Document Type
Article
Publication Date
2024
Abstract
The First Amendment to the U.S. Constitution constrains FDA’s power to impose content-based restrictions on physicians’ professional speech – that is, on the expert medical advice licensed physicians render to patients during clinical treatment encounters. In 2022, the U.S. Food and Drug Administration (FDA) clarified its plans to regulate clinical decision support (CDS) software by publishing a final guidance document. CDS tools process patient-specific health information along with various other sources of medical knowledge – such as clinical practice guidelines, drug labeling information, insights from published medical literature, or fresh insights gleaned by an artificial intelligence/machine learning (AI/ML) algorithm imbedded in the CDS tool itself – to offer a health care professional a set of patient-specific diagnostic or treatment recommendations for use in the clinical health care setting.
FDA’s final guidance document, while voluntary and directed at software developers and vendors, has the practical binding effect of restricting physicians’ access to information flows that serve as inputs to their professional speech. Restricting physicians’ access to informational inputs of professional speech necessarily alters the content of that speech and amounts to content-based speech regulation. Regulations targeting the speech of a licensed health care provider based on its communicative content are presumptively unconstitutional and the government must bear the burden to show they are justified. FDA’s CDS guidance document did not meet that constitutional burden. The policies FDA has announced for regulation of CDS tools violate the civil rights and the autonomy not only of physicians but of their listeners: patients seeking the best-informed professional advice they can receive as they grapple with difficult and potentially life-altering medical decisions.
Recommended Citation
Barbara Evans, FDA Regulation of Physicians' Professional Speech, 5 J. Free Speech L. 1 (2024)
Included in
Bioethics and Medical Ethics Commons, Health Law and Policy Commons, Other Analytical, Diagnostic and Therapeutic Techniques and Equipment Commons
Comments
Funding Information: This work received support from the University of Florida Levin College of Law and under the National Institutes of Health Common Fund’s Bridge2AI “Patient-Focused Collaborative Hospital Repository Uniting Standards (CHoRUS) for Equitable AI” project (OT2OD0327-01, Eric S. Rosenthal, PI).