Debate on mobile app regulatory oversight heats up

By Judy Mottl, for FierceMobileHealthcare

The mHealth Regulatory Coalition says a proposed law to eliminate oversight by the U.S. Food and Drug Administration  on mobile healthcare software poses serious risks to patients and that Congress must play a key role in ensuring FDA guidance on mobile applications.

The coalition's statement, released Thursday, is its latest salvo against the proposed Preventing Regulatory Overreach To Enhance Care Technology Act of 2014, a bill that aims to curb FDA regulatory power regarding mobile health apps.

The PROTECT Act, introduced into the Senate two weeks ago by Sens. Angus King (I-Maine) and Deb Fischer (R-Neb.), would put the National Institute of Standards and Technology in charge of technical standards regarding clinical software, and stipulates that the White House administration and Congress develop a risk-based regulatory framework. The bill is a companion bill to the SOFTWARE Act, introduced in the House of Representatives in October.

The coalition's statement comes as debate regarding the PROTECT Act grows louder, with the medical community concerned about potential health risk implications, and lawmakers and business groups worried about the regulatory and economic impact of mobile software.

MRC says the healthcare risks are a much more serious concern, and ones not addressed by the bill.

"The PROTECT Act seems a misnomer. Instead of protecting consumers the act actually eliminates vital consumer health protections," Bradley Merrill Thompson, MRC general counsel, said in the statement. "The rush to avoid expert reviews of complex technologies with far-reaching health ramifications ignores the fact that we cannot separate the high risk from the low risk apps using broad terms in legislation."

MRC adds that the complexity of mobile apps--from general wellness software tools to radiological images used in cancer diagnosis--can't be "grouped into a few simple buckets" and requires FDA oversight to ensure patients' health risks are not increased.

"What if someone using this software doesn't see a doctor because flawed software misses the melanoma?" Thompson asked.

In January, FDA officials took the same message on the road, speaking to software developers at a San Diego panel discussion. The officials stated patient safety is the top priority in the agency's approval process, according to the San Diego Union-Tribune.

As FierceMobileHealthcare reported this week, one recent survey revealed that 37 percent of responding physicians have prescribed a mobile app, while another reported that 42 percent of responding physicians won't prescribe mobile apps, as there is no regulatory oversight.

"It is inconceivable that applications of this complexity would go into the marketplace without FDA approval, yet the PROTECT Act would eliminate those safeguards," Thompson said.

For more information:
- here's the MRC announcement
- read the San Diego Union-Tribune article