Direct-To-Consumer Artificial Intelligence/Machine Learning health apps (DTC AI/ML health apps) are increasingly being made available for download in app stores. However, such apps raise challenges, one of which is providing adequate protection of consumers' privacy. This article analyzes the...

Artificial intelligence (AI), especially its subset machine learning, has tremendous potential to improve health care. However, health AI also raises new regulatory challenges. In this Article, I argue that there is a need for a new regulatory framework for AI-based medical devices in the U.S....

This article contrasts the prevailing model for assessing and improving medical care - the quality of care paradigm - with an alternative approach - the patient accountability paradigm. The first approach is technocratic: it measures and promotes the quality of medical care through technical and...