The impact of the European Health Data Space Regulation and the Open
Data Directive on citizens
Summary
The European health data space (EHDS) aims to increase the
availability, reusability and standardisation of health data systems
across the EU, particularly by promoting the interoperability and the
security of electronic health records systems. The EHDS complements
the ODD, which focuses on making government-held data publicly
available for reuse. The combination of data being made available both
under the EHDS and the ODD is expected to benefit the various
stakeholder groups by providing new opportunities for innovation and
data reuse. This report explores the synergies and complementarities
between these two EU legislative instruments. It investigates how
combining protected health data under the EHDS with open data under
the ODD can create new opportunities for various stakeholder groups,
including citizens, healthcare professionals, researchers and
policymakers.
Body
EXECUTIVE SUMMARY

The European Union (EU) is advancing the creation of data spaces to
foster innovation, enhance data sharing and ensure data sovereignty.
Two key legislative pillars in this effort are the European Health
Data Space (EHDS) Regulation and the Open Data Directive (ODD).

The EHDS aims to increase the availability, reusability and
standardisation of health data systems across the EU, particularly by
promoting the interoperability and the security of electronic health
records systems. The EHDS complements the ODD, which focuses on making
government-held data publicly available for reuse. The combination of
data being made available both under the EHDS and the ODD is expected
to benefit the various stakeholder groups by providing new
opportunities for innovation and data reuse. This report explores the
synergies and complementarities between these two EU legislative
instruments. It investigates how combining protected health data under
the EHDS with open data under the ODD can create new opportunities for
various stakeholder groups, including citizens, healthcare
professionals, researchers and policymakers.

Through a combination of desk research and expert interviews, the
report identifies concrete use cases, benefits and challenges
associated with leveraging open and protected data in the context of
the EHDS. The findings aim to support the implementation of the EHDS
and provide tangible recommendations for enhancing the role of open
data in future data spaces.

PATIENTS

	* BENEFITS for patients include the possibility of data-driven
choices for healthcare providers that offer lower waiting times and
facilities that provide higher quality of care.
	* CHALLENGES include the lack of skills, tools and knowledge to
process, analyse and derive insights from this data in practice.

HEALTHCARE PROVIDERS

	* BENEFITS for healthcare providers include additional access to data
relating to their field of practice, potentially leading to better
diagnosis and treatment.
	* CHALLENGES include the potential additional workload in an
environment that is characterised by time constraints, and the lack of
skills, tools and knowledge available to healthcare providers to
analyse data and extract insights themselves. However, this challenge
can be mitigated by providing applications that use EHDS-related data
and open data and that are integrated into systems used by healthcare
practitioners.

POLICYMAKERS

	* BENEFITS include increased data-driven policy development and
consequentially better health-related (strategic) policy.
	* CHALLENGES relate to the lack of skills and the lack of tools
available to process, analyse and derive insights from this data in
practice.

REUSERS (RESEARCHERS, INNOVATORS)

	* BENEFITS for reusers are numerous, such as access to additional
data. Moreover, reusers benefit from quicker access to data, which
enables faster analysis, decision-making and innovation. Their
expertise in data management allows them to make effective use of this
access.
	* CHALLENGES for reusers include a reluctance to share data, despite
the EHDS’s emphasis on data altruism. This may limit the extent to
which data becomes available for reuse.

It can be seen that the synergy between the data under the EHDS
regulation and the data under the ODD can significantly enhance
data-driven innovation in healthcare. This particularly benefits
reusers such as researchers, as they are the ones who directly engage
with the data. While other stakeholders benefit more indirectly,
through the digital tools and services built on top of this data,
researchers are positioned to immediately leverage the data for
analysis, development and innovation. The provided policy
recommendations focus on ensuring that outcomes generated by
researchers, such as insights, tools or innovations, are made
accessible and usable for other stakeholders, including healthcare
providers, policymakers and developers. Additionally, our
recommendations call for promoting data literacy and analytical skills
among patients and healthcare providers, who primarily use health data
for care, to encourage the reuse of EHDS-related data and open data.

To ensure that open data remains visible and effectively integrated
within emerging data sharing frameworks such as the EHDS,
data.europa.eu should showcase use cases that demonstrate how open
data complements protected data, such as combining mobility and health
data for public health planning, and provide guidance to stakeholders
on best practices for linking and reusing open data within these new
infrastructures. It is also recommended to re-evaluate the synergies
between the EHDS and the ODD in a few years, once the use of the EHDS
infrastructure and the availability of data under its mandate have
become widespread in practice.

 

1. INTRODUCTION

The European health data space (EHDS) ([1]) and the Open Data
Directive (ODD) (Directive (EU) 2019/1024) ([2]) are both key
components of the European Union’s (EU) broader strategy for
data ([3]), yet these legislative instruments differ in scope and the
types of data they cover. In this report, we aim to explore these
differences and complementarities by describing concrete use cases
that illustrate how data made available under these two frameworks can
be applied in practice.

The EHDS is specifically focused on health data ([4]). Its three main
objectives are to (1) increase the availability of healthcare data in
an international setting for care purposes (primary use); (2) increase
the reusability of healthcare data for research, policy and innovation
purposes (secondary use); and (3) increase (technical) standardisation
of European electronic health record (EHR) systems to increase
cross-border interoperability ([5]). In contrast, the ODD targets a
broader range of public sector data, including a list of high-value
datasets ([6]), with the aim of making this information openly
accessible for reuse by any stakeholder ([7]).

To aid understanding, it is important to first clarify the types of
data and access models involved.

	* Open data refers to non-personal, government-held data that is made
freely available for reuse. This is the focus of the ODD.
	* Restricted data includes personal or sensitive data that requires
safeguards for privacy and security. This is the domain of the EHDS,
which governs access to health-related data such as medical records,
insurance claims, clinical trials and data from wearables and health
apps.
	* Personal/private data is a subset of restricted data and includes
identifiable health information.

This distinction also shapes their respective access and sharing
arrangements. Under the EHDS, access to data – especially for
secondary use – is carefully managed through health data access
bodies (HDABs), which evaluate requests and ensure compliance with
data protection regulations. In contrast, the ODD promotes open
access, encouraging public institutions to make data freely available
through portals, with minimal restrictions. A key element of the ODD
is Commission Implementing Regulation (EU) 2023/138, which defines a
list of high-value datasets that public sector bodies are required to
publish. These datasets are grouped into six thematic categories:
geospatial, earth observation and environment, meteorological,
statistics, companies and company ownership and mobility. The
regulation mandates that these datasets be made available free of
charge, in machine-readable formats and via application programming
interfaces, to maximise their reusability and socioeconomic impact.
This framework reinforces the EU’s commitment to data openness by
ensuring that the most valuable public sector data is accessible under
harmonised conditions across Member States ([8]).

Despite these differences, both initiatives share a common ambition:
to unlock the value of data for innovation, transparency and improved
services. While the EHDS is more targeted toward healthcare-specific
advancements, the ODD supports a wider range of economic and societal
benefits. Together, they represent complementary approaches to
building a more data-driven EU, with potential synergies particularly
in areas where health-related public data intersects with broader
datasets under the ODD, albeit combinations like these must be handled
carefully to protect privacy (as discussed later in the report).

The EHDS and the ODD also both encourage the use and reuse of data. In
this regard, the combination of the EHDS and the ODD might have
positive implications for several stakeholder groups (specifically
patients, healthcare providers, policymakers and reusers). The
combination of data made available under these two frameworks offers
new ways for innovation and data reuse. In this report, we explore the
possible benefits of the combination of the EHDS and the ODD for
several stakeholder groups.

This report investigates the following research question: WHAT ARE THE
SYNERGIES AND COMPLEMENTARITIES BETWEEN DATA MADE AVAILABLE UNDER THE
EHDS AND DATA MADE AVAILABLE UNDER THE ODD?

