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
Federal Agencies Prepare to Battle Zika Virus in the U.S.
As spring arrives and the threat of Zika virus grows in the U.S., the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are taking action to address the virus threat. April 1, 2016, the Centers for Disease Control and...
Avoid False Claims Liability: CMS Clarifies How to Comply with 60-Day Deadline for Returning Medicare Overpayments
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FDA’s LDT Oversight Framework Could Impact 60,000+ Tests
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Make Sure Existing Compliance Policies Match Current Operations
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News at a Glance
HHS Reports Medicare Spending Declined. After announcing that the goal of linking 30 percent of Medicare payments to quality was reached months earlier than anticipated, the U.S. Department of Health and Human Services (HHS) reported that Medicare spending between...
Sequenom to Petition U.S. Supreme Court to Regain MaterniT21 Test Patent
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Mayo Clinic to Shut Down New England Laboratory
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FDA Intervenes on Development of New Zika Test
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A Slow But Growing Push for Greener Laboratories
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Patient Age Can Impact Gene Expression
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