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
Digital Health Fundraising Falls in 2022 but May Not Have Bottomed Out
According to a new report, tough macro-economic conditions caused digital health fundraising levels to fall off dramatically in 2022.
Does a Concierge Business Model Make Sense for Your Lab?
Factors to consider when determining if the concierge business model is best for your laboratory.
How to Regulate Workplace Romance in Your Lab
Labs and other companies need a proactive strategy for dealing with romance and fraternization between employees.
Model Conflict of Interest Policy for Employees Romantically Involved with Co-Workers
Here’s a template for a conflict of interest policy that you can adapt for your lab based on its specific situation and HR policies.
Model Workplace Romance ‘Love Contract’
Having employees involved in office romances disclose their relationship and follow key ground rules can help avoid negative impacts on the lab.
Model Workplace Romance & Fraternization Policy
It’s important to implement a policy that allows you to keep control over the potential issues romantic relationships can cause in the lab.
Courts Dismiss Two Whistleblower Lawsuits
In this month’s Labs in Court roundup, a medical device company and genetic testing company each win key victories.
Eleven Things Labs Must Know to Comply with PAMA
An overview of PAMA and key aspects lab compliance officers should be aware of to help ensure compliance.
CMS to Crack Down on Unnecessary COVID-19 Add-on Tests
Recent OIG report suggests some labs might have gamed Medicare coverage rules in 2020 by billing for unusually high numbers of such tests.
An AI Invasion: Improving Breast Cancer Biopsies
Researchers report the first-ever routine clinical use of an AI-based tool for breast cancer biopsies in a pathology lab.
