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 4 ‘exploit the full potential of digitalisation and data exchange in healthcare’, 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 into industrial processes.

c) carry out a landscape analysis to avoid unnecessary overlap and duplication of efforts with existing initiatives/projects and to identify potential synergies and complementarities with the relevant ones. The proposal should include a plan on how to synergise with these identified initiatives.

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

In their proposal, applicants are expected to perform at scale activities that consider the different innovation cycles of the pharmaceutical and medical technology industries and drive concrete and transformational outcomes, in line with the first IHI JU General Objective3. In particular, the topic welcomes integrated pre competitive activities, including demonstration pilots, that could accelerate and improve the discovery, 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, deployment, uptake and piloting use in healthcare of novel treatments and healthcare solutions).

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 be given to the Health Data Access Bodies established under the European Health Data Space Regulation4 in the context of secondary use of data.

Applicants are strongly encouraged to consider relevant measures to provide open access to project generated outputs such as standards, data sets and other research results and, if relevant, share evidence on their clinical utility and economic aspects (efficiency).