The sub-questions relating to this main research question are the
following.

	* In terms of primary use (use of health data for patient care) and
secondary use (reuse of health data for research, policymaking, etc.),
what are the benefits of the EHDS for patients and healthcare
professionals, and what barriers exist that may hinder the full
realisation of these benefits, particularly in light of the existing
ODD?
	* In terms of secondary use, what are the benefits of the EHDS for
reusers and policymakers, and what barriers exist that may hinder the
full realisation of these benefits, particularly in light of the
existing ODD?

The logic of these sub-questions is visualised below.
[https://data.europa.eu/sites/default/files/img/media/EHDS.png]
Figure 1: Visual of research scope, author’s creation

The report starts with a concise summary of the policy and user
landscape in which the European data strategy, the EHDS and the ODD
are introduced. To enrich this landscape, we conducted interviews with
experts from various European Member States, representing diverse
areas of expertise related to the EHDS and open data. This summary is
followed by the research methodology. The report concludes with the
findings of the interviews, a set of use cases, recommendations and
conclusions. These use cases serve as a central component of the
research, offering concrete – though in some cases still
conceptual – examples of how data sharing under the EHDS can
generate value. They are intended to illustrate the potential benefits
of the EHDS and the ODD in practice and to demonstrate how the
frameworks can support innovation, improve services and inform future
policy development.

 

2. POLICY LANDSCAPE: HOW OPEN DATA INTERACTS WITH THE EHDS

2.1. A EUROPEAN STRATEGY FOR DATA

The European strategy for data ([9]), launched by the European
Commission in 2020 ([10]), is a cornerstone of the EU’s digital
transformation agenda. One of its goals is to create a single market
for data, where data can flow freely across sectors and Member States,
while ensuring high standards of privacy, security and ethical use. As
part of building a single market for data, common European data
spaces ([11]) are being created in a number of strategic areas. These
data spaces are supported by a suite of key legislative instruments
that complement domain-specific efforts like the EHDS.

	* The Data Governance Act (Regulation (EU) 2022/868 ([12]))
establishes frameworks for data sharing, including data altruism and
data intermediation services, and sets up the European Data Innovation
Board.
	* The Data Act (Regulation (EU) 2023/2854 ([13])) clarifies rights
and obligations around access to and use of data, especially data
generated by connected devices, ensuring fairness across the data
economy.

These data spaces are a means to bring together relevant data
infrastructures and governance frameworks to facilitate data pooling
and data sharing.

2.2. THE EUROPEAN HEALTH DATA SPACE

In March 2025, the European Health Data Space Regulation ([14])
(Regulation (EU) 2025/327) was officially published in the Official
Journal of the European Union ([15]). The EHDS aims to enhance
citizens’ access to and control over their health data (primary use)
at both the national and the EU levels. The regulation seeks to
establish a legal framework with trusted governance mechanisms and to
ensure a secure environment for data processing. Additional goals
include supporting the free movement of citizens by ensuring their
health data accompanies them and fostering a unified market for
digital health services and products. By involving citizens in their
healthcare, the regulation aims to improve the quality and continuity
of care throughout the EU. Furthermore, standardising rules and
obligations for the interoperability and security of electronic health
record systems is expected to reduce costs associated with the flow of
health data across the EU.

Moreover, the EHDS aims to facilitate the reuse of health data
(secondary use) for research, innovation, regulatory and public policy
purposes across the EU. The secondary use of health data is expected
to provide efficiency gains for data users in the health sector.
Creating a single market for data will allow it to flow freely within
the EU and across sectors for the benefit of the public, businesses,
researchers and public administrations for purposes such as
policymaking, research and innovation. Considering that a substantial
amount of electronic data to be accessed in the EHDS is personal
health data relating to natural persons in the EU, the EHDS was
designed in full compliance with the General Data Protection
Regulation (Regulation (EU) 2016/679) ([16])_._

The EHDS will be rolled out through a combination of technical and
organisational measures. The data space will build on existing
infrastructure like MyHealth@EU ([17]) and promotes the development
of interoperable national platforms. The EHDS aims to overcome the
fragmentation of current health data sharing practices across the EU.
By building on existing infrastructure like MyHealth@EU and promoting
interoperable national platforms, the EHDS aims to create a unified
framework that enables secure, cross-border access and reuse of health
data. It empowers patients, supports innovation and research, ensures
compliance with data protection through HDABs and enhances the
efficiency and resilience of healthcare systems, transforming isolated
data silos into a cohesive, patient-centric and innovation-driven
ecosystem.

The EHDS will not be an entirely open-access platform. Instead, it
will operate under a tiered access model.

	* Patients will have faster, free and secure access to their own
electronic health data.
	* Healthcare professionals will access patient data for treatment
purposes only, with patient consent and under strict data protection
rules.
	* Reusers (e.g. researchers, public authorities, innovators) will be
able to request access to anonymised or pseudonymised data for
secondary use through HDABs. These bodies will evaluate requests and
ensure compliance with ethical, legal and technical safeguards.

The EHDS is not a single database but a federated system of connected
platforms, governed by harmonised rules and supported by robust
technical standards to ensure trustworthy, secure and equitable access
to health data across the EU. The rollout is supported by EU-funded
projects such as EU4Health ([18]), Horizon Europe ([19]) and
TEHDAS2 ([20]), which help define technical standards and pilot
real-world applications. Each Member State will also establish a
HDAB ([21]) to manage and authorise secondary data use, ensuring
compliance and secure sharing15.

2.3. THE OPEN DATA DIRECTIVE

The directive on open data and the reuse of public sector information
(Directive (EU) 2019/1024) ([22]) provides common rules for a
European market for government-held data. One of the main aims of the
open data directive is to make public sector data (e.g. from public
sector bodies in Member States, at the national, regional and local
levels) and publicly funded data (e.g. from meteorological institutes)
available for reuse. The directive also required the adoption of an
implementing regulation regarding high-value datasets (HVDs)
(Commission Implementing Regulation (EU) 2023/138) ([23]). HVDs are
certain public sector datasets that have been identified as having
important benefits for society, the environment and the economy across
six categories: geospatial, earth observation and environment,
meteorological, statistics, companies and mobility. Notably,
‘health’ is not one of the HVD categories, reflecting the
sensitive nature of personal health data and the decision to handle it
via specific frameworks like the EHDS. The HVD regulation strengthens
the EU’s open data ecosystem by applying the FAIR principles
(findable, accessible, interoperable, reusable) and harmonising reuse
conditions across Member States, thereby reducing legal and technical
barriers to data-driven innovation.

On data.europa.eu, the official portal for European data, there are
26 896 datasets categorised as ‘health data’ (as at 3 January
2025) ([24]). Open data related to healthcare could include for
example data on spending, aggregated data on vaccination coverage,
hospital admissions and discharge rates, hospital performance
indicators (wait times, readmission rates) and so on ([25]). Open
data in healthcare can have a significant impact:

	* it can contribute to enhanced public health outcomes by enabling
early detection of disease outbreaks and supporting evidence-based
policymaking;
	* it promotes transparency and accountability through access to
spending and performance data;
	* it drives innovation and research by fuelling data-driven
discoveries and AI development;
	* it empowers citizens to make informed healthcare decisions; and
	* it improves operational efficiency by helping providers benchmark
performance and optimise resources ([26]).

