Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine

 

Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine

Michael J. Malinowski

Drawing from the history of U.S. medicine, Professor Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercialization of personal genome sequencing and testing sectors, as well as to assess their impact on the future of U.S. medicine.

“In the roughly 30 years that I have been researching and writing about these important topics, I have witnessed an explosion in the use of these emerging technologies far beyond anything I could have imagined when I began my career,” said Professor Malinowski, a Yale Law School alumnus who has been an LSU Law faculty member since 2002. “In 2017, when the U.S. Food and Drug Administration approved direct-to-consumer genetic health risk testing that does not meet evidentiary science clinical standards—with medical professional involvement wholly optional—it was a jolting deviation from the U.S. legacy of protecting and promoting the evidentiary-science base of medicine. ‘Personal Genome Medicine’ represents the culmination of my scholarship on this issue to date, and my hope is that it will elevate and advance the conversation in a meaningful way.”