Boosting Innovation For Better Assessment Of The Added Value Of Innovative Integrated Healthcare Solutions

Applicants are expected to define the expected impacts to be achieved by their proposal that will contribute to one or more of the expected impacts linked to IHI JU’s Specific Objective 5 as reflected in the IHI JU SRIA, i.e.:

• seamless and successful implementation in healthcare settings of cross-sectoral innovations, integrated products and services delivering proven benefits to patients, healthcare systems and society as a whole;
• patients have improved access to innovations that meet their needs and those of the healthcare systems;
• better informed decision-making at different levels of the healthcare system (authorities, organisations), that will in turn contribute to a better allocation of resources towards cost effective innovations;
• faster entry to the market of cost-effective innovative solutions developed by industry, which could translate to a positive effect on their R&I investments.

Furthermore, the actions to be funded under this topic are expected to contribute to:

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

b) the implementation of the EU’s Life Sciences Strategy and its specific aims such as:

1. reinforcing European R&I e.g. supporting multinational clinical trials and improving the clinical research ecosystem;
2. providing smooth and rapid market access for life science innovations e.g. through promoting innovation-responsive regulation to ensure timely real value delivery of innovations to people;

c) the improvement of the health technology assessment (HTA) methodology for instance through:

1. development and uptake of innovative HTA approaches tailored to meet the demands of HTA organisations, policy makers, and industry, including aspects such as usability, integration into care pathways, and patient experience. This also covers novel methods for assessment of added value of combined technologies;
2. crafting and deploying dissemination and educational programs to ensure unified HTA expertise throughout the EU, covering both medical technology and pharmaceutical innovations;
3. uptake of innovative medical devices and in-vitro diagnostics.

The actions are expected also to consider and contribute to EU programmes, initiatives and policies such as the European Green Deal, Europe’s Beating Cancer Plan, the EU Mission on Cancer, the Apply AI Strategy, the European Virtual Human Twins Initiative, the 1+ Million Genomes Initiative, the preparedness and response to health emergencies, the upcoming EU Biotech Act, the Regulation on the European Health Data Space (EHDS), and the EU Artificial Intelligence Act, where relevant.

Applicants must define the outcomes expected to be achieved by their proposal, ensuring that they contribute to new and improved methodologies and models for a comprehensive assessment of the added value of innovative and integrated healthcare solutions in line with the IHI JU’s specific objective 5 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. These outcomes are also expected to benefit the relevant stakeholders in the healthcare ecosystem.

The expected outcomes may cover the entire spectrum of care from prevention to disease management and may be centred around disease areas, key themes such as prevention, precision diagnostics, personalised medicine, and chronic disease management. They may also include enabling solutions for digitalisation, artificial intelligence (AI), regulatory science, greener and more sustainable healthcare and the deployment and use of these solutions into practice.

With a view to harnessing new science and technologies, this topic aims to fund pre-competitive research and innovation for novel tools, methods, technologies 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 challenge(s) and scope of the IHI JU’s Specific Objective 5 ‘enable the development of new and improved methodologies and models for a comprehensive assessment of the added value of innovative and integrated healthcare solutions’; 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) inform innovation-responsive guidance and regulatory science approaches;

c) 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.

d) 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 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 be given to the Health Data Access Bodies that are 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).

¹ _{Article 115 of the Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe}

² _{http://www.ihi.europa.eu/sites/default/files/flmngr/IHI_Strategic_Research_and_Innovation_Agenda_3.pdf}

³ _{‘to contribute towards the creation of an EU-wide health research and innovation ecosystem that facilitates translation of scientific knowledge into innovations, notably by launching at least 30 large-scale, cross-sectoral projects, focussing on health innovations’}

⁴ _{http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500327}