WP1 Project management and coordination
Project Management and Coordination, led by NeHA and spanning from Month 1 to Month 30, aims to ensure efficient project management and coordination. This includes timely financial management and reporting, proactive control of contractual obligations, and internal communications among partners and Work Package (WP) leaders.
Close collaboration with the European Commission, the eHealth1) eHealth is the use of ICT in health products, services and processes combined with organisational change in healthcare systems and new skills, in order to improve health of citizens, efficiency and productivity in healthcare delivery, and the economic and social value of health. 2) WHO definition: cost-effective and secure use of information and communications technologies in support of health Read More network, and other relevant projects or initiatives is prioritized. The package also focuses on quality assurance and specification management. Tasks within this package include coordination of the project consortium, alignment with other relevant projects and initiatives, operative management of action development, and maintaining a quality assurance and technical helpdesk to provide support to all WP leaders and Member States. Through these efforts, WP1 aims to facilitate smooth project progress, minimize risks, and ensure compliance with EHDS regulations.
WP2 Dissemination
Dissemination, led by GEMATIK GMBH and spanning from Month 1 to Month 30,aims to enhance dialogue between the project and stakeholders, both internal and external. Through dissemination activities, the package aims to raise awareness of the project, develop effective communication and engagement plans, and foster collaboration with stakeholders such as EU administrations, national governments, healthcare professionals, and industry representatives. Tasks within this package include organizing engagement and education activities, developing strategic communication plans, establishing a publication platform for project artifacts, and implementing an educational and dissemination platform, including the project website. Through these efforts, WP2 seeks to maximize the impact of the project and ensure widespread uptake of its outcomes among target audiences.
WP3 Evaluation
Evaluation, led by GÖG and spanning from Month 1 to Month 30, focuses on assessing the implementation and success of the project. The primary objective is to ensure.
that the project progresses as planned and achieves its targeted objectives. This includes defining evaluation procedures and methods, exploring the impact of project activities on EHDS through targeted interviews, and continuously monitoring project processes using Key Performance Indicators (KPIs). Output indicators such as the availability of implementation guides and technical specifications will be tracked, along with process indicators related to project timeline adherence and stakeholder satisfaction. The package also involves the creation of an Evaluation Plan and tools for continuous monitoring, ensuring ongoing assessment and alignment with project objectives throughout its duration.
WP4 Sustainability
Sustainability and Cross-Border InteroperabilityInteroperability means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support. Definition Source Proposal for a regulation of the European Parliament and the Council Read More, led by VR and ESZFK and spanning from Month 1 to Month 30, addresses critical aspects of health data interoperability to ensure the long-term sustainability of the EHDS environment and support the implementation of the EHDS Regulation. Tasks within this package are intricately linked with relevant EHDS Regulation components and focus on several key areas. These include mapping the current state of EHR adoption in Member States, presenting sustainable EU-wide interoperable EHR systems, providing EHDS Regulation-compliant interoperability requirements, and mapping legal and ethical challenges faced by EU EHR systems. Task descriptions within this package outline activities such as assessing interoperability readiness, developing sustainability plans, and defining conformity assessment schemes to ensure compliance with EHDS Regulation standards. Through these efforts, WP4 aims to strengthen the sustainability and interoperability of EHDS environments and cross-border services, facilitating the seamless exchange of health data across the European Union.
WP5 General requirements for EHRs and system interfaces
General Requirements for EHRs and System Interfaces, led by ESZFK HU and VR and spanning from Month 1 to Month 30, aims to define essential requirements and specifications for EHR systems and their interfaces. Task descriptions within this package outline activities such as enumerating functional and non-functional requirements for implementing standardized EHR systems under the EHDS Regulation, and addressing challenges related to data input and output for algorithm-based clinical decision support. Additionally, the package focuses on requirements for patient identification processes across Europe and defining metadata standards for the European Electronic Health Record Exchange FormatThe Commission Recommendation on a European Electronic Health Record exchange format of 6. February 2019 sets out a framework for the development of a European electronic health record exchange format in order to achieve secure, interoperable, cross-border access to, and exchange of, electronic health data in the Union. Acronym / Synonym EEHRxF Definition Source Commission Recommendation on a European Electronic Read More (EEHRxF). Through these efforts, WP5 seeks to establish a robust framework for interoperable EHR systems and interfaces, ensuring compliance with EHDS Regulation standards and facilitating seamless data exchange across the European Union.
