About the project

The overarching objective of ASSESS DHT is to consolidate and streamline existing methods and tools for approval of innovative DHT and develop a new fit-for-purpose generic (overarching) assessment framework, harmonised for Europe and aligned with the European Health Data Space (EHDS) Regulation proposal, but also catering for variability between settings, to respond to the methodological challenges with assessing DHTs, including their added value and health benefits for patients and the digital transformation of health systems.

To achieve this, a number of further objectives have been identified:

  • To specifically investigate and incorporate assessment criteria on privacy, cybersecurity, data storage and handling, interoperability, usability, etc.
  • To incorporate a phased adoption (including fast track) path through this framework, utilising the methods and experiences of the German DiGA, the French PECAN models, including industry experiences, exemplified for digital therapeutic DHT (digiceuticals)
  • To develop a deep dive framework with criteria and a methodology suitable for iterative assessment of dynamic learning/improving DHT, including their optimal timings, on top of the generic framework
  • To develop a holistic assessment layer on top of the generic framework for evidencing and assessing the value of digitally transformed care pathways underpinned by DHT
  • To engage with key stakeholders in order to ensure relevant views and inputs are taken into account for developing and later validating the generic framework and the other components foreseen in the project
  • To establish an open access European repository for collecting and sharing evaluation methods, studies, results and objective evidence of the impact of DHT and associated digital and data services on health systems and health outcomes

The work in ASSESS-DHT is organised in four pillars

Pillar 1

A consolidation and preparation pillar that collates and synthesises the existing assessment frameworks and tools, state-of-the-art findings from initiatives, projects, relevant standards and regulatory inputs. This will be combined with learning from HTA partners and invited experts about challenging areas in assessing innovative DHT, and healthcare delivery and patient engagement needs that the future of DHT must address well.

Pillar 2

A toolkit development pillar which is the innovation powerhouse of the project, constructing a new assessment framework with pathways for special case DHT and a fast track pathway, initially published for consultation and for road-testing by our nominated case studies and updated as a result of that feedback, to be externally published as an overarching manual for DHT assessment accompanied by guidance and checklist tools.

Pillar 3

A testing and validation pillar that will undertake deep dive road-testing of our initial framework with software developers that we have chosen to exemplify DHT challenge areas of interest and importance across Europe. The feedback from this experience from ICT companies and HTA bodies assessing them will be used to refine our framework and tools of the previous pillar.

Pillar 4

An uptake and sustainability pillar that engages with external stakeholders throughout the project, initially as requirements holders to focus attention on the most important challenges, later to review our proposed framework including the case study experience, and finally to endorse and promote our new framework across Europe. This pillar will ensure sustainability of the repository of assessment framework guidance and evidence it accumulates.