Category: Laws & Regulations

Laws & Regulations

Telemedicine Legal Update 2020

A healthcare attorney outlines sleep telemedicine and telehealth reimbursement issues, licensure, common requirements, and more.

Laws & Regulations

FDA Warning Letter: EPAP Mask Maker Is Misbranding Its Snoring Device

CPAPNEA Medical Supply has a cleared 510(k) for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults, states the FDA in a warning letter.Your device is misbranded under section...

Laws & Regulations

Mylan Launches Generic of Nuvigil Tablets

Mylan NV on June 1 announced the US launch of Armodafinil tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon’s Nuvigil. Mylan received final approval from the Food and Drug Administration (FDA) for its...

FDA

Public Notification: U-Dream Full Night Contains Hidden Drug Ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use U-Dream Full Night, a product promoted and sold as a sleep aid on various websites, as an FDA aboratory analysis confirmed that U-Dream...

Patient Rights, Privacy

Police Arrest Pasco County Sleep Technician for Sexual Assault

The incident was captured on surveillance camera inside the sleep lab, reports WFTS Tampa Bay.One victim reported to police that she woke up to Chickoree washing her feet, then moving his hands up her leg.Get the full story at...

Medicare & Medicaid

CMS: Oral Appliances Made from Digital Scans Now OK for Medicare Beneficiaries

After requests from dental sleep medicine practitioners, the Centers for Medicare and Medicaid...

Fraud & Malpractice

Medical Malpractice Insurer: Inadequate Pre-Op Assessments Create Risks for Anesthesiologists

When reviewers identified inadequate histories and physicals, 67% of those patients were found to...

Financial

Without Determining Liability, Jazz Pharmaceuticals Agrees to Pay $57 Million to Resolve US Government Allegations that It Paid Kickbacks Through Copay Assistance Foundation

Jazz Pharmaceuticals plc has agreed to pay $57 million to resolve allegations it violated the False Claims Act by illegally paying the Medicare or Civilian Health and Medical Program (ChampVA) copays for its own products,...

Commercial Transportation

Drowsy Driving: Car Camera System Could Help Keep Drivers Awake at the Wheel

A new artificial intelligence (AI) system will detect when a driver becomes too drowsy to safely drive a vehicle, reports CNN Business.As of 2022, new safety technologies will become mandatory in new European vehicles, including...