JMIR Publications

ABSTRACT

Background:

The exponential growth of electronic health records (EHRs) coupled with the recent entry into force of the European Health Data Space (EHDS) regulation underscore the urgency of creating secure and interoperable environments for the secondary use of health data. In response to this need, HealthData@MAD-R&I® emerges as a pioneering initiative in Madrid (Spain), fully aligned with the EHDS strategy and the European Commission's vision for data sovereignty.

Objective:

The project seeks to develop and implement HealthData@MAD-R&I®, a regional health data space enabling responsible access to high-quality health data to improve clinical research, innovation, and healthcare decision-making.

Methods:

HealthData@MAD-R&I® mission is to establish a sustainable, scalable, and ethically governed health data space. The project adopts a structured, iterative methodology based on the Data Management Association (DAMA) framework and it is organized into nine work packages across three thematic areas: project management and sustainability; governance and technological infrastructure; and validation through four real-world use cases. The technical architecture uses a federated model using open-source components, with data integration based on the Observational Medical Outcomes Partnership (OMOP) standard to ensure semantic and syntactic interoperability. Artificial intelligence, machine learning, natural language processing, and privacy-preserving techniques are employed for data curation and secure access.

Results:

As of August 2025, the main achievements of the HealthData@MAD-R&I® project are the following ones: i) drafting of a data governance model that articulates principles of quality, transparency, and regulatory compliance; ii) development of a secure and interoperable technological architecture with data federation capabilities, based on international standards (DAMA and OMOP); and iii) design and implementation of four use cases (optimizing referrals in rheumatology; care pathways for long-term breast cancer survivors; predicting unplanned hospitalizations; and evaluating the effectiveness of statins in elderly patients) that will validate our health data space while addressing diverse clinical and policy challenges and will demonstrate the potential of data spaces to support evidence-based clinical practice and public policy.

Conclusions:

HealthData@MAD-R&I® aims to strengthen Madrid's leadership in digital health innovation, while also contributing to the European health data ecosystem by promoting interoperable, privacy-compliant secondary data use. The evaluation framework includes metrics on data quality, research output, and healthcare system impact.