News & Analysis as of

Enforcement Actions Digital Health

Robinson+Cole Data Privacy + Security Insider

Illinois Enacts Act Prohibiting AI Therapy

On August 4, 2025, Illinois Governor JB Pritzker signed the Wellness and Oversight for Psychological Resources Act into law, which went into immediate effect, and “prohibits anyone from using AI to provide mental health and...more

Orrick, Herrington & Sutcliffe LLP

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

Sheppard Mullin Richter & Hampton LLP

What to Watch: WHOOP Warning Letter

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more

Robinson+Cole Data Privacy + Security Insider

California’s Latest Dose of Enforcement Regarding Health Data

On July 1, 2025, California Attorney General Rob Bonta announced a settlement with Healthline Media LLC stemming from alleged violations of the state’s consumer privacy law, the California Consumer Privacy Act (CCPA)....more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

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Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

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We are in an era where smartphones track sleep patterns, fitness apps monitor heart rates, and online searches reveal sensitive medical inquiries. As a result, the notion of “health data” has expanded dramatically. This...more

Foley & Lardner LLP

HIPAA Risk Analyses for Digital Health: Navigating AI, M&A and Vendor Diligence

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Share on Twitter Share by Email Share Back to top HIPAA Security Risk Analyses (SRAs) should be the foundation of every digital health company’s cybersecurity compliance. Far more than a checkbox exercise, a comprehensive SRA...more

Wiley Rein LLP

What to Expect from New FTC Leadership on Digital Health Care

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Digital health care companies have navigated a wave of new developments at the Federal Trade Commission (FTC) over the past few years. With new leadership in the Trump Administration, the FTC may be poised to change some of...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

BakerHostetler

FTC Continues Focus on Disclosure of Health Information to Third-Party Technologies

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A recently announced settlement with online alcohol addiction treatment service Monument Inc. demonstrates the Federal Trade Commission’s (FTC) continued focus on the use and disclosure of health data. The proposed settlement...more

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

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The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

Burr & Forman

FTC Accelerates Enforcement Actions to Protect Consumer Digital Health Information

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The Federal Trade Commission (FTC) has been aggressively pursuing enforcement actions that involve companies using applications that share consumer personal health information with third parties in violation of the Health...more

Sheppard Mullin Richter & Hampton LLP

FTC Looks to Update Health Breach Notification Rule, Targeting Digital Health Industry

The FTC recently proposed amendments to the Health Breach Notification Rule (HBNR). This is on trend with its aggressive interest over the last couple of years in health data not covered by HIPAA....more

WilmerHale

FTC Proposes Changes to Clarify the Health Breach Notification Rule’s Applicability to Health Apps and Other Evolving Technologies

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On May 18, the Federal Trade Commission (FTC) proposed changes to the Health Breach Notification Rule (the HBNR or the Rule), including clarifying the rule’s applicability to health apps and other similar technologies. These...more

Holland & Knight LLP

Lessons Learned from FTC Enforcement Action Against BetterHelp

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The Federal Trade Commission (FTC) is on a roll in its efforts to signal to the digital health industry that data privacy must be a priority. The FTC announced a consent decree with BetterHelp on March 2, 2023, to settle...more

Perkins Coie

FTC Claims Sharing User Health Data With Advertising Platforms Is a “Security Breach”

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For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

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Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

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The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Bradley Arant Boult Cummings LLP

Enforcement and Health Care Technology: Navigating Fraud and Abuse Issues in Emerging Digital Health Care Areas

Like many industries, the health care industry has become increasingly digitized and reliant on technology. Technology advancements also have had a major effect on enforcement. In his comments to the Federal Bar Association...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Digital Health - June 8th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

Health Care Compliance Association (HCCA)

[Webinar] Digital Tech, Liability, Compliance, and Enforcement in the COVID-19 Era - April 29th, 12:00 pm - 1:30 pm CDT

Learning Objectives: - Hear from former state and federal prosecutors and regulators regarding the state of affairs for healthcare providers, operational, and compliance professionals - Learn about how the pandemic has...more

Sheppard Mullin Richter & Hampton LLP

Recent FTC Settlement Serves as Reminder For Digital Health Developers

Many digital health app developers offering health and wellness solutions directly to consumers may find themselves in a space unregulated by the Health Insurance Portability and Accountability Act (“HIPAA”). While...more

White & Case LLP

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement - Part I

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Digital health is exciting, innovative and forward-looking. Investors have invested billions of dollars anticipating dividends from the next phase of the Big Data revolution: collecting and synthesizing millions of data...more

Foley & Lardner LLP

Top 5 Telehealth Law Predictions for 2021

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With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more

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