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
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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
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.
Congress Passes New FDA Medical Devices User Fee Amendments (MDUFA V) Deal
The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027.
Clinical Lab Pays Big to Settle UDT False Claims Allegations in NC
In this week’s enforcement roundup, Radeas reaches a settlement with the State of North Carolina after alleged improper billing.
Holmes Wins Sentencing Delay and May Get a New Trial
Judge Edward Davila postponed sentencing for at least one month to consider new evidence of possible government misconduct.
Lab Institute Who’s Who: Cameron S. Hill
Learn more about the legal remedies potentially available to clinical labs who have not been fully paid for COVID testing by insurers.
