The Food and Drug Administration (FDA) released for public comment this week non-binding draft guidance for artificial intelligence-enabled medical devices. Healthcare and Data Privacy Partner Betsy Hodge tells Healthcare Info Security that, while not binding, the document provides device makers a clear outline of the FDA's current position, particularly regarding cybersecurity.

"It is imperative for AI-enabled medical device makers to consider cybersecurity issues in the life cycle of their products because cybersecurity threats can compromise the safety and/or effectiveness of a device, potentially resulting in harm to patients," Hodge told the publication.