regulation

By Brian Dolan 08:10 am July 29, 2009
"It is really not all about the technology," explained Dr. Daniel Sands, senior medical informatics director for Cisco Systems, during his keynote at the World Health Care Congress's Wireless Health event this week. "My talk is entitled 'It's not about the technology, confessions of a healthcare technologist.'" "So it's a first," Sands said. "Everything we do is a first. So, we are excited by the...
By Brian Dolan 06:52 am July 13, 2009
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C. It can come as a bit of a shock to people in the consumer electronics, IT and telecommunications industries that FDA might regulate certain equipment like cell phones that companies are planning to put at the center of connected health services. My goal is to outline the factors that FDA considers when deciding whether to...
By Brian Dolan 07:33 am June 26, 2009
By Russell Fox, Communications Practice, Mintz Levin Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development of new "mHealth" (mobile health) applications and services that enable medical professionals to monitor patient data and help patients manage...
By Brian Dolan 09:06 am June 2, 2009
Michael Goldberg of Mohr Davidow Ventures (MDV) is currently, actively pursuing start-ups in the personalized medicine sector, including companies that make use of wireless sensors to collect clinically-actionable data for point-of-care. Goldberg's firm recently invested in wireless remote monitoring company Corventis. mobihealthnews recently had the opportunity to discuss MDV's interest in the...
By Brian Dolan 12:38 pm May 7, 2009
The U.S. Food and Drug Administration (FDA) announced today that it is requesting a budget of $3.2 billion, which represents a 19 percent increase over the current FDA fiscal year budget. Given the recent buzz over the FDA's intent to take a closer look at health and medical applications for the iPhone, we wonder if any of fraction of these billions will go toward sharpening the FDA's ability to...
By Brian Dolan 11:36 am February 18, 2009
Even though the FDA recently began an open dialog with the wireless medical device community over mHealth regulation, enforcement of federal quality regulations at labs that develop medical devices has been scaled back by the FDA, according to a recent report by the Project on Government Oversight. FDA inspections of "good laboratory practices" at facilities that do early testing of medical...