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
FDA Reclassifies Rapid Flu Antigen Tests
From - Diagnostic Testing & Emerging Technologies
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used…
AACC Collaborates on Adaptive Learning Resource
From - Laboratory Industry Report
Laboratory professionals will now have a new tool in the search for knowledge. The American Association for Clinical Chemistry, the NEJM Group, and Area9 Learning are joining forces to…
Brief Your CEO about Individual Liability
From - G2 Compliance Advisor
False Claims Act (FCA) and Anti-Kickback (AKS) prosecutions against labs are just two ways the US Justice Department cracks down on…
Five Things Labs Need to Know About the Trump Travel Ban
From - G2 Compliance Advisor
We'll leave it to others to argue whether it's legal, moral or wise. What we can tell you is that President Trump issued an Executive Order Jan. 27, 2017, establishing a…
Health Care Fraud and Abuse Program Faces Declining ROI
From - National Intelligence Report
The federal government's return on investment (ROI) in the fight against health care fraud continues a steady decline according to the latest numbers reported for the Health Care Fraud and…
Diagnostics Sector Reports 4Q Earnings
From - Laboratory Industry Report
Fourth quarter earnings reports are starting to trickle in. Here is a big picture roundup of some of the key results so far…
Preemptive PGx Testing Gaining New Momentum
From - Diagnostic Testing & Emerging Technologies
The application of pharmacogenomics (PGx) into routine, clinical care remains very limited, despite its potential to improve drug and…
Theranos Faces Potential Consumer Fraud Litigation
From - National Intelligence Report
The Arizona Attorney General's Office (AGO) recently issued a request for proposal signaling a new legal battle for Theranos…