News & Analysis as of

Enforcement Actions Digital Health Healthcare

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

Clark Hill PLC on

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

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

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

Knobbe Martens on

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

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

Perkins Coie

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

Perkins Coie on

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

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