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Espaço Europeu de Dados de Saúde

Opinion Number: CDR 3754/2022
Rapporteur: CÎMPEAN Daniela
Commission: NAT
Status: Adopted
Date: 08/02/2023

to ensure that both the legislative and non-legislative framework related to the future European Health Union and more specifically the legal framework for the European Health Data Space reflects the responsibilities of local and regional authorities in public health and takes into account their positions, given that 19 of the 27 Member States have opted to give LRAs primary responsibility for healthcare
In its follow-up report from 31 May 2023, the European Commission touches upon selected issues raised in the Opinion.

The Commission shares the concerns of the Committee as regards:
the important role of local and regional authorities depending on the internal organisation of the Member States. When the proposal refers to Member State authorities, these can be at various level, in line with Member States’ internal organisation.
the importance of digital health literacy. It is important to identify possible risks of widening health inequalities through digital exclusion in the introduction of new technological tools.
the crucial importance of capacity building and investments in Member States. Digital skills of experts and technical know-how are key for the development of the EHDS, the health data systems and infrastructures both for primary and secondary uses of health data. Alongside with investments for the implementation of the EHDS, the Commission is also supporting capacity building on health data and digital health matters at Member States level through EU4Health.

The Commission also takes note of a few issues raised in the Opinion, such as the need for support for new additional infrastructure, suggesting funding programmes as a solution; possible fragmented approach and implementation due to absence of clear guidelines, maintaining that the aim of the EHDS Regulation is to reduce the fragmentation including via implementing acts and guidelines; and the issue of quality of data due to individuals' right to enter data in their electronic health records, citing as a solution that it has to be clearly marked as such.

Moreover, the Commission takes note of the call to have CoR represented on the EHDS Board, admitting but not committing to the idea that the Committee can be invited to attend meetings of the EHDS Board and to participate in its work when relevant, depending on the topics discussed and their degree of technicality and sensitivity.

- underlines that citizens' health-related expectations towards the EU were reflected in the conclusions of the Conference on the Future of Europe, in particular as regards strengthening the resilience and quality of the health systems by "creating a European Health Data Space";

 stresses that the success of the EHDS requires a multi-level governance approach and solutions not only at EU and national level, but also at regional and local level;

 believes that one of the challenges involved in rolling out the EHDS will be providing sufficient resources and infrastructure, including physical infrastructure at national, regional and local level, to cover the storage of, access to and exchange of health data for healthcare provision, research, policy-making and regulatory activities; the cost estimates included in the proposal do not identify local and regional costs clearly enough and it is unclear to what extent Member States' transition costs will be covered and how the costs incurred by the various stakeholders will be handled;

 calls on the Commission to discuss and present suggestions on how the Union can support the development of additional physical infrastructure for data storage in the Member States, including at local and regional level;

 notes that several Member States are already working at national and decentralised level to find digital solutions for the exchange of data across sectors, and for many of the other elements contained in the Regulation. Therefore, the experience acquired through this type of initiative should be harnessed and tapped in future through the EHDS;

 stresses the need to further clarify the role and powers of the EHDS Board and calls for the CoR, as the representative of local and regional authorities, to be represented on the EHDS Board.
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