We are pleased to share that XpanDH’s 4th webinar on 16th November 2023 titled ‘Unlocking the Potential: The European Health Data Space and the Digital Future of European Healthcare’ shared insights from the European Commission, The European Parliament, and the French Ministry of Health on the strengths and importance of the European Health Data Space (EHDS) and the widespread implementation of the European Electronic Health Record Exchange Format (EEHRxF). Y
Here is a summary of the key insights and discussions from the webinar:
Moderator Prof Dr Henrique Martins, XpanDH Project Coordinator, Associate Professor in Health Management and Leadership at FCS-UBI and ISCTE-IUL, Portugal facilitated the discussion.
Our distinguished speakers included:
Dr Konstantin HYPPONEN, Policy Officer on Digital Health at DG SANTE, European Commission;
Isabelle ZABLIT-SCHMITZ, Europe & International Director, French Ministry of Health & Prevention, Digital Health Delegation.
MEP Dr Tomislav Sokol, Member of the European Parliament, Group of the European People’s Party (Christian Democrats);
Revolutionising Healthcare: EHDS and EEHRxF Impact on Data Harmonisation and Innovation in the EU
The European Health Data Space Regulation (EHDS) signifies a significant shift in digital health governance, demanding coordination between national and European levels, and presenting novel opportunities for Member States. EHDS encapsulates a transformative journey involving patient engagement, industry compliance, and digital device alignment within a harmonised framework.
The European Electronic Health Records Exchange Format (EEHRxF) plays a pivotal role in harmonising data. Its integration into the EHDS Regulation offers substantial potential for transformative healthcare solutions. To address health data challenges and enable access and exchange among healthcare providers and patients in the European Union (EU), the EEHRxF will foster innovation by standardising data formats, enabling research opportunities, single market access and improving healthcare outcomes according to Dr Hypponen.
Empowering Healthcare Exchange: MyHealth@EU and the Role of EEHRxF in EHDS Standardisation
Article Six of the EHDS Regulation specifies the EEHRxF as the universal European language for data exchange, facilitating patient data transfer across healthcare providers. The EEHRxF stands as a cornerstone in the EHDS, promoting data standardisation and harmonisation, allowing individuals to access, submit, and share health data across Member States.
The MyHealth@EU infrastructure streamlines cross-border health data exchange of e-prescriptions and patient summaries for healthcare professionals and patients. Both Dr. Hypponen and Ms Zablit-Schmidt spoke about the importance of this seminal infrastructure for the development of a federated EHDS. Using the EEHRxF MyHealth@EU facilitates seamless prescription dispensation, supporting the cross-border continuum of quality care. MyHealth@EU connects 12 Member States and is concurrently expanding geographically and diversifying use cases and functionalities within the system. With the EHDS implementation, enrolment in MyHealth@EU will become mandatory advised Ms Zablit-Schmidt. It will finally incorporate up to 30 countries and include services like lab results, medical images, and hospital discharge reports. The broadening of services within MyHealth@EU offers a wider scope for enhancing patient care and medical research across borders.
Urgency in EHDS Negotiations: Imperatives and Challenges Prior to the European Parliament Elections
Time sensitivity in political negotiations of the proposed EHDS Regulation is paramount, requiring the completion of the final text before the upcoming European Parliament elections. Parliament discussions have centred on primary and secondary data use, agreeing on third-party assessment of EHR systems, labelling data sources, and restricting healthcare professionals’ access to certain patient data. Debates persist regarding justifiable access to health data for both public and private sectors. Patient rights remain contentious, with the Parliament favouring an opt-out mechanism, pending Member States’ views.
In essence, EHDS signifies an ambitious journey necessitating collaboration and technical readiness. The Regulation promises a transformed landscape in digital health, fostering continuity of care, innovation, and trust in digital health systems. Compliance for software providers with both European and national requirements is crucial, requiring collaboration and alignment with EHDS prerequisites. France’s CI-SIS Interoperability Framework is an example of the collaborative efforts needed for readiness and alignment with EHDS standards. Successful EHDS implementation hinges upon public trust. Thus, adopting European ethical principles for digital health is pivotal for public confidence in the EHDS. Implementation will necessitate substantial financial investments and alignment with national regulations. Balancing data privacy and access is crucial, highlighting the need for a harmonised approach to data standardisation.
You can access the webinar slides here or watch the recording below.
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