Shaiped
Supporting Health Data Access Bodies to establish AI pathways enabling Deployment of AI as medical device tools. Empowering AI in Healthcare through Enhanced Data Access. SHAIPED supports the development of AI as a medical device by optimizing data pathways and enabling Health Data Access Bodies (HDABs) to strengthen the European Health Data Space.
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Project
SHAIPED is a project funded by the EU’s Digital Europe Program. It aims to create secure, efficient, and regulation-compliant pathways for the development and deployment of artificial intelligence (AI) as medical devices. By optimizing how Health Data Access Bodies (HDABs) collaborate across Europe, SHAIPED leverages the European Health Data Space (EHDS) regulation and AI Act to improve patient outcomes, reduce time-to-market for AI medical devices, and strengthen the EU’s leadership in digital healthcare innovation.
Soil Health Improvement for stronger plant.
Innovative Seeds in various conditions.
Agricultural with Technology Integration
Secure, efficient, and regulation-compliant pathways for the development and deployment of artificial intelligence as medical devices.
Duration 3 years 2025 - 2028
Budget
4M EUR
funded by the EU through the Digital Europe Programme
31 Partners & Affiliated & Associated Entities
80+ Experts
11 Member States
18 Tasks
16 Specifics
Objectives
15 Milestones
10 Deliverables
News & Events
Services
Project Phases
SHAIPED is structured into three primary phases to effectively address the product life cycle of AI medical devices, adopting a phased approach to ensure comprehensive development and successful outcomes.
Kick-off – Laying the Groundwork
The first phase of SHAIPED focuses on establishing a foundational understanding of the current landscape and regulatory requirements for AI medical devices. During this initial phase, the project conducts an in-depth analysis of stakeholders, product life cycles, certification practices, and relevant legal frameworks. This groundwork provides essential insights into the existing ecosystem and lays the framework for the following project phases, ensuring that all stakeholders and regulatory aspects are well-aligned from the start.
Design – Pathways Development and Use Case Realization
Building on the insights from Phase 1, the Design phase centers on identifying specific opportunities for HDABs to impact AI integration in medical devices. This stage involves developing structured pathways and methodologies for HDABs to facilitate AI integration, leveraging HDAB tools and services to support AI medical device life cycles. The phase also includes the practical application of these pathways through the execution of real-world use cases, emphasizing the role of synthetic data and establishing protocols for data handling, compliance, and regulatory adherence.
Wrap-Up – Learning Consolidation and Recommendations
The final phase focuses on consolidating the findings and outcomes from the previous phases. This includes finalizing methodologies, refining tools, and compiling learnings from the use cases to formulate guidelines and recommendations for future projects. By sharing these results and best practices, SHAIPED aims to foster widespread adoption of the developed frameworks across the AI healthcare ecosystem. Disseminating these insights not only facilitates knowledge transfer but also empowers stakeholders across Europe to integrate these AI pathways into their healthcare systems effectively.
Secure, efficient, and regulation-compliant pathways for the development and deployment of artificial intelligence (AI) as medical devices.
Our Value
Work Packages
SHAIPED’s work is divided into structured work packages (WPs) focused on achieving key project objectives and milestones. These work packages ensure that SHAIPED’s goals are met through dedicated teams working on specific aspects of AI medical device deployment.
Project Management and Coordination
Communication and Stakeholder Engagement
HDAB Mapping and Tools Development
AI Deployment Pathways
Pilot Project Implementation and Testing
Case Studies
The SHAIPED use cases serve as practical applications that demonstrate the project’s approach to integrating AI in healthcare through HDABs. Each use case targets specific healthcare challenges, offering real-world insights into the deployment, testing, and validation of AI medical devices. By implementing these cases across multiple European countries, SHAIPED showcases how AI pathways can be adapted to meet diverse medical, regulatory, and operational needs, ultimately enhancing patient outcomes.
Soil Health Improvement for stronger plant.
Innovative Seeds in various conditions.
Agricultural with Technology Integration
Blog
Partners
SHAIPED brings together a robust network of over 30 partners, including health authorities, research institutions, and public health organizations from across Europe. These partnerships allow SHAIPED to integrate diverse perspectives and expertise to advance AI in healthcare.
