FDA expects to have a medical app guidance by end of 2013

The FDA (Food and Drugs Administration) expects to have a regulation for mobile health applications by the end of 2013. As they say, it will be restricted to those applications that are considered a medical device. Medical device apps include those that monitor the patient’s vital signs, as would be blood pressure or blood glucose.
By doing this the FDA hopes to somewhat balance the sector to ensure appropriate protections for the patient, while trying not to hinder the development of apps in the healthcare market focusing only on this set in particular.

On the other hand there is the argument that long regulatory processes, can stifle innovation in the field. This is an emerging market and the FDA may suffer a little to keep the field well regulated.

How does this affect us? The Apps market is international, with an app developed here potentially being bought in the U.S., so we have to take into account the FDA and HIPAA regulations.


I leave the link to read more about this regulation from FierceMobile


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