Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
- Healthcare-related laws
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- Business deals in the diagnostics space, and more
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
The New Overtime Rules are Put on Hold. What Does That Mean for You?
By Mike O'Brien bio
As most of you know by now, I'm sure, the United States Department of Labor (DOL) has finalized a new Fair Labor Standards Act (FLSA) rule that, among other things, raises the minimum salary threshold required to qualify for…
Budget Blueprint: Funding for Tech Down But Increases for Enforcement
From - National Intelligence Report
The headlines are harsh. "Terrible," devastating," and "crippling," are words the biomedical industry is using to describe…
CMS, OIG Reps Address Attendees at ACLA Annual Meeting
From - G2 Compliance Advisor
At the American Clinical Laboratory Association annual meeting in Washington, D.C. March 23, representatives of the Centers for Medicare & Medicaid Services (CMS) and the…
NGS Clinically Useful for Pediatric Cancers
From - Diagnostic Testing & Emerging Technologies
The Precision in Pediatric Sequencing (PIPseq) Program at Columbia University Medical Center released data on its first…
Strategic Alliances Promote Test Access and Development
From - Laboratory Industry Report
In the early months of 2017, the diagnostic industry has seen several strategic alliances develop.
Among the most active companies…
Wellness Program Bill Threatens Privacy of Genetic Test Results
From - National Intelligence Report
A new bill promoted as supporting workplace wellness programs has met with significant backlash, criticized as forcing employees to give their employers…
Hologic Sells Blood Screening Business
From - Laboratory Industry Report
During a slow month for diagnostic M&A activity, a noteworthy deal was the closing of Grifols's acquisition of Hologic's blood screening business. The acquired assets include…
OSHA Fines Address Bloodborne Pathogen and Violence Hazards
From - G2 Compliance Advisor
Case: OSHA fined a Pennsylvania mental health hospital $32,158 for a trio of safety violations, including failing to protect nurses, medical technicians and other…
Joint Guideline Issued for CRC Molecular Testing
From - Diagnostic Testing & Emerging Technologies
A joint guideline from the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and…
TOOL: Model HIPAA Breach Notification Letter to Patient
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