Phoenix-based healthcare provider Banner Health expanded its partnership with Los Angeles-based clinical decision software company Regard, bringing clinical support decision-making to clinicians across Banner Health hospitals.
Regard utilizes algorithms and artificial intelligence to generate clinical decisions, documentation and facilitate clinician-to-clinician communications. Through the...
Patients deciding the next step of their care may soon be doing so with the help of an AI on their phone. Today, Insightin Health — a Gaithersburg, Maryland-based company that develops a data-based clinical decision-making platform — announced that it has launched a consumer-facing version of its machine learning-based service, which presents all of a user's health data and future options via a...
Healthcare technology company ThinkMD has partnered with international development company DAI to bring ThinkMD’s first digital health product to scale. DAI also led ThinkMD’s latest funding round for an undisclosed amount.
ThinkMD’s first product is a clinical assessment platform called MedSinc, which is designed to be used on a mobile phone by even minimally skilled health workers to gauge the...
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...
By Bradley Merrill Thompson
Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps. Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well...
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...
