Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
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
The Role of Advanced Molecular Diagnostics in Pathogen Detection
Explore how molecular diagnostics transform pathogen detection, providing faster, more accurate results compared to traditional testing methods
How Advances in T-Cell Receptor Profiling Can Boost Early Cancer Diagnosis
New developments in flow cytometry and molecular biology promise to improve the detection of rare cancers
Diagnostics Pipeline: Savara Introduces Blood Test to Detect aPAP, a Rare Lung Disorder
Savara’s ClearPath assay needs just a few drops of blood to test for aPAP, a condition that can be difficult and invasive to diagnose
