FDA may regulate mobile health apps

By on Jul 22, 2011 at 12:00 AM
mobile July 22, 2011

The U.S. Food and Drug Administration may soon approve or reject mobile health applications. The government agency said on Wednesday that it is proposing to oversee the applications in an effort to ensure the apps perform as advertised and aren’t actually hurting users. “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” FDA policy advisor Bakul Patel said. The administration hopes to approve and reject mobile applications that:

  • Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis;
  • Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

“We want to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help us finalize the proposed guidelines,” Patel said. The proposed guidelines will be published on Wednesday.

[Via Gizmodo]

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7 Comments

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  • Anonymous

    Oh, thank GOODNESS!  I about broke my darn neck trying out some of the positions in the iKamasutra app!  PLEASE STOP THE MADNESS, FDA, FROM MY UNCONTROLLABLY HORNY GIRLFRIEND!  It’s ruining my body and my bedroom, kitchen, and living room furniture!

  • Knuckles

    SEGA?

  • Tony

    This is actually a pretty huge thing, and it is important for regulation.  My wife is a MD and she, along with the majority of younger Dr’s, use apps like Medscape for quick reference at times.

  • Greg Swann

    Where would the FDA get the lawful authority to regulate software? This is a bright line violation of the first amendment,

  • ray mysterio

    And now you know why the costs of healthcare will never go down.

    Medical equipment and medical providers protect their turf to such an extent that the costs are prevented from going down. 

    Of course quality is a concern, but there is always a trade off between quality, innovation, and cost.

    We could commodotize so much of the healthcare field and provide so much more to everyone, but the medical industry will never allow it.

  • Anonymous

    Good idea. One on my iPhone 3GS I was having a heart attack, but it shows normal on the iPhone 4. I’ll stick to the iPhone 4 and eat some more french fries. 

  • Anonymous

    More fiscally irresponsible regulation from the FDA. Big surprise. 

    Medical apps are a small proportion of our medical devices. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality.  They also said themselves that “The safety of America’s food and medical products remains under serious threat… it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.” The FDA is lacking in resources and manpower. The FDA’s budget was slashed recently by 258 million. This new set of regulations is only one instance of new regulations that are taking away resources from more important areas. This lack of resources has made the 2011 Food Safety and Modernization Act reactionary instead of preventative as the FDA will need to establish a myriad of partnerships, coalitions and improved intelligence-gathering techniques.  Even then, resources will still be deployed on  “data-driven risk analytics.” Hardly all-inclusive, hardly preventative. By overregulating this new field of technology and handing over monopolies to big pharma, we crush innovation. Many companies, especially small tech startups cannot afford the increased research. For example since 1968 about 41 less new pharmaceuticals have been approved each year according to the Independent Institute and even more aren’t even researched due to the costs associated. 

    Initially, for the first 86 years of FDA’s existence, from 1906-1992the U.S. treasury department funded the FDA. In 1992 a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth. 

    Once again the FDA kills growth and initiative in favor of Big Pharma.

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