21.12.2022
EN
Official Journal of the European Union
C 486/127
4.2 The fact that the European Health Data Space is built on the General Data Protection Regulation (GDPR) (2), the Data Governance Act (3), the draft Data Act (4) and the NIS Directive (5) provides citizens with a dimension of trust and transparency.
As horizontal frameworks, these provide rules (including security measures) that apply to the health sector.
However, the particularly sensitive nature of health data is a fact and must be properly addressed.
4.3 Over half of Member States do not have specific legislation on re-using electronic health data, for instance for research, policy-making or regulatory purposes, and rely on the general provisions of the GDPR, often using consent for processing health data (6).
This situation results in limited health data re-use.
Not all Member States have a competent body for health data access, but where such a body exists, the number of requests to use health data for research or policy-making projects is rapidly increasing (7), showing the interest in such a system and the level of suppressed demand.
The EESC understands and believes that this concept also supports the need for such a strategy.
4.4 The European Health Data Space will open up innovative approaches to cancer registration, with potential alternatives to gather timely, geo-localised information on various types of cancers.
This could provide a real-time state of play of cancers across the EU.
At the same time, it could identify trends, disparities and inequalities between Member States and regions.
4.5 Importantly, this could make it easier to spot the challenges and specific areas of action requiring investment and other action at EU, national and regional level.
It will also make cancer screening and care more targeted, more effective and more accessible, to give but one example.
4.6 Cybersecurity is central to people’s lives.
The benefits from technology are huge and when they relate to people’s data, the potential is even higher, but so is the risk of losing important and valuable information.
The EESC is aware of the risks involved and the recent examples in different Members States call for action.
A coordinated strategy to combat ‘cyber piracy’ and to increase levels of cybersecurity is very important.
Without this kind of investment, the proposal is useless.
5.
Governance, funding and interaction with other health policies 5.1 The EESC firmly believes that this project is an opportunity to empower the EU, and to benefit from stronger rights and safeguards over EU health data.
It is supposed to be easier to access and share health data with other health professionals, without having to re-do the same tests unnecessarily.
At the same time, easier access to interoperable data of high quality will also facilitate innovation and the development of new treatments, new vaccines and personalised medicine.
Therefore, proper coordination among all stakeholders — public health systems, governments, citizens, policymakers and communicators — is needed to achieve these goals.
5.2 The EESC agrees that investing in digitalisation means investing in better healthcare and the resilience of the Member States’ health systems.
However, the EESC also understands that there is an opportunity for the Member States to make better use of the resources provided by the European financial schemes, particularly the Recovery and Resilience Facility (RRF), as the main pillar of the European recovery plan, NextGenerationEU, aimed at providing financial aid to Member States to combat the economic and social effects of the COVID-19 pandemic and to make the European economy more resistant to future shocks.
(2) (3) (4) (5) (6) (7)
OJ L 119, 4.5.2016, p. 1.
OJ L 152, 3.6.2022, p. 1.
Proposal for a Regulation on harmonised rules on fair access and use of data (Data Act); COM(2022) 68 final.
OJ L 194, 19.7.2016, p. 1.
Hansen J. et al, Assessment of the EU Member States' rules on health data in the light of GDPR, available at https://ec.europa.eu/health/ system/files/2021-02/ms_rules_health-data_en_0.pdf According to the impact assessment accompanying the proposal (p. 15), forthcoming.