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
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.
Press release
Healthcare community calls for action: Do not fail patients and undermine the full potential of the European Health Data Space
BioMed Alliance, as part of a multi-stakeholder group consisting of 32 European patient organisations, medical associations, research organisations, data collaborations and industry associations met EU officials, including MEP Tomislav Sokol, Co-Rapporteur, as well as several permanent representations that will hold upcoming Presidencies of the Council of the European Union, to discuss how the European Health Data Space (EHDS) can facilitate health research and innovation to create tangible benefits for patients in the EU.
News
Multi-stakeholder EHDS Workshop to kicked off discussions on the proposal
The EU Health Coalition, with the support of BioMed Alliance, EAU, EFPIA and COCIR organised a hybrid workshop with stakeholders and policy makers on 18 May to 'Maximise EHDS impact on better health data sharing'. During the meeting we started by listening to the Commission who presented the main elements of the proposal, then we continued with two case studies with practical examples of health data sharing. We finished with a panel discussion on health data sharing with a range of panellists from the EMA, Sciensano/TEHDAS, EPF, COCIR, BioMed Alliance/EAU and the Danish Health Data Authority. Discussions showed that facilitating health data sharing can contribute to better healthcare and research, and that there are numerous best practices that can be incorporated in the development of EHDS.