Category: Laws & Regulations

Laws & Regulations

Participant Screening Begins for Phase 2 Study of Novel OSA Therapy

Incannex Healthcare has initiated screening for its DReAMzz dose confirmation study evaluating IHL-42X for obstructive sleep apnea.

Laws & Regulations

Sleep Physician Sentenced to Prison for Altering Recalled CPAPs

He was sentenced to over a year in prison and ordered to pay restitution for manually removing foam from recalled devices and billing them to Medicaid as new.

Laws & Regulations

FDA Updates Injury, Death Reports from Ventilator Inoperative Alarm-Related Recall

The recall involves correcting devices and does not involve removing them from where they are used or sold.

FDA

FDA Issues Draft Guidance on AI Use in Drug and Biologic Development

The FDA’s draft guidance provides a framework for assessing the credibility of AI models used to support regulatory decisions for drug and biologic submissions.

Patient Rights, Privacy

Lawsuit Alleges Secret Bathroom Videotaping at Sleep Disorders Center

The lawsuit claims that hidden cameras were placed in restrooms at a New York sleep disorders center, capturing patients, staff, and visitors without their knowledge.

Medicare & Medicaid

Medicare Advantage Plan Adds Oura Ring to Member Benefits

Starting in 2025, certain Essence Medicare Advantage members will have the option to receive a complimentary Oura Ring and a subscription to the Oura App.

Fraud & Malpractice

California Man Sentenced to Prison for $1.5M Sleep Study Fraud Scheme

A former Fresno sleep clinic owner was sentenced to nearly four years in prison for fraudulently billing Medicare and Medi-Cal for thousands of sleep studies that were never performed on patients.

Financial

Daybreak Now Accepting CareCredit

The CareCredit health and wellness credit card is now accepted as a payment option for Daybreak's sleep testing kits and oral appliance.

Commercial Transportation

The Probable Cause of Cindy B Maritime Accident Is Sleep-Related

The National Transportation Safety Board published its accident report on the contact of Cindy B tow with a dock in Oregon.