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What is EHDS - an introduction to European Health Data Space
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European Health Data Space – an introduction to the EHDS

The EU Parliament approved the text of the European Health Data Space (EHDS) provisional agreement on 24 April 2024. The provisional EHDS agreement awaits approval by the Council of the European Union before its official adoption into EU law.

The EHDS endeavours to give EU citizens greater control of and access to their health data and health records. Health records entail, for example, patient summaries, electronic prescriptions, medical imagery and lab results. The EHDS aims to provide access to these types of health records and medical data both inside of the individual’s member state, as well as across EU borders.

Harmonising EU electronic health data in the context of EHDS

Preparing electronic health data to be used in the manner envisioned by the EHDS will take considerable effort and preparation. A crucial component of the EHDS regulation will be to harmonise electronic health data both internally and across the different member states.

Hence, the EHDS will create rules to harmonise concepts on data quality, security and interoperability of electronic health records.  To accomplish this enormous feat, and in real time, it will be necessary to standardise electronic health data and records. This will entail cleaning and structuring the health data.

In order to begin aligning to the targets of the EHDS, LNDS would like to call attention particularly to concepts in health data quality, curation and data cataloguing.

The EHDS text (Article 56) elaborates on an agreed protocol of how data is described, explaining the specific obligations to data holders in the section called ‘data quality and utility label’. We will not discuss the standardised EU labelling protocol in depth in this article, as not all health data holders will need to provide a quality label.

Thinking early about the steps towards achieving data quality for electronic health data will enable you to more readily achieve compliance with the EHDS within the proposed timelines.

(a) data documentation: meta-data, support documentation, data dictionary, format and standards used, provenance, and when applicable, data model;
(b) technical quality assessment: completeness, uniqueness, accuracy, validity, timeliness and consistency of the data;
(c) data quality management processes: level of maturity of the data quality management processes, including review and audit processes, biases examination;
(d) coverage assessment: time period, population coverage and, when applicable, representativity of population sampled, and average timeframe in which a natural person appears in a dataset;
(e) access and provision information: time between the collection of the electronic health data and their addition to the dataset, time to provide electronic health data following an electronic health data access application approval;
(f) data modifications information: merging and adding data to an existing dataset, including links with other datasets.

(a) data documentation: meta-data, support documentation, data dictionary, format and standards used, provenance, and when applicable, data model;
(b) technical quality assessment: completeness, uniqueness, accuracy, validity, timeliness and consistency of the data;
(c) data quality management processes: level of maturity of the data quality management processes, including review and audit processes, biases examination;
(d) coverage assessment: time period, population coverage and, when applicable, representativity of population sampled, and average timeframe in which a natural person appears in a dataset;
(e) access and provision information: time between the collection of the electronic health data and their addition to the dataset, time to provide electronic health data following an electronic health data access application approval;
(f) data modifications information: merging and adding data to an existing dataset, including links with other datasets.

Data Catalogue in the context of EHDS

In addition to achieving a baseline standard for data quality and utility for electronic health data, the next step would be to establish a national data catalogue of health datasets. This catalogue will be supported by a cross-border communication IT infrastructure, “HealthData@EU”, to be established by the EU commission. This communication infrastructure will connect the EU national dataset catalogues established by each Member State. Authorised participants will also be called upon to populate dataset catalogues.

To this effect, LNDS is currently working on a national data catalogue, addressing the need to develop a cataloguing infrastructure. You can access the current Luxembourg National Data Catalogue here.

Next Steps and Implementation Timeline 

The provisional agreement still awaits formal approval by the Council of the European Union. Once the legislation is published in the EU’s Official Journal, it will enter into force twenty days later. The EHDS will be applied between 2 – 6 years depending on the complexity of the requirement(s).

The implementation deadline for most data categories will be 4 years after the entry into force. On the other hand, there will be a 6 years’ window of entry into force for more complex categories of electronic health data usage. These categories include genomic and epigenomic data, amongst others. The 6 years’ window also applies for implementing health data into clinical trials and research projects. This timeline underscores the EU’s commitment to accelerating digital transformation in healthcare and realizing the potential of health data for the benefit of citizens.

We look forward to beginning the journey of implementing the EHDS with you. 

The article was written by LNDS’ ELSI and Data Cataloguing experts; Erin Anzelmo, Principal ELSI Expert, and Danielle Welter, Principal Data Scientist.