OBJECTIVES: Although not consistently defined, digital health technologies (DHT) are increasingly being used as interventions for managing chronic conditions (i.e. mental disorders, cardiovascular disease, and diabetes). We aimed to 1) identify, review and summarize guidance for the assessment of DHT by HTA bodies; 2) review DHT assessments by HTA body; 3) identify challenges from HTA body.

METHODS: The Centre for Reviews and Dissemination (CRD) database was searched along with governmental and HTA bodies’ websites (NICE, HAS, IQWIG, EUnetHTA) to identify guidelines, programs, frameworks, and initiatives that exist to evaluate DHTs. The same databases were searched to identify relevant submissions. The geographical scope included the UK, France, and Germany.

RESULTS: Four guidance documents or initiatives and two HTA reports were identified. Digital health technologies included applications, telemedicine and connected medical devices. Two programmes exist within NICE: Improving Access to Psychologic Therapies programme and the Medical Technologies Evaluation programme. In France, the CNEDiMTS is developing clinical guidance for evaluating connected devices. In Germany, while no formal guidance is available, a governmentally funded initiative for telemedicine platform was identified. While clinical evidence is a requirement for all initiatives, economic evidence is not always considered. Very few HTA reports were identified (n=1 in France (Diabeo), n=1 in the UK (Deprexis)). Challenges encountered in HTA reviews included: how to define an “intervention”, impact of socio-demographics on effectiveness, uncertainty in economic impact, small clinical and economic evidence pool, and difficulty to assess organization implications.

CONCLUSIONS: Few initiatives and guidance for formally evaluating DHTs were identified. Given the dynamic market for DHTs, there is a need for clear guidance for decision-makers choosing which technologies will be funded. Having standardized evaluation guidance could improve consistency of evidence reports for DHTs, consistency with the assessment of other health technologies, and facilitate patient access to DHTs.