ArticleJMIR research protocols2026
HealthData@MAD-R&I: Protocol for Design and Development of a Regional Health Data Infrastructure to Enable Secondary Use of Health Data in Research and Innovation.
Article in JMIR research protocols, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Correction: HealthData@MAD-R&I: Protocol for Design and Development of a Regional Health Data Infrastructure to Enable Secondary Use of Health Data in Research and Innovation.JMIR research protocols · 2026Article
- Dynamic Consent for Secondary Use of Health Data: Challenges and Opportunities Under European Law.JMIR medical informatics · 2026Review
Corrections and comments
- Erratum issued
Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe exponential growth of electronic health records (EHRs), together with the recent entry into force of the European Health Data Space (EHDS) Regulation, highlights the urgent need for secure, interoperable environments that support the secondary use of health data. In response, HealthData@MAD-R&I emerges as a pioneering initiative in Madrid (Spain), aligned with the EHDS strategy and the European Commission's vision for data sovereignty and trustworthy data reuse.
objectiveThis study aims to design and implement HealthData@MAD-R&I, a regional health data space that enables responsible access to high-quality health data to support clinical research, health care innovation, and evidence-informed decision-making.
methodsHealthData@MAD-R&I aims to establish an ethically governed, scalable, and sustainable health data space. The project adopts a structured, iterative methodology based on the Data Management Association (DAMA) framework. and it is organized into 9 work packages across three thematic areas: (1) project management and sustainability, (2) governance and technological infrastructure, and (3) validation through 4 real-world use cases. The technical architecture adopts a hybrid federated model built with open-source components, and data harmonization is performed using the Observational Medical Outcomes Partnership (OMOP) common data model to ensure semantic and syntactic interoperability. Artificial intelligence, machine learning, natural language processing, and privacy-preserving techniques are applied for data curation and secure access.
resultsAs of November 2025, the main achievements include (1) the development of a data governance model that articulates principles of quality, transparency, and regulatory compliance; (2) the design of a secure, interoperable technological architecture with federated capabilities based on international standards (DAMA and OMOP); and (3) the implementation of 4 use cases-optimizing rheumatology referrals, characterizing care pathways for long-term survivors of breast cancer, predicting unplanned hospitalizations, and evaluating the effectiveness of statins in older adults-to validate the data space while addressing diverse clinical and policy challenges. Together, these components demonstrate the potential of regional data spaces to support evidence-based clinical practice and public policy.
conclusionsHealthData@MAD-R&I seeks to strengthen Madrid's role in digital health innovation and contribute to the broader European health data ecosystem by promoting interoperable, privacy-compliant secondary use of health data. The project's evaluation framework includes indicators for data quality, research outputs, and health care system impact. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/82815.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.