IDERHA: Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance

IDERHA将解决实现适当获取、共享、使用和再利用肺癌数据的主要障碍，从而加强监管和HTA对综合健康研究的决策建议，目的是改善护理，更好地满足患者和卫生保健专业人员的需求。多模式卫生数据的IDERHA开放平台将加强欧盟卫生保健系统的创新，并可通过连接其他系统、数据源、额外服务和工具直接扩展。它将扩展和详细制定语义解释、数据质量、道德和可转移性方面的标准，以确保异构数据源的协调和更广泛的卫生数据重用。定位在肺癌患者路径上的用例将使用回顾性数据和远程患者护理环境来实施。这些实际实施将显示多模式数据汇总和分析的附加价值，预计将对公共卫生、患者负担、健康结果和成本产生影响。我们将利用患者的电子病历和改进的基于CT图像的AI/ML进行基于AI/ML的肺癌风险分析，为潜在肺癌患者提供风险预测，并探讨疾病进展的个人预后的可能性。利用患者监测和参与，包括数字生物标志物、prom和连接设备，IDERHA平台将实现患者远程监测，并为患者健康专业人员联合决策提供数据。与卫生保健利益相关者一起，IDERHA将为适当的数据共享制定共识性政策建议，以实现多利益相关者的研究。根据患者咨询小组的通知，我们将解决主要和次要使用异构健康数据的关键障碍和问题。监管机构和卫生事务管理局将参与制定标准，以评估监管机构和卫生事务管理局决策过程中异质卫生研究结果的可接受性。

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.