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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Additional Business Intelligence Offerings
Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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”
Compliance Perspectives: How to Comply with the CMS 60-Day Overpayment Repayment Rule
While overpayments may not be your fault, they expose your lab to the risk of liability under the Affordable Care Act.
How to Ensure Proper Documentation for Billing Laboratory Services
What do lab professionals need to do to ensure sufficient documentation for billing clinical laboratory and pathology services?
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
September 2023 Labs in Court
In last month’s key cases, Illumina and Guardant seek to dismiss lawsuit related to trade secrets and breach of contract.
DX Deals: Teaming with Google Leads to WGS Success for PacBio
A strategic partnership with Google enables more accurate whole genome sequencing with machine learning.
September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
The Top 10 Clinical Lab Acquisitions of 2023
Seven months into the year, there were already four reported deals valued at over $1 billion in 2023, as many as in all of 2022.
Sweeping New FTC Rules Could Chill Healthcare Mergers and Acquisitions
Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.
OIG Sheds Light on Kickback Implications of Online Healthcare Directories
Recent advisory opinion offers insight on how healthcare providers may want to structure arrangements involving online directories.
What Are the Latest CFTR Carrier Screening Recommendations?
New ACMG recommendations aim to make CFTR carrier detection more equitable among a wider range of ancestries.