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).
• have people-centric, rather than product- and pathology-centric, approaches – the focus being on the patient and citizen journey through health care, with the help of most suitable health technologies and social innovations and taking account of demographic trends;
• 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 into industrial processes.

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 3, as set out in the IHI JU SRIA, i.e.

• raised awareness among citizens and patients on their own role in managing their health;
• improved patient adherence to prevention programmes and medical interventions;
• people, including vulnerable populations (e.g. elderly and children as well as their carers and/or representatives), are better able to make informed decisions with their healthcare professionals about prevention, treatment interventions and disease management;
• increased frequency and quality of cooperation between patients, citizens and industrial stakeholders in the development of healthcare solutions, in particular integrated care solutions;
• patients benefit from prevention and treatment better adapted to their needs through improved diagnostic and monitoring;
• integrated healthcare solutions, including those based on the use of digital solutions, better responding to the needs and preferences of patients and citizens, supporting an inclusive approach;
• successful implementation of digital solutions supporting people-centred care;
• facilitated introduction of innovative solutions for improved home care of patients;
• healthcare solutions assessed according to criteria that matter to patients and citizens (in particular, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) contributing to achieving people-centred healthcare.

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.