Lawmakers Aim to Limit Regulation of Mobile Health Tech

A new U.S. Senate bill wants to limit federal oversight of mobile health technology—specifically that of the Food and Drug Administration—in a bid to reduce the industry’s regulatory burden, foster innovation, and protect jobs.

Senators Angus King (I-Maine) and Deb Fischer (R-Neb.), the sponsors of S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, hope it will serve to promote healthcare information technology innovation and job creation.

“Federal overregulation is one of the key challenges holding back entrepreneurs and job creators in Nebraska and across the country,” Senator Fischer said 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.”

Advertisement

The President and U.S. Congress should intervene to “facilitate interagency coordination” across regulatory bodies to make sure agency efforts focus on fostering health IT and mobile health innovation, while better protecting patient safety, improving health care, and creating jobs in the U.S., the Senators say.

“Consumers and innovators need a new risk-based framework for the oversight of clinical and health software that improves on the framework of the Food and Drug Administration,” the bill says.

The market for mobile health application is expected to exceed $26 billion by 2017, the legislation notes, and the mobile application economy in the U.S. is responsible for nearly 500,000 new jobs.

Advertisement

“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,” Senator King said in a statement.

Benefits of the market include consumer health information technologies, such as smart phones and tablets, that have the potential to “transform” health care delivery by reducing systemic costs, improving patient safety, and producing better clinical outcomes.

Access the bill, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014.

Written by Alyssa Gerace