Topic:
Regulatory & Risk Management
Latest Headlines
Latest Headlines
GAO: States misusing wireless Enhanced 911 implementation funds
Over the past decade, states have made significant progress in implementing wireless Enhanced 911 (E911), concludes a Government Accountability Office report . But some states, auditors say, are...
Welcome, Mr. Quinn, I don't believe we've been introduced
I'm amazed at how quietly the Federal Communications Commission recently selected the agency's first Director of Health Care Initiatives, Matthew Quinn . To say that it was without fanfare...
FCC taps Matthew Quinn to lead healthcare initiatives
After a four-month job search, the Federal Communications Commission (FCC) has picked its first Director of Health Care Initiatives, according to MobiHealthNews. Although the agency has not...
Talk of Affordable Care Act, taxes detract from constructive mHealth hearings
When the House Energy and Commerce Committee announced plans earlier this month for its subcommittees to hold three days of hearings on mobile healthcare, it seemed like a promising development,...
FDA: Final mobile medical app guidance expected by end of fiscal 2013
In testimony last Thursday before the House Energy and Commerce Subcommittee on Oversight and Investigations, the U.S. Food and Drug Administration reassured Congress and the mHealth industry at large that the focus of the regulatory agency's oversight will be a "small subset" of mobile medical applications.
FDA needs streamlined, clear mHealth regulations, critics say
The U.S. Food and Drug Administration came under fire Wednesday in a congressional subcommittee hearing for being slow to finalize the agency's draft guidance for mobile medical applications, which critics charge remain unclear and unpredictable.
Threat of med device tax on mHealth dominates initial House hearing
The regulation of mobile healthcare apps and devices could trigger a 2.3 percent excise tax required by the Affordable Care Act, hampering innovation by the budding mHealth industry, according to testimony at Tuesday morning's hearing of the House Energy and Commerce Committee's Subcommittee on Communications and Technology.
House hearings underway on mobile health regulations
Continuing to pressure the U.S. Food and Drug Administration on whether it intends to regulate smartphones, tablets and mHealth apps as medical devices under the Affordable Care Act, the House Energy and Commerce Committee began a three-day series of hearings on Tuesday to examine how such regulations would impact patients, physicians and developers.
Three days of reckoning for mHealth regulations
Today begins the first of three days of hearings held by the House Energy and Commerce Committee to consider the weighty issue of how the U.S. Food and Drug Administration should regulate mobile medical applications. It is a central question that has far-reaching consequences for a mobile healthcare industry still trying to get off the ground.
Regulatory front is biggest potential drag on mHealth
It's been said that medicine is a science, healing is an art, and healthcare is a business. While we can all agree that promoting better health, healing the sick and curing disease is a noble...
