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

Informazioni relative al progetto

ASSESS-DHT

ID dell’accordo di sovvenzione: 101137347

DOI

10.3030/101137347

Data della firma CE 13 Novembre 2023

Data di avvio 1 Gennaio 2024

Data di completamento 31 Dicembre 2026

Finanziato da

• Health

Costo totale

€ 6 422 635,00

Contributo UE

€ 6 422 635,00

Coordinato da

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Germany

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Pubblicazioni

Other (1)

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

Autori: Hendrikje Rödiger, Laura Wittich,Reinhard Jeindl,Yui Hidaka, Dionne Bowie, Juan Carlos Rejón Parrilla, Zoe Garrett, Claudia Wild, Reinhard Busse, Cornelia Henschke
Pubblicato in: Open Science Framework, 2024
Editore: OSF

Peer reviewed articles (11)

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

Autori: Magdalena Katharina Wekenborg, Stephen Gilbert, Jakob Nikolas Kather
Pubblicato in: npj Digital Medicine, Numero 8, 2025, ISSN 2398-6352
Editore: 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”

Autori: Rebecca Mathias, Anett Schönfelder, Cindy Welzel, Stephen Gilbert
Pubblicato in: IEEE Journal of Translational Engineering in Health and Medicine, Numero 13, 2025, ISSN 2168-2372
Editore: 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

Autori: Stephen Gilbert, Rebecca Mathias, Anett Schönfelder, Magdalena Wekenborg, Julia Steinigen-Fuchs, Anja Dillenseger, Tjalf Ziemssen
Pubblicato in: Science Advances, Numero 11, 2025, ISSN 2375-2548
Editore: 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?

Autori: Stephen Gilbert, Rasmus Adler, Taras Holoyad, Eva Weicken
Pubblicato in: npj Digital Medicine, Numero 8, 2025, ISSN 2398-6352
Editore: 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

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

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

Autori: Rebecca Mathias; Baptiste Vasey; Anastasia Chalkidou; Lars Riedemann; Tom Melvin; Stephen Gilbert
Pubblicato in: Nature Medicine, 2025, ISSN 1546-170X
Editore: 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

Autori: Cindy Welzel; Stefanie Brückner; Celia Brightwell; Matthew Fenech; Stephen Gilbert
Pubblicato in: PLOS Digital Health, 2024, ISSN 2767-3170
Editore: PLOS Digital Health
DOI: 10.1371/JOURNAL.PDIG.0000656

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

Autori: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Pubblicato in: npj Digital Medicine, Numero 7, 2024, ISSN 2398-6352
Editore: 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?

Autori: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Pubblicato in: npj Digital Medicine, Numero 7, 2024, ISSN 2398-6352
Editore: 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

Autori: 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
Pubblicato in: npj Digital Medicine, 2025, ISSN 2398-6352
Editore: 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

Autori: Stephen Gilbert, Tinglong Dai, Rebecca Mathias
Pubblicato in: npj Digital Medicine, Numero 8, 2025, ISSN 2398-6352
Editore: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-01540-2