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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
Compliance Corner: Must Employee Notify Lab of DUI?
QUESTION If one of our employees gets a DUI, do they have to notify us? ANSWER It depends. EXPLANATION There are at least four factors affecting whether the employee would have to come forward and tell you about the DUI? Your HR policies: What, if anything, do your...
Marketing Pitfalls to Avoid: Deceptive Advertising—the Other Kind of “False Claims”
We all know that marketing activity is a breeding ground for potential lab liability. But while most labs are sensitive to the risks posed by the Antikickback Statute, Stark Law and False Claims Act, federal false advertising laws may fly under the radar. Here’s a...
Pay rates, vacations while recovering, gig economy
Department of Labor enters final stage of update to ‘regular rate’ rule under FLSA. As we have discussed previously in these updates, the Department of Labor has been working to update the definition
FDA Watch: Agency Resounds the Alarm on Biotin Test Interference
In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning
FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials
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, 2019, the US Food and Drug Administration (FDA) issued final guidance setting out a streamlined process that allows companies to apply
Immigration alert, social media, salary threshold, minimum wage, trafficking and more
By Mike O’Brien bio
Immigration alert—more Social Security “no-match” letters to issue this fall: The Social Security Administration (SSA) has announced its plan to mail a second set of “no-match letters” to employers this fall…