“AI and IP: Considerations for Medtech”

In a January 10 column in Med-Tech Innovation, Marshall Gerstein Partner and patent attorney Ryan N. Phelan advises medical technology industry leaders about the challenges of navigating artificial intelligence tools, including the Food & Drug Administration’s (FDA) viewpoint on AI with software-based medical devices.

“The FDA categorizes software-based medical devices into two main types: Software in a Medical Device (SiMD), which is embedded software within a medical device, and Software as a Medical Device (SaMD), software used for medical purposes without being part of a hardware medical device,” Phelan explains. “This classification helps to regulate the technology by correctly classifying such technology, and ensuring it meets quality standards and performs as intended. Digital health products in the medical device space, e.g., especially those involving software such as AI, underscore the importance of trustworthy and high-quality software-based medical devices, not only for health and safety reasons but also for various risks inherently brought by AI as a technology.”

To mitigate the risks associated with AI, Phelan suggests medtech companies give careful attention to developing a solid AI policy: “Navigating AI adoption requires caution and a comprehensive AI policy. This policy should address the risks of AI tool usage while maximizing their benefits. AI integration, like ChatGPT and GitHub Copilot, offers growth opportunities but also poses unique challenges in IP protection.”

To read the full article in Med-Tech Innovation, click here.