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Open data, apps and the FDA | Opensource.com
Open data, apps and the FDA
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One June 9th, The Department of Health and Human Services hosted the second Health Data Initiative challenge. The point behind the challenge is to promote and accelerate the use of open data to improve health. As part of the presentation, winning apps, utilizing the public data and conceived and produced by three teams of college students (one of which I use on a daily basis) were showcased. Very cool stuff.
On July 19th, the FDA announced that it was recommending regulation of Mobile Medical Applications. This sent Twitter and several bloggers into a bit of a frenzy. Everyone wants to know what it means. What will the ramifications be to those people who are diving into that open medical data provided by the Department of Health?
The answer? Not much. The guidance recommended is for medical health apps, defined as those that are used as an accessory to a regulated medical device or those that transform a mobile platform into a regulated medical device.
From Ogilvy PR:
The FDA used the examples of an app that allows healthcare professionals (or HCPs) to view medical images and make a diagnosis or an app that gives smartphone abilities to detect abnormal heart rhythms – both would fall under the Agency’s regulation. As Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health noted, the guidance “calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
What’s not included? The apps you use to track your sleep or your calorie intake. The apps you use to monitor your workout. The apps that give advice or recommendations that are generally related to your health are clearly not included in the FDA’s proposed guidelines. You get to keep FitBit and Lose It and any similar app that has now become a huge part of your daily life.
So all those smart and excited people out there should keep delving into the Department of Health’s open data and see what they can make of it. It means that there should be no end to the innovation and possibilities that come from the development of health apps. It means, simply, that everyone should keep going.