Access and responsible use of health data They are essential to the transformation of health systems in Europe, this was evident during the meeting The value of data in biomedical and scientific researchorganized by MSD in collaboration with the Spanish Society for Health Informatics (SEIS). This event organized in the city of Leon, topics highlighted such as the creation of European Health Data Space (EEDS) which can mark a before and after in the prevention, research and personalization of medical treatments.
Thus, the European Health Data Space (EEDS) will be a key pillar of a strong European Health Union and it is the first common space EU data in a specific area arising from the European Data Strategy.
In spring 2024, the European Parliament and the Council reached political agreement on the Commission’s proposal for this space which will allow citizens to take charge control of your health data and will facilitate the data exchange for the provision of healthcare across the EU (primary use of data); promote a truly single market for electronic health record systems; Provide a consistent, reliable and efficient system for the reuse of health data in research, innovation, policy development and regulation (secondary data use).
In this way, the EEDS will allow the EU fully harness the potential of safe and secure sharing, use and reuse of health data for the benefit of patients, researchers, innovators and regulators.
Trust This is an essential factor in the success of the European Health Data Space. The EEDS will provide a reliable framework for the secure access and processing of a wide range of health data. It is based on these texts:
The EEDS will also include opt-out rules:
- Main use: Member States can propose a total exclusion of infrastructure built under the EEDS;
- Secondary use: The text includes opt-out rules that strike a good balance between respecting patients’ wishes and ensuring that the right data is accessible to the right people in the public interest.
What is the European Health Data Space?
The EEDS, promoted by the European Commission in 2022, aims to create an infrastructure enabling secure cross-border access to electronic health data, both for direct medical assistance (primary use) and for research, innovation and health policies (secondary use). According to the Commission’s estimates, EEDS could generate 20-30% growth in the digital health market and save 11 billion euros over the next decade, by optimizing data management and promoting health innovation.
The implementation of the European Health Data Space (EEDS) represents an unprecedented opportunity to shape the future digital and health data ecosystem and reposition Europe as a leader in the biomedical R&D environment.
Thus, at the opening of this seminar in León, Sarah Cebrian, MSD Associate Director of Communicationsstressed that “promoting health research through health data is an essential objective for our society. Access to data for secondary use and the implementation of a European Health Data Space (EEDS) can lead to improved prevention and healthcare provision, in the sustainability of our systems national health systems and in the development of innovative and more personalized treatments.
For his part, Christine NadalExecutive Director of Government Affairs of MSD in Spain, insisted on the need to find the delicate balance between the protection of the data of each individual and their use for the benefit of all: “We envisage collaboration between the different actors involved, from the society and patients, through public administrations, institutions and governments, to the private sector. “All points of view must be included to build this common health data space. » On the other hand, he also emphasized that “health data is an important enabler promote the discovery of innovative therapies, particularly in areas where therapeutic options do not exist or are not satisfactory.
Experts have warned of the need to audit and ensure the quality of shared health data to turn it into valuable information.
The vice-president of SEIS, Jesus Galvanhighlighted his organization’s commitment to the sustainability of our National Health System (SNS) and the generation of knowledge based on the digitalization of information related to “heal and care“. The SNS is a “unique territory” where data and its metadata are accessible to citizens for direct use and common science to advance knowledge. We face “a unique opportunity to contribute to future medical science, to save time from ignorance and to bring knowledge to life.”
Health data as valuable information: challenges and opportunities
The legislative proposal relating to EEDS is based on an innovative initiative presented by the European Commission in May 2022, and aims to facilitate access and sharing of electronic health data across borders, both to support health care delivery (“use of primary data”) and to inform research and development of health care policies (data reuse or “secondary data use”).
The EEDS is a fundamental element in enabling Europe to continue to play an important role in the development and manufacturing of innovative medicines, within a useful, flexible and understandable legal framework, in order to care for the patients who need it most. need. Just in economic terms, The European Commission estimates that its implementation will represent between 20 and 30% additional growth in the digital health market and savings of €11 billion over the next ten years, thanks to better access, exchange and use of health data ci, which will result in improvements in innovation, research and public health strategies.
Always, “There are significant obstacles that make things difficult the availability of data and the development of a digital health ecosystem in the EU. “There is a need for more interoperability and standards between health data systems, a greater culture of exchange and more training in new technologies, guaranteeing confidentiality, security and respect for rights fundamentals of patients,” he said. Paula Ramirez of MSD.
Specifically, experts cautioned on the need to audit and ensure the quality of shared health data by following the necessary steps in data management and governance, in order to convert it valuable information and reuse it in research activities, innovation, policy formulation and regulation. “Our SNS manages a huge amount of unaudited data, mainly electronic medical records, for which we do not yet have homogenized management models and evaluation systems to measure their quality and transparency,” he said. he assured. Dolores Ruiz, member of the board of directors of SIX.
An opinion that you share Carlos Gallego, director of Digital Transformation in Health at the Fundació TIC Salut Social, and general coordinator of the SEIS AI Technical Committee, who recognized that, despite the progress made in interoperability, there is still a way to go in the health data management: “For a long time we have focused on recording data, but now we are in the era of their processing, a new phase with which we seek to assist in diagnosis and treatment, in which artificial intelligence is called upon to play. a crucial role.
One of the biggest challenges is striking a balance between protecting individual data and benefiting society from its use in care and innovation.
In this new stage, one of the biggest challenges will be to integrate the analysis of EEDS data, particularly genomic information, into the discovery of new population health modelscapable of saving lives, as well as the development of precision medicine and personalized treatments, creating a framework that truly encourages innovation and competitiveness within the EU.
For Tomas Castillo, first vice-president of the Platform of Patient Organizations (POP), the population must be made aware of the enormous potential of EEDS to transform healthcare in the EU, beyond its benefits at the individual level: “Many patients are concerned that their data will be misused or your privacy rights will not be respected, so you need to be very transparent in your messages and convey trust. To this end, it is essential that EEDS is not designed just for patients, but with patients, taking into account their needs and preferences.
To build this trust, “there is no doubt that cybersecurity must be taken into account”. by design in EEDS implementation projects,” said Juan Diez Gonzalezresponsible for Security of the strategic sectors of health, food and research of the National Institute of Cybersecurity (INCIBE). In the healthcare sector, a lot of patient data is generated and managed, it is very sensitive and has great value in the underground economy. “The price of a medical record can vary from $30 to $1,000 in specific cases, while comparatively the value of a credit card is between $1 and $6 on average 3, the technological infrastructure that supports Data space must therefore be secure. , in terms of having appropriate access control (identification, authentication, authorization) and security (integrity and confidentiality) measures in place for information in transit and at rest.
In 2024, the EEDS has significantly advanced its legal framework thanks to the agreement reached between the European Parliament and the Council of the EU. This agreement provides the regulatory framework that supports both citizens’ controlled access to their health data and the creation of a secure and harmonized system for the use of health data in the EU.
Likewise, the relevance of developing regulations guaranteeing the protection of intellectual property and commercial information was discussed. “The next steps include the final approval of the regulation by the European Parliament and the Council of the EU, the creation of specific protocols for its application in each nation and the formation of control entities at national and European level, responsible for manage access. and use of information,” explained Rosa E. Lillo, director of the UC3M-Santander Big Data Institute (IBIDAT).
These advances must be based on a previously agreed commitment between the different agents, which balances the desired improvement in quality of life. data exchange mechanisms with the preservation of a competitive European innovation ecosystem, the protection of individuals and their right to privacy, as well as the need to harmonize national pathways to access this data.
