Their management is very complex, requiring consideration of various factors (such as tissue types, healing levels, and patient-specific characteristics) which influence clinical strategies and the selection of appropriate wound dressings.
Although there are great experts in the field, chronic wounds are often followed up by primary care professionals who may lack the expertise needed for the most appropriate clinical decision-making. This results in considerable variability in care, making recovery more difficult, longer, and significantly more expensive.
ICAREWOUNDS aims to design, deploy, implement and validate a care model that will facilitate the sustainability and efficiency of chronic wounds management. This model will be based on a platform that integrates new and existing eHealth technologies and Trustworthy Artificial Intelligence.
The project aims to deliver significant benefits for both the healthcare community and society; it also aims to develop guidelines for the implementation of similar models in other regions, promoting its large-scale adoption. In addition, the project will evaluate the socioeconomic models’ impact, providing insights into its sustainability and emphasising the need for updated policies and strategies at the European level.
Smart chronic wound management has the potential to enhance clinical outcomes and improve the quality of life for millions of patients by reducing recovery times and suffering. This positive impact also extends to patients’ families and caregivers.
CyberEthics Lab. ensures the compliance with ethical standards and regulatory frameworks throughout the project’s lifecycle, covering both technological development and clinical research across three pilot studies involving stakeholders. We will also use and further develop original methods to assess and evaluate the social acceptance of the technologies involved, identifying ethical, societal, and regulatory concerns based on findings throughout the project. Using these insights, CyberEthics Lab. will provide recommendations for policymakers and healthcare operators
We provides advisory support to manufacturers on obtaining a certificate (CE mark) for medical devices. Legal consultants of our team have in-depth knowledge of MDR and experience in this kind of activity within the framework of European projects in the field of health care.
Cooperation includes a pre-assessment and based on its results, the determination of successive steps on the way to obtaining a CE mark. In addition, we can support companies in their relations with notified bodies, which are in most cases authorized to issue certificates.