OBJECTIVES : To understand the evaluation process by Health Technology Assessment (HTA) bodies in Europe for assessing digital health technologies (DHTs) and determine drivers and challenges regarding evaluations of these technologies.

METHODS : We reviewed guidance, frameworks, and assessments by HTA bodies in selected European countries for DHTs.

RESULTS : Prior to the pandemic, most European countries were slow to accept DHTs for access and reimbursement due to what was perceived to be a lack of high quality, comparative evidence. Given the challenges faced by European health systems due to the COVID-19 pandemic, digital health has emerged as a source for efficient healthcare services, particularly for patients suffering from chronic conditions or those in need of immediate care. In fact, European regulators and governments cleared barriers to DHTs and services, for example telemedicine, by temporarily expanding reimbursement.

Even before to the pandemic, National Institute for Health and Care Excellence (NICE) has been at the forefront among European HTA bodies in establishing frameworks for evaluation of DHTs. In 2019, NICE established an evidence standards framework for DHTs that describes evidence that should be available, or developed for DHTs to demonstrate their value in UK healthcare system. DHT pilot assessments are currently underway with the publication date of myCOPD for self-management of chronic obstructive pulmonary disease (COPD) Medical technologies guidance expected for March 31, 2022.

CONCLUSIONS : With the recent increase in acceptance of DHTs, it is likely that there will be an increased number of HTA for DHTs. Given the novelty of these solutions, some HTA bodies may be unprepared to conduct comprehensive assessments of these technologies due to lack of experience and challenges with data quality. Therefore, HTA bodies will need to ensure they have appropriate expertise within their organization around DHTs and frameworks in place to evaluate data when conducting these evaluations.