News & Analysis as of

Food and Drug Administration (FDA) Mobile Apps

Arnall Golden Gregory LLP

FDA Issues New Draft Guidance on Regulatory Considerations for Prescription Drug Use-Related Software

New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...more

Mintz - Health Care Viewpoints

Things to Consider When Determining the Regulatory Requirements for Software (Hint: It’s More Than the Device Classification)

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 10

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A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal...more

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

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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

Lippes Mathias LLP

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

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Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more

BakerHostetler

AD-ttorneys@law – June 2021 #1

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Will COPPA Enter Its Surly Teenage Years as CTOPPA? Bipartisan bill aims to beef up everyone’s favorite kiddie privacy law - Data-luge - It’s now a truism of our collective pandemic experience that the mass adoption of online...more

MoFo Life Sciences

FDA Authorizes First Full At-Home Test For The Detection Of SARS-COV-2

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On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely...more

BakerHostetler

AD-ttorneys@law – August 2020 #4

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Consumers Sue Mobile App Maker Over Loot Boxes - Supercell singled out for creating a gambling space for youngsters - Too Old for This - We need a minute. Just a minute. Our heads are throbbing. We just got through looking at...more

McDermott Will & Emery

The Toughest Problem Set: Navigating Regulatory and Operational Challenges on University Campuses

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When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old...more

Morgan Lewis

FDA Regulation of COVID-19 Apps, Digital Therapeutics, and Other Digital Health Technologies

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With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19...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

Skadden, Arps, Slate, Meagher & Flom LLP

Protecting Lives Without Destroying Jobs — Using Technology To Suppress COVID-19

Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more

Faegre Drinker Biddle & Reath LLP

FDA Relaxes Modification Restrictions for Non-Invasive Remote Monitoring Devices During COVID-19 Public Health Emergency

On March 20, 2020, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued a new guidance document for industry and FDA staff, attempting to “help expand the availability and capability...more

Nossaman LLP

FDA Policy for Mobile Medical Applications

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The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

McDermott Will & Emery

[Event] Munich Life Sciences Bootcamp For In-House Counsel - November 21st, Munich, Germany

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McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

Patterson Belknap Webb & Tyler LLP

FDA Issues Updated Guidance on Medical Apps Oversight

Last month, the Food & Drug Administration (FDA) issued a long-awaited revision to its Policy for Device Software Functions and Mobile Medical Applications Medical App - Guidance for Industry and Food and Drug Administration...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

Jackson Lewis P.C.

Health Apps: Convenience Vs. Security Risks

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The pace of innovation in healthcare today has produced an amazing increase in the number of available mobile apps for health-related information. More than 300,000 healthcare apps are available online. These apps are...more

Wilson Sonsini Goodrich & Rosati

Digital Health: FDA Gives Nod to Multiple First-in-Class Devices

Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more

Mintz - Health Care Viewpoints

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Troutman Pepper

AGs Weave Themselves Into Patchwork of Digital-Health Regs

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There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

Kelley Drye & Warren LLP

NY AG Enters Mobile Health App Enforcement Arena with Settlements Targeting Health Claims and Privacy Practices

New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The...more

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