In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data holders; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.

1: Health data holder

The term “health data holder” includes, among others, any natural or legal person developing products or services intended for health, developing or manufacturing wellness applications, or performing research in relation to healthcare, who:

• in relation to personal electronic health data: in its capacity of a data controller has the right or obligation to process the health data, including for research and innovation purposes; or
• in relation to non-personal electronic health data: has the ability to make the data available through control of the technical design of a product and related services.  These terms appear to be taken from the Data Act, but they are not defined under the EHDS.

In practice, this means that, for example, hospitals, as data controllers, are data holders of their electronic health records.  Similarly, pharmaceutical companies are data holders of clinical trial data and biobanks.  Medical device companies may be data holders of non-personal data generated by their devices, if they have access to that data and an ability to produce it.  However, medical device companies would not qualify as a data holder where they merely process personal electronic health data on behalf of a hospital.

Individual researchers and micro enterprises are not data holders, unless EU Member States decide differently for their territory.

2: Data sets covered by EHDS

The EHDS sets out a long list of covered electronic health data that should be made available for secondary use under the EHDS.  It includes, among others:

• electronic health records;
• human genetic data;
• biobanks;
• data from wellness applications;
• clinical trial data – though according to the recitals, this only applies when the trial has ended;
• medical device data;
• data from registries; and
• data from research cohorts and surveys, after the first publication of the results – a qualifier that does not seem to apply for clinical trial data.

Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective