Today’s smartphone is a camera, a GPS system, an e-reader, a game console and even a remote car starter. Why can’t it also be a blood glucose meter, X-ray viewer, stethoscope or diagnostic aid? That’s ...
My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on ...
Here's a look at how to make sure you're jumping through all the right regulatory hoops to bring your mobile medical app to market. iPhones are the new medical device. It’s true. Every time I login to ...
The U.S. Food and Drug Administration intends to regulate only mobile apps that are medical devices and could pose a risk to a patient’s safety if they do not function as intended. Some of the risks ...
(Reuters) - The U.S. Food and Drug Administration has issued final rules governing the development of mobile medical apps, saying it will focus its oversight on those products that have the potential ...
LOS ANGELES (Reuters) - A fast-growing number of software applications offers doctors the chance to view X-rays or monitor heart rates from iPads or smartphones, prompting U.S. health officials on ...
Harvard Medical School encourages its students to take advantage of the growing number of mobile medical apps. While the school does not distribute devices to its students, they are instructed to ...
The U.S. Food and Drug Administration (FDA) has issued final guidance for developers of mobile medical applications. The agency intends to exercise enforcement discretion (meaning it will not enforce ...
If mobile medical apps are going to stand any chance of survival -- with physicians as well as consumers -- they'll have to be able to integrate with other devices and healthcare platforms, with ...
Alpha Software has released a guide on mobile app data capture for healthcare organizations. The resource addresses HIPAA ...
How should the U.S. Food and Drug Administration (FDA) regulate mobile medical apps? More than 20 experts shared their opinions with the FDA on September 12, the first day of a two-day public forum in ...
The FDA's recent guidance on mobile medical apps creates a gray area in which the agency will not automatically require approval for all new mobile medical apps, but may exercise "enforcement ...
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