2.4. RELATIONSHIP BETWEEN THE OPEN DATA DIRECTIVE AND THE EUROPEAN
HEALTH DATA SPACE

Since both the ODD and the EHDS are part of the European data
strategy, a complementary relationship is expected. For example, both
the ODD and the EHDS emphasise the benefits of making data available
for reuse. Their complementarity lies in the conditions under which
data can be shared. Open data covered by the ODD concerns aggregated
health statistics that are non-sensitive and broadly reusable, while
the EHDS governs access to individual-level health data under strict
conditions for authorised secondary uses such as research. The ODD
facilitates broad public access and innovation through open licensing,
whereas the EHDS introduces a controlled environment with governance,
consent and security mechanisms tailored to sensitive health
data ([27]). Both initiatives aim to foster a culture of data sharing
across the EU. The ODD does this by promoting open data practices
among public institutions, while the EHDS relies on data altruism;
individuals voluntarily making their health data available. This
shared cultural ambition – to normalise and encourage responsible
data sharing – highlights a key area of convergence between the two
frameworks and lays the groundwork for addressing the cultural and
institutional barriers that may hinder their implementation.

Together, these regimes form a layered approach to data sharing. For
example, aggregated health statistics published under the ODD can be
combined with granular, individual level data accessed through the
EHDS to support more robust and innovative analyses. This creates a
synergy between restricted data under the EHDS and open data.
Specifically, open data made available by public institutions can play
a foundational role in powering a wide range of data-driven
applications, including those that will draw on additional data shared
through data spaces.

Each framework offers distinct benefits and opportunities for
different target audiences.

	* PATIENTS benefit from greater transparency and empowerment. The ODD
ensures public access to health-related statistics and environmental
data, while the EHDS gives individuals control over their personal
health data and the ability to contribute to research.
	* HEALTHCARE PROFESSIONALS gain access to cross-border patient data,
improving continuity of care. This also helps continuity of care
within Member States, since not every Member State currently has good
access to patient data.
	* RESEARCHERS can combine open datasets with controlled access to
health data through the EHDS to develop more precise models, tools and
interventions. This supports data-driven innovation.
	* POLICYMAKERS can use open data for transparency and accountability,
while leveraging EHDS data for evidence-based policymaking, public
health planning and crisis response.

The interaction between the ODD and EHDS raises some risks that
require mitigation. Combining open data with data accessed through the
EHDS could potentially increase the chance of identifying individuals.
Open data is typically anonymised and aggregated, but it may still
contain quasi-identifiers (e.g. age range, region, diagnosis codes)
that, when combined with more granular data from the EHDS, could
narrow down the identity of individuals. Data shared under the EHDS,
while accessed under strict governance and for authorised secondary
use, may include pseudonymised individual-level health data. If a
reuser has access to both datasets, they might be able to
cross-reference them to infer identities – especially in small
populations or rare disease cases. However, this is provided for in
the legislation and is strictly forbidden under the EHDS
(Article 61).

 

3. KEY STAKEHOLDERS IN DATA SHARING UNDER THE EUROPEAN HEALTH DATA
SPACE AND THE OPEN DATA DIRECTIVE: ROLES, INTERESTS AND IMPACT

In the context of the EHDS and the ODD, several user groups play an
important role in data sharing practices. To ensure a focused and
meaningful analysis, this section concentrates on the key user groups
that are most directly involved in or affected by these legislative
frameworks. A fundamental distinction throughout this section is made
between primary use – the use of data for the original purpose for
which it was collected, such as direct patient care – and secondary
use, which refers to the reuse of data for other purposes such as
research, policymaking, innovation and public health planning. This
distinction is essential for understanding the different ways in which
various user groups engage with and derive value from data sharing
under the EHDS and ODD, and it frames the analysis that follows.

The selection of user groups in this report – patients, healthcare
providers, policymakers and reusers –reflects a deliberate effort
to combine the core target audiences of both legal frameworks. These
groups represent the intersection of those most impacted by the
EHDS’s governance of sensitive health data and those who stand to
benefit from the ODD’s open data ecosystem. This combined
perspective allows for a more comprehensive understanding of how both
frameworks contribute to a shared goal: fostering a culture of
responsible and impactful data sharing across the EU.

3.1. PATIENTS

Patients (citizens in their role as recipients of care) are the
primary end users, benefiting from both primary and secondary uses of
health data. Through the EHDS, they gain direct advantages such as
improved access to their health records and better continuity of care,
especially across borders via systems like MyHealth@EU. Indirectly,
they benefit from secondary uses of anonymised data, which support
research and innovation, leading to new treatments, diagnostic tools
and personalised care. The EHDS ensures this is done securely, with
strong governance and consent mechanisms. Meanwhile, the ODD
complements this by making aggregated health statistics openly
available, enhancing transparency and public awareness. Together,
these frameworks empower patients and place them at the heart of a
responsible, data-driven healthcare ecosystem.

3.2. HEALTHCARE PROVIDERS

Healthcare providers play a central role in the exchange and use of
health data. They directly interact with patients and utilise health
data for primary purposes such as diagnosis, treatment and the
optimisation of care. Additionally, they benefit indirectly from
secondary use of data: if research leads to new medical technologies,
improved treatment protocols or healthcare innovations, providers can
enhance their services through more efficient workflows, reduced
operational costs and access to improved tools for diagnosis and
treatment. For example, AI-powered clinical decision support systems
trained on anonymised datasets accessed through the EHDS could help
physicians identify rare diseases more quickly or recommend
personalised treatment plans based on real-world evidence. This not
only improves patient outcomes but also supports healthcare
professionals in making more informed, data-driven decisions.

3.3. POLICYMAKERS

Policymakers shape the regulatory frameworks and guidelines governing
the use and exchange of health data. Their decisions impact primary
use by ensuring that the ways data are handled align with ethical and
legal standards. Policymakers also influence secondary use by
promoting responsible data reuse for research and innovation. If
data-driven policies lead to improved healthcare systems,
accessibility or patient rights, the broader population, including
patients, benefits from these advancements.

3.4. REUSERS

Reusers encompass researchers, data analysts and organisations that
leverage health data for secondary purposes, such as scientific
studies, technological development and improvements to public health.
Their work may not involve direct interactions with patients, but it
contributes to innovations that enhance healthcare delivery. Reusers
benefit from access to data because they can create products and
services that would otherwise not be possible, e.g. through new
business models.

 

4. RESULTS: ADVANTAGES AND CHALLENGES RELATED TO THE INTERACTION OF
EHDS DATA WITH OPEN DATA

Through both literature research and analysing the interview data (see
Annex A for the full methodology), we have extracted several key
conclusions per end user group. We have described the advantages and
challenges that are experienced by patients, healthcare providers,
researchers and policymakers. Each section starts with a description
of the benefits of combining data shared under the ODD and EHDS and
concludes with the challenges that may arise. Firstly, for clarity, we
have included a table that summarises the different benefits and
challenges for each user group.

 

		PATIENTS

		This user group is comprised of the general group of patients who
receive a form of healthcare in a medical facility.

		 
		NATURE OF THE BENEFIT OR CHALLENGE
		SUMMARY DESCRIPTION

		BENEFITS
		Patients can make better informed outcomes.
		Increased ownership of healthcare data from the EHDS and access to
open data can enable patients to make better informed outcomes. This
leads to choices for facilities where they perceive additional
benefits, such as higher quality of care or lower waiting times.

		CHALLENGES
		Patients currently lack the skills, tools and knowledge to combine
their data.
		Patients currently, in general, do not have access to or are not
able to find and use the right tools, skills and knowledge to
effectively combine EHDS data and open data.

		Patients lack incentives to combine EHDS data and open data.
		In general, the broad user group of patients is not incentivised to
combine different sources of data. An exception is the subgroup of
patients who are motivated to and experienced in managing their own
health (e.g. those with rare diseases).

		HEALTHCARE PROVIDERS

		This user group is comprised of professional healthcare providers
such as doctors in a medical facility.

