SHAIPED is an EU-funded initiative that is transforming how AI-based medical devices are developed, tested and deployed in Europe. With the European Health Data Space (EHDS) regulation and the AI Act reshaping the healthcare data and innovation landscape, SHAIPED is optimizing the pathways that connect innovators with Health Data Access Bodies (HDABs) to accelerate responsible AI in healthcare.



The project brings together leading expertise from across Europe to identify and pilot practical tools and services that HDABs can provide to support AI medical device development. By creating clear, HDAB-supported pathways, SHAIPED strengthens the EHDS ecosystem, builds capacity at national and EU level, and shortens the time-to-market for trustworthy AI solutions.



Ultimately, SHAIPED aims to help AI medical devices use real-world health data safely and ethically, improve patient outcomes, and enhance Europe’s competitiveness and innovation leadership in the digital health domain.