Britt Elmedal Laursen

Consultant, Associate Professor, Department of Molecular Medicine & Department of Oncology, Aarhus University Hospital, Institute of Biomedicine, Pharmacology & Precision Medicine, Aarhus University, Denmark

Britt shared a clinical perspective on integrating genomic data into oncology practice. In Denmark, patients with incurable cancer are offered WGS to target their treatment, with nearly 300 patients reviewed at national molecular tumour boards in the last three months of 2024. Britt shared examples where WGS enabled targeted treatments and long-term remission in patients with terminal disease. Moving forward, she advocates for expanding the access of WGS to reach more patients, improving data analysis through the development of knowledge databases such as frequency- and variant databases, adopt new sequencing technologies (e.g. long-read sequencing), and incorporating other “omics”-data. However, challenges remain as patients still struggle to get access the necessary targeted treatments, pointing to the need for better implementation pathways.

Sisse Rye Ostrowski

Professor, Consultant, Head of Research, Head of Studies for Master’s Programme in Personalised Medicine, Rigshospitalet and University of Copenhagen, Denmark

Sisse discussed the potential of Denmark’s unique health data resources to advance research in personalised medicine. She pointed to opportunities in combining genomic and registry data for data-driven research to improve our understanding of diseases, treatment, and prevention, while noting the importance of addressing ethical, technical, and organisational barriers. She called upon politicians to enable legislation that allows for better use of existing data, ensure transparency for patients and security for researchers, create a steady foundation for projects to continue smoothly, and expand technical competencies for effective data use.

Ida Sofie Jensen

CEO, Danish Association of the Pharmaceutical Industry (Lif), Denmark

Ida presented the life science industry’s perspective on creating sustainable conditions for personalised medicine. Denmark already has a strong tradition of public-private partnerships, which are essential to realising national PM goals. She stressed that optimal implementation requires political focus and trust, a robust digital health system, removing legal barriers to progress, building new competencies and capacity in the health sector, the coupling of genomic and clinical data, developing new models for payment, evidence gathering, and risk-sharing (especially for ATMPs), strengthening ATMP Denmark as a single-entry knowledge centre, and a Medicines Council that supports innovation. Ida highlighted that industry is ready to support clinical practice and work in new collaborative models, but the central message: public and private need each other to succeed with the ambitious new strategy for PM.

Thomas Fredenslund Director General, and Jacob Hartmann Sørensen, Head of Programme

Danish Health Data Authority, Denmark

Thomas outlined the vision for Digital Health Denmark, focusing on better use of healthcare data to support innovation, collaboration, and system efficiency. Digital Health Denmark is the biggest health reform in 20 years, bringing together 20 years, bringing together five organisations (including SDS, NGC, MedCom, sundhed.dk) into one unified body, with the purpose to use health data to support communities, improve patient care, strengthen innovation, and improve system response. To follow, Jacob introduced the Vision for Better Use of Health Data, which aims to establish a more simple and seamless access point for health data. This would offer a better user experience and stronger analysis ecosystem.

Dame Sue Hill

Professor, Chief Scientific Officer for England & Senior Responsible Officer for Genomics in the NHS, NHS England, United Kingdom

Sue shared lessons from the National Health Service (NHS) Genomic Medicine Service, describing how an ambitious and long-term political focus has made UK a world leader in genomics. The strategic and collaborative approach has created an organisation that effectively supports the use of genomics for both healthcare, research and innovation to the benefit of patients. A wide range of genomic initiatives have successfully been integrated into the national healthcare delivery and by 2035, genomics is expected to be a part of up to 50% of healthcare episodes/interventions. Novel initiatives include developing a Unified Genomic Record that will provide a single point of administration and access to genomic data for each patient. Sue underscored that success in the implementation of genomics depends on strong political and health system leadership and close collaboration with partners to rapidly reuse data for patient benefit.

