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

Información del proyecto

ASSESS-DHT

Identificador del acuerdo de subvención: 101137347

DOI

10.3030/101137347

Fecha de la firma de la CE 13 Noviembre 2023

Fecha de inicio 1 Enero 2024

Fecha de finalización 31 Diciembre 2026

Financiado con arreglo a

• Health

Coste total

€ 6 422 635,00

Aportación de la UE

€ 6 422 635,00

Coordinado por

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Germany

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Publicaciones

Other (1)

Frameworks on Methods for Assessing Digital Health Technologies: A Scoping Review

Autores: Hendrikje Rödiger, Laura Wittich,Reinhard Jeindl,Yui Hidaka, Dionne Bowie, Juan Carlos Rejón Parrilla, Zoe Garrett, Claudia Wild, Reinhard Busse, Cornelia Henschke
Publicado en: Open Science Framework, 2024
Editor: OSF

Peer reviewed articles (11)

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

Autores: Magdalena Katharina Wekenborg, Stephen Gilbert, Jakob Nikolas Kather
Publicado en: npj Digital Medicine, Edición 8, 2025, ISSN 2398-6352
Editor: 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”

Autores: Rebecca Mathias, Anett Schönfelder, Cindy Welzel, Stephen Gilbert
Publicado en: IEEE Journal of Translational Engineering in Health and Medicine, Edición 13, 2025, ISSN 2168-2372
Editor: 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

Autores: Stephen Gilbert, Rebecca Mathias, Anett Schönfelder, Magdalena Wekenborg, Julia Steinigen-Fuchs, Anja Dillenseger, Tjalf Ziemssen
Publicado en: Science Advances, Edición 11, 2025, ISSN 2375-2548
Editor: 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?

Autores: Stephen Gilbert, Rasmus Adler, Taras Holoyad, Eva Weicken
Publicado en: npj Digital Medicine, Edición 8, 2025, ISSN 2398-6352
Editor: 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

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

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

Autores: Rebecca Mathias; Baptiste Vasey; Anastasia Chalkidou; Lars Riedemann; Tom Melvin; Stephen Gilbert
Publicado en: Nature Medicine, 2025, ISSN 1546-170X
Editor: 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

Autores: Cindy Welzel; Stefanie Brückner; Celia Brightwell; Matthew Fenech; Stephen Gilbert
Publicado en: PLOS Digital Health, 2024, ISSN 2767-3170
Editor: PLOS Digital Health
DOI: 10.1371/JOURNAL.PDIG.0000656

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

Autores: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Publicado en: npj Digital Medicine, Edición 7, 2024, ISSN 2398-6352
Editor: 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?

Autores: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Publicado en: npj Digital Medicine, Edición 7, 2024, ISSN 2398-6352
Editor: 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

Autores: 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
Publicado en: npj Digital Medicine, 2025, ISSN 2398-6352
Editor: 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

Autores: Stephen Gilbert, Tinglong Dai, Rebecca Mathias
Publicado en: npj Digital Medicine, Edición 8, 2025, ISSN 2398-6352
Editor: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-01540-2