Periodic Reporting for period 2 - HealthyCloud (HealthyCloud – Health Research & Innovation Cloud)
Période du rapport: 2022-09-01 au 2023-11-30
Health systems today generate and collect vast amounts of health-related data. Simultaneously, research networks compile patient and/or population-level health data for various diseases in research cohorts. European research infrastructures like BBMRI and ECRIN work on harmonizing the collection of biological samples and promoting clinical trial development for broader researcher reuse. However, challenges such as dispersed data generation, ethical/legal constraints, unstructured clinical data, limited interoperability, and a lack of specific computing resources hamper health data's use in research.
Data sharing for secondary use, using data generated in healthcare systems not for care activities but for research, will be key driver of the digital revolution in health research. The convergence of health data availability and Big Data techniques is expected to revolutionize healthcare by facilitating unprecedented studies. This includes benefits for drug development, utilizing real-life effectiveness data of known drugs. Moreover, artificial intelligence models derived from high-quality FAIR (Findable, Accessible, Interoperable, and Reusable) data may enable novel decision support systems. The FAIRification of high-quality health data and its integration for secondary use could usher in a new era of personalized medicine, focusing on individual genetic profiles and their interactions with lifestyle and environmental factors. Crucially, FAIR data has the potential to enhance data-driven decision-making across the healthcare value chain, providing better-informed insights for researchers, healthcare professionals, regulators, HTA bodies, and policymakers, ultimately positively impacting healthcare organisation and management.
HealthyCloud aims to drive this convergence of health data availability and Big Data techniques and align health data expertise shared between European and international actors to lay the foundations for the future European Health Research and Innovation Cloud (HRIC). The HRIC will enable health data sharing, secondary use of health data and data analytics capabilities to push the boundaries of health research, within an ethically sound and legally compliant framework that fosters patient and citizen trust. To this end, HealthyCloud produced a Strategic Agenda based proposing the following services:
- A monitoring service for health-related research to periodically survey the landscape of data-driven health research activities in Europe, capturing developments and gathering feedback from research communities.
- A legal/regulatory guidance service to provide guidance, compliance support, and advocacy for collective interests for the use and re-use of health-related data for research, innovation and policy-making purposes.
- A metadata standards and data interoperability guidance service to Provision of information, training, and guidance for consistently using data and metadata standards, aiming to improve the findability and interoperability for data use and re-use.
- A health research community interface service, with the EOSC to set a reference point to foster the interaction between EOSC service providers and health researchers.
- and, a health research community interface service, with EHDS to establish a direct communication channel to facilitate the integration and adoption of European Health Data Space (EHDS) capabilities into health-related research communities.
Data sharing for secondary use, using data generated in healthcare systems not for care activities but for research, will be key driver of the digital revolution in health research. The convergence of health data availability and Big Data techniques is expected to revolutionize healthcare by facilitating unprecedented studies. This includes benefits for drug development, utilizing real-life effectiveness data of known drugs. Moreover, artificial intelligence models derived from high-quality FAIR (Findable, Accessible, Interoperable, and Reusable) data may enable novel decision support systems. The FAIRification of high-quality health data and its integration for secondary use could usher in a new era of personalized medicine, focusing on individual genetic profiles and their interactions with lifestyle and environmental factors. Crucially, FAIR data has the potential to enhance data-driven decision-making across the healthcare value chain, providing better-informed insights for researchers, healthcare professionals, regulators, HTA bodies, and policymakers, ultimately positively impacting healthcare organisation and management.
HealthyCloud aims to drive this convergence of health data availability and Big Data techniques and align health data expertise shared between European and international actors to lay the foundations for the future European Health Research and Innovation Cloud (HRIC). The HRIC will enable health data sharing, secondary use of health data and data analytics capabilities to push the boundaries of health research, within an ethically sound and legally compliant framework that fosters patient and citizen trust. To this end, HealthyCloud produced a Strategic Agenda based proposing the following services:
- A monitoring service for health-related research to periodically survey the landscape of data-driven health research activities in Europe, capturing developments and gathering feedback from research communities.
- A legal/regulatory guidance service to provide guidance, compliance support, and advocacy for collective interests for the use and re-use of health-related data for research, innovation and policy-making purposes.
- A metadata standards and data interoperability guidance service to Provision of information, training, and guidance for consistently using data and metadata standards, aiming to improve the findability and interoperability for data use and re-use.
- A health research community interface service, with the EOSC to set a reference point to foster the interaction between EOSC service providers and health researchers.
- and, a health research community interface service, with EHDS to establish a direct communication channel to facilitate the integration and adoption of European Health Data Space (EHDS) capabilities into health-related research communities.
The work performed from the beginning of the project has been structured in three main dimensions: the data dimension, the computation dimension, and the Ethical, Legal and Societal Impact (ELSI) dimension.
