A coalition of 12 patient advocacy groups has come forward to express concern over the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014, which would limit the Food and Drug Administration's ability to regulate certain health IT products.
Introduced by Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine) in February, the PROTECT Act would remove FDA oversight from health technology not used for diagnostic purposes, including electronic health records and many medical devices and mobile apps.
Proponents of the bill say it will foster innovation and improve patient access to new technology. However, several industry groups have claimed the bill would compromise patient safety by allowing unsafe products on the market.
"The PROTECT Act seems a misnomer. Instead of protecting consumers the act actually eliminates vital consumer health protections," said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, in a news release. "The rush to avoid expert reviews of complex technologies with far-reaching health ramifications ignores the fact that we cannot separate the high-risk from the low-risk apps using broad terms in legislation."
Now, 12 members of the Patient, Consumer, and Public Health Coalition have joined the fight to keep the bill from passing in its current form. In a letter to Sen. Tom Harkin (D-Iowa), chairman of the Senate Committee on Health, Education, Labor and Pensions, the coalition writes the act would have "harmful consequences" if passed.
"Healthcare providers and patients rely on the FDA to establish that a device is reasonably safe and effective," the groups wrote. "Without the FDA to carefully scrutinize the risks and benefits of a device, patients' health may be seriously harmed."
The letter also echoes other calls to wait until draft guidance on the FDA's role in regulating EHR and other health IT products is released. The guidance is expected by the end of this month.
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