This week the European Commission announced a consultation -- similar to a public notice from the FDA here in the US -- that asks digital health companies and others for help in identifying ways to encourage and regulate mobile health, which the Commission defines as "ways to enhance the health and wellbeing of Europeans with the use of mobile devices, such as mobile phones, tablets, patient...
There are now more than 100 mobile medical apps registered with or cleared by the FDA as medical devices, according to MobiHealthNews' just-updated report, aptly named: The 103 FDA Regulated Mobile Medical Apps.
When we first published our extensive round-up of FDA regulated mobile medical apps in December 2012, we found 75 apps in FDA's databases. This time around we added those that received...
By Bradley Merrill Thompson
More than three years have passed since I wrote the first edition of this e-book for MobiHealthNews, and much has changed. Among other things, FDA at last has published its final guidance on mobile medical apps. Further, the mHealth industry has morphed several times over the last couple years. Consequently, in this second edition, more than 80 percent of the content...
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
Some technology companies are sitting on the sidelines, or just dipping their toes in the mHealth waters, out of fear of the unknown. Will FDA regulate this space? If we get into healthcare, will we get sued if someone breaks a finger nail using our app? Will the FTC come after us if we don’t have a bunch of clinical trials to support every claim we make? Will a...
During a panel discussion organized by the Office of the National Coordinator and the HHS last week, Federal Trade Commission Attorney Cora Tung Han, who works in the FTC's Division of Privacy and Identity Protection and the FDA's Policy Advisor Bakul Patel, who works at the agency's Center for Devices and Radiological Health helped explain how the two organizations work together when it comes to...
The Wall Street Journal published a report last summer that questioned whether "toning" sneakers like Skechers Shape-Ups or Reebok's EasyTones really help users get in better shape. The article included two links to case studies on the respective sneaker makers' sites that touted the various fitness benefits provided by the sneakers. The sneakermakers actually asked the WSJ to update the article...
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...
In recent months it's become clear that the media is increasingly turning its attention to mobile health.
The attention, of course, is welcomed by most everyone working in mHealth today, but sometimes it's painful to read the hyperbole, exaggerations, and misconceptions that are perhaps inevitable with the increase in coverage.
Proteus Biomedical is one company that has noticed this hyperbole....
The US Food and Drug Administration (FDA) has granted 510(k) regulatory clearance to the Curvus Arrhythmia Monitoring Device (C-AD), a wireless-enabled and continuous tracker of real-time ECG readings. Curvus is a subsidiary of WPR Medical, which is based in Norway. C-AD will enter the market where a handful of other wireless cardiac monitoring companies are already playing: CardioNet, LifeWatch...
