EIT Health Spain launches an initiative to speed up the adoption of digital health applications
EIT Health Spain -the Spanish hub of EIT Health, based in the Barcelona Science Park- has launched the F3T project to establish a roadmap and recommend feasible solutions that accelerate the arrival of the highest value digital health applications to the patient and the market while reducing barriers to innovators. The strategic group that will lead this initiative is made up of fourteen representatives from the health administration and institutions, hospitals, evaluation agencies, industry, and start-ups in the health sector.
The F3T – Framework for Fast Fast-Track of Digital Health Solutions project brings together experts and players in the health innovation value chain to define a framework to speed up the adoption of digital health applications in Spain, with implementable recommendations for decision-makers. The project, at the same time, aims to ease the difficult path for innovators and entrepreneurs.
The F3T Core Group is composed of representatives from the health administration and institutions, hospitals, evaluation agencies, industry, and start-ups in the health sector, invited by EIT Health Spain, which acts as facilitator and coordinator of the initiative to bring together the health innovation ecosystem.
The ultimate goal is to reach a minimum consensus for harmonisation in the processes of evaluation, adoption and financing of digital health applications in Spain, as well as to facilitate the scalability of solutions.
The F3T is the result of consultations and meetings that EIT Health held in 2022 which are included in the report ‘Accelerating the adoption of digital health applications in Spain’. The report identifies the obstacles in the way of innovation in digital health apps and the areas where is key to intervene as a priority.
“In the future, high-quality and clinically validated mobile health apps will help to fill some gaps in healthcare, improve or even replace some conventional treatments, and help make healthcare systems more resilient and financially viable. “But if we are not able to ensure that the best innovations in this field reach the patient and the system quickly, equitably and safely, we will be missing the opportunity provided by European and national transformation funds and plans,” points Izabel Alfany, director of Operations at EIT Health Spain.
Clinical validation: a challenge for innovators
Getting evidence of the efficacy or benefits of these digital solutions through quality clinical studies can be a challenge for innovators. “Strong evidence is essential if digital applications are to be prescribed and funded. And at the same time, it is critical to have the right regulatory conditions in place so that this requirement for clinical evidence does not kill innovation,” says Alfany.
In this sense, the Core Group aspires to a common minimum harmonisation framework for all Autonomous Regions and healthcare organisations, avoiding ineffective repetition of pilots, which reduces the scalability of applications and equity in patient access to innovation.
Germany took the lead by launching a novel process for the fast-track approval of digital, prescribable and reimbursable apps (popularly known as DiGA fast-track). France, Belgium and Luxembourg are also moving in this direction.
“Spain cannot be left behind and needs a consensus of all the stakeholders so that the solutions that bring value for patients reach them as soon as possible and in a safe way. As the main driving force in the health innovation ecosystem, at EIT Health we believe we have the responsibility and the capacity to facilitate this process,” states Ángeles Barrios, public affairs lead at EIT Health Spain, who is responsible for coordinating the project.
Experts and organisations from the public and private sectors
The project will focus on four areas: value-based assessment criteria, design of the regulatory process (fast track), procurement and financing models and, the development of tools or processes to support innovators and entrepreneurs in the phases before CE certification, providing guidance on clinical needs, value-based outcomes and the regulatory pathway itself.
Between March and May, the Core Group will extend participation to other relevant stakeholders and experts. Under the coordination of EIT Health, they will work, through consultations and workshops, on developing proposals, identifying bottlenecks, and devising implementable solutions.
“At EIT Health we want to facilitate the work of key stakeholders to develop a feasible process in Spain, which will enable the difficult balance between the reality and regulations of Spanish healthcare systems, the complex nature of digital solutions, patient protection and needs, and the success of innovators,” explains Cristina Bescós, managing director of EIT Health Spain and Director of Innovation for the organisation at European level. “We want the conclusions of this project to have the greatest possible legitimacy by bringing experts, stakeholders and decision-makers to the table. Only with a collaborative, inclusive approach and with the generosity of all, we will be able to make progress in an area as in need of consensus and progress as the adoption of digital health solutions for unmet health needs”.
» For further information: EIT Health Spain website [+]