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
Special Report: The Lab Kickback Risks of “Freebies”
How to avoid six common compliance risks involving free supplies, equipment, software, and other non-monetary compensation
Tool: Third-Party Risk Management Guide for Medical Labs
Key cybersecurity points to address when working with a third party that has access to protected health information
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Expert Q&A: Responding to the Change Healthcare Cyberattack
Cybersecurity expert outlines steps labs and other healthcare providers should take to prepare for future cyberattacks
Understanding and Avoiding Compliance Errors
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Dx Deals: New Deal Expands Reach of Oral Cancer Test to Dental Practices
Recently announced collaboration between Viome and Henry Schein allows dentists to offer sample collection for Viome’s assay to patients
Key Things Labs Need to Know About the FDA’s Final LDTs Rule
This webinar will discuss steps lab leaders will need to take in the near future to ensure they are prepared for the final LDTs rule
FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Building a Home for Health Equity
The laboratory’s role in reaching underserved patient populations: an interview with Richard Levenson, Keisuke Nakagawa, and Michele Mitchell
Bringing the Lab to the Patients
Actions clinical laboratories can take to better reach underserved communities, raise the lab’s profile, and increase health equity for all
