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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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.

Strategic Alliances, Partnerships & Collaborations Analysis – October 2019

By Glenn S. Demby | Oct 31, 2019

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FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials

By Glenn S. Demby | Oct 31, 2019

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final guidance allowing companies to submit for simultaneous review for the clinical trial.

The DX Pipeline: A roundup of the month’s key new product launches

By Glenn S. Demby | Oct 31, 2019

With 10 days still left to run, October was shaping up to be the busiest month of 2019 for new product launches. Here’s a summary of the key diagnostic products unveiled so far:

Compliance Perspectives: Using Document Management Systems to Avoid HIPAA Pitfalls

By Glenn S. Demby | Oct 30, 2019

By Andreas Rivera bio
Record-keeping can be one of the most stressful aspects of running a healthcare business since privacy compliance is scrutinized in healthcare more than any other industry.
Anyone with experience in the healthcare industry knows that violating HIPAA comes with steep penalties…

. . . read more

Federal Court Dismisses Urine Drug Test False Billing Claim

By Glenn S. Demby | Oct 30, 2019

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Enforcement Trends: New Takedown Is Evidence that Genetic Testing Has Become an Enforcement Priority

By Glenn S. Demby | Oct 29, 2019

It’s a pretty good sign that fraudulent billing of genetic lab testing has become a priority for federal fraud enforcers when it gets its very own “takedown.”