Our Approach

From EHDS Readiness to Practical Implementation

Developing Scalable Solutions for Responsible Secondary Use

Vivli Europe combines practical implementation activities, trusted data-sharing expertise and collaboration with European stakeholders to support the transition to the European Health Data Space.

Our approach brings together immediate readiness activities with the longer-term development of operational models that can support cross-border secondary use.

01EHDS Readiness and ImplementationHelping Organisations Prepare

We work with industry and academic health data holders to understand the practical implications of EHDS secondary-use requirements and identify effective approaches to implementation.

Our activities include:

  • Convening EHDS Readiness Forums for industry and academia.
  • Defining governance and operational requirements for secondary use.
  • Mapping practical approaches to metadata, discoverability and access workflows.
  • Building implementation scenarios and readiness guidance.
  • Sharing stakeholder perspectives with European institutions.

Our aim is to support informed preparation and promote practical, consistent approaches to EHDS implementation.

02Cross-Border Operational CoordinationSupporting Efficient Secondary Use Across Europe

The EHDS creates opportunities for health data to be used responsibly across European jurisdictions.

Vivli Europe is developing operational approaches that can help international health data holders coordinate secondary-use activities and support efficient interaction across national systems.

Areas of focus include:

  • Consistent operational processes for international data holders.
  • Coordinated approaches to secondary-use workflows.
  • Governance and accountability arrangements.
  • Operational support for cross-border research activities.
  • Collaborative use cases and pilots to test practical solutions.

Our ambition is to contribute scalable arrangements that make participation in EHDS secondary use more efficient for organisations operating internationally.

03Trusted Data Access and InfrastructureBuilding on Established Clinical Data-Sharing Expertise

Trusted governance and secure access are essential foundations for the responsible reuse of health data.

Vivli Europe draws on Vivli’s established global experience in supporting governed access to participant-level clinical research data.

This experience provides a foundation for exploring EHDS-aligned approaches to secure data access, research workflows and potential secure processing environment services.

Future EHDS-specific infrastructure services will be developed in line with applicable legal, technical and governance requirements.

04European CollaborationWorking Together to Advance Implementation

Vivli Europe engages with European institutions, national authorities, industry associations, research organisations and other initiatives contributing to EHDS implementation.

We aim to bring practical clinical data-sharing experience into these discussions and support the development of coordinated approaches that meet the needs of international data holders and researchers.

Through collaboration, practical use cases and implementation-focused initiatives, we are helping turn the opportunities created by the EHDS into workable solutions.

Our Development Roadmap

2026–2028Readiness and DevelopmentEngagement with international data holders and European stakeholders, readiness activities, development of governance and operating models, and practical pilot initiatives.
2029–2031Supporting EHDS ImplementationSupporting organisations as applicable secondary-use provisions come into effect and developing operational services aligned with the phased implementation of the EHDS.
Longer TermSustainable Cross-Border ServicesDeveloping and scaling trusted operational coordination and access services to support responsible secondary use across Europe, subject to applicable regulatory and implementation arrangements.