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Chronic wounds are a major concern to healthcare systems, accounting for an estimated 5% of total healthcare expenditure.

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

Service involved

Assessment of technology impact on privacy
We help our clients and partners to achieve their business goals while addressing ethics, privacy and cybersecurity concerns in a manner that prevents conflicts, sanctions and loss of money derived by the lack of ethical and legal compliance to national and European applicable regulations. All information technologies must respect human fundamental rights and ensure the rights of people in relation to the protection of their private life, personal data and freedom. The new EU General Data Protection Regulation (GDPR) that replaced the Data Protection Directive in all EU member states on May 2018 introduces many new obligations for companies and a comprehensive set of rights for data subjects, including the right to an effective judicial remedy against a controller or a processor and the right to compensation. Therefore, in addition to being at the receiving end of an enforcement action, data controllers and processors may be subject to court proceedings and have to pay compensation to data subjects for their infringements of the GDPR. Our approach to help our clients to avoid this kind of issues consists of a holistic service composed by the following main components: providing a Data Protection Officer to drive the organization’s legal compliance action; mapping the data processed by the organisation to measure its impact on the ethical principles and legal framework; assessing the cybersecurity mechanisms used by the organisation technologies; conducting an impact assessment for all data processing mechanisms identifying ethical, legal and security risks; making recommendations for the implementation of the organisational and technical means to be compliant with the legal framework while ensuring data confidentiality (preserving authorized restrictions on information access and disclosure, including personal privacy and proprietary information protection), integrity (assurance that data is not modified or deleted in an unauthorized and undetected manner), availability (ensuring there’s timely and reliable access to and use of information) and accountability (supporting non‐repudiation, deterrence, fault isolation, intrusion detection and prevention, and after‐action recovery and legal action).
Social acceptance of technologies assessment
Connected, disruptive technologies permeate all aspects of our daily lives and pose challenges to the real foundation of human rights, such as the right to privacy or the freedom of speech. One could say that human values such as trust, accountability, and dignity are mutually influenced by the social acceptance of technologies. We support our clients to conceive a novel way of aligning the thus-far divergent concepts of sustainability, ethics impact, and technological innovation. By combining these three concepts, we respond to the need of a socially responsible innovation ecosystem by developing a tailored methodology for assessing users’/citizens’ social acceptance of technologies, a fundamental driver for technology market adoption. Our social acceptance framework includes six fundamental dimensions over which social acceptability (i.e. perception, motivation, trust, awareness, capacity enabling, and accountability) is measured and assessed through a two-step approach based on an online Sentiment Analysis (SA) – to create structured and actionable knowledge from the web – and the engagement of our client’s stakeholders (e.g. relevant target groups, associations of citizens, domain operators, decision makers, etc.) for the technology co-creation and communication regarding its social acceptance.
Medical device Assessment

 

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.