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 health technology assessment (HTA) framework of Digital Health Technologies (DHTs), harmonised for Europe and aligned with key regulations like the European Health Data Space (EHDS).
This is achieved as follows:
(1) investigate and incorporate assessment criteria on privacy, cybersecurity, data storage and handling, interoperability, usability, etc.
(2) incorporate a phased adoption path through this framework, utilise methods and experiences of the German DiGA, French PECAN models, include industry experience, exemplified for digital therapeutic DHT (digiceuticals)
(3) deep dive framework with criteria and methodology suitable for iterative assessment of dynamic learning/improving DHT, including their optimal timings
(4) 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
(5) engage with key stakeholders to ensure uptake of relevant views and inputs for developing and later validating the generic framework and other components in the project
(6) establish an open access European repository for collecting and sharing evaluation methods, studies, results.
The projects pathway to impact is in four pillars
Pillar 1: A consolidation and preparation pillar that collates and synthesises the existing assessment frameworks and tools for HTA of DHTs, state-of-the-art findings from initiatives, projects, relevant standards and regulatory inputs.
Pillar 2: Toolkit development is the innovation powerhouse of the project, constructing a new assessment framework with pathways for special case DHT and fast track, published for consultation and for road-testing by our case studies and updated with 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 for HTA of DHTs with chosen software developers to exemplify DHT challenge areas of interest and importance across Europe.
Pillar 4: An uptake and sustainability pillar that engages with external stakeholders, initially as requirements holders to focus attention on important challenges, later to review proposed framework, case study experience, and finally endorse/ promote the new framework across Europe.
