​​Functional Processes - Research PoC​

This document defines the functional processes for deploying the Dataspace4Health (DS4H) framework in clinical settings, focusing on two healthcare use cases: diabetes care using Digital Twin (DT) technology and oncology care involving Molecular Tumor Boards (MTBs). It bridges technical data workflows with real-world medical practices, emphasizing secure, compliant data use to improve care delivery and research. The document outlines current and future workflows, patient consent management, and data anonymization/pseudonymization strategies to enable a proof of concept in standard care environments.

Diabetes Use Case

Current Diabetes Process

The diabetes care process begins with patient presentation of symptoms and referral to specialists who conduct laboratory tests (e.g., HbA1c, glucose tolerance). Diagnosis is established based on clinical evaluation and tests, followed by assessment of disease severity and complication risks, potentially involving multiple specialists. Treatment plans combine lifestyle changes, medications, and follow-up care, with education provided by various healthcare professionals (HCPs). Current digital tool use is fragmented, with limited integration of device data into electronic health records (EHR), restricting personalized, data-driven care.

Envisioned Future Process Using Digital Twin

The future care model integrates the DT concept, a dynamic virtual patient model updated continuously with clinical, laboratory, and lifestyle data. The DT supports personalized simulation and prediction of disease progression and complications, aiding clinical decision-making and patient education. It enables continuous monitoring, early intervention, and shared views of patient data among authorized HCPs. Consent-driven data use ensures privacy, with secondary data uses anonymized or pseudonymized. This approach aims to improve clinical outcomes, patient care, and enable compliant secondary data use for research, setting a foundation for scalable digital care models.

Benefits of the Digital Twin in Diabetes Care

The DT enhances care quality and personalization by synthesizing patient-specific data with clinical guidelines, supporting HCPs in making evidence-based decisions. It aids in precision prevention by identifying high-risk patients and suggesting alternative treatments if needed. For nurses, it serves as an educational and motivational tool by simulating lifestyle and treatment impacts, fostering patient understanding and adherence. Overall, the DT transforms diabetes care from reactive to proactive and integrated, empowering both HCPs and patients.

Integration of Digital Twin in Care Pathway

The DT is applied at multiple stages: initial diagnosis consultation for treatment planning, patient education and coaching by nurses, and routine follow-ups for risk assessment and treatment adjustment. Additional applications include training junior medical staff, supporting general practitioners in decentralized care, personalized nutrition advice by dietitians, and integration with telemedicine for remote monitoring. The DT complements HCP roles and requires robust consent and data governance for ethical use.

Patient Consent and Data Privacy in Diabetes Care

Patient consent is mandatory for processing sensitive health data within the DT framework, categorized into primary use (clinical decision-making) and secondary use (research, model training). Primary use consent is obtained through an opt-in process, with data used only for individual care and fully compliant with GDPR. Secondary use requires explicit, separate consent, with data anonymized or pseudonymized to protect privacy. Pseudonymization may be managed by trusted third parties to reduce re-identification risks. Patients must be informed about data use scope, safeguards, access, and their right to withdraw consent without care impact.

Consent Management System

A structured consent management system is proposed, featuring modular consent forms for primary and secondary use, digital tracking integrated into EHR, clear communication in multiple languages, options for consent renewal or withdrawal, audit trails, and electronic capture methods. Consent options in EHR would control data extraction accordingly. Patients have rights to access their data and consent records, with secure archiving and retention policies aligned with regulations. The system emphasizes voluntariness and neutrality, with provisions for authorized representatives in cases of minors or incapacitated individuals.

Oncology Use Case

Current Organization of Molecular Tumor Boards (MTBs)

MTBs in Luxembourg operate nationally under the National Cancer Institute (INC), focusing on patients with complex cancer cases who may benefit from molecular analysis after initial multidisciplinary consultation meetings (RCPs). Patient consent is obtained at two stages: for case discussion in RCP and prior to MTB referral and genomic testing. The process involves manual completion of detailed request forms by treating physicians, genomic testing via Next Generation Sequencing (NGS), and MTB meetings every 4-6 weeks via videoconference with multidisciplinary participation. MTB reports are prepared, reviewed, and shared with treating physicians who decide on treatment adherence. Current challenges include manual data collection, limited data sharing, and lack of systematic monitoring of MTB recommendation implementation.

Envisioned Improvements to MTB Organization

Improvements focus on data standardization and interoperability using international standards (e.g., HL7 FHIR, mCODE), automation of data collection to reduce manual workload, and structured datasets to enable secondary data use. Performance monitoring frameworks would track patient discussions, recommendation types, implementation rates, and patient outcomes. Efforts to increase national participation include clinician engagement, education, streamlined referral pathways, and dedicated MTB navigators. Integration of MTB reports into EHRs in both human- and machine-readable formats is planned to enhance care continuity and decision-making. Alignment with European health data initiatives aims for cross-border interoperability.

Substantial Future Enhancements

Two key strategic enhancements are proposed: introduction of Whole Genome Sequencing (WGS) for comprehensive genomic profiling, offering unbiased discovery and detection of complex genomic events, and embedding research activities within the MTB workflow. WGS data's reusability supports longitudinal patient management and advanced analytics, requiring bioinformatics expertise and collaboration with research institutions. Integrating research enables discovery of novel biomarkers and AI-driven decision support, necessitating a national infrastructure for secure data storage, governance, and patient consent supporting clinical and research uses.

Patient Consent and Data Pseudonymization in Oncology

Currently, MTB data use is limited to primary care with consent for case discussion; no secondary use or pseudonymization is applied. Future integrated MTB models will require additional voluntary opt-in consent for secondary use, including pseudonymized data sharing for research. Consent forms should clearly explain data use, protections, and withdrawal rights. Consent management is recommended to be digitalized, with EHR fields capturing consent status and scanned forms attached. Long-term integration into Luxembourg’s national shared electronic health record (DSP) is proposed for harmonized, auditable consent collection.

Conclusion

The document demonstrates how DS4H framework components like the DT and MTB can be functionally integrated into existing clinical workflows to enhance personalized care, decision support, and early complication prevention. It emphasizes the need for structured data exchange, interdisciplinary collaboration, research integration, and robust consent and data governance systems. These innovations aim to advance Luxembourg’s healthcare toward a patient-centered, research-enabled system. Subsequent deliverables will address technical deployment aspects of these functional processes.