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
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Top of the News: Early Results Show Blood Test’s Effectiveness in Early Alzheimer’s Detection
From - Diagnostic Testing & Emerging Technologies
Developing a cost-effective blood test capable of accurately detecting early Alzheimer's disease that can be…
Pennsylvania M.D. Used Addiction Clinics as Front for Opioid Scheme
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ACLA Court Win May Tip the Battle Over PAMA Pricing
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Data Breaches Leave Labs and Patients Exposed
From - National Intelligence Report
Two recent data breaches at major labs may have compromised the personal health information of approximately 19.6 million patients…
Investment Returns on the Federal Enforcement Dollar Continue to Drop
From - Laboratory Industry Report
The business of enforcing federal health care fraud laws isn't as robust as it used to be. While revenues have…
Nonculture Molecular Tests Speed Diagnosis of Bloodstream Infections
From - Diagnostic Testing & Emerging Technologies
The T2Bacteria Panel (T2Biosystems; Lexington, Mass.) can rapidly and accurately diagnoses bloodstream infections (BSIs) caused by…
New York Breaks Up $28 Million Medicaid Diagnostics Mill
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Earning our Spot on the Patient-Centered Care Team
By Jennifer Dawson, MHA, FACHE, CPHQ, LSSBB, DLM(ASCP)SLS, QIHC, QLC bio
There is a lot of talk these days about integrating the laboratory into patient-centered care teams1 and about forming…
Business Trends: Commercial Testing Companies ‘Sell’ Health Screenings
From - Laboratory Industry Report
Several companies market an array of preventive tests directly to consumers. Are these companies and tests legit? What does…
HIPAA: New HIPAA Penalties System Rewards Labs that Try to Comply
From - National Intelligence Report
New HHS rules significantly increase the amount of money your lab can save by making diligent and demonstrable efforts to prevent HIPAA violations even when…