News & Analysis as of

Mobile Health Apps

Fox Rothschild LLP

HIPAA, but for non-Covered Entities?

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New bill, proposed by Bill Cassidy (R-LA), Chair of the Senate Health, Education, Labor and Pensions Committee (HELP), purports to apply the privacy and security practices under the HITECH Act, to entities that process non...more

Stark & Stark

Beyond the Average: What Daily Cognitive Fluctuations Reveal About Chronic Concussion

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When most people think about the lingering effects of a concussion, they picture persistent headaches, light sensitivity, or forgetfulness. ...more

DLA Piper

HHS Steps Up Enforcement on Health Information Blocking

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The US Department of Health and Human Services (HHS) announced, on September 3, 2025, a major enforcement initiative targeting “information blocking” – the practice of restricting access, exchange, or use of electronic health...more

Coblentz Patch Duffy & Bass

Updates to U.S. Health-Data Privacy and Wearable Tech

This year marks a pivotal shift from the era of rapid, unregulated health-tech innovation to one of stringent governance. The proliferation of wearable devices, health applications and remote monitoring tools has led to an...more

Wilson Sonsini Goodrich & Rosati

The FDA and WHOOP Debate Challenges the Line Between Wellness Products and Medical Devices

In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the...more

Zelle  LLP

Judge Donato Rules on MSJ Dismissing UCL Claims But Not CIPA Claims – Trial Started on July 21, 2025 Frasco v. Flo Health, Inc.,...

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In late May, Judge James Donato of the U.S. District Court for the Northern District of California ruled on summary judgment motions filed by Meta and Flo Health Inc.—both defendants in the ongoing Frasco v. Flo Health, Inc....more

Constangy, Brooks, Smith & Prophete, LLP

California limits certification, revealing challenges for litigating privacy cases

In the recent high-profile civil class action, Frasco v. Flo Health, a California federal court issued a significant ruling partially certifying a nationwide class and California subclass of individuals who used the Flo...more

Fenwick & West LLP

NY Tech Week 2025: The Future of Femtech

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Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more

Cimplifi

Going Mobile: Data Discoverable on Mobile Devices

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If you ask most legal professionals about discovery of data from mobile devices, the discussion typically turns to text messages. However, there are several other data types unique to mobile devices that are not only...more

Ballard Spahr LLP

Michigan Legislature Introduces Reproductive Health Privacy Bill

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On November 7, 2024, Michigan lawmakers in the Senate introduced the Reproductive Data Privacy Act (“RDPA”), also known as Senate Bill 1082 (SB 1082).  The bill aims to strengthen privacy protections for sensitive...more

Paul Hastings LLP

New CPPA Regulations for Data Brokers and ADMT Rulemaking Package Advance

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On November 8, 2024, the California Privacy Protection Agency (CPPA) Board voted to adopt new regulations for data broker registration requirements. The CPPA Board also voted to advance proposed rules for insurance companies,...more

Baker Botts L.L.P.

California Extends Privacy Law to Cover Neural Data

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On September 29, 2024, California took a significant step forward in data privacy protection by passing a law that extends the California Consumer Privacy Act (CCPA) to cover neural data—brain activity and related information...more

Bricker Graydon LLP

AI and Healthcare: Decoding the Latest 1557 Non-Discrimination Regulations

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Section 1557 of the Affordable Care Act (ACA) prohibits providers and health plans that receive reimbursement from the federal government from discriminating against individuals in the Covered Entities’ health programs. Such...more

BCLP

Navigating the FemTech Regulatory Landscape: Best Practice & Future Developments

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The stakes are high for FemTech – as Benjamin Franklin noted: ‘it takes many good deeds to build a good reputation and only one bad one to lose it.’...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

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Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

BakerHostetler

Diving Deeper into the Revised Health Breach Notification Rule

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As we previously reported, the Federal Trade Commission (FTC) recently announced its final changes to the Health Breach Notification Rule (HBNR), vastly expanding the scope of the Rule’s coverage....more

Akerman LLP

FTC’s Updated Health Breach Notification Rule Puts Health App Developers on Notice

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The Federal Trade Commission’s (FTC) years-long effort to modernize its Health Breach Notification Rule (HBNR) in the midst of a swiftly changing technological landscape appears to be coming to an end. On Thursday, May 30,...more

BakerHostetler

FTC Vastly Expands Reach of the Health Breach Notification Rule

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On April 26, the Federal Trade Commission (FTC) announced its final rule (Final Rule) making changes to the Health Breach Notification Rule (HBNR)....more

BCLP

What is FemTech and How Can It Meet the Privacy Needs of Its Users?

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In part one of our series "FemTech: how this growing industry can build trust, protect privacy and redress healthcare inequity… one app at a time", we take an introductory look at the industry, and offer some...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

Bodman

Legal Restrictions on Health Information – Beyond HIPAA

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Appropriately so, providers look first to the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA), to ensure that they comply with regulations regarding patients’ protected health information...more

Fox Rothschild LLP

The FTC is Looking to Protect Health Information… and More

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The Federal Trade Commission has published a detailed blog post on health information, setting the stage for future enforcement … and not just regarding health information. There is some eye opening takeaways in it, making...more

Epstein Becker & Green

FTC Highlights Risks to Data in a Post-Dobbs World

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The 21st Century digital age has provided women with numerous sexual and reproductive health tools that track periods, ovulation, and pregnancy. By simply plugging certain health data inputs into these apps, women can now...more

Sheppard Mullin Richter & Hampton LLP

FTC Proposes Changes to Health Breach Notification Rule Clarifying Application to Health and Wellness Apps

In May, the Federal Trade Commission (“FTC”) proposed changes (the “Proposed Rule”) to the Health Breach Notification Rule (the “Rule”), which, among other items, emphasize that the Rule applies to mobile health applications...more

Orrick, Herrington & Sutcliffe LLP

DOJ and FTC crack down on deceptive claims for healthcare corporation

On June 23, the DOJ and FTC announced the government has obtained substantial injunctive relief, and that the department will collect $100,000 in civil penalties, from an Illinois-based healthcare corporation pursuant to a...more

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