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Digital Health Enforcement Actions Mobile Health Apps

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

Burr & Forman

FTC Accelerates Enforcement Actions to Protect Consumer Digital Health Information

Burr & Forman on

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

WilmerHale

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

WilmerHale on

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

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