Richard Rosenquist Brandell

Professor, Clinical Genetics at Department of Molecular Medicine and Surgery, Karolinska Institutet, Sweden

Richard presented the Swedish experience with a bottom-up approach to data-driven personalised medicine, where the regionally organised Swedish healthcare system has been integrated through Genomic Medicine Sweden. He explained how the National Genomics Platform supports clinical practice and research, enabling the rapid uptake of genomics in healthcare, particularly in rare diseases. Richard highlighted an upcoming roadmap for implementing precision medicine in Swedish healthcare by combining projects and initiatives to further drive(?) the development of personalised medicine and accelerate the integration of research discoveries to be used in healthcare.

Emmanuel Bacry

Scientific Director, Health Data Hub, France

Emmanuel presented the role of the French Health Data Hub (HDH) in advancing personalised medicine. The HDH is a public health data platform that provides a single secure gateway to, and a catalogue of, national databases, supporting diverse partners and projects. It was built on the French National Healthcare Data System (SNDS) (covering the French population of 67 million people with >20 years of data, including reimbursement and clinical data). In 2019, it was expanded with additional health databases, and aiming to incorporate public health databases in the future. He highlighted that access to the HDH builds on substantial HPC capacity, storage, and secure analysis environments, enabling the integration and scaling of diverse data sources to benefit both clinical practice and research. Looking ahead, AI initiatives such as the SHAPID project are of major interest.

Dr Laura Anne Whelan

PhD, Lecturer in Human Genetics and Genomics, Project Management Lead, Genomic Data Infrastructure Ireland and Genome of Ireland, RCSI University of Medicine and Health Sciences, Ireland

Laura presented the Irish experience with genomic data infrastructures, noting Ireland’s strong foundation in genomics and its renewed efforts to strengthen infrastructure. The focus is on simple, actionable steps: developing Genome of Ireland (a national reference genome cohort, in line with GoE) to illuminate population genetics, inform research, and improve clinical decision-making; and repatriating data to enable reanalysis and future use. She emphasized the ambition to remove barriers between research and healthcare and to advance genomics through clearly defined steps.

James Buchanan

Senior Lecturer, Health Economics and Policy Research Unit (HEPRU), Queen Mary University of London, United Kingdom

James explored the value of data sharing from a health economics perspective. He outlined that data sharing supports more robust economic evaluations and enables resource allocation decisions. This can, in turn, facilitate new insights in personalised medicine and result in better diagnostics and more cost-effective treatment. However, economic evaluations measure value narrowly while the value of data sharing for personalised medicine is much broader, resulting in gaps and uncertainties. To tackle uncertainties and harness the potential of data sharing, value frameworks must evolve while direct and indirect empirical evidence is being generated.

Bodil Ørkild

Deputy Director, University Hospital at Herlev and Gentofte, Denmark

Bodil discussed the competencies required to support a transition to data-driven healthcare. She highlighted that Denmark generates vast amounts of valuable data (CPR system, biobanks, EHRs), and with improved data quality and standardisation, this resource could be even more impactful. Strengthening competencies in data engineering and bioinformatics, clinical data use, and hospital leadership will help Denmark fully engage in the EHDS. Moving towards a data-driven healthcare system will also benefit from a digital-first strategy, cultural change in hospitals, and strengthened trust between hospitals, countries, and patients.

The Q&A focussed on how to utilise hospital data to improve healthcare throughout Europe. While healthcare has always collected data, the big changes today are the vast amount of available data and the chance to share it across sectors and borders. However, systems are still fragmented across sectors, regions, and borders, with different levels of and standards for digitalisation. Harmonisation and standardisation can support sharing of data, while the establishment of common principles and standardised frameworks for assessing value and costs can streamline the assessment process to determine cost-effectiveness in a particular country or setting. Public-private partnerships could help but data must be compatible and shareable. Participants highlighted the importance of developing European-made, standardised systems to reduce reliance on external tools such as EPIC. AI could bring big benefits but is slowed by regulations and needs easy-to-use software and better training for healthcare professionals. A key theme was breaking down barriers between research and healthcare, encouraging interdisciplinary collaboration, e.g. between clinicians, IT-professionals and technicians, and building hospital systems that learn and adapt. Lessons from past digitalisation should guide the next steps.

