Presentation (CTI)

OBJECTIVES: The ASSESS DHT Evidence generation support tool aims to help developers to identify evidence requirements for assessing their digital health technologies (DHTs) across Europe. Underlying the tool is a comprehensive evidence recommendations library that has been compiled from reviews of health technology assessment (HTA) agency documents, frameworks and guidance. This research presents a pragmatic review of NICE HealthTech guidance (HTG) on DHTs. We sought to identify evidence requirements from the assessments, committee discussions and evidence generation plans to inform the evidence recommendations library and capture detail and nuance that may not be reflected in HTA literature.
METHODS: In March 2026, we searched NICE’s website for guidance on DHTs. We identified 26 HTGs that met the inclusion criteria. Given the agile development of the tool, we planned to conduct the review in two stages. First, we extracted and analysed data from the 10 most recent HTGs to produce detailed findings that were incorporated into the library. Next, we will sift the remaining 16 HTGs to identify requirements not yet included in the tool.
RESULTS: We identified 72 evidence requirements - 24 provided additional detail to existing items in the library while 48 were new requirements. Most requirements related to defining the population, intervention, comparator and outcomes (PICO) (n=37), with requirements related to choice of outcomes being most common (n=18). These included suggested outcomes on performance, clinical benefits, engagement and acceptability, economic and resource impact, and system level effects. Several requirements also related to Clinical effectiveness (n=30), mostly acceptable types of evidence (n=21) which included advice on data collection, study designs, and real-world data.
CONCLUSIONS: This research generated a wealth of evidence requirements not captured in previous reviews, providing additional depth and nuance from real-world discussions and learnings. This has added to the richness of the library and strengthened the practical applicability of the tool.