Perspectives

Safety and Effectiveness in the Use of Clinical Artificial Intelligence

Authors: Neil Nusbaum, JD, MD

Abstract

It is a routine expectation in clinical care that any medication be approved only for those indications for which it has been demonstrated to be both safe and effective, and this expectation is readily translatable to the domain of artificial intelligence (AI).1 Emerging positive experience with the initially approved indications may provide incremental evidence to support expansion of use to broader indications. I submit that this prudent model should also be applied when considering how to implement AI in clinical medicine today. 

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References

1. Daneshvar N, Pandita D, Erickson S, et al. Artificial intelligence in the provision of health care: an American College of Physicians Policy Position Paper. Ann Intern Med 2024;177: 964–967.
 
2. Sun S, Lin Z, Wu X. Hallucinations of large multimodal models: problem and countermeasures. Information Fusion 2025;118:102970.