Developing a Data Quality and Utility Label for the European Health Data Space
HORIZON Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-HLTH-2023-TOOL-05-09
- Programme
- Tools and technologies for a healthy society (Single stage - 2023)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- January 12, 2023
- Deadline
- April 13, 2023
- Deadline Model
- single-stage
- Budget
- €4,000,000
- Min Grant Amount
- €4,000,000
- Max Grant Amount
- €4,000,000
- Expected Number of Grants
- 1
- Keywords
- HORIZON-HLTH-2023-TOOL-05-09HORIZON-HLTH-2023-TOOL-05Health dataHealth policy and servicesHealth services, health care research
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim to deliver results that are directed towards and contributing to all of the following expected outcomes:
- Data Users (researchers, innovators, regulators, policymakers, clinicians) are able to identify the most relevant datasets that meet their specific needs through a label describing accurately and in a standard way the quality and utility dimensions of the datasets, as proposed in the legal provisions of the European Health Data Space (EHDS).
- Data holders have clear specifications for dataset quality and utility labelling to comply with the requirements proposed in the EHDS legal provisions. In addition to that, data holders have access to a maturity model with the requirements a dataset needs to fulfil to achieve higher levels of data quality and utility.
- European and National public funders ensure that the datasets, for which they provided funding for the creation and curation of, are more widely available, furthering their reuse for secondary uses as proposed in the EHDS legal provisions (research, innovation, regulatory work, policymaking, personalised medicine).
- The European Commission has access to a set of specifications for the data quality and utility label supporting the implementation of the EHDS legal provisions.
A vast quantity of health datasets exist across Europe, from multiple sources (individual care, medical registries, social, environmental behavioural, wellbeing, clinical trials, research, administrative, etc.), and of varying quality. This represents a tremendous opportunity for the reuse of this data for purposes other than for the one for which they were originally collected and spur the development of better prevention strategies, diagnoses, treatments and care plans.
The European Health Data Space (EHDS) will provide a common EU framework for secondary use of health data such as research, innovation, regulatory purposes, policymaking and personalised medicine. It will enable data users to have access to large amounts of health data through health data access bodies empowered with the EHDS legal provisions to overcome existing limitations regarding the processing of health data for secondary uses.
To support data users in the discovery and selection of datasets for their purposes, there is a growing need to develop a data quality and utility framework to articulate the characteristics and the potential usefulness of datasets. This framework will also support data holders in identifying and addressing areas of improvement which can, in turn, allow for wider and better use of these datasets.
Several initiatives have developed or are developing guidelines and recommendations for health data quality, however, these typically focus on specific data types (i.e. 1+ Million Genome Initiative[1]) or areas of applications (i.e. European Medicines Agency – EMA and Heads of Medicines Agencies’ Big Data Steering Group activities to support medicines regulation[2]). Similarly, previous studies and initiatives have addressed specific dimensions of ‘data quality’ for health data but none are offering a framework suitable for the breadth of data types and encompassing the quality and utility elements proposed in the EHDS legal provisions. The proposed framework should take into account the various needs of data users whilst at the same time avoid becoming an excessive burden on data holders which will need to produce the data quality and utility label.
Proposals should address all of the following activities:
- Perform a mapping of existing data quality and utility principles/initiatives/frameworks (i.e. EMA/HMA Big Data Stakeholders Group Data quality efforts, TEHDAS Data Quality Working Group[3], EOSC-LIFE[4] Health Data Research UK’s data quality and utility framework[5], and relevant data principles, resources and tools (FAIR, FAIR Cookbook, etc.)[6];
- Conduct various stakeholder consultations, integrating all relevant data users and data holders of health data, EHDS Health Data Access Bodies (HDABs) and other relevant actors to validate data user needs and adequately take into account relevant initiatives when developing the proposed framework;
- Develop a framework (set of technical specifications) for the data quality and utility label that supports the implementation of the EHDS legal provisions and the roll out of the label by the data holders and EHDS Health Data Access Bodies;
- Pilot and evaluate the use of the proposed framework (as a label and as a maturity model) on a datasets sample representing the wide-ranging data types (such as electronic health records, genomics datasets, medical registries, administrative data, etc.) and taking into account the needs of all data users identified.
- Develop recommendations for the successful implementation and adoption of the data quality and utility label and maturity model across European Member States considering the maturity levels regarding secondary of health data.
The consortium should be composed of representatives from data users, data holders, health data access bodies, and other relevant stakeholders to the scope of secondary use of health data, adequately covering the diversity of heath data types and users’ needs across European Member States.
[1] https://b1mg-project.eu/work-packages/wp3
[2] https://www.ema.europa.eu/en/about-us/how-we-work/big-data
[3] https://tehdas.eu/packages/
[5] Development of a data utility framework to support effective health data curation: https://informatics.bmj.com/content/28/1/e100303?utm_source=twitter&utm_medium=social&utm_term=hootsuite&utm_content=sme&utm_campaign=usage
[6] See definition of FAIR data in the introduction to this work programme part.
