EXHALE
BioMed Alliance is a recipient of the EU4Health Operating Grant EXHALE (Grant Agreement No. 101176496): EXpertise in health across legislation at EU level.
Within EXHALE, BioMed Alliance focused on capacity building for medical experts, thus ensuring that appropriate expertise is shared with legislators, thereby facilitating networking and cooperation. The Alliance focused on EU4Health priorities including: strengthening primary and secondary sharing and use of health data for healthcare and research, the implementation of the Medical Devices Regulation, the In Vitro Diagnostics Regulation, and the Health Technology Assessment Regulation. EXHALE aimed to bridge the gap between clinical practice and decision making at EU level by strengthening inclusion of evidence-based approaches during multi-stakeholder phases of development.
EXHALE aimed to enhance capacity building and bridge the gap between clinical practice and EU decision-making by:
- Piloting a Training session for clinicians and researchers on EU Regulatory Affairs
- Organising workshops on relevant EU health policy files including the European Health Data Space (EHDS), the Medical Devices Regulation (MDR), and the In Vitro Diagnostics Regulation (IVDR) as well as on Global Health challenges
- Organising in-person Taskforce meetings for the BioMed Alliance Committees to facilitate networking and cooperation
- Writing policy papers and organising internal meetings
- Launching a revamped website with new videos
- Attending policy sessions at member congresses and meetings
Work on Health Data
Workshop
On 15 October 2024, BioMed Alliance organised a workshop focusing on how to make the European Health Data Space (EHDS) a reality. The event emphasized building on existing initiatives and fostering collaboration with the health community and medical societies to strengthen both the primary and secondary use of health data. Stakeholders across the spectrum have much to offer and gain from the EHDS, and the workshop provided a platform to explore how the health community can prepare for and contribute to its implementation. The workshop featured a diverse panel of speakers from the European Commission, patient organizations, industry, and research, aimed at educating different health stakeholders on the EHDS initiative and its benefits.
The workshop followed the BioMed Alliance Health Data task force meeting during which task force members discussed main challenges and next steps regarding the collective work on health data.
Policy Paper
Within EXHALE, the BioMed Alliance published policy recommendations for the implementation of the health data space. The insights for the paper stem from the health data workshop organised in October. The document can be found here.
Work on Medical Devices and IVDs
Workshop
On 7th November 2024, the BioMed Alliance hosted a workshop at its Brussels office to address pressing challenges in the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). This timely event brought together key stakeholders to discuss critical issues such as limited clinical evidence, limited transparency, the use of in-house IVDs, and the reduced availability of essential medical devices. Interactive roundtable discussions provided a platform for brainstorming practical solutions, ensuring meaningful contributions to the ongoing evaluation and improvement of these regulations.
The workshop followed the Medical Devices Task Force meeting, while the IVD Task Force convened the next day, on 8 November to discuss regulation specific issues.
Policy Paper
With the operating grant, the BioMed Alliance produced two policy documents with recommendations for the implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). The policy documents can be found here.
Training of medical experts
Training Day
On 27 November, the BioMed Alliance organised a Training Day on Regulatory Affairs, aimed at equipping researchers and clinicians from our member societies with a deeper understanding of relevant EU Health Policies and preparing them to take a more active role as experts in these areas. The event featured an extensive agenda covering key health policy files in which the BioMed Alliance is actively involved, such as the European Health Data Space, Health Technology Assessment, the Medical Devices Regulation, and more.
Activities related to HERA
Global Health Workshop
On the 28th of November, the BioMed Alliance organized a Global Health Workshop for its member
societies, focusing on themes directly linked to its work with the Health Emergency Preparedness and
Response Authority (HERA). The topics of the workshop included an introduction to the global impact of the European Health Union, the role of Europe in defining global health priorities, the societal impact of tobacco and alcohol use, and an overview of the work of HERA.
The global health workshop was part of the BioMed Alliance General Assembly during which members of the Alliance come together to discuss ongoing activities, governance issues and future priorities.
Meetings
The BioMed Alliance is a registered stakeholder in the HERA Civil Society Forum. The Alliance attended the HERA Civil Society Forum Meetings throughout the year, bringing the voices of healthcare professionals into the discussions on current and future health threats.
Health Data task force meeting
EHDS panel
Training Day
Global Health workshop
GA attendees
Global Health workshop
Health Data workshop
MD&IVD workshop
MD & IVD Workshop: Michael Neumaier
GA – EMacintyre (2)
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.