There has been an issue that has come to light for the better part of this year that deals with legislation in New York State which does not allow for pathologists to speak directly with patients. For the past several months I have been...

On February 6, 2014, the Department of Health and Human Services (HHS) released a final amendment to both CLIA 1988 and HIPAA 1996 rules in order to allow patients direct access to their lab results. In CLIA Final Rule 42 CFR 493.1291,...

Very nice read by Dr. Holger Lange of Flagship Biosciences in this month's ASCP LabMedicine (subscription required) on regulatory issues in digital pathology.  Holger provides a clear overview of the issues pertinent...

The following post was submitted by Dr. Holger Lange, CTO of Flagship Biosciences, who is working with a number of pharmaceutical partners on regulatory companion diagnostics development. Digital Pathology is a new technology, a new industry,...

In this series of posts on Laboratory Developed Tests (LDTs), I discuss the history of the regulation of LDTs and impending changes (posts #1 and #2).  I also discuss possible criteria that pathologists, treating physicians, and...