		 
		NATURE OF THE BENEFIT OR CHALLENGE
		SUMMARY DESCRIPTION

		BENEFITS
		Healthcare providers might be able to increase the quality of the
care they provide.
		When healthcare providers gain access to tools that combine data
from the EHDS with other sources of open data, they can benefit from
these insights to improve their quality of care.

		CHALLENGES
		A significant (time) investment is seen as necessary.
		To make effective use of EHDS data and open data, investment of time
and resources is required, which is not always possible for this end
user group.

		Skills to combine data and extract insights are currently lacking.
		Healthcare providers, in general, do not always possess the right
skills and knowledge to effectively use and directly benefit from the
combination of data from the EHDS and open data.

		The right tools are missing.
		There are currently no, or limited, tools available that provide a
user-friendly way (such as integration into an EHR system) to let
healthcare providers benefit from the combination of open data and
data from the EHDS.

		POLICYMAKERS

		This user group refers to policymakers in a general sense, including
local, regional, national and international policymakers.

		 
		NATURE OF THE BENEFIT OR CHALLENGE
		SUMMARY DESCRIPTION

		BENEFITS
		Additional options for data-driven policymaking become available.
		Policymakers can combine data under the EHDS and other open data to
generate insights valuable for policymaking.

		CHALLENGES
		Skills to combine data and extract insights may be lacking.
		In general, policymakers may not have access to or are not
sufficiently equipped to effectively benefit from using data from the
EHDS in combination with other sources of open data.

		RESEARCHERS/REUSERS

		This user group refers to researchers in a broad sense, be it from
an academic perspective or other research institutions.

		 
		NATURE OF THE BENEFIT OR CHALLENGE
		SUMMARY DESCRIPTION

		BENEFITS
		Greater availability and accessibility of data can lead to better
research outcomes.
		Researchers can greatly benefit from the combination of data from
the EHDS and other open data, as they are, in general, equipped with
the right tools and skills to make use of this data.

		CHALLENGES
		Although the EHDS promotes data altruism, the culture around data
sharing is not yet fully developed.
		Although the EHDS contributes to additional availability of data,
there are still concerns regarding the operationalisation of ‘data
altruism’. The concern centres around the lack of willingness to
share data more broadly.

		The scope of data availability and discoverability is good, but not
yet complete.
		The EHDS will improve data availability and discoverability at the
EU level, but lacks global coverage, which inherently might lead to
incomplete data availability.

Below we further elaborate the benefits and challenges for each user
group.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

4.1. PATIENTS

4.1.1. BENEFITS

A. PATIENTS CAN MAKE BETTER-INFORMED DECISIONS ON HEALTHCARE PROVIDERS

A recurring benefit identified through the interviews is that patients
can make better-informed outcomes in terms of selecting healthcare
institutions where they receive healthcare. For example, patients may
research facilities that promise lower waiting times for planned
medical care or greater quality of care (that is, use public/open data
sources on healthcare facilities or websites from healthcare
institutions to make informed decisions about the healthcare
provider). Under the EHDS, the patient’s health data is easily
shared between providers to deliver healthcare (primary use).

4.1.2. CHALLENGES

A. IN GENERAL, PATIENTS CURRENTLY LACK THE SKILLS, TOOLS AND KNOWLEDGE
TO COMBINE THEIR DATA

Patients who require care often expect to receive it from their
current healthcare provider. Through both desk research and interviews
it was found that patients, in general, may lack the right skills,
tools and knowledge to effectively combine their own medical data with
other open data. Even when patients have sufficient digital literacy
to access data, analysing the data to retrieve valuable and impactful
insights is an additional challenge that requires even more advanced
skills, tools and/or training. Open data, especially in the form of
open datasets, can be too technical for many patients to effectively
work with ([28]). Indirectly, this challenge could be mitigated by
(private sector) organisations who do have the skills and tools to
combine data from the EHDS and other open data, who can share their
insights with patients.

B. PATIENTS ARE LACKING AN INCENTIVE TO COMBINE EHDS DATA AND OPEN
DATA

Although in theory patients can combine their online accessible EHDS
data and open data to gain insights into better healthcare facilities
and shorter waiting lists, for example, it has been noted that a clear
incentive for patients to combine data is still lacking. As patients
are, in general, at the receiving end of care, it is unlikely that
patients will actively research their own EHDS data and combine this
with other open data.

It is worth stressing that this observation does not represent the
whole patient end user group. There might be patients who are in
practice willing and able to combine their own healthcare data with
other sources to research possibilities for better personal health
outcomes, especially chronically ill patients or patients with rare
diseases. In these cases, patients could make use of digital platforms
such as the PatientLikeMe concept ([29]) to share their data to
gather more insights about a specific disease or disease trajectories.

4.2. HEALTHCARE PROVIDERS

4.2.1. BENEFITS

A. HEALTHCARE PROVIDERS MIGHT BE ABLE TO INCREASE THE QUALITY OF CARE
THEY PROVIDE

Primarily, interviewees acknowledge that the EHDS can and will have
strong benefits in their daily practice. It allows for easier and
faster access to patient-related data that can increase the quality of
healthcare. This strongly relates to the primary use side of the EHDS,
which will be facilitated through EU-wide digital infrastructure.

When researching the benefits of combining data from the EHDS with
other open data, it was noted that when healthcare providers receive
the right tools, they can benefit from this combination of data. These
tools can help healthcare providers increase their quality of care if
these tools have a high degree of usability and are preferably
integrated into EHR systems. This would allow healthcare providers to
benefit from insights from this combined data.

4.2.2. CHALLENGES

A. A SIGNIFICANT (TIME) INVESTMENT IS SEEN AS NECESSARY

This report finds that a challenge for this end user group is the time
investment needed for them to combine healthcare data under the EHDS
with other open data. Specific examples include experts who mention
that doctors in general have approximately 10 minutes per patient to
provide actual care, which leaves no time for performing analyses that
require combining data that directly leads to better outcomes in terms
of healthcare. One interviewee stated that it is not reasonable to
expect healthcare professionals to combine data from the EHDS and open
data in practice, as they might be not able to do so in a time
efficient way.

Furthermore, generating usable and reliable health data requires
significant investments. This includes investments in technology,
infrastructure, staff training and ensuring the security and privacy
of the data ([30]).

B. SKILLS TO COMBINE DATA AND EXTRACT INSIGHTS ARE CURRENTLY LACKING

Another barrier that has emerged from the research is that the skills
that are required to combine data from the EHDS and other open data
are lacking. Although availability may not be an issue since open data
is readily available, the specific tools required to combine data and
gather relevant insights is a barrier. This report finds that while
combining data requires specific skills, it is also difficult to
ensure high quality outcomes. Currently, it is unclear for this end
user group how to assess the outcomes of combined data.

A specific example relates to the complexity surrounding healthcare
data standardisation. Although there are common standards, such as the
health DCAT-AP (data catalogue vocabulary application profile for data
portals in the EU) standard for describing the metadata of
datasets ([31]), a lack of skill and knowledge of this
standardisation limits its effective usage.

C. THE RIGHT TOOLS ARE MISSING

One interviewee mentioned that there is currently a lack of
understandable tools available to healthcare providers for combining
data. Even if healthcare professionals wish to combine data and have
the required time available, they still lack the specific tools
required to do so. The EHR system has been identified as a tool that
is potentially helpful. This is already an important source of patient
data. Additional, specific tools could also be made available within
these systems to allow healthcare providers to experience clear
benefits.

4.3. POLICYMAKERS

4.3.1. BENEFITS

A. ADDITIONAL OPTIONS FOR DATA DRIVEN POLICYMAKING BECOME AVAILABLE

Policymakers are frequently mentioned as important beneficiaries of
the EHDS ([32]) and of the combination of EHDS data and other open
data. By combining multiple sources of data, insights might be
generated that lead to better policy development and policy decisions.
Yet, in both desk research and interviews, it was mentioned that this
is currently still a theoretical scenario, since it is not expected
that policymakers will be directly able to process and analyse this
combination of data.

