Presentation (CTI)

OBJECTIVES: Developers of Digital Health Technologies (DHTs) often find it unclear what evidence is needed for health technology assessment (HTA), as processes and expectations vary across Europe. The ASSESS-DHT project aims to consolidate and streamline existing methods and tools for the approval of innovative DHTs. This activity created an online, interactive tool: the Evidence Generation Support Tool (EGST) to support developers in optimising their evidence generation using recommendations based on current HTA practices and frameworks.
METHODS: Three reviews were undertaken: a review of HTA agency documents, a scoping review of HTA frameworks, and a review of NICE Health Technology Guidance. Findings were then synthesised into two tiers: concise ‘Overarching Recommendations’ and detailed ‘Explanatory Notes’, validated for accuracy by HTA bodies within the consortium. Applicability criteria were developed to determine which recommendations apply based on developer-reported technology characteristics. This was adapted into an online tool, which generates a tailored Evidence Generation Report and a PICO framework from a structured technology profile. The tool is currently undergoing external user testing and validation by HTA bodies and DHT developers.
RESULTS: The synthesis produced an evidence recommendations library comprised of 144 requirements, across nine HTA domains. Applicability criteria were created to determine which recommendations apply based on a technology’s profile (e.g. intended purpose, type, AI/autonomous functionality). The resulting report contains a bespoke PICO framework and matched evidence recommendations based on the characteristics of the DHT. The tool also signposts DHT developers to relevant external resources that may help them to develop their evidence generation plans before HTA.
CONCLUSIONS: Synthesising HTA frameworks into transparent and accessible evidence recommendations enabled the development of an interactive support tool for DHT developers that is grounded in current practice. Planned enhancements, such as country-specific guidance, editable PICO outputs, and custom report curation, will further support HTDs across Europe when planning their evidence generation.