FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
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Articles and Reports
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
Protect Your Lab against HIPAA Right of Access Liability Risks
Key points to educate your staff on when it comes to patient requests for test records and other protected health information.
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
In this month’s key cases, Myriad Genetics shells out, Illumina wins a decisive victory, a whistleblower suit is tossed, and false billing of UDTs costs a lab at least $11.6 million.
A Model Script to Help Avoid HIPAA Right of Access Violations
This script helps prepare frontline staff to answer questions that patients seeking access to their PHI are likely to ask.
Who’s Allowed to Bill for Laboratory Reference Testing?
An overview of the rules and requirements to help you keep your reference laboratory billing arrangements compliant.
Lowering the Boom on COVID-19 Relief Scammers
The DOJ recently charged 21 defendants across the US for allegedly carrying out COVID-19 scams worth just under $150 million.
Medicaid Fraud Enforcement Trends: Fewer Cases, Higher Penalties
MFCU enforcement activity has rebounded from recent declines but still hasn’t reached pre-pandemic levels, according to a recent OIG report.
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.
