Health groups fight Republican push to deregulate medical technology

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 HarkinTom HarkinDistance education: Tumultuous today and yesterday Grassley challenger no stranger to defying odds Clinton ally stands between Sanders and chairmanship dream MORE (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.

ADVERTISEMENT
"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 FischerDeb FischerSenate takes lead on Trump’s infrastructure proposal Updated fuel regulations would modernize options at gas pumps McConnell promises women can take part in healthcare meetings MORE (R-Neb.) and Angus KingAngus KingOvernight Healthcare: Senate GOP to start writing its healthcare bill Trump budget chief: Medicaid cuts won’t affect anyone now on program Medicare’s billion challenge: preventing older adult falls MORE (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 BlackburnMarsha BlackburnNew GOP bill may revive internet privacy fight Overnight Cybersecurity: Bad Russian intel may have swayed Comey's handling of Clinton probe | Apple sees spike in data requests | More subpoenas for Flynn | DOJ's plan for data warrants Overnight Tech: Internet lobby criticizes GOP privacy bill | Apple sees security requests for user data skyrocket | Airbnb beefs up lobbying MORE (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.