Intelligent Ecosystem to improve the governance, the sharing and the re-use of health Data for Rare Cancers

Project Information

IDEA4RC

Grant agreement ID: 101057048

DOI

10.3030/101057048

EC signature date 23 May 2022

Start date 1 September 2022

End date 31 August 2026

Funded under

• Health

Total cost

€ 8 190 468,01

EU contribution

€ 8 190 468,00

Coordinated by

FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
Italy

Periodic Reporting for period 2 - IDEA4RC (Intelligent Ecosystem to improve the governance, the sharing and the re-use of health Data for Rare Cancers)

Reporting period: 2024-03-01 to 2025-08-31

Summary of the context and overall objectives of the project

Rare cancers comprise more than 200 different tumours, 74% of which have an annual incidence rate below one case every 200,000 European citizens.
Taken together rare cancers account for 20%-25% of all new cancer diagnoses, however knowledge on rare cancers is scarce due to small sample sizes and lack of data. Clinical and translational research need large international collaborations exploiting networks specialized in rare cancers, that pool knowledge and data together.

The IDEA4RC ambition is to establish a first-in-the-field European data ecosystem for rare cancer linking in a federated network data provided by eleven centres of the European Reference Network on rare adult solid cancers (EURACAN), including about 70 health care providers in 26 EU Member States.

This ecosystem builds on a federation of local data repositories, the IDEA4RC capsules, hosted at each EURACAN centre and totally interoperable. Access to the capsules will be governed by data access permits, rules and conditions tailored to the specific needs and constraints of each centre. Thus, not only data will never leave the centre, but data analysis and processing will be performed on each local capsule and only aggregated data will be shared. AI tools will be built to enable multi-language data processing and analysis; a data navigator will assist clinicians and researchers in finding and accessing available data of stipulated quality and modern trust-building technologies will orchestrate data governance. The developed tools will be tested in relevant pilot cases across 11 EURACAN centres .

The IDEA4RC data ecosystem will advance clinical research contributing to improve the quality of care, patients’ access to optimal diagnosis and treatment, so that all patients have equal access to high quality specialist care all over EU, in compliance with principle 16 of the European Pillar of Social Rights.
Pathways to scale towards significant impact revolve around: (i) coordination with EURACAN governing bodies to propose the data ecosystem to other centres; (ii) dissemination towards other ERNs on rare diseases; (iii) creation of a community of interest among wider audience of interested stakeholders; (iv) possible commercial exploitation of software technologies developed within the project.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The following results have been achieved:
1. Agreements have been signed among Consortium partners to enable data sharing and data processing
2. Data governance rules have been finalized, tools for data governance and access control defined. The Independent Legal and Ethics Advisors supervised and advised on he work performed to ensure legal and ethical compliance.
3. A first set of data has been produced by all clinical partners to be made available in each partner's data capsule
4. The IDEA4RC data model and the associated data dictionary have been finalized, the FHIR implementation guide has been upgraded to include more concepts, the metadata taxonomy has been finalized.
5. The multilingual dictionaries and the tools for the textual data annotation have been completed and delivered
6. Quality check is ongoing at each clinical centre in order to ensure high-quality data injection into the capsules
8. NLP models for three languages (Swedish, Italian and Polish) have been produced and are currently improved with more data
9. Capsules version 2 is implemented in 10 pilot sites and has been successfully tested for data injection
9. The engagement of stakeholders for a wider community of interest progressed involving patients advocates, clinical stakeholders outside the IDEA4RC Consortium and other interested parties
10. Exploitation activities are ongoing: definition of the project results, value proposition and preliminary business canvas.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

IDEA4RC encompasses cutting-edge methodologies, technologies, and strategies aimed at advancing healthcare data management, research, and innovation, with a focus on addressing the challenges posed by research on rare cancers and, particularly, privacy preserving data processing. IDEA4RC's innovative solutions not only drive advancements in oncology research but also intend to adhere to the approach being established by the EHDS regulation.

IDEA4RC's data model is being designed following the newer and most adopted standard terminologies to facilitate collaboration and data sharing among healthcare stakeholders across Europe.
The project also emphasizes the identification, protection, management, and exploitation of valuable intellectual property arising from its outcomes. It employs mechanisms such as open-source licensing, patents, copyrights, and trade secrets to safeguard innovations and maximize their impact.

By aligning with industry standards like OMOP and FHIR, IDEA4RC facilitates the exchange of healthcare data in a format that makes it easier to comply with the EHDS regulation.
IDEA4RC zero-trust philosophy and service mesh technology ensure a secure processing environment for privacy-preserving data processing. IDEA4RC robust security measures and encryption protocols, safeguard sensitive healthcare data from unauthorized access or breaches, in alignment with EHDS principles for the protection of patient privacy and confidentiality in all data processing activities.

IDEA4RC innovative data governance approach based on social sciences and humanities research reflects EHDS goals of promoting responsible research and innovation. IDEA4RC transparent policies and procedures for data collection, storage, and usage ensure compliance with regulations regarding data governance. The integration of technologies like blockchain enhances data traceability and integrity, further aligning with EHDS objectives of fostering trust and accountability in healthcare data management.

Finally, IDEA4RC will develop Natural Language Processing algorithms to tackle the scarcity of structured health data most of which is currently available in natural language text. By transforming such texts into structured variables, conducive to automated analysis, IDEA4RC NLP algorithms will enhance the usability and interoperability of healthcare data for secondary use, including scientific research, aligning with one of the main EHDS objectives.

IDEA4RC data governance to rule and manage requests for data use

Challenge: making patient data available for research in an ethical, legal and practical way

IDEA4RC metadata layer, that supports data query and data selection

the Virtual Assistant that facilitates dta query and cohorts building for research and data analysis

Analyses happen within the ecosystem using Federated Learning: data never leaves the hosptial

IDEA4RC data interoperability by applying a standard common data model

Secure data sharing and access is ensured by a Zero Trust Architecture

The IDEA4RC data holder journey is designed to ensure health data is FAIR and EHDS compliant

IDEA4RC data management at local data provider site for data extraction from different data surces

The system runs quality checks and creates metadata to aid data discovery and understanding

The overall IDEA4RC ecosystem and its layered components

Data is extracted using LLMs and harmonised according to an oncology-tailored common data model

IDEA4RC Federated data analysis by AI algorithms

IDEA4RC offers hospital an intelligent ecosystem to overcome this challenge