Periodic Reporting for period 1 - IDERHA (Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance)
Reporting period: 2023-04-01 to 2024-03-31
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 the control over which individuals and organisations can access their data. Researchers will benefit from a novel 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 leverage 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 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.
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 the control over which individuals and organisations can access their data. Researchers will benefit from a novel 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 leverage 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 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 taking a federated approach (compute to data) as envisioned in the proposed EHDS and enabling novel data access and evaluation principles. This will support healthcare professionals, patients and researchers with new capabilities to improve patients’ outcomes.
The IDERHA data space infrastructure architecture has been designed in year 1 and the technical build is about to start. The team have identified the minimum-set of requirements for aligning the IDERHA infrastructure with the planned EHDS regulations, including user journey, concepts, terminologies, and standards. This includes aligning with key internal and external data providers to clarify the requirements and plan the setup of federated IDERHA nodes in the jointly modelled architecture. To build on the expertise of external experts, we involved stakeholders in workshops and our first public forum event and have held meetings with HTA, regulators and the Integrated Data Access Governance Council (IDAGC). IDERHA follows a patient centric approach guided by our patient advisory board and we are currently building the clinical and ethics advisory boards. In IDERHA we are formulating a scalable health data access and governance process which relies upon the purposes and means of data analysis to be clearly defined in the DMP and DPIA documents, currently being finalized and linked to the CA. They will be the basis for the development of a concise Joint Controller Agreement (JCA) and Data Sharing Agreement (DSA) with agreed compliant concepts and the anticipated impact that accessing data from internal and external organizations will be rapid and less complex in the future. This in turn will benefit our overall sustainability and wider use post IHI funding, and is an integral part of IDERHA’s sustainability plan which’s development has been initiated in month 6 of the project.
The IDERHA data space infrastructure architecture has been designed in year 1 and the technical build is about to start. The team have identified the minimum-set of requirements for aligning the IDERHA infrastructure with the planned EHDS regulations, including user journey, concepts, terminologies, and standards. This includes aligning with key internal and external data providers to clarify the requirements and plan the setup of federated IDERHA nodes in the jointly modelled architecture. To build on the expertise of external experts, we involved stakeholders in workshops and our first public forum event and have held meetings with HTA, regulators and the Integrated Data Access Governance Council (IDAGC). IDERHA follows a patient centric approach guided by our patient advisory board and we are currently building the clinical and ethics advisory boards. In IDERHA we are formulating a scalable health data access and governance process which relies upon the purposes and means of data analysis to be clearly defined in the DMP and DPIA documents, currently being finalized and linked to the CA. They will be the basis for the development of a concise Joint Controller Agreement (JCA) and Data Sharing Agreement (DSA) with agreed compliant concepts and the anticipated impact that accessing data from internal and external organizations will be rapid and less complex in the future. This in turn will benefit our overall sustainability and wider use post IHI funding, and is an integral part of IDERHA’s sustainability plan which’s development has been initiated in month 6 of the project.
Not applicable at this stage of the project.