FDA Impedes Medical App Development

As the Supreme Court decision on Obamacare looms, there are a few things that both sides of the political spectrum can generally agree on when it comes to health care—and one of them is the need for more and better technology, both for consumers and in the IT field, for the medical industry.  The introduction of new technologies promises to more innovation, which in turn would ideally help to keep costs down at a time when health care costs are skyrocketing.

One of the most interesting new innovations in the health care field is the introduction of mobile apps.  Since the advent of smartphones, developers have been working on apps that would help patients and doctors with a variety of ailments—there are apps that monitor blood pressure and heart rate, help assess your vision, reference prescription information, or help doctors communicate with their patients.  Some doctors are using technology to communicate directly with their patients via messaging or video chat, sometimes eliminating the need for an office visit.  These innovations help to keep costs down for patients, doctors and insurers by cutting down on waste and inefficiencies.  In a study produced last year, over 50% of doctors said they would be using a medical app in one way or another in 2012.

Almost everyone agrees that introducing these new innovations are great for medicine — doctors like them, patients like them, politicians like them, and insurers like them.  In the study referenced above, two-thirds of doctors surveyed said that implementing these new technologies is a high priority for them, which makes the FDA’s stifling of these technologies all the more frustrating.  In July 2011, the FDA released a draft guidance on mobile medical applications.  This put the medical field and app developers on notice that this new burgeoning industry would be subject to regulation.  This immediately set off alarm bells to anyone interested or currently working on apps, as this could mean years of lawyers fees and a costly bureaucratic mess.

As the tech blog TheNextWeb points out:

To date, bringing a medical product to market through the FDA requires an additional 72 months at an average cost of $75 million — approximately 77% of the cost.  As Joel White, executive director of Health IT Now explained, “Just for context, a 2010 report prepared by Stanford University indicated that the time elapsed from first communication with FDA to final clearance was 31 months; apps have several life cycles in that time.”

Considering that most app makers are young, technologically focused entrepreneurs, this is especially worrisome.  Not only do app makers have that kind of money, but they don’t have the experience of navigating the FDA regulatory process as well.  This makes creating innovative products produced by forward thinking, technologically-minded people looking for creative solutions nearly impossible—the FDA’s regulatory burdens could make innovation in in this field a short, flash in the pan.

For more on the struggle between the FDA and medical app creators, I recommend taking a look at this excellent piece in the Wall Street Journal detailing the legal wrangling taking place.  If the FDA gets its way, there could be a huge gap in useful tools the medical industry has at its disposal.

Zack Christenson is a digital tech writer for the American Consumer Institute

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