In practice, for effective secondary use of data, policymakers will
have to send in a data request or request a permit for data access as
required under the EHDS ([33]). This requires that policymakers have
a thorough understanding of the requirements needed to gain access to
the data and that they have the skills to further combine this data
and extract insights. A practical example of combining protected
health data with open data given by interviewees is the combination of
health data and environmental data to assess health outcomes. These
kinds of combinations can be valuable for policymakers but require
skill to execute in practice.

4.3.2. CHALLENGES

A. IN GENERAL, POLICYMAKERS CURRENTLY DO NOT HAVE THE RIGHT SKILLSET

Our findings indicate that there is a specific data-related skillset
required to combine data and extract insights. The simple act of
effectively combining data is already complex, let alone extracting
insights from this combined data. The interviews indicate that it may
be necessary for policymakers to gain these new skills.

4.4. USER GROUP: REUSERS

4.4.1. BENEFITS

A. HIGHER AVAILABILITY AND ACCESSIBILITY OF DATA CAN LEAD TO BETTER
RESEARCH OUTCOMES

Our results indicate that out of all the end user groups, reusers and
especially researchers will benefit the most from access to data under
the EHDS combined with other open data. In both desk research and the
interviews, it was indicated that researchers tend to have the right
skillset and tools available to combine this data and extract
insights. Also, in terms of time, researchers and other data users
have the greatest possibilities to make optimal use of combined data
since their focus is already on this topic. Currently, many
researchers already combine multiple datasets for research purposes.
The EHDS will enable the upscaling of this process by offering faster
and easier access to more data sources.

Examples mentioned by interviewees include research on the combination
of environmental data and healthcare data. For example, a project
called Green Data for Health ([34]) in France uses open data to
research the impact of environmental noise on sleep, in combination
with prescription drugs, for over 10 million inhabitants. Besides this
example, the Green Data for Health project has several studies in
which they combine environmental data with health outcomes ([35]).

4.4.2. CHALLENGES

A. ALTHOUGH THE EHDS PROMOTES DATA ALTRUISM, THE CULTURE AROUND DATA
SHARING IS NOT YET FULLY DEVELOPED

A challenge that is mentioned is the current culture around data.
Interviewees expressed the sentiment that in the general community of
data holders and researchers, there is still a strong emphasis placed
on data protection, leading to reluctance to share data freely. This
reluctance could lead to lower eventual availability of healthcare
data. On the other hand, the EHDS mandates that data holders make
their data available for reuse purposes. Over time, as the legal
requirements become practice and successful examples of data use
accumulate, the culture might change and the reluctance around data
sharing may diminish.

B. THE SCOPE OF DATA AVAILABILITY AND DISCOVERABILITY IS GOOD, BUT NOT
YET COMPLETE

Interviewees mentioned that the increasingly standardised digital
infrastructure that is to be provided under the EHDS will further
improve data availability and data discoverability. Yet, it was also
mentioned that although this will ultimately lead to better data
availability on a EU scale, researchers may also frequently carry out
research that is global in scope. Some interviewees identified this as
a challenge in terms of using data from the EHDS.

C. DIFFERENTATION IN THE MATURITY OF HOW EHDS PROCESSES ARE ADOPTED

As the EHDS has entered into force, Member States are starting to
initiate different processes to fully apply the EHDS. This requires
the development and implementation of digital capabilities, such as
the HDABs for secondary use of data. An issue identied in the
interviews is the possible disparities in terms of the maturity of
EHDS processes in Member States. Several Member States that
participated in the interviews, such as Portugal and France, have
already made significant efforts to technically develop and implement
the capabilities required for primary and secondary use. It is
expected that other Member States may be behind in terms of maturity,
which may now and in the (near) future limit the usability of
EHDS-related data and other open data for reuse.

 

5. USE CASES, RECOMMENDATIONS AND CONCLUSIONS

Throughout the interviews and the desk research, several use cases
were discovered and discussed. We have summarised several of the use
cases below. After that we have provided policy recommendations,
before ending with our conclusions.

5.1. USE CASES

The use cases mentioned below are formulated to illustrate clear
examples of the benefits that can arise from combining both
EHDS-related data and other sources of open data. We separate use
cases related to the primary use of data, which mostly benefit
patients and healthcare providers, and use cases related to the
secondary use of data, which mostly benefit researchers and other
reusers.

USE CASES RELATED TO THE PRIMARY USE OF DATA

	* USE CASE 1 – CITIZENS

An Italian citizen is on the waiting list to undergo a surgical
procedure. The waiting list is over six months. Determined to find a
solution, he began researching hospitals across Europe with shorter
waiting times by accessing open data sources ([36]). His search led
him to a renowned hospital in Austria, known for its excellent
healthcare services and shorter waiting periods. The hospital in
Austria could access his health data to perform the surgery, as this
is facilitated through the EHDS. All the information on the procedure
is available in Italy through the same EHDS mechanism, in the
electronic healthcare record system. Combining his own personal data
on the specific medical condition with open data on healthcare quality
and having international access to data is a relevant use case and
improves the experience for the patient and the quality of healthcare.

	* USE CASE 2 – HEALTHCARE PROVIDERS

Healthcare providers who deliver care in clinical practice benefit
from the ability to access healthcare data faster and easier under the
EHDS. Also, in general, practitioners face time constraints when it
comes to activities that do not relate to the primary functions of
care delivery. By providing practitioners with the right digital tools
and applications that can effectively combine EHDS-related data from
primary use with other sources of open data, they can benefit from the
complementarities between EHDS-related data and open data. A
requirement of such tools and applications is that they are integrated
into the electronic healthcare record system to allow for quick access
and user-friendly usage of these tools in the daily activities of
healthcare practitioners.

USE CASES RELATED TO THE SECONDARY USE OF DATA

	* USE CASE 3 – RESEARCHERS

In France, a project called Green Data for Health ([37]) is utilising
open-source environmental data to assess healthcare effects. The goal
of the project is to investigate the impact of environmental noise on
the sleep of approximately 10 million French residents. The project
exemplifies a powerful synergy between two distinct data sources:

	* OPEN ENVIRONMENTAL DATA– publicly available noise statistics
which are used to map and quantify environmental noise exposure across
regions, and
	* SENSITIVE HEALTH DATA – prescription data for sleep medications,
securely accessed via the Health Data Hub, which provides insights
into how individuals manage sleep disturbances potentially linked to
noise.

This research combines these datasets and aims to uncover correlations
between environmental noise statistics and sleep-related outcomes. The
project is a scientific research initiative, jointly managed by the
French Ministry of Healthcare and the French Health Data Hub, which is
the HDAB in France.

	* USE CASE 4 – POLICYMAKERS

Mr Dorent, a policymaker in Germany, is committed to improving
healthcare outcomes for diabetes patients, whose conditions vary
widely due to genetic, lifestyle and environmental factors. To
formulate effective policies, he requires comprehensive health data
from diverse populations across Europe. However, collecting this data
is often complicated by national regulations, fragmented data sources
and interoperability challenges. The EHDS mitigates these issues by
providing Mr Dorent with access to anonymised health data from
patients across multiple Member States. This data, combined with open
data from Eurostat, enables him to gather the necessary information to
develop informed policies that support personalised treatment plans
and enhance healthcare delivery.

These use cases, though simplified, illustrate tangible ways in which
the EHDS (with the help of open data) could benefit different end
users, from individual patients to researchers and policymakers, once
the frameworks are operational.

