Expertise
Supporting data holders
Does your organization work with health data?
Then you are probably a data holder. New European legislation, the European Health Data Space (EHDS), introduces new obligations for organizations that manage data. Health-RI helps data holders prepare for these changes.
The European Health Data Space (EHDS) will bring major changes for organizations that work with health data. This new European regulation introduces rights for the use of health data for research, policy and innovation, as well as new obligations for organizations that manage this data.
Many organizations will need to make health data more discoverable, provide metadata and make data available for secondary use.
Health-RI supports data holders in preparing for these changes, for example through advice, guidelines, tools and support in describing and making data available.
Am I a data holder?
According to the European Health Data Space (EHDS), a data holder is an organization that manages or generates health data. This can include a wide range of organizations, such as:
- healthcare providers
- laboratories and diagnostic centers
- public health organizations
- health insurers
- registries and biobanks
- government organizations
- companies that develop products or services for the healthcare sector
- developers of wellness apps
- research organizations that work with health data
The EHDS applies to organizations with more than 10 employees. As shown above, a wide variety of organizations fall under this regulation. Many organizations are therefore data holders without always being aware of it.
Are you unsure whether your organization falls under the EHDS?
Please feel free to contact Health-RI for advice.
Impact of the EHDS on data holders
The EHDS will change the way health data is made available across Europe. From 26 March 2029, the EHDS must be largely implemented. Organizations that manage health data will be required to make data more discoverable and available for reuse.
An important part of the EHDS is the establishment of a Health Data Access Body (HDAB) in each European Member State. This organization will be responsible for processing requests to use health data.
This means that organizations managing health data may, under certain conditions, be required to make datasets available when a data request has been approved through the HDAB.
What obligations will I have as a data holder?
Under the EHDS, data holders will have various obligations regarding the description and availability of health data. In broad terms, this means that a data holder must:
- provide metadata about datasets to the Health Data Access Body (HDAB), so that datasets become discoverable for potential users
- check and update at least once a year whether the metadata and dataset descriptions are still correct
- make datasets available when a data request has been approved through the HDAB
- charge a fee for making data available, up to the amount of the marginal costs
What steps can you take now to prepare for the arrival of the EHDS?
Organizations can already take steps to prepare for the arrival of the EHDS. The following actions help to gain insight into the data within your organization and prepare for future obligations:
- Read the EHDS regulation and explore together with colleagues the impact on the current infrastructure and work processes within your organization
- Create an overview of the data sources and datasets within your organization that fall under Article 51 of the EHDS
- Identify which data request and data provision processes are currently in place within your organization
- Create a single point of contact for providing metadata about your datasets to the HDAB and for providing datasets after an approved request
- Start metadata mapping for a dataset using Health DCAT-AP
- Inform your patients/clients about the reuse of data within your organization and use the VWS communication toolkit for secondary use for this purpose
Health-RI can of course support you with this. Do you need help preparing for the EHDS? Please contact us via Sabrina Timmers (sabrina.timmers@health-ri.nl).
Making data discoverable for reuse
An important step in preparing for the EHDS is making datasets discoverable for reuse. This is done by publishing metadata in an online, accessible metadata catalog.
Metadata is information about a dataset, such as the title, description, type of data, origin or funding organization. Metadata does not contain sensitive or personal data, but it helps potential users understand what data is available.
By publishing metadata, researchers, policymakers and other organizations can find datasets more easily and assess whether they are suitable for their research or analyses.
Health-RI supports data holders in describing and publishing metadata in the National Health Data Catalogue.
Support and services from Health-RI
Health-RI offers various tools, guidelines and support to organizations that work with health data.
Practical guidelines and documentation
Through the Health-RI Agreement Framework, Health-RI provides practical guides, tools and examples. These help organizations describe and publish metadata according to national and European standards.
The National Health Data Portal
Through the National Health Data Portal, Health-RI supports both data holders and data users. On the portal, organizations can:
- find information about using the National Health Data Catalogue
- ask questions about data requests
- receive support with publishing metadata
Training and guidance
The portal also offers training and guidance, including through the Health-RI Academy and other organizations. These trainings cover topics such as:
- onboarding datasets into the National Health Data Catalogue
- data availability and suitability
- making data FAIR (Findable, Accessible, Interoperable and Reusable)
- data stewardship
Tools and infrastructure
Through the portal, organizations also gain access to various tools and data infrastructures, such as:
- other data catalogues (for example the BBMRI catalogue and cBioPortal)
- tools for medical imaging data, such as XNAT
- secure processing environments such as SURF SANE
These services help organizations better manage, describe and make health data available for responsible reuse.
ELSI servicedesk
The ELSI Service Desk helps researchers, professionals, ethicists, legal experts, policy advisors and patient representatives with questions related to:
- ethical aspects
- legal frameworks
- societal implications of data use
The service desk provides information and advice to enable the responsible use of health data.
Need help preparing for the EHDS?
Health-RI supports organizations in describing datasets, publishing metadata and preparing for the new obligations under the EHDS.