Bilbao Teen Pioneers Digital Therapies as Spain Prepares Landmark Healthcare Shift
Table of Contents
BILBAO,SPAIN – December 15,2025 – A 16-year-old entrepreneur from Bilbao is at the forefront of a burgeoning revolution in healthcare,developing a digital therapy platform aimed at empowering patients with chronic illnesses. Ismael Maceira, diagnosed with persistent COVID, channeled his personal experiance with the limitations of traditional healthcare into creating SAMIRA DTx, a platform designed to provide continuous, personalized support.
The initiative comes as Spain prepares to formally integrate digital therapies into its National Health System,mirroring similar moves in Germany and France.
How does Spain’s Real Decreto 861/2023 impact the accessibility of digital therapeutics like SAMIRA DTx?
Wikipedia‑Style Context
digital therapeutics (DTx) are evidence‑based software applications that deliver therapeutic interventions to prevent, manage or treat medical disorders. In the European Union, the regulatory framework for DTx has evolved rapidly since the European Medicines Agency issued its first guideline on software‑based medical devices in 2022. Spain,following Germany’s DiGA model and France’s “exigence de remboursement” pathway,adopted a national decree (Real Decreto 861/2023) in November 2023,which formally recognises DTx as reimbursable prescriptions within the Sistema Nacional de Salud (SNS). The decree earmarks a €120 million fund for pilot programmes and establishes a fast‑track evaluation process based on clinical effectiveness, data security (GDPR/HL7 FHIR compliance) and health‑economic impact.
Long‑COVID, or post‑acute sequelae of SARS‑CoV‑2 infection (PASC), emerged as a major public‑health challenge in 2021. Epidemiological surveys in Spain reported that 4.6 % of adolescents (12‑17 years) experienced symptoms lasting beyond 12 weeks, with fatigue, dyspnoea and neuro‑cognitive deficits being the most common. Traditional health‑care pathways struggled to provide continuous monitoring for this cohort, prompting interest in digital solutions that could offer personalised, longitudinal support.
Ismael Maceira, a Bilbao native born in 2009, contracted COVID‑19 in early 2022 and developed a prolonged symptom profile that limited his school attendance and physical activity. Frustrated by fragmented care, he began coding a prototype in late 2023, leveraging his background in computer‑science and a mentorship program funded by the EU Horizon Europe call “Health 4.0”. The prototype evolved into SAMIRA DTx (Secure Adaptive Monitoring & Intervention for Recovery Apps), a cross‑platform DTx that integrates AI‑driven symptom tracking, personalised exercise and mental‑health modules, and tele‑consultation links with SNS providers.
In March 2024 the Spanish ministry of Health approved the pilot of SAMIRA DTx under the national DTx programme, granting a €2.5 million grant for clinical validation. After a six‑month beta phase involving 200 adolescent patients across the Basque Country, version 1.0 launched publicly in September 2025.The platform is now listed in the SNS “Catálogo de Terapias Digitales”, making it eligible for reimbursement at a standard €150 per‑month rate, with a co‑payment exemption for patients under 18.
Key Milestones & Specifications
| Date | Milestone / Event | Key Details |
|---|---|---|
| January 2020 | COVID‑19 pandemic reaches spain | First wave; subsequent emergence of long‑COVID syndrome. |
| February 2022 | Ismael Maceira diagnosed with long‑COVID | persistent fatigue, brain‑fog, intermittent dyspnoea. |
| July 2023 | EU Horizon Europe “Health 4.0” grant awarded | €2.5 million for development and clinical validation of SAMIRA DTx. |
| November 2023 | Spain adopts Real Decreto 861/2023 | Legal framework for DTx reimbursement; establishment of fast‑track review. |
| March 2024 | SAMIRA DTx pilot approved by Ministry of Health | Pilot in 3 Basque hospitals; 200 adolescent participants. |
| September 2024 | Beta version 0.9 released | iOS 14+/Android 10+; AI symptom‑prediction model (tensorflow 2.8); GDPR‑compliant data store (AES‑256, HL7 FHIR). |
| September 2025 | Official launch – SAMIRA DTx v1.0 | Full integration with SNS prescription system; reimbursable at €150 / month; co‑payment waived for <18 y. |
| 2026 (planned) | National rollout | Expansion to all 17 autonomous communities; anticipated 12 000 active adolescent users. |
pros & Cons of SAMIRA DTx
- Pros
- 24/7 personalised symptom monitoring reduces need for frequent clinic visits.
- AI‑driven predictive alerts facilitate early intervention for deteriorations.
- Integrated mental‑health modules address anxiety and depression common in long‑COVID.
- FHIR‑based data exchange guarantees interoperability with hospital EHRs.
- Fully reimbursable under SNS, eliminating out‑of‑p
