The Architecture of Health Data in Europe.

We promote a secure and public-interest-oriented health data space in Europe.

Bringing Health Data from Theory into Practice – for the Benefit of Citizens

Acting as a trailblazer, EHDA supports companies and research institutions in successfully developing pioneering health-related projects aligned with the European Health Data Space (EHDS).
EHDA builds on the results and expertise of nationally funded initiatives such as HEALTH-X, TEAM-X, and the GAIA-X Med project funded by the state of Schleswig-Holstein. Leveraging these foundations, the Alliance invites European partners to further develop technical and organisational solutions into secure processing environments (sVUs) for cross-border and cross-sector use cases.

At its core, EHDA focuses on transforming existing solutions into scalable, EHDS-compliant data space frameworks. These frameworks serve as secure processing environments for trusted healthcare and research scenarios, enabling the responsible and interoperable use of health data across Europe.
In addition, EHDA actively fosters the exchange of expertise and the collaborative development of solutions to technical and organisational challenges.
By transferring knowledge and practical insights to member organisations, policymakers, and the broader public, the Alliance helps raise awareness of the diverse possibilities of data-driven healthcare and promotes a deeper understanding of its societal value.

Through this work, EHDA contributes to establishing a robust, trustworthy foundation for the future of data-driven healthcare - placing citizens at the center while enabling innovation, collaboration, and sustainable progress across Europe.

The tasks of the EHDA e.V. are

Further development and promotion of health data room technologies:

 

Support and further development of EHDS-compliant Gaia-X technologies and secure processing environments (sVU), including the permanent establishment of structures and results from projects such as "HEALTH-X dataLOFT", "GAIA-X-MED" and "TEAM-X".

Integration and utilisation of data infrastructures:

 

Establishment, coordination and further development of centralised and decentralised data infrastructures for the use of primary and secondary data in research, healthcare, prevention and rehabilitation

Promotion of co-operation and knowledge exchange:

 

Establishing national and international co-operations, strategic alliances and promoting the exchange between members, science, industry and politics through events and public relations work.

For me, involvement in EHDA e.V. means the chance to actively help shape digital healthcare solutions and drive forward networked, patient-centred healthcare in Europe. It is an opportunity to combine technological innovation with social responsibility and to ensure that healthcare data is used securely and for the benefit of all.

Prof. Dr. Björn Eskofier
Chair of AI-supported Therapy Decisions, LMU & LMU Hospital and Chief Financial Officer and Deputy Chairman of EHDA e.V.

Mitglieder & Partner

Our DNA: the Golden Rules of the EHDA e.V

We act according to the values of EHDS, Gaia-X and IDSA

The concepts and values of Gaia-X, European Health Data Space and the International Data Spaces are the guiding principles for the implementation of the EHDA Data Space and the execution of (decentralised) data exchange transactions in the EHDA Data Space.

Data protection: privacy as standard

Effective and reliable data protection is of paramount importance not only as a goal, but also to ensure citizens' trust in the data space. This means that data should be protected and kept private by default, above and beyond the legal requirements.

Focus on citizen centricity

The EHDA data room is based entirely on the consent of citizens.

All transactions involving an individual's data may only commence if the data subject has given active and valid consent to the transaction in question. The EHDA Data Space relies fully on the consent of citizens in the context of the forthcoming EHDS Regulation for the transfer of data from one data holder to another via the EHDA Data Space

Data sovereignty

The EHDA data space is designed as a sustainable solution for the digitisation of health data to enable new health research, better health services and more efficient digital healthcare. It aims to combine primary and secondary health data markets.

All participants should be able to participate on equal terms and have sovereignty over their data. They ensure that the services they offer or use remain open and fair and are free from discrimination and undesirable lock-in effects.

Governance framework

EHDA e.V. defines and establishes the governance framework required to enable (decentralised) data exchange transactions in the EHDA Data Space ("Governance Framework"). The EHDA e.V. may define technical standards ("Standards"), non-technical requirements ("Non-Technical Requirements") and other guidelines for participants and the products and services they make available in the EHDA Data Space.

The EHDA e.V. can use certifications and other legal instruments to give effect to the Governance Framework.

Freedom of contract for citizens

Citizens enjoy freedom of contract within the EHDA data space in accordance with the governance framework and applicable laws and regulations. Data-holding participants respect citizens' choices and wishes as long as they are in line with applicable laws and regulations.

Registration and certification

Each participant undertakes to comply with the Governance Framework by registering in the EHDA data room. Participants require certification for certain products and services, which is issued by a conformity assessment body authorised for the EHDA data room.

Personal responsibility and compliance with the law in the EHDA data room

Each Participant is obliged to comply with all applicable laws and regulations in its actions within the EHDA Data Space on its own responsibility, in particular competition law, data protection laws

(GDPR and others), legislation under the EU Digital Strategy (including in particular the EHDS, the Digital Market Act, the Digital Services Act, the Data Governance Act, the Data Act and the AI Regulation) and all applicable cybersecurity legislation ("Compliance by Conduct").

Technical requirements to ensure compliance

As part of the governance framework, EHDA e.V. can define specific requirements for the design of technologies and processes to ensure compliance with applicable laws and regulations. Even if EHDA e.V. specifies such requirements, each participant is still responsible for its own compliance behaviour.

Safety standards

Each Participant shall manage its access to and use of the EHDA Data Room responsibly at all times and in accordance with all applicable technical security standards set out in the Governance Framework.

Participants bear a responsibility towards other participants arising from non-compliance with these safety standards.

Ensuring compliance with the Golden Rules

EHDA e.V. reserves the right to monitor Participants' compliance with these 12 Golden Rules (including delegating such monitoring to third parties). EHDA e.V. reserves the right to enforce the Governance Framework (including through third party participants), including by withdrawing certifications and/or registration as a participant or other measures that are reasonably necessary.

Legal provisions and disclaimer

These 12 golden rules apply as part of the governance framework until they are amended or replaced by EHDA e.V.. They are binding for every participant on the basis of the corresponding registration process. They only establish a contractual relationship with EHDA e.V. or form part of such a relationship if this has been expressly agreed between EHDA e.V. and the participant.

The EHDA e.V. is not responsible for the data exchange transactions concluded between the participants. Each participant acts at his/her own risk and responsibility in accordance with the conditions agreed with other participants.