As medical technology and medical devices have advanced with new technology and increasing connectivity, so have the threats to their cybersecurity. These threats endanger patient health, lives, and privacy. Cybersecurity is a major concern, and the U.S. government moved to address it by passing a December 2022 bill that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding Section 524B. This gave the Food and Drug Administration (FDA) statutory authority and a mandate around cybersecurity.