FDA mHealth regulation

By MHN Staff 09:30 am August 27, 2013
By Bradley Merrill Thompson I feel like a dissident trying to convince the government to free a political prisoner. That’s a pretty apt description, considering that the FDA’s Mobile Medical App (MMA) guidance document is being held hostage purely on political grounds. Earlier this year, a DC advocacy group decided they wanted Congress to adopt an entirely different approach to health IT. The...
By Brian Dolan 06:09 am 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...
By Brian Dolan 08:13 am 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...
By Neil Versel 02:33 am December 22, 2011
As you learned from MobiHealthNews this week, MIM Software received a second FDA 510(k) clearance for its MobileMIM radiology app. In this case, the Food and Drug Administration approved MobileMIM radiology app for viewing x-rays and ultrasound images for diagnostic purposes. The federal agency also cleared the iPhone and iPad app for reviewing and approving of radiation therapy plans. "Adding...
By Neil Versel 05:30 am March 30, 2011
A special report on “Innovations in Health Care” that appeared in the Wall Street Journal on Monday included a feature on mobile devices. Most of what the Journal reported shouldn’t be a surprise to anyone who reads MobiHealthNews: Dr. Eric Topol, chief academic officer at Scripps Health in San Diego, thinks the pocket ultrasound is ending the 200-year reign of the stethoscope. Telemedicine...
By Neil Versel 05:19 am March 23, 2011
A week ago, MobiHealthNews shot down the myth that the U.S. Food and Drug Administration (FDA) plans to start regulating mobile medical apps. In reality, the FDA has been regulating mobile software for years. Way back in 1997, Data Critical, a company bought by GE Healthcare in 2001, earned FDA 510(k) clearance for its RhythmStat XL software that wirelessly transmits ECG data from a heart monitor...
By Brian Dolan 07:21 am December 29, 2010
By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C. The mHealth Regulatory Coalition (MRC) recently released “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth," which is a 60-page paper that focuses on two fundamental questions: (1) what mHealth hardware and software will FDA regulate and (2) if a product is regulated, to what degree? The Coalition...
By Brian Dolan 09:20 pm November 10, 2010
"Some of the [mHealth] technologies that come before us certainly fit squarely into the model we traditionally have for regulatory oversight," Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health at the FDA said during a panel discussion at the mHealth Summit in Washington DC this week. "Some of the things we are thinking about are... Where do we want to draw that line?...
By Brian Dolan 06:54 pm September 22, 2010
FDA and Health Canada recently cleared Calgary Scientific's Resolution MD app,  the system is certified for clinical use by Health Canada and the FDA. The smartphone application is offered free of charge to doctors who are affiliated with hospitals and diagnostic labs that implement the solution. Update: The company is still seeking FDA approval for the app for handheld devices. A report over at...
By Brian Dolan 05:48 am June 11, 2010
By Bradley Merrill Thompson (Several friends commented on this draft, and I would like to thank them.) Warning, this article contains explicit and sometimes graphic depictions of possible FDA regulation. If you've been reading the prior articles in the series, you know I've been leading up to this last article in which I offer some predictions as to where FDA regulation will end up with regard to...