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
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…