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 "MRC to Congress: Don't Pass Legislation, Wait for FDASIA Report."
Following is an excerpt:
Bradley Merrill Thompson, MRC's general counsel, has been an outspoken critic of the SOFTWARE Act, which defines three classification levels of software--clinical software, health software and medical software--in which both clinical and health software would not be subject to regulation under this proposed legislation.
"One of my biggest concerns is that I know many of the private stakeholder proponents of this legislation want to take regulatory responsibility for these categories of software away from FDA," Thompson told FierceMobileHealthcare in October. "They express great frustration with the agency, and think that Congress should come up with a new regulatory scheme and the new regulator. I do not share that view. I think the act of separating the software is fraught with challenges that will leave any legislative articulation subject to much interpretation." ...
Thompson, who is also general counsel for the Clinical Decision Support Coalition, told FierceMobileHealthcare that the organization is currently working on a policy proposal which is focusing specifically on the definition of CDS. In November, he sent a letter to several key congressmen 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 the FDASIA-mandated report to Congress is slated for early 2014.
