New bill takes aim at FDA overregulation

Seeks to unburden 'low-risk health IT' from red tape, taxes
By Mike Miliard
10:37 AM
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Independent Maine Sen. Angus King and Republican Nebraska Sen. Deb Fischer have introduced legislation they say will reduce regulatory burden on the health IT industry and protect jobs.

The Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014 seeks to develop a more specific regulatory framework for health IT that promotes innovation and job creation while protecting patient safety, say the bill's sponsors.

Specifically, the proposed law sets its sights on Food and Drug Administration, which under current law can use its definition of a medical device to impose broad regulatory authority over a wide array of "low-risk health IT" such as electronic health records, scheduling software and wellness apps

The PROTECT Act seeks to bring clarity to FDA's regulatory process, ensuring that it focuses on products that pose a legitimate risk to human health.

By prioritizing FDA's attention to technologies that pose the greatest health risk, the bill would both improve patient safety and protect other species of health IT from too much regulation that can stifle job creation, innovation and care improvement, its sponsors say.

The legislation would also relieve certain categories of low-risk clinical and health software from the medical device tax.

The PROTECT Act has so far found support from vendors such as IBM, McKesson and athenahealth, and trade groups such as the Software & Information Industry Association and the Newborn Coalition.

"Not only is health IT one of the most innovative and rapidly growing fields of technology in the country, but it's also fundamentally transforming the way we think about health care," said King, in a press statement.

"As these technologies develop, it's critical to implement a clear, risk-based framework that would protect patient health and ensure that FDA rules are appropriately targeted to support and not stifle innovation," he added. "The PROTECT Act would provide important regulatory clarity that will safeguard patient safety, make the health care sector more efficient, and allow businesses across Maine and the nation to continue developing groundbreaking ideas."

"Federal overregulation is one of the key challenges holding back entrepreneurs and job creators in Nebraska and across the country," said Fischer in a statement. "While economic growth remains sluggish, it's critical we prevent these costly and time-consuming bureaucratic hurdles from hurting one of the fastest growing sectors of our economy – technology. The PROTECT Act increases regulatory efficiency over health IT to promote innovation, expand consumer access to information, and improve patient safety."

Similar legislation addressing health software, the SOFTWARE Act (H.R. 3303), was introduced in the House of Representatives by Republican Tennessee Rep. Marsha Blackburn this past October.

"I am pleased that Senators Fischer and King are joining our bipartisan House effort to address this issue head on and promote the innovation of these low-risk health technologies," said Blackburn in a statement. "It is imperative that we work to encourage the continued development of new technologies to improve healthcare and create new jobs without added regulatory burdens that would place disincentives on private sector innovation."

Full text of the PROTECT Act can be read here (PDF).