FDA wireless health regulation

By Brian Dolan December 1, 2010
This week the Federal Communications Commission (FCC) announced a proposal to create a new medical program experimental radio license that would help create "cutting-edge test-bed facilities, where manufacturers and developers could try out new wireless medical technologies and assess operational readiness." The FCC said that the idea for such a program arose during its meeting with the Food and...
By Brian Dolan November 10, 2010
"Some of the [mHealth] technologies that come before us certainly fit squarely into the model we traditionally have for regulatory oversight," Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health at the FDA said during a panel discussion at the mHealth Summit in Washington DC this week. "Some of the things we are thinking about are... Where do we want to draw that line?...
By Brian Dolan July 27, 2010
The FCC's Director of Healthcare Dr. Mohit Kaushal posted a video tour of the wireless health companies exhibiting at the FDA-FCC wireless health meeting today and tomorrow. Watch as FCC Chairman Julius Genachowski, FDA Commissioner Peggy Hamburg and Federal Chief Technology Officer Annesh Chopra meet with a few of the 25 companies at the event. Lots of recognizable faces from the industry:
By Brian Dolan July 14, 2010
If you have been following Babyforyou.net.ua’ series of contributed articles penned by Bradley Merrill Thompson, a strategic counsel at EBG Advisors, you know that the regulatory environment facing the mobile health industry is one of the sector's biggest barriers. As we reported earlier this year, Thompson and Dane Stout, Executive Director of the Anson Group, have formed a “temporary” mHealth...