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...
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...
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...
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...
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...
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-...
April 22, 2013
Some time last month, the Federal Communications Commission (FCC) quietly filled its long-vacant Director of Healthcare Initiatives position, responding to a call made last September by its mHealth task force. The FCC's appointee, Matthew Quinn, is no stranger to healthcare innovation. With a background in two previous government agencies and a number of large and small healthcare companies,...
January 9, 2013
The Federal Communications Commission will provide $400 million in funding to rural hospitals and care facilities to support telemedicine infrastructure.
Starting at the end of the summer in 2013, nonprofit hospitals will be able to apply for funding to build or expand their broadband networks, allowing rural clinics to connect to urban medical centers to allow remote consultation with...
December 13, 2012
Back in September, MobiHealthNews reported that the Federal Communications Commission's (FCC) mHealth taskforce recommended, among other things, that the FCC hire a healthcare director. A job posting for that position has now been posted by the FCC.
According to the post, the Director of Health Care Initiatives will serve for a maximum of four years. The Commission hopes to hire someone with a...
December 11, 2012
According to the Pew Internet and American Life Project, 85 percent of American adults own a mobile phone, and 80 percent of those mobile phone owners use their phone to send and receive text messages. Yet the only way to contact emergency services in the event of a fire, health emergency, or criminal activity is still by dialing 9-1-1 and making a phone call.
In August of last year, FCC chairman...