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EHDS Launch

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EHDS Launch

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In March 2025, the EHDS-legislation (European Health Data Space) was published in the Official Journal, marking the beginning of the implementation period. The legislation will become effective starting from March 2029. Meanwhile, there is a transition period in which all stakeholders involved should take the necessary actions to comply with the regulation.

• What impact will there be on your company?
• How can companies and instustry parties prepare themselves for this upcoming legislation?
• What actions need to be taken?

This guide will help you to prepare in due time, so you can enjoy a smooth transition.

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EHDS Launch

EHDS roles and responsibilities

The European Health Data Space (EHDS) Regulation introduces a governance and operational framework for the secure, transparent and efficient handling of health data. Five roles have been defined, that is

• health data users,
• health data holder,
• trusted health data holder,
• health data intermediation entity and
• health data access body.

The roles are necessary to structure complex processes surrounding the primary and secondary use of health data, with a focus on security, interoperability and governance. They are there to:

• Clearly separate tasks and responsibilities: each role has specific responsibilities, so that there is no overlap or conflict between tasks and duties.
• Better management of risks and compliance: by dividing functions, it becomes easier to ensure compliance with privacy, security and quality standards.
• Efficiency and scalability: the EHDS implementation must work in all European Member States. Separate roles make it possible to standardise processes while allowing for national flexibility.
• Transparency and trust: by assigning different roles to different parties, neutrality and objectivity can be guaranteed. This increases trust in the system.

EHDS Launch

Health data holders

A data holder is a person, an organization, institution, or entity that collects, stores, and manages health-related data. Member States can designate trusted data holders for which the data permit issuing procedure can be performed in a simplified manner. This will alleviate the administrative burden for health data access bodies (HDAB's) for secondary use of health data of managing requests for the data processed by them. Institutions like Departement Zorg, RIZIV and FOD Public Health are examples of possible trusted data holders. They have some other responsibilities than data holders. The advantage is the less administrative burden and faster access to data thanks to the simplified procedure, provided that the organization itself is able to minimize, pseudonymize, and make data available.

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Data holder

Trusted data holder

Article 50

Article 72

Duties as a trusted health data holder: They have the same duties as data holders, as well as some additional responsabilities:

• They make the metadata for their received datasets available so interested people know which information the dataset contains.
• They have the necessary expertise to assess health data access applications submitted under a simplified data permit issuing procedure.
• They can issue a recommendation on the delivery of a data permit.
• They can make data available through a secure processing environment (SPE) after the approval of the health data request or the permit delivery for the health data access application.
• They provide the necessary guarantees to ensure compliance with this Regulation.

Duties as a data holder:

• Provide metadata for the available datasets: provide a description of the dataset and check at least annually that the dataset description in the dataset catalogue is accurate and up to date.

• Use the common validated European standard Health DCAT-AP for the metadata. Sciensano is designing an Editor and there is a Health DCAT-AP validator from the European Commission.
• Onboard the metadata in the (HDA) metadata catalog. The HDA metadata catalog is connected to the European platform HealthData@EU for the European exchange of health data.
• Make the requested health data available upon an approved request, so the data user has access to the requested data.
• Calculate the actual costs for providing the requested data.
• If applicable, provide documentation for the quality and utility labels.
• Consider the possibility of trusted open source databases.

Discover the other roles

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More EHDS information

The European Health Data Space (EHDS) brings a fundamental change in the management and use of health data. For data holders – such as hospitals, registries, companies and research institutions – this means new obligations and opportunities. Do you want to discover more about the EHDS regulation? Visit the following e-learnings to sharpen your EHDS knowledge.

• Webinars EHDS

• Dutch learning “HDA legt uit: EHDS”

• French learning “L’HDA explique: l’EHDS”

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Process for a data holder

When implementing the EHDS, a data holder follows a structured roadmap to make health data available safely and efficiently. By carefully following this roadmap, the data holder not only ensures compliance with European regulations, but also guarantees the quality, transparency, and security of data sharing within the healthcare sector. The roadmap for data holders within the EHDS is of great importance because it provides structure and clarity in a complex process of data sharing. Following this established procedure ensures that health data is made available in a secure, transparent, and standardized manner. This is essential to comply with European regulations and to ensure the trust of patients, healthcare providers, and researchers. In addition, the roadmap helps to increase the quality and usability of the data, thereby stimulating innovation and collaboration within the healthcare sector.

