New guidelines from the United States Food and Drug Administration have cleared the way for the development of medical mobile apps. All smartphone applications pertaining the health field will now be regulated by the FDA. New guidelines were put in place after the FDA ruled that many of the existing medical smartphone apps have the potential to harm consumers.
New FDA Regulation for Medical Mobile Apps
According to VentureBeat, "Agency officials estimate that 500 million smartphone users worldwide will use some type of health app by 2015." FDA regulations will focus on apps that use smartphones as a modified medical device, such as apps that monitor your blood pressure or provide medical advice will be subject to FDA scrutiny. One example is Scanadu Scout, a medical device that monitors vital signs and feeds the information to an iOS or Android medical app for tracking. Any app that could be used in lieu of a doctor's advice will require FDA approval under the new guidelines. Apps that help you sleep soundly through relaxation and those that track caloric intake, for example, are unlikely to receive attention from the FDA.
While the chances of some apps getting approval under the new guidelines may seem dismal, the regulations will prove to be a blessing for many quality healthcare apps. Concrete guidelines will help developers find financial backing for the development of medical apps where previous attempts may have been unsuccessful due to a lack of clear guidelines. Set FDA guidelines will help get new medical devices and corresponding medical apps approved in a timely manner.
Medical Apps in the Field
If you've been to the doctor's office or hospital lately, you're sure to have seen a rise in the number of iPads, iPhones, tablets, and smartphones being used by medical professionals while treating patients. The ability to have a wealth of quickly searchable information at your fingertips is a life-saver (literally) in many medical situations. Drug dosage calculations are now practically foolproof, as are drug interaction problems- both situations that previously required multiple checks and time-consuming research to administer some medications safely. Apps are even available for non-medical consumers for emergency first-aid guidance and CPR walkthroughs- information that could save lives in the community. But these apps must be accurate with information and meet FDA approval to avoid doing harm rather than good. It may be hard to believe some app developers would knowingly produce an app with incorrect information just to make a fast buck, but even mistakes or improper research can lead to fatal mistakes. Since The App Store has no way to verify a consumer's medical credentials in order to use a medical app along with medical training to decide if an app's guidance is correct, FDA regulations during the app approval phase is the next best safeguard.
New medical app regulation could also mean an increase in interest for medical professionals who were previously hesitant to embrace unregulated apps in the field. Overall, FDA regulation is good news for mobile app developers seeking to produce medical apps.
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