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
Billing & Coding: MAAA Coding 101
What labs and billing managers need to know about multianalyte assays with algorithmic analyses coding for tests based on molecular platforms.
Clinical Lab Owner Pleads Guilty to Healthcare-Related Scheme
On Nov. 15, a psychiatrist and clinical lab owner pled guilty to his role in a complicated $3.8 million fraud scheme.
White House Proposes New AI “Bill of Rights”
US takes first steps to rein in abusive and privacy-invasive use of AI by corporations.
Theranos in Court: Holmes Sentenced to 11 Years Behind Bars
After delays in sentencing and attempts by her legal team to win a mistrial, Holmes was sentenced last week for her role in defrauding investors of millions.
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.
