Including medication treatment data in the European Health Data Space
22 February 2023
As discussion progresses on the Draft Regulation for a European Health Data Space (EHDS), the Alliance for the Digitalisation of Hospitals’ Medication Management Pathways, initiated and led by EHMA, has produced a position paper addressed to the European Parliament and the Member States with recommendations on including medication treatment data in the EHDS. The data space aims to ensure secure, seamless and timely communication and use of electronic health data both for inter-organisational and cross-border treatment, patient safety, research, innovation, policy-making and regulatory purposes. However, the collection and exchange of electronic health data are limited to community healthcare settings, and the role of healthcare institutions is largely omitted from the draft regulation.
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, 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.
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.
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What our Members say
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
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Prof. Todorka Kostadinova, Medical University of Varna, Bulgaria
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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
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Dr Alexandre Lourenco, APAH - Association of Portuguese Hospital Managers, Portugal
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