Wird diese Nachricht nicht richtig dargestellt, klicken Sie bitte hier.

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

Newsletter #2

NOVEMBER 24, 2025

ASSESS-DHT Second Sustainability Roundtable

ASSESS-DHT held its second Sustainability Roundtable on Thursday, November 13th, from 16:00 – 18:00 CET. This meeting was co-organized by empirica and AIHTA, and  brought together the project consortium and representatives from all four ASSESS-DHT Use Cases. The focus of the meeting was to look at the current work on the use cases and their role in shaping the draft manual.

Read more about the roundtable outcomes

ASSESS-DHT Vienna Consortium Meeting 2025

The ASSESS-DHT Consortium met in Vienna, Austria, on 11-12 June 2025 to discuss the latest project results, planned activities, and how we should strengthen our collaboration with European stakeholders to harmonise the assessment of Digital Health Technologies. During the two-day assembly, project members gathered to share insights on progress across project tasks, the upcoming piloting of the assessment method with DHT developers and real-life use cases conducted by HTA bodies, updates on work towards the DHT assessment manual, and more.

Read more about the assembly discussions

ASSESS-DHT at the MedTech Forum 2025

ASSESS-DHT is honored to have been represented at MedTech Forum 2025! Juan Carlos Rejón Parrilla, Senior Researcher (Fundación Progreso y Salud, Spain) and Scientific Co-lead of ASSESS-DHT, and Rubén Casado Arroyo, Director of Electrophysiology (Erasme Hospital, Belgium) and ASSESS-DHT Consortium Member, represented the ASSESS-DHT project at this event. They participated as panellists in the session "Advancing the Assessment of Digital Health to Foster Innovation", which spotlighted EU-level initiatives supporting the development of inclusive, fit-for-purpose European assessment frameworks for digital health technologies.

Read more about the forum

ASSESS-DHT at Vitalis 2025

ASSESS-DHT project partner TLV represented our project at the Vitalis2025 session "National Joint Introduction of Digital Medical Devices". Johanna Ringkvist, Head of the Medical Technology Unit at TLV, held a presentation titled "How Does TLV Evaluate Medical Devices?" as part of the session. You can read more about it here (in Swedish). Louise Lindström, Health Economist at TLV, joined the discussion "How Can We Make the Right Decisions When Introducing Digital Medical Technology in Diabetes Care?" as a panellist. Read more about the session (in Swedish) here.

ASSESS-DHT at the WHO Webinar on HTAs

Earlier this year, ASSESS-DHT was represented at the WHO Webinar on HTAs for Digital Health Technologies by our Scientific Co-lead, Juan Carlos Rejón Parrilla. In his presentation titled "Development & Harmonisation of Methodologies for Assessing Innovative Digital Health Technologies in Europe", he highlighted the practical approaches to evaluating DHTs that ASSESS DHT develops. Read more about the webinar.

You can read more about other events where ASSESS-DHT was represented, and our upcoming events on our website.

ASSESS-DHT EVENTS

ASSESS-DHT Publications

The ASSESS-DHT project partners have been hard at work, producing key project outputs. Below are a few of the scientific publications the project team has produced over the past few months.

AI is revolutionizing healthcare, but its actual impact depends on seamless human interaction. This paper proposes a multimodal toolkit combining ecological momentary assessment, quantitative observation, and baseline measurements to optimize AI implementation. Read the full paper here.

The increasing use of connected medical devices has created substantial cybersecurity challenges, putting patient safety and the integrity of healthcare infrastructure at risk. This study examines regulatory guidance on medical device cybersecurity in the European Union and the United States and identifies their strengths and weaknesses.  Read the full paper here.

“Living Labs” offer a collaborative environment for testing technologies in near-real-world settings; however, they frequently clash with the European Union’s rigid regulatory frameworks for medical devices that were not designed for digital technologies. This publication examines this intersection, showing how flexibility in evaluation and patient interaction can coexist with safety guardrails. Read the full paper here.

You can find more recently published and older ASSESS-DHT publications on our website!

ASSESS-DHT PUBLICATIONS

Recommended Reading

The OECD working paper "Towards identifying good practices in the assessment of digital medical devices" explores how several OECD countries are tackling the complex task of evaluating digital health technologies. Drawing on practical experience from these countries, it highlights emerging best practices and frameworks to ensure safety, effectiveness, and value—covering the clinical, technical, and economic dimensions of assessment. ASSESS DHT is featured as a key example of innovative work advancing the structured evaluation of digital health technologies.

Read the Full Paper

Stay updated and follow our social media!

ASSESS-DHT Website

If you don´t want to receive any more messages (to: unknown@noemail.com) any longer, you can unsubscribe free of charge at any time.

empirica Gesellschaft für Kommunikations- und Technologieforschung mbH Oxfordstr. 2 53111 Bonn Deutschland info@assess-dht.eu https://assess-dht.eu