The European Health Data Space (EHDS) is a landmark EU initiative designed to unlock the full value of health data across Europe. Officially adopted in 2025, this new regulatory framework establishes a single market for health data across the EU.

As part of the European Data Strategy, the EHDS is the first fully regulated, sector-specific data space (see FAQs, below) in Europe. It aligns with the EU’s Digital Single Market initiative creating a single market for digital goods and services.

For senior leaders across healthcare, life sciences, MedTech, insurance, and public health, the EHDS is more than a compliance requirement; it is a strategic platform to enhance patient outcomes, accelerate innovation, and strengthen competitive position in an increasingly data-driven health economy.

To illustrate how the EHDS is reshaping healthcare institutions, governments, and patient outcomes, we will be sharing a series of perspectives and practical examples over the coming months.

The implications span from the European to the local level, and the imperative to act is immediate. This article outlines the strategic implications of the EHDS for senior leaders and the actions that should begin now.

What are the key characteristics of the European Health Data Space?

The EHDS is trailblazing the use of data spaces for public sector data sharing in Europe – embracing both government bodies (healthcare providers) and non-governmental organizations (researchers, innovators, industry, etc.).

As a core member of the EC-funded Data Spaces Support Centre (DSSC) consortium (see FAQs, below), Capgemini is at the heart of Europe’s data space ecosystem – see our previous article Are data spaces the future? on the value of a data-driven economy.

We categorize the three key characteristics of the EHDS as follows:

  • Cornerstone of a Single Market for Health Data: The EHDS is the EU’s first fully regulated data space, building a common framework to share health data securely across 27 countries. It aims to unify Europe’s fragmented digital health landscape to enable seamless cross border data flows.
  • Primary vs. secondary use – Trust by design: The EHDS clearly separates primary use (patient care) from secondary use (research and policy) of health data. Access for secondary purposes is regulated via Health Data Access Bodies (HDABs) to ensure privacy and compliance.
  • Not just compliance – Strategic vision: The EHDS could unlock huge economic value. Early European Commission estimates projected €11 billion of benefits over a decade, but new analysis suggests up to ~€90 billion per year when leveraged fully with AI.

How will the European Health Data Space create value?

The rationale for the EHDS is both strategic and economic. Today, much of Europe’s most valuable health data remains fragmented across disconnected systems and is therefore underutilized.

As health data becomes an increasingly critical asset in the era of AI and advanced analytics, patients, institutions, and governments are unable to capture its full value under the current model.

By unlocking this data within the EHDS, three key benefits come to the surface:

  • Improved patient care: By developing a seamless, integrated infrastructure for the exchange of medical information across Europe, patients will directly benefit from better healthcare. No more physical prescriptions, no more explaining, and no more misaligned international healthcare. Our health is what matters most, and the EHDS directly strengthens this.
  • Accelerated research and innovation: A well-governed, large-scale health data space boosts medical research and innovation (for example, through easier access to real-world evidence for clinical trials). Making data available in a structure manner will super-charge the use of sovereign clinical  AI and search matching within the EU. This directly enhances cross-Member State research potential and scaling of clinical trials by combining data.
  • Stronger sovereignty: By acting now, the EU is seeking not only to improve health outcomes but also to ensure global competitiveness and digital autonomy in Europe’s sovereign and interoperable healthcare arena. Increased access to – and availability of – healthcare (and cross-border healthcare data) also strongly contributes to the development of “sovereign” health AI models trained on European data.

What is the likely economic impact of the European Health Data Space?

From an economic standpoint, the EU estimates that more effective use of health data across Member States could generate €11 billion in value. This includes €5.5 billion in healthcare savings and €4.5 billion in research and innovation benefits.

In parallel, the digital health sector is expected to expand by 20–30%. Over time, the “AI multiplier” effect of EHDS-scale data is projected to materially increase annual value creation, potentially reaching ~€90 billion per year at maturity.

While these projections are forward-looking, the strategic conclusion is clear: the EHDS is not merely foundational infrastructure, but the basis of a major European capability and growth platform.

How does the European Health Data Space work?

To balance innovation with privacy, the EHDS distinguishes between two complementary data flows:

  • Primary use – Enhancing care delivery
  • Secondary use – Unlocking data for innovation

Primary use – Enhancing care delivery

This covers the use of a person’s own health records for direct care, nationally or across borders.

