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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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
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
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.
AI Combined with DM and ABUS Can Improve Breast Cancer Detection
Researchers found that combining AI with both imaging technologies can improve the detection of cancer in women with dense breasts.
Federal Court Tosses Consumer Fraud Lawsuit Against Labcorp
Not disclosing list prices of uncovered lab tests on ABN is not consumer fraud, court says.
New Breakthrough Device Designations Fall 37 Percent in 2022
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
Bringing Multi-Cancer Tests Closer to Reality
A new method for early detection of 14 cancer types based on glycosaminoglycan profiles shows promise.
USPSTF Again Declines to Recommend Lipid Screening for Asymptomatic Children
The panel recently said there was still not enough evidence to properly assess the harms and benefits of such screening.