The European Commission has published its long-awaited proposal for a European Health Data Space. This space will be the “backbone of the Union for Health”, says the EU Commissioner for Health, Stella Kyriakides.
The proposal is described as revolutionary by Vice-President Margaritis Schinás.
Health and economic rationales converge, said Commissioner Kyriakides. With 450 million Europeans, the Commission wants to change the game and make the EU a world leader in this field. It intends to introduce a high standard of digitalisation to reduce the fragmentation resulting from the different levels of digitalisation of health data in the Member States.
The proposal for a European Health Data Space is based on two pillars and introduces two different infrastructures.
The first pillar will promote the primary use of health data. This pillar aims to offer patients, at no additional cost, the possibility to access their health data through access points located in the Member States, to correct them, to share them or not with the practitioners of their choice and to visualise the operators who have access to their data. This component should also simplify the work of health practitioners.
A cross-border infrastructure, MyHealth@EU, would be established to enable the exchange of health data in the context of healthcare provision.
Normative elements would be introduced to enable these exchanges in a safe and secure space and to improve the interoperability of data. Member States will have to set priority categories of data available in a common sharing format.
On the governance side, Member States will be obliged to set up a digital health authority to ensure that individuals’ rights are respected.
The second pillar of the proposed area is a European framework for the secondary use of health data. This component should allow researchers and industrialists access to health data and promote innovation and research in the health field.
The data will have to be anonymised and users will have to obtain authorisation to access the data in a secure environment. The Commission wants to accompany the secondary use of data with a prohibition on using it in a way that is harmful to individuals.
A second decentralised infrastructure is proposed: HealthData@EU. It will connect the entities providing access to health data, which will have to be set up in each Member State.
The Commission proposes a common governance system. It wants to see the creation of a ‘Health Data Space Board’ which it would chair. The board would be composed of representatives of digital health authorities and health data access bodies as well as observers who would ensure the consistent and transparent implementation of the regulation and coordinate practices and cooperation at European level.
The estimated benefit of this second pillar is 5.4 billion by the Commission for the next decade.
For Commissioner Kyriakides, the proposal is based on trust and respect, especially for citizens’ rights and EU data protection and security legislation. The Commission points to the experience gained with the implementation of the digital “Covid” certificate and the eHealth network.
The proposed instrument to implement the European Health Data Space is a regulation based on Articles 16 and 114 of the Treaty on the Functioning of the European Union.
A transition period is foreseen. However, the Commission wants the space to be operational by 2025-2026, if the proposal is adopted by the co-legislators.
To finance these initiatives, Margaritis Schinás says that sufficient funding is available: 800 million euros would be available for this type of expenditure under EU funds. Commissioner Kyriakides mentioned the mobilisation of EU4health and Horizon Europe. Between 10-12 billion would be available under the Recovery and Resilience Facility for Member States, with the digital transition of health systems being one of the political priorities of this EU mandate.
Link to the proposal for a regulation: https://aeur.eu/f/1gs (Original version in French by Emilie Vanderhulst)