Monday, March 25, 2013

Will regulation of medical apps hinder their potential?

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Medical apps have seen huge success in the iTunes Store - but could their innovation and creativity that makes these apps one-of-a-kind soon be stifled? Politicians have asked the FDA how it intends to regulate these apps and warns that steep regulation could hinder the creativity in this sector.  A Draft Guidance as released in July 2011, but no information has followed.

According to PM Live, these are the other things government officials inquired about:
  • When will the FDA issue final or updated guidance for mobile medical applications designed for use on smartphones or other mobile computing devices
  • Has the FDA discussed, prepared or analysed the effect of the medical device tax, mandated by the Patient Protection and Affordable Care Act, on smartphones (as well as tablets or similar devices)?
  • Will the actual use of a smartphone, tablet or app be a factor in whether the FDA chooses to regulate the device or app as a medical device?
  • How many mobile medical apps have sought approval from the FDA before entering the market? How many mobile medical apps have been subject to oversight by the FDA after introduction to the market?
  • How many apps have either been changed or removed from the market by FDA oversight, and why?
Do you believe that the FDA should regulate medical apps? Why or why not?
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