Joint research collaboration with Care and Public Health Research Institute (CAPHRI)
Susanne Sivonen (ITEM)health data
Timo Clemens (CAPHRI)
Introduction
Sharing health data has an extra dimension in border regions such as the Euregio Meuse-Rhine, where individuals, healthcare professionals and healthcare services move across the border more frequently. For instance, hospitals in Aachen, Liège and Maastricht intend to have cooperate more closely in paediatric surgery, where in order to ensure quality and continuity of care, it is crucial that healthcare professionals can access the medical data of their patients. Data is also essential in the provision of digital health services. One example is the cooperation between the university hospitals of Maastricht and Aachen on large vessel surgery, where surgeons operate on a patient at Aachen Hospital while a neurophysiologist in Maastricht monitors the patient’s condition real-time from a distance. In addition, health data is valuable for research, innovation and policymaking, particularly to strengthen the resilience of health care systems. Resilience is especially key in border regions with deteriorating socioeconomic conditions, a shorter life expectancy and an aging population. Moreover, as the COVID-19 pandemic has demonstrated, health data plays also a crucial role in providing efficient crisis management in border regions. Indeed, the Euregio-Meuse Rhine was negatively affected by the lack of relevant cross-border data to ground policy decisions.
The diverse monitoring systems on infection rates produced incompatible data, with each country applying its own definitions and indicators. Although border closures as ad hoc crisis measure had a negative social and economic impact on the region, it was found to have no impact on infection numbers.
New EU initiatives on data
The fragmented standards and specifications for storing and sharing data, legal and administrative rules, insecurity about the application of data protection provisions and limited interoperability pose obstacles to the exchange of health data. The European Commission addressed this issue at the EU level within the context of the European Strategy for Data in 2020, which was the first to propose the creation of Common European data spaces. With the data spaces, the EU intends to establish a single market for data in which data can freely flow within the EU and across sectors for the benefit of businesses, researchers and public administrations. In light of the European Commission’s priorities in the areas of health and building the European Health Union, the European Commission published a proposal for Regulation on European Health Data Space (‘EHDS’) on 3 May 2022 as the first of these data spaces. The proposal addresses health-specific obstacles to electronic health data access and sharing and advances the development of a digital health single market. The purpose of the Regulation is to facilitate a more secure and safe exchange of health data without barriers.
This dossier provides an ex-ante assessment of the possible effects of the proposed legislation on the European Health Data Space on the Euregio Meuse-Rhine (EMR). Under the themes of European Integration, Socio-economic Development and Euregional Cohesion, the dossier aims to assess current practices of health data exchange within national borders, as well as in the cross-border EMR context. By means of literature review, legal analysis and interview conducted with stakeholders involved in health data exchange, the dossier identifies the challenges and best practices involved in health data exchange. It also inquires whether or not the proposed EHDS Regulation could provide solutions for these.
Regarding primary use, the Regulation provides a set of rights and obligations for individuals and healthcare professionals in respect to use of personal electronic health data. Individuals have the right to access one’s health data, in a readable, consolidated and accessible format. Patients’ medical histories, image and laboratory results will be issued in an European electronic health record exchange format, that is used and updated by the health professionals in the course of treatment of their patients, irrespective of the Member State of affiliation and the Member State of treatment. The Regulation also establishes a right for patients to transfer their data within and across national borders to their choice of healthcare professional, immediately and free of charge. To enable sharing of health data, the Regulation established common requirements and standards for interoperability, security and privacy. An infrastructure called MyHealth@EU will facilitate cross-border exchange of electronic health data for primary use. However, the Regulation does not propose a centralised European database, but rather the exchange of personal health data via national contact points, which are to be established in each Member State. Healthcare providers are directly connected to the national points.
Pharmacies, for instance, may share and access e-prescriptions via these points. Furthermore, the proposal requires each Member State to designate a digital health authority, which will supervise the national contact points and implement as well as enforce the Regulation at the national level.
Health data for secondary use will be governed on the national level by health data access bodies, which are tasked with authorising and issuing data permits to data users. The data permit will specify for which purposes the data may be used. Furthermore, the data is always to be provided in an unidentifiable form that cannot be traced back to the data subject. The proposal also entails the obligation for holders of health data (for instance, hospitals, authorities and research institutes), to make certain categories of data available for secondary use. The health data access bodies are connected to an EU-infrastructure, HealthData@EU, which will facilitate the access to cross-border data for secondary purposes.
On the EU-level, cross-border cooperation between the established national authorities will be facilitated by a new European Health Data Space Board, that will be composed of representatives of digital health authorities and new health data access bodies from all the Member States, and the Commission.
Health data exchange in the Euregio Meuse-Rhine
The interviews conducted in the context of this research confirmed that health data plays a crucial role in the Euregio Meuse-Rhine, both in healthcare delivery (primary use) and research and policy-making (secondary use). However, it became quickly clear that health data exchange is subject to several challenges, within and across the national borders in the Euregio Meuse-Rhine. These obstacles can be in divided into three categories: legal, infrastructural and technical obstacles.
Overall, health data exchange was perceived as a time-consuming and complex process, subject to the General Data Protection Regulation (GDPR) and privacy laws. Depending on the nature of the data, the procedure frequently involves obtaining patient consent, approval from a medical and ethical review committee and a review of data management plans. Infrastructural obstacles were encountered because health data for research purposes had to be frequently extracted from fragmented data sources, in the absence of a centralised point of contact. Interoperability was also viewed as a barrier. Frequently, technical systems and interfaces were incompatible. However, primary obstacles of health data exchange are not only associated with data retrievability, but also on data quality. It was noted that especially in a cross-border context, inconsistencies may exist in the data’s underlying indicators and terminology. Due to these differences in methodology and data collection, even when data can be accessed from a neighbouring country, it is not always comparable and useful for research purposes.
Conclusions
In general, the proposal Regulation on the European Health Data Space was received positively: the interviewees indicated that the legal framework as well as technical infrastructure could provide many possibilities for them to overcome the obstacles that they are currently experiencing. Nevertheless, there has been scepticism about how far existing data exchange arrangements in a bi-or trilateral setting in the EMR (accommodating data infrastructures and legal provision from two or three jurisdictions) can be scaled and generalised to 27 Member States and remain practical implementable and meaningful at the same time. Furthermore, due to the sensitive nature of health data, concerns were expressed in relation to privacy and cybersecurity of the data. The interviewees’ perception has been that if the Regulation were to be adopted, it would be essential that all relevant actors in cross-border healthcare be involved in its implementation, and that everyone’s rights and responsibilities under the Regulation be made clear.
Due to a wide scope of the proposal, the Regulation will have an impact to various actors of healthcare in the Euregio Meuse-Rhine. The current state of health data exchange is indeed an impediment to Euregional Cohesion on healthcare. The European Health Data Space proposal could improve patient care, facilitate hospital, researcher, and government cooperation and reduce costs and bureaucracy. It could also be advantageous for the Socioeconomic development and economic position of the Euregion, creating more opportunities for cross-border development of (digital) healthcare products and services. Furthermore, the proposal could foster the mobility of patients and healthcare professionals from the perspective of the theme of European Integration. However, while the proposal can mitigate certain challenges in health data exchange, it may not be a solution for all obstacles experienced. The impact of the Regulation on European Health Data Space on the Euregio Meuse-Rhine will be discussed in depth in the full dossier.
