Back in March, when President Donald Trump chose Dr. Scott Gottlieb to head up the FDA under his administration, MobiHealthNews noted that he had a history of advocating for a hands-off approach to mobile health regulation. Now, just three months later (and a little over a month after his confirmation to the post), Gottlieb has articulated his new -- and somewhat radical -- approach to mobile...
By Bradley Merrill Thompson
With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor...
Last year Verizon stopped offering both its patient-to-provider Virtual Visits product and its FDA-cleared telehealth hub software. This moves Verizon away from end-to-end telehealth products and re-focuses it on providing its healthcare customers HIPAA-ready cloud services, advanced security services, and various mobility solutions.
MedCity News first reported on one of the telehealth product...
On Friday the FDA issued a draft guidance document that revealed the agency intends to further deregulate medical device data systems (MDDS) and some medical image transfer systems. The FDA wrote that these types of devices are so low risk that they won't be regulating them at all.
Examples of health software platforms that have class 1 medical device clearance as an MDDS includes Validic's...
As MobiHealthNews noted last week in the introduction to our In-Depth report on Apple's Health app feature set, the FDA made a rare move on Wednesday by adding a new description for a type of mobile medical app that it would not regulate as a medical device. The FDA has actually added a total of four such new descriptions to its list in 2014.
It just so happened that the latest app description to...
Vital Connect's HealthPatch
This past month the FDA cleared two mobile medical apps and one digital health platform as 510(k) Class II medical devices.
McKesson, one of the most vocal health IT companies lobbying for changes to how the FDA regulates medical software, secured clearance for a mobile medical app called McKesson Cardiology ECG Mobile. The web-based version of McKesson Cardiology...
Baltimore, Maryland-based WellDoc, one of the earliest and best known mobile health companies focused on diabetes management, has appointed Kevin McRaith as the company's new president. McRaith most recently served as VP of Sales & Marketing at Human Genome Sciences, and previously worked at Genentech, Abbott and Baxter. In this role McRaith will report to WellDoc CEO Ryan Sysko. WellDoc's...
Image from the office of Senator Deb Fischer (R-Neb.)
Longtime MobiHealthNews columnist Bradley Merrill Thompson, a member of the lawfirm Epstein, Becker & Green, and one of the founders of the mHealth Regulatory Coalition and the CDS Regulatory Coalition, sent over a few examples of the types of apps that a bill in Congress, called the PROTECT Act, would instruct the FDA to stop...
by Bradley Merrill Thompson
As just about everyone knows, last week the FDA published its final guidance on mobile medical apps. That guidance explains in plain English the types of mHealth apps the agency regulates. Over the coming weeks, many of us will be dissecting that guidance to assess what it really means and how the guidance affects the numerous apps already released, as well as those on...
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...
