FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
Labs in Court: A Focus on Individual Accountability
Recent False Claims Act settlements underscore the government’s emphasis on individual accountability in healthcare fraud matters
Keeping Your AI Tools Safe
The potential occupational safety pros and cons of artificial intelligence implementation into the clinical lab
Expert Q&A: Quality, Proficiency, and CLIA Updates
Lighthouse Lab Services chief quality officer Anna Hill offers advice on keeping your lab compliant with the latest CLIA changes.
Transitioning the Clinical Lab
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
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
Special Report: The Lab Kickback Risks of “Freebies”
How to avoid six common compliance risks involving free supplies, equipment, software, and other non-monetary compensation
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
