Vivli Europe

Making EHDS Secondary Use Work in Practice

Built to Help Data Holders Meet Europe’s Secondary Use Requirements

Vivli Europe is an independent European non-profit organisation established to help data holders meet Europe’s secondary-use of health data requirements and unlock the value of clinical research data responsibly.

Building on Vivli’s longstanding global expertise, Vivli Europe supports responsible, secure, cross-border governance of clinical research data. We help connect organisations that hold data with researchers who can use it to advance science, generate new evidence, and improve health.

As Europe’s regulatory landscape evolves, Vivli Europe provides coordinated leadership, trusted infrastructure, governance expertise, and practical implementation support. We help data holders and data users build operational models that are compliant, transparent, patient-protective, and research-enabling.

European-led, with leadership and staff on the ground, Vivli Europe operates as a neutral intermediary with its own governance, mandate, and European legal standing.

Vivli Europe turns Europe’s secondary-use data requirements into practical, trusted, research-ready solution

The Regulatory Moment

Europe is entering a defining period for the secondary use of health data.

The European Health Data Space Regulation entered into force in March 2025, beginning a transition period that will reshape how health data is accessed and reused across Europe. By March 2029, key secondary-use provisions are expected to apply, requiring organisations to have the governance, access, transparency, and operational models needed to support compliant reuse of health data for research, innovation, regulatory, and public-interest purposes.

Today, access to participant-level clinical research data remains fragmented across EU Member States. Data holders face varying governance expectations, researchers often encounter duplicated access processes, and many organisations lack a neutral European intermediary with the legal standing and practical experience needed to support trusted cross-border data access.

Vivli Europe addresses this gap.

We create a trusted space for data holders, researchers, institutions, funders, and policymakers to share perspectives, identify common challenges, and help shape practical solutions as Europe’s data governance landscape continues to develop.

Why Vivli Europe

Europe’s health data landscape is changing quickly. Data holders are being asked to prepare for new secondary-use requirements, while researchers need clearer, more efficient pathways to access high-quality clinical research data.

Vivli Europe exists to make that shift practical.

We bring together trusted governance, secure infrastructure, and deep clinical data-sharing expertise to help organisations move from regulatory complexity to operational readiness. As an independent European non-profit with legal standing in Europe, Vivli Europe provides a neutral, credible partner for data holders, researchers, funders, and policymakers working to advance responsible data reuse.

Our value lies in combining European leadership with proven global experience. Vivli has spent more than a decade supporting responsible clinical data sharing across industry, academia, and the research community. Vivli Europe builds on that foundation to meet the specific needs of the European environment, including the implementation challenges created by the European Health Data Space.

  • For data holders, Vivli Europe offers practical implementation support: access governance, review processes, transparency mechanisms, secure data access, and operational models that can support compliant secondary use.
  • For researchers, Vivli Europe helps reduce fragmentation and duplicated effort by creating clearer routes to discover and request participant-level clinical research data.
  • For Europe, Vivli Europe supports a trusted, patient-protective approach to data reuse that enables research, innovation, and public benefit.

How We Work

We Partner with European Institutions

Vivli Europe works with policymakers, regulators, institutions, and research organisations to help shape practical operational models for the secondary use of health data.

Our work supports alignment between emerging European requirements and the global standards for responsible clinical data sharing that Vivli has helped establish with industry, academic, and research partners.

We focus on ensuring that global clinical data-sharing practices and European regulatory frameworks work together, particularly in relation to data privacy, governance, transparency, and responsible reuse.

We Connect Researchers with Data

Vivli Europe supports governed access to participant-level datasets from completed clinical research.

Through secure, structured access processes, researchers can discover and request anonymised data that is ready for rigorous secondary analysis. This helps reduce fragmentation, avoid duplicated governance effort, and enable responsible reuse of valuable clinical research data across multiple data holders.

By improving the route between data holders and qualified researchers, Vivli Europe helps completed studies continue to generate scientific value long after the original research has ended.

We Support Data Holders

Vivli Europe helps data holders operationalise readiness for European secondary-use requirements.

We support organisations in defining access conditions, establishing structured review processes, enabling transparency into how data is used, and implementing governance models that support compliant secondary use.

Our approach helps data holders move from policy intent to practical implementation, with solutions designed for the real operational demands of responsible clinical data sharing.

What Vivli Europe Offers

Practical implementation support

We help organisations translate European secondary-use requirements into workable governance and operational models.

Trusted access governance

We support structured, transparent processes for reviewing data requests and managing responsible reuse.

Secure infrastructure

We provide access to established systems and processes designed to support secure, governed use of clinical research data.

European leadership

Vivli Europe is built for the European environment, with European legal standing, governance, and leadership.

Global experience

Vivli Europe builds on Vivli’s established international expertise in responsible clinical data sharing across industry, academia, funders, and the wider research community.

Structure & Governance

Vivli Europe is registered as a Netherlands Stichting and operates as an independent non-profit organisation governed by its own Board of Directors.

Leadership

Jennifer O’Callaghan

Executive Director, Vivli Europe

Jennifer O’Callaghan brings deep expertise in clinical data sharing and the governance of responsible secondary use of clinical research data.

Her experience spans roles as a research funder, advisor to multi-stakeholder consortia, and executive within global pharmaceutical organisations. She has been involved with Vivli for over a decade, including serving on the foundational working group that helped establish high standards for patient privacy, governance, transparency, and responsible data reuse.

Jennifer’s work has supported collaboration across pharma, biotech, academia, funders, and the research community to unlock new insights from clinical research data while maintaining trust and protecting participants.

Get Involved

Vivli Europe works with organisations and individuals committed to responsible health data reuse in Europe.

Whether you are a researcher seeking access to data, an institution looking to contribute datasets, a data holder preparing for EHDS secondary-use requirements, or a funder or policymaker interested in partnership, we would like to hear from you.

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