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘High quality digital services for all’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘Health technologies, new tools and digital solutions are applied effectively thanks to their inclusive, secure and ethical development, delivery, integration and deployment in health policies and health and care systems’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘A competitive and secure data-economy’, ‘Industrial leadership in key and emerging technologies that work for people’, and ‘Good health and high-quality accessible health care’.
Technology is a key driver for innovation in the health care sector. It can provide better and more cost-efficient solutions with high societal impact, tailored to the specific health care needs of the individual. However, novel tools, therapies, technologies and digital approaches face specific barriers and hurdles in piloting, implementing and scaling-up before reaching the patient, encountering additional challenges such as public acceptance and trust. Emerging and disruptive technologies offer big opportunities for transforming health care, thereby promoting the health and well-being of citizens. Unlocking this potential and harnessing the opportunities depends on the capacity to collect, integrate and interpret large amounts of data, as well as ensure compatibility with appropriate regulatory frameworks and infrastructures that will both safeguard the rights of the individual and of society and stimulate innovation to develop impactful solutions. In addition to existing European Research Infrastructures, the European Health Data Space will promote health-data exchange and facilitate cross-border research activities. Moreover, the European Health Emergency Preparedness and Response Authority (HERA) aims to improve to improve the EU's readiness for health emergencies by supporting research, innovation and development of technologies and medical countermeasures needed against potential cross-border health threats. This destination aims to promote the development of tools, technologies and digital solutions for treatments, medicines, medical devices and improved health outcomes, taking into consideration safety, effectiveness, appropriateness, accessibility, comparative value-added and fiscal sustainability as well as issues of ethical, legal and regulatory nature.
In this work programme destination 5 has a strong focus on the personalisation of health technologies and will address the following issues:
Developing computational systems for point-of-care applications, developing and validating computational models of physiological systems and integrating health data from different sources, for better patient management and improved clinical outcomes;
Fostering translational biomedical research and advancing regenerative medicine approaches into clinical settings and manufacturing;
Preparing for potential cross-border health threats through the development of innovative in-vitro-diagnostics;
Supporting the establishment of the European Health Data Space by designing a data quality label.
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health, the European Innovation Ecosystems (EIE) interregional networks on health and EIT-KIC Health (under pillar III of Horizon Europe) or in areas cutting across the health and other clusters (under pillar II of Horizon Europe), like, for instance, with cluster 4 “Digital, Industry and Space” on digitalisation of the health sector or key enabling technologies.
Expected Impacts
Proposals for topics under this destination should set out a credible pathway towards unlocking the full potential of new tools, technologies and digital solutions for a healthy society, and more specifically to several of the following expected impacts:
- Europe’s scientific and technological expertise and know-how, its capabilities for innovation in new tools, technologies and digital solutions, and its ability to take-up, scale-up and integrate innovation in health care is world-class.
- Citizens benefit from targeted and faster research resulting in safer, more sustainable, efficient, cost-effective and affordable tools, technologies and digital solutions for improved (personalised) disease prevention, diagnosis, treatment and monitoring for better patient outcome and well-being, in particular through increasingly shared health resources (interoperable data, infrastructure, expertise, citizen/patient driven co-creation)[1].
- The EU gains high visibility and leadership in terms of health technology development, including through international cooperation.
- The burden of diseases in the EU and worldwide is reduced through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, digital and other people-centred solutions for health care.
- Both the productivity of health research and innovation, and the quality and outcome of health care is improved thanks to the use of health data and innovative analytical tools, such as artificial intelligence (AI) supported decision-making, in a secure and ethical manner, respecting individual integrity and underpinned with public acceptance and trust.
- Citizens trust and support the opportunities offered by innovative technologies for health care, based on expected health outcomes and potential risks involved.
Legal entities established in China are not eligible to participate in Innovation Actions in any capacity. Please refer to the Annex B of the General Annexes of this Work Programme for further details.
[1] Commission Communication on the digital transformation of health and care; COM(2018) 233 final.
Eligibility & Conditions
General conditions
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
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 Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE CSA) - call-specific application form is available in the Submission System
Standard evaluation form (HE CSA)
HE General MGA v1.0
Information on clinical studies (HE)
Additional documents:
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
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Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
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CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
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Latest Updates
Call HORIZON-HLTH-2023-TOOL-05
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 170
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 71
Total budget requested for above-threshold proposals: EUR 634,646,986.
Call HORIZON-HLTH-2023-TOOL-05
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 170
Number of inadmissible proposals: 1
Number of ineligible proposals: 1
Number of above-threshold proposals: 71
Total budget requested for above-threshold proposals: EUR 634,646,986.
Call HORIZON-HLTH-2023-TOOL-05 closed on 13 April 2023. 170 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2023-TOOL-05-01: 8 proposals
- HORIZON-HLTH-2023-TOOL-05-03: 65 proposals
- HORIZON-HLTH-2023-TOOL-05-04: 49 proposals
- HORIZON-HLTH-2023-TOOL-05-05: 23 proposals
- HORIZON-HLTH-2023-TOOL-05-08: 24 proposals
- HORIZON-HLTH-2023-TOOL-05-09: 1 proposals
Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.