Photo credit: navilystmedical.com
It is safe to say that mobile apps have permeated almost every facet of society, from the way you buy tickets to the way you play scrabble with friends. Mobile apps have simplified life for those who are too busy to actually take the time to do the things mobile innovation replaces.
The medical space is one of the last areas where mobile apps have not completely taken over, a topic making headlines in recent days. The FDA recently announced its plan to issue a Draft Guidance on the Oversight of Medical Applications and is seeking outside input on the draft.
The agency is considering an app to be anything that is used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device. Only those that fall into the categories above would face FDA scrutiny. Regulators are hoping these guidelines provide more clarity on their expectations and spark new and improved app development.
I think the question swirling in everyone’s heads, especially for those with apps already out there, is will the FDA come after us with these regulations? This is my thought, for the people who have produced apps, I don’t see these regulations being applied. For future apps, I see only apps being scrutinized if it is considered to transform a phone into a device, as stated above. A co-worker and I were discussing this very matter, what makes a medical app different from a running app? In my opinion, medical apps don’t just regurgitate information to you that you otherwise wouldn’t know without it, they go beyond that and analyze data to tell you how it affects your personal health, i.e. a diabetes app.
However, I believe the debate on apps and FDA regulation will not end there.
As an avid BlackBerry user, my app use is limited to Facebook and Twitter, so this news doesn’t affect me all that much, as medical apps haven’t progressed too far on RIM devices. But for iPhone and Droid users, regulated and approved medical apps have entered the arena and given you back the time you would have ordinarily spent sitting in the doctor’s office.
The October 2011 Term of the Supreme Court of the United States (SCOTUS) opened Monday October 3 and with it a host of potentially decisive arguments on health care reform (HCR). Several cases on the docket for the six month session cut to the roots of the legislation; everything from the logistical implementation of individual elements of HCR to the very constitutionality of the measures passed by President Obama.
