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 “Representatives Grill Shuren, Advance SOFTWARE Act.”
Following is an excerpt:
The SOFTWARE Act debuted at a Nov. 19 hearing of the Health Subcommittee of the House Energy & Commerce Committee to favorable reactions from House members and the experts who testified.
The bill, sponsored by Rep. Marsha Blackburn, R-Tenn., among others, would clarify FDA’s jurisdiction in health information technology, deregulating the sector and exempting these products from the medical device tax. ?…
According to SOFTWARE Act proponents, while FDA meant well in finalizing guidance for mobile medical apps, and means well in collaborating with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, their efforts are likely to produce unclear, uncertain regulation that hampers innovation in the digital health space. ?…
Bradley Thompson, the head of the mHealth Regulatory Coalition and the Clinical Decision Support Coalition, wrote two long comments to the Committee critiquing the bill. He argued that “it seems inconsistent for Congress to move forward with legislation to address the regulation of CDS in the fall of 2013 when Congress previously directed the agency to develop a regulatory strategy and report to Congress in 2014.”
Thompson’s letter on behalf of the CDS Coalition also states, “The draft legislation does not seem to embrace the recommendations of the FDASIA advisory committee,” specifically in regards to its treatment of high-risk CDS systems.
Thompson believes that the bill’s separation of software into three categories defies the trend in medical software, which is becoming increasingly interlaced and interconnected. “Even three sizes do not fit all,” the letter states. He elaborates that the “clinical software” category does not account for differing risk categories of CDS, characterizing software that calculates body mass index and computer-aided diagnosis as the same.
He also criticizes the lack of detail envisioned by the bill’s authors for the regulation of health software and clinical software. By creating separate categories, he writes, the bill envisions that clinical software — which has additional stipulations — “will be regulated to a greater degree than health software. Why else would the two categories exist?”
“But the present draft contains no such distinction,” Thompson writes, and articulates no particular way of regulating it; instead, the decision would be left to Congress and the president.
“We need to do more than just identify the categories,” he concludes. “We need to come up with the appropriate regulatory oversight needed to protect the safety of Americans and at the same time assure continued innovation.”