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In Europe, there were almost twice as many patents granted for medical technology (13,795) compared to pharmaceuticals (7441) in 2018. It is important to ask how to integrate such an amount of innovations into routine clinical practice and how to measure the value it brings to the healthcare system. Given the novelty of digital health interventions (DHI), one can even question whether the quality-adjusted life years (QALY) approach developed for pharmaceuticals can be used or whether we need to develop a new DHI's value assessment framework. We conducted a systematic literature review of published DHIs' assessment guidelines. Each publication was analyzed with a 12-items checklist based on a EUnetHTA core model enriched with additional criteria such as usability, interoperability, and data security. In total, 11 value assessment guidelines were identified. The review revealed that safety, clinical effectiveness, usability, economic aspects, and interoperability were most often discussed (seven out of 11). More than half of the guidelines addressed organizational impact, data security, choice of comparator, and technical considerations (six out of 11). The unmet medical needs (three out of 11), along with the ethical (two out of 11) and legal aspects (one out of 11), were given the least attention. No author provided an analytical framework for the calculation of clinical and economic outcomes. We elicited five recommendations for the choice of DHI's value criteria and a methodological suggestion for the pricing and reimbursement framework. Our conclusions lead to the need for a new DHI's value assessment framework instead of a QALY approach.
Kolasa et al. (Mon,) studied this question.