How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
EKRA 101: A Brief Backgrounder and How to Stay Compliant
How the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) came to be, what laboratory leaders should know about it, and how to comply
June 2024 Labs in Court
Examining DOJ and OIG investigations of labs and their owners: Recent cases show continued focus on the usual enforcement targets.
FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Compliance Tool: Addressing EKRA When Selling Your Lab
Key steps to follow when selling your lab to ensure compliance with the Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
Why You Need to Address EKRA When Selling Your Lab
When selling your laboratory, in order to remain compliant with federal code, EKRA is something you will want to consider
Marketing Your Clinical Lab
Outreach and advertising can be tricky prospects for the clinical lab—but the right questions and strategies can help guide your efforts
Tool: Third-Party Risk Management Guide for Medical Labs
Key cybersecurity points to address when working with a third party that has access to protected health information
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Expert Q&A: Responding to the Change Healthcare Cyberattack
Cybersecurity expert outlines steps labs and other healthcare providers should take to prepare for future cyberattacks
Understanding and Avoiding Compliance Errors
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
