Medical Device Artificial Intelligence: The New Tort Frontier

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient. The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the safety and efficacy of medical devices, has not effectively addressed AI system safety issues for its clearance processes. If the FDA cannot reasonably reduce the risk of injury for AI-enabled medical devices, injured patients should be able to rely on ex post recovery options, as in products liability cases. However, the Medical Device Amendments Act (MDA) of 1976 introduced an express preemption clause that the U.S. Supreme Court has interpreted to nearly foreclose liability claims, based almost completely on the comprehensiveness of FDA clearance review processes. At its inception, MDA preemption aimed to balance consumer interests in safe medical devices with efficient, consistent regulation to promote innovation and reduce costs. Although preemption remains an important mechanism for balancing injury risks with device availability, the introduction of AI software dramatically changes the risk profile for medical devices. Due to the inherent opacity and changeability of AI algorithms powering AI machines, it is nearly impossible to predict all potential safety hazards a faulty AI system might pose to patients. This Article identifies key preemption issues for AI machines as they affect ex ante and ex post regulatory-tort allocation, including actual FDA review for parallel claims, bifurcation of software and device reviews, and dynamics of the technology itself that may enable plaintiffs to avoid preemption. This Author then recommends an alternative conception of the regulatory-tort allocation for AI machines that will create a more comprehensive and complementary safety and compensatory model

Rights through making : skills for pervasive ethics

This thesis starts with a Manifesto, bold, passionate and ambitious. Goals are set high, as to commit to a major endeavour: how can design contribute to a new civilisation. The first version was written in 2006 in Bertinoro, Italy, where Caroline Hummels, Kees Overbeeke and I were giving a workshop on Aesthetics of Interaction for the University of Bologna. In this Manifesto, we declared our belief and proposed a vision, concerning how design can change Western thinking towards pervasive ethics. By pervasive ethics I mean a social praxis aimed at justice and freedom, which pervades society in a capillary way, becoming a Universal attitude that makes people aware of their own rights, able and willing to contribute to seeing their own rights and those of all people fulfilled. I called this approach Rights though Making. The manifesto stated a mission1, which was later applied and validated. The main lines of thoughts of the manifesto have been respected and enforced through several actions. This thesis will describe these actions, the underlying theory and the related reflection both on the approach and on the outcomes. The Manifesto integrated the points of view of the writers, united by a common drive, in a world riddled with all sorts of social uncertainties. In the Manifesto we declared our intention of preparing and doing workshops with students of different nationalities, stimulating the integration of skilful points of view among future designers. When the Manifesto was written, there was not yet a concrete strategy on how to empower people towards pervasive ethics. The only anchor point was the Universal Declaration of Human Rights. We wanted the values contained in this document materialised, embodied in (intelligent) products or systems. Both the outcome of what we were envisioning (intelligent products or systems empowering towards the realisation of human rights) and the process of realising it (workshop) had to work towards ethics. This was all I knew at that point. Later I designed the way to do it, based on this solid and enthusiastic shared vision. Throughout the years, the underlying theoretical framework started to acquire its own body. Only after the realisation of the first 5 workshops (out of 7 in total), was I able to explicitly structure and describe the platform of theory that was supporting my endeavour. These actions (the workshops), contributed to the formation of a body of knowledge, of which the potential strength and soundness until then had exclusively been perceived through intuition. This tacit knowledge was dredged out, reflected upon and refined, through iterations of reflection-on-action, in which the "active" parts were the individual workshops. Thus the forming of this theoretical platform, the refinement of the research quest or design challenge and giving the workshops were overlapping in time and closely intertwined. For clarity, in this thesis I chose to position them in the following order: • Part 1: defining the design challenge / research quest and the Rights through Making Approach; • Part 2: illustrating the theoretical framework underlying the whole work. This theoretical framework is formed by three elements: (1) Ethics (2) Making and (3) their integration, i.e. how Making empowers towards Ethics: the core of the RtM approach. • Part 3: describing how this theory is applied in design workshops and how the Rights through Making (RtM) approach evolved; • Part 4: reflecting on the overall research experience and the underlying personal motivations. Before this central body I placed and introductory part, containing acknowledgments, rights of the readers, synopsis (this chapter) and tables of contents. After the fourth part, I positioned a part called "Annexes", which is composed of two main sections: • In the first section I present the RtM workshops in detail, in regard to both the process of each RtM workshop and their evolution; • In the second section, I illustrate the direction in which I envision the