Publication Feature: Challenges and Opportunities in Software-Driven Medical Devices
This recently published pair of studies provide an overview of the landscape for software-driven medical devices and explores topics that are crucial for regulators such as cybersecurity and product updates. The first study, led by CRS faculty member Ariel Stern and co-authored with William Gordon, discusses how the safety and security of digital medical devices, the software development processes, and the need for data collection and privacy, offer unique challenges and opportunities for device regulation and clinical care. The second study, co-authored with a group of Harvard faculty members, examines all FDA medical device product summaries from 2002-2016 to characterize the prevalence and trends of cybersecurity content. The authors find that only a small share of devices identified as including software contained cybersecurity information in their product summaries.