Key data
| Regulation | Resolución de 23 de marzo de 2026, de la Secretaría General de Salud Digital, Información e Innovación del SNS |
|---|---|
| BOE Publication | April 4, 2026 |
| Entry into force | Not specified |
| Affected parties | Patients, patient associations, healthcare professionals and technology companies in the health sector |
| Category | Regulatory Changes |
| Agreement parties | Secretaría General de Salud Digital, Información e Innovación del SNS and Foro Español de Pacientes |
| Affected areas | Health applications, digital clinical history, SNS interoperability |
Health sector technology companies working with the Sistema Nacional de Salud have a new reference framework as of April 4, 2026. The Secretaría General de Salud Digital, Información e Innovación del SNS has formalized an agreement with the Foro Español de Pacientes to drive the digital transformation of the public health system with a patient-centered approach.
This is not a symbolic agreement. It represents a clear signal that the patient perspective will be a key criterion in the design, evaluation and implementation of digital tools within the SNS. For any company that bids for or develops technology projects in the public healthcare sector, ignoring this change may result in being excluded from future tenders and contracts.
What does this regulation establish?
The agreement establishes a formal collaboration framework between two bodies with complementary roles: the Secretaría General de Salud Digital, which leads the technological transformation of the SNS, and the Foro Español de Pacientes, which represents the interests of users of the healthcare system.
The specific elements included in the agreement are as follows:
- Active participation of patient associations in the design and implementation of digital healthcare tools.
- Guarantee that technological solutions respond to the real needs of system users, not just technical or administrative criteria.
- Direct influence on the development of health applications, digital clinical history and interoperability between systems.
- Patient perspective criterion as an evaluable element in future digital projects of the SNS.
The agreement was signed on March 23, 2026 and published in the BOE on April 4, 2026 by means of a Resolución of the Secretaría General de Salud Digital, Información e Innovación del SNS. The date of entry into force has not been specified in the published text.
Economic and operational impact
This agreement does not generate direct costs or immediate financial penalties for companies. Its impact is strategic and operational: it redefines the criteria by which the SNS will evaluate and select technological solutions in the future.
The specific operational implications for companies in the sector are:
- Redesign of product development processes: incorporating mechanisms for patient and association participation in the design and validation phases.
- Adaptation of commercial proposals and tenders: demonstrating that solutions have been designed with a focus on the end user, not just the healthcare professional or administrator.
- Differentiation opportunity: companies that already work with user-centered design methodologies have a competitive advantage in future SNS contracts.
- Risk of exclusion: companies that do not adapt their approach may be at a disadvantage in tender processes where the patient perspective is an evaluable criterion.
The technology areas directly affected are health applications, digital clinical history and interoperability between SNS systems. These are precisely the segments with the highest volume of public investment in healthcare digitalization in the coming years.
Who is affected?
- Health sector technology companies that develop or bid for digital solutions for the SNS (applications, platforms, clinical history systems, interoperability).
- Healthtech startups and scaleups seeking contracts with public health administrations.
- Technology consultancies with projects in the field of public digital health.
- Patient associations that now have a formal role in the design of digital healthcare tools.
- Healthcare professionals who will use tools designed with greater patient participation.
- Managers and executives of public healthcare centers who will need to incorporate this approach into their technology procurement processes.
Practical example
A healthcare software company that develops a digital clinical history platform and wants to bid for a contract with a regional government for its implementation in SNS hospitals.
Until now, its proposal focused on technical functionalities, integration with existing systems and regulatory compliance. Under this new framework, project evaluation may include criteria such as:
- Has any patient association participated in the design of the interface or functionalities?
- Have usability tests been conducted with real patients?
- Does the solution address needs identified by system users, not just healthcare professionals?
The company that can demonstrate it has worked with the Foro Español de Pacientes or equivalent associations in its development process will have a real competitive advantage over competitors that have not. Adapting the development process now, before these criteria become mandatory in tender specifications, is the right strategic decision.
What should companies do now?
- Review product development processes to identify at which stages patient participation or involvement from associations such as the Foro Español de Pacientes can be incorporated.
- Establish contact with relevant patient associations for the health area in which the company operates, before this becomes a formal requirement in tenders.
- Update commercial and tender proposals to include evidence of patient-centered design: usability testing, end-user participation, validation with associations.
- Monitor SNS tender specifications in the areas of health applications, digital clinical history and interoperability to detect when the patient perspective becomes a formal evaluable criterion.
- Train product and sales teams in user-centered design methodologies applied to the healthcare environment, in order to be able to demonstrate this to public administrations.
Frequently asked questions
What does this agreement mean for health sector technology companies?
The agreement establishes that the patient perspective will be a key criterion in the design and implementation of digital tools within the SNS. Tech companies developing solutions for the public system will need to incorporate patient association participation into their design processes.
When does the agreement between the Ministry of Health and the Foro Español de Pacientes come into force?
The date of entry into force is not specified in the regulation published on April 4, 2026. The agreement was signed on March 23, 2026 and published in the BOE on April 4, 2026.
Which digital areas of the SNS does this agreement affect?
The agreement may directly influence the development of health applications, the digital clinical history and SNS interoperability systems. These are the areas where the patient perspective will be integrated as a design criterion.
What role do patient associations play in SNS digitalization?
Patient associations, represented through the Foro Español de Pacientes, will actively participate in the design and implementation of digital healthcare tools, ensuring that technological solutions respond to the real needs of system users.
What should health tech companies working with the SNS do now?
They should review their product development processes to incorporate patient and association participation mechanisms. Those bidding for SNS digital projects should anticipate that the patient perspective will be an evaluable criterion in future tenders and projects.
Official source
View the full regulation at the official sourceDisclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, please consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-7699