HIMSS14: Regulatory Showdown Looms Over Mobile Health

Greg Slabodkin | Health Data Management | February 25, 2014

A legislative showdown is brewing between Congress and the U.S. Food and Drug Administration over the right balance between promoting innovation in a fledgling mobile health industry and protecting patient safety. 2014 could be the year that several laws are passed with significant implications for health I.T., according to a HIMSS14 panel discussion on congressional affairs.

"You have the FDA rule that came out in 2013 which basically said they will regulate mobile apps as a medical device if they see fit. So, that is a cause for some concern," said Mitchell Vakerics, Legislative Counsel for Congresswoman Renee Ellmers (R-N.C.), who sits on the House Energy and Commerce Committee where she serves on the Health, Communications and Technology Subcommittee. 

"What we don't want is the FDA to go too far, stifle an industry and over-regulate it," Vakerics added. "We're talking about a 1970s law that they're working with."

In late October, a bipartisan bill called the SOFTWARE Act was introduced in the House of Representatives to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA's regulatory authority over mobile medical apps. [...]