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 "Congress Must Wait for FDASIA Report."
Following is an excerpt:
At the Nov. 19 hearing, a panel of industry witnesses with similar agendas testified in support of the SOFTWARE Act and urged Congress to pass the proposed legislation, which seeks to limit the FDA's authority to regulate mobile medical apps and other software that function as medical devices. ...
Personally, I would liked to have seen Bradley Merrill Thompson, general counsel for both the Clinical Decision Support Coalition and mHealth Regulatory Coalition, included in the panel of witnesses representing industry. ...
Thompson sent a letter to the committee on behalf of the Clinical Decision Support Coalition asserting that "it seems inconsistent for Congress to move forward with legislation to address the regulation of [clinical decision support software]," when a FDASIA-mandated report to Congress on a risk-based regulatory framework for health IT (including clinical decision support software, which was not addressed by the FDA's final guidance on mobile medical apps) is expected in early 2014.
"We do not understand why Congress, after directing this work to be done, would proceed with the SOFTWARE bill now, before the FDASIA process is complete," he wrote. "We think it is important to first hear what the federal experts on health information technology recommend before proceeding to develop legislation."
Moreover, as Thompson points out, the SOFTWARE Act runs contrary to the recommendations of the FDASIA advisory committee in regulating high-risk clinical decision support apps such as computer-aided diagnosis. "The proposed legislation's category of 'clinical software' casts its net too widely, and therefore removes from FDA regulation some software and hardware that really should not be removed," he wrote to the committee.
