Senators Push for Less Health IT Regulation

Several Senators renewed their call Wednesday for less government oversight of some health IT products, saying too many regulatory hurdles for low-risk software would stifle innovation.

At a Capitol Hill briefing Wednesday, Sens. Angus King (I-Maine), Deb Fischer (R-Neb.) and Orrin Hatch (R-Utah) promoted the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014, which would remove Food and Drug Administration oversight from health IT products not used for diagnostic purposes, including electronic health records and many medical devices and mobile apps.

The briefing paid special focus to the potential of personal mobile devices and apps to help consumers self-monitor and maintain their own wellness, "the kinds of things you might have on your iPhone to keep track of how many steps you take, or your pulse, those kinds of things," said Sen. King, according to a Maine Public Broadcasting report. These devices are both low-risk and carry great promise to improve consumers health, the Senators said, and therefore should be able to avoid lengthy FDA approval processes.

"Technology is always improving and it holds the power to make a huge difference in terms of the general health of the population. The high technology — the powerful computing — is a big part of the future," Sen. King said, according to a news release from his office. "But to use the technology that's available to all of us on a daily basis to increase our health and decrease risks is an important part of the solution as well."

The IBM-sponsored briefing also included a presentation of the powerful computing referenced by Sen. King — an IBM scientist demonstrated Watson's potential to deliver evidence-based treatment recommendations to physicians, according to a report in Politico.

The Senators' PROTECT Act is not without opposition. In March, a coalition of 12 patient advocacy groups came forward to express concern about the bill. "Healthcare providers and patients rely on the FDA to establish that a device is reasonably safe and effective," according to a statement from the groups. "Without the FDA to carefully scrutinize the risks and benefits of a device, patients' health may be seriously harmed."

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