The DTx Consortium, a multi-sectoral Spanish alliance participated by Ferrer, has taken a significant step in advancing digital therapies (DTx) in Spain by releasing a White Paper that thoroughly examines the current landscape of DTx in the country. This comprehensive analysis, titled “Current State, Challenges, and Recommendations for the Adoption of Digital Therapies in Spain”, highlights the growing importance of DTx and underscores the urgent need for clear regulations to facilitate their integration into the Spanish National Health System (SNS).
Formed in the summer of 2022 in Barcelona, the DTx Consortium includes leaders from the pharmaceutical, technology, telecommunications, insurance, start-up, innovation, and patient association sectors. This alliance aims to promote the adoption of digital therapies and facilitate their entry into the Spanish healthcare market.
The White Paper provides the first exhaustive analysis of the state of DTx in Spain. This document explores the world of digital therapies, starting with an introduction that contextualizes their significance and purpose, as well as their scopes and limitations. There you can also find an overview of the regulation of digital therapies, highlighting the necessity and advantages of appropriate regulation, alongside the existing regulatory framework in pioneering countries and initiatives at the European and international levels. The paper then goes into analyzing the status of digital therapies in Spain, the challenges for their adoption, and recommendations for their implementation.
Here we highlight some of the findings and give you a glimpse of the current Spanish landscape and main challenges and recommendations pointed up in the study.
The current landscape of DTx in Spain
Spain’s healthcare system has significantly advanced in digitalization, with notable achievements such as the widespread use of electronic health records and e-prescriptions. These technological strides are pivotal for integrating digital therapies into the healthcare ecosystem. However, despite these advancements, Spain faces substantial challenges in fully adopting digital therapies due to regulatory and financial gaps.
The regulatory landscape for digital therapies in Spain is currently very sparse. Unlike traditional medical devices, digital therapies lack specific regulatory frameworks at both the European and Spanish levels. This regulatory ambiguity creates hurdles for the clear classification and approval of digital therapies, impeding their integration into the healthcare system.
The funding for digital therapies by Spain’s National Health System (SNS) is virtually non-existent. Without inclusion in the SNS’s common services portfolio, these therapies remain inaccessible to many patients. This lack of funding is a significant barrier to the widespread adoption of digital therapies within the national healthcare framework.
Moreover, the decentralized nature of Spain’s healthcare system adds another layer of complexity. While the decision to include medical products in the national portfolio is made at the national level, the financial responsibility for these services falls to the Autonomous Communities. This decentralization can lead to disparities in the availability and adoption of digital therapies across different regions of Spain, as each community manages its budget independently.
The White Paper: a roadmap for the future
The White Paper doesn’t stop at analyzing the current landscape, it also outlines the primary challenges faced in adopting digital therapies and provides well-defined recommendations to overcome these hurdles.
Recommendations for the adoption of digital therapies:
- Establishment of a specific regulatory and funding framework: This should include a fast-track process, dedicated funding, and comprehensive evaluation criteria.
- Healthcare professional and patient training and awareness: Providing education and training is critical for successful DTx adoption.
- Evaluation models and evidence generation: A clear framework accommodating specific evaluation dimensions for digital technologies is essential for robust assessment.
- Clinical integration: Adapting the infrastructure and improving interoperability with the public and private healthcare sectors is necessary to integrate DTx into clinical workflows effectively.
- Promotion of research: Encouraging rigorous studies and clinical investigations to evaluate the efficacy and safety of DTx is key for demonstrating their value to healthcare systems and policymakers and building trust among healthcare providers and patients.
- Data security and privacy: Ensuring ethical practices regarding data quality, safety, and privacy is necessary to build trust among users, payers and prescribers.
- Collaboration: Fostering open innovation and collaboration between different types of companies and the public and private sectors is important to drive the development and adoption of digital therapies.
- Patient-centered approach: Focusing on the needs and experiences of patients is key to ensure DTx are effective and widely adopted.
With the publication of this report, the DTx Consortium establishes an initial reference framework for Spain to become a global leader in digital health. By providing a comprehensive analysis and clear recommendations, this report paves the way for the effective integration of DTx into the Spanish healthcare system. The collaborative efforts of the Consortium and its stakeholders, including Ferrer, will be instrumental in overcoming barriers and realizing the full potential of digital therapies.