Features and objectives of the European Health Data Space

Features and objectives of the European Health Data Space

In May 2022, the European Commission introduced a regulation to establish a European Health Data Space (EHDS). The EHDS is defined as a specific health ecosystem consisting of common rules, standards, and practices, infrastructure, and a governance framework.

During December 2023, the permanent representatives of the European Union member states reached a consensus on the Council’s mandate for the creation of a new regulation aimed at facilitating the exchange of health data and its access at the European Union level.

Main objective of the European Health Data Space

The main objectives of this proposal are:

• Empower individuals to take control of their health data, whether they are in their home country or another EU member state.
• Support the use of health data to enhance various sectors such as healthcare provision, research, innovation, and policy development.
• Enable the European Union to harness the potential offered by secure exchange, use, and reuse of health data.
• EU member states are required to establish a digital health authority to implement the new provisions.

Currently, the ability to access health data across borders varies among EU countries. The recent regulation aims to facilitate scenarios such as a Spanish visitor obtaining a prescription from a pharmacy in Belgium or healthcare professionals accessing health information of an Italian patient undergoing treatment in Portugal.

Council’s Position about the European Health Data Space

The mandate agreed upon in December 2023 elaborates on the Commission’s proposal in several key aspects:

• New clarifications: The Council’s mandate seeks to address uncertainties regarding the regulation’s scope, adaptation to the General Data Protection Regulation (GDPR), and criteria for providing electronic health data.
• Steering groups: In its mandate, the Council proposes the creation of two steering groups composed of representatives from member states, responsible for managing MiHealth@EU and DataHealth@EU. Other stakeholders may be invited as observers to discuss relevant issues.
• Governance: The mandate expands the roles of EU member states in the proposed EHDS management board and requires national digital health authorities to publish an activity report every two years.
• Electronic health records: According to the Council’s mandate, the format for exchanging electronic health records at the European level may have distinct national and cross-border profiles.
• Opt-Out pption: Member states have discretion to allow patients to opt out of the new data exchange system.

The mandate includes a delay in the regulation’s implementation for up to two years after its entry into force.

European Health Data Space: Parliament’s position

In December 2023, the Parliament adopted its position, suggesting the following aspects:

• Certain sensitive health data should only be used for research and development, policy-making, education, patient safety, or regulation if patients provide explicit consent.
• Implementation of a voluntary opt-out mechanism if individuals choose not to share other types of data.
• The need to prohibit the use of health data in the job market or the provision of financial services.

As next steps, the Parliament is ready to commence negotiations with EU governments on the final legislative text, and the approval of relevant regulations is expected in a short period.

At Letslaw our team of digital lawyers specialised in data protection will assist you in this matter and any other related matter you may need. So do not hesitate to contact us.