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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Launches Free Medicare Coverage of OTC COVID-19 Rapid Antigen Tests
Starting April 4, Medicare beneficiaries can get eight free tests per month for each month the public health emergency remains in effect.
Lawmakers Squabble as Country Runs Out of COVID-19 Response Money
The relief package agreed to on April 4 appears to have become a collateral victim of a politically incendiary issue regarding immigration.
It Was All Elizabeth Holmes’ Fault, Sunny’s Lawyers Claim
amesh “Sunny” Balwani’s legal team makes the case that Holmes is solely responsible for Theranos misdoings.
Don’t Drag Your Feet When Responding to HIPAA Right of Access Requests
The Biden administration OCR has now issued 13 right of access fines, including a whopping $160,000 penalty.
New Cancer Consortium Aims to Improve Access to Precision Diagnostics
Collaboration between several key pharmaceutical companies looks to remove barriers for cancer patients to improve treatment selection.
FDA Issues First Ever Approval for a COVID-19 Breathalyzer
The FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
Labs in Court Weekly Roundup
All of last week’s key cases announced by the DOJ involving the health care industry related to companies settling false claims-related allegations.
Annual Screening for Breast Cancer Survivors Is Declining
Recently published research shows that annual mammography rates for survivors aged 40 to 64 have been dropping since 2009.
False Billing of Urine Drug Tests Costs NC Lab $11.6 Million
Radeas LLC is also required to enter into a five-year corporate integrity agreement as part of the settlement.
Mastermind or Swindled Shareholder? The Balwani Trial Continues
Prosecution insists that Holmes and Balwani were “partners in everything, including their crimes.”