Key data
| Regulation | Resolution of August 5, 2026, from the Under-Secretariat, publishing the Agreement between the Ministry of Health, the Community of Madrid, the Madrid Health Service and Red.es, M.P., for the development of intelligent digital services within the NHS |
|---|---|
| Publication | August 12, 2026 |
| Entry into force | August 12, 2026 |
| Agreement signature date | July 7, 2026 |
| Affected parties | NHS patients in Madrid, healthcare professionals and technology companies in the health sector |
| Category | Regulatory Changes |
| Financing | Recovery Plan funds (Next Generation EU) |
| European framework | EU Regulation 2025/327 — European Health Data Space (EHDS) |
Healthcare technology and artificial intelligence companies have a concrete window of opportunity: the agreement signed on July 7, 2026 between the Ministry of Health, the Community of Madrid (through the Directorate of Digitalization and the Madrid Health Service) and the Public Business Entity Red.es, M.P. launches high-value digital projects in the Madrid NHS. The Resolution of August 5, 2026 from the Under-Secretariat publishes this agreement in the Official State Gazette with effect from August 12, 2026.
The agreement is framed within the NHS Digital Health Strategy and its action plans, with financing from the Recovery, Transformation and Resilience Plan (Next Generation EU funds). The reference regulatory framework is EU Regulation 2025/327, which regulates the European Health Data Space (EHDS).
What does this regulation establish?
The agreement articulates collaboration between four organizations to develop intelligent digital services within the National Health System in Madrid. The specific projects identified are as follows:
| Project | Description | Direct beneficiaries |
|---|---|---|
| ÚNICAS Network | Network connecting specialized centers for pediatric rare diseases, sharing clinical information between them | Pediatric patients with rare diseases and their reference centers |
| National Health Data Space | Massive repository of health data with real-time analysis and integrated artificial intelligence tools | Healthcare professionals, researchers and health administration |
Both projects are supported by the framework of EU Regulation 2025/327 on the European Health Data Space, which establishes the conditions for secondary use of health data for research, public policy and innovation purposes within the EU.
Economic and operational impact
From a business perspective, this agreement has two dimensions of impact:
1. Business opportunities for technology providers. The activation of projects such as the National Health Data Space and the ÚNICAS network generates demand for solutions in areas such as clinical system interoperability, real-time data analysis platforms, artificial intelligence tools applied to diagnosis or management, and healthcare cybersecurity. These needs will likely be channeled through public tenders derived from the agreement.
2. Regulatory compliance obligations. Companies that already operate or want to operate in the health data ecosystem must adapt to EU Regulation 2025/327 (EHDS). This regulation governs the access, processing and transfer of health data, with direct implications for any technology provider handling clinical information in the NHS environment.
Financing with Recovery Plan funds ensures that projects have already committed budget support, which reduces the risk of paralysis due to ordinary budget restrictions.
Who does it affect?
- Healthcare technology companies (healthtech) that develop electronic health record, interoperability or hospital management solutions.
- Artificial intelligence companies with applications in clinical data analysis, assisted diagnosis or epidemiological prediction.
- Cloud infrastructure and cybersecurity providers oriented to the public health sector.
- Data and analytics companies that want to participate in the National Health Data Space.
- Hospitals and private clinics contracted with the NHS in Madrid, which will have to adapt to new interoperability systems.
- Healthcare professionals from the Madrid Health Service who will work with the new digital tools.
- Pediatric patients with rare diseases treated in specialized centers connected to the ÚNICAS network.
Practical example
A software company specialized in clinical data management wants to participate in the development of the National Health Data Space. To do so, it must comply with EU Regulation 2025/327 (EHDS), which regulates how health information is accessed and processed in public digital environments.
The first step is to verify that its technology architecture meets the interoperability standards required by the NHS and that it has the security certifications required to handle health data. Once accredited, it can apply for tenders that Red.es or the Madrid Health Service convene within the framework of this agreement. Financing with Recovery Plan funds means that tender timelines are relatively predictable and subject to execution milestones committed to the European Commission.
In the case of the ÚNICAS network, a company specialized in hospital system interoperability could participate in the technical integration of specialized centers for pediatric rare diseases, developing the modules for exchanging clinical information between them.
What should companies do now?
- Review compliance with EU Regulation 2025/327 (EHDS). Any company that wants to operate with health data in the NHS environment must audit its data architecture and privacy policies against this European regulation, which is already in force.
- Identify which projects they can participate in. The two specific projects of the agreement (ÚNICAS network and National Health Data Space) have different technical profiles. Determining which one fits the company's offering is the first step to prepare an application.
- Monitor derived tenders. Calls will be published on the Public Sector Contracting Platform. Set up alerts for tenders from Red.es, Madrid Health Service and Ministry of Health related to digitalization and AI.
- Obtain necessary accreditations. Access to public contracts in the healthcare field may require specific security certifications (ENS — National Security Scheme) and health data management. Starting these processes in advance avoids missing tender deadlines.
- Establish strategic alliances. Projects of this scale are usually awarded to consortiums or joint ventures. Identifying complementary partners (integrators, specialized consultancies, cybersecurity companies) can be decisive for winning tenders.
Frequently asked questions
What is the ÚNICAS network and which companies can participate in its development?
The ÚNICAS network is a project included in the agreement that connects specialized centers for pediatric rare diseases to share clinical information between them. Companies specializing in hospital system interoperability, clinical software development and health data management that meet the technical and security requirements of the NHS and EU Regulation 2025/327 can participate.
What is the National Health Data Space and how do companies access it?
It is a massive repository of health data with real-time analysis capacity and integration of artificial intelligence tools, driven by this agreement. Access for technology companies will be articulated through public tenders called by Red.es or the Madrid Health Service. The reference legal framework is EU Regulation 2025/327 on the European Health Data Space.
When does this agreement enter into force and what are the deadlines for companies?
The agreement was signed on July 7, 2026 and published in the Official State Gazette on August 12, 2026, the date from which it takes effect. There is no single adaptation deadline: companies must be prepared for when derived tenders are called, which will depend on the Recovery Plan execution schedule.
What is EU Regulation 2025/327 and what does it require tech companies to comply with?
EU Regulation 2025/327 regulates the European Health Data Space (EHDS) and establishes the conditions for access, processing and transfer of health data in the EU, both for primary use (healthcare) and secondary use (research, innovation, public policies). Companies handling health data in the NHS environment must adapt their technology architecture and privacy policies to this regulation.
What funds finance this agreement and what guarantees does it offer to providers?
The agreement is financed with funds from the Recovery, Transformation and Resilience Plan (Next Generation EU). This means that the budget is committed to the European Commission and subject to execution milestones, which provides greater predictability to tender timelines and reduces the risk of budget paralysis.
Official source
View complete regulation in official source
Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-17599