Sparks fly over mHealth regs

'Too much money is sitting on the sidelines.’
By Diana Manos
10:45 AM

A fire continues to burn unchallenged as various stakeholders take sides over the anticipated depth and timing of mobile app regulation. It appears this most recent iteration flamed up after the Food and Drug Administration issued an "it has come to our attention" letter to Biosense for its UChek urine analyzer.

FDA’s May 21 letter, asking the company to produce proof of its FDA clearance, was not as serious as an official FDA warning letter. However it was the first letter of its kind in quite some time, says Linda Bentley, a member at the global law firm Mintz Levin and chair of the firm’s FDA practice group.

A group of 100 organizations including medical trade associations and electronic health record product companies wrote to federal regulators June 18, urging the need for slowing the course on mHealth regulation, particularly until a mandated federal workgroup finishes working on a report to guide Congress on the issue. FDA officials have nodded toward an October 2013 release of regulations.

[See also: Stakeholders urge a delay in federal oversight of IT and apps.]

Brad Thompson, attorney for the mHealth Regulatory Coalition, submitted a letter to regulators the same week urging the release of mobile app regulations as soon as possible.

Thompson is a member of the workgroup preparing the report. He wants to make it clear he doesn’t speak for the workgroup; however, as a member, he said he’s “pretty familiar with what that group is doing, and I don’t see publishing the FDA guidance as frustrating that at all.”

Mobile app developers need regulations now in order to know if their product needs FDA approval. Without it, they could be breaking a federal statute if they go to market. “It's unconscionable to not have regulations,” Thompson said.

There are “a whole bunch of companies” that want to release high-level effectiveness apps, but they are afraid they will be undersold by cheaper apps that don’t go for FDA approval, Thompson said. “Too much money is sitting on the sidelines.”