Förderung der Protoypenentwicklung einer interoperablen elektronischen Patientenakte (EHR) – EU-Förderaufruf

Specific Challenge
Large amounts of valuable health data are generated and collected during and between citizens' medical examinations across Europe. However, opportunities to reuse these data for research and better healthcare are often missed because health data continue to be confined in data silos, often not matching semantic standards, quality needs and safe data exchange techniques. With 24 official languages spoken across EU Member States, the EU eHealth interoperability task is even more daunting. In order to fully unlock these sources of value, effort must be invested in standardisation and harmonisation (including common clinical models, tools and agreed approaches), privacy and security (including data access and data integrity) and communication (towards citizens, patients and healthcare providers) to allow citizen/patient empowerment, advance medical science and improve health for everyone. Infrastructures are nowadays mature enough to host extensible and secure EHR services that can extend the healthcare continuum across borders and possibly embrace social care as well as healthcare-related data storage services such as fitness/wellbeing.
The focus is on developing and testing an extensible, secure and interoperable platform in compliance with the General Data Protection Regulation[1] and the Network and Information Systems directive[2]. The work should include the development of a European prototype implementation with embedded security and large scale testing and validation in a set of use cases with demonstrated relevance for citizens' health and with involvement of citizens, hospitals, medical doctors, pharmacies and health professionals across Europe. Health authorities should be involved in the relevant parts of the proposed work.

This action is expected to prototype a (i) citizen-centered implementation of a platform that can be integrated in a federated platform structure, easy-to-use and secure, constantly accessible and portable within any other Member States of the EU and (ii) a data-driven platform to help the scientific community to benefit from user generated data (health, care, and health-related) going beyond the currently established level of implementation. Social Sciences and Humanities should thereby be considered appropriately.

The proposal should demonstrate its ability to providing a harmonised/standardised and interoperable platform with demonstrated relevant functionalities at the different user levels including, but not limited to:

Ingest appropriate and relevant data and information sets in real time or in batch mode, including multilingual text and binary data;
Expandable to new fields and datasets, extensible so as to be able to integrate subsequent types of data;
Ensure the translations, mappings of source information towards the clinical/database models while using appropriate standards and semantic services;
Ensure scalability and performance of the services, such as in a cloud-based platform;
Ensure data and metadata quality and curation to provide analytics and reporting capabilities;
Provide rigorous security mechanisms such as identification, authentication and encryption services to allow secured data access and privacy, for example building on distributed ledgers such as blockchain;
Operate in a secure environment;
Provide citizen health data and health information import capabilities through a secured API;
Provide appropriate export and/or access/use functionalities for citizens' health data and health information;
Ensure citizens' opt-in processes are properly undertaken in order to allow the secondary use of data for scientific purposes and promoted health;
Provide anonymisation/pseudonymisation capabilities to allow open access to health data for research and public health purposes;
Ensure the proper and legitimate governance of the platform, ensuring the privacy and confidentiality of all citizens/patients/users at all time;
Ensure compliance with relevant EU legislation, in particular REGULATION (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data;
Ensure compliance with the Medical Devices Regulation as appropriate and regarding the specific requirements, such as the need for a unique device identification and proof of cybersecurity;
Consider legal aspects related to data contributions and use, such as portability, data donorship, based on existing regulations on national and EU level;
Compliance or harmonisation with requirements of respective national legislation as appropriate, especially in terms of data protection and regarding electronic patient consent.

This prototype should be primarily focused on citizens' health data generated by the citizens themselves, healthcare professionals or sourced from relevant healthcare organisations. It should include relevant components to enable further medical purposes and health research. This prototype should also be extensible so as to be able to integrate subsequent types of data such as quantified-self data or Omics data.

The consortium should cover a wide range of relevant stakeholders with multi-disciplinary expertise in technology, health and care, legal aspects, interoperability and user engagement. Involvement of Industry and health organisations is encouraged in the most appropriate phases of the project. as well as a balanced European collaboration.

The design of the prototype should be user driven as to ensure the early buy-in of final users (from citizens to healthcare professionals and scientists). It should demonstrate tested and validated functionality in exchange of realistic and fit for the purpose EHR datasets exchange bi-directionally between: 1. hospitals, 2. medical doctor practitioners and hospitals, 3. hospitals and citizen, 4. medical doctor practitioner and citizen 5. Cross-border hospitals and 6. Citizen and research database.

Additionally, a targeted communication and education campaign with key information and tools should be produced to explain the functioning and purpose of the infrastructure (from empowerment of the citizen and promotion of health to the contribution to research) and incentives should be provided to users to accelerate the take-up and sustainability of the platform. The Connecting Europe facilities[3] and the activities of the eHealth network[4] should be taken into account to avoid duplication.

The Commission considers that proposals requesting a contribution from the EU of between EUR 6 and 10 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Expected Impact
The proposal should provide appropriate indicators to measure its progress and specific impact in the following areas:

Interoperable and secure electronic health data use across Europe for citizens and for promoting health,
Improved health services and health conditions, enhanced quality and safety;
Improved efficiency in terms of health economics such as on timeliness of intervention or measures taken, preventive actions/recommendations;
Extended healthcare continuum across borders, actors and confinements;
Improved collection and re-use of data and information sets for citizens' health and related research;
Open, extensible and harmonisation-based EHR solution for app developers;
Easy and safe for citizens to donate their health data for research;
Contribution to the creation of the digital single market providing a scalable, extensible interoperable platform;
Support integration with services under the Connecting Europe Facility.

(Source: European Commission)

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