5.2. RECOMMENDATIONS

	* STIMULATE RESEARCH ON THE INTERSECTION OF EHDS AND OPEN DATA
THROUGH FUNDING

As our interviews and desk research indicate that there are several
end user groups who can in general benefit significantly from
EHDS-related data and other open data, it is recommended that these
groups of end users are incentivised to share their results with other
user groups. For example, researchers who combine EHDS-related data
and other open data should be encouraged and funded to translate their
findings into better quality standards for treatment or into
innovative treatment protocols. This way, the end users who are in
general not able to combine EHDS-related data and other open data
(e.g. patients) can benefit from the skills of other end users.

In addition, through this process, the EU can encourage further use of
open data and EHDS-related data by sharing best practices across
Member States and/or could appoint open data ambassadors who upskill,
educate and facilitate interested end users in combining open data
with EHDS-related data. Open data ambassadors could be persons or
legal entities who have demonstrated their capability to combine
EHDS-related data with other open data for better healthcare related
outcomes. In addition, open data best practices for data.europa.eu can
also be shared more widely. These best practices can inspire and guide
users into exploring new combinations of EHDS data and other sources
of open data.

	* ASSESS IF AND HOW THE AVAILABILITY OF EHDS-RELATED DATA IN
COMBINATION WITH OPEN DATA CAN BE OF DIRECT USE FOR HEALTHCARE
PROVIDERS AND PATIENTS AND PROVIDE TOOLS TO FACILITATE THIS

Although the experts interviewed indicated that it is unlikely that
healthcare providers and patients will directly combine and analyse
EHDS-related data and open data themselves, it may be the case that
healthcare providers and patients currently lack the tools and skills
to combine this data and therefore have not expressed a strong
interest in doing so or have not been able to combine and use data.
Therefore, one recommendation is to promote data literacy among these
user groups to promote the use of data. If these end user groups do in
fact show interest in making direct use of EHDS-related data and open
data, tools can be provided that guide and support healthcare
providers and patients in combining data and getting valuable
insights.

	* PROVIDE SUPPORT AND FACILITATE GOOD GOVERNANCE THROUGH EDUCATION
AND REGULATORY BODIES

Governmental supervisory and educational bodies can play an essential
role in strengthening the knowledge base and skill set of several end
user groups. As in the coming years several technical entities and
capabilities under the EHDS become operational (for example the HDABs
and the health data authorities of Member States), it is essential
that end user groups are educated on how these entities will
facilitate them in having better and easier access to health data. In
addition, it is valuable to continuously educate users on the
availability of open data and how this can be combined with
EHDS-related data. This should be done under clear governance
frameworks that provide guidelines for data protection and security,
ensuring end users that their health data is protected.

	* FOLLOW DEVELOPMENTS AND REASSESS LATER

In the period of 2025–2031 additional requirements of the EHDS will
enter into force. Alongside this, the digital capabilities under the
EHDS will become operational and will allow for real user interaction.
As end users start using these capabilities and start accessing
EHDS-related data, it is recommended that periodic evaluation take
place on how this data is used and how users combine this EHDS-related
data with other open data. t is advisable to monitor the realisation
of the technical capabilities across Member States in the coming years
and re-evaluate some of the research questions addressed in this
report once the maturity of these areas has advanced. It is advisable
to do this for example at the end of 2026 or at the beginning of 2027
as EHDS obligations enter into force ([38]).

5.3. CONCLUSIONS

The combination of data that will become available under the EHDS with
other open data holds substantial potential for advancing data-driven
innovation and healthcare in the EU. Under the EHDS, primary use and
secondary use of data will increase data access and reusability for
several end user groups. In addition to this, these user groups have
access to other sources of open data which allow for even greater
insights. Below, we summarise how each end user group can benefit from
the combination of EHDS-related data and other open data and what
possible challenges might arise.

In terms of primary use, patients and healthcare providers can benefit
from EHDS-related data in combination with open data. Patients who are
willing and able to combine their own healthcare data with other open
data sources may be able to make more informed decisions in terms of
better healthcare outcomes by, for example, researching options for
lower waiting times or facilities that are rated higher in terms of
quality of care. A challenge for this end user group is the access to
the right skills, tools and knowledge to do this in practice. On the
other hand, healthcare providers can benefit through access to
applications that combine EHDS-related data and open data and that can
be integrated into healthcare practitioners’ daily work. The
challenges for this end user group, in general, are the lack of tools
and perceived time constraints to understand and use the tools.

In terms of secondary use, the main beneficiaries of EHDS-related data
in combination with open data are researchers who are equipped with
the right skills, tools and knowledge. In general, possession of these
skills, tools and knowledge allow researchers to find, access and
reuse data that is made available to them. For policymakers, these
benefits are similar, but our results indicate that there is a
stronger need for education, skills training and knowledge improvement
for this end user group. Of course, other end user groups can benefit
from the innovations of secondary use achieved by researchers,
policymakers and other reusers.

 

6. ACKNOWLEDGEMENTS

This research report has been made possible through the valuable
contributions of many stakeholders. Below is a list of organisations
that have contributed and wished to be acknowledged. Besides these
public acknowledgements, we would like to express our sincere
appreciation to all the other stakeholders that participated in this
report:

	* Digital Health Unit of the European Commission’s
Directorate-General for Health and Food Safety,
	* Health Data Hub France,
	* Integrating the Healthcare Enterprise,
	* MyHealth@EU Ireland,
	* Nederlandse Federatie Universitaire Medische Centra (Dutch
Federation of University Medical Centres),
	* Sciensano Belgium,
	* Serviços Partilhados do Ministério da Saúde (Ministry of Health
in Portugal),
	* Ministerie Volksgezondheid, Welzijn en Sport (Ministry of Health in
the Netherlands).

 

ANNEX A: METHODOLOGY

To explore how the EHDS and the ODD can support data-driven innovation
and benefit various stakeholders, we applied two main research
methodologies: literature research and structured expert interviews.
Literature research was used to gather existing insights and policy
context, while expert interviews allowed us to collect in-depth,
practice-based perspectives from professionals across the EU with
diverse expertise in health data and open data. In addition, use cases
developed under the EHDS were investigated through the interviews to
ground the discussions in real-world applications and assess their
relevance and impact.

A.1. LITERATURE RESEARCH

The findings are based on a structured desk research methodology
designed to identify and analyse use cases that illustrate the value
of data sharing within the frameworks of the EU’s data strategy, the
EHDS and the ODD. This approach involved targeted exploration of
practical implementations and stakeholder experiences. Search terms
such as ‘European health data space use cases,’ ‘Open Data
Directive implementation’ and ‘EU data strategy applications’
were used across platforms like Google, Google Scholar and
institutional websites. The research prioritised authoritative
sources, including official European Commission materials, national
portals on data exchange, outputs from initiatives like TEHDAS and
TEHDAS-2 ([39]) and relevant scientific literature. Use cases were
selected based on their relevance to the legislative frameworks,
clarity of outcomes and demonstrable value creation, with particular
attention to examples involving cross-border collaboration, secondary
use of health data and innovative applications of open data. This
method ensured that the findings are grounded in real-world practices
and reflect a broad spectrum of perspectives across the EU.

A.2. EXPERT INTERVIEWS

Expert interviews were conducted for deep insights into the
interactions between the EHDS and the ODD, with a particular focus on
identifying concrete or conceptual use cases that demonstrate the
potential benefits of data sharing. The selection of the experts for
the interviews was based on the requirement that they have deep
material understanding of both the EHDS and the ODD. This was assessed
by researching experiences and (research) contributions on these
topics. Also, experts that contributed to the development of the EHDS
or the ODD were included.

