Unlocking the potential of health data: the role of hospital pharmacies in the European Health Data Space Regulation

4 July 2023

In the realm of healthcare, the digitalisation of data has opened doors to revolutionary advancements in patient care and medical research. The European Health Data Space Regulation (EHDS) is a crucial initiative that aims to make health data more accessible, portable, secure, and transferable across the European Union. However, the negotiations surrounding this legislative proposal have encountered significant challenges, resulting in a slowdown and postponement of discussions. One important aspect that requires explicit attention within the EHDS is the role of hospital pharmacies besides that of community pharmacies. Our Alliance for the Digitalisation of Hospitals Medication Management Pathways (EPACT) is delighted to share the European Commission’s clarification in this regard.

The EHDS represents a ground-breaking initiative that has the potential to transform healthcare by ensuring the seamless exchange of health data across borders. It aims to improve patient outcomes, facilitate medical research, and foster collaboration among healthcare professionals throughout the EU. Hospital pharmacies play a critical role in healthcare settings, ensuring safe and effective medication management for patients. Their inclusion in the EHDS is vital for the comprehensive digitalisation of healthcare data. The EPACT Alliance has been actively advocating for the explicit reference of hospital pharmacies in the EHDS to remove uncertainty and ensure the regulation’s implementation across the entire care continuum.

Recognising the importance of hospital pharmacies, the European Commission has provided clarification regarding their coverage in the EHDS. The Commission affirms that hospital pharmacies, including those in ambulatory and one-day settings, are covered by the regulation. By importing relevant definitions from Directive 2011/24 (Cross Border Healthcare Directive), the Commission acknowledges that pharmacists are healthcare professionals, and pharmacies are healthcare providers, independent of the setting in which they operate. This clarification paves the way for addressing technical differences in handling prescriptions between community pharmacies and hospital pharmacies through implementing acts and specifications.

The explicit inclusion of hospital pharmacies in the EHDS is particularly important for patients accessing care across borders. For individuals like Ukrainian citizens with cancer, the ability to share medication data across healthcare settings is essential for consistent, continuous, cross-border care. Without standardised and interoperable data, providing safe and high-quality care becomes challenging. By deploying digital tools in hospital and ambulatory care medication management pathways, the EHDS can be effectively implemented, ensuring seamless healthcare for patients.

As the negotiations surrounding the European Health Data Space Regulation continue, it is imperative to recognise the significance of including hospital pharmacies in this legislative initiative. The recent clarification provided by the European Commission acknowledging the coverage of hospital pharmacies in the EHDS is a significant step forward. To ensure medication data is digitalised funding will also be required to deploy digital tools, so we can pave the way for a healthcare landscape where data flows seamlessly, enabling improved safety in patient care and advancements in medical research.

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