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

CORDIS provides links to public deliverables and publications of HORIZON projects.

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 .

Deliverables

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

Publications

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