The EHDS gives individuals the right to access and share their electronic health data seamlessly for treatment. This might be , for example, a patient’s ePrescription or medical summary being accessible when they visit another EU country.

By 2029, all EU member states should be able to exchange core patient data categories, such as ePrescriptions and Patient Summaries (see FAQs, below) for cross-border care. This exchange uses Europe’s existing digital infrastructure for cross-border health record exchange – and extends it.

This extension means that by the early 2030s any European patient’s key health data can travel with them safely and instantly wherever they receive care.

Crucially, patients remain in control of their data: they can see who accessed it, correct errors, and even opt out of cross-border sharing if allowed by their country.

Secondary use – Unlocking data for innovation

Secondary use refers to the reuse of health data for purposes beyond immediate patient care. This includes data used in medical research, public health planning, innovation, health policymaking or regulatory analysis.

Under the EHDS, this will not happen ad-hoc or without oversight. Instead, each EU Member State will establish at least one Health Data Access Body (HDAB).This is a public authority or designated entity that manages requests for health data access from researchers, companies, or policymakers.

These bodies will issue data permits for specific permitted purposes only (e.g. research, innovation, public health). This will never include data for marketing purposes or for decisions harmful to individuals.

The HDABs also ensure that any analysis happens in secure processing environments (SPEs), meaning that sensitive data never leaves a controlled, privacy-protected setting.

In short, the EHDS’s secondary use framework creates a trusted “research data space”: vast pools of de-identified health data accessible on demand for societal good – but with strict governance to uphold patient privacy and data security at every step.

How do primary and secondary use come together?

Together, these two pillars of the EHDS create an integrated ecosystem. They empower patients and clinicians in daily healthcare, while fueling a new pan-European health data economy for innovation and policy.

This clear separation ensures that trust remains central: patients can feel confident that their personal health data is only used in well-defined ways, and organizations can engage in data-driven collaboration knowing there is a uniform legal and technical framework across the EU.

Who is affected by the European Health Data Space?

From hospitals to pharma, every stakeholder in the healthcare field will be impacted by the EHDS, sooner or later. In other words, it will have an ecosystem-level impact.

Healthcare institutions become data holders who have an obligation to report metadata on their available data. Some organizations can become data users who can request access to health data.

Others (especially public authorities or large research institutions) might become, or partner with, a Health Data Access Body (HDAB), i.e. directly assessing requests and orchestrating data access. This offers more control and prestige but comes with heavy responsibilities like legal review of requests, operating secure data platforms, and managing user support.

Although there is some EU Member State-level freedom in the implementation of the EHDS, governments, healthcare institutions and other stakeholders should prepare.

What should those affected by the EHDS start to do?

Regardless of the implementation model, senior management should now determine where the organization sits in the EHDS landscape and what capabilities are required to succeed. For some, the priority will be compliance as a data holder; for others, it may be strategic participation as a data user, trusted partner, or orchestrator.

Private-sector organizations should move quickly to assess both opportunity and obligation: the EHDS creates significant headroom for research and innovation, but only within a governance model defined by privacy, security, and interoperability.

In particular, technology leaders should anticipate additional requirements for Electronic Health Record (EHR) systems, including EU interoperability standards, self-certification obligations, and logging requirements that will be subject to regulatory oversight.

What is the timeline of the European Health Data Space?

The EHDS implementation is deliberately phased over several years. This gives organizations time to adapt while maintaining momentum.

Key milestones include:

  • March 2025: EHDS regulation enters into force
    The legal framework officially kicks in, starting a transition period for Member States and stakeholders to prepare.
  • March 2027: Implementing acts and HDAB setup
    The European Commission finalizes detailed technical rules (“implementing acts”), and Member States must establish their Health Data Access Bodies.
  • March 2029: First data sharing obligations apply
    • Primary use: All EU countries must enable cross-border exchange of initial priority data (Patient Summaries, ePrescriptions/eDispensations)
    • Secondary use: HDABs begin handling data requests for most categories of health data (e.g. EHRs).
  • March 2031: Expansion of data categories
    • Primary use: Additional data types (medical images, lab results, hospital discharge reports) must be fully exchangeable EU-wide.
    • Secondary use: Remaining categories (like genomic data) come under EHDS rules.
  • March 2035: International participation
    Non-EU countries and organizations will be allowed to apply to join HealthData@EU for secondary use, reflecting a mature, global-scale system.

