FDA mobile health regulation

By Jonah Comstock March 13, 2017
With previous rumored Trump picks to lead the FDA, we’ve had to rely on speculation to gauge their approach to mobile and digital health. Not so with former FDA deputy commissioner Dr. Scott Gottlieb, Trump’s final pick as of Friday.  Gottlieb, who will still have to be confirmed by the Senate, has made his feelings about mobile health regulation very clear. In 2014, he co-authored a piece for...
By MHN Staff April 8, 2014
By Bradley Merrill Thompson I don’t know about you, but when I read the FDASIA Health IT Report released by HHS on April 3, I found it to be largely quite predictable.  Indeed I’ve been scanning the media coverage of the report and I haven’t seen anyone so far express shock or surprise at what was in the report. How is it that we all pretty much knew what would be in there? Quite simply the three...
By Brian Dolan September 19, 2011
By Bradley Merrill Thompson FDA's exemption for EHRs seems headed the way of the dodo bird.  Nobody planned it that way, but a combination of opposing trends-- the trend toward greater and greater functionality for EHRs and the trend toward greater FDA regulation of any software functionality that can impact patients -- means there may very well be little left of the traditional EHR exemption in...
By Brian Dolan May 5, 2011
"We need to balance our desire for safety with rational risk tolerance and transparency," the West Wireless Health Institute's Chief Medical Officer Dr. Joseph Smith said during his presentation at the Institute's Health Care Innovation day in Washington, DC last week. "And I think -- I've not shared this with them -- but I think we need to get the FDA out of the business of assuring absolute...
By Brian Dolan January 20, 2011
In an opinion piece published in the Wall Street Journal this week, US President Barack Obama wrote that the US Food and Drug Administration (FDA) is set for reform: "Tomorrow the FDA will lay out a new effort to improve the process for approving medical devices, to keep patients safer while getting innovative and life-saving products to market faster," President Obama wrote Tuesday. The next day...
By Brian Dolan November 3, 2010
GE Healthcare announced that its Carescape B650 monitor secured FDA clearance this week. The monitor offers data integration and connectivity, consistency between care areas and -- mobility. "The monitor can run via a wireless local area network and can be battery operated, reducing the need for wall cables. The CARESCAPE Monitor B650 continuously transmits data to the central station, even when...
By Brian Dolan July 27, 2010
The Federal Communications Commission and the Food & Drug Association signed a memorandum of understanding (MOU) today that each agency would work with the other to create an efficient regulatory structure for wireless-enabled medical devices and services. The agreement has a five-year sunset provision built into it. "The MOU between the FCC and the FDA is intended to promote collaboration ...

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