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 "mHealth Regulatory Coalition Proposes HIT Paradigm, Counters House Bill."
Following is an excerpt:
The mHealth Regulatory Coalition is floating a proposal for a new regulatory paradigm for health information technology that would rely largely on third parties to certify low-risk medical software, urging lawmakers and other industry groups to hold off pursuing legislative changes until there is more public discussion on the issue. The group says it is premature to act on pending legislation that attempts to divide software products into those that would be regulated by FDA and those that would escape agency oversight. ?...
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said the proposal is targeted at but not limited to SOFTWARE Act House sponsors which also include Republicans Phil Gingrey (GA) and Greg Walden (OR) as well as Democrats Diana DeGette (CO) and G.K. Butterfield (NC). "I think there is a lot of interest in this topic that goes well beyond those sponsors," Thompson told FDA Week. "We will share it with other coalitions and trade groups as well as those in the government who are interested, in both the executive and legislative branches."
Thompson said the Clinical Decision Support Coalition, for which he also serves as general counsel, is planning to issue a separate proposal focused specifically on the definition of clinical decision support software this month.
