CLASSICA - Regulatory and legal aspects of an AI-based medical device

CLASSICA is an EU-Horizon-funded project that evaluates an AI-based clinical decision support tool for cancer surgeons through clinical validation as well as investigation of regulatory and legal aspects.

Colorectal cancer is the third most common cancer type globally and the second most common cause of cancer death, leading to almost one million deaths annually. CLASSICA builds on breakthrough research in AI analysis that allows excellent detection of cancerous tissue. In CLASSICA, we transform a research prototype for such detection of colorectal cancer into a real-time tool for surgeons. A consortium of researchers are working in parallel to make this transformation.

The University of Copenhagen and PennState Law in the US are in charge of the regulatory and legal aspects of CLASSICA. We will investigate:

• The regulatory landscape pertaining to data privacy, AI regulation, and medical devices.
• Bias and how to mitigate bias in AI-assisted surgery.
• Liability in AI-assisted surgery (including comparison between the US and EU).

For more information on CLASSICA, please see the project website: https://classicaproject.eu/

External researchers

The project involves 11 partners from 9 countries across Europe, with expertise in in colorectal cancer, precision surgery, AI and technology, biomedical law and ethics, surgical training, and surgical guidelines.

See more at https://classicaproject.eu/team/