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FDA Actively Monitoring Medical And Healthcare Apps

September 2nd, 2010 by Iltifat Husain, M.D. in Better Health Network, Health Policy, News, Opinion
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Bradley Merrill Thompson, an attorney with expertise in the FDA approval process for medical devices, is stating that the FDA is actively monitoring app stores on various platforms. Regulating medical devices and health care-related applications falls under the FDA’s jurisdiction.

James Kendrick from JkOnTheRun spoke with Thompson, where he stated the following:

The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.

By “various app stores,” Thompson is likely referring to the App store [Apple], Palm App Catalog [Web OS], App World [BlackBerry], and the Android Marketplace [Android OS]. Read more »

*This blog post was originally published at iMedicalApps*

Doctors In Cubicles: A Barrier To Patient Care

August 17th, 2010 by John Mandrola, M.D. in Better Health Network, Health Policy, Opinion
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I present interesting cases to colleagues often because it’s educational and good for patient care and because I like to. But it has been many years since I was mandated to present a case.

It seems that I’m not the only doctor exasperated by a pesky new barrier to patient care: Doctors in cubicles.

An old friend and mentor, Dr. Richard Kovacs, now chair of the American College of Cardiology’s Board of Governors (and IU guy), has written about these same pre-certification barriers. Dr. Kovacs, being a professor and distinguished ACC official, kindly terms these obstructionists “radiology benefit managers” (RBMs). Read more »

*This blog post was originally published at Dr John M*