Periodic Reporting for period 2 - IDERHA (Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance)
Periodo di rendicontazione: 2024-04-01 al 2025-09-30
In recent years, there has been a significant increase in the generation of health data from various sources such as digital technologies, patient-reported outcome measures, clinical trials, and routine clinical care. This data holds great potential for advancing both research and patient care. However, accessing and analyzing this data in order to derive additional value for patients, researchers, clinicians and innovators still remains a significant challenge. The objective of IDERHA is to establish a scalable European Union-wide platform for health data, enabling secure access and analysis of diverse data types. The IDERHA platform will also focus on developing policy recommendations for the use of real-world data in regulatory and health technology assessment (HTA) decision-making. To ensure compliance with current and future health data legislation, the IDERHA platform will prioritize adherence to legal requirements including the European Health Data Space (EHDS). Additionally, the platform will develop a solution to empower patients with control over which individuals and organisations can access their data. Researchers will benefit from a remote access approach to health data, enabling them to gain new insights into health and disease. Regulators and HTA bodies can also utilize the platform for their decision-making processes. The platform will connect multiple public and private data sources and incorporate interoperable tools and services within a secure environment to analyse the data. The primary use cases of the platform will be focused on lung cancer. Using artificial intelligence and machine learning techniques, the project aims to profile lung cancer risk based on patient electronic health records (EHRs) and improve risk prediction through CT image analysis. Furthermore, we aim to explore personalized prognosis of disease progression. This supports the goal of identifying patients in the early stages of disease development, thus enabling early treatment and thereby positively impacting survival rates. Through patient monitoring and engagement, including digital biomarkers, patient-reported outcome measures, and connected devices, the IDERHA platform will facilitate remote patient monitoring and provide data for shared decision-making between patients and healthcare professionals. This approach can also contribute to early patient discharge and help alleviate the burden on healthcare providers. The project will actively involve patients and other healthcare stakeholders including, complementary projects working on HTA policy questions, regulatory and HTA agencies to develop consensus policy recommendations regarding the acceptance of heterogeneous health data for regulatory and HTA decision-making, as well as data access principles. Patient Advisory Groups will inform and address critical obstacles and concerns regarding the primary and secondary use of heterogeneous health data.
IDERHA is building one of the first pan-European health data spaces, using a federated “compute-to-data” model aligned with the emerging EHDS and enabling new principles for secure data access, interoperability and evidence generation. This approach is designed to support healthcare professionals, patients, and researchers with improved analytical capabilities and more personalised care pathways.
Following completion of the architectural design in year 1, the project advanced into technical implementation, deploying core federated services, metadata publishing, data-discovery workflows and early federated learning capacity. The consortium defined the minimum requirements for alignment with EHDS, including user journeys, terminology standards, and interoperability models—supported by joint work with clinical partners preparing the first IDERHA nodes. Engagement with external experts has intensified through multi-stakeholder workshops, the public forum event, and meetings with HTA bodies, parallel project teams, regulators and the Integrated Data Access Governance Council (IDAGC), ensuring coherence with emerging policy and regulatory expectations. IDERHA continues to apply a strongly patient-centered approach, guided by the Patient Advisory Board and complemented by the establishment of Clinical and Ethics Advisory Boards. Substantial progress was achieved in governance: the Data Management Plan and DPIA framework were expanded into a unified, multi-layer governance system underpinning compliant processing of heterogeneous data across all nodes. These components also support the implementation of a Joint Controller Agreement (JCA), designed to streamline data access and reduce future administrative burden. In parallel, sustainability activities advanced through dedicated working groups developing the long-term operational model, ensuring that the data-space infrastructure, governance processes and onboarding procedures remain viable and accessible beyond the duration of IHI funding.
Following completion of the architectural design in year 1, the project advanced into technical implementation, deploying core federated services, metadata publishing, data-discovery workflows and early federated learning capacity. The consortium defined the minimum requirements for alignment with EHDS, including user journeys, terminology standards, and interoperability models—supported by joint work with clinical partners preparing the first IDERHA nodes. Engagement with external experts has intensified through multi-stakeholder workshops, the public forum event, and meetings with HTA bodies, parallel project teams, regulators and the Integrated Data Access Governance Council (IDAGC), ensuring coherence with emerging policy and regulatory expectations. IDERHA continues to apply a strongly patient-centered approach, guided by the Patient Advisory Board and complemented by the establishment of Clinical and Ethics Advisory Boards. Substantial progress was achieved in governance: the Data Management Plan and DPIA framework were expanded into a unified, multi-layer governance system underpinning compliant processing of heterogeneous data across all nodes. These components also support the implementation of a Joint Controller Agreement (JCA), designed to streamline data access and reduce future administrative burden. In parallel, sustainability activities advanced through dedicated working groups developing the long-term operational model, ensuring that the data-space infrastructure, governance processes and onboarding procedures remain viable and accessible beyond the duration of IHI funding.
IDERHA advances the state of the art by implementing a pan-European federated “compute-to-data” infrastructure aligned with the EHDS, combining technical, governance, and clinical innovations to enable secure, cross-border access to heterogeneous health data. The project has developed a unified approach linking DMP, DPIA and a JCA into a coherent governance framework, simplifying data access across multiple institutions and supporting future sustainability beyond IHI funding. IDERHA has also facilitated alignment across projects and federated data infrastructures, encouraged dialogue on interoperable governance frameworks for secondary RWD use, and identified pathways for long-term policy harmonisation and sustainable RWE infrastructures. Citizen-centric innovation is provided by the Hygiaso app, which can empower patients with secure access to their health data and the ability to share it transparently.