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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Lab Industry Advisor Subscriptions Include
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
Compliance Perspective: How to Comply with New OSHA Electronic Injury Recordkeeping & Reporting Rules
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Testosterone Testing Rises with DTC Ads
From - Diagnostic Testing & Emerging Technologies
Televised direct-to-consumer advertising (DTCA) is associated with greater testosterone testing, according to a study published March 21 in the Journal of the American Medical Association…
Brief Your CEO: Explaining How Trump Budget Will Affect Your Lab
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Labs In Court:
A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Quest to Pay $1.15 Million Case:for Self-Disclosed CMP Violations
Quest Diagnostics, Inc., New Jersey has agreed to fork over $1.151 million for a trio of…
Diagnostics Earnings Show Gains in 1st Q
From - Laboratory Industry Report
The laboratory industry is off to a strong start in 2017. Although growth rates varied, most firms were up for the quarter. Here's an overview of 1Q 2017 based on…
Senate Renews Efforts to Reform LCD Processes
From - National Intelligence Report
Efforts to improve the local coverage determination process have been renewed with the introduction of the Local Coverage Determination Clarification Act of 2017. The proposed bill is the result of…
Will AHCA Adversely Affect Genetic Testing?
From - National Intelligence Report
While it remains uncertain what the Senate will do with the American Health Care Act (AHCA), alarm is spreading about the legislation's implications for the estimated quarter of…
The Dx Pipeline
A roundup of the month’s key new product launches
From - Laboratory Industry Report
As usual, genome and sequencing products dominated the diagnostics pipeline last month. Exceptions included rapid diagnostic testing products from…
Biomarkers Personalize PSA Screening
From - Diagnostic Testing & Emerging Technologies
Early diagnosis of prostate cancer (PCa) is marred by a lack of consensus on the best screening strategy. Prostate specific antigen (PSA) had been…
8 Tips for Investigating Sexual Harassment
From - G2 Compliance Advisor
President Trump declared April National Sexual Assault Awareness and Prevention Month. Sexual harassment is a related problem that all employers must proactively address and…