diffusion of RtM in the future, through the realisation of an Internet platform. I now summarize the content of the central body of this thesis, parts 1, 2, 3 and 4. Part 1 – Design challenge / Research quest The first part of this thesis focuses on defining the challenge that I proposed and the general actions, taken to face this challenge. In the chapter "Skills for an ethical society: a new civilisation", I start by defining "pervasive ethics" through design, of which the achievement is the goal of the present work. I envision a social transformation, towards a new civilisation, in which the praxis2 of ethics is embedded in society. The creation of a new civilisation, starts, as stated in the Manifesto, from an attempt of embodying values expressed by the Universal Declaration of Human Rights, which is the lowest common denominator on ethics. My ambition is to approach this matter from a designerly perspective; I therefore motivate how I believe the discipline of design is able to contribute in this social transformation. I start to do so, by defining my perspective on transformation. To introduce the three actions that I consider necessary for my aim to be reached, I describe the case of an excellent craftsman: Chiara Vigo. Although she embodies all the characteristics that are necessary to transform society towards an ethical direction, I point out why I believe that craftsmanship alone, cannot be the key for pervasive ethics. It is necessary, but it has to be associated with other elements. The three actions that I state as indispensible for my toil are the following: (1) levelling the social importance of Making, with respect to Thinking; (2) educating people’s skills, not only manual skills, but also towards autonomy; (3) creating opportunities for skilful points of view to be integrated, so that the skill of empathy is trained as well. People making together, combining their own sensitivities, experiences and values form the third action to contribute to the revolution towards universal ethics. I later introduce my approach, Rights through Making (RtM), describing point by point how it intervenes on these three elements. The approach will be later documented by means of examples in part 3. Yet before this, I expand on the theoretical background. Part 2 - Theoretical background This part presents the theoretical background on which this thesis is based. The first chapter of the second part (1 Towards Universal Human Rights) summarizes the historical and social foundations of the Universal Declaration of Human Rights, going through the three steps of consolidation of Human Rights in history: naturalisation, generalisation and internationalisation. This chapter explains why it was chosen to adopt the UN charter as the authority on ethics and as a tool to empower people towards the respect of Human Rights. The second chapter (2 Making), together with the third chapter (3 Ethics through Making), constitutes the theoretical core of this thesis. In the second chapter (2 Making) I face (2.3) "The phenomenology of Making". I take a phenomenological perspective, where experience, the naive contact with the world, is inherently meaningful: acting in the world and perceiving/conceiving transformations is what we (humans) do. Starting from the preferred interface with which people operate transformations, i.e., the hand, I describe how the evolution of (fine) manipulation permitted our species to evolve the ability to abstract thinking. The designerly way towards transformation is sketching (two- and three-dimensional), as a way to embody knowledge. It is a way to make sense of the world and to make new sense of the world, directing our human intentionality towards what we (humans) can transform. Another fundamental aspect in Making is culture. The unbreakable link between Making and places is therefore illustrated. Every artefact is permeated with cultural elements and values: the way artefacts appear, behave and function, reflects the presence of their designers and of the environment in which they are brought into functioning. These values give body to an artefact, tell its story and attribute a personality to it. The third chapter (3 Ethics through Making) presents the main proposition I aim to demonstrate with this research: there are three reasons why I believe that Making and especially Making together are praxis that lead to the realisation of pervasive ethics. The three reasons are: (1) a enomenological argument, which implies that a shared Making process empowers towards a constructive integration of points of view; (2) limitation of expressivity imposed by language; (3) historical grounding, i.e. showing that in history, the periods in which Thinking and Making were considered of the same importance, were actually enlightened periods for humanity. On this grounding, the RtM approach is rooted and proposes a way for design to actively and consciously contribute to pervasive ethics, both in the action of design and in its outcomes. In the next part, the theory is applied through workshops. Part 3 – Theory’s application through workshops and RtM approach development In this part, I describe 3 of the 8 workshops I organized and taught, applying the RtM approach: WS 8 - Designing for Points of View, WS 5 – Urban Lights and WS 7 – Online Collaborative Design Space. These workshops materialised the theory illustrated in the first part and formed the enabling tool of such theory. In Chapter 1, I describe the workshop "1 Designing for Points of View, a metaworkshop". Although this was the last workshop that was done, I start this part by illustrating it, because its findings were the key to enrich and soundly consolidate the initial propositions of the Manifesto, and therefore ground the RtM approach. I designed the workshop WS 8 - Designing for Points of View, to tackle the difficulty