apps

As FDA officials consider the more than 130 industry comments on draft regulations for mobile medical apps, they are trying to strike a balance between encouraging development and ensuring safety.

“We are very supportive in terms of where mobile technology will take us [in] healthcare,” said Bakul Patel, an FDA policy advisor who spoke last week at the American College of Radiology’s inaugural summit on informatics in Washington, DC.

The agency published its draft guidance in July and accepted comments through last month. The guidance outlined what kinds of medical apps would be regulated by the FDA, such as those that can be used as an accessory to a medical device or those that transform a mobile computer and convert it to a medical device would ideally fall under their purview, Patel said.
Patel said many in the industry understand the intent of the regulations, but have requested more clarity.

The first mobile app for diagnostic radiology to received FDA clearance was MIM Software Inc.’s Mobile MIM, which was cleared in February after a process that started in 2008. The app was approved for viewing images and making medical diagnoses based on CT, MRI and nuclear medical technology.

Its approval seemed to signal a shift at the FDA to a greater focus on medical mobile apps.
Mark Cain, MIM Software’s CTO, who also spoke at the informatics forum, detailed the FDA’s concerns about their app and his company’s solutions to the problems. He also expressed his frustrations over the FDA’s delay in addressing the need for regulation.

“It’s a shame that it has been over three years that medical apps came into existence, and we are still debating guidance,” he said. “What has taken so long?”

Cain said the industry should have been at the FDA’s doorstep demanding the regulation, adding that some advances could have already appeared on the market. If you have a device, he told the audience, don’t wait. Go to the FDA for regulation so it can get on the market. That will allow the entire medical mobile apps industry to advance, he said.

Donna-Bea Tillman, director of regulations and policy at Microsoft Health Solutions who spend many years directing the FDA’s Office of Device Evaluation, said one reason it’s take so long is that the industry - a bit in denial - is not used to being regulated by the FDA.

She also said clinicians should be more involved, as they are the owners of best practices and standards of care. “We need to find a way for you in the clinical community to take more ownership of the rules,” she said, speaking at the forum. “The FDA isn’t used to partnering extensively with the clinical community.”