April 9, 2013
In a recent blog post about its quarterly funding round-up, San Francisco-based health incubator Rock Health wrote that it's "hearing WellDoc will be the first major acquisition announced in Q2." Given WellDoc's stature in mobile health, such a deal would be quite a story.
MedCity News was sure to mention the prediction in its coverage of Rock Health's funding report and VentureBeat appeared to...
March 28, 2013
Coinciding with the second day of congressional hearings on FDA regulation of mobile medical apps last week, McKesson announced the launch of a new app, Medisoft Mobile, for doctors and their staff that aims to make it easier to manage their practice through iPhones or iPads. Between the Medisoft Mobile app and the newest version of Medisoft software, care providers can now use their mobile...
March 26, 2013
By Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green
My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on mHealth, I feel the urge to plan for the regulatory world after FDA publishes its final guidance. FDA testified the...
March 21, 2013
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...
March 20, 2013
We are live blogging day two of the Congressional hearings on FDA regulation of mobile medical apps. Hit "refresh" on your browser every few minutes for updates! (Liveblogging is now concluded!)
1200PM: With that Rep. Pitts concludes the hearing after saying it has been a very interesting hearing on an important issue. Members may have follow-up questions and they have 10 business days to submit...
March 6, 2013
Source: mHealth Regulatory Coalition FDA Report
Last week six members of the US House of Representatives Committee on Energy and Commerce wrote a letter to FDA Commissioner Margaret Hamburg MD to ask her when the agency expects to publish its final guidelines for how and when it regulates mobile medical apps as medical devices. The FDA draft guidance document on mobile medical apps was published...
March 4, 2013
A little more than a month ago, Naomi Fried, chief innovation officer at Boston Children's Hospital, tweeted: that most healthcare mobile apps are built for consumers and focus on health and wellness, while only 20 percent are clinical apps. She wrote: "We need more #hospital apps." Naturally, this caught our attention.
"There's a huge opportunity for mobile apps in the hospital environment,"...
February 18, 2013
Perhaps more than any other metric, the time it takes to secure clearance is the one that gets the most attention for 510(k) devices. An updated analysis from medical device quality assurance and regulatory consultants, The Emergo Group, finds that the average time it took for a medical device to complete the 510(k) process was about 138 days in 2011, down from 146 days in 2010. The company...
December 20, 2012
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...
November 15, 2012
We've all heard the election post-mortem by now. President Obama's surprisingly comfortable re-election — along with the continued split control of Congress — means that the Patient Protection and Affordable Care Act, a.k.a., Obamacare, is here to stay, although some Republican governors are deciding to let the federal government run their states' health insurance exchanges and are opting out of...