THOUGHT LEADERSHIP

Having worked in the world of clinical research for 15 years, I can’t help but be baffled by the rampant misuse of the word “de-identified” as it relates to the classification of clinical data sets.  In the United States, “the HIPAA Privacy Rule provides federal protections for personal health information [PHI] held by covered entities and gives patients an array of rights with respect to that information.”  De-identified health information is not PHI and thus is not protected by HIPAA.

It’s a common misconception that if you remove patients’ names from a set of clinical data, then it becomes de-identified and is no longer governed by HIPAA.  However, to make a set of clinical data truly de-identified, you must remove much more than just the patients’ names. 

Remote interactions—often termed eClinical Technology—are making their way into clinical trials. Precipitated by the COVID-19 pandemic, we have seen an uptick in the adoption of televisits, remote monitoring, and eConsent in clinical trials.