Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance

IDERHA will address the key obstacles to achieving appropriate access, sharing, use and reuse of lung cancer data, and thus enable enhanced regulatory and HTA decision-making recommendations for integrated health research, with the aim to improve care and better meet the needs of patients and health care professionals. The IDERHA open platform for multi-modal health data will enhance innovation in EU health care systems and is directly scalable by means of connecting additional systems, data sources and additional services and tools. It will extend and elaborate standards in semantic interpretation, data quality, ethics and transferability to ensure the harmonisation of heterogeneous data sources and wider health data reuse. Use cases positioned along the lung cancer patient pathway will be implemented using retrospective data and in a remote patient care context. These practical implementations will demonstrate the added value of multi-modal data aggregation and analysis with impacts expected on public health, patient burden, health outcomes and cost. We will perform AI/ML based lung-cancer risk profiling using patient`s EHRs, and improved CT image- based AI/ML to provide risk prediction of potential lung cancer patients, and explore the possibilility of personal prognosis of disease progression. Using patient monitoring and engagement, including digital biomarker, PROMs, and connected devices, the IDERHA platform will enable remote patient monitoring, and provide data for joint patient-health professional decision making. Along with health care stakeholders, IDERHA will develop consensus policy recommendations for appropriate data sharing to enable multi-stakeholder research. Informed by Patient Advisory Groups, we will address critical obstacles and issues to heterogeneous health data primary and secondary use. Regulatory and HTA agencies will be engaged to create criteria for assessing the acceptability of heterogeneous health research results in regulatory and HTA decision-making.