HORIZON EUROPE
Europeo
Specific Challenge:The ability to access and understand high-quality health information is central to health literacy, and this affects the day-to-day decisions citizens make in the management of their health and care that will ultimately determine adherence to treatment. A lack of adherence is an established public health concern, with significant effects on the individual patient, as well as healthcare systems as a whole.
A multitude of health-related information resources are now available to patients, tapping into demands for greater engagement with personal healthcare. This digital era, however, is compromised by two major concerns. Firstly, the sheer volume of information available has become disorientating to users, many of whom have poor health literacy to start with, and do not know which source to trust for up-to-date guidance. Distribution of this information across different source locations only compounds the issue. Secondly, existing health-related resources are generally not personalised to their specific needs or health literacy level, and therefore large amounts of the information available are irrelevant to the patient. Indeed, product information is...
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Specific Challenge:The ability to access and understand high-quality health information is central to health literacy, and this affects the day-to-day decisions citizens make in the management of their health and care that will ultimately determine adherence to treatment. A lack of adherence is an established public health concern, with significant effects on the individual patient, as well as healthcare systems as a whole.
A multitude of health-related information resources are now available to patients, tapping into demands for greater engagement with personal healthcare. This digital era, however, is compromised by two major concerns. Firstly, the sheer volume of information available has become disorientating to users, many of whom have poor health literacy to start with, and do not know which source to trust for up-to-date guidance. Distribution of this information across different source locations only compounds the issue. Secondly, existing health-related resources are generally not personalised to their specific needs or health literacy level, and therefore large amounts of the information available are irrelevant to the patient. Indeed, product information is a prime example of this phenomenon, with little direct evidence to suggest that patients are actively reading, understanding and adhering to details in the patient leaflet (PL). Bearing in mind that the product information is considered for most products to be the primary risk minimisation measure, this paradigm clearly needs to change.
There is therefore the need to lay the foundations for the application of digital technologies to health information in order to transform citizens’ understanding of their health and care, thereby promoting adherence to prescribed treatments, and ultimately contributing to better outcomes. The topic is consistent with the EU Digital Single Market Strategy which highlights the need and opportunity to introduce a digital transformation of health and care, and is aligned with the IMI Strategic Research Agenda under Axis 4 ‘Patient Tailored Adherence Programmes’. The topic is also consistent with the key benefits noted in the European Medicines Agency (EMA) Action Plan on e-Product Information (ePI) and subsequently in the draft key principles for electronic product information published by EMA following an EMA/HMA/EC stakeholder workshop. During the workshop, this topic was presented alongside other initiatives in the context of a future vision for electronic product information in the broader digital health landscape, and the EMA also shared details of their mapping of ongoing ePI initiatives, illustrating the very considerable degree of interest and activity in this area at the present time.
Scope:The principle objective of this topic is to demonstrate how the use of an integrated, digital, user-centric health information solution could enable a tangible improvement in the ability of citizens to access and understand reliable, relevant health information from different sources.
Access to and understanding of health information are key components determining health literacy, and the health literacy level of a citizen underlies their decision-making in regarding to management of their health and care, including adherence to treatment. Accordingly, a secondary objective will be to measure how improved access to and understanding of health information translates into higher levels of treatment adherence, safer use of medicines and consequently better health outcomes, with new insights into how health information can be optimised to act as an effective risk minimisation measure.
The topic objectives will be achieved by a phased approach, in which later stages build on the outputs of the earlier research activities in an agile manner:
1. Establishing stakeholder needs and development of appropriate KPIs
Research will be conducted to establish an in-depth understanding of citizens’ expectations and aspirations for the provision of healthcare information in a digital setting to form the basis for future project activities and design-planning for technology development. Specific contexts/patient journeys will be mapped at this stage either on specific therapy areas or other product-type scenarios, such as non-prescription medicines or vaccines. The needs of different patient populations, including vulnerable patients, will also be considered. KPIs will be developed in relation to the two key objectives outlined above to enable the measurement of the success of the proposed integrated digital health information approach versus the current paradigm (which typically relies on paper-based product information for the patient and/or fragmented digital sources).
2. Technology platform and digital solution
Development of an underlying open source technology platform, and a digital solution to enable testing and measurement of the effectiveness of a digital approach to meet defined user needs.
The initial focus will be on product information, electronic health records (EHRs) and a two-way communication channel with the patient. Appropriate, trusted data sources will be linked to the platform taking into account applicable data security and General Data Protection Regulation (GDPR) considerations. A digital solution with tailored information in line with patient needs will be developed for the proof of concept testing of understanding and acceptability. Alignment with the key principles on the common standard for ePI coming from the EMA Action Plan will also be taken into account.
Depending on technical progress with product information and EHRs, the latter stages of the project may include a wider range of trusted health educational materials (HEMs) within the platform, with the aim of further enhancing patient understanding.
3. Evaluation of the ability of digital solutions to enhance risk minimisation approaches through the generation of real-world evidence
Feedback gathered via the digital tool can be used to assess understandability and options can be evaluated for how to further assess the effectiveness of the platform as a risk minimisation tool.
Ongoing: Development and execution of a sustainability plan
A sustainability plan will be developed over the life of the project which details recommendations for how successful concepts/technology approaches will be carried forward and implemented into the digital healthcare ecosystem at the national/regional level in a sustainable and practical manner. The draft plan will be developed early in the life of the project and adapted in an agile manner based on the project outcomes.
Any form of promotional materials will not be in scope for this project.
Expected Impact:Applicants should describe how the outputs of the proposed project will contribute to the following impacts and include baseline, targets and metrics to measure impact.
Allow individual patients to easily access trusted health information, tailored to be relevant to their specific needs. Empower these patients and better prepare them for informed interaction with national healthcare systems.Further build patients’ (digital) health literacy, so allowing for better decision-making concerning their health care, disease prevention and health promotion, to maintain or improve quality of life throughout the course of life.Positively impact healthcare at a societal level through enhanced adherence, better use of resources, and improved overall patient outcomes; the approach may offer particular benefits in complex scenarios, for example where patients are managing multiple morbidities.Improve the effectiveness of ePIs as a primary risk minimisation measure by surfacing greater insights on access, understanding and the usability of the information provided to them.The technology platform/tools developed for the purposes of the project will be made available open-source, and will be accessible to other companies/developers to use this as a basis for further market-specific applications which can accommodate the specifics of local digital ecosystems, allowing flexibility to best support longer-term implementation of the integrated digital healthcare approach.The implementation will enable relevant and approved updated trusted health information to be pushed in a timely manner to ensure adherence with changes in safety or usage information to continue to enhance patient adherence and safety after and with patient permission to receive alerts pertinent to them;The digital approach and technology developed under the project has the potential to transform the patient experience as they engage with and manage their health and care throughout their healthcare journey. The figure below illustrates how such a journey may be envisaged in the future, in an environment in which digital information sources are integrated effectively and tailored to the needs of the individual. Applicants should indicate how their proposal will impact the competitiveness and industrial leadership of Europe by, for example, engaging suitable small and medium-sized enterprises (SMEs).
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signat... Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Standard evaluation form
Proposal templates are available after entering the submission tool
Proposal template stage 1
Proposal template stage 2
IMI2 Model Grant Agreement
Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !
6. 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 H2020 main 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.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
1st Amended IMI2 Amended Annual Work Plan 2019
IMI2 Regulators Guidance tool for researchers
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Información adicional de la convocatoria
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