Discover the roadmap

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Count down: preparational tasks

Following the roadmap, there are some first preparatory tasks helping you to prepare for the EHDS implementation in March 2029.

EHDS Launch

EHDS Launch

Preparation: reflexionsfor a smooth start

Dataset level

Situation-specific

Data solidarity

Defining your role is not on company level nor on medical device level, but solely on each dataset itself.

For the same health data, you could be data controller or data processor, depending on the situation.

There is data solidarity with data control, rather than data ownership.

EHDS Launch

EHDS Launch

Is there a data policy in the company, and what does it state?

Hover over the buttons to discover more information.

EHDS Launch

EHDS Launch

Intellectual property (IP)

The EHDS legislation mentions that IP protected datasets (article 52) have to be communicated immediately when onboarding metadata, or at the latest following a request. The IP protection for a specific set needs to be negotiated with HDAB who will not disclose the dataset in the metadata catalogue. DigitalEurope has written a paper about safeguarding intellectual property and trade secrets in the European Health Data Space (EHDS). Moreover, this paper has been acknowlegded by the European Commission. Click here to read the paper. The Fortify project was set up to tackle a crucial challenge: how can we share health data securely without compromising the intellectual property rights (IP) of data holders? Fortify is developing an integrated framework of legal, technical, and governance measures to protect innovation (IP, trade secrets, commercially confidential information and regulatory data protection) while enabling responsible data use and research. Several partners, like HDA and Digital Europe are involved to share knowledge and expertise.

EHDS Launch

EHDS Launch

Step 1: Save the data

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Get an overview of all registered data

Think about a metadata catalog

EHDS Launch

EHDS Launch

Step 2: Provide the dataset description

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Provide a description of the data

Provide a data quality and utility label

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Health DCAT-AP

HealthDCAT-AP is a metadata schema designed to improve the discoverability, accessibility, and interoperability of health datasets across Europe. It provides a common framework for describing datasets that enables seamless data exchange between platforms. The standard guarantees:

• interoperability: A uniform description of datasets allows national catalogs to be linked to the European portal HealthData@EU. This prevents fragmentation and facilitates cross-border cooperation.
• findability and transparency: Researchers, policymakers, and innovators can more quickly gain insight into what data is available and under what conditions it can be accessed.
• consistency: The use of controlled vocabularies and machine-readable formats ensures unambiguous interpretation of metadata across different systems.

Click for more info

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More technical information

Do you want to discover more about the technical aspect of the EHDS preparedness for data holders? Visit the following e-learnings to get started.

• Data maturity analysis

• Privacy and data protection

• Introduction to metadata

• Fairification of (meta)data

• DCAT, DCAT-AP, Health DCAT-AP

The HDA offers technical and semantic support for onboarding datasets in accordance with Health DCAT-AP guidelines. Visit the HDA website to discover the data holder onboarding process.

See the result of your datasets in the HDA metadata catalogue.

EHDS Launch

EHDS Launch

Next steps

This is only the beginning of the preparatory work! After this first preparation, we will go to the next phase. In a later phase, we will provide more information about step 3 Handling requests with the fees and penalties. Data holders can charge fees for the operational costs for preparing the data and make it available. The European Commission will develop a fee pricing calculation model. A first draft has been published for public consultation and feedback has been collected. The same applies for the penalties. The first draft guidelines state that the HDA monitors compliance with regulations and that it can revoke data licences, suspend data processing or exclude parties that do not comply with the rules from accessing electronic health data for up to 5 years. In cases where health data holders obstruct access to data or fail to meet deadlines, the HDAB may impose fines. Information about non-compliance is shared between HDABs and may be published online. In step 4, the requested data is being prepared to meet the requirements stated in the health data request or the health data access application. This means the principles of pseudonymization, anonymization and minimalization have to be applied. We will focus on this topic in a later phase as well. Step 5 holds the sharing of the data, either directly to the data user in case of a health data request, or through a secure processing environment in case of a data access application. This will also be explained during a later phase.

