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
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
This month’s roundup of cases includes Walgreens’ settlement with Theranos customers, kickbacks, and age discrimination.
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
This template aims to help lab leaders develop a policy for donations of cybersecurity technology that complies with safe harbor requirements.
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
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.
An analysis of recent OCR enforcement actions and settlements identifies the common pitfalls labs should watch out for.
Here are what G2 Intelligence considers the three most significant deals announced in the period from late August to early September.