Assessment of medical device software supporting healthcare services for chronic patients: experience from a tertiary hospital (Preprint)

Abstract

<sec> <title>BACKGROUND</title> Innovative digital health tools are increasingly being evaluated and, in some instances, integrated at scale into health systems. However, applicability of assessment methodologies in real-life scenarios to demonstrate value generation and, consequently, foster sustainable adoption of digitally enabled health services still shows bottlenecks. </sec> <sec> <title>OBJECTIVE</title> To build on lessons learnt in the process of pre-market assessment of four digital health interventions piloted at Hospital Clinic of Barcelona (HCB), as well as in the analysis of current Medical Device Software (MDSW) regulations and post-market surveillance in EU and USA, to generate recommendations towards large scale adoption. </sec> <sec> <title>METHODS</title> Four digital health interventions using prototypes were piloted at HCB. Co-creation and quality improvement methodologies were used to consolidate a pragmatic evaluation method to assess end-user’s (both patients and healthcare professionals) perceived usability and satisfaction by means of the System Usability Scale and the Net Promoter Score, including general questions about satisfaction. Analyses of both Medical Software Device (MDSW) regulations and post-market surveillance in EU and USA (2017-2021) were done. Finally, an overarching analysis on lessons learnt was conducted considering four domains (technical, clinical, usability and cost), as well as differentiating among three different eHealth strategies (Telehealth, Integrated Care and Digital Therapeutics). </sec> <sec> <title>RESULTS</title> Among the participant stakeholders, the system usability scale was consistently higher in case of patients (78, 67, 56 and 76) than in health professionals (52, 43, and 54), and, in general terms, patients would recommend more the use of the supporting digital health tools (NPS of -3, 31, -21 and 31) than professionals (NPS of -67, 1 and -80). The overarching analysis resulted in pragmatic recommendations for the digital health evaluation domains and the eHealth strategies considered. </sec> <sec> <title>CONCLUSIONS</title> Lessons learnt on digitalisation of health resulted in practical recommendations that could contribute to fostering future deployment experiences. </sec>

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