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

Informacje na temat projektu

ASSESS-DHT

Identyfikator umowy o grant: 101137347

DOI

10.3030/101137347

Data podpisania przez KE 13 Listopada 2023

Data rozpoczęcia 1 Stycznia 2024

Data zakończenia 31 Grudnia 2026

Finansowanie w ramach

• Health

Koszt całkowity

€ 6 422 635,00

Wkład UE

€ 6 422 635,00

Koordynowany przez

EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH
Germany

CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.

Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .

Rezultaty

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

Publikacje

Peer reviewed articles (11)

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

Autorzy: Magdalena Katharina Wekenborg, Stephen Gilbert, Jakob Nikolas Kather
Opublikowane w: npj Digital Medicine, Numer 8, 2025, ISSN 2398-6352
Wydawca: 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”

Autorzy: Rebecca Mathias, Anett Schönfelder, Cindy Welzel, Stephen Gilbert
Opublikowane w: IEEE Journal of Translational Engineering in Health and Medicine, Numer 13, 2025, ISSN 2168-2372
Wydawca: 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

Autorzy: Stephen Gilbert, Rebecca Mathias, Anett Schönfelder, Magdalena Wekenborg, Julia Steinigen-Fuchs, Anja Dillenseger, Tjalf Ziemssen
Opublikowane w: Science Advances, Numer 11, 2025, ISSN 2375-2548
Wydawca: 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?

Autorzy: Stephen Gilbert, Rasmus Adler, Taras Holoyad, Eva Weicken
Opublikowane w: npj Digital Medicine, Numer 8, 2025, ISSN 2398-6352
Wydawca: 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

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

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

Autorzy: Rebecca Mathias; Baptiste Vasey; Anastasia Chalkidou; Lars Riedemann; Tom Melvin; Stephen Gilbert
Opublikowane w: Nature Medicine, 2025, ISSN 1546-170X
Wydawca: 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

Autorzy: Cindy Welzel; Stefanie Brückner; Celia Brightwell; Matthew Fenech; Stephen Gilbert
Opublikowane w: PLOS Digital Health, 2024, ISSN 2767-3170
Wydawca: PLOS Digital Health
DOI: 10.1371/JOURNAL.PDIG.0000656

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

Autorzy: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Opublikowane w: npj Digital Medicine, Numer 7, 2024, ISSN 2398-6352
Wydawca: 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?

Autorzy: Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, Stephen Gilbert
Opublikowane w: npj Digital Medicine, Numer 7, 2024, ISSN 2398-6352
Wydawca: 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

Autorzy: 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
Opublikowane w: npj Digital Medicine, 2025, ISSN 2398-6352
Wydawca: 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

Autorzy: Stephen Gilbert, Tinglong Dai, Rebecca Mathias
Opublikowane w: npj Digital Medicine, Numer 8, 2025, ISSN 2398-6352
Wydawca: Springer Science and Business Media LLC
DOI: 10.1038/S41746-025-01540-2