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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Additional Business Intelligence Offerings
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
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
Genomic Markers May ID Risk of Chemo Side Effects
From - Diagnostic Testing & Emerging Technologies
While much attention is focused on using genomic markers to target the effectiveness of treatments, simultaneous research is exploring use of genomic markers to…
Abbott and Alere Reach New Deal Terms
From - Laboratory Industry Report
Abbott's deal to acquire Alere is back on. Both companies announced Friday, April 14, 2017, that they will move forward with the deal and have revised its terms…
Test Kits Included in Class 1 Devices Exempt from 510k Filing
From - National Intelligence Report
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks that…
Screening Test Use Up After ACA
From - Diagnostic Testing & Emerging Technologies
There was an uptick in preventive screening after enactment of the Affordable Care Act (ACA), yet cancer-screening rates in the United States remain below…
Avoid Liability for Commission-Based Marketing Arrangements
From - G2 Compliance Advisor
Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on…