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

Project Information

ASSESS-DHT

Grant agreement ID: 101137347

DOI

10.3030/101137347

EC signature date 13 November 2023

Start date 1 January 2024

End date 31 December 2026

Funded under

• Health

Total cost

€ 6 422 635,00

EU contribution

€ 6 422 635,00

Coordinated by

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Germany

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Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Publications

Other (1)

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

Author(s): Hendrikje Rödiger, Laura Wittich,Reinhard Jeindl,Yui Hidaka, Dionne Bowie, Juan Carlos Rejón Parrilla, Zoe Garrett, Claudia Wild, Reinhard Busse, Cornelia Henschke
Published in: Open Science Framework, 2024
Publisher: OSF

Peer reviewed articles (11)

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

Author(s): Magdalena Katharina Wekenborg, Stephen Gilbert, Jakob Nikolas Kather
Published in: npj Digital Medicine, Issue 8, 2025, ISSN 2398-6352
Publisher: 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”

Author(s): Rebecca Mathias, Anett Schönfelder, Cindy Welzel, Stephen Gilbert
Published in: IEEE Journal of Translational Engineering in Health and Medicine, Issue 13, 2025, ISSN 2168-2372
Publisher: 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

Author(s): Stephen Gilbert, Rebecca Mathias, Anett Schönfelder, Magdalena Wekenborg, Julia Steinigen-Fuchs, Anja Dillenseger, Tjalf Ziemssen
Published in: Science Advances, Issue 11, 2025, ISSN 2375-2548
Publisher: 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?

Author(s): Stephen Gilbert, Rasmus Adler, Taras Holoyad, Eva Weicken
Published in: npj Digital Medicine, Issue 8, 2025, ISSN 2398-6352
Publisher: 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

Author(s): Max Ostermann, Rebecca Mathias, Fatemeh Jahed, Mitchell B. Parker, Florence D. Hudson, William C. Harding, Stephen Gilbert, Oscar Freyer
Published in: Computational and Structural Biotechnology Journal, Issue 28, 2025, ISSN 2001-0370
Publisher: Elsevier BV
DOI: 10.1016/J.CSBJ.2025.07.024

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

Author(s): Rebecca Mathias; Baptiste Vasey; Anastasia Chalkidou; Lars Riedemann; Tom Melvin; Stephen Gilbert
Published in: Nature Medicine, 2025, ISSN 1546-170X
Publisher: 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

Author(s): Cindy Welzel; Stefanie Brückner; Celia Brightwell; Matthew Fenech; Stephen Gilbert
Published in: PLOS Digital Health, 2024, ISSN 2767-3170
Publisher: PLOS Digital Health
DOI: 10.1371/JOURNAL.PDIG.0000656

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

Author(s): Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Published in: npj Digital Medicine, Issue 7, 2024, ISSN 2398-6352
Publisher: 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?

Author(s): Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Published in: npj Digital Medicine, Issue 7, 2024, ISSN 2398-6352
Publisher: 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

Author(s): 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
Published in: npj Digital Medicine, 2025, ISSN 2398-6352
Publisher: 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

Author(s): Stephen Gilbert, Tinglong Dai, Rebecca Mathias
Published in: npj Digital Medicine, Issue 8, 2025, ISSN 2398-6352
Publisher: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-01540-2