FAQ for Data Holders

The researchers in the IDERHA project aim to do the following: 

• Create a federated data infrastructure architecture that allows existing platforms to integrate and connect with new data sources in health data spaces. 
• Validate optimised AI/ML algorithms on anonymised data sets to support more efficient and accurate risk profiling, malignancy risk prediction, diagnosis, and prognosis for lung cancer. 
• Develop a digital application to remotely monitor the health status of individual patients post-discharge.   
• Extend the OMOP (Observational Medical Outcomes Partnership) common data model. 
• Bridge gaps in the current electronic health data standards and FAIRification framework, including necessary extensions of standards. 
• Provide policy recommendations for developing laws, guidelines, and policies that are suitable for the current and future states of digitalisation. These policy recommendations should also be consistent with the secondary use of health data for research and innovation, as well as the acceptability of RWD for regulatory and HTA decision-making.

Patients

Enhanced patient access to health innovations, by enabling better use of health data . This can lead to improved patient outcomes through early diagnosis. Additionally, remote monitoring can reduce the need for frequent hospital visits. 

Economic

Lung cancer has the highest economic burden of all cancers in Europe. It costs 18.8 billion euros per year, which is 15% of the overall cancer costs. Health care costs account for 23% of this amount. Novel technologies, such as wearables and digital applications, can lower these costs by enabling patient monitoring at home.

Scientific/regulatory

After diagnosis, the five-year survival rate in Europe ranges from 6% to 16%. Late diagnosis is linked to this poor prognosis. Patients typically present in advanced stage 4 in 50-70% of cases, compared to 15-25% in the early stage 1, which has a relatively better prognosis and more treatment options for incidental cases. The aim of IDERHA is to improve the early detection of lung cancer. 

Societal 

In 2020, lung cancer made up 12% of all new cancer diagnoses and 20% of all cancer-related deaths in the 27 EU countries. Early diagnosis and remote monitoring can improve the quality of life and reduce the burden of the disease.

IDERHA contains mostly clinical care data or data related to the evaluation of care units. The infrastructure can handle a variety of data related to lung cancer, including: 

• Electronic Health Records (EHRs) containing clinical diagnostics and therapy data 
• Blood test data
• Imaging data 
• General pathology data
• Specific drug treatment data
• Specific radiotherapy data 
• Patient safety data
• Patient-reported outcome measurements (PROMs) and experiences (PREMs) data
• Environmental data

In addition to the patient data, research data, including clinical and molecular data, will be shared with IDERHA. 

• The data will be used to demonstrate the benefits of integration of diverse data sources.
• The demonstration of complementary combinations of data standards, infrastructures, tools and services. 
• To demonstrate the benefits of sharing health data, a diverse range of data providers and users should be gathered.
• Interoperable services that connect various data sources, both public and private, should be created.
• The project aims to make health data easily accessible, findable, interoperable, and reusable for legitimate purposes.
• The data will be used to demonstrate the benefits of federated data management and analysis, as well as the evaluation of personal data with privacy-preserving and distributed analytics.   
• The usefulness of accessing diverse health data in lung cancer cases 
• Personalized insights from real-world data should be unlocked to improve care across different stages of treatment. 
• Solutions and policies will be developed to apply to other diseases and healthcare settings. 
• The project aims to make diverse health data accessible and reusable, focusing on lung cancer patient journeys.

IDERHA will ensure that all (electronic) personal health data collected in the project is managed, secured, protected, accessed, and processed in compliance with current good practice, as well as all applicable European and national laws and regulations. IDERHA will ensure compliance with regulations and ethical norms through state-of-the-art governance and oversight. This includes the use of appropriate privacy-preserving measures such as pseudonymisation, de-identification, anonymisation, or privacy-preserving evaluation techniques. IDERHA participants will receive support for compliance through education, training, and advice. We will ensure that the tools and processes adopted are suitable for emerging European regulations and EHDS.

The Consortium Agreement will include partner rights and timescales for data-sharing. IDERHA may keep certain datasets closed, following the principle of 'as open as possible, as closed as necessary'. Consortium members will have access to the data, regulated by appropriate authentication and authorization services. The data within IDERHA will be shared and made available through a secure and encrypted channel.

• IDERHA is involving a significant number of stakeholders in the early stages to achieve the common goal of transitioning EU healthcare in MedTech and Pharma. 
• IDERHA aims to achieve mutually acceptable agreements, including cross-border transfers, which are essential tools to safeguard global processing and research activities, especially in times when international cooperation is at risk of being subordinated to national sovereignty and interests. 
• IDERHA proactively identifies policy gaps and advocates for recommendations. Technical approaches implemented are flexible and resilient. 
• IDERHA will implement a dynamic specific consenting model. 
• IDERHA is an open platform to which new parties can join. 
• To create engagement with patients and healthcare professionals, IDERHA organises annual events. 
• The PREMS approach will be used to evaluate the willingness of participants to engage in remote patient monitoring and identify potential barriers. 
• Data providers will be consulted to determine the actual needs and restrictions of the data infrastructure. IDERHA will demonstrate the hybrid approach and evaluate its advantages and disadvantages. 

IDERHA will collaborate with important healthcare stakeholders to establish agreement on policy recommendations and clarify appropriate data sharing to facilitate multi-stakeholder research. The patient advisory board provide valuable input on this work.

IDERHA is funded by the Innovative Health Initiative (IHI), a public-private partnership between the European Union and the European life science industries. The IHI supports transformative research and innovation.

IDERHA will pilot novel approaches in lung cancer, but these principles can be applied to many other diseases. 

Early detection is crucial for successful treatment of lung cancer and other diseases. This shift from sick care to health care is essential. 

The new methods could lower the economic burden on the system by detecting diseases earlier, providing personalised healthcare, and remote monitoring. 

The open platform will enable high-quality research based on diverse health data, allowing academia and industry to gain new insights, promote personalised healthcare, and develop innovative data-driven healthcare solutions. The platform will allow new data and research partners to join once the technical requirements are established.