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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I have been active in EHMA since the first years of the '90s and I have seen its evolution from a small association of members interested in sharing knowledge on health management practices to the current status of reference and advisory key player for EU, health systems and organisations, stakeholders associations, industry and universities. EHMA is now a unique knowledge hub, policy advisor, community of practice and network of best in class organisations involved in health policy and management. A place where health managers can build their competences, policy-makers and stakeholder associations envision how to implement and sustain change through health management, industry leaders understand how to engage more effectively with health organisations and systems. The right place to nurture and grow health management capabilities and capacity for every stakeholder of health systems.

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Prof. Sandra C. Buttigieg, University of Malta, Malta

EHMA is a pre-eminent organisation for everyone working in planning, managing and delivering health services across Europe. As a long standing member of EHMA I have always been impressed by the vibrant community of managers, researchers and academics it has created and by the many opportunities for sharing knowledge and funding opportunities it has brought to its members. Its international scope is impressive and its impact is often felt in management and research across European and national health systems.

Prof. Axel Kaehne, Edge Hill University, UK

Health workforce has become more essential in operating, managing and maintaining health systems lately, particularly in crisis and emergency situations. European healthcare professions and the workforce need to be high on the agenda of managers and decision makers. The Health Services Management Training Centre, Semmelweis University in Hungary is a longstanding EHMA member, because it connects us with collaborators and experts, with whom we can have complex debates, from whom we can learn and at the end find solutions in various challenging fields of healthcare management.

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Dr Alexandre Lourenco, APAH - Association of Portuguese Hospital Managers, Portugal

Many healthcare systems in Europe and beyond are facing similar challenges which require innovative and creative solutions. EHMA’s annual conference, webinars, Programme Directors’ group and other activities and resources provide incredible opportunities for networking, connecting and sharing experiences. A distinct feature of EHMA is the diversity of members with representation from many countries, sectors and different communities of practice – academic, policy-makers, practitioners, managers, leaders and students. The annual conference is a highlight in the calendar year, offering a friendly, fun and learningful environment for emerging and established members to engage, collaborate and meet up with old and new friends. I am proud to be a member of the EHMA Board.

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