Expected Impact:

The actions to be funded under this topic are expected to achieve the following:

a) contribute to one or more of IHI JU’s expected impacts linked to IHI JU’s Specific Objective 2, as set out in the IHI JU SRIA, i.e.

breaking down fragmentation between various disciplines of medicine and technological areas in order to conceive and develop technologically and socially innovative, people-centred, integrated healthcare solutions that can seamlessly be introduced in healthcare systems;

fostering development of safe and effective innovative health technologies and their combinations thanks to new and harmonised approaches to data generation;

better and faster integration of future products, services and tools along the healthcare pathway (including health promotion and disease prevention), responding to patients’ specific needs and leading to improved health outcomes and patient well-being;

patients and industry benefit from innovative manufacturing processes such as 3D printing, on-demand small-scale good manufacturing practice (GMP) synthesis, on-site portable production systems etc.;

green transition enabled across all aspects of healthcare, both in the delivery of healthcare to patients, and in the technologies and products that emerge from a competitive European industry.

b) contribute to strengthening the competitiveness of the EU’s health industry, via increased economic activity in the development of health technologies, in particular, integrated health solutions, thus fostering European technological leadership and the digital transformation of our societies.

The actions are expected to contribute to EU programmes, initiatives and policies such as the European Green Deal, Europe’s Beating Cancer Plan, the EU Mission on Cancer, the European Health Emergency Preparedness and Response Authority (HERA), the European Commission’s proposal for the European Health Data Space (EHDS), and the EU Artificial Intelligence Act1, where relevant.

1 EU Artificial Intelligence Act | Up-to-date developments and analyses of the EU AI Act

Expected Outcome:

Applicants must define the outcomes expected to be achieved by the project, ensuring that they contribute to at least one of IHI JU’s potential outputs linked to the IHI JU Specific Objective 2‘integrate fragmented health research and innovation efforts bringing together health industry sectors and other stakeholders, focussing on unmet public health needs, to enable the development of tools, data, platforms, technologies and processes for improved prediction, prevention, interception, diagnosis, treatment and management of diseases, meeting the needs of end-users’ as set out in the IHI JU Strategic Research and Innovation Agenda (SRIA).

Actions (projects) to be funded under this topic must deliver results that address public health needs and support the development of future health innovations that are safe, people-centred, effective, cost-effective and affordable for patients and for health care systems.

The expected outcomes may cover the entire spectrum of care and may be health technologies centred around disease areas and/or key themes such as prevention, precision diagnostics, personalised medicine, and chronic disease management. They may also include solutions for key enablers such as digital data and solutions, artificial intelligence (AI), regulatory science, greener and more sustainable healthcare, and implementation science1.

1 In the context of IHI, ‘implementation science’ refers to the development and piloting of methods and strategies that facilitate the uptake of evidence-based practice and research outcomes into regular use (e.g. translation of results, uptake, scale-up, piloting in healthcare).

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 2 ‘integrate fragmented health research and innovation efforts bringing together health industry sectors and other stakeholders, focussing on unmet public health needs, to enable the development of tools, data, platforms, technologies and processes for improved prediction, prevention, interception, diagnosis, treatment and management of diseases, meeting the needs of end-users’ 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 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.

Proposals may address specific target populations, underserved communities or areas with limited resources, and/or support challenging unmet needs and diagnostic or treatment gaps.

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 technologies 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 they propose to synergise with these initiatives.