FDA Seeks To Regulate Critical Health Apps
Jul 19, 2011, 8:59 AM by Rich Brome @richbrome
The US Food and Drug Administration today announced draft guidelines for how it should regulate health-related mobile apps. The agency is seeking input, but currently proposes that it regulate just two specific types of apps. The first category is apps "used as an accessory to medical device already regulated by the FDA," such as a remote medical scan viewer, used by doctors to diagnose patients. The second category is apps that essentially transform the mobile device into a medical device, such as an app that works with a sensor to detect abnormal heart rhythms. The FDA is not proposing to regulate more benign apps, such as those that offer diet and fitness guidance.
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Comments
Nanny State
The government should worry about regulating over spending then apps for smartphones.
This is why the country is in the sad state it is right now - too much government.
The FDA is ridiculous to want to "regulate" this kind of thing. Why don't they worry more about keeping bacteria out of our foods and such.
The FDA is ridiculous to want to "regulate" this kind of thing. Why don't they worry more about keeping bacteria out of our foods and such.
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Absolutely regulate these apps. What if they give false readings and cause false information. We all know there are apps out there that don't work properly, after all, these are just cheep phones with nowhere near the high quality parts a medical devi...
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Good Points
--- "The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."--
1) The high increased level of smartphones has brought apps to the markets that are not necessarily overseen by professionals or underwriters. A Physician's medical view associated with apps, is no different. This can cause vague medical definitions or remedies of certain physiological or mental issues to patients who haven't seen professional advice. Since each patient is di...
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1) The high increased level of smartphones has brought apps to the markets that are not necessarily overseen by professionals or underwriters. A Physician's medical view associated with apps, is no different. This can cause vague medical definitions or remedies of certain physiological or mental issues to patients who haven't seen professional advice. Since each patient is di...
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