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Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Possible Job Description for a Diagnostic Health Consultant
The role at this point is theoretical, but our editors asked AI for help in drafting what the position might entail
Diagnostic Health Consultant: A New Role Proposed for the Clinical Laboratory
While still in the early stages, Clinical Lab 2.0’s pitch for this new position fits with the need to better use lab data
No Signs of the DOJ Letting Off the Pedal with Medicare Fraud Investigations
However, a new memo instructs federal prosecutors to ‘avoid overreach’ when parties cooperate with authorities
Audits, the False Claims Act and Clinical Lab Enforcement: 2025 Trends and Compliance Tips
June 11th, 1:00pm ET Significant cases decided in 2024 and 2025 are shaping the landscape of enforcement for clinical laboratories. Government regulators continue to focus on medical necessity and improper business relationships, but they have expanded their focus...
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
Dx Deals: Quest Diagnostics M&A Centers on Precision-Focused Approach
Recent inroads into testing of water for dialysis equipment illustrates Quest’s expanded scope with deals
Interconnected Clinical Lab Devices Can Increase Operational Capabilities
However, integrated technologies must take into account data protection concerns
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
