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5 J. Free Speech L. 1 (2024-2025)

handle is hein.journals/jfspl5 and id is 1 raw text is: FDA REGULATION OF PHYSICIANS' PROFESSIONAL SPEECH Barbara J. Evans In tro d u ctio n ..................................................................................................................... 2 I. First Amendment Protection of Physicians' Professional Speech..............7 A. Values Served by Protecting Physicians' Freedom to Formulate and Express Expert Clinical Opinions .............................................. 10 B. Non-Constitutional Protections for Physicians' Professional S p eech ......................................................................................................... 16 C. The Challenge of New Medical Technologies................................... 20 II. The Cures Act Traced a Constitutionally Sound Line Between Medical Practice Software and FDA-Regulable Device Software............................24 A. Section 3060 Does Not Itself Impose Content-Based Regulation of Professional Speech ........................................................................... . 27 Professor of Law and Stephen C. O'Connell Chair, University of Florida Levin College of Law; Professor of Engineering and Glenn and Deborah Renwick Faculty Fellow in Al and Ethics, Univer- sity of Florida Wertheim College of Engineering, Gainesville, FL, evans@law.ufl.edu. Author has no conflicts to disclose. This work received support from the University of Florida Levin College of Law, the Renwick Faculty Fellowship in Al and Ethics, and the National Institutes of Health Com- mon Fund's Bridge2AI Patient-Focused Collaborative Hospital Repository Uniting Standards (CHoRUS) for Equitable Al project (OT20Do327-01, Eric S. Rosenthal, PI), but the views ex- pressed are the author's own and do not necessarily reflect positions of her institution, research collaborators, or funders. The author is grateful to editors Jane Bambauer and Eugene Volokh and to Ashutosh A. Bhagwat, Adam Candeub, I. Glenn Cohen, Nathan Cortez, Sara Gerke, Lewis Gross- man, Peter Barton Hutt, Holly Fernandez Lynch, Adam Muchmore, Lars Noah, Patricia Zettler, and others who offered helpful comments at the University of Arizona's Information as Medicine Work- shop and the SMU Law School's Tsai Center Summit/Food & Drug Scholars Retreat, and she thanks Nader Abou Mrad for capable research assistance. 1

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