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FDA Looking to Regulate Medical Apps

News Article

FDA Looking to Regulate Medical Apps

News Article by Jonathan Vanian | Comments: (0) | Fri, 07/20/2012 - 6:46pm
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It’s now common knowledge that health-care professionals are increasingly using medical apps to aid them in their daily tasks, which might include checking out a patient’s X-rays or keeping track of administrative records. A recent study conducted by The Computing Technology Industry Association found that 38 percent of doctors with access to mobile devices use medical apps each day. But what happens when these apps are available to the layperson who might be putting his life’s safety in the hands of an untested product? That’s the dilemma the Food and Drug Administration is currently facing as it considers regulating medical apps, Kaiser Health News reports.

According to Kaiser Health News, there are currently 40,000 medically-related apps available on the mobile and tablet market today, which happens to be unregulated.  As the sophistication of these apps grow, the FDA is worried that not enough scrutiny is being placed on the development of these products, some of which are designed for critical tasks like helping diabetics keep track of their blood sugar counts, NPR reports.

But what does the spell for software developers who may not be used to designing products with watchful eyes reigning over them? NPR chatted with the American Enterprise Institute’s Dr. Scott Gottlieb who said that the increased scrutiny will cause investors to flee and programmers to reconsider what they might be getting themselves into. However, the FDA tells NPR that the agency only has plans to review and check apps designed for complex tasks like working as mini-EKG machines rather than functioning as simple health and fitness apps.

And it looks like it’s getting more likely that the FDA will be successful in its attempt to regulate, reports Eric Wicklund for Healthcare Finance News.

From Healthcare Finance News:

In the rush to regulate the fast-growing industry of mobile medical apps, Congress has apparently sidestepped a potential power struggle with the Food and Drug Administration over the agency’s authority to regulate them.

Meanwhile, if you feel the need to grab a medically-related app to aid you in your well-being, check out this nifty listicle in InformationWeek that details some interesting mobile apps out now.

 

  • Development & Deployment
  • app
  • government
  • regulatory compliance

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