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
- 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
2016 Investments Steady, Exits Decline
From - Diagnostic Testing & Emerging Technologies
Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report…
Update: Travel Ban to be Revised
From - National Intelligence Report
Two weeks ago we explained what President Trump's executive order, otherwise known as the travel ban, could mean for labs. We also said that…
Alliance Promotes Greater Understanding of Genomics
From - Diagnostic Testing & Emerging Technologies
The case has been made repeatedly over the past few years regarding the need to increase physicians' genomics knowledge. Now, for the first time…
HHS Blocked from Enforcing Gender Identity Antidiscrimination Rule
From - G2 Compliance Advisor
Section 1557 of the Affordable Care Act bans Medicare participants from committing discrimination on the basis of…
Health Orgs Seek LDT Oversight
From - National Intelligence Report
Calling the current regulatory system for laboratory developed tests (LDTs) "inadequate and in urgent need of updating," the…
FDA Reclassifies Rapid Flu Antigen Tests
From - Diagnostic Testing & Emerging Technologies
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used…
AACC Collaborates on Adaptive Learning Resource
From - Laboratory Industry Report
Laboratory professionals will now have a new tool in the search for knowledge. The American Association for Clinical Chemistry, the NEJM Group, and Area9 Learning are joining forces to…
Brief Your CEO about Individual Liability
From - G2 Compliance Advisor
False Claims Act (FCA) and Anti-Kickback (AKS) prosecutions against labs are just two ways the US Justice Department cracks down on…
Five Things Labs Need to Know About the Trump Travel Ban
From - G2 Compliance Advisor
We'll leave it to others to argue whether it's legal, moral or wise. What we can tell you is that President Trump issued an Executive Order Jan. 27, 2017, establishing a…
Health Care Fraud and Abuse Program Faces Declining ROI
From - National Intelligence Report
The federal government's return on investment (ROI) in the fight against health care fraud continues a steady decline according to the latest numbers reported for the Health Care Fraud and…