OBJECTIVES: Digital Health Technologies (DHTs) present significant and unique Health Technology Assessment (HTA) challenges due to their rapid pace of advancement and limited ability to meet existing evidence standards. These challenges highlight issues regarding current assessment methods’ abilities to reflect a technology’s value aspects and stakeholders’ relevant value concerns. To address this, we provide a comparison between findings from a multi-stakeholder consensus building exercise on value assessment and the policies that govern their health systems.

METHODS: Stakeholder value preferences are represented by a DHT value framework based on a study by Haig et al. which utilized a web-Delphi panel. The framework results were presented at ISPOR Boston 2023. The scope of relevant DHTs includes patient-facing technologies that provide active data monitoring and transmission. A systematic review of DHT assessment policies in the study countries of UK, USA, and Germany was conducted to identify current practices and a comparative assessment was conducted using the value framework’s domains and HTA bodies’ risk categories as guides.

RESULTS: Several value indicators had stakeholder consensus but are not fully reflected in HTA assessments or regulations. This includes but is not limited to data ownership, data privacy and security, and interoperability. Currently, none of the study countries have policies that allow users to retain ownership of their data and data privacy and security laws need updating to match current innovations, which need to be transparently communicated. There are many efforts to ensure interoperability on the health system side, but greater focus on interoperability for users is needed.

CONCLUSIONS: Identifying the differences between stakeholder value judgements and current policies is the first step in implementation of a value framework. In order to introduce ideas around regulatory and HTA adaptations, it is important to outline how the current state of assessment differs from the values of the affected population.