Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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 Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
OCR Cracks Down on Right of Access Foot Dragging
Thanks to recent federal enforcement initiatives, prompt response to patient PHI requests should be a growing priority for HIPAA compliance.
Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry
This month’s roundup includes the continued court battle between BGI and Illumina, an FCA lawsuit, and the latest version of OSHA’s COVID-19 rule.
Ellume Faces Lawsuit for Not Refunding Costs of Recalled COVID-19 Tests
Company involved in recent Class 1 recalls of COVID-19 rapid tests now faces further fallout by not refunding customers for faulty tests.
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.
