EUHA has released a consensus standpoint, written up by the Digital Health and Data Network (DHDN) and the Policy Working Group, on the essential aspects of the European Health Data Space (EHDS). All EUHA members joined the statement that emphasises how EUHA hospitals are ready to help unlock the potential of the EHDS.
In May 2022, the European Commission expressed interest in the establishment of domain-specific common European data spaces by presenting the proposal “Regulation of the European Parliament and the Council on the European Health Data Space”. This unified EU framework aims to make health data accessible throughout Europe for direct patient care, research, and health policy.
In response, EUHA took up strategic objectives: to harness the potential of data exchange, increase interoperability and develop common approaches to establish the EHDS. Not only this, but through the DHDN, EUHA became an advisory stakeholder to the EU-funded project TEHDAS (Towards the European Health Data Space).
EUHA has now also released a consensus position “EUHA statement: Key aspects for a successful EHDS – University Hospitals are ready to help unlock its potential” which presents the aspects that EUHA considers to be essential for a successful EHDS implementation.
The position aims to highlight that EUHA, as a cross-border network of digitally driven university hospitals, is a valuable stakeholder that can proactively drive the delivery of the EHDS, raise issues, contribute with recommendations regarding operationalisation and support the European Commission to realise policy aims.
The most critical aspects mentioned in the EUHA statement are the following:
The EHDS needs a governance framework that regulates consent, establishes workflows, and creates trust in the operation of the EHDS. For instance, common principles for data processing should be added to the General Data Protection Regulation (GDPR) to facilitate cross-border data-sharing. In addition, the framework should provide recommendations on patient consent aligned with data altruism and the data protection agencies in member states. In this regard, EUHA strongly recommends using an opt-out basis for the EHDS and avoiding cronyism by rejecting the creation of a joint data protection authority.
EUHA believes that the budget allocated to the EHDS project is underestimated compared to the project’s ambition.
Health data from personal devices should be integrated into Electronic Health Records (EHR) to be used in digital solutions for professionals and patients. These solutions require transparent planning and improved operational and financial processes. Thus, EUHA proposes the incorporation of a dedicated budget to the EHDS business to cover the expenditures of data holders and reinforces the obligation of medical device manufacturers to prove the interoperability and transfer of generated data to existing EHR systems.
EUHA believes that the research infrastructure should include a scientific data permit authority and ethical rules to guarantee trust between all parties involved. For secondary use of data, EUHA supports a federated approach, in which data is stored locally but can be processed by other users in secure environments without leaving the national borders.
EUHA advocates for the strict use of international operability standards, terminologies, and data models, and the FAIR principles of findability, accessibility, interoperability, and reusability.
Moreover, EUHA emphasises the importance of setting up transparent governance models that give public healthcare providers custody of patients’ health data.
For a successful implementation of the EHDS, EUHA encourages member states to invest in teaching the new multidisciplinary digital reality within healthcare and life-sciences education.
Finally, with this statement, EUHA welcomes the creation of the EHDS and a digital reality that allows the exchange and reuse of health data to meet the needs of patients, providers, and healthcare systems.
Read the EUHA consensus paper here: “EUHA Statement: Key aspects for a successful EHDS – University Hospitals are ready to help unlock its potential”.