Clinical validation study of the stepcare e-health system to optimise COVID-19 patient monitoring and facilitate home hospitalisation and isolation. A pilot study

By project TITTAN

Published on 14 July 2022

Spain

País Vasco

About this good practice

StepCare is intended for cases where the patient's symptomatology is mild, or when the hospital system cannot offer it (due to lack of resources or security), and home isolation is recommended. StepCare allows patients to extend the time during which they can follow their disease progression from home. The system detects and prioritizes patients, based on the severity of their symptoms, allowing healthcare staff to act quickly and appropriately, without the need to increase resources.

This good practice was supported by Innosasun Program and Medtech Initiative, two support mechanisms for the business sector, created by the Ministry for Health of the Basque Government, to articulate the interaction with the Basque Public Health System (BPHS) and related agents, responding to their needs in terms of innovation.

INNOSASUN and Medtech initiative offered to Naru Intelligence the Basque Public Health System framework– specifically the Biodonostia Health Research Institute and the Healthcare System, Osakidetza- to perform a clinical validation. This allowed the company to demonstrate that their medical device works in a real scenario, safely and effectively, and due to this study their software medical device was granted the CE mark.

StepCare is a good example of how INNOSASUN and Medtech boost the development of a software tool (StepCare) that helps in the fight against the COVID19, which achieved the market faster, complying with all the requirements applicable.

Resources needed

28.998,85 € for clinical validation

Evidence of success

After performing the clinical validation
• It is concluded that StepCare is a clinically safe, reliable and efficient system.
• The results point to a reduction in the workload of the staff of the Primary Care and Home Hospitalization services and the optimization of patient care and follow-up, providing the clinical staff with the necessary information to anticipate a worsening of the patient, which has supposed an improvement with respect to the procedures habitually used.

Potential for learning or transfer

Clinical validation in a real scenario is an essential tool for ensuring medical device software is safe. Here we present a real example of the use of regional program tools (INNOSASUN and MEDTECH).

This example shows that both tools fulfil their purpose as sufficient support for the development of medical devices. Thus, we believe that similar programmes implemented in other health systems could serve to boost industry in the health sector.