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
National Lab Reporter
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Articles and Reports
Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
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.
Compliance Tool: Model Policy on Use of HIPAA-Protected Health Information for Marketing Purposes
This template helps lab leaders implement a written policy limiting and establishing procedures governing use of PHI for marketing.
