December 17, 2013 | By 

It was a momentous year for mobile health, and in my estimation there were four pivotal events or trends–two good, two bad–that best captured the current state of mHealth as this year comes to a close.

Those stories included: record-breaking levels of mHealth venture capital funding; the FDA issued its final guidance on mobile medical apps; a damning report found that most of the 43,000 health apps available on iTunes store have limited use and simple functionality; and a lack of evidence is a major obstacle to mHealth adoption.

The good news is that venture capital continues to pour into mHealth startups fueling investment in innovative technologies. From January to August of this year, 50 mobile health companies secured $310 million in VC money compared to $229 million raised by 42 firms during the same period in 2012.

Of particular note, Fitbit, the San Francisco-based startup that has helped drive the growth of the health and fitness sensing market with its activity tracking devices, raised $43 million in new funding. Last year, the mobile healthcare sector saw venture capital investments reach more than $900 million. We’ll have to wait for the final tally, but in 2013 mHealth-related VC money is expected to exceed $1 billion.

Without a doubt, the most anticipated mHealth event of 2013 was the FDA’s release in late September of its final guidance on mobile medical apps, which I believe provides more clarity and predictability for what comprises the small subset of apps that the FDA aims to regulate. It’s worth noting, however, that the FDA guidance is just that–guidance–and is not a formal law or regulation. And, as such, leaves the regulatory agency open to challenge.

The SOFTWARE Act, a bipartisan bill introduced in October, is one such challenge seeking to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA’s authority. Who will win this regulatory tug of war–Congress or the FDA–remains to be seen.

Regardless, a new Health Policy Brief makes the case that the regulation of apps will become more important as mobile devices become even more ubiquitous. So far, the FDA has cleared more than 100 mobile medical apps through the 510(k) process. Yet, Apple’s iTunes Store alone hosts more than 43,000 health apps, of which nearly 20,000 could be considered medical apps, which brings me to one of the most negative mHealth stories of 2013.

An Oct. 30 report analyzed the more than 43,000 health apps available on the iTunes store and concluded that the vast majority have limited use and simple functionality, with most apps doing little more than providing information. The report also revealed a lack of evidence of the clinical benefits of the apps, without which app use will not be able to move from “a novelty into the mainstream of healthcare” nor realize its full potential.

The lack of evidence, in particular, the report argued is holding back the adoption of health apps because most physicians remain wary of formally recommending these apps. Who can blame them? In February, as the year began, I wrote a column expressing my hope that 2013 would be a year of evidence for mHealth. However, a lack of evidence continues to be a major obstacle to mHealth adoption and to provide the much-needed proof of the impact of new mobile technologies for improved health outcomes.

As FDA Commissioner Margaret Hamburg said last week at the mHealth Summit: “Medicine alone, without the proper context, thought and appropriate care, will fall short.” As a physician, Hamburg told the audience that she “certainly appreciates” the promise of mHealth but she stressed that each new medical product needs hard scientific evidence and data. So, it seems we have taken two steps forward, two steps back in mHealth for the year that was 2013. – Greg(@Slabodkin)


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