Mobile Apps for Health Care Regulated by FDA

mobile apps for health care
Smartphones have revolutionized the way people approach everything from finding a good restaurant and quoting the latest political debate while on the go, to measuring insulin levels and monitoring heart rates.  If you want to know what’s playing at your nearest theater, you don’t find a newspaper anymore, you simply click on on-line application and watch movie trailer after movie trailer for your nearest cinema until determining the right show for you.  You can even purchase the tickets before you get there.  For medical and health needs, mobile apps have become extraordinary self-monitoring agents assisting people in keeping their health on track, even without a visit to the doctors office.  But now, wouldn’t you know, the FDA is setting up regulations for mobile apps that govern health care, especially those that deal specifically with diagnosis?

Apparently, your smartphone can do many of the same things hospitals can do these days in mini-form, such as measuring blood sugar levels, diagnosing abnormal heart rhythms and even act as an ultrasound device.  This is going too far for the FDA, who is okay with people being able to track medications and exercise routines with an application, but are not so keen on the idea of people taking on tools meant “only for medical professionals.”

The age of technology is progressing faster than many can keep up with.  It is estimated that by 2015, 500 million smartphone users will have and be using some sort of health care application.  That estimate continues to predict that by 2018, half of the 3.4 billion people with smartphones will have health care applications downloaded onto their phones.  The FDA is concerned about the general public having access to tools only used by health care professionals and so are planning to have in place regulations on any apps that perform diagnosis, making the announcement Monday (September 23, 2013).

Dr. Jeffrey Shuren, who is acting director of the FDA’s Radiological Health and Center for Devices stated “Today, mobile apps are fast becoming a staple of everyday life. Although many mobile apps pertain to health, we are only continuing our oversight for a very small subset of those mobile apps.”  In essence, if it’s an ECG device, it’s an ECG device, no matter the size and they want to regulate it.

Again, applications that help people keep track of appointments, exercise and nutrition routines, medications, health recommendations, yoga practices, correspondence between health care providers, these will all remain unregulated.  It is only those applications which seem deemed to fall under the realm of medical professionals such as insulin and irregular heart beat monitoring and things like ultrasounds that will be regulated by the FDA.

How do you feel about the FDA regulating your smartphone applications?  Is an age of advanced technology supposed to also be an age of advanced personal freedoms?  Does the regulations set out by the FDA to monitor what applications you can freely use on your mobile device regarding health care bother you?  Is it too restrictive, or do you think it’s smart medicine?

Written by: Stasia Bliss

FDA Site; Philly.com

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