April 13, 2015
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...
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Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms,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...
January 20, 2015
Bradley Merrill Thompson
At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an "accessory" device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall...
August 7, 2014
Last month iMedicalApps' Dr. Iltifat Husain penned a great piece of reporting on a paid iPhone app that purported to a sense user's blood pressure using just the phone's camera. Apart from the troubling claim, the developer said it was using a method developed by Johns Hopkins (which has denied any ties to the group). What's more, the $3.99 app, called Instant Blood Pressure, was one of the top...
June 10, 2014
When we first learned that a small team of Apple executives met with FDA officials last December to discuss mobile medical applications, it seemed likely that the discussion was intended to help Apple better avoid FDA regulation for its rumored health products. Thanks to a successful Freedom of Information Act request from the Apple-focused resources site Apple Toolkit, the FDA has furnished a...
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 11, 2013
The champion of legislation to give the Food and Drug Administration (FDA) regulatory power over mobile and wireless health apps, gadgets and other tools believes his plan is something industry wants and consumers need.
"The tech community needs confidence in a consistent, reliable framework for wireless health. The FDA has a critical role to play. Today, there is no confidence [among] industry....