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.
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.
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.
SHAIPED’s work is divided into structured 5 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 CoordinatorThe coordinating institution of SHAIPED is Health Data Hub (HDH)
FundingSHAIPED is a project funded by the European Union – Digital Europe Programme. The views and opinions expressed are solely those of the author(s) and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.
Duration: 3 years (2025-2028)
More information: The IACS team will lead the work of defining data flows and governance in data access for use in AI-based medical tools and devices. It will also be responsible for proposing a methodological approach for evaluating these health technologies for adoption and reimbursement by European health services.
More information: shaiped.eu/
List of SHAIPED´s partners
IACS and SHAIPED
IACS participate with Unidad de Biocomputación, del equipo de Decisiones Basadas en la Evidencia y del Grupo de Ciencia de datos para la investigación en servicios y políticas sanitaria.
The IACS team will lead the work of defining data flows and governance in data access for use in AI-based medical tools and devices. It will also be responsible for proposing a methodological approach for evaluating these health technologies for adoption and reimbursement by European health services.
Edificio CIBA
Avda. San Juan Bosco, 13
50009 Zaragoza
976 715 483
atlasvpm.iacs@aragon.es
cienciadedatosysalud.iacs@aragon.es
Atlas VPM, coordinated by IACS, is recognized by the Spanish Ministry of Health and Social Services and Equality as a privileged source (“Registro de Utilidad”) for the National Health System.
