Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
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
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.
FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
Lab Institute Who’s Who: John (JD) Donnelly
Learn more about how leveraging data automation to get clean patient data at the front end can be a game changer for labs.
FDA Launches Pilot Program to “De-risk the Medical Device Valley of Death”
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.