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
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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
November 2023 Labs in Court
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
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 Tool: Model Policy on Donating Cybersecurity Technology to Physicians
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.
FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
The Basics of Business Associate Agreements (BAAs) for Labs
When it comes to protected health information, it’s important that labs manage contracts with external sources to ensure HIPAA compliance.
Privacy in the Post Roe v. Wade World: How Could Proposed HIPAA Restrictions on Reproductive PHI Affect Labs?
Key points labs should know about the recently proposed OCR rule on privacy protections for PHI associated with reproductive health care.
Enforcement Trends: Six Ways Your Lab Can Avoid HIPAA Right of Access Issues
An analysis of recent OCR enforcement actions and settlements identifies the common pitfalls labs should watch out for.
Dx Deal Roundup: Key Acquisitions for Danaher & Exact, and a Big AI Partnership
Here are what G2 Intelligence considers the three most significant deals announced in the period from late August to early September.
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.
