SHAIPED

Work Package 1 (WP1), led by Health Data Hub (HDH), is responsible for managing and coordinating the SHAIPED project. It ensures that all activities are well-organized and that each partner's contributions align with the project's goals.

Key points:

• Meetings: Regular meetings are held to keep the project on track, address challenges, and monitor progress.
• Evaluation: Key Performance Indicators (KPIs) are used to track milestones and assess outcomes.
• Reporting and risk management: Clear protocols ensure transparency and quick decision-making.
• Administrative and financial oversight: Ensures all partners comply with the project's agreements and standards.

Work Package 2 (WP2), led by the Croatian Institute of Public Health (CIPH), aims to boost SHAIPED’s visibility and impact through effective communication and stakeholder engagement. This initiative focuses on promoting the project's goals, milestones, and achievements to various audiences, including healthcare professionals, policymakers, and the public.

Key points:

• Communication plan: A detailed plan is created to identify target audiences, craft key messages, and choose the best channels to reach stakeholders.
• Visual identity and outreach materials: The visual identity of SHAIPED is developed, and materials such as newsletters, press releases, and scientific publications are produced to build the project's brand and raise awareness across Europe.
• Events and collaboration: Events are organized to encourage dialogue and collaboration, creating a network of stakeholders dedicated to SHAIPED’s mission.

Work Package 3 (WP3), led by Sciensano (Belgium), focuses on identifying the tools, services, and resources that Health Data Access Bodies (HDABs) need to develop and use AI as medical devices. This is crucial for creating a clear and organized framework to integrate AI medical devices, utilize synthetic data, and meet regulatory requirements within the European Health Data Space (EHDS).

Key points:

• AI medical device lifecycle: The entire lifecycle of AI medical devices is examined, ensuring that every stage is well-defined and organized.
• Mapping tools and services: Tools and services provided by HDABs are identified and mapped out, ensuring they meet legal and regulatory standards.
• Synthetic data study: A study on using synthetic data is included to protect data privacy while maintaining its usefulness.

Work Package 4 (WP4), led by Aarhus University Hospital (Denmark), focuses on finding effective ways to deploy AI as medical devices, particularly in real-world settings. This initiative examines the later stages of the AI medical device lifecycle, exploring how real-world data (RWD) from Health Data Access Bodies (HDABs) can enhance the deployment and validation of AI solutions.

Key points:

• Deployment framework: A comprehensive plan is created for deploying AI medical devices in clinical settings, considering regulatory requirements and operational challenges.
• Real-World Data: By leveraging RWD, the work package aims to refine deployment strategies, ensuring that AI tools can be seamlessly integrated into existing healthcare systems.
• Practical challenges: This initiative addresses practical issues related to data management, compliance, and real-world effectiveness, ensuring that deployment pathways meet the standards of both the European Health Data Space (EHDS) and the AI Act.

Work Package 5 (WP5) is dedicated to testing and validating the pathways for AI medical devices supported by Health Data Access Bodies (HDABs) through real-world pilot projects. This initiative takes the theoretical frameworks and tools developed in earlier work packages and applies them to three specific use cases across different healthcare settings.

Key points:

• Real-World pilot projects: WP5 supports three concrete AI medical device testing and deployment projects. These projects aim to understand the challenges and opportunities associated with HDAB support and the use of real-world data.
• Assessing challenges and effectiveness: By testing these pathways in live environments, WP5 evaluates their challenges and effectiveness. This process gathers valuable insights into how HDAB resources are practically applied.
• Refining pathways and tools: By focusing on diverse use cases, WP5 aims to refine the HDAB pathways and tools, ensuring they meet real-world requirements and regulatory standards.
• Capacity building: This work package also helps build capacity at the HDAB level, ensuring that the methods are practical, effective, and scalable for widespread adoption across the EU.