FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
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Articles and Reports
Special Report: The OSHA Inspection Process and How to Survive It
The basics of how the OSHA inspection process works and how laboratories can successfully navigate it.
December 2023 Labs in Court
A settlement for kickback allegations, prison time for lab owners convicted of COVID-19 fraud, and 10x Genomics gets OK for lawsuit.
FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
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.
