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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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
Investment Trends: Venture Capitalists Remain High on Healthcare
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Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
After last month's flurry of transactions, business calmed down as it often does during the start of summer. Here are the key deals and trends from…
Urinary cfDNA Analysis Valuable for Urinary Tract Infections
From - Diagnostic Testing & Emerging Technologies
Sequencing of urinary cell-free DNA (cfDNA) offers a comprehensive examination of bacterial and viral infections of the urinary tract and could be…
Are Genetic Testing Labs Liable for Medical Malpractice?
From - National Intelligence Report
Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth…
The 10 Policies You Need to Stop Lab Employee PHI Breaches
From - G2 Compliance Advisor
Safeguarding personal health information (PHI) data from hackers, identity thieves and other cyber threats isn't just a legal obligation but…
PAMA Unlocks Golden Age for Innovative Diagnostics
By Chance Scott bio
The publication of the 2018 Clinical Laboratory Fee Schedule (CLFS) in January saw a long and heated debate within the lab community come to fruition…
Insurer Accuses Florida Lab, California Hospital of Toxicology Test Billing Fraud
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HIV Testing Opportunities Missed For High-Risk Patients
From - Diagnostic Testing & Emerging Technologies
There are many missed opportunities for testing and diagnosis of HIV among high-risk individuals seen in clinical settings…
Case of the Month: Jury Socks HDL Blood Test Fraud Principles with $114.1 Million Verdict
From - G2 Compliance Advisor
Roughly three years ago at this time, mega-scandals were in the news featuring diagnostic giants like Millennium, Health Diagnostic Laboratory (HDL), Biodiagnostic Laboratory Service and…
DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings
From - Laboratory Industry Report
One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs…