Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
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Articles and Reports
Labs in Court: Alleged Stark Law Violations Lead to $10m Settlement with DOJ
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
A Practical Mentoring Checklist for Clinical Labs
Steps that lab leaders, mentors, and mentees can take when establishing mentorships
Dx Deals: Labcorp Acquires Stake in European Testing Giant
$152.1 million SYNLAB deal is expected to create a new channel for Labcorp to market its sophisticated specialty assays
How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
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.
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
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
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
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
Cybersecurity: What Your Lab Needs to Know
Recent government efforts to address increased cyberattacks in the healthcare space, and how your lab could benefit
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
