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Tag: ‘Food and Drug Administration’

Mobile Smoking Cessation Tool Earns FDA Approval

It seems like mobile apps these days have the power to help us do virtually anything, from hailing a ride to applying for a job to managing our health. Indeed, recent studies have showcased apps’ potential when it comes to health care, including for the prevention and treatment of chronic diseases. And now, the Food […]

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CTeL Summit: Get the Early Bird Rate While You Still Can!

Have you registered for the CTeL Fall Executive Telehealth Summit yet? If you still haven’t bought your ticket (and what’s stopping you?), there’s good news: You can still register at the early bird rate, but only until this Friday. Bonus: Along with a lower rate, early bird registration also gets you complimentary access to any of the […]

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FDA Establishes New Digital Health Unit

The Food and Drug Administration (FDA) is making a new commitment to digital health. As Health Data Management and others first reported, the agency has established a new digital health unit, to be located within its existing Center for Devices and Radiological Health (CDRH). Said Dr. Bakul Patel, who serves as the CDRH associate director, […]

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Are You a Medical Device Manufacturer without Knowing It?

On November 17, 2016 in Washington, D.C., attendees of the CTeL Executive Telehealth Summit will turn their attention to the conditions under which organizational use of telemedicine technologies may trigger unwanted Food and Drug Administration (FDA) attention. Medical devices are subject to FDA approval, and failure to have a device approved can swiftly result in […]

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FDA Sets It’s Sights on Silicon Valley’s Digital Health Boom

As the digital health market continues to grow rapidly, it is expected that regulatory scrutiny from the Food and Drug Association (FDA) and the US Federal Trade Commission (FTC) would continue to increase in innovation centers across the US, specifically Silicon Valley. “When the process is managed right, we know that the government can be […]

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Telemedicine and Mobile Apps — Who’s Watching? How Safe?

As reported by Reuters Health, a new study finds that millions in the United States are engaging in telehealth, measuring blood pressure with downloaded mobile health applications (mHealth apps) that are untested and could deliver inaccurate readings. Researchers analyzed 107 mHealth apps for hypertension and blood pressure available on Google Play and Apple iTunes. While […]

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Continued FDA Device Deregulation? FDA Will Stop Active Regulating MDDS

The Food and Drug Administration (FDA) is continuing to provide clarification regarding its plans for health IT device regulation—and perhaps to provide reassurance to those who had expressed concerns about regulatory overreach. As reported by The Robert J. Waters Center for Telehealth and e-Health Law (CTeL) Legal Resource Team member Anthony Pavel and his colleagues […]

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FDA and Telemedicine Regulation? CTeL June Webinar Answers Questions

When is your smartphone technically a medical device?  When might a practitioner utilizing telemedicine turn into a device manufacturer under the Food and Drug Administration’s (FDA) jurisdiction?  And what will be the impacts of last September’s guidance on mobile medical apps? For answers to these and other questions on the often-confusing topic of the FDA, […]

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CTeL Webinar: How Does FDA Regulation Affect Telemedicine?

“How Does FDA Regulation Affect Telemedicine?”  will be the topic of The Robert J. Waters Center for Telehealth and e-Health Law’s (CTeL) Brown Bag Webinar on Tuesday, June 10, 2014, from 12:00 noon – 1:00 pm EDT. Speakers will be: Anthony Pavel, Partner, Morgan, Lewis & Bockius LLP,   CTeL Board Member Michele Lee Buenafe, Associate, […]

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mHealth Legislation: “Overreach” or “Necessary”?

Over the past few years, the mHealth industry has seen exponential growth, but until recently comparatively little regulation.  With the Food and Drug Administration’s (FDA) release of new regulatory guidelines last September, the agency provided some clarity to the industry.  But debate persisted over how much regulation was “too much”—a debate that is continuing after […]

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