ExpectedOutcome:
Deliverables
Objective
Healthcare demands continue to increase due to factors like population growth, aging populations, and the prevalence of chronic diseases. Healthcare technologies can help meet these demands by, among others, increasing effectiveness of treatment and diagnostic solutions and efficiency of health systems. The deployment of new medical digital technologies and artificial intelligence (AI) powered solutions for healthcare purposes requires access to real world health data. The amount of data available to drive the development of AI should be as large as possible to limit the introduction of biases that could undermine the effectiveness and safety of healthcare AI solutions or increase inequalities in access to care.
The European Health Data Space (EHDS) establishes a common framework for the reuse of health data. It aims to facilitate and streamline access to EU-wide real-world health data for specific purposes such as the development, testing, deployment and uptake of products or services contributing to public health or the training, testing and evaluation of algorithms, including in medical devices, AI systems and digital health applications. The proposal for a Regulation on the EHDS provides for Health Data Access Bodies (HDABs) in each country as trusted anchors to support and supervise the reuse of health data.
As part of the wider AI ecosystem in health, such as Testing and Experimentation Facilities (TEFs) for AI and European Digital Innovation Hubs (EDIHs), this action aims to strengthen the role and capabilities of HDABs in streamlining the testing and deployment pathways for healthcare AI solutions.
The aim of this action is also to reduce time-to-market and foster the development of new AI-based healthcare products and services that significantly improve patient safety and wellbeing, while preserving privacy and security. This action is not only relevant to the implementation of the EHDS, but also to the implementation of the Artificial Intelligence Act (AIA), which establishes an overarching framework for trustworthy AI, including in healthcare (e.g. medical devices).
Scope:Scope
The action comprises the following: