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 "Senate Bill Shifts Oversight of Clinical Support Software from FDA to NIST."
Following is an excerpt:
The Senate bill, "Preventing Regulatory Overreach To Enhance Care Technology Act," would divide health information into two categories: clinical and health software. Unlike the SOFTWARE Act introduced by Rep. Marsha Blackburn (R-TN), which creates three general categories of software, the Senate bill specifies that clinical software means clinical decision support software or other software that "captures, analyzes, changes or presents patient or population clinical data or information" and recommends a course of action, but does not make any structure/function changes to the body. Also, unlike the House legislation, the PROTECT Act does not define medical software, but says that neither clinical or health software includes software intended to diagnose patients or that is a component or integral to the function of the device. ?...
Bradley Merrill Thompson, an attorney with Epstein, Becker & Green, added that while the PROTECT Act resolves some of the technical issues in the House bill, the proposal to remove FDA authority over HIT is a bad idea.
"Fundamentally, the Senate legislation would make NIST responsible for technical standards and take FDA completely out of the equation," he said. "That's just a terrible idea. FDA has a lot of experience in this area, they also have statutory authority that would be useful to regulating certain types of high-risk HIT."
He pointed out that NIST was founded as a non-regulatory agency. While NIST could play an important role in developing standards FDA, as a regulatory agency, actually has authority to conduct inspections, take enforcement actions when a company violates a requirement and establish regulations, he said. Further, Thompson took issue with the lawmakers' reference to findings from a federal workgroup tasked with helping FDA, ONC and FCC craft its proposal for an HIT regulatory framework. The bill says the workgroup identified major barriers to effective regulation of mobile health and health software that could not be addressed without changes to existing laws. But Thompson, who was a member of that working group, said the group was referring to the need for more guidance, not recommending statutory change.
"[I]t seems as though industry has its work cut out for itself because this legislation suffers from the same fundamental flaws that the SOFTWARE Act does and people on Capitol Hill do not seem to be listening to any but a few voices," he said.