Henrik Ullum

CEO, Statens Serum Institut, Denmark

Henrik outlined that the development of personalised medicine requires knowledge and research, supported by strong infrastructure. Currently, the Danish Biobank Register addresses the need for better and broader data access. Moving forward Denmark has ambitious plans, there are plans to expand registries and biobanks under the new 2025–2027 PM strategy, many future analyses will rely on AI, and Henrik emphasised that we must be ambitious in data collection, moving to personalised prevention that depends on sequencing earlier in life and enabling lifelong PM.

Aarno Palotie

Research Director, Institute for Molecular Medicine Finland FIMM, University of Helsinki, Finland

Aarno presented FinnGen as a model for public–private partnership combining genomic and health data in a shared environment for discovery research. He suggested that the implementation and use of infrastructure must be considered in phases: planning and development, use and maintenance, and upscaling. He underlined that there are ongoing national and international challenges of stiff partnership models, siloed infrastructures, and limitations in data collection that must be considered but not seen as deterrents – infrastructures can’t be perfectly planned, you have to start then refine. He stressed that Europe underperforms due to silos, requiring more international collaboration, both in the EU and globally.

Tine Jess

Professor, Center Director, PREDICT National Center of Excellence, Aalborg University Copenhagen, Denmark

Tine highlighted challenges in using health data, including silos, legal barriers, and limited knowledge of available resources. Using inflammatory bowel disease as a model, PREDICT integrates data from multiple sources to map disease trajectories, showing that biomarkers can predict Crohn’s disease up to nine years before onset. Key collaborations span France, the UK, and DNGC, with a long-term goal of shifting from treatment to prevention, supported by EU funding. She emphasizes the need to bridge silos, strengthen international collaboration, and build global capacity as healthcare evolves.

Fulvia Raffaelli

Head of Digital Health, European Commission, Director-General on Health & Food Safety, DG SANTE, EU

Fulvia introduced the European Health Data Space (EHDS) and its potential to enable secure cross-border use of health data, highlighting that it is moving from a vision to a tangible reality for EU citizens. She discussed opportunities for patients, researchers, and health systems, as well as implementation challenges. The success of EHDS depends on trust from patients, healthcare professionals, and industry which is supported by GDPR, cybersecurity measures, and legislative measures. Furthermore, it requires sustained investment in digitalisation to create a truly data-driven Europe.

Peter Goodhand

CEO, Global Alliance for Genomics and Health (GA4GH), Canada

Peter described global initiatives for data sharing and the role of GA4GH in setting standards. He shared that the GA4GH mission is to accelerate progress in genomics and health by developing global standards and policy frameworks. They have a goal to sequence 11 million genomes globally which requires greater interoperability and a movement towards global standards and broader health data.

Saila Rinne

Head of Artificial Intelligence in Health and Life Sciences, European Commission, DG CNECT, EU

Saila presented the AI Continent Action Plan with the aim to make Europe a global leader in trustworthy AI, where healthcare plays an important role. To realise this vision, AI factories have been selected to work with healthcare data sharing, and a new applied AI strategy is posed to be released soon. Overall, the EU wants to leverage health data infrastructures to create high-quality datasets for AI research and application, supported by initiatives like 1+MG and GDI.

Serena Scollen

Head of Human Genomics and Translational Data, ELIXIR (Intergovernmental)

Serena reported on the progress of the European Genomic Data Infrastructure, highlighting that genomic data is the backbone of personalised medicine. She discussed current issues of fragmentation, silos, poor accessibility at national and EU levels, and how interoperable infrastructures are required to integrate genomics with other data types and harness the potential of genomics. By next year, 15 countries will have fully operational GDI nodes, taking us one step closer to accessible, diverse genomic data at scale, feeding into clinical practice to improve patient outcomes.

Troels Tvedegaard Rasmussen

Senior Adviser, Danish National Genome Center, Denmark

Troels offered a national-level perspective on the GDI, emphasising the importance of connecting research and healthcare. He highlighted that Denmark is small and needs collaboration to gain scale – GDI could provide the supportive infrastructure. However, when building this infrastructure, there are challenges to consider, including different incentives, mindsets, and maturity levels across sectors and countries. He highlighted that to overcome these challenges, we need a consistent genomic data infrastructure that is modular, interoperable opportunities and challenges in cross-border collaboration. We also require clear technical standards, governance, accountability, and co-creation.

