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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
NIPS Tests Are under Fire Again—This Time from the FDA
With increasing media coverage about problems with genetic non-invasive prenatal screening, the agency warns of risks of false results.
The Sun Is Setting on the Controversial SUNSET Rule
While HHS hasn’t yet officially withdrawn SUNSET, recent indications are that it’s only a matter of time.
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.