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

Start your Free trial Today

Already a Subscriber? Log in Here

Lab Industry Advisor Subscription

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.

Additional Business Intelligence Offerings

Clinical Diagnostics Insider

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

Virtual Events & Webinars

Virtual events & webinars offer a variety of solutions and strategies for dealing with key issues labs face.

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.

Compliance Concerns: Laboratory Regulations in 2024 and Beyond

By Michael Schubert, PhD | Jan 7, 2025

Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025

Two laboratorians in white lab coats work together at a bench. One sits at a microscope with a box of glass slides, holding one in her hand. The other is supervising, with a laptop open in front of him; he has a document folder in one hand and a pen in the other.

Out with the Old: The 2024 Clinical Lab Experience

By Oscelle Boye, MBiomed | Jan 7, 2025

What challenges and opportunities affected the experience of medical lab professionals in 2024—and what might the new year bring?

A group of lab technicians, with a mix of genders and ethnic backgrounds, stand focused as they use a digital tablet to review data while engaging with sample analysis equipment in a bright laboratory setting.

FDA Watch: How Could the Change in US Government Affect IVDs and Labs?

By Rachel Muenz | Jan 6, 2025

Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing

Diagnostics Pipeline: 2024 Trends in FDA Approvals

By Rachel Muenz | Jan 6, 2025

In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests

A laboratory professional removes a test tube of blood from a rack on a lab bench, illustrating the concept of lab tests involving blood.

2024 Laboratory Reimbursement Trends and What to Expect in 2025

By Tara Cepull, MA | Dec 18, 2024

Revenue cycle management experts weigh in on the biggest developments of 2024 and how labs can best prepare for 2025 and beyond

A laboratory professional interacting with medical icons coming out of a tablet interface, conceptualizing healthcare cybersecurity and laboratory test reimbursement.

Labs in Court: A Full Circle

By Danielle H. Tangorre, Seth B. Orkand | Dec 18, 2024

Cases filed or resolved by the U.S. Department of Justice in the fourth quarter reveal the same compliance issues from early in 2024

A closeup of a female doctor typing on a laptop with a checklist on the screen, illustrating the concept of ordering laboratory tests.

Staffing: 2024’s Biggest Lab Operations Challenge

By Michael Schubert, PhD | Dec 18, 2024

ADLM president Anthony Killeen looks at labs’ staffing struggles in 2024 and what can be done to alleviate them in the coming year

An image of several clinical laboratory scientists in lab coats, hairnets, masks, face shields, and nitrile gloves. A laboratorian in the foreground is working on a laptop; behind her is another using a microscope; two more are partially visible in the background.

Digital Pathology and AI: Now and in 2025

By Michael Schubert, PhD | Dec 18, 2024

Experts Nathan Buchbinder and Julianna Ianni discuss digital pathology and AI trends in 2024—and what the next year may hold

A female laboratory professional pipettes at a lab bench with a microscope, rack of test tubes, and monitor displaying digital pathology images nearby.

A Closer Lab-Patient Connection

By Oscelle Boye, MBiomed | Dec 17, 2024

Patient access to data from the clinical lab is increasing. What does this mean for those generating it?

An illustration of a male patient interacting with a female laboratory professional on a laptop.

New and Improved: The Latest Research in Disease Screening

By Michael Schubert, PhD | Dec 17, 2024

New ideas and innovations look beyond conventional screening options to facilitate improved disease diagnosis and patient outcomes