Development and harmonisation of methodologies for assessing digital health technologies in Europe

Closed

Programme Category

EU Competitive Programmes

Programme Name

Horizon Europe (2021-2027)

Programme Description

Horizon Europe is the European Union (EU) funding programme for the period 2021 – 2027, which targets the sectors of research and innovation. The programme’s budget is around € 95.5 billion, of which € 5.4 billion is from NextGenerationEU to stimulate recovery and strengthen the EU’s resilience in the future, and € 4.5 billion is additional aid.

Programme Details

Identifier Code

HORIZON-HLTH-2023-IND-06-07

Call

Development and harmonisation of methodologies for assessing digital health technologies in Europe

Summary

The proposals under this topic 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.

Detailed Call Description

The proposals should address all of the following activities:

  • Develop and/or expand a general methodological framework and standardised approaches to assess digital health technologies with a particular focus on criteria such as privacy, cybersecurity, data quality, data storage and handling, interoperability etc.;
  • Comply with the relevant requirements proposed in the European Health Data Space (EHDS) legal provisions;
  • Test the robustness of the developed methodologies on minimum 3 different digital health technology use cases;
  • Pilot the development of common specifications to the harmonisation of assessment frameworks (pre-market and post-market phases) throughout the EU and Associated Countries;
  • Include end-users of digital health technologies (be it professionals, care users or citizens), developers of digital health technologies, producers of health services, regulators and governments;
  • Collect best practice for common approaches in methodology for digital health technology assessment and develop an open access European repository for evaluation methods, studies, results and evidence of digital health technologies and services;
  • Contribute to a framework to evaluate and monitor whether the uptake and use of digital health services contribute to the overall goals of the health and care system.

Call Total Budget

€15,00 million

Financing percentage by EU or other bodies / Level of Subsidy or Loan

100%

Contribution per project: between €7,00 and €8,00 million

Thematic Categories

  • Health
  • Research, Technological Development and Innovation

Eligibility for Participation

  • Researchers/Research Centers/Institutions

Eligibility For Participation Notes

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.

Call Opening Date

12/01/2023

Call Closing Date

13/04/2023

National Contact Point(s)

Research and Innovation Foundation

29a Andrea Michalakopoulou, 1075 Nicosia
P.O.Box 23422, 1683 Nicosia

Telephone: +357 22205000
Email Address: support@research.org.cy
Website: https://www.research.org.cy/en/

Contact Persons:
George Christou

Scientific Officer
Email: gchristou@research.org.cy

Ioannis Theodorou
Scientific Officer
Telephone: +357 22 205 038
Contact Email: itheodorou@research.org.cy

(Publish Date: 09/02/2023-for internal use only)

EU Contact Point

European Commission, Directorate-General for Research and Innovation

https://ec.europa.eu/info/departments/research-and-innovation_en#contact