EHDS is Now Law: What it Means for Neurology Data Spaces

The European Health Data Space (EHDS) regulation, adopted in March 2025, represents the most significant health data reform in the European Union. It establishes a legal framework for the primary and secondary use of health data across member states, with direct implications for how sensitive and high-value datasets such as those in neurology will be governed, shared, and leveraged. In this blog, we explore the regulatory context, the opportunities and challenges for neurology, and how initiatives such as the NeuroGenAI project are positioned to lead in this new era of data-driven medicine.

The EHDS, formally adopted as Regulation (EU) 2025/327, aims to harmonise the use of health data for research, innovation, and policymaking across Europe (European Parliament & Council 2025). Historically, health data in the EU has been fragmented, with national differences in governance, consent models, and infrastructure impeding large-scale, cross-border research. The EHDS establishes common standards and governance mechanisms, as well as national data access bodies that will grant researchers, companies, and policymakers secure, federated access to health data (European Commission 2025). The regulation is designed to support the secondary use of data, beyond individual patient care, while upholding safeguards for privacy, security, and ethics.

For neurology, the EHDS unlocks a transformative set of opportunities. Neurological conditions such as Alzheimer's disease, multiple sclerosis, epilepsy, and Parkinson's are highly heterogeneous, requiring vast datasets to identify meaningful patterns. The ability to federate data across borders enables access to imaging datasets, genomics data, and electronic health records (EHRs). This cross-border pooling is essential for training next-generation artificial intelligence (AI) tools capable of early detection, precision diagnostics, and personalised treatment strategies (European Commission 2025).

Moreover, the regulation's emphasis on interoperability and FAIR principles (Findable, Accessible, Interoperable, Reusable) ensures that neurology researchers can access data that is not only larger in scale but also higher in quality (European Parliament & Council 2025). By aligning on standards, the EHDS reduces duplication of effort and accelerates knowledge transfer across Europe.

The NeuroGenAI project is an effort to create the first EHDS-native data space in neurology. With partners across academia, hospitals, and industry, NeuroGenAI is building federated access pipelines that comply with EHDS standards from the outset. The project's ambition is to enable cross-border research on neurological diseases at scale, with AI models trained on harmonised imaging, genomic, and clinical datasets (European Commission 2025).

The EHDS represents an opportunity to consolidate Europe's fragmented health data landscape and unlock the full potential of digital health. For neurology, where data scale and diversity are essential for tackling some of the most complex diseases, the implications are profound. By embracing EHDS principles and aligning with initiatives such as NeuroGenAI, hospitals and researchers can accelerate progress toward earlier diagnoses, tailored therapies, and improved patient outcomes (European Commission 2025).