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Showing posts from July, 2011

Is FDA Governance of Medical Mobile Apps Positive?

According to a Reuters report the FDA has announced that it will start regulating certain mHealth or mobile health applications. The FDA made it clear that they will not be looking into all medical and health apps, but only those that, “mimic the work of medical devices and could cause harm if they failed to perform as promised” according to Food and Drug Administration officials. This policy shift has been long anticipated by many in the medical device space as seen through incremental shifts by the FDA. Such as the case of the radiology app it approved in Feb. 2011, which allowed for secure transmission of CT, MRI, PET, nuclear medicine, and PET images on the go. The positive aspect of these newly published FDA guidelines:  1.        Clearer Guidelines: manufacturers and developers will now have a better understanding of the rules that govern their work and can develop within those parameters. 2.        Public Safety: consumers of mHealth apps regulated by the FDA, whether p