Task Force on 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 Prof. James N Dow and Sarah Collen.

Highlights

  • Multistakeholder statement on EHDS

    The BioMed Alliance has contributed to a joint statement issued on 26 February 2024 by a large multistakeholder group, representing the entire spectrum of the healthcare ecosystem and consisting of 35 European patient organisations, medical associations, health research infrastructures and health industry associations on the EHDS. The statement raises our ongoing common concerns about legislative shortcomings and uncertainties in the proposed Regulation for a European Health Data Space (EHDS) currently being negotiated in trilogues. For more information, please read the statement here.

  • Recommendations trilogue negotiations EHDS

    On 20 February 2024, BioMed Alliance published a new statement in light of the trilogue discussions on the proposal for a European Health Data Space. In the statement, we draw attention to some of the provisions that were being discussed and could lead to fragmentation, legal uncertainty and data bias in the datasets that will be available for research within EHDS. Read the statement here.

  • Stakeholder coalition statement calls for legislative refinement of the EHDS

    Together with a large multi-stakeholder group, representing the entire spectrum of the healthcare ecosystem and consisting of 36 European patient organisations, medical associations, health research infrastructures and health industry associations, we have issued a joint statement in December 2023 to raise the alarm about the significant legislative shortcomings and uncertainties in the proposed Regulation for a European Health Data Space (EHDS). It addresses serious legislative problems with the EHDS in light of the political negotiations at EU level. Read the statement here.

  • Statement calling on policy makers to avoid putting an emergency break of life-saving research through EHDS

    In a statement from November 2023, the BioMed Alliance urgently calls on policy makers to take action to ensure the European Health Data Space (EHDS) will not severely jeopardise health research. The health research community is extremely concerned about a partial opt-in system for the re-use of data for policy making and research in EHDS, which is being discussed by policy makers in the Council and the European Parliament. Opt-in approaches significantly impinge on the availability of datasets for researchers to gain new insights into human health and understanding of disease, or for developing new diagnostics and treatments for patients. Read the statement here.

  • Case Studies from medical societies on the European Health Data Space

    Healthcare professionals and researchers represented within BioMed Alliance believe that we should reduce barriers to health data sharing, while putting in place the appropriate safeguards and maintaining a harmonised approach across the EU. Members of our alliance have collected a set of examples of the secondary use of data in health research and highlight the challenges they face. Read the report here.

  • 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. In line with their consensus statement of June 2023, the multi-stakeholder group expressed concern about the possible scope of an opt-out mechanism, the challenges of ensuring inclusivity and equity, and related operational challenges. The group reiterated its concern that the risk posed by an opt-out or opt-in is that it may amplify rather than help to correct data bias – exaggerating inequalities and disparities through incorrect inferences from the data, leading to health strategies and treatments that are poorly suited to certain groups. Read the report here.

  • Press release and event: 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. Read the press release here.

  • BioMed Alliance joins large group of health stakeholders in their call for an appropriate opt-out mechanism in the EHDS

    A joint statement of 32 European patient organisations, medical associations, research institutes and healthcare companies including the BioMed Alliance, was published to share their common views on specific recommendations for a potential opt-out mechanism in the EHDS. It is also in line with the earlier BioMed Alliance statement on the opt-out mechanism considered in current political discussions on the proposal. Read the statement here.

  • BioMed Alliance shares reaction to opt-out model proposed in EHDS negotiations

    Considering the ongoing political discussions, the BioMed Alliance has published a statement in March 2023 on suggestions to introduce an opt-out model in the European Health Data Space (EHDS) proposal. BioMed Alliance believes that an opt-out model could be an appropriate way forward, if certain conditions are fulfilled to ensure it does not become a barrier to life-saving health research. Read more here

  • Proposed amendments to draft EHDS proposal

    The healthcare professionals, researchers and policy experts in the BioMed Alliance Health Data Taskforce have suggested several amendments that could improve the implementation of EHDS and make sure it can have a concrete positive impact on the healthcare and research sectors and ultimately on the life of patients. The document published in March 2023 also include reactions to the draft ENVI-LIBE report from early February and presents case studies of health data sharing that were collected my medical societies from different disciplines. Read more here.

  • 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.

  • BioMed Alliance shares views of medical societies in EHDS consultation

    The BioMed Alliance replied to the consultation on the proposal for the European Health Data Space (EHDS), welcoming the proposal but also highlighting a series of key considerations that should be taken into account in negotiations on the proposal and its implementation. The reply was developed following several meetings on EHDS and the collection of input from the taskforce. Among the issues that were raised were the need for synergies between EHDS for primary and secondary use of data, interoperability, the responsibilities of data holders, the need for regulatory clarity and the appropriate involvement of stakeholders. The response also includes a series of practical examples of the benefits and challenges related to health data sharing.

    Read the BioMed Alliance consultation response here.

  • BioMed Alliance statement highlighting key recommendations for data sharing ahead of EHDS proposal

    BioMed Alliance has released a statement in December 2021 ahead of the upcoming European Commission legislative proposal on the European Health Data Space (EHDS). The BioMed Alliance Task Force on Health Data Sharing, in close cooperation with the European Association of Urology (EAU) and the European Organisation for Research and Treatment of Cancer (EORTC) have therefore proposed a set of recommendations for the governance, implementation and incentivisation of adoption of the EHDS.  The statement particularly highlights the need to involve a broad range of stakeholders and to align different legislative approaches with a clear and enabling EU legal framework. Read the statement here.

  • Statement on the current state of development of the EHDS

    The BioMed Alliance Task Force on Health Data submitted responses to the public consultations on the European Health Data Space (EHDS) launched by the European Commission. On this occasion we also released statements to convey our views on the current state of development of the EHDS and highlighting the main concerns we expressed in the public consultation. The EHDS can be a promising tool in facilitating health data exchange and contributing to better care and health research, if it is implemented properly. Read our contributions here and here.

  • The BioMed Alliance selected as a stakeholder in the TEHDAS Joint Action

    The Joint Action Towards the European Health Data Space (TEHDAS) is a European project coordinated by the Finnish Innovation Fund SITRA and led by the Member States to develop joint European principles for the secondary use of health data. The project is funded by the Health Programme of the European Union and was launched in February 2021 to guide the establishment of the European Health Data Space. The Taskforce on Health Data is participating to the work of the Joint Action by providing expertise and information to guide the development of the new EHDS. More information on the TEHDAS Joint Action is available here.