On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. It entered into force on 26 March 2025, and will gradually begin to apply. The adopted text can be viewed here.

With so much already shared, it is no secret that the secondary use aspect of the EHDS opens up exciting new opportunities for many, including pharmaceutical and MedTech companies.

The other side of the coin? Pharmaceutical and MedTech companies may qualify as "Health Data Holders" facing a host of new obligations they must comply with.

To help Health Data Holders understand what and when to prepare for and how, or, at least provide an indication of what, when and how, we provide an overview of what we know and what there is yet to know.

(1) Making EHD available on request

What? Health Data Holders can be surprised with requests to provide EHD (Electronic Health Data) to an HDAB (Health Data Access Body) following a data access application made by a Health Data Applicant (i.e. a potential future Health Data User). 

The EHD shall be made available to the HDAB within a maximum time limit of three months. In exceptional circumstances, a longer time limit may be obtained.

When? As of 26 March 2029, such requests can be made at any time.

However, for some data categories, such requests can only be made as of 26 March 2031. These categories include (i) health-impacting factors such as socioeconomic, environmental, and behavioral determinants, (ii) human genetic and genomic data, (iii) other molecular data such as proteomic and metabolomic data, (iv) data from clinical trials and studies, and (v) data from research cohorts, surveys, and health-related questionnaires.

But, what exactly? Naturally, future Health Data Holders will want to prepare their datasets in advance for such requests. The EHDS outlines minimum categories of EHD for secondary use (art. 51), but it's currently unclear which specific data Health Data Holders will need to provide, as these categories are not yet defined, creating uncertainty about what data falls under the scope of the obligation. 

So, what will provide the clarity we're waiting for? Close attention should be paid to the work of TEHDAS2, a joint action consortium producing guidelines and technical specifications for the European Commission and Member States to ensure a harmonized implementation of the EHDS.

The upcoming draft guideline on minimum categories and limitations for the reuse of health data looks especially promising. Scheduled for public consultation in September–October 2025, it is expected to provide full-text definitions and examples for each category, bringing much-needed clarity.

(2). Proactively sharing held datasets 

What? The Health Data Holder must provide a description of their dataset to the HDAB and, at least once a year, ensure the dataset description is accurate and up to date.

When? Starting from 26 March 2029. For the five other categories, starting from 26 March 2031.

But, what exactly, and how? Unfortunately, the answer to what data should be described is the same as for what data to provide on request (see above): we first need clarity on the minimum categories of EHDS.

The EHDS (Art. 77) briefly touches on how the datasets should be described, i.e. the description should include information concerning the source, scope, main characteristics, and nature of the electronic health data in the dataset. 

Again, more clarity is yet to come. The minimum elements and the characteristics of those elements to be included in the description still need to be specified by the European Commission. However, it will probably not be until 26 March 2027 that such implementing act will be available, so the wait is still long.

In the meantime, the work of TEHDAS2 offers a glimpse of what these elements and characteristics could look like. Although not officially acknowledged, the work done will most likely support the European Commission in the drafting of the implementing act.

Currently, TEHDAS2 has already developed a draft guideline on data description (here).

In this draft guideline, the HealthDCAT-AP specification, a practical metadata model/standard developed in the HealthData@EU project, is proposed to describe the datasets. 

The draft guideline explains how to use HealthDCAT-AP to describe datasets and provides clear, practical steps to ensure metadata is accurate, interoperable, and compliant with legal requirements.

(3). Justification of the quality and utility label (if any)

What? If a data quality and utility label accompanies the dataset, the Health Data Holder has to provide sufficient documentation to the HDAB for that body to verify the accuracy of the label.

When? As of 26 March 2029, if such label is present.

But what exactly? The EHDS already establishes the elements that the data quality and utility label has to cover. These elements are grouped in six topics: data documentation, technical quality, data quality management processes, assessment of coverage, information on access and provision, and information on data modifications (Art. 78 (3)).

Again, the elements described in the EHDS do not allow to know exactly what the data quality and utility label will cover. A European Commission implementing act shall set out the visual characteristics and technical specifications of the data quality and utility label, but then again, it will probably not be until 26 March 2027 that such act will be available.

In the meantime, the work of the QUANTUM project offers valuable insight into what these technical specifications might look like, especially QUANTUM’s report on Specification of the datasets' quality and utility label (link). The report provides a technical solution for the development of the technical specifications of the data quality and utility label in accordance with Article 78 of the EHDS.