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Medical Devices › Enforcement Actions › Mobile Health Apps

Wilson Sonsini Goodrich & Rosati

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

Wilson Sonsini Goodrich & Rosati on

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

Mintz - Health Care Viewpoints

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

Mintz - Health Care Viewpoints on

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

Jones Day

New York Attorney General Announces Settlements with Three Mobile Health Application Developers

Jones Day on

New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney General's ("NY AG") March 23, 2017, announcement of settlements with three...more

Hogan Lovells

New York Regulators Lead the Charge to Fill Health Data Protection Gaps Left by Federal Law

Hogan Lovells on

New York AG Settles Data Protection Enforcement Against Mobile Health Apps - After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone...more

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