The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
On this episode of the HealthLaw HotSpot, host Ericka Adler, Roetzel shareholder and Health Law Practice Group Leader, is joined by fellow Roetzel attorney Christina Kuta to discuss laboratory testing investigations related...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
On June 23, 2020, the US Departments of Labor, Health and Human Services, and Treasury issued tri-agency FAQs (Part 43) that clarify important health and welfare provisions under the Families First Coronavirus Response Act...more