Health groups are pushing back against congressional Republicans for efforts they say would deregulate medical technology that is crucial to the well-being of patients.
In a letter to Sen. Tom Harkin (D-Iowa), about a dozen health and public interest groups asked the Senate Health Committee chairman to fight the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act, which they argue could prevent the Food and Drug Administration from reviewing certain medical devices.
{mosads}”This would put the health of millions of Americans at risk,” the groups wrote in the letter.
“We strongly urge you to oppose this bill because it could deregulate medical technology crucial to patient health, causing patients unnecessary risk,” they added.
This comes after Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) introduced the PROTECT Act earlier this month to reduce what they called a “regulatory burden” in the health IT industry by removing certain low-risk clinical and health software from FDA scrutiny.
The senators said the bill would protect patients by encouraging the FDA to focus more attention on higher risk medical devices.
The bill mirrors a piece of legislation known as the SOFTWARE Act that Rep. Marsha Blackburn (R-Tenn.) introduced in the House in October.
Fischer said excessive regulation is one of the “key challenges holding back entrepreneurs and job creators.”
The bill would “protect low-risk health IT from unnecessary regulatory burdens that stifle opportunities for job creation, innovation, and improved care,” the senators said in a press release announcing the rule.
Currently, the FDA can review anything it defines as a medical device, including mobile wellness apps and scheduling software, the senators said. But this bill would narrow the agency’s focus to “products that pose a legitimate risk to human health” and prevent it from reviewing certain devices that rely on software.
But the health groups warned this bill “muddles the definition” of medical devices that the FDA can review. They are concerned health companies could interpret the rule to apply to widely used medical devices, such as MRIs, CT scanners, and heart monitoring devices, that have software elements.
“We are extremely concerned that this bill will deregulate a broad swath of medical devices that rely on software and will create opportunities for rampant ‘gaming’ to avoid regulation,” they wrote in the letter to Harkin.