Monitoring the Pulse of Health Care and Life Sciences
*This post was authored by Nicole Benevento, law intern at Robinson+Cole. Nicole is not admitted to practice law.
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and post-marketing requirements of mass-produced…
Effective January 3, 2018, The Joint Commission (TJC) has revised its standards to no longer require TJC-accredited hospitals, critical access hospitals, and ambulatory care organizations to credential and privilege pathologists that provide diagnostic services through reference laboratories. TJC Introduction to Leadership Standard LD.04.03.09 generally requires that each hospital, critical access hospital or ambulatory care organization…
