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Spain

Towards a European harmonisation for digital health: report “Accelerating the adoption of digital health applications in Spain. Current landscape and roadmap”

19th April 2023

During 2022, EIT Health launched a series of roundtables in different European countries, with the aim of raising awareness and initiating a dialogue on the state of regulation of digital health applications and the changes needed to ensure that the best innovation reaches patients and citizens as soon as possible. 

EIT Health Spain organised several debates on this topic and participated in different activities on a regional level. In February 2022, it brought together a panel of 13 experts on the topic, including clinicians, health managers, patients, innovators and technology assessment experts, whose knowledge, experiences and opinions have been captured in the report ‘Accelerating the adoption of digital health applications in Spain’, which provides insights on how to create a suitable framework to accelerate the adoption of digital health applications in our country. 

The Spanish report  

The report ‘Accelerating the adoption of digital health applications in Spain. Current landscape and roadmap’ takes as a starting point the current situation of evaluation, financing and adoption of health technologies, including digital ones, in our country and the lessons learned from the German Digital Healthcare Act1, the first European fast-track for an accelerated process of evaluation and reimbursement of digital health applications (DiGAs, for its acronym in German). 

The different perspectives and inputs from the experts resulted in a 20-point roadmap to accelerate the adoption of innovative digital health applications that are truly transformative for the healthcare system, generate a thriving business network and, most importantly, deliver value to patients. 

However, accelerating the adoption of transformative digital health applications and solutions requires a collaborative approach, with all players in the value chain at key points in the innovation process: 

  • Develop support tools for innovators in stages before CE certification. 
  • Develop an appropriate regulatory process that balances the reality and regulations of health systems, the nature of digital solutions, protection, patient needs and the success of innovators. 
  • Develop a set of clinical validation criteria – based on value – for digital applications and seek their harmonisation within Europe to support a true European health space and market. 
  • Develop and pilot public procurement and funding models that enable startups and SMEs to develop beneficial digital health applications and access the service portfolio of public health systems. 

The report is available here. 

The European report 

In the coming days, EIT Health will launch a report that addresses the state of play of the adoption of digital health devices and applications and the potential harmonisation of evaluation and access processes at the European level.  

(1) Federal Ministry of Health (s. f.) Driving the digital transformation of Germany’s healthcare system for the good of patients [Online] https://www.bundesgesundheitsministerium.de/en/digital-healthcare-act.html 

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