With November's mid-term elections in the rear-view mirror, it's time to take stock of the healthcare landscape. And while a shift in Congressional clout from the Democrats to the Republicans could open the door to renewed attacks on 'Obamacare,' the general consensus is that any changes will come in small increments.
What this means for mHealth is anyone's guess right now, but rest assured that in one month's time, when the 2014 mHealth Summit convenes, we'll be having some very interesting discussions about the intersection of business innovation and federal regulation. Will the now-dominant Republican leadership push for a more open and less regulated mHealth field, as some are predicting, or is there still enough influence in the ranks to keep a tight rein on the industry?
The Health and Human Services Department and its undermanned Office of the National Coordinator for Health IT may have a tough road ahead, what with a majority of Congress not all that keen on extending government's reach. Will this affect the FDA's mandate going forward on mobile apps? Will FDASIA continue to run its course?
Keep an eye on the House Energy and Commerce Committee, chaired by Rep. Fred Upton (R-Mich.), which will be looking to mold its 21st Century Cure initiative (including, now, the SOFTWARE Act) into something that can pass muster in both houses of Congress. While many of the healthcare-related bills working their way through Washington these past few years have taken great pains to demonstrate bipartisan support, expect some bickering.
The key point of contention will be mHealth regulation. Will we need a law put into place, laying out quite clearly and succinctly what should be governed and what should be left to the marketplace? Or will the HHS and FDA be allowed to exercise their discretion? A pro-business climate in the capital would seem to favor the former, with Congress laying out a rigid framework for mHealth governance.
That said, we've grown weary of the almost weekly reports of data breaches and hacked networks, and of the supposedly revolutionary products and platforms that aren't doing what they'd advertised. This so-called 'Wild Wild West' of healthcare is getting old, and no amount of Congressional bickering is going to overcome the fact that regulation has to be addressed. Lives are, literally, at stake.
Now is the time for mHealth to prove its value. People talk of "tipping points" and plateaus on the evolutionary curve – maybe we've reached that point. Forget questions about reimbursement, of expanding government programs (and funding) to reach more people. Prove that time and money are being saved, and that clinical outcomes are better. Make these innovations work, so that not only consumers but clinicians will use them. Take that debate out of the hands of lawmakers.
See how easy that is? Put your foot down and move forward. The future of mHealth is as decisive as a Cleveland Cavaliers lineup with Lebron James, or a Los Angeles Lakers winning streak directed by Kobe Bryant, or …
Oh, wait. Never mind.
See you in Washington in a month's time. We should have plenty to talk about.
The mHealth Summit 2014 runs from Dec. 7-11 at the Gaylord National Resort and Convention Center just outside Washington, D.C. Register here.
