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
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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
Digital Pathology Business Arrangements Bring Fraud and Kickback Worries
Healthcare attorneys explain three digital pathology models for laboratories to be aware of.
FDA Watch: New BD Collection System Uses Just Tiny Amounts of Blood
Whether the MiniDraw™ device dredges up memories of Theranos’ failed tech remains to be seen.
Dx Deals Roundup: Pact Aims to Improve Prostate Cancer Detection Among Hispanic Males
More aggressive use of artificial intelligence may mitigate issues that lead to the uneven impact of the disease on this group.
Recent FDA Approvals Show Growing Sophistication of At-Home Tests
Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.
Special Report: How to Avoid Problematic Lab Business Arrangements
When structuring business arrangements, addressing six key risk areas can help laboratories avoid major compliance issues.
Expert Q&A: Trends and Challenges in Lab Billing and Coding
Ann Lambrix, vice president of RCM Solutions at Lighthouse Lab Services, discusses key developments in lab billing and coding.
February 2024 Labs in Court
Recent cases show labs should be wary of issues such as improper relationships, medical necessity, kickbacks, and potential telehealth fraud.
At-Home Answers in Infectious Disease
Demand for at-home sample collection and infectious disease testing is at an all-time high—and still growing.
Expert Q&A: Adapting to the Expanding Market of At-Home Testing
Medical director William G. Finn, MD, discusses key trends, challenges, and opportunities related to the expansion of at-home testing.
Screening Shortfalls and Self-Collected Samples
Is at-home sample collection the solution to lagging cancer screening uptake—or does this approach introduce a new set of challenges?
