FDA forum explores regulation of mobile medical apps
AMIA advises FDA on CDS mobile app oversight
AMIA Offers Guidance to FDA on Regulation of Mobile Medical Apps
Text of AMIA PRESENTATION TO FDA Public Workshop - Mobile Medical Applications Draft Guidance September 12-13, 2011
Here is a pull quote that is a good summary:
Look at all these free medical applications: Top 10 Free iPhone Medical Apps for Health care Professionals and this Top 15 Free Android Medical apps for Healthcare
Nobody disagreed that the FDA should regulate mobile medical apps used specifically for diagnostic or clinical treatment purposes. But for apps in which the use might not be clearly defined, apps that are accessories to other medical devices, and accessories supporting medical apps, the opinions that were expressed reflected controversy and concern.
Mobile devices and the medical apps that support them represent a technology explosion, sure to make a revolutionary change in healthcare delivery. The crux is how the FDA can keep up with mobile developments, protecting patients from potential harms without stifling innovation and R&D investment.
What is the FDA going to do when someone creates an anonymous free droid application distributed directly to the public that collects and analyzes ECG data - then it makes a clinical recommendation that is correct 97% of the time? Will a 3% error rate be accepted if the cost is zero?
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