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Medical Devices › Food and Drug Administration (FDA) › Biometric Information

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

Ogletree, Deakins, Nash, Smoak & Stewart,...

Illinois Federal Judge Finds Another Eyewear Virtual Try-on Class Action Is Exempt Under BIPA’s Healthcare Exemption

Ogletree, Deakins, Nash, Smoak & Stewart,... on

A federal judge in Illinois recently ruled that online shoppers cannot sustain claims that a virtual try-on (VTO) tool that allegedly scans facial geometry to preview the look of sunglasses on their face violates the...more

Mintz - Health Care Viewpoints

FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies

Mintz - Health Care Viewpoints on

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 17

Spilman Thomas & Battle, PLLC on

China Passes Major Data Protection Law as Regulatory Scrutiny on Tech Sector Intensifies - A final version of the law has not been published but a previous draft included rules around requiring consent for data protection...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

Polsinelli

Mobile Health Devices and Cybersecurity: Federal Guidance for Management of Threats in Medical Devices

Polsinelli on

New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more

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