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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
UnitedHealthcare Expands Coverage of Genetic Cancer Tests
The health plan issued a new policy expanding coverage of molecular genetic tests for personalized cancer diagnosis, prognosis, and treatment.
Partnership to Promote Multi-Ancestry PRS Breast Cancer Testing
Genomics software developer Allelica to collaborate with Taiwanese precision medicine firm to develop a multi-ancestry breast cancer test.
Lab Industry Earnings Take a Beating in the Fourth Quarter
Drying COVID-19 testing demand drove revenues down, but not as much as expected.
How to Reduce Liability Risk for Lab Sales and Marketing
A code of conduct for sales and marketing staff is essential to allow staff to do their jobs while avoiding liability risk.
How to Explain the Current State of EKRA to Your Lab Executives
How to explain the current state of EKRA to your lab executives.
March 2023 Labs in Court: Labcorp Wins One, Settles Another
In this month’s roundup of cases involving labs, Labcorp gets one lawsuit tossed and settles another.
Six Steps for a Bloodborne Pathogens Exposure Determination
The first phase in protecting your staff is to carry out an exposure determination to figure out which of your workers are at risk.
Model Code of Conduct for Laboratory Sales and Marketing
A template for creating a general code of conduct that sets out broad parameters and ground rules for compliance.
Six Lab Sales and Marketing Compliance Problem Areas and How to Address Them
It’s imperative for labs to establish and maintain an active corporate compliance program that augments the actual scientific testing.
Developing an Automated HIV Self-Test for Use in Developing Countries
Principal investigator discusses a new research initiative to create a low-cost, rapid HIV self-test.
