Red Flags in Clinical Lab Operations Rise from Recent Court Cases
Guilty plea points to patient data collection, while settlement implicates an undisclosed relationship
Already a member? Log in here
Lab Industry Advisor
Keep up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
Subscribe today for access to
Articles and Reports
FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
Already a member? Log in here
Dx Deals: Danaher Acquires StatLab in Deal Valued at More than $1 Billion
The company will fold into Leica Biosystems after the transaction closes at the end of this year
Already a member? Log in here
Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
Already a member? Log in here
Special Analysis: HIPAA Compliance Risks of AI in the Lab: Trends and Tips
The most common AI compliance risk areas related to data security and patient privacy, and the current regulatory landscape
Already a member? Log in here
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”
Already a member? Log in here
Are Current Regulations Keeping Labs from Benefiting from AI?
Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed
Already a member? Log in here
Is Sales Training Really Needed in the Lab Industry?
Why ongoing coaching and learning is required for laboratory sales reps—even experienced ones—to help labs meet their business goals
Already a member? Log in here
Dx Deals: More than $62 Million Invested in Startup Labs in Recent Weeks
The rounds of funding to Clarapath, PreciseDx, and Precision Epigenomics come at a time when other M&A activity is seasonally slow
Already a member? Log in here
Cybersecurity: What Your Lab Needs to Know
Recent government efforts to address increased cyberattacks in the healthcare space, and how your lab could benefit
Already a member? Log in here
Using AI to Improve Reimbursement and Decrease Claim Denials
Though payers’ adoption of AI has made reimbursement more challenging for labs, providers can also use AI to address these issues
Already a member? Log in here
FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
Already a member? Log in here
The First Steps to Implementing Digital Pathology and AI
A guide to understanding, implementing, and benefiting from digital pathology and artificial intelligence in the clinical lab
Already a member? Log in here
