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  • Ernest Sari

Remote Patient Monitoring

Updated: Mar 24, 2020

There are many questions surrounding FDA requirements for wearable devices, especially when using these for RPM.

Today I'm going to give you the $100,000 answer......

According to Attorney Shannon Curtis, AMA assistant director for federal affairs, said during a recent education session that there are three important things for physicians to keep in mind when counseling patients about wearables or mobile health (mHealth) apps.

On FDA regulation, the rule—for now, at least—is clear: Any device that is “intended for use in the diagnosis of disease of other conditions, or in the cure, mitigation, treatment, or prevention of disease” requires FDA approval, Curtis said. This goes for devices meant for humans and animals, as the FDA regulates both.

The scrutiny a new product receives is stratified by three levels of risk with products such as syringes and gauze at the first level and devices such as pacemakers in the third.

Wearable devices—mostly in the form of watches, bracelets, vests or glasses—are not regulated if they are intended for general wellness uses, which include maintaining or encouraging a general state of health or activity, or reducing the risk or impact of chronic disease.

If a device that performs these same tasks is implanted rather than worn, then the FDA will regulate it, Curtis said.

mHealth apps are regulatorily treated in a similar fashion. Apps that purport to do the following get a light touch:

1. Help users self-manage diseases or conditions without offering specific treatment suggestions.

2. Provide information related to conditions and treatment.

3. Organize and track patient health information.

4. Automate physician tasks.

If, however, an app is making specific recommendations or a diagnosis, the FDA is going to take a look at it, Curtis said.

“It’s probably going to change a lot more in the not-so-distant future, just because the innovation in this space is so quick,” she added. “It’s a new area for the FDA and it requires a lot of staff with very new expertise. Innovation is coming fast and furious.”

So there you have it......but don't just take our word for it, always stay informed, and when in doubt call the FDA or consult with an attorney........



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