Health Data
Description
Health data is a hot topic at EU level, and with the number of initiatives steadily increasing there is an opportunity for the medical & research community to provide input. Indeed, the European Commission has recently announced plans for Europe’s digital transformation by 2030, ‘Europe’s Digital Decade’ and launched a series of initiatives relevant for the health sector including the proposal for the Artificial Intelligence Act, the Data Governance Act and plans for the European Health Data Space.
The BioMed Alliance was also recently accepted as a registered stakeholder in the Joint Action Towards the European Health Data Space (TEHDAS) which aims at guiding the establishment of the European Health Data Space. The Task Force on Health Data was established to combine the expertise of experts in health data sharing and contribute efficiently and meaningfully to on-going and future health-data related initiatives and policies, included the TEHDAS Joint Action.
Chair
This Task Force is chaired by Sarah Collen.
Board Representatives
The Board Representatives for this task force are Prof. Wim Oyen and Prof. Ruth Loos.
Highlights
News
New multi stakeholder statement: Health Stakeholders advocate for enhanced collaboration in European Health Data Space (EHDS) Implementation
A coalition of 39 leading representatives from the European health community has publised a joint statement welcoming the publication of the European Health Data Space (EHDS) regulation in the EU's Official Journal. The group underscores the need to promptly establish an inclusive and well-resourced Stakeholder Forum to ensure the effective implementation of the EHDS.
The Stakeholder Forum is envisioned as the cornerstone of the collaborative effort to successfully implement the EHDS, providing a platform for diverse voices to engage in meaningful dialogue. A collaborative approach that includes citizens, civil society, healthcare professionals, scientists, academia, healthcare providers, payers, industry stakeholders, and patient representatives will foster trust and contribute to the acceptance, effectiveness, and rapid adoption of EHDS initiatives. The coalition is calling for early and sustained investment in the Forum’s operations, including measures to promote inclusivity, transparency, and actionable contributions.
Key Recommendations include:
- Promptly set up the Stakeholder Forum:
- Establish the Forum promptly and allocate sufficient resources for its operation.
- Ensure representation from diverse stakeholders and foster regular, transparent dialogue.
- Develop use cases and Key Performance Indicators (KPIs) to monitor implementation progress and accountability.
- Complement the Forum’s efforts with open public consultations to build broader trust.
- Invest in Capacity Building and Funding:
- Support cross-border knowledge exchange and training in data governance and digital literacy.
- Ensure equitable and sustainable funding for Member States, enabling all stakeholders to align with EHDS standards and regulations.
- Maintain, and where possible, increase ongoing funding through initiatives like EU4Health to support the EHDS implementation.
- Promote Transparency in the EHDS Board:
- Establish and agree on clear principles of transparency for the EHDS Board.
- Publish meeting agendas, papers, and minutes promptly, and consider webcasts, leveraging best practices from EU agencies.
- Define procedures for regular consultation with the Stakeholder Forum and ensure feedback is integrated and reflected into the work of the Board.
News
New recommendations: How the Healthcare & Research Community Can Help Build the European Health Data Space
The BioMed Alliance has published a new policy document, How the Healthcare & Research Community Can Help Build the European Health Data Space, focusing on crucial recommendations for shaping and implementing the EHDS. This paper builds on the experiences of healthcare professionals and researchers with health data sharing, and emphasises challenges and opportunities for enhancing the EHDS's functionality and impact.
The insights for this document stem from our workshop, Building Bridges: Towards the Implementation of the EHDS, held on October 15. This event brought together various stakeholders to discuss collaborative approaches to the EHDS, highlighting opportunities for medical societies to contribute meaningfully and ensure the EHDS meets the sector's needs. Now that the proposal has been finalised and we move towards the implementation phase, it is essential that stakeholders are closely involved in setting up the EHDS and ensuring remaining issues are addressed.
Event
BioMed Alliance Workshop on how the healthcare & research community can help build the European Health Data Space
BioMed Alliance is organising a public workshop on 'Building Bridges: how the healthcare & research community can help build the European Health Data Space' taking place on 15 October from 14:00-16:30 CET at the BioMed Office in Brussels. The workshop will be followed by a networking cocktail.
As we move to the implementation phase of the European Health Data Space (EHDS), there are still many challenges to be addressed to ensure EHDS has a concrete positive impact on the primary and secondary use of health data. During the workshop we will exploring ways in which the health stakeholder community can contribute, with policy makers, clinicians and researchers and other stakeholders from the health field. The event will also be a great opportunity to meet face to face and network with colleagues!
News
Enhancing BioMed Alliance Activities with the EXHALE operating grant
The BioMed Alliance has been awarded the EXHALE operating grant (BioMed Alliance EXpertise in Health Across Legislation at EU level) for 2024 under the EU4Health programme (grant agreement no 101176496). This grant aims to further strengthen the representation of medical societies, healthcare professionals, and researchers in the EU health field.
The EXHALE grant will enable the Alliance to enhance the expertise and knowledge of the medical and research communities on the regulatory system and policy developments in the health field, and how these impact their work. The focus will be on EU4Health priorities including the Medical Devices Regulation, In Vitro Diagnostics Regulation, the European Health Data Space, Health Technology Files, and the Health Emergency Preparedness and Response authority.
Over the coming months the BioMed Alliance will work with its Committees and Task Forces to build on the proposed activities, strengthen its representation at EU level and build skills in the regulatory field. We will organise a series of workshops and share materials, and more information will follow soon.
Statement
Implementing EHDS: medical societies advise on how to bring health data sharing to the next level
In a new BioMed Alliance statement, medical societies provide key recommendations on the European Health Data Space (EHDS) implementation. The statement follows the European Parliaments adoption of the political agreement with the Council on 24 April and highlights what is necessary to make EHDS provide a concrete added benefit to patients, doctors and researchers across Europe.
In the statement, the 34 members of the Alliance welcome the agreement, while providing input on remaining key issues that need to be addressed in the implementation and operation phases. These include the need for further stakeholder engagement, the importance of ensuring a harmonized opt-out mechanism, further clarification for definitions and legality, and increased support for healthcare professionals and researchers.
Statement
Statement on the implementation of the EHDS
In a new BioMed Alliance statement, medical societies provide key recommendations on the European Health Data Space (EHDS) implementation. The statement follows the European Parliaments adoption of the political agreement with the Council on 24 April and highlights what is necessary to make EHDS provide a concrete added benefit to patients, doctors and researchers across Europe.
In the statement, the 34 members of the Alliance welcome the agreement, while providing input on remaining key issues that need to be addressed in the implementation and operation phases. These include the need for further stakeholder engagement, the importance of ensuring a harmonized opt-out mechanism, further clarification for definitions and legality, and increased support for healthcare professionals and researchers.
Joint Statement
Charting the path forward: New joint stakeholder statement on the implementation of the EHDS
BioMed Alliance contributed to a new statement on the implementation of the European Health Data Space signed by 36 organisations representing healthcare professionals, patients, industry and other health-related stakeholders. In the statement, the EU health community welcomes the agreement on the European Health Data Space (EHDS) proposal, but also provides key recommendations to ensure the EHDS will be implemented in a way that provides most added value for patients and European health systems.