Shaping the future of ethical genomic data use in cancer care

How can we make personalised cancer care a reality while protecting the sensitive data that makes it possible? This is one of the key questions of the CAN.HEAL project – a Europe-wide initiative working to unlock the potential of genomics for better cancer prevention, diagnosis, prognosis and treatment. Supported by the European Commission, CAN.HEAL aims to bridge the gap between personalised medicine and public health, aligning with the goals of the Europe’s Beating Cancer Plan and the Mission on Cancer.

At the Luxembourg National Data Service (LNDS), we are proud to contribute our expertise to this ambitious collaboration. In collaboration with our partners at Sciensano from Belgium, we therefore focused on one of the most critical challenges in genomics today: how to enable the responsible sharing and reuse of sensitive genomic data legally, ethically, and with the trust of patients and citizens at its core.

Glossary of Acronyms & Concepts

Why data governance matters in cancer genomics

Cancer remains one of the most difficult diseases to diagnose and treat, mainly due to its genomic diversity and variability between patients. Even within the same cancer type, tumours may carry different genetic mutations that influence how they grow and respond to the therapy. Modern technologies like Next Generation Sequencing (NGS), including comprehensive genomic profiling, whole genome sequencing (WGS), and liquid biopsy, have transformed cancer research. They have opened the door to understanding genetic drivers of cancer and developing more advanced, personalised treatment approaches.

However, as recently highlighted by the World Health Organization (WHO), around 40% of cancers are preventable. Many cases could be avoiding by reducing well-known risk factors such as smoking, poor diet, alcohol consumption, physical inactivity, sun exposure, and infections like HPV. At the same time, genetic risk factors are still often underestimated. Current studies show that approximately 10% of cancer patients, particularly children, carry cancer predisposing genetic variants. Understanding inherited risk factors and preventable causes of cancer requires large-scale studies, biobanks, and cancer genomics research involving both healthy individuals and patients.

The success of such research, including the use of NGS technologies, largely depends on the ability to access and share genomic data across borders, healthcare systems and research communities. At the same time, that raises important questions about privacy, data protection and ethical use of sensitive health information. This is where data governance plays a crucial role. Such activities must respect legal and ethical boundaries to protect the rights and privacy of individuals whose data is used. Clear rules and guidelines for how genomic data can be used, shared, and reused are essential for supporting innovation.

The CAN.HEAL approach: structure and objectives

In response to these challenges, CAN.HEAL is working towards the development of a comprehensive Medical and Public Health Cancer Genomics Platform. This platform aims to harmonise data interpretation, support equitable access to diagnostic and therapeutic approaches, and improve counseling on cancer risk for patients and their families.

One of the aims of the Can.Heal project is to bridge the gaps between prevention, diagnosis, treatment, and supportive care in cancer, fitting into a comprehensive network of cancer and data-sharing initiatives.

Jaroslav Jirsa, Senior ELSI Specialist at LNDS and Co-Lead of WP12 (ELSI) within the CAN.HEAL

In line with this objectives, the consortium’s activities are organised into two complementary initiatives:

1. Clinical Arm: Cancer Diagnostic and Treatment for All

• Enhance Genetic Profiling by applying NGS technologies, data sharing platforms, and molecular tumor boards (MTB).
• Harmonise data interpretation by enabling Cancer Centers to share data across the EU.
• Improve cancer risk counseling by implementing molecular tumor profiling biomarkers.

2. Public Health Arm: Genomics for Public Health

• Develop Polygenic Risk Scores for cancer prediction.
• Enable telegenetics and remote counselling.
• Apply genetic screening, including NIPT and pediatric cancer profiling.

A collaborative effort across Europe

The CAN.HEAL consortium unites 42 partners across 17 countries. This large-scale collaboration connects a wide range of experts to combat cancer. These include healthcare professionals, molecular biologists, bioinformaticians, epidemiologists, IT specialists, sociologists, philosophers, communication scientists, health services researchers, and patient advocates.

Such multidisciplinary cooperation reflects the complexity of cancer care and the shared ambition to make genomics-driven healthcare accessible across Europe.

Role of LNDS within the CAN.HEAL project

The CAN.HEAL project organizes its work into 14 work packages, covering the full spectrum of activities needed to achieve its mission – from overall coordination and clinical genomics to public health strategies, education, and ethical data governance. LNDS contributed to Work Package 12 (WP12) – “Law, Ethics, and Citizen Engagement”. Together with Sciensano team from Belgium, we worked on one of the project’s core challenges:  how to enable the responsible reuse and sharing of sensitive genomic data in cancer care and research.

