The IT geniuses who create health apps and turn them out in record time have run into a snag in the form of potential FDA regulations, according to FDA tangles with wireless medical-app makers at Politico.
RunKeeper Health and Fitness app screenshots via iTunes
The problem centers around the definition of what apps need regulation. Here's how Amanda Coolong explains it at TechZulu.
Is a mobile health app a medical device? Should an app that shows you how many steps you’ve taken be regulated exactly the same way as a blood glucose monitor? According to the FDA the answer is yes, and if pending legislation passes in the U.S. House of Representatives it could sound a death knell for innovation in the healthcare sector.
The Health IT NOW organization argues that regulatory authority over mobile apps overlap among agencies and impose a confusing array of requirements. They claim the proposed legislation will stifle innovation and be prohibitively expensive for app development. The Health IT NOW group cites figures like:
- On average medical devices that require FDA evaluation are available to patients in the U.S. a full two years after they were available to patients in Europe.
- Bringing a product to market through FDA requires an additional 72 months and $75 million
- FDA requirements account for 77 percent of the cost of bringing a medical device to market.
Most mobile app makers are small companies who don't have the resources to endure a process like that. What would it mean in lost creativity, lost innovation if every tech entrepreneur with an idea for a mobile health app had to navigate those steps?
One issue hinges on the definition of what a medical device is according to the FDA. The other side of the debate centers on safety. Mobile Medical Apps Gold Rush Needs Scrutiny at Information Week says it takes some study to separate the glitz from the gold in the rapidly developing market for mobile health apps. Who is going to be in charge of distinguishing glitz from gold? And which needs regulation – or do they both?
What the Health IT NOW group and medical app makers want is for the FDA to balance the need for patient safety and the desire to promote innovation by modifying its guidance document such that it provides a "clear, predictable, and appropriately tailored regulatory framework."
Alan W. Silberberg at The Huffington Post sums up many of the issues nicely in Mobile App for Lifesaving Technology? Or Regulated Industry?
If something on my smart phone is working to regulate my pacemaker and keep my heart beating regularly, yes I want the FDA to make sure it's safe. But what if it's just checking my heart rate? What about Health and Fitness Apps? If something on my smart phone is reminding me to exercise today and only eat 1800 calories before bedtime I'm not sure the FDA needs to spend time regulating it. I want a regulatory structure that makes sense and works cleanly for all types of apps.
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