Archive for July, 2014



FDA Mobile Apps Loophole Hazardous For Healthcare

July 23rd, 2014
Posted by

This post is originally published on InformationWeek Healthcare, July 23, 2014
 
THE FDA’S RELUCTANCE TO OVER-REGULATE MEDICAL APPS OPENS A PITFALL FOR HEALTHCARE ORGANIZATIONS THAT INNOVATE TOO FAR AHEAD OF THE CURVE.

 

The FDA’s recent guidance on mobile medical apps creates a gray area in which the agency will not automatically require approval for all new mobile medical apps, but may exercise “enforcement discretion,” depending on how the app functions, the risks it introduces to patients/consumers, and its intended use.

 
Read full post on InformationWeek Healthcare.

Tags: , ,
Posted in Our News | No Comments »





What Does the Future Hold for Medtech? (Physicians Will Be More Like Engineers)

July 14th, 2014
Posted by

This post is originally published on MD+DI “Medical Device Business,” July 10, 2014
 

When I was asked to think about how physicians will be affected by the changes in the medtech industry over the next 5–10 years, I initially thought “not much.”

 

The field of medicine is a slow-moving beast with substantial inertia. Physicians tend to be quite conservative when treating patients for a number of reasons. Many physicians practice the way they were trained, which may have been a number of years ago, despite the continuing medical education requirements to maintain state licenses. Moreover, physicians may be liable if a bad outcome results from treatment that deviates too far from the current standard of care, so they may be reluctant jump on the latest trends in treatment, no matter how promising they seem. And the very first oath a future physician takes when entering medical school is Hippocrates’s, promising to “do no harm,” which often means “watchful waiting.”

 
Read full post on MD+DI.

Posted in Our News | No Comments »