The Assessment of Medical Device Software Supporting Health Care Services for Chronic Patients in a Tertiary Hospital: Overarching Study.

ABSTRACT

BACKGROUND: Innovative digital health tools are increasingly being evaluated and, in some instances, integrated at scale into health systems. However, the applicability of assessment methodologies in real-life scenarios to demonstrate value generation and consequently foster sustainable adoption of digitally enabled health interventions has some bottlenecks. OBJECTIVE: We aimed to build on the process of premarket assessment of 4 digital health interventions piloted at the Hospital Clinic de Barcelona (HCB), as well as on the analysis of current medical device software regulations and postmarket surveillance in the European Union and United States in order to generate recommendations and lessons learnt for the sustainable adoption of digitally enabled health interventions. METHODS: Four digital health interventions involving prototypes were piloted at the HCB (studies 1-4). Cocreation and quality improvement methodologies were used to consolidate a pragmatic evaluation method to assess the perceived usability and satisfaction of end users (both patients and health care professionals) by means of the System Usability Scale and the Net Promoter Score, including general questions about satisfaction. Analyses of both medical software device regulations and postmarket surveillance in the European Union and United States (2017-2021) were performed. Finally, an overarching analysis on lessons learnt was conducted considering 4 domains (technical, clinical, usability, and cost), as well as differentiating among 3 different eHealth strategies (telehealth, integrated care, and digital therapeutics). RESULTS: Among the participant stakeholders, the System Usability Scale score was consistently higher in patients (studies 1, 2, 3, and 4 78, 67, 56, and 76, respectively) than in health professionals (studies 2, 3, and 4 52, 43, and 54, respectively). In general, use of the supporting digital health tools was recommended more by patients (studies 1, 2, 3, and 4 Net Promoter Scores of -3%, 31%, -21%, and 31%, respectively) than by professionals (studies 2, 3, and 4 Net Promoter Scores of -67%, 1%, and -80%, respectively). The overarching analysis resulted in pragmatic recommendations for the digital health evaluation domains and the eHealth strategies considered. CONCLUSIONS: Lessons learnt on the digitalization of health resulted in practical recommendations that could contribute to future deployment experiences.