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 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.

Chair

This Task Force is chaired by Sarah Collen.

Board Representatives

The Board Representatives for this task force are Prof. Wim Oyen and Prof. Lena Eliasson.

Highlights

Healthcare professionals and researchers call for more clarity on data sharing for health research

The BioMed Alliance, representing 34 European medical and research societies, has submitted feedback to the European Data Protection Board (EDPB) on the draft Guidelines 1/2026 on the processing of personal data for scientific research purposes. The General Data Protection Regulation (GDPR), which has applied since 2018, provides the legal framework for how personal data can be used and shared across the EU, including for health research. The EDPB guidelines aim to further clarify how these rules apply in the context of scientific research. While we welcome the EDPB’s efforts to improve legal clarity under the GDPR, we highlight that its interpretation and implementation for health research remains fragmented across Member States, cretating uncertainty. This often results in risk-averse approaches that can restrict data sharing, even where it is permitted under EU law and beneficial for patients and research. Overall, we call for clearer, more practical, and more consistent guidance to support high-quality health research across Europe and reduce the legal uncertainty that currently hinders data sharing and innovation. The full feedback document is available below.

29 June 2026Read more

How to balance innovation and privacy protection in the healthcare sector: BioMed Alliance recommendations on the Digital Omnibus proposal

As healthcare and research continue to embrace digital transformation, navigating the complex regulatory landscape is more challenging than ever. To address this, BioMed Alliance has released a position statement with key recommendations on the European Commission's Digital Omnibus Proposals. Built on feedback from healthcare professionals and researchers across Europe, our statement calls for improvements to the General Data Protection Regulation (GDPR), the AI Act, and other regulatory simplifications.

While we welcome the opportunities presented by the Digital Omnibus Proposals to advance digital health, it is crucial to carefully consider their implications for data-driven healthcare, AI integration, and the protection of sensitive patient data. The Alliance calls for clearer guidelines on pseudonymisation and health data processing for AI, as well as sector-specific guidance on GDPR compliance for health research. It also advocates for stronger safeguards to protect health data, post-market monitoring of AI systems to ensure patient safety, measures to reduce AI bias, and clearer definitions of roles and responsibilities to promote AI literacy in healthcare.

13 March 2026Read more

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.

See the full statement in the attachments below.

05 March 2025Read more

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!

15 October 2024Read more

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.

25 April 2024Read more

Statement on the implementation of the EHDS

24 April 2024Read more

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.

22 April 2024Read more

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