October 8, 2015
By Bradley Merrill Thompson
If I invented an unprecedented mobile technology for treating tennis elbow, the law would require me to do substantial and expensive clinical trials before bringing it to market. In my last post, I argued that the FDA regulatory system is structurally biased against new technology, including novel software, even if it is low risk. By law, any medical device that is...
April 13, 2015
A brain training game fined by the FTC earlier this year.
Developers of mobile health apps need to be mindful of regulation from a number of different quarters. Among others, developers need to be aware of the FDA, OCR (HIPAA), and the FTC, which is increasingly regulating areas that would seem to be the purview of one of the other two groups.
At a HIMSS session on mobile and digital health...
February 9, 2015
FDA's Bakul Patel
Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status. Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where...
June 16, 2014
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...
April 10, 2014
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...
February 13, 2014
While the most recent meeting made headlines, the first time Apple executives actually met with the FDA wasn't at the end of 2013, but rather three-and-a-half years ago. The Financial Times pointed this out earlier this month.
On June 11, 2010 Apple's Vice President of Software Technology Bud Tribble and the company's VP of Worldwide Government Affairs Cathy Novelli met with the FDA's Director of...
December 6, 2013
Research firm Frost & Sullivan listed mHealth among the top three hot topics in healthcare in 2013, garnered from a global survey of 1,835 executives, about 260 of whom worked in the healthcare industry.
Fifty-one percent of respondents nominated mobility in healthcare, or mHealth, as a top trend for the year. The runners up were cloud computing, at 45 percent, and regulatory environments, at...
November 11, 2013
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...
September 30, 2013
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...
September 19, 2013
Departing national health IT coordinator Dr. Farzad Mostashari would prefer that the Food and Drug Administration unilaterally issue a long-anticipated final guidance on mobile medical apps rather than waiting for inter-agency consensus with the Federal Communications Commission and Mostashari's own Office of the National Coordinator for Health Information Technology.
"I testified before Congress...