SHAIPED and the European Health Data Space (EHDS): Shaping the Future of AI-Driven Healthcare in Europe

As Europe strides forward in the digital transformation of healthcare, the recent announcement of the SHAIPED project, led by the Health Data Hub (HDH), marks a significant milestone. SHAIPED aims to leverage artificial intelligence (AI) to enhance medical devices by improving accessibility to health data while prioritizing robust data governance. In alignment with the European Health Data Space (EHDS) regulation, SHAIPED represents a collective ambition to create a secure and innovative health ecosystem for European citizens. This initiative not only reflects the growing importance of AI and data in healthcare but also underscores Europe’s commitment to setting the highest standards in data protection and digital health. 

The European Health Data Space (EHDS): A Vision for Health Data Sharing Across Europe

The European Health Data Space is one of the European Union’s most ambitious regulatory frameworks. The EHDS aims to foster a comprehensive and secure environment for health data exchange among EU member states. With an emphasis on empowering citizens, the EHDS promotes patient control over their health data and ensures that data sharing remains voluntary, secure, and in line with the General Data Protection Regulation (GDPR).

The core goals of the EHDS include: 

1. Supporting Primary Use of Data for Patient Care: By enhancing data access, the EHDS supports continuity of care across borders, enabling better-informed clinical decisions and improving patient outcomes while empowering citizens over their health data.
2. Enhancing Cross-Border Healthcare: By allowing interoperable data exchange across member states, the EHDS aims to make healthcare more accessible and effective for all EU citizens.
3. Enabling Secondary Use of Data: Beyond patient care, the EHDS supports using health data for research, policy-making, and innovation purposes.
4. Supporting Innovation: EHDS will allow innovators to access diverse, high-quality health data for developing and testing digital health solutions, AI-driven diagnostics, and other medical advancements. 

The EHDS is a response to the growing need for an integrated European approach to healthcare data. As populations age and healthcare costs rise, the EHDS will support the development of personalized, data-driven solutions that meet the unique needs of citizens across the EU.

The SHAIPED project will help us to gain insights of a direct implementation of such a framework at the European level in the context of AI. 

SHAIPED: A Strategic Response to Data Needs in AI for Healthcare

SHAIPED, which will launch in 2025, represents a coalition of 30 partners from 11 EU member states, with a budget of €4 million. SHAIPED’s primary objective is to address the challenges of training, testing, and validating AI-based medical devices by providing access to real-world health data. 

AI in healthcare holds enormous potential to improve patient care, diagnostics, and overall system efficiency. However, these AI tools require extensive, diverse, and high-quality datasets to function accurately and effectively. SHAIPED’s focus is on enabling this access and, in doing so, facilitating the integration of AI-driven medical devices into European healthcare systems. 

Key Objectives of SHAIPED

SHAIPED’s work centers around three main areas: 

1. Data Accessibility for AI-Driven Medical Devices: By creating frameworks and agreements for data sharing, SHAIPED aims to ensure that developers have the necessary datasets to train and validate their AI-based tools across borders.
2. Large-Scale Validation of Clinical Efficacy: SHAIPED seeks to validate the clinical effectiveness of AI-based medical devices at a broader scale, ensuring they meet EU standards and are effective for patient care.
3. Integration into Health Information Systems: SHAIPED will work on standardizing the integration of AI medical devices into European health systems, ensuring these devices align with existing healthcare data infrastructure. 

These efforts will allow SHAIPED to play a crucial role in the implementation of the EHDS when it comes to the development of AI solutions that are not only innovative but also clinically effective and widely accessible. 

Use Cases: AI Solutions Addressing Critical Health Issues

SHAIPED will pilot three critical use cases to validate its AI solutions: 

1. Chronic Kidney Disease Management: Led by Aarhus University Hospital in Denmark, this case study will explore how AI models can adapt to data from various European sources, enhancing personalized treatment strategies for kidney disease.
2. Metastasis Detection: In partnership with Centre Léon Bérard and the HDH, this use case will test AI’s ability to detect pulmonary metastases and mammography anomalies, aiming to improve early cancer detection and treatment accuracy.
3. Heart Failure Prevention: Conducted by Implicity in France, this case will assess an AI tool for pacemakers, designed to prevent heart failure, demonstrating the impact of AI on chronic disease management and preventive care. Implicity is a company previously supported by EIT Health’s Bridgehead Europe program where they benefited from individualized support for market expansion and gaining operational support for deploying their business in Europe. 

These case studies exemplify AI’s potential to transform healthcare by offering solutions that enhance diagnosis, treatment, and patient outcomes across Europe. 

Addressing Strategic Challenges for European Health

SHAIPED is a timely initiative given the European Union’s growing focus on digital sovereignty and global competitiveness. The project directly addresses several strategic priorities: 

• Quality of Care: By enhancing diagnostic accuracy and treatment outcomes, SHAIPED contributes to improving the overall quality of care available to EU citizens. 

• European Competitiveness: As international competition in AI and digital health intensifies, SHAIPED aims to position Europe as a leader in healthcare innovation, supporting the growth and competitiveness of EU-based companies.

• Data Privacy and Security: SHAIPED is committed to maintaining rigorous data privacy standards. It aligns with the GDPR and the EHDS framework, ensuring that AI solutions respect patients’ rights to privacy and data protection. 

 

The Road Ahead

Thanks to the experience of EIT Health on cross european panel discussions such as the DMD Taskforce or the one on the Think Tank on the ‘Implementation of the European dataspace’, EIT Health will be involved in the identification of bottlenecks of the AI medical device deployment, especially when it comes to the reimbursement process. 

SHAIPED is set to deliver its first set of results in the autumn of 2025. Its success will pave the way for broader adoption of AI in healthcare, offering a sustainable model for future projects that seek to harness data for medical innovation. By establishing best practices and setting up a collaborative network of health data stakeholders, SHAIPED will support the European Commission’s ambition for a connected, data-driven healthcare ecosystem that serves the well-being of all European citizens. 

More information in the Health Data Hub press release.