The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), and Tina Smith (D-Minn.).
The 12-page letter contains no less than 50 questions for the agency about the program, ranging from how it will derive its statutory authority to how it will pay for the program absent traditional...
The cost of healthcare in the United States is a burden for many living in the country but some congressional representatives are looking to change that with more innovation in the space.
Yesterday, a bipartisan group of congressional representatives announced a new Healthcare Innovation Caucus, which is set to focus on encouraging innovative policy ideas and improving the quality of care while...
When Suneel Gupta founded Rise Health in 2013, his inspiration was his father. He shared with MobiHealthNews that he started the digital health company after seeing his father struggle with making lifestyle changes after a triple bypass surgery. But for Gupta's latest endeavor — a Democratic run for Michigan's hotly-contested 11th District — it's his mother who serves as his inspiration.
"My mom...
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...
The ONC issued a report to Congress today laying out the gaps that exist in health data protection. The report opines at length about non-covered entities (NCEs), the large swath of consumer-facing companies that aren’t subject to HIPAA.
“The wearable fitness trackers, social media sites where individuals share health information through specific social networks, and other technologies that are...
A bipartisan group of US Senators led by Brian Schatz (D-HI) has introduced new telemedicine legislation that would move to waive restrictions on Medicare telehealth coverage that many consider antiquated or arbitrary. In addition to a coalition of six senators and three representatives, the bill has the support of the American Medical Association, the American Telemedicine Association, and a...
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...
On December 30th, at the very end of the 112th Congress, Rep. Mike Thompson (D-Cali.) introduced a comprehensive bill to improve Medicare and Medicaid coverage of telehealth. This isn't new territory for Thompson; he introduced some major telehealth legislation as a California State Senator in the 1990s.
The latest bill's definition of "telehealth" covers various health services delivered...
As expected, Silicon Valley's Congressman Mike Honda (D-CA) introduced a bill this week that -- among other things -- seeks to create an Office of Wireless Health at the Food and Drug Administration (FDA). While the bill has been talked about in the past few weeks, its specific details have only now been made public. The bill also calls for a HIPAA-focused developer support program at HHS, an X...
After two years of research and a joint effort between groups of security experts working at separate academic institutions, a professor and a graduate student showed attendees at hacker conferences Black Hat and Defcon how to build a "cheap" $1,000 system to mimic the control mechanism on a pacemaker. The researchers were able to eavesdrop on private data that identified the patient, doctor,...
