Interest in health care is coming from new directions — including groundbreaking technological developments — and this new interest promises better health for all Americans.
Estimates indicate that the number of consumers using medical apps on their smartphones will grow to 500 million by 2015. The numbers support this assertion: Rock Health reported that digital health funding grew past a record $1.9 billion in 2013, growing 39 percent over the previous year and more than doubling since 2011.
The time is now to energize the tech community regarding this issue. We can attract smart, creative, and talented innovators to solve the country’s massive healthcare challenges, or we can allow an overreach by the FDA to rob our economy of this momentum. We can encourage engineers to develop the next mobile medical app to help patients, or we can allow the Food and Drug Administration (FDA) to stifle that interest. The lack of clarity and fear of overwhelming regulation will mean closing the doors on smaller, start-up businesses or — even worse — preventing smart, creative, and energetic individuals from entering the health information technology field because they can find more freedom to innovate in other sectors.
New commercial entities such as healthcare technology accelerators like Blueprint Health, Healthbox, and Rock Health are helping to provide resources to drive innovation. The nation’s academic institutions are spurring student entrepreneurship through organizations like MIT’s H@cking Medicine, Stanford’s Medicine X, and Vanderbilt’s MyRoutine.
Despite this excitement and interest in health entrepreneurship, one topic seems to leave both entrepreneurs and policy-makers concerned: the over-regulation of health information technology (HIT) by the FDA. Over the past year, I have talked to a countless number of both large and small HIT companies. Repeatedly, I hear that if the FDA regulates new HIT as it currently regulates traditional medical devices and drugs, innovation will stop dead in its tracks. My experience is echoed by Zen Chu, the creator of MIT’s Healthcare Ventures course, who said, “We have witnessed many entrepreneurs forced to trade superior functionality and patient experience to avoid the delays and costs of FDA regulation. This creates barriers for large segments of health software which pose minimal risk to patient safety. Clearly defining FDA’s oversight would allow software developers to create better software faster amid the tectonic shifts driving healthcare reform and quality improvement.”
When I chat with young tech entrepreneurs I hear the element of fear in their voice and it shades their plans, hopes and dreams. They are going to innovate and they hope they can innovate something that will better the quality of life for mankind. Their concern is that the overreach of government regulation will limit their options for creativity. Unfortunately, those bright minds perceive that designing games like Candy Crush may be more expedient and lucrative than fighting bureaucrats for the ability to work on life-saving innovations.
Concern for stopping a promising technology before it starts is why I introduced bipartisan legislation, H.R. 3303, the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. This legislation will provide the regulatory certainty that technology companies need to ensure consumer safety, as well as encourage innovation.
Entrepreneurs with exciting technologies will improve health outcomes and reduce the inefficiencies plaguing health care. We need to clear a path for them by removing the ambiguity and uncertainty surrounding the FDA’s role in the HIT space.
