Developing an Evidence Gaps Tool for Developers of Digital Health Technologies (DHTS): A Scoping Review of Evidence Requirements for Evaluating the Value of DHTs

OBJECTIVES: There is evidence suggesting that existing health technology assessment (HTA) frameworks do not consider the specific peculiarities and challenges of digital health technologies (DHTs). HTA frameworks typically do not consider the unique evidence requirements for evaluating DHTs and may not specify evidence criteria that need extra consideration when assessing the relative benefits and risks of these technologies. We aim to address these shortcomings by developing a tool to help developers to understand the quality of their existing evidence, identify important evidence gaps, and address these through robust evidence development plans. This tool is part of the ASSESS DHT project, which aims to develop a new assessment framework and toolkit for assessing DHTs across Europe.

METHODS: We will conduct a scoping review of evidence requirements for DHTs in existing HTA frameworks and European HTA agency documents. Data will be extracted and synthesized across assessment domains, types of DHTs, and stage in lifecycle. Evidence requirements will inform the development of a practical online tool to help developers to understand the evidence requirements for their specific DHTs and to identify gaps in their supporting evidence before assessment.

RESULTS: The evidence gaps tool will help developers to better prepare and generate evidence for the evaluation of their DHTs. Specifically, it will assist developers in (1) identifying evidence requirements for their DHT based on technology type and stage in lifecycle, (2) assessing and developing their evidence generation plans, (3) considering options for real-world evidence generation where appropriate, (4) prioritizing outcomes for further evidence generation, and (5) considering if further expert input is needed.

CONCLUSIONS: The proposed evidence gaps tool will advance the evaluation of DHTs by facilitating targeted evidence generation and HTA submissions. This will benefit not only developers of DHTs, but HTA agencies evaluating the value of DHTs across Europe.