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 .

Resultado final

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

Publicaciones

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