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
DX Earnings Report: PAMA Cuts Make Little Dent on Q1 Lab Earnings
From - Laboratory Industry Report
One quarter into its existence, the new PAMA Medicare Part B fee schedule seems to be having only a marginal impact on at least publicly traded labs…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here's a rundown of the key diagnostic product launches from mid-May through the third week of June…
Early Lactate Tests Impactful, But Often Not Performed With Sepsis
From - Diagnostic Testing & Emerging Technologies
Early lactate measurements appear to improve results for patients with sepsis, but initial and repeat serum lactate levels are frequently not drawn in the recommended…
CMS Mulls Stark Law Relief: This Time It May Be for Real
From - National Intelligence Report
After decades of complaining about the Stark Law, the lab industry may now have an actual opportunity to secure meaningful relief…
Cancer Center Hit with $4.3 Million HIPAA Fine for Failure to Encrypt
From - National Intelligence Report
Case: The University of Texas MD Anderson Cancer Center was on the wrong end of the fourth largest HIPAA fine ever dished out by the HHS Office for…