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
Genomic Data Improves Pediatric Cancer Management
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Geochemical Assay Proving Useful as Real-Time Marker of Bone Change
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Feds, Private Actors Increasing Scrutiny of Anti- Competitive Activity
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DOJ Memo Emphasizes Focus on Individual Liability for Corporate Misconduct
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Most Hospital Labs Shut Out of PAMA Reporting Requirements
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CMS Releases Proposed Rule Implementing PAMA
By Kelly A. Briganti, Editorial Director, G2 Intelligence The Centers for Medicare & Medicaid Services (CMS) will publish a proposed rule in the Oct. 1 Federal Register implementing the Protecting Access to Medicare Act of 2014 (PAMA) and requiring Applicable...
NeoGenomics Launches New FISH Test for Abnormal Pap Smears
By Ron Shinkman, Editor, Laboratory Industry Report Florida-based molecular laboratory NeoGenomics has introduced a new test focused on providing more diagnostic information for women who have abnormal pap smears. The test, known as the NeoSITE Cervical Assay, is...
Latest IOM Quality Chasm Series Report Targets Diagnostic Errors
By Kelly A. Briganti, Editorial Director, G2 Intelligence What the Institute of Medicine (IOM) did for the discussion of medical errors in its To Err is Human report, it now seeks to do for diagnostic errors with the latest installment of its Quality Chasm Series...