Bradley Merrill Thompson Quoted in Article, “Bipartisan House Bill Introduced to Curb FDA Health IT Oversight”

The Gray Sheet

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 Introduced to Curb FDA Health IT Oversight."

Following is an excerpt:

Rep. Marsha Blackburn, R-Tenn., and a bipartisan group of colleagues in the House introduced the SOFTWARE Act Oct. 22 to redefine the regulation of health information technology, with the probable effect of deregulating much of the sector.

Besides Blackburn, the bill is cosponsored by Reps. Gene Green, D-Texas, Phil Gingrey, R-Ga., Diana DeGette, D-Colo., Greg Walden, R-Ore., and G.K. Butterfield, D-N.C. ?...

The bill appears to have support from health IT people who have been pushing FDA to slow down in its effort to map out a regulatory framework for mobile apps. ?...

Meanwhile, Bradley Thompson says he has concerns with the bill, while noting he is "very pleased" by the representatives' interest in the field.

Conceptually, Thompson disputed the segmentation of software into three categories. "There is an inherent challenge in trying to segment out software into distinct categories when in fact the development of software is going precisely the opposite direction, toward greater convergence," he wrote.

"The fact of the matter is that software operates like connective tissue holding together different parts of the healthcare system. But indeed software goes much farther than simply holding together those different parts; if designed properly the software actually integrates those various functionalities into a more singular system. Thus, if we were to follow the lead of the technology, we would not try to separate out software into distinct buckets, but rather look for a more holistic way to approach software that creates large systems of care delivery," he continued.

Thompson also criticized the decision to leave the process of deciding regulation of clinical and health software to Congress, calling the bill "half done."

Thompson was a member of the HHS workgroup that recently sent recommendations on a health IT regulatory framework to FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission. The agencies are charged with issuing a report to Congress on the topic in January.

"Over the summer, the FDASIA workgroup was fairly clear in its recommendation that software in these categories would require regulation," Thompson said.

But the current language, Thompson feels, produces the possibility — perhaps contrary to intent — that certain software currently considered high-risk would be exempted from regulation, citing for example computer-assisted diagnostics for radiologists.

Thompson further worries that "clinical" and "health" software would be delegated to a separate regulator, potentially creating confusion — especially since software categories will blur together. "So if in addition to separating the regulatory schemes we layer on top of that separating the regulators, we face the very real potential of having to deal with two different agencies trying to regulate the gray area in between," he wrote.