In the data dimension, the efforts focused on understating how FAIR the clinical and research data is, understanding first the data itself and identifying gaps, e.g. which standards are used to codify the data types or if there is metadata available to make possible its discoverability. And understanding how the organisation of data hubs, i.e. capturing how the facilities with the mandate of storing data operate.
In the computation dimension, the progress focused on first providing recommendations on how the computing facilities that will deal with highly sensitive data, such as health data, should be managed; and second, analysing the software tools which can support the development of future applications that facilitate the analysis of the health data. Third, defining the expected user profiles of such HRIC.
In the ELSI dimension, the efforts were structured in conceptualising the possible computational solutions and mapping them to the legal frameworks and analysing a wide range of possible GDPR-compliant contracts used to transfer data by data hubs to data users, with the aim of providing guidelines for a flexible and adaptable contract for data processing and analysis in the future HRIC.
Two theoretical use cases (cancer risk factors associated with genes in combination with environmental and lifestyle factors, and machine learning models for atrial fibrillation) were used to drive the work done in the three dimensions. At this stage of the project, work aimed to capture the data requirements from the use cases to provide inputs to the data dimension work.
All the inputs from the three dimensions served to understand the health data research needs and gaps and to propose a Strategic Agenda for the future Health Research and Innovation Cloud. The Strategic Agenda will serve to drive the development of the HRIC which will address the missing elements and demands to maximise the use and reuse of health data.
In the data dimension, the efforts focused on understating how FAIR the clinical and research data is, understanding first the data itself and identifying gaps, e.g. which standards are used to codify the data types or if there is metadata available to make possible its discoverability. And understanding how the organisation of data hubs, i.e. capturing how the facilities with the mandate of storing data operate.
In the computation dimension, the progress focused on first providing recommendations on how the computing facilities that will deal with highly sensitive data, such as health data, should be managed; and second, analysing the software tools which can support the development of future applications that facilitate the analysis of the health data. Third, defining the expected user profiles of such HRIC.
In the ELSI dimension, the efforts were structured in conceptualising the possible computational solutions and mapping them to the legal frameworks and analysing a wide range of possible GDPR-compliant contracts used to transfer data by data hubs to data users, with the aim of providing guidelines for a flexible and adaptable contract for data processing and analysis in the future HRIC.
Two theoretical use cases (cancer risk factors associated with genes in combination with environmental and lifestyle factors, and machine learning models for atrial fibrillation) were used to drive the work done in the three dimensions. At this stage of the project, work aimed to capture the data requirements from the use cases to provide inputs to the data dimension work.
All the inputs from the three dimensions served to understand the health data research needs and gaps and to propose a Strategic Agenda for the future Health Research and Innovation Cloud. The Strategic Agenda will serve to drive the development of the HRIC which will address the missing elements and demands to maximise the use and reuse of health data.
One of the priorities of the current European Commission is to exploit the available health data to its maximum for better and more sustainable public health systems across Europe. Succeeding in this ambitious mission will contribute to reducing inequities and inequalities and advance towards a trusted ecosystem for conducting health research at a European scale, with faster turnarounds and better reproducibility.
The HealthyCloud project helped to characterise the European health data exchange ecosystem from the researchers' point of view. With this knowledge and the expertise of the consortium partners, the Strategic Agenda produced in the project propose a set of services to foster the synergies of existing data sharing activities, ranging from well-established health-related research infrastructures to public health institutions and healthcare facilities aiming to make clinical data under their responsibility available for secondary use.
HealthyCloud's expected impact extends to the creation of EOSC-Health thematic group, already approved by the EOSC Association, within the European Open Science Cloud, and further contribution to the European Health Data Space. A full deployment of the services described in Strategic Agenda will facilitate the understanding of the health research in Europe, its regulation and th integration of existing and future systems for processing health data across millions of citizens within and beyond EU borders, utilizing various computing capabilities. These advancements promise a deeper understanding of population health dynamics, improving clinical care for a more robust response to communicable and non-communicable diseases.
The HealthyCloud project helped to characterise the European health data exchange ecosystem from the researchers' point of view. With this knowledge and the expertise of the consortium partners, the Strategic Agenda produced in the project propose a set of services to foster the synergies of existing data sharing activities, ranging from well-established health-related research infrastructures to public health institutions and healthcare facilities aiming to make clinical data under their responsibility available for secondary use.
HealthyCloud's expected impact extends to the creation of EOSC-Health thematic group, already approved by the EOSC Association, within the European Open Science Cloud, and further contribution to the European Health Data Space. A full deployment of the services described in Strategic Agenda will facilitate the understanding of the health research in Europe, its regulation and th integration of existing and future systems for processing health data across millions of citizens within and beyond EU borders, utilizing various computing capabilities. These advancements promise a deeper understanding of population health dynamics, improving clinical care for a more robust response to communicable and non-communicable diseases.