In short
SHAIPED is a project funded by the EU’s Digital Europe Programme. SHAIPED supports the European Data Strategy by advancing the European Health Data Space and facilitating artificial intelligence (AI) Act implementation, driving innovation in AI medical devices. It aims to create secure, efficient, and regulation-compliant pathways for the development and deployment of AI as medical devices. By optimising how Health Data Access Bodies (HDABs) collaborate across Europe, SHAIPED leverages the European Health Data Space (EHDS) regulation and the AI Act to improve patient outcomes, reduce time-to-market for AI medical devices, and strengthen the EU’s leadership in digital healthcare innovation.
Project description
The main objective of the SHAIPED project are to:
- strengthen the role and capabilities of HDABs in streamlining the testing and deployment pathways for healthcare AI solutions
- reduce time-to-market and foster the development of new AI-based healthcare products and services that significantly improve patient safety and wellbeing, while preserving privacy and security
- support the EHDS implementation and AI Act implementation.
In this project, Sciensano is leading a work package dedicated to the identification of pathways for supporting AI developments and testing. The goal is to focus on the interplay between Real World Data and regulatory processes crucial to AI as medical devices deployment.
Complete list of partners of the project: https://shaiped.eu/partners/
