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
Digital Pathology and AI: Now and in 2025
Experts Nathan Buchbinder and Julianna Ianni discuss digital pathology and AI trends in 2024—and what the next year may hold
A Closer Lab-Patient Connection
Patient access to data from the clinical lab is increasing. What does this mean for those generating it?
New and Improved: The Latest Research in Disease Screening
New ideas and innovations look beyond conventional screening options to facilitate improved disease diagnosis and patient outcomes
A Lasting Impact: COVID-19 and Cancer Screening
Several years after the onset of the COVID-19 pandemic, labs are still dealing with the effects of missed and delayed screenings
Lab Data’s New Role as the Backbone of AI-Driven Clinical Trials
Learn how research and development labs can leverage AI to transform laboratory data into actionable insights
FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Labs in Court: A Focus on Individual Accountability
Recent False Claims Act settlements underscore the government’s emphasis on individual accountability in healthcare fraud matters
Keeping Your AI Tools Safe
The potential occupational safety pros and cons of artificial intelligence implementation into the clinical lab
Clinical Lab Data: Unlocking Profit Potential for Health Systems
How labs can better use their valuable data and highlight that data’s benefits to the health systems they serve
Common OSHA Violations: What Could Go Wrong?
What lab safety violations are most common? What happens when lab safety is overlooked? And how can your lab avoid becoming a statistic?
