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
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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
Normal Kickback and Billing Rules Return When PHE Ends on May 11
A look at the US end-of-emergency game plan and how it will impact lab compliance.
Lab Sales & Marketing Compliance: The Current State of EKRA
Sales and marketing operations liability risks and the measures labs should and shouldn’t take to manage those risks.
Weekly Enforcement Report: 23 People Charged in 2 Big Fraud Schemes
Last week saw the usual False Claims Act and kickback-related charges, with the biggest action involving urine drug testing.
End of Public Health Emergency Won’t End COVID-19 EUAs
FDA will still be able to issue EUAs for COVID-19 tests after May 11.
A Better Test for Early Detection of Multiple Cancers?
A new method of early, multi-cancer detection could prove more effective for non-invasive screening than other emerging options.
Lab Industry Hit by New Wave of Layoffs
Cost cutting and restructuring has become the order of the day for many lab companies.
Researchers Report First “Routine Clinical Use” of AI for Breast Biopsies
While AI as a diagnostic tool is still years away from regular clinical use, recent research is an important step.
Lab Compliance Will Change When Public Health Emergency Ends
Your current COVID-19 testing arrangements may no longer be compliant on May 11.
Weekly Enforcement Report: Telemedicine Scheme Trend Continues
Most of last week’s healthcare-related actions involved telemedicine in some way, with the lone lab-related case centering on genetic testing.
The 2022 Year in FDA 510(k) Approvals
Roche and Abbott received the most approvals for new lab tests last year.