Clinical Decision Support: The Regulatory and Practical Implications of a Rapidly Developing Power Tool

While clinical decision support tools, especially with the advent of artificial intelligence, have the potential to greatly improve patient care, there are concerns related to patient health and safety and fraud and abuse. Anthony Burba, Partner, Barnes & Thornburg LLP, and Gail Javitt, Director, Hyman Phelps & McNamara PC, discuss the promise and perils of these tools, navigating the Food and Drug Administration’s regulatory efforts, issues related to data storage and validation, and...