Bridging the Gap: What Spain Can Learn From European Leaders in Digital Therapy Reimbursement
Author(s)
Ana M. Durán Esteban, MSc, Almudena González Domínguez, MSc, María Merino, MSc, Alexandra Ivanova, MSc.
Theorema4H, Madrid, Spain.
Theorema4H, Madrid, Spain.
OBJECTIVES: The aim of this study is to compare the regulatory frameworks for the reimbursement of digital therapies (DTx) in Germany, France, Belgium, and Spain, and to identify opportunities for improvement within the Spanish National Healthcare System.
METHODS: A comparative analysis was conducted in June 2025 using twelve official sources, including regulatory documents, health technology assessment guidelines, and national digital health directories. The sources reviewed included documents from the Federal Institute for Drugs and Medical Devices in Germany; the High Authority of Health and the National Gateway for Innovation and Digital Health in France; the National Institute for Health and Disability Insurance and the Federal Center for Healthcare Expertise in Belgium, and the Spanish Agency for Medicines and Health Products and the Ministry of Health. The study examined six key dimensions: legal frameworks, evaluation procedures, requirements for clinical and economic evidence, cybersecurity standards, interoperability with healthcare institutions, and institutional support mechanisms.
RESULTS: Germany, France, and Belgium have implemented structured and transparent pathways for evaluating and reimbursing DTx. Germany uses an accelerated approval process, France allows temporary reimbursement while evidence is generated, and Belgium applies a evaluation that it supported by a multidisciplinary assessment process. All three countries require CE marking, clinical benefit evidence, cybersecurity compliance, and integration with their respective national health systems. In contrast, Spain lacks a dedicated regulatory framework, formal evaluation procedures, and a public directory of reimbursed DTx. Although general health technology and data protection regulations exist, the absence of specific processes limits the systematic adoption of these therapies.
CONCLUSIONS: Spain faces significant challenges in aligning with European best practices for DTx reimbursement. Establishing a dedicated regulatory pathway, adopting recognized cybersecurity certification standards, and creating a national directory of reimbursed digital tools are essential steps to enhance transparency, efficiency, and innovation in the Spanish National Healthcare System.
METHODS: A comparative analysis was conducted in June 2025 using twelve official sources, including regulatory documents, health technology assessment guidelines, and national digital health directories. The sources reviewed included documents from the Federal Institute for Drugs and Medical Devices in Germany; the High Authority of Health and the National Gateway for Innovation and Digital Health in France; the National Institute for Health and Disability Insurance and the Federal Center for Healthcare Expertise in Belgium, and the Spanish Agency for Medicines and Health Products and the Ministry of Health. The study examined six key dimensions: legal frameworks, evaluation procedures, requirements for clinical and economic evidence, cybersecurity standards, interoperability with healthcare institutions, and institutional support mechanisms.
RESULTS: Germany, France, and Belgium have implemented structured and transparent pathways for evaluating and reimbursing DTx. Germany uses an accelerated approval process, France allows temporary reimbursement while evidence is generated, and Belgium applies a evaluation that it supported by a multidisciplinary assessment process. All three countries require CE marking, clinical benefit evidence, cybersecurity compliance, and integration with their respective national health systems. In contrast, Spain lacks a dedicated regulatory framework, formal evaluation procedures, and a public directory of reimbursed DTx. Although general health technology and data protection regulations exist, the absence of specific processes limits the systematic adoption of these therapies.
CONCLUSIONS: Spain faces significant challenges in aligning with European best practices for DTx reimbursement. Establishing a dedicated regulatory pathway, adopting recognized cybersecurity certification standards, and creating a national directory of reimbursed digital tools are essential steps to enhance transparency, efficiency, and innovation in the Spanish National Healthcare System.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR38
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas