On May 3d, the European Commission launched the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union. The EU states that the EHDS will help “to achieve a quantum leap forward in the way healthcare is provided to people across Europe”. The text below explains the concept of data space, places it in the European context, elaborates on the governance, quality, and infrastructure behind the EHDS.
What is a data space?
A data space is a concept in data management that focuses to solve problems in data integration. Data space reduces efforts needed to establish data integration by mapping and matching stakeholders.
What is a data space in the EU context?
The EU data strategy envisions to create a single market for data. This vision includes creation of Common European data spaces to
- ensure more data available to economy and society
- ensure interaction with data generators
To establish Common European data spaces in health, transport, supply chain, public procurements, environmental and energy sectors, the EU intends to employ the following:
- adopt legislation on data governance, access and reuse
- open public datasets across the EU with free reuse
- invest €2B in data processing infrastructure, data sharing, architectures and governance mechanism to share and to federate energy-efficient cloud infrastructures and related services
- establish a procurement marketplace for data processing services + develop a clear regulatory framework on clouds
What is the European Health Data Space?
The European Health Data Space (EHDS) aims to promote better exchange and access to different types of health data (specifically mentioned: EHRs and genomics data), not only to support healthcare delivery (primary use of health data) but also for health research and health policy making purposes (secondary use of health data).
The European Health Data Space is envisioned to be built on 3 main pillars:
- a strong system of data governance and rules for data exchange
- data quality
- strong infrastructure and interoperability
What is Data Governance in the EHDS?
An important concept in the European data governance, as defined in the Data Governance Act (DGA) is data altruism, where “data that is made available without reward for purely non-commercial usage that benefits communities or society at large, such as the use of mobility data to improve local transport”.
Currently few Member States have systems to support data altruism at national levels, however in series of workshops by the EU to develop data governance in the EHDS, reps of 14 EU countries indicated in 2021 that the concept of data altruism seems to be well accepted. Ten were not sure and one rejected the idea of setting up such a system.
The challenges envisioned by the reps to deploy support systems to data altruism include:
- the need for clear information to the public to create awareness
- understanding and willingness with regards to data donation
- issues of potential gain of commercial organisations to be addressed
- the need for unification of rules concerning topics such as the legal bases, collection of data, storage, access, and security measures
- the need to build trust in any system adopted
The conclusions of these workshops and the study to the EHDC governance provide the framework for the primary (care delivery) and the secondary (research + policy) use of health data through:
- mapping GDPR implementations in the EU member States, with an overview of legal and technical modalities to ensure health data sharing
- an overview of existing governance structures for secondary use
- recommendations to possible actions, to facilitate data sharing for both uses
The recommendations cover four interlinked potential areas of further EU level action:
• An EU level Code of Conduct (as a voluntary accountability tool that helps to set out specific data protection rules for data controllers and data processors, a guidebook that will “provide operational meaning to the GDPR principles. However, the suggestion is also that “a Code of Conduct could be given an EU level legal status through an implementing act, which is a legally binding act that enables the Commission to set conditions that ensure that EU laws are applied uniformly)
• A new health sector specific EU level legislation (EU level law on the functioning of the internal market and on incentive measures to protect human health and to combat major cross-border health threats, plus update the eHealth Network, to promote better use and re-use of health data)
• Non-legislative measures including guidelines and policy actions (more guidance by the
European Data Protection Board to ensure consistent application of GDPR, more collaboration on technical issues in infrastructure, technical interoperability, data quality and semantic interoperability, more efforts to reach goals on FAIR data at the EU level, inter alia, more guidance on the inclusion of technical standards in public procurement tenders, more financial support through the Connecting Europe Facility, Digital Europe, EU4Health to collaboration on building infrastructures, improving quality of health data and capacity building in the Member
States, to further improve digitalisation and data sharing for the secondary use (research + policy) across borders
• Practical measures to support a European Health Data Space: anonymisation (the processing of personal data in a manner that makes it impossible to identify individuals from them) and pseudonymisation (replacing any information which could be used to identify an individual with a pseudonym) of health data, security (common approaches to security, including cyber security), data quality and minimal datasets (at the EU level to find agreement on core elements of data sets in order to facilitate better co-operative use of such data sets for research and health system administration), interoperability of health data (specifically, the EHDS can foster compliance with specific technical standards to ensure that such data can be shared across borders in an interoperable manner)
The EHDS data quality
The aim of the EHDS is to ensure data quality and that software run by various stakeholders (e.g. electronic health records, different registries, various IT or digital tools) can talk to each other. This requires technical and semantic interoperability, and to ensure FAIR data principles (findable, accessible, interoperable and reusable). The EU Commission supports mapping and “FAIR-ification” of existing health data registries and other data sources to establish common data sets for exchanges for health research and policy making purposes.
The EHDS infrastructure
The EHDS infrastructure at European level will follow the strategy of the European Data Space. It will build on and scale up existing initiatives, specifically mentioned are:
- the eHealth Digital Service Infrastructure: infrastructure to ensure continuity of care for European citizens while they are travelling abroad in the EU, including ePrescription and eDispensation (act of electronically retrieving a prescription and reporting on giving the medicine to the patient as indicated in the corresponding ePrescription), and Patient Summaries (health information on important aspects such as allergies, current medication, previous illnesses and surgeries, lifestyle indicators, nursing care aspects etc, necessary for proper treatment and care of a patient, especially when there is a language barrier between the healthcare professional and the patient)
- the European Reference Networks: virtual networks of healthcare providers across Europe, to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. To review a patient’s diagnosis and treatment, ERN coordinators convene ‘virtual’ advisory panels of medical specialists across different disciplines, using a dedicated IT platform and telemedicine tools. The first ERNs were launched in March 2017 involving more than 900 highly-specialised healthcare units from over 300 hospitals in 26 EU countries. Currently some 24 ERNs are working on a range of thematic issues including bone disorders, childhood cancer and immunodeficiency)
- the Genomics project (the current The ‘1+ Million Genomes’ (1+MG) initiative among 22 EU countries, the UK and Norway with a goal to have at least 1 million sequenced genomes accessible in the EU by 2022) and the Beyond 1 Million Genome Project