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
How to Create an Enhanced Cleaning and Disinfection Policy
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The Evolving COVID-19 Market: FDA Clears the Way for Asymptomatic Screening Products
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Despite Improvements, Supplies Shortages Continue to Hinder COVID-19 Testing
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A roundup of recent cases and enforcement actions involving the diagnostics industry
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The HDL Saga Continues with $114 Million Verdict against Lab’s CEO and Marketing Principles
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COVID-19 Surge Lifts Overall Molecular Point of Care Testing Market to $900 Million
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Price Transparency: 2 of 3 Hospitals Not Complying with New CMS Disclosure Rules, Study Finds
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Medicare Medical Necessity Denials and How Your Lab Can Prevent Them
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Brief Your CEO: New OCR Data Shed Light on the Costs of Privacy Noncompliance
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EHR Technology Vendor Settles Kickback Charges for $18.25 Million
Case: Athenahealth Inc., a Massachusetts-based EHR software vendor has agreed to fork over $18.25 million to settle charges of paying kickbacks to generate sales. The DOJ complaint cites three marketing programs that allegedly crossed the line: A “Concierge Events”...