Petitioner Says FDA’s Clinical Decision Software Guidance Violates First Amendment

The FDA’s recent final guidance on clinical decision support software prevents physicians from fully disclosing critical health information and therefore violates the First Amendment, a Florida law professor has written in her citizen petition to the FDA. 

Barbara Evans, a law and engineering professor at the University of Florida, states that she is petitioning the FDA on her own behalf “as a private citizen and as a patient desiring to consult with physicians whose professional advice to me can incorporate insights developed using clinical decision support (CDS) tools.” 

Evans argues that even though the guidance is “voluntary and directed at software developers and vendors, [it] has the practical binding effect of restricting physicians’ access to information flows that serve as inputs to their professional speech.”

Evans is asking that the FDA rescind the final guidance.

Read the Evans Petition here.

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