Crafting An AI Policy For Protecting Medical Device Intellectual Property

The integration of AI tools like ChatGPT and GitHub Copilot into corporate structures can revolutionize efficiency and productivity, especially in software development and content generation.

However, this integration poses challenges, particularly for protecting intellectual property (IP) rights. AI tools process and generate vast data, some sensitive or proprietary. The inadvertent public disclosure of such information through AI interactions could compromise patent rights or trade secrets — a concern in stringent patent law jurisdictions like the United States.

The FDA has recognized the growing importance of software-based medical devices, especially those incorporating AI. The agency's Digital Health Innovation Action Plan underlines the transformative impact of digital technology in healthcare, including mobile medical apps, fitness trackers and clinical decision-support software.