by Grant Elliott, Founder & CEO, Ostendio
By simply following the media hype around the recent September 23rd implementation deadline, you could be forgiven for thinking that the final omnibus rule is bad news for mobile health application developers. To recap, the final omnibus rule came into effect on March 23, 2013 but "business associates" were given six months from that date to become...
By Bradley Merrill Thompson
In response to my prior post on this topic, athenahealth's VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions.
As I said in my original...
By Dan Haley, VP of Government Affairs, athenahealth
In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile...
Ideal Life's Blood Pressure Cuff
Verizon Wireless' plans for an FDA-cleared mobile health platform focused on chronic disease management and other health conditions has been in the works for some time. The software platform, officially called The Verizon Wireless Converged Health Management (CHM) Device has just secured Class II 510(k) clearance from the FDA this month. Once it commercially...
By Bradley Merrill Thompson
As I said in the prior post, this series is for two types of companies: (1) those that are merely dipping their toes into mHealth because they’re afraid of the water, and (2) those that are diving right in head first with no idea how deep the water is. Both types of companies might be making mistakes, either by letting good opportunities go by or by incurring undue...
By Bradley Merrill Thompson, EpsteinBeckerGreen
I’ve always found the saying, “Be careful what you wish for; you might just get it” to be rather condescending. In a way it suggests that we are too stupid to manage our own affairs. But like any popular saying, it probably has a kernel of truth.
Frankly, I’m a little nervous about a request made by industry for international medical device...
As expected, the third and final (for now, at least) congressional hearing focused on the FDA's regulation of mobile medical apps was the only one that provided new information for those already well-versed in mobile health. While the past two days of testimonies likely helped members of Congress better understand the concerns of those working or lobbying for the healthcare and technology...
How many mobile medical apps have received 510(k) clearance from the FDA? It's a question I get asked often. For a while the standard response that I've given and heard others give was that you could count on two hands how many apps have received FDA clearance. Over the course of the past two years, however, it has become clear that an increasing number of wireless-enabled medical devices with...
AFrame Digital, a Reston, Va.-based maker of telemonitoring technology, has received 510(k) clearance from the FDA to sell its MobileCare Monitor as a Class II medical device in the US. The company has had less-stringent Class I approval for its flagship monitoring product since 2009.
MobileCare Monitor is a wristwatch-like device that offers continuous, real-time monitoring for seniors, people...
San Francisco-based AliveCor, which has developed the iPhoneECG and iCard ECG, electrocardiogram peripheral devices for smartphones, has raised $10.5 million in its second round of funding. New investor Khosla Ventures led the latest round of funding along with return backer Burrill & Company. Existing investors Qualcomm Life Fund and Oklahoma Life Sciences Fund also contributed. AliveCor,...
