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.

Essential

Insight for every clinical laboratory

Subscribe today for updates on key developments in the clinical lab industry.

Premium

Exclusive, in-depth monthly reports

Subscribe today for additional insider reports about important lab trends.

Elite

Expert analysis & technology advice

Subscribe today for quarterly expert analysis & Clinical Diagnostics Insider.

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Clinical Diagnostics Insider

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.

What Labs Need to Know About Reporting Adverse Events to the FDA

By Tara Cepull, MA | Nov 1, 2024

Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events

Closeup of a laboratory professional in PPE sitting at a desk with a computer monitor and filling out a form on a clipboard.

Meeting the Needs of Laboratory Learners

By Michael Schubert, PhD | Nov 1, 2024

The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals

AI in Health Care: Balancing Benefits and Barriers

By Michael Schubert, PhD | Oct 30, 2024

AI can help alleviate the burden on clinical labs—but only with sufficient investment, enthusiasm, and understanding

Background photo showing medical record changing from paperwork to electronic medical record.

Esophageal Pre-Cancer Testing Gaining Greater Traction

By Ron Shinkman | Oct 29, 2024

How three companies are addressing screening challenges with tests that help improve chances of early detection

An elderly male patient holds a hand to his throat as he speaks with his doctor, illustrating the concept of throat problems and potential esophageal cancer.

Computing the Future of the Lab

By Michael Schubert, PhD | Oct 28, 2024

Computational biology expert Keaun Amani shares his advice and insights on AI and machine learning tools for the clinical lab

neuron 3D illustration, illustrating convolutional neural networks concept.

Dissecting the Data Behind Healthcare AI

By Oscelle Boye, MBiomed | Oct 28, 2024

How do the underlying datasets affect artificial intelligence tools’ performance in the lab—and beyond?

A wire frame image of a female face with various healthcare-related icons in front of it, illustrating a healthcare AI concept.

Labs in Court: Two EKRA-Related Cases and Some Usual Suspects

By Danielle Sloane, Morgan Tandy | Oct 28, 2024

Recent enforcement actions involved usual targets such as COVID-19, genetic, and urine drug testing, but EKRA also made an appearance

A judge’s gavel sits on a lab bench next to racks of test tubes and a pair of safety glasses, illustrating legal issues related to laboratories.

Dx Deals: Labcorp Acquires Stake in European Testing Giant

By Ron Shinkman | Oct 28, 2024

$152.1 million SYNLAB deal is expected to create a new channel for Labcorp to market its sophisticated specialty assays

A doctor stands next to a microscope with a European Union flag, graphs, and DNA helix in the background, illustrating the concept of diagnostics industry deals in the EU.

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