The European Commission has proposed a regulation on a European Health Data Space to facilitate the access, control and use of health data across the EU.
On 3 May 2022, the European Commission (EC) proposed a regulation for setting up a European Health Data Space (EHDS), which would give people the ability to access, control and use their health data in their home country or across EU Member States. Through the EHDS, the EC also aims to promote a single market for digital health services and products as well as a health data framework that complies with the EU’s data protection standards. This EHDS is part of the European Strategy for data, which aims to create multiple ‘common European data spaces’ to make more data available for use in the economy and society, while ensuring that companies and citizens stay in control of their own data. The EC intends to create these common European data spaces in nine sectors: i. Industrial & Manufacturing; ii. Green Deal; iii. Mobility; iv. Health; v. Finance; vi. Energy; vii. Agriculture; viii. Public Administration; ix. Skills.
Especially in the context of the COVID-19 pandemic, the importance of digital tools regarding health data has been highlighted. However, the current system among the EU Member States with varying rules and processes makes it difficult to share health data across countries. Furthermore, threats such as cyberattacks are increasing continuously, particularly as digital services become more significant in the health sector. Thus, the EHDS builds upon other EU legislation and initiatives regarding the digital sector, such as the proposed Data Governance Act and Data Act or the Network and Information Systems (NIS) Directive.
The EC’s proposal plans that citizens will be given complete control over their own health data, ensuring immediate, easy and free access to their data, which they can then choose to share with other health professionals within their country and across the Member States. Additionally, a common European format is foreseen to be used for issuing patient summaries, e-prescriptions, images and image reports, laboratory results and discharge reports to facilitate data sharing and ensure interoperability, which will become a mandatory requirement. The EHDS will also introduce digital health authorities in each Member State to ensure that citizens’ rights are protected. The MyHealth@EU digital infrastructure will assist the sharing of health data across borders. Furthermore, a strong legal framework will be created to access and use health data for research, innovation, public health, policy-making and regulatory purposes. It ensures that researchers or public institutions will have the necessary information to develop treatments, vaccines or medical devices and create more resilient health systems with access for all. Thus, researchers or public institutions will be able to access health data with a specific permit issued by a health data access body to be established in every Member State and to be connected to the new HealthData@EU decentralised infrastructure. The researchers or institutions will only be allowed to access the data if they plan to use it “for specific purposes, in closed, secure environments and without revealing the identity of the individual”. Additionally, they are especially prohibited from accessing health data for harmful uses, such as designing harmful products or increasing an insurance premium.
The establishment of an EHDS will require funding from EU programmes and Member States’ national public funding. The EC foresees €220 million to be provided by the EU between 2023 and 2027, the majority of which should come from the EU4Health programme (€170 million) that has already supported the EHDS with €110 million in its 2021 and 2022 Work Programmes. Additionally, the Digital Europe Programme (DEP) is expected to provide €50 million for the MyHealth@EU digital infrastructure. However, this support will come from the existing budget of these programmes and not increase either of those budgets. Beyond, the EC also plans for additional financial support to come from the DEP, Connecting Europe Facility and Horizon Europe, as well as direct technical support from the Technical Support Instrument. Moreover, the Recovery and Resilience Facility (RRF) and the European Regional Development Fund (ERDF) are expected to cover the costs of connecting Member States to the European infrastructures. The EC aims for the EHDS to be launched in 2025. In a next step, the EC’s proposal for a EHDS will be discussed by the Council of the EU and the European Parliament.
On 3 May 2022, the Guild published an opinion on the EC’s proposal for the EHDS. They support the EC’s ambition in facilitating health data sharing for research purposes and improving the health and well-being of citizens across Europe. However, they urge the EC to go further and to “maximise the potential of collaboration and the exchange of patient data for research purposes”, highlighting the importance of cross-border collaboration. Furthermore, on 3 May 2022, DIGITALEUROPE also issued a statement supporting the EHDS. While they recognise that the EC has taken an essential step forward, they call for faster action and more clarity regarding certain contents. These specifications include, for example, the interactions with other EU data legislation such as the Data Act or the AI Act, how to coordinate and secure enough budget from both the EU and the Member States, or how the EU will play a more significant role in harmonising the Single Market for digital health and data while ensuring that the Member States and regions remain in control over their own healthcare systems.