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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
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…
Deal of the Month: $25 Billion Acquisition of St. Jude Med Cements Abbott as Leader in Cardiovascular Device Market
From - Laboratory Industry Report
In a month with an unusually heavy volume of diagnostic deal making, the headline story was Abbott Laboratories' $25 billion purchase of…
10 Things to Include in Your HIPAA Breach Notification Policy
From - G2 Compliance Advisor
Earlier this month we told you about a $475,000 settlement one provider reached in a HIPAA breach notification case. Privacy lapses can occur despite…
Updated TB Guidelines Recommend Newer Tests
From - Diagnostic Testing & Emerging Technologies
Patients at risk for tuberculosis (TB) infection should be assessed with newer tests, including interferon-gamma release assays (IGRAs) and molecular diagnostics, according to…