Why Big Data should have patients’ welfare at its heart

Europe can reach consensus on its European Health Data Space strategy if patients’ data rights are kept at its core.
Source: Adobe Stock

By Roche Pharma AG

Erika Schirghuber, Marina Schehlmann and Claudia Ivascu, Roche Pharma AG, Grenzach-Wyhlen, Germany, Benjamin Horbach, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

05 Jul 2021

Just days before the rotating presidency of the Council of the European Union passed to Slovenia, a high-level conference took place on the present and future strengths of European healthcare data governance systems.

The event, which was held under the patronage of Fraunhofer Institute of Applied Information Technology Germany and in collaboration with the Springer Publisher House and Roche Pharma AG, focused on the essentials of data sharing and the enablers and collaborative frameworks needed to facilitate it. Overall, the event aimed to build a common EU understanding and framework for tackling the underlying challenges facing Member States when collecting, connecting, and harnessing the full potential of health data.

The conference concluded that big data is here and here to stay, and therefore the EU must establish how we can use health data in a way that benefits society as a whole.

COVID-19 and the Stakeholder Approach

Amid the backdrop of the COVID-19 crisis, which has repeatedly shown how crucial reliable data, statistics and analytics is for decision making at all levels, the conference then heard that patients, researchers, policymakers, payers, and industry all need access to this information. However, patients must be in control of their own data so that they can help themselves and others facing health challenges.  For example, the situation could be more impactful for patients if data on rare diseases was collected, shared, and analysed so that diseases can be identified earlier, and new medicinal products developed sooner.

The event also informed that ensuring continuous and seamless access to medical data is crucial for medical research and innovation. However, there is need for acceleration because the take-up of new methods for data capture and data processing is insufficient, and even the EU’s new data protection rules pose major regulatory constraints.

Session 1 Moderator: Dr. Lydia Unger-Hunt (large image), top left: Birgit Bauer, Patient Expert, Germany, top right: Prof. Dr. Thomas Berlage, Fraunhofer-Institute for Applied Information Technology, Germany, middle left: Dr. André Breddemann, BARMER Health Insurance, Germany, middle right: Dr. Martin Hager, Roche Pharma AG, Germany, bottom left: Prof. Dr. Bettina Borisch, Institute of Global Health, Switzerland, bottom right: Markus Kalliola, TEHDAS Coordinator, Finland.

Changing the way we process data

When abundant health data is combined with innovative analysis strategies in a multidisciplinary setting, powerful models of complex diseases emerge. While cross-disciplinary collaborative research efforts provide new insights at national and EU level.

The conference concluded that for understanding disease mechanisms and deciphering the relations between multiple molecular alterations and disease outcomes, it is necessary to connect existing data and to share advanced statistical analysis methods to create robust models of diseases that help develop innovative therapies. However, the real challenge is to define how these data can be used to predict individual risk, disease course, treatment response, and the likelihood of adverse events.

This was highlighted by the fact that the current potential for data generation outstrips today’s resources for data integration and analysis. Therefore, new approaches are needed to integrate and interpret different datasets and link the findings to specific outcomes in individual patients. Yet the ability to sustain and expand on scientific innovations depends largely upon continued availability of data, which in biomedical research means access to health data. In many cases, novel findings - such as new biomarkers - emerge midway through a study, or even after it has closed, and rapid re-analysis of existing data is vital to getting this new knowledge swiftly into personalised treatments. Furthermore, discoveries must be reproducible and validated by independent experts with access to the data.

Member States in Action

Several EU Member States are already taking action to facilitate health data sharing, such as the Joint Action Towards the European Health Data Space (TEHDAS) developing principles for secondary use of health data. In Germany where the Genome Sequencing Model Project, recently signed into a legislative act, has the purpose of merging genomic and clinical data in rare and oncologic diseases. In the Netherlands, the DRUP-study, a clinical trial by oncologists, has highlighted the practical experiences of collaboration with clinical centres, the health industry, and payers for evidence generation in precision oncology, data sharing and reimbursement models. While in Finland (Findata) and France (HealthData Hub), the potential to contribute to learning health care systems by government infrastructures facilitating access to health data for public interest research was shown.

Session 2  Moderator: Dr. Lydia Unger-Hunt (large image), top left: Dr. Denis Horgan, Executive Director European Alliance of Personalised Medicine (EAPM), Belgium, top right: Dr. Martin Hager, Roche Pharma AG, Germany, middle left: Dr. Emmanuel Bacry, Health Data Hub, France, middle right: Dr. André Breddemann, BARMER Health Insurance, Germany, bottom left: Prof. Dr. A.J. Gelderblom, Leiden University, The Netherlands, bottom right: Birgit Bauer, Patient Expert, Germany.

Digital Single Market and health

The conference also heard that over the years, stakeholders have fought hard to break down the barriers holding up the integration of personalised medicine into the EU’s healthcare systems. As part of this, the Commission has introduced what it calls its ‘Digital Days’. This, of course, affects healthcare too.

At the 2018 event, what became known as the ‘B1MG (Beyond 1 Million Genomes) Project’, a number of Member States signed a declaration to gather one million genomes across Europe by 2022. At the 2019 edition, then Digital Commissioner, Andrus Ansip, explained how the Digital Single Market has progressed and taken shape, including health data. This was followed in February 2020 by the Commission’s publishing of its strategy for building a unified and sustainable data economy which falls within the overarching ambition of the European Health Data Space. It set out how public institutions and companies will be given low-barrier access to unlimited amounts of high-quality personal and non-personal data as well as free-flow of data across Member State borders. Furthermore, fragmented data silos are to be merged into sector-specific data spaces and be able to communicate horizontally with each other.

To conclude, the future strengths of European healthcare systems lie in the capability to collect, connect and harness the full potential of health data along with the collaborational spirit of all involved stakeholders. 

This content was commissioned by the Roche Pharma AG and produced by Dods.