Experts included in this study are categorised into four categories to
ensure diverse viewpoints and diverse expertise. The four categories
were designed to represent the spectrum of relevant end user groups:

	* EU/national policymakers,
	* technology specialists,
	* healthcare providers/patient associations,
	* public- and private-sector researchers/academics/innovators and
reusers.

Interviews lasted about one hour and were transcribed. After the
interview, the interviewee had the opportunity to review the notes.
The interview guideline is included in Annex B of the report and
focused on the impact of combining data made available under the EHDS
and ODD for several end user groups. Feedback from the interviews is
presented anonymously in this report. To ensure a broad and informed
perspective, experts were drawn from a diverse range of organisations
involved in digital health and data governance across the EU. These
include Integrating the Healthcare Enterprise, Sciensano Belgium,
MyHealth@EU Ireland, Health Data Hub France, the Digital Health Unit
of the European Commission’s Directorate-General for Health and Food
Safety, Serviços Partilhados do Ministério da Saúde (Portugal), the
Dutch Ministry of Health, Welfare and Sport and the Dutch Federation
of University Medical Centres. In total nine interviews were carried
out; a summary of participants and/or participating organisations can
be found in the acknowledgement section.

 

ANNEX B: INTERVIEW TOPIC LIST

GENERAL QUESTIONS

	* What topics concerning the EHDS and ODD are you involved in?
	* To start with the end user groups, we identified the next end user
groups (citizens, healthcare professionals, private sector
organisations, policymakers, and researchers). Are they complete? And
with which end user group are you most involved in with your
organisation?
	* In general, do you see any positive use cases for patients when
combining the EHDS and the Open Data Directive?
	* If yes, what do these use cases look like?
	* Do you foresee benefits on the national level from the EHDS and/or
in combination with the ODD?
	* Specifically for the end user group the interviewee is interacting
with a lot.
	* Do you see any barriers that may hinder the full realisation of
these benefits – particularly in light of the existing Open Data
Directive?
	* Do you have any policy recommendations for the European Commission
on the intersection of the EHDS and ODD?
	* Any specific ethical challenges?
	* Would you like to address any other topics?
	* Can we mention you or your organisation in the acknowledgements?

Depending on the specific expertise, questions about a specific end
user group were asked.

QUESTIONS SPECIFIC TO PATIENTS

	* Will patients be able to combine EHDS data with other data? For
example would they be able to compare organisations internationally on
waiting times?
	* How will EHDS change the way citizens interact with their health
data?
	* What are concerns for citizens, and how are these addressed?
	* One of the goals of the EHDS is to give the patient more control of
their patient data: how is that done?

QUESTIONS SPECIFIC TO HEALTHCARE PROFESSIONALS

	* Will healthcare professionals be able to combine data?
	* How will the EHDS impact healthcare professionals regarding the
primary use of data?
	* How will EHDS change the way professionals access and use patient
data?
	* How useful is it for professionals to access patient data from
other EU countries?
	* Do you see EHDS as a time-saver or an additional administrative
burden?
	* Will the way of working change when accessing and supplying data
cross-border? (In terms of how to register, systems, etc.)
	* What challenges do you expect when interpreting health records from
different countries?
	* Do you foresee any ethical dilemmas regarding access to patient
data?
	* What challenges might arise for healthcare professionals in terms
of training or adapting to EHDS?

QUESTIONS SPECIFIC TO RESEARCHERS AND REUSERS

	* How can, in general, reusers benefit from the combination of the
EHDS and ODD?
	* Do you think the EHDS alone, or the ODD alone, has already
benefitted reusers of data?
	* Does it seem realistic that reusers combine the EHDS and the ODD to
their full extent for their benefit?
	* If yes, how can they do this and what would use cases look like?
	* If not, what are challenges for reusers that prevent them from
using the full benefits from the EHDS in combination with the ODD?
	* Are there any other challenges that might arise in:
	* the use of the EHDS and the ODD combined,
	* the general use of the EHDS,
	* the general use of the ODD?

QUESTIONS SPECIFIC TO POLICYMAKERS

	* For what end goals can policymakers and regulators use data?
	* How do governments directly benefit from the ODD x EHDS?
	* Is it realistic that policymakers will directly be able to combine
information from data spaces and the ODD to make their work easier?

 

GLOSSARY

		TERM
		DEFINITION

		DATA ALTRUISM
		A concept introduced in EU data legislation where individuals
voluntarily make their data available for the common good, such as for
research or for public interest purposes.

		EUROPEAN HEALTH DATA SPACE (EHDS)
		An EU initiative aimed at enabling secure access to and sharing of
health data across EU Member States for both primary (care) and
secondary (research, policy) uses.

		HEALTH DATA ACCESS BODY (HDAB)
		National bodies responsible for managing access to health data for
secondary use under the EHDS, ensuring compliance with legal and
ethical standards.

		HEALTHCARE PROVIDERS
		Professionals and institutions that use health data for diagnosis,
treatment and care coordination. They benefit from improved data flows
and cross-border access.

		HIGH-VALUE DATASETS (HVDS)
		Public sector datasets identified under Commission Implementing
Regulation (EU) 2023/138 as having significant value for society and
the economy, required to be made available under open data conditions.

		OPEN DATA DIRECTIVE (ODD)
		Directive (EU) 2019/1024 that promotes the availability and reuse of
public sector and publicly funded data across the EU.

		PATIENTS
		Individuals who are the primary beneficiaries of health data
sharing. They gain access to their own health records and may
contribute to research through data altruism.

		POLICYMAKERS
		Authorities who design and implement regulations and policies. They
use health data to inform evidence-based decisions and ensure ethical
data governance.

		PRIMARY USE OF DATA
		The use of health data for the original purpose for which it was
collected, such as direct patient care.

		REUSERS
		Researchers, academics and innovators who access anonymised or
pseudonymised health data for secondary purposes such as scientific
research, public health and innovation.

		SECONDARY USE OF DATA
		The reuse of health data for purposes other than direct care, such
as research, innovation, policymaking and public health planning.

		USE CASE
		A scenario that illustrates how a specific user group interacts with
the EHDS or open data, highlighting benefits, challenges and potential
solutions.

 

 

-([1]) Regulation (EU) 2025/327 of the European Parliament and of the
Council of 11 February 2025 on the European Health Data Space and
amending Directive 2011/24/EU and Regulation (EU) 2024/2847, OJ L,
2025/327, 5.3.2025, ELI:
https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng.

([2]) Directive (EU) 2019/1024 of the European Parliament and of the
Council of 20 June 2019 on open data and the re-use of public sector
information (recast), OJ L 172, 26.6.2019, p. 56, ELI:
https://eur-lex.europa.eu/eli/dir/2019/1024/oj/eng.

([3]) European Commission, ‘A European strategy for data’,
European Commission website, 9 April 2025,
https://digital-strategy.ec.europa.eu/en/policies/strategy-data.

([4]) Publications Office of the European Union, ‘Pioneering the
EU’s sector-specific data spaces: The European Health Data Space’,
data.europa.eu website, 19 September 2024,
https://data.europa.eu/en/publications/datastories/pioneering-eus-sector-specific-data-spaces-european-health-data-space.

([5]) European Commission, ‘Digital health and care’, European
Commission website,
https://health.ec.europa.eu/ehealth-digital-health-and-care/digital-health-and-care_en.

([6]) Commission Implementing Regulation (EU) 2023/138 of 21 December
2022 laying down a list of specific high-value datasets and the
arrangements for their publication and re-use, OJ L 19, 20.1.2023,
p. 43, ELI: http://data.europa.eu/eli/reg_impl/2023/138/oj.

([7]) European Commission: Directorate-General for Communications
Networks, Content and Technology and PwC, _Identification of data
themes for the extensions of public sector high-value datasets –
Final study_, Publications Office of the European Union, Luxembourg,
2023, https://data.europa.eu/doi/10.2759/739414.

