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
Lab Institute Who’s Who: Mason Shaw
Learn more about how to tackle the key staffing challenges facing diagnostics laboratories today and tomorrow.
Lab Institute Who’s Who: Edward Dooling
Learn more about practical ways you can handle today’s lab staffing challenges, and how to prepare for those of the future.
Abbott Scores First FDA Greenlight for Commercial Use of Monkeypox Test
Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.
New Legislation Could Make MA Prior Authorization Process Less Tedious
For labs and other healthcare providers, a bill now before the Senate could mean a less labor-intensive prior authorization process.
Lab Institute Who’s Who: Joyce Gresko
Learn more about how Congress could change PAMA, why it matters to your lab, and how you can prepare.
How COVID-19 Transformed Healthcare Delivery
The pandemic came with great pain and suffering for many, but it also allowed telehealth and other technologies to flourish.
Despite MDUFA Setback, VALID Act Is Back on Track for Passage
Though Congress didn’t pass VALID as part of the medical devices user fees bill, there’s still a good chance it will pass before year’s end.
Holmes May Get a New Trial on Basis of Witness Tampering
Sentencing has been postponed for one month to explore possible government mishandling of key witness testimony.
HHS’ Proposed New Anti-Discrimination Rule & What You Can Do to Comply with It
What you need to know about the 308-page proposed rule and its potential impact on your lab, along with a basic strategy to implement it.
Ambry Genetics Shells Out Millions to Settle Data Breach Class Action
The problems began in January 2020 when hackers got access to an employee’s email account, compromising clients’ personal data.
