The European Health Data Space (EHDS) is a project by the European Commission aimed at unlocking the full potential of European health data. This initiative seeks to enable the use of health data to enhance healthcare, innovative medical research, and informed policy decision-making. Simultaneously, it aims to empower citizens to have control over their electronic personal health data at the national and EU levels.
The EHDS is a health data ecosystem based on rules, common standards, best practices, infrastructures, and a governance framework. The main objectives of EHDS include:
Empowering Citizens: By increasing digital accessibility and control over their electronic personal health data at the national and EU levels, and supporting the free movement of health data. This also supports the development of a common market for electronic health records, relevant medical devices, and medical AI systems (primary data usage).
Efficient Use of Health Data: Providing a consistent, trustworthy, and efficient framework for using health data in research, innovation, policy decision-making, and regulatory activities (secondary data usage).
EHDS forms a key pillar of the strong European Health Union and will be the first shared EU data space in a specific area resulting from the European data strategy.
Trust is fundamental to the success of EHDS, offering a reliable environment for secure access and processing of a wide range of health data. It builds upon the General Data Protection Regulation (GDPR), the proposed Data Governance Act, the Data Act draft, and the Network and Information Systems Directive. While horizontal conditions apply, more specific rules are being developed under the EHDS Regulation, taking into account the sensitivity of health data.
The EHDS Regulation is proposed by the European Commission and is the result of a comprehensive process that includes impact assessment and public consultation.
A crucial aspect of EHDS is interoperability, enabling seamless and efficient data utilization. This involves creating standards to effectively exchange and use health data, including the representation of medical information and laboratory results. The European Commission collaborates closely with various committees and stakeholders to ensure interoperability is ensured.
Honic actively participates in various committees, including Working Group 1 of the Health Location Forum BW in the German state of Baden-Württemberg. This participation allows Honic to engage in discussions regarding the Health Data Usage Act, which supports the preparation of EHDS and is set to be introduced shortly in a draft form by the Federal Ministry of Health.
Official information from the EU Commission on EHDS (in English)
Summary of the EHDS draft text by Honic (in German)
E-HEALTH-COM article on the impact of EHDS on the German healthcare system (in German)
Interview with Brussels officials responsible for EHDS (in English)
EHDS is a milestone on the path to improved healthcare and medical innovations in Europe. At Honic, we are actively committed to the successful implementation of this project and will keep you informed about relevant developments.