News & Analysis as of

Food and Drug Administration (FDA) Federal Trade Commission (FTC) Mobile Apps

Harris Beach PLLC

There’s an app for that! But is your health care app in compliance?

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The health care industry is increasingly adopting mobile apps for a variety of purposes, including tracking patient health conditions and sharing patient data. Privacy and security are important considerations, and it is...more

Holland & Knight LLP

FTC Seeks First-Ever Health Breach Notification Rule Enforcement: Pixel Users Beware

Holland & Knight LLP on

For the first time ever, the Federal Trade Commission (FTC) is seeking enforcement under the Health Breach Notification Rule. This regulation requires certain businesses not covered by the Health Insurance Portability and...more

Hinch Newman LLP

Advertising Law Alert: FTC Announces New Health Products Compliance Guidance

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In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission...more

BakerHostetler

AD-ttorneys@law - September 2022

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CSPI to FDA: Move to the Front! Watchdog barks at industry efforts to highlight nutrition facts - Gesundheit FOPNL. It’s sweeping the globe. What is it, you ask? A new government agency? An awful skin condition? A...more

Kelley Drye & Warren LLP

Keep Calm and Go Online: Regulatory Considerations Around the Spike in Demand for Mental Health Apps

A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention. As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - July 2018 #2

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We have previously reported on the ongoing cybersecurity issues with St. Jude defibrillators [view related posts here, here, and here]. On June 29, 2018, the Food and Drug Administration (FDA) classified the required firmware...more

Kelley Drye & Warren LLP

FTC Cries Foul On Breathometer Accuracy Claims

The FTC recently announced a settlement with Breathometer, Inc., a company that marketed a smartphone accessory that it claimed could detect blood alcohol levels. Users could simply plug the accessory into the headphone...more

Robins Kaplan LLP

The Tech Industry’s Next Frontier?

Robins Kaplan LLP on

Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more

Troutman Pepper

A New Tool for Health App Developers to Navigate a Crowded Regulatory Field

Troutman Pepper on

As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more

McGuireWoods LLP

FTC Releases Mobile Health Apps Interactive Tool

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Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more

Mintz - Consumer Product Safety Viewpoints

“Multi-Agency Interactive Tool” Available for Developers of Health Apps

It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies. My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The...more

Robinson+Cole Data Privacy + Security Insider

FTC, ONC, OCR and FDA release online tool for mobile health app developers

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

Dickinson Wright

Healthcare Legal News Volume 5 Number 2

Dickinson Wright on

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Morgan Lewis

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

Morgan Lewis on

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

Manatt, Phelps & Phillips, LLP

Advertising Law - Oct 2014

FTC Mows Down Astroturfing at Yahoo - The Federal Trade Commission has closed an investigation into “astroturfing” by Yahoo employees and declined to take enforcement action because of the limited number of workers...more

Manatt, Phelps & Phillips, LLP

Advertising Law - August 2014 #3

FTC: Telemarketing Sales Rule Ripe For Review - It’s time to review the Telemarketing Sales Rule, the Federal Trade Commission has announced. Enacted in 1995, the Telemarketing Sales Rule (the Rule) has been...more

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