How to Value Digital Health Interventions? A Systematic Literature Review

Abstract

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.

Success Factors of Artificial Intelligence Implementation in Healthcare

“…Although further approaches such as comparator evaluation, multi-stakeholder analysis or organizational impact were discussed within prior research, a concrete approach with QALYs and quality criteria is needed immediately in order to generate short term results ( 45 ).…”

The hospital telemedicine TELEMED database: Providing information on evidence-based telemedicine services to hospital managers and healthcare professionals

“…Thus, the database goes further than other databases with respect to the assessment of the consequences of implementation of telemedicine technologies. The TELEMED database reflects many examples of the domains included in HTA of telemedicine and digital health technologies 9,10 although it can be criticised for not including all relevant domains, e.g. the ethical and legal aspects of telemedicine included in some HTA models.…”

“…The data extraction was designed to reflect the domains included in HTA of telemedicine and digital health technologies to ensure the relevance of the TELEMED database for decisions on selection and implementation of new telemedicine services. 9,10 The following general study characteristics were extracted from all articles where possible: Source: author, year of publication, PubMed ID. Setting: country, type and number of hospitals involved in the study. Study design: randomised controlled trial or observational study. Follow-up: duration of follow-up per patient. Patient group: the number of patients in the total sample, in the intervention group and the control group. Inclusion criteria: criteria described in the article. Type of technology: description of the information and communication technology including devices etc. Intervention: description of the intervention including information about the objective, the patients’ use of the service and the duration of the intervention measured in weeks or months. Clinical effects: whether or not statistically significant differences were found on primary and secondary outcomes. Types of outcome measures were also described. Patient safety: description of incidents or adverse effects. Patient experiences: information on the patients’ use of and experience with the telemedicine service. Staff experiences: information on staff experiences and time used by the staff as part of the telemedicine services. Costs and organization: information on investments, use of hospital staff, statistically significant differences in healthcare utilization between the intervention and control group.…”

Developing a Transnational Health Record Framework with Level-Specific Interoperability Guidelines Based on a Related Literature Review

“…For this purpose, healthcare data sharing is a prerequisite [ 5 ]. Interoperability issues should be considered first for data sharing because it is difficult for patients to manage their healthcare data only in one place [ 6 ]. It is hard to access personal health records outside one’s residence area, so the benefits of computerized health-related information are seriously compromised.…”