Diana Arsovic Nielsen

CEO, Danish Life Science Cluster, Denmark

Diana reflected on how public-private partnerships can advance personalised medicine. She pointed to collaboration as key to innovation, emphasising that if we want to move beyond silos, we must first recognise that they exist. When approaching this collaboration, we must keep the patient pathway and focus and make use of actors’ strengths. She underscored that the private sector excels at understanding patients as customers and that the healthcare sector could learn from this. Partners must align on incentives, highlight the value of PM for end users, and create governance structures that support innovation.

Dr. Regina Becker, ELSI Fellow, Luxembourg National Data Service (LNDS), Luxembourg

Richard Rosenquist Brandell, Professor, Clinical Genetics at the Department of Molecular Medicine and Surgery, Karolinska Institutet, Sweden

Dilemma one considered genetic data sharing across borders and ask whether researchers should be able to pool data across EU borders if citizens give their consent. Panellists highlighted the need for international collaboration in genomics, especially in rare diseases and cancer, where stratification of patients into small groups make data sharing critical to find the right diagnosis and treatment, and to enable knowledge and innovation. Informed consent was seen as the cornerstone for data sharing, with patients consenting based on clear information adapted to the local setting and their individual needs. While the GDPR provides a framework for secure cross-border data sharing, barriers may arise from national legislation, differing interpretations, and, in some cases, a lack of trust, including at the policy level. Trust was a recurring theme: many patients are interested in sharing their data to enhance knowledge about their condition, provided that the proper safeguards are in place, but policymakers remain cautious. To make data sharing work across borders, panellists highlighted the need for accessible yet secure data collected and stored in a harmonised manner .

Ida Sofie Jensen, CEO, Danish Association of the Pharmaceutical Industry (Lif), Denmark

Aarno Palotie, Research Director, Institute for Molecular Medi-cine Finland FIMM, University of Helsinki, Finland

Katharina O’Cathaoir, PhD, Associate Professor, Faculty of Law, University of Copenhagen, Denmark

Dilemma two posed a question on the ethics of private access to public genetic data, asking whether private pharmaceutical companies should be able to buy access to national genomic databases. Panellists agreed that access to public genomic data by private companies is essential for innovation, including development of new treatments, provided it serves a clear societal benefit and maintains public trust. Similar considerations were applied to the public sector. Panellists noted that private companies can protect data as securely as public institutions, and are often working only with pseudonymised data. Challenges shared across both the private and the public sector lies in fragmented national rules that make access to data slow and difficult, especially for rare disease where drug development requires cross-border collaboration to reach the necessary volume of patients. A balanced approach is required to enable secure, consent-based use of data while safeguarding patient rights and public trust.

Dr. Anne Cambon-Thomsen, Emeritus Research Director at CNRS, Inserm and University of Toulouse, France

Francisca Nordfalk, PhD, Project Manager, National Center for Ethics / Danish Data Ethics Council, Denmark

Gry Hasselbalch, PhD, Academic Director, DataEthics.eu, Denmark

Dilemma three focused on the use of AI in healthcare, posing the question, should we allow AI models to help diagnose patients and suggest treatment? The panel agreed that AI has great potential in genomics, for example, for managing and analysing large amounts of data, or combining datasets to identify better treatments or determine what is cost-effective. However, the use of AI must be guided by strong ethical frameworks and public trust, and be supported by proper governance, transparency, and communication with patients and professionals. The EU was recognised as being relatively quick in developing regulations such as the AI Act and GDPR, though implementation remains complex due to diverse stakeholders and national differences. Also, it was recognised that legislation generally needs time to be developed and implemented to new technologies. Overall, AI in genomics was seen as valuable and necessary, provided it is implemented responsibly, securely, and with clear safeguards – similarly to other novel technologies.