ASSESS-DHT: DEVELOPMENT AND HARMONISATION OF METHODOLOGIES FOR ASSESSING DIGITAL HEALTH TECHNOLOGIES IN EUROPE

Informations projet

ASSESS-DHT

N° de convention de subvention: 101137347

DOI

10.3030/101137347

Date de signature de la CE 13 Novembre 2023

Date de début 1 Janvier 2024

Date de fin 31 Decembre 2026

Financé au titre de

• Health

Coût total

€ 6 422 635,00

Contribution de l’UE

€ 6 422 635,00

Coordonné par

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Germany

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (7)

​​​Taxonomy of DHT for assessment purposes

Formal categorisation of DHT to characterise their assessment requirements and life cycles

Communication and Disseminiation Plan

Stakeholder-targeted strategy, messages, channels, timing

​​Interim report on communication and dissemination

Midpoint account of what has been disseminated, how, to whom

Manual for piloting assessment methods for digital health technologies (interim/piloting version of the full manual D4.6)

Consolidated framework with complete criteria and DHT-type-specialist pathways + workflows, draft version for use by case studies

Landscape and gap analysis of assessment frameworks and methods for Digital Health Technologies

Consolidation and critique of methods and frameworks used by HTA across Europe, at present, on which we will build and improve

Engagement and exploitation strategy

Plan for targeted stakeholder engagement & for each consultation channel: expert groups, roundtables

Requirements specification for the Repository of evidence

Requirements and technical specification of the repository, plus inventory of initial content

Publications

Peer reviewed articles (11)

Examining human-AI interaction in real-world healthcare beyond the laboratory

Auteurs: Magdalena Katharina Wekenborg, Stephen Gilbert, Jakob Nikolas Kather
Publié dans: npj Digital Medicine, Numéro 8, 2025, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-01559-5

Letter to the Editor on “From Concept to Clinic: Living Labs and Regulatory Sandboxes for Health System Digitalization and the Integration of Innovative Devices Into Clinical Workflows”

Auteurs: Rebecca Mathias, Anett Schönfelder, Cindy Welzel, Stephen Gilbert
Publié dans: IEEE Journal of Translational Engineering in Health and Medicine, Numéro 13, 2025, ISSN 2168-2372
Éditeur: Institute of Electrical and Electronics Engineers (IEEE)
DOI: 10.1109/JTEHM.2025.3557508

A roadmap for safe, regulation-compliant Living Labs for AI and digital health development

Auteurs: Stephen Gilbert, Rebecca Mathias, Anett Schönfelder, Magdalena Wekenborg, Julia Steinigen-Fuchs, Anja Dillenseger, Tjalf Ziemssen
Publié dans: Science Advances, Numéro 11, 2025, ISSN 2375-2548
Éditeur: American Association for the Advancement of Science (AAAS)
DOI: 10.1126/SCIADV.ADV7719

Could transparent model cards with layered accessible information drive trust and safety in health AI?

Auteurs: Stephen Gilbert, Rasmus Adler, Taras Holoyad, Eva Weicken
Publié dans: npj Digital Medicine, Numéro 8, 2025, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-01482-9

Cybersecurity requirements for medical devices in the EU and US - A comparison and gap analysis of the MDCG 2019–16 and FDA premarket cybersecurity guidance

Auteurs: Max Ostermann, Rebecca Mathias, Fatemeh Jahed, Mitchell B. Parker, Florence D. Hudson, William C. Harding, Stephen Gilbert, Oscar Freyer
Publié dans: Computational and Structural Biotechnology Journal, Numéro 28, 2025, ISSN 2001-0370
Éditeur: Elsevier BV
DOI: 10.1016/J.CSBJ.2025.07.024

Safe AI-enabled digital health technologies need built-in open feedback

Auteurs: Rebecca Mathias; Baptiste Vasey; Anastasia Chalkidou; Lars Riedemann; Tom Melvin; Stephen Gilbert
Publié dans: Nature Medicine, 2025, ISSN 1546-170X
Éditeur: Nature Medicine
DOI: 10.1038/S41591-024-03397-6

A transparent and standardized performance measurement platform is needed for on-prescription digital health apps to enable ongoing performance monitoring

Auteurs: Cindy Welzel; Stefanie Brückner; Celia Brightwell; Matthew Fenech; Stephen Gilbert
Publié dans: PLOS Digital Health, 2024, ISSN 2767-3170
Éditeur: PLOS Digital Health
DOI: 10.1371/JOURNAL.PDIG.0000656

Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings

Auteurs: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Publié dans: npj Digital Medicine, Numéro 7, 2024, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41746-024-01147-Z

How can regulation and reimbursement better accommodate flexible suites of digital health technologies?

Auteurs: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Publié dans: npj Digital Medicine, Numéro 7, 2024, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41746-024-01156-Y

CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software

Auteurs: Rademakers, FE; Biasin, E; Bruining, N; Caiani, EG; Davies, RH; Gilbert, SH; Kamenjasevic, E; McGauran, G; O’Connor, G; Rouffet, J; Vasey, B; Fraser, AG
Publié dans: npj Digital Medicine, 2025, ISSN 2398-6352
Éditeur: npj Digital Medicine
DOI: 10.1038/S41746-025-01459-8

Consternation as Congress proposal for autonomous prescribing AI coincides with the haphazard cuts at the FDA

Auteurs: Stephen Gilbert, Tinglong Dai, Rebecca Mathias
Publié dans: npj Digital Medicine, Numéro 8, 2025, ISSN 2398-6352
Éditeur: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-01540-2