Bradley Merrill Thompson Quoted in Article, “Bipartisan House Bill Attempts to Limit FDA’s HIT Oversight”

FDA Week

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 "Bipartisan House Bill Attempts to Limit FDA's HIT Oversight."

Following is an excerpt:

A bipartisan House bill introduced late Tuesday (Oct. 22) aims to clarify FDA's authority over health information technology by amending the Federal Food, Drug and Cosmetic Act so the agency will only regulate mobile medical applications that change the physiology of a patient and with little opportunity for human intervention. The move was applauded by industry and patient groups that see the bill as the first step in implementing a recommendation from a federal working group to re-focus FDA. ?...

The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act was introduced by Rep. Marsha Blackburn (R-TN) and co-sponsored by a bipartisan group of House lawmakers, including Republicans Phil Gingrey (GA) and Greg Walden (OR) as well as Democrats Diana DeGette (CO) and G.K. Butterfield (NC). The bill comes less than a month after FDA released finalized guidance for mobile medical applications that laid out a strategy of using enforcement discretion on low-risk devices. ?...

However, Bradley Merrill Thompson, an attorney with Epstein, Becker and Green, took issue with the legislation's "piecemeal" approach, saying it could have adverse effects. He said while bipartisan support of health IT innovation is welcome, the lawmakers seem intent to follow the recommendation of the Bipartisan Policy Center and stratify health IT into three different layers -- administrative or non-clinical software; clinical software; and medical device software. There is an inherent challenge in trying to segment software when the development of software is going in the opposite direction, toward convergence, he said.

"The fact of the matter is that software operates like connective tissue holding together different parts of the health care system," Thompson said. "Thus, if we were to follow the lead of the technology, we would not try to separate out software into distinct bucket, but rather look for a more holistic way to approach software that creates large systems of care delivery."

He also raised concerns that the legislation was only "half done" since it does not explain how clinical and health software would be regulated, if not under FDA. The FDASIA workgroup was fairly clear in its recommendation that software in these categories would require regulation, said Thompson, who was a member of the workgroup. He highlighted computer-aided diagnosis, which takes X-rays and applies algorithms that identify abnormalities, as an example of why clinical software oversight was needed. Currently, the riskiest versions of the software are class III devices regulated by FDA, but the legislation would place the software in the category of clinical software, to be unregulated "until the future as of yet unspecified regulatory system is put in place." While the legislators appear to have reached consensus around the problem, they have not been able to develop a solution that would address such an outcome, he said.

"Personally, I would encourage them to continue their internal discussions to reach the point of a solution," Thompson said. "We should not approach this in a piecemeal fashion, first only agreeing as to somehow separating the types of software without completing the work to decide how the categories would, in fact, be regulated."