Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs

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Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.

Lab Industry Advisor to the Rescue! Lab Industry Advisor provides comprehensive, up-to-date insights and analyses tailored to your needs. With expert commentary and actionable advice, you’ll stay ahead of the curve. No more sifting through endless sources—everything you need is right here!

Start your free trial today and see how Lab Industry Advisor can transform your approach. Get instant access to invaluable resources designed to keep you informed and competitive. Explore detailed reports, in-depth articles, and exclusive industry insights that help you make better decisions faster. Choose from three subscription levels tailored to fit your needs: Essential, Premium, and Elite.

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Insight for every clinical laboratory

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Exclusive, in-depth monthly reports

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Expert analysis & technology advice

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Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies

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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
Healthcare-related laws
FDA approvals
Business deals in the diagnostics space, and more

Latest Articles

LDTs Rule Update: More Support for Legal Challenges Against FDA

By Rachel Muenz | Oct 10, 2024

Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”

A closeup of someone looking at legal documents at a desk

New FDA LDTs Guidance Offers Useful Summary, But Questions Remain

By Rachel Muenz | Jun 27, 2024

Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details

A wooden stamp lies on a red surface next to stamped white

CMS Slated to Close Change Healthcare Payment Program

By Centers for Medicare & Medicaid Services | Jun 21, 2024

Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July

A medical billing professional sits at a computer with two monitors and reads paperwork, illustrating a healthcare reimbursement concept.

Website Ad Doesn’t Bar Qui Tam Suit for Rewards Program Fraud

By Glenn S. Demby | Mar 14, 2022

A new case from the US Court of Appeals for the Ninth Circuit tests how far the public disclosure bar goes.

New Federal Prosecutor to Target COVID-19 Fraud

By Glenn S. Demby | Mar 14, 2022

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Regulatory Roundup: New laws, regulations, cases, and enforcement actions affecting labs and the lab industry

By Glenn S. Demby | Mar 14, 2022

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A closeup of a person typing at a laptop with document and court-related icons floating around them to symbolize regulations.

FDA Sounds the Warning on Use of Unauthorized SARS-CoV-2 Rapid Tests

By Glenn S. Demby | Mar 14, 2022

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An image of SARS-CoV-2 rapid tests and associated materials on a blue background.

CMS Releases the Top 10 Lab CLIA Deficiencies for 2021

By Glenn S. Demby | Mar 14, 2022

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Study Finds Screening Tool for Autism Is World’s Most Accurate

By Tania Ewing and Associates | Mar 11, 2022

Research has found an early screening tool for autism developed by La Trobe University, Australia, researchers—and already used across eleven countries—is the world's most accurate. Published in JAMA Open, the five-year study of over 13,500 Victorian children found...

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Theranos Story Gets the Miniseries Treatment on Hulu

By Rachel Muenz | Mar 11, 2022

Those who want more of the Theranos story can get their fill now that The Dropout, a miniseries starring Amanda Seyfried as founder Elizabeth Holmes, has launched on streaming service Hulu. Premiering on March 3, the series currently has a 7.4/10 rating on IMDb.com...

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Report Highlights Serious Concerns About Marketing of NIPTs

By Rachel Muenz | Mar 11, 2022

Noninvasive prenatal tests (NIPTs) have taken a lot of flak recently and now a new report is throwing more dirt on the marketing side of these tests. The Hastings Center Report study, released on March 9, assessed all English-language brochures for consumers of...