The mHealth Regulatory Coalition (MRC), an alliance of healthcare providers, device and software makers, is speaking out against legislation introduced earlier this year that would limit FDA’s regulatory oversight over certain low-risk clinical software.
Introduced by Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine), the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 has garnered the support of IBM, athenahealth, Software & Information Industry Association, Newborn Coalition and McKesson. Shortly after introducing the act, the legislators penned an editorial in USA Today calling FDA’s regulatory process burdensome and a hindrance to innovation.
Firing back, MRC issued a statement against the legislation, arguing that it would pose serious, potentially life-threatening risks to patients and consumers. It urged lawmakers to put their energies into “achieving the right balance” between patient safety and regulation.
"The PROTECT Act seems a misnomer. Instead of protecting consumers the act actually eliminates vital consumer health protections," wrote Bradley Merrill Thompson, MRC general counsel. "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."
Thompson went on to say that grouping the hundreds of different categories of currently available software into a “few simple buckets” is not feasible. "And that's the problem the backers of this legislation are confronting. With so many factors that determine the risk of a piece of clinical software, two Washington, D.C.-based advocacy groups are pushing legislative language that works about as well as a meat cleaver in surgery."
MRC also listed out certain high risk apps that would face deregulation under the PROTECT Act, including software intended to diagnose possible melanomas when the consumer takes pictures of a mole with a smartphone camera. "What if someone using this software doesn't see a doctor because flawed software misses the melanoma?" wrote Thompson.