The legal aspect of interoperability of cross border electronic health services: A study of the european and national legal framework.

Legal interoperability constitutes a prerequisite for the provision of high-quality cross border e-health services, like ePrescription and ePatientSummary. A review of EU legislation, policy initiatives and relevant judgments of the European Court of Justice (ECJ) and the European Court of Human Rights (ECHR) was held, concerning personal medical data. Four European social welfare systems, according to Esping - Andersen's typology, were selected and a study of health policy in relation to the national legal framework regarding the data protection regulation is examined. A model of legal interoperability for cross-border eHealth services is proposed for policy makers at EU level based on the following major domains: protection and security of data, transparency and liability, further analyzed in multiple axes and combined with EU targets, policy priorities and basic European legal principles. This model could be viable because of the EU's transnational existence, the coexistence of national and Community law, and the need of novel models of political governance under a unified regulatory and normative base.

Coping with interoperability in the development of a federated research infrastructure: achievements, challenges and recommendations from the JA-InfAct.

BACKGROUND: Information for Action! is a Joint Action (JA-InfAct) on Health Information promoted by the EU Member States and funded by the European Commission within the Third EU Health Programme (2014-2020) to create and develop solid sustainable infrastructure on EU health information. The main objective of this the JA-InfAct is to build an EU health information system infrastructure and strengthen its core elements by a) establishing a sustainable research infrastructure to support population health and health system performance assessment, b) enhancing the European health information and knowledge bases, as well as health information research capacities to reduce health information inequalities, and c) supporting health information interoperability and innovative health information tools and data sources. METHODS: Following a federated analysis approach, JA-InfAct developed an ad hoc federated infrastructure based on distributing a well-defined process-mining analysis methodology to be deployed at each participating partners' systems to reproduce the analysis and pool the aggregated results from the analyses. To overcome the legal interoperability issues on international data sharing, data linkage and management, partners (EU regions) participating in the case studies worked coordinately to query their real-world healthcare data sources complying with a common data model, executed the process-mining analysis pipeline on their premises, and shared the results enabling international comparison and the identification of best practices on stroke care. RESULTS: The ad hoc federated infrastructure was designed and built upon open source technologies, providing partners with the capacity to exploit their data and generate dashboards exploring the stroke care pathways. These dashboards can be shared among the participating partners or to a coordination hub without legal issues, enabling the comparative evaluation of the caregiving activities for acute stroke across regions. Nonetheless, the approach is not free of a number of challenges that have been solved, and new challenges that should be addressed in the eventual case of scaling up. For that eventual case, 12 recommendations considering the different layers of interoperability have been provided. CONCLUSION: The proposed approach, when successfully deployed as a federated analysis infrastructure, such as the one developed within the JA-InfAct, can concisely tackle all levels of the interoperability requirements from organisational to technical interoperability, supported by the close collaboration of the partners participating in the study. Any proposal for extension, should require further thinking on how to deal with new challenges on interoperability.

Policy-aware data lakes: a flexible approach to achieve legal interoperability for global research collaborations.

A popular model for global scientific repositories is the data commons, which pools or connects many datasets alongside supporting infrastructure. A data commons must establish legally interoperability between datasets to ensure researchers can aggregate and reuse them. This is usually achieved by establishing a shared governance structure. Unfortunately, governance often takes years to negotiate and involves a trade-off between data inclusion and data availability. It can also be difficult for repositories to modify governance structures in response to changing scientific priorities, data sharing practices, or legal frameworks. This problem has been laid bare by the sudden shock of the COVID-19 pandemic. This paper proposes a rapid and flexible strategy for scientific repositories to achieve legal interoperability: the policy-aware data lake. This strategy draws on technical concepts of modularity, metadata, and data lakes. Datasets are treated as independent modules, which can be subject to distinctive legal requirements. Each module must, however, be described using standard legal metadata. This allows legally compatible datasets to be rapidly combined and made available on a just-in-time basis to certain researchers for certain purposes. Global scientific repositories increasingly need such flexibility to manage scientific, organizational, and legal complexity, and to improve their responsiveness to global pandemics.