Wearables making health claims will now be FDA regulated

sparkpeople fitness tracker mhealth wearable technology

In an effort to ensure that medical promises made by wearable technology are trustworthy, they will be subject to regulation. The idea of putting on wearables such as pedometers, fitness bands, and even smartwatches, before beginning a workout has become relatively commonplace, to the point that there are many people who simply wear their devices all the time, regardless of whether they are awake or asleep. That said, the more products there are on the wearable technology shelves, the grander their claims seem to be. The U.S. Food and Drug…

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Mhealth app for head injury diagnosis receives nod from FDA

mobile health app news

The U.S. Food and Drug Administration has now given clearance to this mobile application for traumatic brain injury identification. The FDA has now given clearance to an mhealth app called the Defense Automated Neurobehavioral Assessment, which is a smartphone based application that is meant to offer medical providers with assistance in identifying situations in which traumatic brain injury may be present. The mobile health app can be used in virtually any setting and could help in making a diagnosis very quickly. As little as five minutes could be needed in…

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Mhealth to benefit from newly proposed FDA regulations

mhealth apps mobile technology

A new rule has been recommended in the Federal Register, which would change mobile health technology classifications. The Food and Drug Administration has now proposed a new rule within the Federal Register which would make changes to the way that it would classify mhealth devices, which could be quite beneficial to that industry. The proposed rule would make it easier for the agency to classify a mobile medical device. Should this become the rule, it will be simpler for the FDA to be able to classify mhealth devices under 2012’s…

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Mhealth will be defined by regulatory issues in 2013

mhealth apps mobile technology

Attorneys are cautioning that this year will face significant changes in rules. With 2012 behind us, the first year in which mhealth played an important role in patient education and care has come to a close, and this year will open up new opportunities for both the use of the technology and for its regulation. There were already regulatory issues for mobile health in 2012 and these will carry over into this year.

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New FDA regulations have significant impact on health apps for mobile devices

augmented reality Health Care

The Food and Drug Administration (FDA) is considering a proposal that would apply stricter regulations to mobile apps that are designed to provide medical information or advice. This type of application has been growing in popularity as smartphones are used by Americans on an increasing basis, as they make additional efforts for their own healthcare management. Current estimates are suggesting that by the year 2015, if regulations remain as they are, there will be approximately 500 million consumers using medical apps. Clearly, the demand for health related information is very…

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