mHealth Regulatory Coalition Criticizes PROTECT Act

March 4, 2014 in News

The mHealth Regulatory Coalition argues that legislation introduced last month to limit FDA’s regulatory oversight of health IT would put patient safety at risk, Clinical Innovation Technology reports (Pedulli, Clinical Innovation Technology, 3/3).

Background on Bill

Last month, Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced the Preventing Regulatory Overreach To Enhance Care Technology — or PROTECT — Act of 2014 (S 2007).

The bill would provide with FDA guidance on regulating mobile medical applications. Specifically, it would clarify the agency’s regulatory process to make sure it primarily focuses on technologies that pose the most health risks.

The bill also would exempt certain health IT software from being charged a 2.3% medical device tax (iHealthBeat, 2/11).

Details of MRC’s Opposition

In a statement, MRC — an alliance of health care providers, device manufactures and software developers — said the bill could jeopardize patient safety.

MRC general counsel Bradley Merrill Thompson said, “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.”

He added that grouping hundreds of categories of software into a “few simple buckets” is not practical.

According to Merrill Thompson, certain high-risk applications — such as software designed to diagnose possible melanomas based on patients’ smartphone pictures — would become deregulated under the bill, putting patient safety at risk.

MRC argued that lawmakers should focus on “achieving the right balance” between regulation and patient safety (Clinical Innovation Technology, 3/3).

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