2014: Déjà vu for mHealth

As we ring in the New Year, mobile healthcare stands at a crossroads of unprecedented transition and opportunity. Never before has technology provided such tremendous potential to radically transform medicine. But, will 2014 be the year mHealth scales up and moves from just pilots to truly transforming health systems?

Steven Krein, co-founder and CEO of StartUp Health, addressed an audience earlier this month at the 2013 mHealth Summit, making the case that that we are about to enter an "epic decade" for the re-imagination and transformation of healthcare. Krein believes the entire healthcare industry is in the beginning phases of its "creative destruction"--a term coined in the mid-20th century by economist Joseph Schumpeter to describe the revolutionary process by which innovation replaces old industries with new ones. 

It is a view shared by Eric Topol, M.D., director of the Scripps Translational Science Institute and chief academic officer for Scripps Health, who authored the 2012 book "The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare." Topol writes in his book that "we desperately need medicine to be Schumpetered" and that a "propitious convergence of a maturing Internet, ever-increasing bandwidth, near-ubiquitous connectivity and remarkable miniature pocket computers in the form of mobile phones" are taking doctors and patients places they've never been before.

Other industries have been "creatively destroyed" and radically transformed--media, entertainment, music, travel, and retail/commerce--yet, as Krein points out, healthcare is one of the few remaining sectors holding out. Thankfully, the medical community's hesitance to embrace mobile technology is starting to change. According to Krein, the confluence of four conditions are ushering in this transformation--healthcare reform, chronic disease/aging/out-of-control healthcare costs, mobile/digital technology and a golden age of entrepreneurship. 

In that vein, some entrepreneurs and members of Congress charge that the U.S. Food and Drug Administration is stifling medical innovation. As a result, an mHealth regulatory showdown is looming in 2014 between Congress and the FDA. The battle lines were drawn at a Nov. 19 hearing held by the House Energy and Commerce Subcommittee on Health which examined federal regulation of mobile medical apps and other health software. At the hearing, Rep. Joe Pitts (R-Pa.), chairman of the Subcommittee on Health, defiantly declared that "software is not a medical device" and voiced his support for the SOFTWARE Act, a bipartisan bill that was introduced in late October to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA's authority. 

However, as FDA Commissioner Margaret Hamburg wrote in a Dec. 20 blog on the agency's website, the FDA's "regulation of software as a medical device--and a mobile app is software--is based on risk and functionality, and that functionality should be treated the same regardless of the platform on which it is used." As an example, Hamburg argued that an electrocardiography device--an ECG machine--that measures heart rhythms to help doctors diagnose patients "is still an ECG machine, regardless of whether it is the size of a bread box or the size of a smartphone."

Thus, 2014 begins where 2013 left off--with the mHealth community, Congress and government regulators continuing to quarrel over the right balance between promoting innovation and protecting patient safety. I believe the FDA's final guidance on mobile medical apps released in September is an appropriate risk-based regulatory framework focused on a small subset of the app market that is the proper balance for ensuring safety and fostering innovation. Those gaps in the final guidance--such as the area of clinical decision support software--will be addressed by the FDA, working with the FCC and ONC, in a FDASIA-mandated report to Congress on an overall risk-based regulatory framework for health IT which is expected in early 2014. Stay tuned. - Greg (@Slabodkin)