OBJECTIVES: With the rapid development of digital technology, there is a new challenge of how to evaluate digital health interventions (DHI) if they are to be funded by the public budget. Although systematic reviews have identified published DHI value assessment frameworks, it is unclear what evidence is required by health technology assessment (HTA) agencies. This study aims to understand whether DHI specific guidelines from HTA agencies have been implemented.

METHODS: A literature review was conducted to identify guidelines from HTA agencies across EU5, Netherlands, Sweden, Australia, Canada, USA, Japan, and Korea, using the keywords "artificial intelligence", "digital", "health app", "tele", "mhealth", and "wearables". If available, data on the scope and functional classification of DHIs as well as evidence requirements were extracted. Each identified guideline was analysed with a 12-item checklist based on a EUnetHTA core model with additional criteria (interoperability, data security, and stability).

RESULTS: Across 12 countries, only France, Germany and the UK have DHI specific guidelines. Canada, Spain, and USA do not have DHI specific guidelines but have HTA reports on DHIs. Italy, the Netherlands, and Sweden only have documents discussing the potential opportunities for using DHIs in specific therapeutic areas. Australia, Japan, and Korea do not mention DHIs on their websites. While Germany and UK have general guidelines for DHIs, France focuses on a specific category (mobile health). All three guidelines include health problem, technical aspect, clinical effectiveness, safety, organisational aspect, data security, and interoperability. Only the UK has an economic evaluation framework, requiring evidence for economic impact standards including key economic information, appropriate economic analysis, and economic analysis reporting standards.

CONCLUSIONS: Few countries have guidelines to assess DHIs, with only the UK providing an economic evaluation framework. With the rapid development and complexity of appraisal of DHIs, formal guidelines from HTA agencies are urgently needed.