The challenges of the future European Health Data Space (EHDS)
A little over a year ago, the European Commission presented its proposal for the creation of a European Health Data Space, which is still under negotiation. European countries are already working on the future translation of the regulation. From the BioRegion of Catalonia, Biocat coordinates the European project EDAH (an acronym for "Interconnecting innovation ecosystems for common European data space in Health"), with which it is finalizing a report on the situation of the subject in Spain. We review some of the challenges and key aspects that representatives of the different actors involved have told us about.
The European Health Data Space aims to make it easier for citizens to access and share their health records in a "single market", harmonized at the European level, while at the same time providing an efficient framework for the secondary use of these health data. In this sense, the European Health Data Space opens up great opportunities for the healthcare sector, for example, by enabling progress in predictive medicine and personalized medicine, facilitating medical and diagnostic decision-making, and avoiding duplicate testing. For researchers and companies, the European Health Data Space should facilitate the discovery of new drugs (taking into account the genetics, diseases, or lifestyle of each patient), the reduction of adverse events, and the optimization of clinical trials. With more data available, the number of clinical trials needed can be reduced, participants can be selected according to certain prerequisites, and researchers can monitor participants in real time.
The European Commission's proposal is still in the negotiation phase, but the different European countries are already working on the future translation of this regulation into the reality of their territories. From July 1 until the end of the year, Spain holds the presidency of the Council of the European Union. The sector is waiting expectantly to see how the trio formed by Spain, Belgium, and Bulgaria will advance in the regulation of this European Health Data Space, an issue that was among the priorities of the previous trio (France, Czech Republic, and Sweden).
Biocat participates in coordinating the EDAH project, funded by Horizon Europe, which aims to promote dialogue and development towards more inclusive, dynamic, diverse, and interconnected European innovative ecosystems to achieve the European Health Data Space (EEDS). Within the framework of this project and in collaboration with other agents, Biocat has carried out case studies of various European countries (available on the project website) and has organized two working sessions this July with representatives from public administrations and industry to discuss and collaborate in the creation of this data space: As a result, it will soon publish a report on the situation of the issue in Spain.
"Data is a challenge. There is no point in having the capacity to store and connect data, and for there to be interoperability between the different healthcare systems, if we cannot access that data to drive research and innovation, not only in the public sector but also in the private sector, to validate their technologies," recalls Robert Fabregat, CEO of Biocat.
What is the current situation in the BioRegion of Catalonia?
Pol Pérez Sust, Director of Information Systems at the Servei Català de la Salut, explains that "in Catalonia, we have a lot of healthcare information, probably too much". Specifically, 27 different hospital information systems. Until now, the Servei Català de la Salut has worked on "syntactic interoperability" (one center can interpret the data of another, for example), but now the challenge is the so-called "semantic interoperability": to be able to exchange not only data but also the associated content and context. The objective? "To have all the information available, regardless of where it is collected, with a data standardization structure that is the same in all countries, so that a study carried out in Catalonia or Germany can recover the data from another country to help improve the quality of care," explains Pérez Sust.
Míriam Méndez, Head of Research and Innovation of the Office of the Delegate for Health Data Protection at the Fundació TIC Salut Social, warns that "the European Health Data Space will provide the structures to make secondary use of the data, but the principles for doing so are already in place with the current regulations". Currently, article 18 of Law 41/2002, which regulates the basic autonomy of the patient and the rights and obligations regarding clinical information and documentation, is the rule that recognizes the right of access to medical records under certain terms. Health data are considered sensitive data, and their processing is prohibited unless the circumstances provided for in Article 9 of the General Data Protection Regulation (GDPR) are met.
Many research studies that require the use of clinical data run into obstacles when they are already before ethics committees. For this reason, Miriam Méndez calls on research entities to "make an effort to comply with the principle of privacy right from the start" of the studies. An example of good practice in this regard is the Vall d'Hebron Hospital, which two years ago created the "Data Access Commission" to harmonize all initiatives involving the use of health data.
Joaquín Cayón, Vice-President of the European Health Law Association, claims that the new European regulation must be ambitious and go "much further" than the GDPR. "We must seek solutions to the eventual risks that have made the current regulation so defensive," he points out. For example, through the pseudo-anonymization of data, the establishment of "broad consent," and ensuring the compatibility of data for secondary use. Cayón defends the need to abandon the Helsinki model and move towards a pro-research model, apply data mutualization formulas, and ensure that the regulation of health data is autonomous since they have characteristics that are very different from those of other sensitive data, such as, for example, banking data.
And where is the role of patients?
"If we want to create a healthcare data space, we need to have the collaboration of the citizens, who are the owners of that data, and that translates into trust and compliance," warns Juan Ignacio Coll Claver, Director General of Digital Transformation, Innovation, and Users' Rights of the Government of Aragon. If we want citizens to give their consent, we must provide them with something more; they need channels of participation to take co-responsibility for the data from the very first moment". In this sense, Pedro Carrascal, Director General of the Platform of Patients' Organizations, claims that European healthcare systems should provide more ways for patients to participate. "They should participate in ethics committees, care process committees, etc. so that they can begin to understand what their clinical data are for," warns Carrascal, who reminds us that these data can be useful for creating new therapies and monitoring chronic patients.