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 .

Risultati finali

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

Pubblicazioni

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