Healthcare is an industry that has typically been dominated by huge insurance companies, massive hospitals and crippling treatment costs. But as technology advances, smaller clinics and the patients themselves have more access to affordable care and state-of-the-art equipment. Startup companies and mobile apps have begun to shift the balance of power, giving opportunities to those who might not have had them in years past. As individuals and small businesses develop new ways of interacting with healthcare, platforms and regulations will arise to handle these evolving circumstances.
Health startups take center stage
In 2014, investors sent billions of dollars into healthcare startups – a trend that should carry on in 2015, according to Information Week. This support comes from a variety of sources, including the federal government, corporations like Google and Apple, and regional hubs.
The Neuro Startup Challenge, assembled by the Center for Advancing Innovation, pushes entrepreneurs, scholars and others to patent and commercialize healthcare inventions. Last year, the challenge centered on breast cancer. It acted as a catalyst for those who create technologies and platforms that could impact healthcare.
"We believe this proven challenge framework creates a new pillar for [Health and Human Services] to impact human health by launching startups from promising HHS conceived and developed inventions," Bryan Sivak, chief technology officer at the US Department of Health and Human Services, told Information Week. "The challenge uses a novel model that gets tangible, expeditious, and efficient results; we hope to see this approach institutionalized across all federal labs."
Healthcare apps subject to different regulations
Typically, healthcare technology like instruments and machines are subject to a stringent set of regulations from the FDA according to the Food, Drugs and Cosmetics Act of 1976, reported Forbes. However, those guidelines were implemented during an era devoid of the Internet, let alone the plethora of mobile apps that have dominated the industry. In 2013, the Apple app store had 97,000 mobile health apps and 60 percent of physicians used tablets.
Old regulations don't necessarily hold up with new technologies, so the FDA should figure out a way to either update the amendment or govern use of these platforms to provide standards and direction. Thus far, the administration has not regulated most apps as it would with other medical devices.
"The agency intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers," reads the FDA's final guidance on mobile app regulation enforcement. "The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended."
For most inventors, that is a good sign – it means mobile apps not used for surgery will not be subject to regulatory measures. But these terms are still nebulous at best and Congress may be forced to define specific parameters surrounding mobile healthcare apps. Forbes argues that the FDA, as regulator, should not be the body that determines the terms of the devices it regulates – those must be set forth by Congress.
In 2015, as healthcare apps expand and physicians rely on technology more and more, expect regulations to come about to hold these platforms to certain standards.
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