D4.5 Manual for piloting assessment methods for digital health technologies (interim/piloting version of the full manual D4.6)

Methods for the assessment of digital health technologies (DHTs) are not currently standardised, and DHTs pose new challenges for traditional health technology assessment (HTA) methods. The ASSESS-DHT manual presents a systematic and standardised approach for the assessment of DHTs, and is intended to serve two purposes: firstly, to support health technology developers (HTDs) through the assessment process; and to support HTA bodies assessing DHTs across Europe. This is an interim version of the ASSESS-DHT manual. This version of the manual collates deliverables and interim work from ASSESS-DHT and has been developed in collaboration with partners across the ASSESS-DHT consortium. It provides guidance and tools on DHT challenge areas to support the piloting activities to take place in the second half of the project. The manual provides guidance on conducting assessments of DHTs with different characteristics and at different stages of their life cycle. Topics covered include areas traditionally assessed in HTA such as safety, effectiveness and cost-effectiveness and also specialist topic considerations such as cybersecurity, AI, data protection and data quality