Healthcare institutions are implementing artificial intelligence (AI) at a rapid pace. The hope is that AI will improve the quality of care and reduce costs in the long run. However, the deployment of AI in healthcare settings also presents new ethical and legal challenges. For example, AI can reproduce health disparities and pose a risk to patients if human factors, like implicit or explicit bias, are present in the training data set or it lacks representation from population subgroups. AI also raises challenges for regulators like the U.S. Food and Drug Administration (FDA).