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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
M&A & Strategic Deals: Dealmaking Shows New Signs of Life but FTC Scrutiny Casts a Dark Shadow
After a significant lull, M&As in the lab diagnostics space heated up in May, with several key deals announced.
June 2023 FDA Watch
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
DX Deals: Large Healthcare Bankruptcies Rebound from Pandemic Lull
A recent report offers new insight into bankruptcy trends within the sector starting before the COVID-19 pandemic.
Compliance Tool: Model Mandatory Excluded Provider Screening Policy
A written policy helps establish your right to do excluded persons checks and take appropriate actions if they come back positive.
Labs in Court
In recent key cases, the national drug retailer must stand trial for failing to protect customers from faulty Theranos products.
Billing & Coding: What to Know About New Category III CPT Codes for Digital Pathology
The new codes have garnered attention as a future mechanism for additional reimbursement and thus deserve further discussion.
Compliance Perspectives: How to Perform Excluded Provider Checks
Hiring, retaining, or simply doing business with the wrong people may expose your lab to significant financial penalties.
Expert Q&A: Trends in Precision Medicine
Christian Olsen, a leader in R&D scientific software, discusses recent developments related to AI and solutions to current precision medicine challenges.
The Diagnostics Pipeline: FDA Issues Groundbreaking Clearance for an RSV Vaccine
In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.
Investigating the Cause of the 2022 Severe Acute Hepatitis Outbreak in Children
AAV2 virus detected with metagenomics, TE sequencing, and PCR in non-A–E hepatitis cases from two cohorts in Scotland/the UK and the US.