The European Health Data Space (EHDS) is one of the most ambitious digital health initiatives Europe has ever undertaken. While its goals are broadly understood and strongly supported, many health systems are struggling to move from policy ambition to operational reality. National readiness varies widely, governance models remain unclear, and key elements such as secondary use, trust, and delivery capacity risk stalling progress.
It is based on in-depth interviews with stakeholders involved in EHDS preparation and implementation, such as national health officials, programme leads, technical architects in clinical informaticists. All interviews were conducted anonymously to enable open and candid discussion. The report captures real concerns, uncertainties, and practical constraints, offering a pragmatic view of current readiness, key risks, and no-regret investments that can create value regardless of how EHDS timelines evolve.
What can you expect?
From compliance to clinical value
Why EHDS success will be measured by real improvements in care delivery, not by regulatory box-ticking.
Clinical relevance as the starting point
What makes cross-provider and cross-border data genuinely useful for clinicians without disrupting workflows.
Trust as a prerequisite
How data quality, transparency, auditability, and governance shape adoption by clinicians and acceptance by patients.
Execution over regulation
Why governance strength, delivery capacity, and organisational readiness matter more than standards alone.
Embedding EHDS into national reform agendas
How aligning EHDS with existing programmes creates momentum and avoids parallel, low-impact implementations.
No-regret foundations for long-term value
The core capabilities that strengthen health systems while enabling confident EHDS progress.
Samo Drnovšek,
Health Data Strategy & Product Marketing Manager, Better
Samo Drnovšek works at the intersection of interoperability, health data platforms, and large-scale digital health ecosystems. With more than 20 years of experience, he connects product strategy, architecture, and market-facing narratives, helping healthcare organisations translate regulatory and interoperability frameworks into practical, sustainable platform capabilities.
Download the white paper to understand where Europe stands today, what is at risk, and how to start building real clinical and system value.
FAQ
What is the European Health Data Space (EHDS)?
- The European Health Data Space (EHDS) is an EU regulation that establishes a common framework for accessing, sharing, and reusing electronic health data across Europe. Its goal is to support healthcare delivery, research, innovation, and policymaking while improving interoperability, security, and trust.
Why was the European Health Data Space created?
- EHDS was created to address fragmentation of health data systems across EU countries and to improve cross-border healthcare. It also aims to enable secure and lawful reuse of health data for research, public health, and innovation while strengthening patient rights.
What is primary use of health data under EHDS?
- Primary use refers to the use of health data directly for patient care. This includes activities such as diagnosis, treatment, prescriptions, and care coordination within and across EU countries.
What is secondary use of health data under EHDS?
Secondary use refers to the reuse of health data for purposes such as research, innovation, public health, policymaking, and the development of artificial intelligence. Access is governed through strict rules, approvals, and secure processing environments.
Who must comply with the European Health Data Space?
EHDS applies to healthcare providers, hospitals, electronic health record (EHR) vendors, digital health companies, researchers, public authorities, pharmaceutical companies, and other organizations that create or use electronic health data in the EU.