Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
Full-Text Articles in Law
Digital Health And Regulatory Experimentation At The Fda, Nathan Cortez
Digital Health And Regulatory Experimentation At The Fda, Nathan Cortez
Faculty Journal Articles and Book Chapters
For well over a decade the U.S. Food and Drug Administration (FDA) has been told that its framework for regulating traditional medical devices is not modern or flexible enough to address increasingly novel digital health technologies. Very recently, however, the FDA introduced a series of digital health initiatives that represent important experiments in medical product regulation, departing from longstanding precedents applied to therapeutic products like drugs and devices. The FDA will experiment with shifting its scrutiny from the pre-market to the post-market phase, shifting the locus of regulation from products to firms, and shifting from centralized government review to decentralized …
A Black Box For Patient Safety?, Nathan Cortez
A Black Box For Patient Safety?, Nathan Cortez
Faculty Journal Articles and Book Chapters
Technology now makes it possible to record surgical procedures with striking granularity. And new methods of artificial intelligence (A.I.) and machine learning allow data from surgeries to be used to identify and predict errors. These technologies are now being deployed, on a research basis, in hospitals around the world, including in U.S. hospitals. This Article evaluates whether such recordings – and whether subsequent software analyses of such recordings – are discoverable and admissible in U.S. courts in medical malpractice actions. I then argue for reformulating traditional "information policy" to accommodate the use of these new technologies without losing sight of …