August 5, 2015
By Bradley Merrill Thompson
Healthcare in America needs disrupting. The media has widely reported on the high cost of, and poor outcomes produced by, the US health care system. Fortunately, attracted by possible profit in a market that currently constitutes over 17 percent of GDP, quite a few startups are anxious to do the needed disrupting. Indeed, innovators from many places outside of...
March 16, 2010
Within the healthcare chapter of the FCC's National Broadband Plan, which the agency published this morning, the FCC recommended that it work together with the FDA to clarify regulatory requirements and the approval processes for converged communications and health care devices. The FCC specifically pointed to mobile health apps, smartphone remote monitoring apps, point of care diagnostic...
January 14, 2010
By Bradley Merrill Thompson, MBA, JD
(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to the commenter’s.)
At the risk of insulting my new friends in Silicon Valley, I submit that traditionally-unregulated IT companies...
January 5, 2010
The wireless association CTIA put together a series of video interviews and presentations focused on wireless health for their Wonder of Wireless (WoW) series. The wireless health focused segment includes an interview with MedApps, an interview with CTIA President Steve Largent about wireless trends for 2010, a presentation on carriers' needs for additional spectrum because of wireless health,...
January 4, 2010
Wireless remote monitoring company MedApps announced that it has received ISO 13485:2003 and ISO 9001:2008 certification from Underwriters Laboratories (UL), which subsequently led to a CE Mark certification and CMDCAS approval, enabling the company to market its products throughout Europe and Canada.
To date, MedApps has secured two FDA clearances, various FCC certifications, AT&T and...
September 24, 2009
Changes for 510(k) in 2011? The AP reports that the Food and Drug Administration (FDA) has agreed to a review of its 510(k) review procedure, which has come under fire by both safety advocates and government watchdogs, the report said. The nonprofit Institute of Medicine will conduct the two-year review of the 510k procedure. More
On managing de-centralized care: "There seems to exist almost an...
September 22, 2009
FCC's Open Internet threatens telemedicine? A PBS Nightly Business Report yesterday noted that the new FCC Chairman, Julius Genachowski's plans for an open Internet could end up stunting growth in telemedicine or wireless health services. AT&T, Verizon and Comcast are worried that proposed FCC requirements to treat all web traffic equally will prevent them from effectively managing their...
August 28, 2009
The U.S. Federal Communications Commission (FCC) just announced a plan to examine the mobile phone industry in an effort to determine ways that the agency can spur innovation and competition in the industry. The FCC highlighted four key markets ripe for wireless innovation: health care, energy, education and public safety and is seeking comments on how it can best go about facilitating innovation...
August 24, 2009
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.
Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA requirements that would apply to a mobile phone that crosses that line.
To summarize the July 13 article on "FDA may regulate...
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...