WP6 Electronic prescriptions and patient summary towards EHDS
Work Package 6, led by SeHA and co-led by ARIA, spanning from Month 1 to Month 30, is dedicated to advancing electronic prescriptions and patient summaries toward the European Health Data SpaceThe creation of a European Data Space is one of the priorities of the Commission 2019-2025, including the health sector. In the Communication on “A European strategy for data” it states that the Commission will support the establishment of nine common European data spaces with one of them being the Common European health data space, which is essential for advances Read More (EHDS). The primary objective is to establish interoperability standards for securely exchanging health data, particularly focusing on patient summaries and electronic prescriptions, across Electronic Health RecordElectronic health record means a collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes. Acronym / Synonym EHR Definition Source Proposal for a Regulation of the European Parliament and of the Council on the European Health Data Space Read More (EHR) systems. This will involve revising the European Electronic Health Record Exchange Format (EEHRxF) and developing functional and technical requirements and specifications aligned with EHDS Regulation articles 6 and 23. Task 6.1 will focus on patient summaries, ensuring compliance with EHDS standards, while Task 6.2 will address electronic prescriptions and dispensations. These efforts will contribute to the development of implementing acts under EHDS, fostering seamless data exchange and supporting the EHDS vision. Collaboration with eHealth Network (eHN) and MyHealth@EU communities, as well as interdependencies with other work packages, will be crucial in achieving these objectives.
WP7 New services for EHR systems towards EHDS
Work Package 7, spearheaded by SPMS and spanning from Month 1 to Month 29, is dedicated to advancing new services for Electronic Health Record (EHR) systems towards the European Health Data Space (EHDS). The primary focus lies on discharge reports, laboratory reports, and medical images and reports, aiming to support Member States (MS) in EHDS implementation. WP7 will provide implementation guides aligned with EHDS regulation needs, fostering interoperability for securely exchanging these critical health data and documents. Task 7.1 will concentrate on laboratory results and reports, defining requirements for safe and interoperable exchange based on international terminologies like LOINC, NPU and SNOMED CT and international standards like HL7 FHIR. Task will also elaborate essential requirements and interoperability principles for EHR systems in the laboratory information domain. Similarly, Task 7.2 will address medical images and reports, ensuring compliance with HL7, FHIR, and DICOM standards. Task 7.3 will focus on discharge reports, aligning with HL7 CDA and FHIR standards. These efforts will culminate in implementation guides supporting cross-border data exchange, as outlined in EHDS regulations. Collaboration with eHealth Network (eHN) and EHDSI communities, as well as interdependencies with other work packages, will be essential for achieving these objectives and ensuring seamless integration into the EHDS framework.
WP8 Certification and Labelling framework
Work Package 8, led by IDIKA SA over a span of 30 months, is tasked with establishing guidelines to support the forthcoming EHDS regulation, particularly focusing on Chapter 3 concerning EHR systems and wellness applications. The objectives encompass preparing assessment frameworks and technical specifications for evaluating the interoperability of electronic health records and other health software, developing guidelines for assessing the interoperability and security of mobile wellness applications, and evaluating previous and ongoing initiatives in evaluation and labeling across Europe. Task 8.1 will propose functional profiles for EHR systems aligned with the EEHRxF and specifications from other work packages, while Task 8.2 will focus on testable assertions for conformity assessment, drawing on concepts from previous initiatives like EURO-CAS. Task 8.3 will evaluate ongoing labeling initiatives and propose guidelines for wellness application developers, ensuring compliance with EHDS regulations. These tasks, interdependent and supportive of EHDS regulations, aim to provide the necessary guidelines and documentation for conformity assessment and labeling of EHR systems and wellness applications.
WP9 Telemedicine under MyHealth@EU in alignment with EHDS proposal
Work Package 9, spearheaded by SPMS over 26 months, is dedicated to establishing the groundwork for the implementation of cross-border telemedicine services within the framework of MyHealth@EU and in alignment with the EHDS proposal. Task 9.1 focuses on defining the requirements and specifications for cross-border telemedicine services, encompassing priority use cases, business requirements, and technical specifications to ensure interoperability with MyHealth@EU infrastructure. Task 9.2 delves into interventions aimed at accelerating the large-scale uptake of telemedicine services, particularly in cross-border scenarios, by assessing existing pilots, Member States’ experiences, validation, and reimbursement best practices. These efforts aim to contribute to the EHDS by laying the groundwork for telemedicine services, as outlined in articles 3, 8, and 13 of the regulation proposal, and will be coordinated closely with relevant tasks across WP4 to WP8 to ensure alignment and effective management of interdependencies.