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.

Molecular Mysteries in the Blood

By Michael Schubert, PhD | Aug 29, 2024

The current landscape of molecular hematopathology—and what steps clinical labs can take to stay at the forefront of the discipline

Artist’s representation of molecular hematopathology showing a geometric drop of blood containing a DNA double helix.

The Latest Developments in Liquid Biopsy and ctDNA Testing

By Oscelle Boye, MBiomed | Aug 28, 2024

The latest developments in liquid biopsy and ctDNA testing and why they should be of interest to clinical laboratory professionals

Illustration of red blood cells and cancer cells to represent the concept of ctDNA testing.

Loper Bright and the Potential Impact on the Laboratory Industry

By G2 Intelligence Staff | Aug 27, 2024

This webinar explains how Loper Bright could impact the laboratory industry and what it means for clinical lab operations

Oncology LDTs: How Cancer Labs Can Best Navigate the FDA’s Final Rule

By G2 Intelligence Staff | Aug 21, 2024

This webinar shares how the FDA's final rule applies to oncology LDTs and what it means for precision medicine efforts

Key Developments and Challenges in Laboratory Networks

By Rachel Muenz | Jul 30, 2024

The current landscape of medical laboratory networks and challenges that will need to be addressed to improve data sharing and efficiency.

An image of a healthcare professional in business attire working on a laptop, with a graphical overlay of medical icons and lines representing a healthcare network concept.

Dx Deals: Outreach Deals by Quest, Labcorp Are Still Ramping Up

By Ron Shinkman | Jul 24, 2024

Though the two national players have closed dozens of such deals over the past decade, much runway for new transactions apparently remains

A closeup of two businesspeople shaking hands in an office with a graphical overlay of various types of charts and graphs, illustrating the concept of business deals.

Electronic Device Use in the Laboratory: The Keys to Safety

By Dan Scungio, MLS (ASCP), SLS, CQA (ASQ) | Jul 24, 2024

Three main risks to consider when it comes to personal electronic devices, and how to safely incorporate their use in the laboratory

Female scientist wearing a lab coat and nitrile gloves is working with a digital tablet and stylus in the laboratory.

Considering the Impact of Digital Pathology on Recruitment Efforts

By Tara Cepull, MA | Jul 24, 2024

How might a modestly sized lab or pathology group harness technology to address their recruitment needs?

Female medical worker doing video call via a laptop at her desk in the laboratory, illustrating the concept of remote laboratory recruitment.

August 2024 Labs in Court

By Karen Lovitch, Jane Haviland | Jul 24, 2024

COVID-19-related schemes dominated recent enforcement efforts, which include a national healthcare fraud enforcement action

A closeup of a laboratory professional in a darkened laboratory holding up two test tubes at a bench with a rack of more test tubes, illustrating a COVID-19 testing concept.

FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?