Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Labs in Court: Two EKRA-Related Cases and Some Usual Suspects
Recent enforcement actions involved usual targets such as COVID-19, genetic, and urine drug testing, but EKRA also made an appearance
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
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
