The continuing challenges of regulating software as a medical device

Muireann Quigley, Laura Downey, and Louise Hatherall discuss how software as a medical device challenges regulatory frameworks around physical goods.

Three people walking under the Law School foyer

Software is now everywhere in healthcare. From period-tracking apps and mental health platforms to artificial intelligence (AI) systems that help diagnose disease, software is reshaping how healthcare is delivered. Some estimates suggest there are now hundreds of thousands of health-related apps available, while AI-enabled medical technologies continue to expand rapidly.