HINT Pulse Sessions
Join us for an insightful session where we delve into the complexities of handling sensitive patient data in the context of AI and medical device studies. Using real-world cases, including a 3D Renal Perfusion Model and a 3D Planning and Printing project from UZ Gent, we will explore critical questions and challenges such as:
- What constitutes "sensitive patient data" and with whom can it be shared? For example: anonymized CT images, patient/tumor characteristics, anonymized surgery videos...
- Using an online website as an interface for studies involving patient data?
- What policies exist at UGent/UZ Gent regarding AI/medical device studies? What legislation must be followed, and are there preferred partners?
- Is there a U(Z)Gent policy on the "commercial value" of patient data? For example: collaboration with a commercial company to reduce costs by allowing the use of shared CT images for AI training, highlighting the need for clarity on the market value of such data.
Case Studies:
- 3D Renal Perfusion Model: This model aids urologists in planning and performing robot-assisted surgeries for kidney cancer patients, requiring the sharing of sensitive patient data with researchers and commercial entities.
- 3D Planning and Printing tool: This project involves creating 3D models from radiological images for use in various surgical applications, emphasizing the importance of multidisciplinary collaboration and the regulatory challenges of using digital 3D models as medical devices.
Key Takeaways:
- Understand the intricacies of managing sensitive patient data in research and clinical settings.
- Learn about existing policies and legislation governing AI and medical device studies.
- Gain insights into the commercial aspects of patient data and how to navigate negotiations with commercial partners.