A Senate bill to restrict FDA's oversight of health information technology is expected to be introduced next week, according to two industry sources with close connections to policy developments on digital health issues. A copy of the bill obtained by "The Gray Sheet" shows it to be similar in many of its particulars to the SOFTWARE Act, a companion piece of legislation introduced in the House by Rep. Marsha Blackburn, R-Tenn., late last year. (See "Bipartisan House Bill Introduced To Curb FDA Health IT Oversight" — "The Gray Sheet," Oct. 23, 2013.)
The Senate bill will be called the PROTECT Act. It is expected to be introduced by Sen. Deb Fischer, R-Neb., with a bipartisan cosponsor.
The controversy animating the bill arises from a perception among some health IT stakeholders that FDA's approval process is too slow and unwieldy for health IT and mobile medical apps; the draft bill's "sense of Congress" section states that "clinical and health software innovation cycles evolve and move faster than the existing regulatory approval process."
The bill also looks askance at FDA's recent mobile medical apps guidance. Despite the agency's argument that the final guidance loosened FDA's grip over the sector, the draft bill language argues that the guidance does the opposite, stating that the agency has "sought to expand its enforcement discretion by regulating the dynamic mobile health and mobile application market" and in so doing has "failed to defer to Congress' stated preference" expressed in the FDA Safety and Innovation Act (FDASIA) of 2011. ?...
Bradley Merrill Thompson, head of the mHealth Regulatory Coalition, responded to language in the draft PROTECT Act in an email to "The Gray Sheet." Thompson has been a critic of the SOFTWARE Act.
"I think the drafters of the PROTECT act tried to solve some of the technical problems [of the SOFTWARE Act] and they solved a few, but not the biggest and most important ones," Thompson wrote.
"The biggest issue with both the SOFTWARE act and the PROTECT act is that it would deregulate certain standalone software used for such things as guiding therapeutic decision-making. For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program."
The decision to place clinical software in NIST's jurisdiction while sidelining FDA also bothered Thompson: "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 [health IT]."
Thompson also felt the criticisms of FDA and its statutory authority embodied in the bill were off-the-mark. In particular — due to Thompson's experience serving on the FDASIA workgroup — the charge concerning the workgroup's report rankled. "We indicated that there were some areas of the 'written law' that needed to be changed. But that was a reference to guidance, not statute," Thompson wrote. "The working group never recommended statutory change." Thompson pointed out that he wrote the section in question of the workgroup report.
"This legislation suffers from the same fundamental flaws that the SOFTWARE act does and people on Capitol Hill did not seem to be listening to any but a few voices," Thompson concludes.