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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 become an invaluable asset, promising revolutionary advancements in patient care and medical research. The European Health Data Space Regulation (EHDS) aims to facilitate the exchange of health data across the European Union, but its negotiations have encountered a significant slowdown. The technicalities involved in this critical legislation have presented a formidable challenge, needing comprehensive analysis and understanding to ensure a balanced and effective framework. EHMA’s Alliance for the Digitalisation of Hospitals Medication Management Pathways (EPACT) is delighted to share the European Commission’s clarification that hospital pharmacies, including those in ambulatory and one-day settings, are covered by the regulation. The continuity of care is of special importance to citizens (e.g. cancer and immunotherapy patients) accessing care across borders and receiving treatment in several healthcare settings, including retail pharmacies, hospitals, and ambulatory care/day hospitals.

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. The EHMA’s 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 groundbreaking 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.
Prof. Federico Lega, University of Milan, Italy
Health management has a crucial function in shaping public health and health system challenges. The Medical University of Varna, Bulgaria had success in collaborating with EHMA on EU-funded projects that has resourced us to create new health management competencies for the future workforce. In addition to all classical definitions, health management is a science dealing with individuals, groups, and society at large. It is an art contributing to the beauty of our lives and an interactive communication process at all levels of institutions and human energy. I have also had the pleasure to chair the South Eastern European Special Interest Group which gives members a space to discuss and tools to address how health systems are managed in our regions.
Prof. Todorka Kostadinova, Medical University of Varna, Bulgaria
I enjoy the high level of interaction and engagement in EHMA’s activities, in particular during the annual conference where the panel discussions are rich and well prepared. As a hospital manager and professor of health management, EHMA motivates and inspires me to be creative. You go back home feeling energised from seeing old friends and making new connections, as well as being convinced of serving as EHMA’s ambassador. It’s a strong feeling of interdisciplinary engagement, but it also feels like being part of family-like community.
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.
Dr Eszter Kovács, Health Services Management Training Centre, Semmelweis University, Hungary
As a hospital administrator and health management professor, I see on a daily basis that the healthcare challenges require talented and skilled managers to transform it. the EHMA membership has been beneficial to bring healthcare management research and education to the demanding healthcare services world, promoting healthcare management competencies and knowledge creation.
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.
Prof. Ann Mahon, University of Manchester, UK
Society evolution, pandemics and ageing modify health needs. So, health policies and services are to change dramatically. EHMA, through webinars, workshops and annual conference provides an excellent insight to a professional changing world, favouring closeness to management innovation and the protagonists of these changes. As a primary care services’ manager, participating in EHMA activities is really worth it and allows to involve oneself in the innovation processes.
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