regulatory

By Dean Koh May 14, 2019
Although health tech and digital health startups have much to offer in terms of transforming healthcare, they often face the challenges of overcoming regulatory hurdles, which are especially stringent in healthcare for the safety of patients. In addition, clinicians can often be torn between being in medical practice and being involved in health tech innovation/research, particularly for those in...
By Brian Dolan August 25, 2009
"The single fastest growing medical device we have in this country is probably the iPhone," Jon Linkous, CEO of the American Telemedicine Association told Mobihealthnews. "I have discussions about the iPhone every single day." Linkous also explained how the telemedicine industry has grown from "white labeled" (literally) corporate video conferencing solutions to the rapidly growing wireless...
By Brian Dolan July 6, 2009
By Mintz Levin's Russel Fox, Howard Symons, Susan Berson and Heather Westphal The Federal Communications Commission (FCC) has proposed to allocate radiofrequency spectrum and establish service and technical rules for the operation of Medical Body Area Network (MBAN) systems. The FCC envisions that MBANs would provide a platform for the wireless networking of multiple body sensors used for...
By Brian Dolan June 9, 2009
The U.S. Food and Drug Administration has indicated in the past that under certain circumstances the iPhone may be considered a medical device and therefore regulated as one, however, as of February the FDA still hadn't figured out exactly which circumstances those might be. Turns out Apple isn't waiting around for the FDA. iPhone application developer and GraniteKey COO Mike Ahmadi wrote in to...