The iToBoS project has previously written on the emergence of policy initiatives, regulatory frameworks and legislative proposals concerning a European Health Data Space [1].
Trilateral Research and MPNE are at the forefront of these developments and envisioned implementation within Europe. Trilateral Research have previously discussed regulatory tensions between the proposal and complementary regulatory frameworks [2], while MPNE have directed and coordinated a number of workshops on the issue to draw out important perspectives from existing patients [3].
Recently, the European Commission and the World Health Organization (WHO) have reached a partnership agreement [4], which paves the way for better cross-border data sharing, governance practice, and interoperability of health informatics systems. The four-year project aims to improve the overall use and re-use of health data, with the overarching aim of improving societal public health. The partnership between the European Commission and WHO/Europe will be based on well-established European principles, European best practices, and rooted in European Fundamental Rights - with the aim of creating “safe, reliable and resilient health information systems” [5].
This effort is supported by the previous development of the Proposal for European Health Data Space [6], which continues to move through the European legislative process. The Director-General of Health and Food Safety at the European Commission, Ms Sandra Gallina, explained in the press publication [7] that one of the primary goals of the partnership between the two bodies, was to ensure that European health data governance, and technical, standards were established as best practice. This best practice effort would form the common ground between countries that wish to utilise health data both within and outside of Europe. This third-country perspective is critical for ensuring the safety, reliability, and privacy of European citizen data, as well as setting a minimum expected criteria on how health data will be stored, shared, and processed across borders.
The programme is funded under the EU4HEALTH programme [8], which is the funding vehicle for ensuring better health outcomes for all of Europe. The programme was specifically designed and developed in response to the COVID-19 crisis, with the goal of fixing the fragility of national health systems and improving the overall resiliency and crisis recovery ability of European health systems. The programme’s initiative to improve governance, data sharing mechanisms, and both the technical and non-technical expectations within the health domain are viewed as critical, as we move into the realm of wide genomics data sharing practices, as outlined previously in an iToBoS blog [9].
Raising general standards for data governance, data sharing, and health information technology is the fundamental element required to ensure that the future, where health outcomes are based on genomic analysis is safe, reliable, and secure.
[1] https://itobos.eu/index.php/dissemination-open-access/articles-blog/679-european-health-data-spaces
[2] https://itobos.eu/index.php/dissemination-open-access/articles-blog/448-the-conundrum-of-health-data-in-a-world-of-ai-enhanced-diagnosis-legislative-frameworks
[3] https://itobos.eu/index.php/events-activities/891-mpneminimeet-22-the-european-health-data-space-patients-need
[4] https://ec.europa.eu/newsroom/sante/newsletter-archives/49640
[5] https://ec.europa.eu/newsroom/sante/newsletter-archives/49640
[6] https://health.ec.europa.eu/publications/proposal-regulation-european-health-data-space_en
[7] https://ec.europa.eu/newsroom/sante/newsletter-archives/49640
[8] https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en
[9] https://itobos.eu/index.php/dissemination-open-access/articles-blog/771-ethical-and-governance-considerations-for-genomic-data-sharing-in-the-development-of-medical-technologies-for-melanoma