Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates...

There has been increasing interest in the use of home monitoring technologies during the COVID-19 pandemic to decrease interpersonal contacts and the resultant risks of exposure for people to the coronavirus SARS-CoV-2. This Perspective explores how the accelerated development of these...

As use of artificial intelligence and machine learning (AI/ML) in medicine continues to grow, regulators face a fundamental problem: After evaluating a medical AI/ML technology and deeming it safe and effective, should the regulator limit its authorization to market only the version of 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....

Since the late 1960s the U.S. has attempted to develop a strategy for controlling the rate of growth of health care spending. During the 1970s this strategy relied heavily on various forms of regulation. Some regulatory programs were partially successful in moderating spending increases, but...