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Full-Text Articles in Law
Information Mischief Under The Trump Administration, Nathan Cortez
Information Mischief Under The Trump Administration, Nathan Cortez
Faculty Journal Articles and Book Chapters
The Trump administration has used government information in more cynical ways than its predecessors. For example, it has removed certain information from the public domain, scrubbed certain terminology from government web sites, censored scientists, manipulated public data, and used “transparency” initiatives as a pretext for anti-regulatory policies, particularly environmental policy. This article attempts to tease out an emerging “information policy” for the Trump administration, explain how it departs from the information policies of predecessors, and evaluate the extent to which both legal and non-legal mechanisms might constrain executive discretion.
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 …