Heather Whitney

Artificial intelligence in medical imaging (AI-MI), categorized by the U.S. Food and Drug Administration (FDA) as “Software as a Medical Device,” can offer significant benefit to medical care. FDA approval—represented by a “label”—indicates that the device has demonstrated safety and efficacy for a specific clinical task and population for which the device is intended. Off-label use of AI-MI outside of the task and/or population can be medically and ethically problematic, yet benefits may be reduced or missed if entirely prohibited. Ethical responsibility frameworks can assist in evaluating and establishing boundaries and opportunities in off-label use of AI-MI. In this work, we review three different models for ethical responsibility and apply them to off-label use of AI-MI. We find that a future-looking collective responsibility framework, involving stakeholders such as industry developers, healthcare organizations, clinicians, and, most importantly, patients and/or their representatives, promotes proactive and practical actions to help ensure safe and ethical use of AI-MI off-label. By adopting this approach, stakeholders can balance innovation with safeguards, advancing patient-centered care while mitigating potential harms associated with off-label AI-MI use. This framework is crucial as AI-MI becomes increasingly integral to clinical decision-making processes.

This chapter investigates whether search engines and other new modes of online communication should be covered by free speech principles. It criticizes the analogical reasoning that contemporary American courts and scholars have used to liken search engines to newspapers, and to extend free speech coverage to them based on that likeness. There are dissimilarities between search engines and newspapers that undermine the key analogy, and also rival analogies that can be drawn which do not recommend free speech protection for search engines. Partly on these bases, we argue that an analogical approach to questions of free speech coverage is of limited use in this context. Credible verdicts about how free speech principles should apply to new modes of online communication require us to re-excavate the normative foundations of free speech. This method for deciding free speech coverage suggests that only a subset of search engine outputs and similar online communication should receive special protection against government regulation.

This paper investigates whether search engines and other new modes of online communication should be covered by free speech principles. It criticizes the analogical reason-ing that contemporary American courts and scholars have used to liken search engines to newspapers, and to extend free speech coverage to them based on that likeness. There are dissimilarities between search engines and newspapers that undermine the key analogy, and also rival analogies that can be drawn which don’t recommend free speech protection for search engines. Partly on these bases, we argue that an analogical approach to questions of free speech coverage is of limited use in this context. Credible verdicts about how free speech principles should apply to new modes of online com-munication require us to re-excavate the normative foundations of free speech. This method for deciding free speech coverage suggests that only a subset of search engine outputs and similar online communication should receive special protection against government regulation.