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
Choosing and Using Wisely
The value of lab test utilization management—and the ASCP’s latest best practice recommendations for effective test utilization
Assessing At-Home Testing Accuracy
Patients desire direct-to-consumer testing, but are the results this testing provides accurate and reliable?
FTC’s Ban of Noncompete Agreements Halted
With the rule recently struck down by a Texas court, how should employers, including labs, handle such agreements going forward?
Six Sigma Can Help Monitor New CLIA Proficiency Testing Changes
A PT update went into effect on January 1, focusing on revised acceptance limits, among other modifications
ProPhase Labs’ Resolution for 2025: Nail Down a ‘Liquidity Event’
The company has lost nearly $36 million since 2023, but its CEO is aggressively pursuing new revenue options
Compliance Concerns: Laboratory Regulations in 2024 and Beyond
Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025
Out with the Old: The 2024 Clinical Lab Experience
What challenges and opportunities affected the experience of medical lab professionals in 2024—and what might the new year bring?
FDA Watch: How Could the Change in US Government Affect IVDs and Labs?
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
2024 Laboratory Reimbursement Trends and What to Expect in 2025
Revenue cycle management experts weigh in on the biggest developments of 2024 and how labs can best prepare for 2025 and beyond
