A Consideration – Putting On the Brakes So We Can Move Faster…

by Kevin Fickenscher

Kevin Fickenscher, MD, CEO AMIA

by Kevin Fickenscher

Kevin Fickenscher, MD, CEO AMIA

Recently, in the May 30 opinion section of The Wall Street Journal, Scott Glottlieb and J.D. Kleinke wrote an editorial chastising the FDA for moving in to quickly to regulate apps used by physicians and consumers alike (See “There’s a Medical App for That – Or Not”.  Gottlieb is the former Deputy Commission of the FDA and J.D. is a well known thought leader in healthcare.  Both are resident fellows at the American Enterprise Institute.  Their basic premise is that despite all of the partisan bickering on Capitol Hill, the one demilitarized zone of discussion over the last several years has been the promotion of information technology in healthcare.

In the last year, the FDA has moved more aggressively in the direction of regulating software used to support decisions by clinicians and patients much in the same way that they monitor other types of devices such as x-ray equipment, cardiac monitors and the like.  Gottlieb and Kleinke note that more than 60 percent of clinicians are now using technology –– most often in the form of tablets, iPhones, and other similar devices –– at the point of care.  This represents a dramatic shift from even a couple of years ago.  The hope, or, should we say, the anticipation is that the use of information technology will create more efficiency, result in better outcomes, reduce costs and enhance overall service.  There is a lot of literature pointing in the direction, but the final results are still to be fully captured and analyzed.  However, if we are intuitive, it seems to make sense that the anticipated results will yield the real results.  Or, at least most of us hope so…

However, the FDA’s move into the regulatory space is putting a crimp into creativity.  There are many, myself included, who believe that we should take a more measured approach to the regulation of these new software applications (= “apps”).  Senators Michael Bennett (D-CO) and Orrin Hatch (R-UT) agree and have introduced legislation to place a moratorium on the FDA move toward enhanced regulatory oversight of software apps.   I do not disagree with the notion that oversight is needed.  However, we are moving into new space.  Let’s not use the paradigm of past decades to create a structure and methodology for the new decade when that may not be the best approach.  Rather, those of us in healthcare who are involved in the use of technologies should work with the FDA to create a reasonable framework for effective regulatory oversight.  None of us – the FDA included – want to preclude creativity and new ideas.  The “apps” industry is exploding.  Let’s work together to solve this problem.   Rather than a unilateral approach toward regulation, it seems to me that FDA along with technology experts and policy makers should take a step back, examine the data, and develop new and reasonable guidelines before promulgating rigid regulations.  The industry is ready.  Sometimes putting on the brakes allows us all to move a bit faster down the road.  That would seem to be the case related to regulatory oversight of “apps.”