Regulatory front is biggest potential drag on mHealth

It's been said that medicine is a science, healing is an art, and healthcare is a business. While we can all agree that promoting better health, healing the sick and curing disease is a noble pursuit, no matter how you slice it, healthcare at the end of the day is most certainly a business.

In fact, with healthcare spending at nearly 18 percent of America's gross domestic product, healthcare is the biggest business in our economy. Like other businesses, profit motive in the healthcare industry is what drives competition, innovation and entrepreneurship.

Mobile healthcare is one of the most exciting and growing areas of the industry. mHealth services not only have the potential to improve quality, efficiency and access to healthcare, but also to reduce costs in both developed and emerging markets.

According to a new report by mobile research firm research2guidance, within the next four years, the mobile healthcare services market will begin the commercialization phase and reach $26 billion worldwide as smartphone apps enable the mHealth industry to monetize these services.

Last year, the mobile healthcare sector saw venture capital investments reach more than $900 million and in 2013 mHealth-related VC money is expected to exceed $1 billion. However, mHealth's ability to continue on an upward trajectory of investment and to realize its true market potential is to a great extent dependent on regulations coming out of Washington.

The biggest potential drag on mHealth is on the regulatory front.  Uncertainty remains as the FDA finalizes its rules for regulating mobile medical apps. Industry observers are rightfully concerned that when the agency releases final guidance later this year, mHealth developers will be subjected to the same slow, burdensome approval process that medical devices must go through.

Cutting to the chase, Republican members of the House Energy and Commerce Committee earlier this month directly and specifically asked the FDA if it intends to regulate smartphones, tablets and mobile apps as medical devices under the Affordable Care Act. 

Their questions will be critical in determining the ability of health app developers to bring their technological innovations to market quickly and effectively. If mobile healthcare is going to be a viable business model, developers need to know what they can expect in terms of regulations. In the absence of clear mobile guidelines and consistent enforcement from the FDA, mHealth companies and the market forces at large will continue to struggle with uncertainty. - Greg (@Slabodkin)