What does this timeline mean in practical terms?

For leadership teams, the 2025–2035 timeline signals that transformation is both imminent and manageable. The initial phase is focused on establishing governance, infrastructure, and technical standards, including National Digital Health Authorities and Health Data Access Bodies by 2027.

By 2029, organizations will need tangible operational capabilities in place, including cross-border EHR exchange and compliant mechanisms for regulated data sharing.

In practice, this creates a narrow but actionable window – roughly the next two to three years – to build readiness across critical areas. This includes IT modernization, interoperability, data-access procedures, and compliance with security and consent requirements.

In addition, as shown in the timeline above, there will be additional technical rules published that might strongly impact Member States. This is done through so-called “implementing acts”, which are currently being developed and will be put in place from 2027 onwards.

What do senior leaders need to do right now ?

The EHDS is approaching quickly, bringing both mandatory obligations and significant strategic upside. For senior leaders across healthcare and adjacent sectors, the time to engage is now, not in 2029.

Capgemini’s role in delivering consulting and support services to data spaces across Europe through the DSSC gives us a unique perspective on what needs to be done right now.

Here’s what we recommend:

  • Recognize the dual nature of the EHDS: It is both a regulatory mandate and a strategic enabler. Compliance is non-negotiable, but leadership teams should also define how the organization can capture value through stronger operations, research partnerships, and new data-driven services.
  • Define your role: Determine which role or combination of roles is appropriate for your organization within the EHDS ecosystem.
    • At a minimum, health data holders require readiness across data inventory, interoperability, and privacy controls.
    • Those with greater scale or influence should also consider whether to play a more active role – for example, by partnering with national authorities as a trusted node, pilot site, or implementation partner for secondary-use processes.
  • Build EHDS readiness step by step: The phased timeline gives a roadmap. Start early on foundational capabilities, such as:
    • Creating an inventory and metadata catalog of your health data (using standards like Health DCAT-AP).
    • Setting up or aligning pseudonymization and data anonymization processes so you can share data safely.
    • Planning for secure data access, e.g. decide whether to rely on a central HDAB’s secure environment or invest in your own capacity to integrate with it.
    • For healthcare providers: Upgrade EHR systems to meet interoperability criteria, ideally well before the 2029 deadline.
  • Stay engaged with the rollout: Implementation details are still being refined. It’s wise for management to follow updates from the EU and national health authorities, perhaps assign an internal task force to monitor EHDS developments. Being informed will help anticipate changes.
  • Leverage the upside responsibly: Look beyond compliance and define how the EHDS can advance your strategic agenda.
    • Healthcare executives can use it to enable cross-border care models and stronger quality improvement.
    • Pharma and MedTech leaders can position for pan-European data collaboration and accelerate AI-enabled innovation through access to richer real-world evidence.
    • Public-sector leaders can embed EHDS milestones into digital health strategies to improve system performance and innovation. In every case, success will depend on a disciplined, patient-centric approach supported by strong governance, transparency, and trust.
  • Prepare for legislative change: For governments and public health administrations, it is important to note that this regulation is directly applicable in national law. However, several of its provisions introduce new requirements that will necessitate adjustments to national legislative and regulatory frameworks in each Member State.

For example, Member States will need to designate and operationalize Health Data Access Bodies, as well as a Digital Health Authority and a Market Surveillance Authority. There are no free riders in this: Member States are obligated by law to commit.

Accelerating Europe’s single market for health data

In conclusion, the European Health Data Space marks a structural shift in how health data will be governed, accessed, and applied across Europe. By 2029, the sector is expected to operate on a far more connected and evidence-rich foundation – provided organizations act with sufficient urgency.

For senior management, early understanding and decisive action are essential. What may begin as a compliance initiative can become a broader strategic transformation agenda:one that strengthens governance, accelerates digital capability, and positions the organization to lead in the next phase of European health innovation.

Europe is building a single market for health data. The organizations that act early will be best positioned to lead in it.

Talk to our public sector and healthcare experts to take your European Health Data Space journey forward and learn how to turn legal compliance into value creation.