Bradley Merrill Thompson Quoted in Article, “Let the SOFTWARE Act Die in Committee”


Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Let the SOFTWARE Act Die in Committee."

Following is an excerpt:

The SOFTWARE Act got a mixed response from industry groups. While the Software & Information Industry Association, was quick to voice its support for the proposed legislation, calling it "an effective regulatory framework for medical software that will promote safety while advancing innovation."

Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition (MRC), got it right when he said "the act of separating the software is fraught with challenges" which might "produce some unexpected outcomes." ?...

"Presently, the riskiest versions of this software are class III medical devices regulated by FDA," Thompson told FierceMobileHealthcare. "If I read this legislation correctly, it would put this CAD in the category of clinical software, to be unregulated until the future as-of-yet unspecified regulatory system is put in place. I don't think the drafters intend for that outcome."