Friday, September 16, 2011

FDA regulation: mobile applications and clinical decision support systems

The FDA recently held a public forum to discuss the regulation of mobile medical applications and clinical decision support systems. The meeting is discussed here:

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Text of AMIA PRESENTATION TO FDA Public Workshop - Mobile Medical Applications Draft Guidance September 12-13, 2011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:

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.
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

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? 
Blog Updates:

FDA Law Blog: FDA Public Meeting on Mobile Medical Apps and ...
By Carmelina G. Allis - Below is a summary of some of the key issues discussed during FDA's September 12 and 13, 2011, public meeting on the recently issued ...
FDA public workshop weighs clinical decision support - AuntMinnie ...
The FDA wanted to get input from panel members on how to assess these kinds of software, including important factors to assess, allowing the agency to ...
Mobile medical apps, clinical decision support software
FDA panel discussions on the difficulties of regulating clinical decision support software.

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