The European Health Data Space is Spain’s great opportunity to advance in innovation and digital health

• Experts brought together by EIT Health Spain address the challenges for the implementation of the European Health Data Space in Spain at the DES.

• Flexibility, “smart” financing, agile regulation, training of professionals and interoperability are some of the aspects that our healthcare system will have to face to implement it successfully.

• Spain is in a privileged position for the integration of the European Health Data Space.

• The roundtable is part of a pan-European initiative, promoted by the EIT Health Think Tank and with the support of the European Commission. Its conclusions will feed into a report to be presented in Brussels at the end of the year.

Malaga, 15 June 2023. The European Health Data Space (EHDS) is a unique opportunity to advance innovation and digital health in Spain. This is what the experts brought together by EIT Health Spain, a Co-Location Centre (regional hub) of EIT Health, which is part of the European Institute of Innovation and Technology, a body of the European Union, affirmed in the roundtable at the Digital Enterprise Show (DES) in Malaga with the title `Data-driven innovation and European Health Data Space – Is Spain prepared for its implementation?`

A pan-European initiative

The meeting is part of a pan-European initiative promoted by the EIT Health Think Tank and coordinated by Andrzej Rys, Director for health systems, medical products and innovation at the European Commission. Under this initiative, similar roundtables will be held in 10 European countries, the conclusions of which will provide input for local reports and a European report to be presented later this year in Brussels.

To analyse Spain’s level of preparedness for this legislation, which is key to the construction of the European Health Union, the experts addressed six dimensions of implementation: data governance, financing, capacities and skills, data quality, the link between data for healthcare use and use in innovation, and aspects of education and communication for professionals, patients, and citizens.

For Izabel Alfany, Managing Director of EIT Health Spain, the European Health Data Space is a unique opportunity for the transformation of our healthcare system, for value-based care for patients and especially to impulse innovation in health in Spain and Europe.

“As a country, we are in a great starting position due to our high level of digitalisation. We need to analyse our strengths and weaknesses so that this regulation can be implemented quickly and successfully in our country, and we can make the most of the great potential that health data offers,” said Alfany.

Experts agree that the successful implementation of the European Health Data Space will depend to a large extent on specific regulations, as well as on the governance model, funding where it is needed, and adequate resources.

At the same time, they point out that the ecosystem of regulations, procedures, standards, and interoperability that is being developed with the EHDS is a great opportunity to drive funding to the right projects and to prioritise what is relevant.

Towards a culture of data in health

Throughout the session, a dozen experts from the public and private sectors provided recommendations on how to address the main challenges that the EHDS presents for its implementation in Spain.

All the experts agreed that Spain is in a privileged position to integrate the EHDS. Ana Miquel, Responsible for Health Innovation and International Projects in the Ministry of Health of the Community of Madrid and member of the Steering Committee of the pan-European EIT Health’s initiative on EHDS implementation said: “We start from a very good situation concerning digitalisation, a very mature level that positions Spain as a leading country for change”.

According to Pedro Luis Sánchez, director of the Research Department at Farmaindustria, Spain is “relatively well positioned compared to other European countries, both in the secondary use of data and in the digitalisation of its healthcare system”. In his opinion, the measurement of health outcomes “is increasingly important in global health decision-making, because, among other purposes, it can improve patients’ access to new drugs and increase efficacy”.

However, several challenges for our country urgently need to be addressed. For Carlos Tellería, from the Aragon Institute for Health Science and representative in Gaia-X of the European Commission’s Joint Action to implement the EHDS (TEHDAS), the governance model of the European Health Data Space must be fully respectful of the patient’s privacy, “but flexible enough to allow rapid-cycle research and innovation, avoiding a useless bureaucracy and tailor-made structures for the needs of regulators”.

He also called for “smart” funding that directs funds “to the deployment of innovative technologies and the empowerment of people, rather than hardware and computing infrastructures”.

Joaquín Cayón, Director of the Research Group on Health Law & Bioethics at IDIVAL, defended the implementation of the European Health Data Space “through specific digital health regulations”. To this end, he called for “abandoning defensive biomedical research that renounces to treat ambitiously the clinical data for fear of a restrictive legal framework.”

Regarding Spain’s capabilities in terms of infrastructure and people, Montserrat Daban, Director of Science Policy and Internationalisation at BIOCAT said: “It is mandatory to address key capacity gaps and skills needs to ensure the secure and responsible sharing of health information for primary and secondary use.”. She added that it is essential to “address interoperability issues to ensure that quality data can be interpreted and shared”.

Data quality

According to Francisco José Sánchez, Coordinator of the Digital Transformation Plan of the Andalusian Public Health System, it is important to “improve data quality in our information systems, provide us with the necessary resources, raise awareness and train our professionals”.

In this respect, Ana Miquel encouraged to work on the implementation of standards “not only to facilitate the secondary use of healthcare data”, but also to improve the quality of the data itself. “It is not just about standardising the origin of the data, but also its processing”, she added.

Finally, Pedro Carrascal, CEO of the Platform of Patient Organizations (POP), said that the European Health Data Space “generates excitement among patients, but also concerns about data security and data governance”. He also called for “progress in the integration of patients within the healthcare system so that they can participate first-hand in the transformation that the implementation of the EHDS will require”.

The conclusions of this session within DES 2023 will be incorporated into a national report on the Spanish situation regarding the implementation of the European Health Data Space, which is expected to be presented next autumn. Later this year, EIT Health will present a report in Brussels with the assessment of all European countries concerning the EHDS.