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
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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
No One-Size-Fits-All Answer for Frequency of Billing and Coding Audits
From - G2 Compliance Advisor
The Office of Inspector General's Compliance Program Guidance for Clinical Laboratories includes among its seven elements for a comprehensive compliance program…
Trovagene and USC Collaborate on Liquid Biopsy Test
From - Laboratory Industry Report
Trovagene, the San Diego-based molecular laboratory, has entered into a deal with the University of Southern California's Norris Comprehensive Cancer Center to collaborate on creating a…
Public Comment Sought on Blood Donor Deferral Policies to Reduce HIV Transmission
From - National Intelligence Report
While the annual rate of new diagnosed cases has declined in the last 10 years, HIV still remains a significant concern. The Centers for Disease Control and Prevention (CDC) reports…
HIPAA Turns 20!
From - National Intelligence Report
It’s a milestone birthday for a law that is not generally celebrated among health care providers. The Health Insurance Portability and Accountability Act of 1996, better known as…
Lab Sector Generates Job Growth
From - Laboratory Industry Report
Laboratories have been a significant generator of jobs over the past decade, with the entire sector growing by…
Check Compliance Policies Against Current Operations
From - G2 Compliance Advisor
While labs may draft a comprehensive compliance plan and policies and procedures, those policies, procedures and plan can be a liability if…
Mass Spec Receiving Broader Application
From - Diagnostic Testing & Emerging Technologies
Mass spectrometry (MS) is rapidly transitioning from specialized clinical testing—drugs of abuse confirmations, newborn screening, and steroid analysis—to being broadly applied throughout…
Remember Compliance Risks When Hiring and Firing
From - G2 Compliance Advisor
Hiring and firing staff are difficult challenges. While there are many factors to consider in making either decision, compliance should be front of mind in…
Study Identifies Urine as Preferred Zika Sample
From - Diagnostic Testing & Emerging Technologies
Diagnosing Zika virus is challenging. While diagnosis previously relied on serology, it is difficult to differentiate Zika antibodies from other closely related viruses…
Thermo Fisher Scientific Collaborates with Chinese Hospital on Precision Medicine Platform
From - Laboratory Industry Report
In another sign of the continuing globalization of laboratory services and the allure of the world's most populous nation, Massachusetts-based Thermo Fisher Scientific has…