FCC

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...
By Brian Dolan November 21, 2013
Rep. Joseph Pitts (R-PA) This week the US House of Representatives' Energy and Commerce Committee's subcommittee on Health held a hearing to discuss the "Federal Regulation of Mobile Medical Apps and Other Health Software", which ended up being a partial re-run of the committee's FDA-apps hearings back in March. This time around, however, the committee stacked the witness table with supporters...
By Neil Versel September 19, 2013
Departing national health IT coordinator Dr. Farzad Mostashari would prefer that the Food and Drug Administration unilaterally issue a long-anticipated final guidance on mobile medical apps rather than waiting for inter-agency consensus with the Federal Communications Commission and Mostashari's own Office of the National Coordinator for Health Information Technology. "I testified before Congress...
By Jonah Comstock June 18, 2013
Speedy response is what emergency services are all about. But when it comes to responding to changes in technology, emergency response providers can be a little slow. The Federal Communications Commission announced last year that, with the penetration of smartphones and cellphones, the time had finally come for a next generation 911 service where people could use text messages, and even...
By Jonah Comstock May 3, 2013
Although disposable body-worn wireless medical sensors have barely begun to see usage in healthcare, research firm ABI is predicting they will rise to prominence very quickly. By 2018, ABI analysts say, disposable Medical Body Area Network (MBAN) sensor shipments will hit 5 million. Previously, ABI reported that 160 million wireless wearable health devices, of which disposable sensors are a sub-...