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
- 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”
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
Lab Institute Virtual Event: Advancing the Profession of Diagnostic Medicine
Our upcoming event will provide lab leaders with analysis of recent legal and regulatory developments, enforcement trends, and more
Will LDTs Soon Be Regulated?
The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.
New CMS Rule Unlikely to Speed Medicare Coverage of Breakthrough Devices
The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.
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.
