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
Compliance Perspectives-lca
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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
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
Compliance Perspectives: When Do Cybersecurity Donations Violate Kickback Laws?
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
Compliance Perspectives: How to Ensure HIPAA Compliance among Marketing Staff
Lab leaders are at the greatest risk of HIPAA violations when they get complacent about privacy training.
Compliance Perspectives: How to Comply with the CMS 60-Day Overpayment Repayment Rule
While overpayments may not be your fault, they expose your lab to the risk of liability under the Affordable Care Act.
Compliance Perspectives: The Risks of Using ChatGPT & How to Manage Them
While ChatGPT has its place, allowing lab staff to use it exposes you to liabilities—here are some ways to manage the risks involved.
Compliance Perspectives: How to Perform Excluded Provider Checks
Hiring, retaining, or simply doing business with the wrong people may expose your lab to significant financial penalties.
Turning Whistleblower Lemons into Compliance Lemonade
A False Claims Act whistleblower lawsuit can do significant damage to your lab and its reputation, even if the case lacks truth and merit.
How to Reduce Liability Risk for Lab Sales and Marketing
A code of conduct for sales and marketing staff is essential to allow staff to do their jobs while avoiding liability risk.
Protect Your Lab against HIPAA Right of Access Liability Risks
Key points to educate your staff on when it comes to patient requests for test records and other protected health information.
How to Comply with Medicare Signature & Documentation Requirements
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Eight Lab Sales & Marketing Liability Pitfalls to Avoid
How to avoid eight of the most common liability pitfalls when it comes to sales and marketing operations in your lab.
