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Development and Harmonisation of Methodologies for ASSESSing Digital Health Technologies in Europe

Newsletter #4

JULY 21, 2026

ASSESS DHT Open Consultation

Join the ASSESS-DHT Open Consultation and help us shape our DHT assessment framework!

Digital health technologies (DHTs) – including mobile health apps, telehealth solutions, AI‑based decision support systems and other software medical devices – are now a central part of Europe’s health systems. Methods for assessing their value, safety, and long‑term impact have developed unevenly across EU countries and organisations, and existing frameworks are not adapted to the fast-evolving landscape of AI-based technologies.

The ASSESS‑DHT project aims to address these gaps by developing a European framework, toolkit, and manual for the assessment of DHTs across their full lifecycle. The open public consultation offers stakeholders across the European health ecosystem an opportunity to shape this emerging framework. We want to understand whether the proposed approach is relevant and feasible, and how it should be adapted to different contexts. We also seek to ensure that the framework supports innovation while primarily protecting patients, promoting equity and trust in digital health, aligns with European regulations, and is compatible with existing national processes. Your feedback will support validation of the methods and tools developed in the project and guide the design of the final ASSESS‑DHT knowledge hub, with the Manual, Toolkit, and learning resources.

The open consultation will be available until July 31st, 2026.

The ASSESS DHT Conference,  “Harmonised Digital Health Assessment: From Framework to Practice. Final Results from ASSESS DHT” will take place on 30 November - 1 December 2026, in Brussels, Belgium!

This hybrid event marks the conclusion of the ASSESS DHT project's three-year efforts. The planned Final Conference of ASSESS DHT looks forward to inviting at least 40 experts for Roundtable discussions and testing of the Knowledge Hub. 

Save the Date and stay updated - a tentative event schedule will be shared soon!

ASSESS DHT Berlin Consortium Meeting 2026

The ASSESS DHT Consortium met in Berlin, Germany, on 16-17 June 2026 to discuss the latest project results, planned activities, and ways to strengthen our collaboration with European stakeholders to harmonise the assessment of Digital Health Technologies.

During the first day, the partners gathered to discuss project updates and activities for all Work Packages over the past 6 months. Consortium members subsequently divided into breakout groups to discuss the sustainable platform in development, the ASSESS DHT Knowledge Hub and how this project outcome will add value for HTAs, HTDs, and other stakeholders.

The second day of discussions centered around the ASSESS DHT Manual and the ongoing Usability Testing for the ASSESS DHT process and tools for DHT assessment. Following the Sustainability Roundtable held on 15 June, the consortium discussed the outcomes of the roundtable and how they can be integrated into the final stage of the project’s work.

We thank all partners and consortium members who joined these productive discussions, and especially Technische Universität Berlin for hosting and organizing this meeting. Open exchanges and collaborations fuel our project’s work!

ASSESS DHT at HIMSS Europe 2026

ASSESS DHT was represented at HIMSS Europe 2026.

Consortium members from project partner empirica represented the ASSESS-DHT project at a booth in the HIMSS European Project Pavilion. Over the three days, they connected with DHT developers, regulators, clinicians, and other stakeholders, exploring how ASSESS-DHT is driving innovation in healthcare technology and working towards boosting the adoption of trustworthy and effective DHT across Europe.

Joint ASSESS DHT and EDiHTA Workshop

ASSESS DHT and EDiHTA recently came together in London for a two-day in-person workshop, kindly hosted by NICE - National Institute for Health and Care Excellence, to discuss the scientific work developed across both projects, their respective end products, and their shared ambition to strengthen the European digital health ecosystem.

Read more about the workshop outcomes on our website.
You can read more about other events where ASSESS DHT was represented, and our upcoming events on our website.

ASSESS DHT Publications

The ASSESS DHT project partners have been hard at work, producing key project outputs. Below are the scientific publications the project team has produced over the past couple of months, and the social media series we are using to highlight our publications, old and new.
AI is increasingly used in cardiovascular care to support diagnosis, monitoring, and clinical decision-making. However, its dynamic and adaptive nature challenges conventional HTA frameworks, which are typically designed for static interventions.

This review aims to assess how existing literature supports HTA-relevant evaluation of AI-based cardiovascular technologies and examine their alignment with the evidentiary requirements outlined in the European Union Health Technology Assessment Regulation (EU HTAR).

Read the Full Paper Here
The rapid evolution of DHTs presents distinct challenges for HTA. Existing HTA frameworks, largely designed for conventional health interventions, may not sufficiently address these unique complexities. This scoping review provides an overview of existing assessment frameworks for DHTs, analyzing their purpose and the guidance they offer within the domains of the EUnetHTA Core Model. 

Read the Full Paper

Social Media

ASSESS DHT Milestone: Data Requirements

The ASSESS DHT deliverables D3.1, D3.2, and D3.3 explore data-related criteria related to issues such as data protection, ethical AI, regulatory compliance, data quality, interoperability, FAIR data, and security measures. These data requirements build the foundation of the ASSESS DHT Interim Manual.

Read More about the Deliverables.
ASSESS DHT Milestone: Interim Manual

The ASSESS-DHT manual is an overarching document that describes work completed in the ASSESS-DHT project and aims to support HTDs and HTA agencies. This interim manual collates ongoing work in ASSESS-DHT for testing during the project's piloting phase. For HTDs, the manual provides guidance on the methodological approach to assessing DHTs, including requirements for the evidence to be provided. For HTA agencies, the manual provides guidance on the assessment process.

Read More about the Interim Manual

Save the Date: ASSESS DHT Final Conference

You can find more ASSESS DHT publications on our website!
Finf our public deliverables and other project-related materials on our Zenodo community 

Stay updated and follow our social media!

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info@assess-dht.eu
https://assess-dht.eu