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.

Applicants should consider the following points in their proposals:

• 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).
• 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.

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.

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

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.