The European Strategy for Data (2020) seeks to create a single European market for data that upholds data privacy for individuals while enabling data use for competition and innovation. As part of the strategy, the European Commission (EC) proposed the creation of sector-specific data spaces that bring together a range of stakeholders within a given domain to encourage the data sharing and collaboration on common issues such as data ethics, data standardisation, data governance, and shared practices.
The European Health Data Space (EHDS) is the first data space to be created under this strategic initiative, with the purpose of promoting health-data exchange and supporting research on new preventive strategies, as well as on treatments, medicines, medical devices and outcomes.
The EHDS aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It aims to promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policymaking and legislation. Innovative solutions and digital technologies including artificial intelligence (AI) can transform healthcare systems. They make them more sustainable and improve people’s health. The development of these technologies requires secure access by researchers and innovators to substantial amounts of health data. The EHDS aims to place individuals’ rights to control their own personal health data at its core.
This public consultation (July 2021) focussed on:
- the access to and use of health data for healthcare provision, research and innovation, policymaking and regulatory decision;
- fostering a genuine single market for digital health services and products, including innovative ones.
We submitted our response to the consultation in July 2021, which you can read here.
We commended the European Commission’s initiative to establish data spaces that bring together all stakeholders within a sector domain, and for prioritising health as the first sector for establishment of this European data space model.
Data is national and international infrastructure, critical to the flourishing of both open economies and open societies. It underpins operations, policy and decision-making across the public sector, business and civil society, and makes innovation possible around emerging digital technologies such as AI. Open, trustworthy data infrastructure and ecosystems enable the free flow of data across sectors, domains and borders.
In our consultation response, we highlighted three specific data infrastructure and ecosystem tools that will require leadership from the EHDS:
- Open health data standards, allowing data interoperability and building on the policy priority of digital technical standards;
- Open models for cooperation and innovation, recognising the opportunity to foster new health industry ecosystems built on responsible and consensual reuse of quality health data;
- Data institutions for trusted data sharing, crucial for data free flows with trust, cross-sector collaboration, industry innovation, pandemic resilience, and crisis response.
In our consultation response we also draw on our relevant evidence base, which includes:
- How Covid-19 symptom tracker apps can collate health-surveillance data for early diagnostics, without exposing personal health data
- The role data intermediaries can play to protect the privacy of health data while also making anonymised, aggregated health data available for scientific research
- The opportunity of secondary use of health data to open new markets in physical activity businesses, which in turn generates greater preventative health opportunities for local populations
- How competitive industry stakeholders are able to collaborate and share clinical trial data on global health challenges such as antimicrobial resistance, while still protecting their commercial advantage
- Summary of the global data governance environment, including current debates on health data as a global public good, and current maturity of data governance globally and emerging best practices, created as pre-reads for the WHO Data Governance Summit held on 30 June 2021
- An analysis of existing European health data policies, and gaps and opportunities
The European Commission is expected to announce its response to the consultation and to outline future plans to implement a European Health Data Space in Spring 2022.
For more about our work on European Health Data, please explore our project on secondary use of health data in Europe, our white paper and briefing event on the European Health Data Space, our mapping of health data standards in Europe, and our health data governance playbook.