Why Choose Us
About
Supporting Health Data Access Bodies to establish AI pathways enabling Deployment of AI as medical device tools
The European Health Data Space (EHDS) regulation and the AI Act are set to transform the AI medical device ecosystem.
To harness the potential of these regulations and overcome existing bottlenecks, SHAIPED aims to optimize the pathways for AI medical device development, testing, and deployment by leveraging Health Data Access Bodies (HDABs).
SHAIPED will build on expertise from various EU-funded initiatives to identify tools and services to offer HDAB-supported pathways, for AI medical devices and ultimately improve patient outcomes.
SHAIPED will
The project will support the synergetic implementation of the EHDS regulation and the AI Act, strengthen the EHDS ecosystem and support capacity building at the HDAB level.
SHAIPED will also bring the EHDS ecosystem closer to the AI medical device innovation and regulatory ecosystems to accelerate the benefit generation of the new regulations. The project will contribute to ultimately reducing time-to-market for AI medical devices and enhancing the EU’s attractiveness and competitiveness in the field.
The project supports the Digital Europe program’s objective of bringing advanced digital technology to businesses, citizens, and public administrations.
In that context, SHAIPED aims at identifying, building new and strengthening existing pathways for AI medical device development, testing and deployment provided by Health Data Access Bodies. For that overall aim, SHAIPED leverages the unique positioning of HDABs while also involving other actors involved in the AI medical device product lifecycle and building on expertise and experience from other EU-funded initiatives
Demonstrate in practice how HDABs can bring added value to innovators who are developing, testing or deploying AI medical devices and
develop tools, pathways and methodologies that will enable HDABs to accelerate time to market for these devices and to improve patient outcomes.
Bring together different ecosystems to enhance the mutual understanding and build synergies around the EHDS and AI Act. These ecosystems include the EHDS ecosystem, AI medical device innovators and actors from the regulatory ecosystem like national competent authorities, HTA bodies, notified bodies under MDR/AI Act and others
Why Choose Us
Project Goals
SHAIPED’s overarching goals include the establishment of a streamlined, regulatory-aligned framework for AI medical devices, centered around the main goals.
Understand Existing Pathways and Identify Limitations
SHAIPED aims to evaluate the current pathways for AI medical device development and testing, identifying key limitations and bottlenecks that hinder their effectiveness. This involves mapping the regulatory landscape and clarifying roles within the lifecycle of AI medical devices.
Strengthen and Create Pathways Using EHDS and AI Act
By building on the regulatory frameworks set forth by the AI Act and the EHDS, SHAIPED aims to establish new and strengthen existing pathways, placing HDABs at the center. The goal here is to ensure HDABs can provide the necessary data support, ensuring data quality and privacy to facilitate the entire AI lifecycle for medical devices.
Build Capacity and Forge Connections Across Ecosystems
SHAIPED also focuses on strengthening the HDAB ecosystem by connecting it with various research, innovation, and regulatory communities, including innovators, notified bodies, health technology assessment (HTA) bodies, and other authorities. This creates a collaborative network that can better respond to regulatory demands and enables seamless integration within the EHDS ecosystem.
Real-World Testing of Pathways Through Use Cases
SHAIPED will conduct real-world testing of its established pathways by implementing use cases in critical areas. These use cases will provide insights into the operational challenges and benefits of HDAB-supported pathways, refining the support processes required for effective AI medical device deployment.
Reduce Time-to-Market and Enhance Patient Outcomes
Ultimately, SHAIPED aims to make the European market more attractive and competitive by reducing the time-to-market for AI medical devices and improving patient outcomes. By accelerating the integration of AI in healthcare, SHAIPED contributes to better healthcare delivery, timely patient care, and strengthened regulatory compliance.
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.
PHASE 1 – Months 1>9
Kick-off
Laying the Groundwork
PHASE 2 – Months 10>27
Design
Pathways Development and Use Case Realization
PHASE 3 – Months 28>36
Wrap-Up
Learning Consolidation & Recommendations
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.
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.
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.
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.
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.
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
Competitiveness And Benefits For The Society
Artificial Intelligence presents vast opportunities for healthcare systems to improve patients’s lives
Artificial Intelligence (AI) is poised to be a key driver of technological advancement, revolutionizing various sectors and enhancing our quality of life. AI holds particular promise for health systems, which are under considerable strain. In healthcare, AI solutions are relatively mature, especially in areas such as imaging and decision support. These technologies can greatly alleviate the burden on healthcare systems, and improve patient outcomes. In the context of the European Health Data Space, it will be crucial to ensure that the organisational, legal and technical pathways for the (secondary) use of health data are in place so that innovators can move towards the deployment at scale.
This initiative will aim to reduce the barriers to entry for innovators within the EU market
This initiative will aim to ensure that European conditions (patient data, standards & regulations) are incorporated into the development process of AI medical devices.
This initiative places a strong emphasis on managing the risks associated with AI deployment, ensuring that these technologies are safe, ethical, and beneficial for all segments of society.
Expected Outcomes And Deliverables
Report on AI Testing and Deployment Pathways: Limitations and Gaps in the Current Landscape
Report on the identified pathways for testing and deployment of AI in health and their limitations and gaps in the current landscape: This goal will be fulfilled with WP3 “Tools and services for AI development, test and deployment pathways in the EHDS” that will conduct a robust landscape analysis of the AI medical devices lifecycle and identify relevant tools and services to establish pathways. ( notably through tasks 3.1 and 3.2 (full details below)). This work package will produce the following deliverable “D3.1 – Guidelines for HDABs to support AI development” that allow to identify pathways for testing and deployment of AI in health and their limitations and gaps in the current landscape.