mHealth and the FDA – where is the path leading?


Mention FDA in the healthcare world, especially around us software geeks, and everyone gets quiet and cringes.  I’ve been in healthcare for over 25 years and 15 of those included pharmacy work. So I am very familiar with the FDA. And let me tell you, they have some strong points and some weak points. (And this is my opinion only.)

I am passionate about mHealth and what it can do for the patient and the public. And right now we are at the cusp of an explosion with this. Mobile apps, including Apple’s health app, Healthbook, is getting a lot of attention lately. But this attention, in general, has gotten the attention of the FDA and even Congress.

Now, I’m not a person to tell you which app to use, as I have personally experienced the search to find that app that does what I want it to do, preferably for free, and doesn’t charge me to use more of the good stuff/functions. Taking a look at the Healthbook app courtesy of 9to5mac I like what I see because it is not just a fitness, food, exercise tracker but gives some real tools to help those with chronic conditions. But don’t let me get off track here….

Back to my main point with the FDA and Congress. A few days ago mHealth News shared an article by Erik Wicklund telling us of some of what Congress wants to know from the FDA on their (what I call) control of mobile health apps. And of course, Congress sent the FDA a nice little letter.

“It is important for the FDA to be well-equipped with the proper tools to advance public health while taking care that innovation is not stifled through uncertainty or over-regulation,” the letter stated. “While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated.”

Then they provided 9 questions to the FDA. When reading thru them I caught note of a few that asked how Congress might help with XYZ. That’s awfully nice of them to ask the FDA. And Congress had some really good technical questions for the FDA. They asked about risk levels, software update tracking, how do they know that the if the app has a function not classified by the FDA, and if they have been coordinating with the Office of the National Coordinator and the FCC. But my favorite question was:

“What approach does the FDA use to regulate complex medical software with multiple and separate functions?”

That made my gut churn. So far the medical software companies have been good at keeping themselves out of the FDA reach. But this question tells me that not only does the FDA have them on their minds but now Congress has caught onto this idea of regulation. I’ve worked in healthcare IT for over 10 years now and mainly with the software implementations and it truly alarms me to think of the FDA stepping in, much less Congress (we’re familiar with their record in other areas lately) and the effect and total chaos that they could bring to the industry.

But I’m going to sit back and pay close attention to this development and I’ll keep sharing my opinion with you. Again, some may not agree with my opinion but maybe you/they will take it as food for thought…
In the meantime look for upcoming posts!

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About Tisha Clinkenbeard

Born and raised in a rural Texas town, went off to college in the big city and now I'm living in a rural town and working in the big city. I have a loving, supportive husband, fellow adventurer and love of my life as well as 4 kiddos and 2 dogs. We love traveling, adventures and spending time together. My goal is to share what I find Round & About through the lens of my camera, in the news of healthcare and out in the world, with YOU! View all posts by Tisha Clinkenbeard

One response to “mHealth and the FDA – where is the path leading?

  • FDA and mHealth: Upcoming FDASIA report implications | The Technology of Healthcare Today

    […] In an article from mobihealth news  March 3rd, Bradley Merrill Thompson talks about current events with the Food and Drug Administration Safety and Innovation Act (FDASIA) and the PROTECT Act. Congress gave specific direction to convene a working group which included the FDA (Food & Drug Administration) , ONC (Office of the National Coordinator for health information technology), and FCC (Federal Communications Commission) to make recommendations for the regulation or lack of regulation for HIT. The report from the group is due at the end of this month and frankly, based on my research, we don’t have a really good idea of what they are going to come out with. I talked about some of the questions that Congress recently sent to the FDA in a letter in this blog. […]

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