The inadequacy of regulatory frameworks in time of crisis and in low-resource settings : personal protective equipment and COVID-19

COVID-19 pandemic is plaguing the world and representing the most significant stress test for many national healthcare systems and services, since their foundation. The supply-chain disruption and the unprecedented request for intensive care unit (ICU) beds have created in Europe conditions typical of low-resources settings. This generated a remarkable race to find solutions for the prevention, treatment and management of this disease which is involving a large amount of people. Every day, new Do-It-Yourself (DIY) solutions regarding personal protective equipment and medical devices populate social media feeds. Many companies (e.g., automotive or textile) are converting their traditional production to manufacture the most needed equipment (e.g., respirators, face shields, ventilators etc.). In this chaotic scenario, policy makers, international and national standards bodies, along with the World Health Organization (WHO) and scientific societies are making a joint effort to increase global awareness and knowledge about the importance of respecting the relevant requirements to guarantee appropriate quality and safety for patients and healthcare workers. Nonetheless, ordinary procedures for testing and certification are currently questioned and empowered with fast-track pathways in order to speed-up the deployment of new solutions for COVID-19. This paper shares critical reflections on the current regulatory framework for the certification of personal protective equipment. We hope that these reflections may help readers in navigating the framework of regulations, norms and international standards relevant for key personal protective equipment, sharing a subset of tests that should be deemed essential even in a period of crisis

Why do People Adopt, or Reject, Smartphone Security Tools?

A large variety of security tools exist for Smartphones, to help their owners to secure the phones and prevent unauthorised others from accessing their data and services. These range from screen locks to antivirus software to password managers. Yet many Smartphone owners do not use these tools despite their being free and easy to use. We were interested in exploring this apparent anomaly. A number of researchers have applied existing models of behaviour from other disciplines to try to understand these kinds of behaviours in a security context, and a great deal of research has examined adoption of screen locking mechanisms. We review the proposed models and consider how they might fail to describe adoption behaviours. We then present the Integrated Model of Behaviour Prediction (IMBP), a richer model than the ones tested thus far. We consider the kinds of factors that could be incorporated into this model in order to understand Smartphone owner adoption, or rejection, of security tools. The model seems promising, based on existing literature, and we plan to test its efficacy in future studies

Towards Data Protection Compliance

Privacy and data protection are fundamental issues nowadays for every organization. This paper calls for the development of methods, techniques and infrastructure to allow the deployment of privacy-aware IT systems, in which humans are integral part of the organizational processes and accountable for their possible misconduct. In particular, we discuss the challenges to be addressed in order to improve organizations privacy practices, as well as the approach to ensure compliance with legal requirements and increasing efficiency

The role of user requirements research in medical device development

Aims and Objectives: This research aims to suggest a concise framework to help in the better conceptualisation and integration of users in the medical device development (MDD) process. The current economic, political and social climate concerning the matter of healthcare delivery has resulted in the emergence of numerous users and user groups for whom the healthcare system has not previously catered for. These users have created ambiguity for the designers and manufacturers of medical devices as the boundaries between their needs and requirements have blurred, outdating current methods of MDD to meet consumer needs. Research Design and Methodology: The research methodology begins primarily with conducting a literature search on the theories relating to user requirements and medical device development. The paper outlines these findings through initially describing users and user involvement and relating them to medical devices. The cross-disciplinary nature of healthcare influenced the investigation into multiple disciplines including; IT, Ergonomics – particularly participatory research, Psychology and Design. These disciplines expose various methods and processes, which are useful to user requirements research. These methods were analysed for their compatibility, and then used to construct a conceptual framework for user involvement in MDD. Results: The research insinuates the true significance of user involvement and hence resulted in the formation of a conceptual framework to aid user involvement in the MDD process. The framework is produced by the amalgamation of relevant methods examined across the disciplines, in a complimentary fashion. Conclusion: The originality of this research lies in its use of a multidisciplinary approach. Previous research claiming multi-methods has dealt with combining two disciplines or methods at a time i.e. Computer supported cooperative work (CSCW) with participatory research (Scandurra et al, 2008) for the needs analysis of healthcare professionals only. Collaboration across disciplines has also been investigated (Johnson et al, 2005), but this was for the purpose of redesign rather than initial designs. This framework can help medical device designers to fully access all user requirements through more extensive collaboration right at the start. It reduces the risk of high costs involved in device rejection, usually associated with belated recognition of user needs in the design cycle