TOPIC : Prototyping a European interoperable Electronic Health Record (EHR) exchange
|Publication date:||27 October 2017|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Opening date:||single-stage 07 November 2017||Deadline:||24 April 2018 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific 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.Scope:
The focus is on developing and testing an extensible, secure and interoperable platform in compliance with the General Data Protection Regulation and the Network and Information Systems directive. 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 and the activities of the eHealth network 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.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation): http://eur-lex.europa.eu/eli/reg/2016/679/oj
Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union: http://eur-lex.europa.eu/eli/dir/2016/1148/oj
The CEF eHealth initiative: https://ec.europa.eu/cefdigital/wiki/display/CEFDIGITAL/CEF+Digital+Home
The eHealth Network activities: https://ec.europa.eu/health/ehealth/policy/network_en
Topic conditions and documents
1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under this topic
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
- Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
- Submission and evaluation processes are described in the Online Manual.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
6. Additional provisions:
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
8. Additional documents:
1. Introduction WP 2018-20
5. Introduction to Leadership in enabling and industrial technologies (LEITs) WP 2018-20
5i. Information and communication technologies (ICT) WP 2018-20
8. Health, demographic change and well-being WP 2018-20
16. Science with and for society WP 2018-20
18. Dissemination, Exploitation and Evaluation WP 2018-20
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|Type of Action||Research and Innovation action [RIA]|
|Topic||Prototyping a European interoperable Electronic Health Record (EHR) exchange - SC1-DTH-08-2018|
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