On 9 September 2025, the SHAIPED consortium officially launched its External Advisory Board (EAB) – a diverse group of independent experts from across Europe, representing ministries of health, national data agencies, competent authorities, universities, industry and major EU projects.
The EAB is much more than a formality. It will actively review deliverables, advise on strategy, and ensure SHAIPED’s solutions remain fully aligned with Europe’s evolving regulatory and technical landscape for AI in healthcare.
A Strategic Compass for SHAIPED
SHAIPED operates at the intersection of several key European regulations — the European Health Data Space (EHDS), the AI Act, the Medical Devices Regulation (MDR) and the Health Technology Assessment Regulation (HTAR).
To navigate this complex terrain, the EAB brings together experts from public authorities, academic institutions, research centers, and industry innovators, ensuring SHAIPED’s outputs are both technically robust and regulatory-ready.
Four Expert Colleges – One Shared Mission
To channel expertise efficiently, the EAB is structured into four thematic groups, each addressing a crucial dimension of SHAIPED’s mission.
⚖️ Legal Group
Comprising legal specialists in health data governance and ethics, this group includes experts in the EHDS Regulation, AI Act, MDR and cross-border legal harmonisation. Their backgrounds span European universities and bioethics councils, ensuring SHAIPED’s proposals are grounded in legal reality and ethical integrity.
🧾 Regulatory Group
This group brings together representatives from competent authorities and health ministries, such as the Italian Ministry of Health and Agenas, alongside HTA advisors, insurance experts and contributors to EU initiatives like IDERHA. Their collective insight will help SHAIPED address market access, certification and post-market surveillance challenges for AI-based medical devices.
💻 Technical / Data Group
A dynamic mix of AI innovators, SMEs, and computing infrastructure leaders, including representatives from the Barcelona Supercomputing Center (EuroHPC), EGI, NHS England AI team, Synthia Project and Enversion, this group focuses on AI development, interoperability, data discovery, and computing capacity. They ensure SHAIPED’s technical outputs meet both performance and compliance standards.
🌐 EHDS & HDABs Group
Representatives from national Health Data Access Bodies (HDABs) and data services — including the German DACO, GÖG (Austria), the Swedish eHealth Agency, the Luxembourg National Data Service and the Italian Ministry of Health — bring firsthand experience from the front lines of health data governance. Their perspectives ensure SHAIPED’s tools and frameworks complement real EHDS infrastructures and support cross-border data sharing.
Key Themes from the Kick-off Discussion
At the inaugural EAB meeting, members discussed how to turn complex European regulatory frameworks into actionable, technically implementable solutions.
Core themes included:
- Harmonising interpretations of EU regulations and translating them into practical technical requirements.
- Ensuring trustworthy and transparent AI, including robust validation and post-market monitoring
- Managing the data lifecycle to safeguard reproducibility, reliability, and cross-border interoperability
- Exploring synthetic and proxy data to enable innovation while protecting privacy
- Embedding machine-actionable compliance – automating data quality and certification checks within SHAIPED’s tools
Looking Ahead
The EAB will remain an integral part of SHAIPED until the project’s conclusion in 2028, providing continuous feedback and strategic direction across work packages — particularly WP3 (Pathways for AIaMD development & testing) and WP4 (Pathways for AIaMD deployment).
Members will review deliverables, join workshops, and advise on regulatory readiness, ensuring that SHAIPED’s technical outputs translate into usable, policy-aligned, and patient-centered innovations.
Strengthening Europe’s AI and Health Data Future
With its External Advisory Board now in place, SHAIPED reinforces its commitment to trustworthy, regulation-compliant, and sustainable AI in health.
By connecting expertise from ministries, research, regulation, and technology, SHAIPED is building a bridge between policy and practice — helping make Europe a global leader in responsible, data-driven healthcare innovation.