Healthcare is shaping up to be an important area for all the big technology companies that focus on mobile devices. And that is pretty much all of them. When Sony sold off its VAIO computer division to Japan Industrial Partners earlier this year, among the reasons given were “drastic changes in the global PC industry”, and a need to “concentrate on … smartphones and tablets.” Over at Microsoft, new CEO Satya Nadella says we’ve entered the “post-post-PC era” and that he is putting mobile and cloud technology first.
Apple has arguably taken a lead in digital health, launching a suite of apps and gadgets aimed at empowering users to assess their personal health status. Samsung, too is upping its game. (See Tuesday’s edition of BIO Buzz “An Innovation Center for Digital Health”.)
This flurry of activity has not gone unnoticed at the US Food and Drug Administration (FDA). Their guidelines on the regulations of mobile medical apps, released last year, stated that “FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended…”. Thus the regulations cover apps that are an extension of one or more medical devices, those that convert the mobile platform into a regulated medical device and mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. Apps that provide general health benefits such as weight management or cardiac function might not come under review.
To learn more visit the Digital Health Zone, Booth #5387.