The Health Data Maze

By Lucia Medori

Have you heard about the European Health Parliament? The European Health Parliament (EHP) is a movement connecting the next generation of European health leaders to rethink EU health policies to address great challenges, from demographic changes, disease burdens, patient empowerment and the uptake of ground-breaking technologies. Last week, the EHP held its third plenary, where every EHP committees had the opportunity to facilitate a roundtable discussion featuring high-level speakers from EU institutions, civil society, industries and academia. During the EHP plenary, I had the pleasure to moderate the discussion on Data for Healthy Societies. The keynote speakers, Annika Nowak (Member of the Cabinet of the Commissioner for Health and Food Safety), Ines Hernando (Healthcare Director at EURORDIS) & Nicky Hekster (Technical Presales at IBM Watson Health EMEA) shared inspiring contributions to the debate on digital infrastructure, data-driven research, patients’ rights and ethics.

Digitalisation has the potential to revolutionise European health systems, but without data, we will not make the most of technological advances – from AI to supercomputing. The EU institutions and businesses can and must stay ahead of the game and contribute to the creation of a trusted and effective data-driven eco-system.

What is the Commission doing to build a health data eco-system? During the debate on Data for Healthy Societies, Annika Nowak illustrated the EU actions for building a truly European data ecosystem, paving the ground for the EHP plenary’s discussion. Although health remains a Member States’ competence, last April Commission’s Communication on eHealth set out an EU plan to enable the digital transformation of care as well as citizens’ secure access to health data across the Union. In this directions, 3 developments have been crucial:

  1. The ongoing work to build a European e-health digital service infrastructure (eHDSI), a foundation for sharing data cross-border e.g. the recent e-Prescription exchange between Estonia and Finland (soon to be followed by Luxembourg and Czech Republic);
  2. The launch of the European Reference Networks (ERNs), connecting healthcare providers and centres of expertise to improve access to diagnosis, treatment and the provision of high-quality care for patients;
  3. The recently adopted Commission’s Recommendation on a European Electronic Health Record exchange format, for the creation of a secure system that will enable citizens to access their electronic health files across Member States

Those initiatives provide a far-reaching toolkit for the next Commission and EU countries, but is it enough to ensure their correct implementation? How can policymakers foster data-driven research and make patients comfortable in sharing their data?  EURORDIS – representing over 30 million people affected by rare diseases in Europe, is one of the best voices to address these questions. Its Director, Ines Hernando, explained that, compared with the general public, rare disease patients are very much keen to share their information due to data scarcity and the difficulties to find a cure, provided that transparency and security of data are guaranteed. Patients’ consent, privacy and access to the results of research for feedback are important conditions, but more can be done to build a trusted eco-system. Patients would also like to be part of the governance arrangements regarding their data, being involved across all the stages of the process.

It goes without saying, GDPR cannot be left out this debate. The challenge of its implementation lies in (1) the unclear rules on secondary use of data for health research and (2) missing common scheme for the anonymisation. Effective solutions should include:

  • Upgrading GDPR framework for health data, going beyond consent, focusing more on patients’ preferences and fostering their participation in decision-making;
  • A European framework for health data donation along with the creation of common standards on anonymity in data (with the smallest impact on the scientific value of the data)

In this debate, the industry’s perspective is also highly important. Trust and data security cannot be achieved without industry’s contribution and its ethical behaviour. For a company like IBM, which builds and deploys artificial intelligence (AI) systems, it is important to understand and include the ethical considerations of their solutions as part of their business performance to ultimately build systems that people can trust. The difficult grammar of algorithms and the risk of data breaches have a big impact on citizens’ confidence in health data access and exchange. On this note, Nicky Hekster stressed the importance of ethics and transparency in data stewardship to better oversee organization’s data assets, provide high-quality data while sharing information responsibly to preventing harm to patients’ interests and privacy. AI systems are set to develop new algorithms and it is essential that systems are transparent on how they are developed and what are the goals pursued. With the uptake of AI in the healthcare sector, fairness, explainability and bias mitigation in algorithms are a must.

The debate provided a great value to EHP ongoing work for shaping its recommendations on Data for Healthy Societies. 3 key messages stuck in everyone’s mind:

  1. Consent is not enough. Data sharing preferences shall be expanded;
  2. Transparency and explainability shall be deployed in every aspect of health data management, from algorithms to data collection;
  3. There are undoubtedly common difficulties on the road to achieve a trusted a secured data eco-system, only working together we can have the best chance to succeed; the eHealth network and ERNs are incredible tools to make this happen.

Our discussion took off with a great timing. On the very same day of the plenary the Commission approved a set of recommendations for the creation of a secure system that will enable citizens to access their electronic health files across EU countries. We are still at the very beginning of this journey and the road to go to achieve a digital world underpinned by ethical and secure infrastructures is still long. Member States has to walk it together and it is definitely well worth the effort.

Stay tuned for the upcoming recommendations from the Committee on Data for Healthy Societies of the European Health Parliament #WeRun4Health