Horizon Europe is the EU’s key funding programme for research and innovation. Read more about the Horizon Europe programme here.
This call aims to develop and harmonise methodologies for assessing digital health technologies in order to facilitate assessment of their added value at individual, health system and society levels.
This topic aims at addressing digital transition challenges through supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”.
More specifically, this topic aims at supporting activities that are contributing to the following impact area: “High quality digital services for all”.
To that end, proposals under this topic should aim to deliver results that are directed towards and contributing to all of the following expected outcomes:
Digital health technologies have been driving a revolution in health and care ranging from general use of computers to algorithms designed to assist radiologists and radiotherapists in detecting and treating diseases, from robotic surgery to artificial intelligence, machine learning, computer aided decision models, and from mobile apps helping patients to self-manage their disease to electronic health records.
Digital health technologies are expected to further contribute to better people-centred health and care systems and have the vast potential to improve our ability to accurately prevent, diagnose and treat diseases.
However, assessing the added value and health benefits for patients and society pose a number of challenges in particular of methodological and technical nature. Best practice for common approaches in methodology for digital health are lacking, especially in the digital health tools that include artificial intelligence algorithms. A framework for the assessment of the digital transformation of health services and its impact is vital to generate the evidence required for decision-making on stimulating, using and/or funding digital health strategies at various levels in the health and care systems.
The Expert Panel on effective ways of investing in Health (EXPH) recommended in its report ‘Assessing the impact of digital transformation of health services’, further investment in the development of assessment methodologies and in a European repository for evaluation methods and evidence of digital health services.
To date, such assessment frameworks are relatively scarce, especially those addressing the transformative aspects of healthcare delivery on the organisational and operational level.
The proposals are expected to develop and harmonise methodologies for assessing digital health technologies (including mhealth apps and telehealth, as well as Artificial Intelligence powered health technologies) in order to facilitate assessment of their added value at individual, health system and society levels and facilitate the cross-border deployment of digital health services within the EU. Existing Health Technology Assessment (HTA) methodology is well developed for health technologies such as medicinal products, but also for some categories of medical devices; however digitalisation raises new methodological challenges to the standardisation of assessment criteria such as privacy, cybersecurity, data storage and handling, interoperability, usability etc. Also including aspects like learning curves, iterative development of innovations, variability between settings, determining optimal timing of evaluations in the development process (maturity) are not yet solved.
Proposals are expected to build on existing frameworks such as (but not restricted to) ‘Model for Assessment of Telemedicine’ (MAST framework – Kidholm et al., 2012) and the results of previous EU-funded projects in particular (but not restricted to) COMED, project that already identified HTA challenges of telehealth and mhealth, and mHealth hub.
Proposals should consider involving the JRC to take advantage of its expertise on assessment frameworks of innovative health technologies and its activities at the interface between research and regulatory aspects and/or in translating assessment results into best practice recommendations anchored in EU policies. In that respect, the JRC is open to collaborate with any successful proposal after its approval.
The proposals should address all of the following activities:
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
To be eligible for funding, applicants must be established in one of the following countries:
See the full list in the General Annexes.
Unless otherwise provided for in the specific call conditions, only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:
The total indicative budget for the topic is EUR 15.00 million.
The Commission estimates that an EU contribution of between EUR 7.00 and 8.00 million would allow these outcomes to be addressed appropriately.