Ethical and Legal Compliance (Led by LNDS)

LNDS led the work on identifying and describing the legal and ethical requirements for the secondary use of genomic data in cancer care, research, and public policy contexts. It focuses on GDPR compliance, cross-border data sharing challenges, and key issues like integrated screening, treatment, and the management of incidental findings, respecting each person’s choice to know or not to know such information. For more insights and details, you can access the full deliverable here – Deliverable D12.1.

Citizen and Patient Perspectives (Led by Sciensano, Belgium)

Sciensano focused on understanding how patients, citizens, and health professionals feel about the use of genomic data. Through research and a stakeholder workshop, the team explored key concerns such as privacy, trust, fear of data misuse, and the desire for involvement in decision-making.

Based on these insights, the deliverable provides ethical recommendations to support transparent communication, build trust, and promote shared decision-making in the reuse of genomic data for oncology. For the complete overview of this work, the full deliverable is available here – Deliverable D12.1.

Delivering impact: personalised medicine and public health genomics

The combined work of LNDS and Sciensano provides a solid foundation for advancing CAN.HEAL’s mission. Our work offers concrete guidance for balancing legal obligations with ethical considerations, ensuring that data sharing practices respect the rights of patients and citizens.

Key achievements of the LNDS & Sciensano contribution include:

• Defining clear ethical and legal conditions for the secondary use of genomic data in cancer care and research.
• Addressing GDPR-related challenges and proposing solutions for safe data sharing across borders.
• Promoting trust and collaboration by integrating patient and citizen perspectives into data governance frameworks.
• Developing practical recommendations for managing incidental findings and supporting informed counseling for patients and their families.

In October 2023, these insights were further explored in a stakeholder workshop on ethical and legal governance of genomic data, providing space for dialogue and practical feedback from across the CAN.HEAL community.

Consequently, these results feed directly into CAN.HEAL’s broader contributions to Europe’s Beating Cancer Plan (EBCP) and the EU efforts to implement personalised medicine at scale, including advancements and strengthening in the DST and MTB fields.

The work within the project has also provided valuable lessons on balancing data deidentification with the return meaningful results to patients, managing incidental findings, and protecting individual rights in data reuse. One key takeaway was the importance of early and continuous stakeholder engagement. Another was the need for clear regulatory guidance to support ethical data governance.

Contribution to personalised medicine and public health genomics

By addressing legal and ethical barriers to data governance, WP12 has advanced the implementation of personalised medicine and public health genomics within CAN.HEAL. The developed recommendations help ensure that data sharing practices respect the core values of patients and citizens, whose support is essential for the success of personalised medicine. Understanding and applying GDPR remains a key element in laying the foundation for safe and responsible data use.

These achievements provide a strong foundation for future work – both within CAN.HEAL and across the wider European genomics landscape – as efforts continue to scale responsible data governance and advance cancer care through personalised medicine.

Looking ahead: spreading ethical data governance beyond CAN.HEAL

The work carried out by LNDS and Sciensano provides a valuable basis for future initiatives. Beyond CAN.HEAL, LNDS aims to further refine ethical and legal frameworks, strengthen stakeholder engagement, and support the broader adoption of these recommendations in other genomic research and public health projects. Both deliverables from WP12 offer valuable insights that can support other large-scale data sharing initiatives, such as Genome of Europe. In this context, CAN.HEAL serves as a use case that demonstrates the relevance and scalability of this work.

At the same time, the CAN.HEAL consortium actively contributes beyond the scope of the current project, aligning its efforts with a broad range of European and national initiatives. Its work aligns with a wide range of initiatives launched under the Europe’s Beating Cancer Plan, the Mission on Cancer, and the Digital Europe strategy. The project is complementary to numerous European and national programs integrating genomics into healthcare systems at both the clinical and public health levels.

Complementing other European projects

• The Beyond 1 Million Genomes (B1MG) project,
• The Genomic Data Infrastructure (GDI),
• The Genome of Europe (GoE),
• The 1+Million Genomes Initiative,
• The European Health Data Space,
• The JRC Knowledge Centre on Cancer,
• The updated EU pharmaceutical legislation and the implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR).

As Europe moves forward with its vision for personalised cancer care and genomic innovations, LNDS remains committed to supporting these efforts by providing expertise in data governance, privacy and ethical standards, helping to ensure that innovation works in service of people.

Can.Heal Project details in a nutshell

Name	CAN.HEAL
Duration	1 Nov 2022 – 30 Apr 2025
Budget	€7,476,270, with €5,981,016 (approximately 80%) funded by the European Union through the EU4Health Programme
Scope	Cross-border, involving 42 partners across 17 countries: Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Italy, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Serbia, Slovenia, and Spain
Related Projects	B1MG, GDI , Genome of Europe (GoE), 1+Million Genomes Initiative