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
SARS-CoV-2 Saliva Testing Gains Traction
Saliva testing for the virus that causes COVID-19 is gaining acceptance in both the scientific community and US market.
New Breast Density Notification Final Rule to Publish Soon
The FDA recently confirmed that a new rule requiring healthcare providers to notify patients of their breast density status will be released in late 2022 or early 2023.
Don’t Let “Digital Nomads” Expose Your Lab to Foreign Tax Liability
Where your remote employees actually work may have significant legal consequences for your lab.
AACC Updates Guidelines for Use of Reproductive POC Testing
The new guidelines address issues with false negatives and positives from POC testing for fertility and reproductive health.
December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
Want Breakthrough Device Designation? You’ll Need to Consider Health Equity
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
New Urine Test Can Detect Synthetic Cannabinoids in Marijuana
Recent study shows the new test can identify a widespread and dangerous class of synthetic cannabinoids called BZO-CHMOXIZID.
SCOTUS Won’t Weigh in on How Whistleblowers Make Valid FCA Claims
The court recently denied the petition to hear a case that would have helped offer clarity on what evidence whistleblowers need to file qui tam lawsuits under the FCA.
White House Unveils New “Bill of Rights” for Responsible Use of AI
The US has taken its first steps to establish legal limits over AI use by publishing a voluntary code to ensure responsible corporate use of AI.
Weekly Enforcement Report: Doctors in Hot Water for Billing-Related Issues
While again light on lab-related cases, this week’s healthcare-related enforcement actions featured improper billing, kickbacks, and telemedicine.
