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.

Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review

“…Transparency promotes trust and allows stakeholders to assess the device’s reliability and potential risks. The HTA should assess whether the device manufacturers provide clear documentation and information to health care professionals and patients about the device’s capabilities, limitations, and potential errors [ 21 , 58 , 59 ]. Transparency is closely linked to regulatory considerations [ 60 , 61 ].…”

Under the Tech Umbrella: Assessing the Landscape of Telemedicine Innovations (Telemechron Study)

“…An analysis of recent studies within this realm [ 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 ] reveals a diverse tapestry of themes and a wide array of focal points in the field of technology assessment (TA). From a nuanced exploration of the One Health paradigm [ 47 ] to considerations of sustainability [ 49 ] and the intricate landscape of personalized medicine [ 50 ], these studies consistently highlight several key dimensions.…”

“…Lastly, the pivotal role of medical devices within telemedicine systems is underscored [ 66 ]. These devices are recognized as integral components that shape the efficacy and scope of telemedicine initiatives and play a key role in influencing the trajectory of remote healthcare delivery.…”

Pioneering a Framework for Robust Telemedicine Technology Assessment (Telemechron Study)

“…The pivotal role of medical devices within telemedicine systems is underscored [20]. Recognized as integral components, these devices shape the efficacy and scope of telemedicine initiatives, playing a key role in influencing the trajectory of remote healthcare delivery.…”