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Deadline expired

The deadline for this call has expired.

Call key data

Developing a Data Quality and Utility Label for the European Health Data Space

Call number

HORIZON-HLTH-2023-TOOL-05-09

deadlines

Opening
12.01.2023

Deadline
13.04.2023 17:00

Deadline - 2nd stage

Opening
31.01.2023

Funding rate

100%

Call budget

€ 4,000,000.00

Estimated EU contribution per project

€ 4,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

Call objectives

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) or areas of applications (i.e. European Medicines Agency – EMA and Heads of Medicines Agencies’ Big Data Steering Group activities to support medicines regulation). 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, EOSC-LIFE Health Data Research UK’s data quality and utility framework, and relevant data principles, resources and tools (FAIR, FAIR Cookbook, etc.);
  • 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.

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Expected effects and impacts

Expected results

  • 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.

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Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom

eligible entities

EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

No

Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating countries

Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.

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.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.

Additional information

Topics

Competitiveness of Enterprises, Employment/Labour Market, SME & entrepreneurship, 
Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

Relevance for EU Macro-Region

EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region

UN Sustainable Development Goals (UN-SDGs)

Additional Information

All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 30  pages.

The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

Call documents

HE-Work Programme 2023-2024, Cluster 1, Destination 5HE-Work Programme 2023-2024, Cluster 1, Destination 5(481kB)

Contact

National Contact Points for Horizon Europe
Website

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