Scope:

With a view to harnessing new science and technologies, this topic aims to fund pre-competitive research and innovation for novel tools, methods, technologies etc. that will foster the development of health innovations to prevent, intercept, diagnose, treat, and manage diseases and enable recovery more efficiently.

Accordingly, applicants must assemble a collaborative public-private partnership consortium reflecting the integrative and cross-sectoral nature of IHI JU, that is capable of addressing the challenge(s) and scope of the IHI JU Specific Objective 1 ‘contribute towards a better understanding of the determinants of health and priority disease areas’, as defined in IHI JU’s legal basis1 and described in more detail in the IHI JU SRIA2:

Applicants should consider the following points in their proposals:

a) address an unmet public health need based on at least one of the below:

• the high burden of the disease for patients and/or society due to its severity and/or the number of people affected by it;
• the high economic impact of the disease for patients and society;
• the transformational nature of the potential results on innovation processes where projects are not focussed on individual disease areas (e.g. health data analytics).

b) demonstrate the ability to translate research into innovative solutions that can be integrated/implemented into the healthcare ecosystem (taking into consideration the fragmented nature of European healthcare systems) and/or in industrial processes.

When applicable, proposals should consider relevant aspects of patient-centricity, with the help of the most suitable health technologies and/or social innovations, including open science, and taking demographic trends into account as relevant.

If applicable, applicants are expected to consider the potential regulatory impact of the anticipated project’s outputs, and, as relevant, develop a regulatory strategy and interaction plan for generating appropriate evidence and for engaging with regulators and other bodies in a timely manner, e.g. EU national competent authorities, notified bodies for medical devices and in-vitro diagnostic devices, health technology assessment (HTA) agencies, and the European Medicines Agency (EMA) through existing opportunities for regulatory support services, such as the Innovation Task Force and qualification advice.

As relevant, consideration should also be given to the Health Data Access Bodies that will be established under the forthcoming European Health Data Space Regulation3 in the context of secondary use of data.

Applicants should consider relevant existing initiatives/projects to ensure synergies and complementarities and avoid unnecessary overlap and duplication of efforts. The proposal should include a plan on how to synergise with these initiatives.