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
Clarisa Blattner: Could Medicare LCD Policy Be Poised for Reform?
Details behind the proposed Timely Access to Coverage Decisions Act
Clarisa Blattner: The MRD Testing Reimbursement Challenge
Why operational readiness is becoming just as important as clinical innovation
Clarisa Blattner: PAMA Reporting 2026—5 Strategic Priorities Clinical Laboratories Can’t Afford to Miss
Validating applicable laboratory status is an important first step in reporting
Expert Q&A: AMR Warnings Need to Be Louder, and It Just Can’t Be Up to Labs
John Osiecki of bioMérieux also discusses AI for outbreaks and regulation trends
Healthcare Fraud Takedown Reveals 4 Lessons for Clinical Labs
The $14.6 billion bust by federal prosecutors shows gaps that every laboratory should monitor
Could Labs Adopt a CLIA Framework for Regulating Clinical AI?
Learn how CLIA could be used as a blueprint to regulate emerging technologies in an effective and dynamic way
Dx Deals: QuidelOrtho Acquires LEX Diagnostics, Plans to Switch Out Respiratory Testing Platforms
The $100 million deal will take advantage of LEX VELO technology to detect influenza and SARS-CoV-2
Diagnostics Pipeline: Labcorp Launches Holistic Medicine Service
The company is offering whole panels and more than 1,000 assays in total to support the new products
Breath Biopsy Aims to Detect Lung Infections Early
A novel breath test that could transform Pseudomonas aeruginosa detection in cystic fibrosis patients
Future of Biomarkers in Multiple Sclerosis Care
MS expert Stephanie Buxhoeveden combines personal experience with scientific expertise to explore how biomarkers are transforming MS care
A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