([8]) Commission Implementing Regulation (EU) 2023/138 of 21 December
2022 laying down a list of specific high-value datasets and the
arrangements for their publication and re-use, OJ L 19, 20.1.2023,
p. 43, ELI: http://data.europa.eu/eli/reg_impl/2023/138/oj.

([9]) Communication from the Commission to the European Parliament,
the Council, the European Economic and Social Committee and the
Committee of the Regions – A European strategy for data,
COM(2020) 66 final of 19 February 2020,
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020DC0066.

([10]) European Commission, ‘A European strategy for data’,
European Commission website, 9 April 2025,
https://digital-strategy.ec.europa.eu/en/policies/strategy-data.

([11]) European Commission, ‘Common European data spaces’,
European Commission website, 9 July 2025,
https://digital-strategy.ec.europa.eu/en/policies/data-spaces.

([12]) Regulation (EU) 2022/868 of the European Parliament and of the
Council of 30 May 2022 on European data governance and amending
Regulation (EU) 2018/1724 (Data Governance Act) OJ L 152, 3.6.2022,
p. 1, ELI: http://data.europa.eu/eli/reg/2022/868/oj.

([13]) Regulation (EU) 2023/2854 of the European Parliament and of the
Council of 13 December 2023 on harmonised rules on fair access to and
use of data and amending Regulation (EU) 2017/2394 and Directive
(EU) 2020/1828 (Data Act), OJ L, 2023/2854, 22.12.2023, ELI:
https://eur-lex.europa.eu/eli/reg/2023/2854/oj/eng.

([14]) Regulation (EU) 2025/327 of the European Parliament and of the
Council of 11 February 2025 on the European Health Data Space and
amending Directive 2011/24/EU and Regulation (EU) 2024/2847, OJ L,
2025/327, 5.3.2025_,_ ELI: http://data.europa.eu/eli/reg/2025/327/oj.

([15]) European Commission, ‘European Health Data Space Regulation
(EHDS)’, European Commission website,
https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en.

([16]) Article 1 of Regulation (EU) 2025/327 of the European
Parliament and of the Council of 11 February 2025 on the European
Health Data Space and amending Directive 2011/24/EU and Regulation
(EU) 2024/2847, OJ L, 2025/327, 5.3.2025, ELI:
https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng.

([17]) European Commission, ‘Electronic cross-border health
services’, European Commission website,
https://health.ec.europa.eu/ehealth-digital-health-and-care/digital-health-and-care/electronic-cross-border-health-services_en.

([18]) European Commission, ‘EU4Health programme 2021–2027 – a
vision for a healthier European Union’, European Commission website,
https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en.

([19]) European Commission, ‘Horizon Europe’, European Commission
website,
https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/horizon-europe_en.

([20]) Finnish Innovation Fund Sitra, ‘Second Joint Action Towards
the European Health Data Space – TEHDAS2’, tehdas.eu website,
https://tehdas.eu/.

([21]) European Commission, ‘Health Data Access Bodies –
Community of Practice’, European Commission website,
https://health.ec.europa.eu/ehealth-digital-health-and-care/ehds-action/projects-supporting-ehds/health-data-access-bodies-community-practice_en.

([22]) Directive (EU) 2019/1024 of the European Parliament and of the
Council of 20 June 2019 on open data and the re-use of public sector
information (recast), OJ L 172, 26.6.2019, p. 56, ELI:
http://data.europa.eu/eli/dir/2019/1024/oj.

([23]) European Commission, ‘INSPIRE Knowledge Base: Policy
context’, INSPIRE Knowledge Base website,
https://knowledge-base.inspire.ec.europa.eu/policy-context_en.

([24]) Publications Office of the European Union, ‘Datasets by
theme: Statistics’, data.europa.eu website, 5 January 2025,
https://data.europa.eu/catalogue-statistics/currentState/category?locale=en.

([25]) Publications Office of the European Union, ‘The value of
health data and its role in Europe’, data.europa.eu website,
22 September 2022,
https://data.europa.eu/en/publications/datastories/value-health-data-and-its-role-europe.

([26]) Ritoré, Á., Jiménez, C. M., González, J. L.,
Rejón-Parrilla, J. C., Hervás P. et al., ‘The role of Open Access
Data in democratizing healthcare AI: A pathway to research
enhancement, patient well-being and treatment equity in Andalusia,
Spain’, _PLOS Digital Health_, e0000599, 2024,
https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000599.

([27]) Commission staff working document – Impact assessment
report – Accompanying the document ‘Proposal for a regulation of
the European Parliament and of the Council on the European health data
space’, SWD(2022) 131 final of 3 May 2022,
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022SC0131&qid=1753366934773.

([28]) Puussaar, A., Johnson, I. G., Montague, K., James P. and Wright
P., ‘Making Open Data Work for Civic Advocacy’, in: Karahalios,
K., Monroy-Hernández, A., Lampinen, A. and Fitzpatrick G. (eds),
_Proceedings of the ACM on Human-Computer Interaction_, Association
for Computing Machinery, New York, November 2018, pp. 1–20,
https://doi.org/10.1145/3274412.

([29]) PatientsLikeMe, PatientsLikeMe website,
https://www.patientslikeme.com/.

([30]) EIT Health, ‘Implementing the European Health Data Space
Across Europe’, April 2024,
https://eithealth.eu/wp-content/uploads/2024/04/EIT_Health_ThinkTank_Implementing_the_EHDS_across_Europe_23.04.24.pdf.

([31]) Derycke, P., ‘HealthDCAT-AP’, 22 December 2023,
https://healthdcat-ap.github.io/.

([32]) See for example the Explanatory Memorandum of the Proposal for
a regulation of the European Parliament and of the Council on the
European health data space COM(2022) 197 final of 3 May 2022,
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52022PC0197.

([33]) Per Member State, specific HDABs are being developed that
manage data requests or give out data access applications.

([34]) Ministry of Ecological Transition and Territorial Cohesion of
France and the Ministry of Energy Transition of France, ‘Green Data
for Health’, Green Data for Health website,
https://gd4h.ecologie.gouv.fr/https://gd4h.ecologie.gouv.fr/en.

([35]) Ministry of Ecological Transition and Territorial Cohesion of
France and the Ministry of Energy Transition of France, ‘Call for
Projects from Green Data for Health and the Health Data Hub’, Green
Data for Health website,
https://gd4h.ecologie.gouv.fr/https://gd4h.ecologie.gouv.fr/enhttps://gd4h.ecologie.gouv.fr/appel-a-projets.

([36]) See for example open data from the Italian Bureau of Statistics
(https://avvisi.istat.it/IdotStat/). It provide datasets on topics
such as healthcare expenditure and status of healthcare facilities.
For an example of a dataset, see the following on public and private
hospitals and their activities:
https://esploradati.istat.it/databrowser/#/en/dw/categories/IT1,Z0810HEA,1.0/HEA_SERVICES/DCIS_OSPED/IT1,43_967_DF_DCIS_OSPED_1,1.0.
For Austria, the following dataset could be an example:
https://www.statistik.at/en/statistics/population-and-society/health/healthcare-and-expenditure/inpatient-healthcare-hospital-discharges.

([37]) Ministry of Ecological Transition and Territorial Cohesion of
France and the Ministry of Energy Transition of France, ‘Green Data
for Health’, Green Data for Health website,
https://gd4h.ecologie.gouv.fr/.

([38]) As the EHDS legislation came into force in March 2025, in March
2027 the first obligations should be in practice.

([39]) Finnish Innovation Fund Sitra, ‘Second Joint Action Towards
the European Health Data Space – TEHDAS2’, tehdas.eu website,
https://tehdas.eu/.
