Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
As is usual at this time of year, deals in the diagnostics industry were up, both in terms of volume and value.
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.
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.