Great start

Visit HDAcademy for more training materials about the EHDS legislation and its implementation! https://academy.hda.belgium.be

Process for data holders

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EHDS legislation

The following infographic gives a short overview of the different roles and their responsibilities. Click on the image to enlargen it.

Generating metadata

1 Identify the required elements: Health DCAT-AP offers standardized categories that you can use to describe your datasets. The standard includes metadata elements such as title, description, publication date, language, license, contact point, theme, format, keywords, and distribution. 2 Use an editor or tool: Sciensano’s HealthDCAT-AP Editor allows you to create metadata in the correct format.

Validator tools check the compliance with the standard. 3 Publish in a metadata catalog: For Belgium, the HDA catalog is linked to HealthData@EU.

You can have a combination of different medical devices. For instance, a company provides a medical device to collect data, a platform and a mobile app for data concerning obesity surgery. Through the platform, the data is linked with the electronic health record (EHR) which is used by the multidisciplinary team, like the surgeon, the physician and the dietician. In this situation, the company acts as a data processor on behalf of the hospital. There is also a post-operative data collection by the patient himself, like weight, symptoms, lifestyle, exercise and training, medication… This useful data is not collected in the EHR and is only accessible for the patient himself. In this situation, the company acts as a data controller for providing customized and tailormade reports for the patient. So, for each medical device, you can be either data controller or data processor depending on the situation. .

So, for each medical device, you can be either data controller or data processor depending on the situation. Therefore, the starting point is each data request and the requested data itself. Thus, it is important to look at each dataset separately instead of choosing a role based on company level.

EHDS regulation

The EHDS legislation (European Health Data Space) is a framework of rules and guidelines to enable timely and simplified exchange and access to health data across European countries, providing hospitals, researchers, universities, businesses and policymakers with faster and easier access to critical health information. The EHDS will allow health data to be used for both primary and secondary use. Primary use of health data refers to the direct use of health data in the provision of health care services, such as a physician using a patient's medical record to make a diagnosis or to determine a treatment plan, and it also allows physicians in all member states to access patient data as needed. Secondary use of health data refers to the (re)use of health data for purposes other than individual care, such as research, public health monitoring or policy making. This could include using health data to monitor disease outbreaks or conduct studies to find new treatments. This data comes from electronic health records (EHRs), clinical trials and more. With the EHDS, these various data sources can be integrated and used to support better, data-driven healthcare decisions. Click here to discover more information about the EHDS.

There is data solidarity to promote health data sharing, since data is for the common good. Discover the data solidarity principles through the e-learning The concept of Data Solidarity. Nevertheless, there are severe criteria and several privacy and protection mechanisms for data protection.

HealthData@EU

MyHealth@EU

MyHealth@EU is the European network for the primary use of health data. So it's all about healthcare provision and direct individual patient treatment. The Myhealth@EU platform gives citizens access to their own health data and allows them to give permission for doctors to access their health data, both within their country and abroad. Its aim is to ensure continuity of care when citizens are in another European country. Healthcare providers can access essential medical information about patients through a secure infrastructure. In Belgium, the eHealth platform is responsible for this primary use of health data.

HealthData@EU is the European platform for secondary use of health data. It facilitates research, innovation and policy making by providing access to anonymised or pseudonymised datasets. Each Member State has a national metadata catalogue which will be connected to the European HealthData@EU platform, providing a metadata catalogue containing descriptions of all member state metadata catalogues and European datasets. This will enable international data requests and the exchange of metadata across Europe. This enables large-scale analyses, for example for clinical research, public health and AI applications, while ensuring privacy and GDPR compliance. The Health Data Agency (HDA)' s metadata catalogue connects Belgium to the European datasets.