FCC

By Jonah Comstock April 26, 2017
RapidSOS, a 4-year-old startup with roots at Harvard and MIT, has raised $14 million to, at long last, bring 9-1-1 and other first responder networks into the smartphone age. The roster of backers for the round includes three former FCC Chairmen and the investment arms of Motorola and Triple A, in addition to a number of other investors. Highland Capital Partners led the round with participation...
By Jonah Comstock February 27, 2017
EpiWatch, the Apple Watch-based ResearchKit study on epilepsy led by Johns Hopkins, shared some early results at a conference last week. The results shared were of 598 participants over 10 months who used the app to track their seizures and provided information to researchers about what was happening before the seizure struck. The most common trigger, named in 37 percent of cases, was stress....
By Heather Mack January 26, 2017
Ajit Pai has been named chairman of the Federal Communications Commission raising speculation that many rules and regulations enacted under the Obama administration will be axed, the Hill reports.  Pai, who has long been in favor of deregulation on things like net neutrality and other consumer protection regulations, was the senior republican on the FCC since 2012. He was the associate general...
By Heather Mack August 22, 2016
In response to a request from Congress, the US Department of Health and Human Services released its report on the agency’s current telehealth efforts. While it wasn’t within the 180-day deadline Congress gave the department in December, the report was comprehensive in its scope of the potential promise of telemedicine, especially given the ever-expanding availability of services, as well as the...
By Jonah Comstock June 27, 2016
At long last, the FCC is almost ready to create a dedicated spectrum band for Medical Body Area Networks, or MBANs. The spectrum was allocated in 2012, making the US the first country to allocate spectrum specifically for connected wearable medical sensors. Now, the FCC has appointed the Enterprise Wireless Alliance to serve as frequency coordinator and the EWA has launched a website where...
By Jonah Comstock August 10, 2015
CareScape V100, a GE patient monitor. Despite protestations from the American Hospital Association and a cadre of 16 Republican members of Congress, the FCC decided at its August meeting to allow unlicensed devices to use some of the spectrum previously reserved for medical devices. The AHA and the Representatives both sent letters to the FCC in the last days of July, urging them to postpone...
By Jonah Comstock December 1, 2014
Bradley Merrill Thompson testifying before Congress last year. Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in consulting with mobile health startups about FDA clearance, is launching a new venture called Aventor that aims to bring discounted regulatory consulting and advocacy services to companies that use mobile health and connected health to help the poor. "In...
By Jonah Comstock August 11, 2014
FCC Commissioner Ajit Pai Last week, the FCC passed an order accelerating its text-to-911 roll out by requiring all carriers, as well as certain dedicated texting apps, to support text-to-911 by the end of the year. However, two members of the commission, Ajit Pai and Michael O'Reilly, dissented from the order, suggesting that because the public safety answering points (PSAPs) that process 911...
By Jonah Comstock April 4, 2014
The FDA, along with the FCC and ONC has finally released the report to Congress required by the FDA Safety and Innovation Act (FDASIA) of 2012. This FDASIA report, called "Proposed Strategy and Recommendations for a Risk-Based Framework," reiterates previously articulated FDA positions on regulatory discretion and avoiding regulatory redundancy between the FDA, ONC, and FDA. It's based on the...
By Jonah Comstock January 28, 2014
Sharon Klein and Dayna Nicholson Even though the FDA guidance on mobile medical apps is now finalized, it only represents a portion of the regulation mobile medical app developers need to concern themselves with, according to Pepper Hamilton lawyers Mark Kadzielski, Sharon Klein, and Dayna Nicholson, who presented a webinar on the topic last week. Particularly in the areas of privacy and...