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
Illumina and Precision Health Team Up for Population Study
Partnership will make use of Illumina’s capabilities and expertise in large-scale genomic sequencing and quickly generate high-quality data.
New Senate Bill Targets PBM Consumer Abuses
Lawmakers blame pharmacy benefit managers for high drug prices, introducing a bill to prevent what they term unfair practices.
The Sun Sets on the Controversial SUNSET Rule
HHS pulls the plug on a Trump rule requiring regulations to expire automatically after 10 years.
DOJ Adds 6 Texas Physicians to Improper Lab Test Claims Complaint
In this week’s Labs in Court roundup, six physicians were accused of billing for unnecessary lab tests in connection with an earlier lab fraud complaint.
BioMérieux and Sema4 Complete Strategic Acquisitions
Two of the biggest merger and acquisition-related deals that came down in May involved BioMérieux and Sema4
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
Collaboration Explores Humanoid Robot for Sequencing Sample Prep
Companies will explore LabDroid’s capacity to automate sample preparation workflows for long-read sequencing systems.
Who Got the Early Jump on the Monkeypox Lab Tests Market?
Companies are using the lessons learned from COVID-19 to get out of the box quickly in developing test kits for monkeypox.
FY 2022 Q1 Could Be the Last Hurrah for the COVID Earnings Surge
Most diagnostics companies experienced modest, flat, or negative top-line revenue growth rates in the first quarter of 2022.
HIPAA vs OSHA: What to Do When Laws Collide
What happens when lab personnel’s OSHA rights to access illness and injury records seemingly clash with HIPAA privacy laws?
