Including medication treatment data in the European Health Data Space

22 February 2023

As revisions on the Draft Regulation for a European Health Data Space (EHDS) progress in the European Parliament and the EU Council, the Alliance for the Digitalisation of Hospitals’ Medication Management Pathways, initiated and led by EHMA, has produced a position paper on the inclusion of Digital Medication Treatment Data in the European Health Data Space.

Currently, the draft regulation does not ensure that all healthcare providers across the care continuum make medication treatment data available in the EHDS. The Alliance members see a major opportunity in the EHDS to integrate relevant and actionable medication treatment data from all healthcare settings in Electronic Health Record (EHR) systems. Data from across the full continuum of care will strengthen the primary and secondary use of electronic health data in the EHDS guaranteeing that all electronic health data is portable for patient safety, research and policy-making purposes.

A key principle of the EHDS is to ensure the secure and free movement of electronic health data across the Union. The ability to freely move electronic health data depends on the collection, availability, and portability of an EHR which is implemented in all healthcare settings. However, levels of integrated digital systems in hospitals’ medication management pathways (including e-prescriptions, e-preparation and e-administration/dispensations) are low across the Union. Furthermore, Article 5 and 12 of the draft regulation limits patient electronic prescription and dispensation of medicines to retail pharmacies; hospitals and ambulatory care/day hospitals are excluded. The same limitation appears in the eHealth Networks Guideline of the Patient summary[1], which mainly refers to medicines prescribed and dispensed in retail pharmacies, but not in hospitals and ambulatory care/day hospitals.

Hospitals are major providers of care in emergency situations, to cancer patients, those with chronic and immunocompromised conditions. Therefore, it is vital that a complete EHR which includes medication treatment data is accessible in the European Health Data Space. The risk of harm to patients from medication errors is at its highest during transitions of care. Unintended medication discrepancies affect nearly every patient moving across the care continuum and incomplete EHRs will not address communication challenges for patients and professionals regarding medication regimes and changes.

[1] ehn_guidelines_patientsummary_en.pdf (

The Position Paper

The Position Paper

To ensure that health data collection and exchange are consistent across the care continuum we recommend:

  • Make hospitals and ambulatory care/day hospitals’ medication data provision to the EHDS more explicit in Articles 5 and 12 of the Regulation and in Annex I.
  • Support countries to invest in digitalisation, data generation and standardisation of hospital medication, so hospitals can be fully integrated into the EHDS through patient summaries, e-prescriptions and e-dispensations.
  • Empower regional and local healthcare providers to making medication hospital data interoperable.
  • Stimulate implementation and development of data standards.
  • Promote and communicate internationally accepted harmonised data standards to facilitate interoperable medication data from healthcare settings into the EHDS.
Download the Position Paper


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