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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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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Data Breaches Leave Labs and Patients Exposed
From - National Intelligence Report
Two recent data breaches at major labs may have compromised the personal health information of approximately 19.6 million patients…
Investment Returns on the Federal Enforcement Dollar Continue to Drop
From - Laboratory Industry Report
The business of enforcing federal health care fraud laws isn't as robust as it used to be. While revenues have…
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Business Trends: Commercial Testing Companies ‘Sell’ Health Screenings
From - Laboratory Industry Report
Several companies market an array of preventive tests directly to consumers. Are these companies and tests legit? What does…
HIPAA: New HIPAA Penalties System Rewards Labs that Try to Comply
From - National Intelligence Report
New HHS rules significantly increase the amount of money your lab can save by making diligent and demonstrable efforts to prevent HIPAA violations even when…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
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Maryland Hospital Fined $457.2K for Free Support Services Kickbacks
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FDA Watch: Agency Issues New Guidance on Biotin Interference Testing
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Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
The strategic deal making pot continues to boil, despite the relative inactivity of the established market leaders like Quest, LabCorp and Abbott. Here's a look at…