Integrating Ethical Principles Into the Regulation of AI-Driven Medical Software.

Abstract

In recent years, a sharp increase in artificial intelligence (AI)-based software as medical devices has been seen in the United States and the European Union. Despite the huge potential of these devices in alleviating suffering through rapid identification and early intervention, their adoption in clinical practice has remained relatively slow due to ethical questions surrounding their usage. Even though there is no universal framework for the approval of these devices, the guiding principles be