of conceptualising through making. Students had found it very hard to actually make together. Defeating the habit of relying upon linear Cartesian processes, where Thinking is prior to Making, is a main challenge within my endeavour, which was only partly achieved by means of the workshops described in the second part of this thesis. I therefore designed a refinement of the RtM approach in which students were induced to translate their skills into a design, integrating different points of view and trusting intuition. This did lead to the expected enrichment of the designing phase: because students had to actually transfer their skilful points of view into a design, they were forced to act within a concrete, first person perspective. This steered them clear from the cloud of abstraction they were used to move about in, where a concept was defined through the discussion of a given assignment. In the chapter "2 RtM workshops’ overview", I give a general overview of all 8 workshops, with factsheets, and I present the workshops’ outcomes. The detailed description of all these workshops, how they were prepared and how they evolved in time, can be found in "Part 5 – Annexes". In chapter "3 WS 5 – Urban Lights" I explain, step by step, how this particular workshop was first prepared and then taught/realised. Concerning its preparation, I report on how the location was chosen; how contributors were involved and for what purpose; how the assignment of the workshop was designed, in concord with the location, the institutions and the contributors participating; I explain what creative techniques, together with the other lecturers, I provided the students with; I report on how the schedule was defined and what was the logic of this preparation. Concerning conducting the workshop, I report on how students were chosen and teams were made. How the inspirational material was proposed to the students and how they worked with the creative techniques that they were supplied with. Then I describe the focal phase of conceptualising by making, when students built low-fidelity experienceable prototypes and designed concepts. I conclude this chapter with the description of the model of the first 6 workshops, grounded on the experience matured during these years of research. I highlight two critical aspects that remained un-tackled. The first relates to the core activity of these workshops: conceptualising through making. This step has never worked as I had thought. Strategies to make it possible had to be designed and this is why WS 8 – Designing for Points of View was later made. The second critical aspect has to do with the "universality" in space and time of this approach. Workshops are spot activities, reserved for few students, few contributors, few people and have a limited visibility. If the aim is a massive change in societal praxis and thinking, the impact of workshops is not sufficient. This is why the Internet Platform was conceived. In chapter "5 Internet Platform: collaborative design space" I face this aspect. Contributing with design to pervasive ethics is my aim. I work towards the formation and spreading of new skills, which can create a new praxis, based on respect of Human Rights. On the basis of this new praxis, a new way of Thinking can then rise. Short multicultural workshops are a good attempt to test the approach, its effectiveness and its results. But in order to really have an impact on society, the approach needs to be communicated, disseminated, and used by as many people as possible. This part faces the issue of disseminating the RtM approach. At the moment of writing this thesis, the project is spread through an Internet showcase. It contains a description of the workshops’ outcomes and of the people and partners participating. Its design process is illustrated in part 5, "Annexes". Within this Internet Showcase, I additionally envisioned a section as a collaborative design space that will be a sort of permanent online RtM workshop. This section is not yet realised. In this section, designers will be able to contribute, respecting the underlying theory of RtM. They will contribute in a constructive, additive way – through Making – to realise a shared design assignment. In this chapter I describe an online trial workshop that gave me elements of motivation to plan such further developments. Part 4 – Make Tomorrow In this part, I reflect on what I learned in facing the design challenge / research quest. The evaluation of the outcomes of the different experiences I did, shapes new directions, and shows the dynamic character of the RtM approach. The main two actions arising from this reflection are the following: (1) the necessity of implementing in the "traditional" RtM workshops, the technique developed during the workshop "designing for points of view" to foster the integration of skilful points of view in a design process; (2) and the realisation of the "Collaborative Design Space", finding ways to create a permanent online space, embodying the RtM approach, where designers can actually integrate their skilful points of view. Afterward, I define several points of improvement of the RtM approach, such as adding sources for competencies on human rights and societal issues, introducing working sessions together with craftsmen/local saper fare3 and refining the approach allowing more iterations of reflection-on-action on interim mock-ups, to strengthen the integration between conceptualising and Making. This work aims at creating an approach that empowers pervasive ethics through design. This thesis ends with an example of a design, realised by a student within one of my workshops, which reconnects to my personal motivation and is a shining example of the effectiveness of the RtM approach. It provides points of reflections for the discipline of design. Yet, it is a temporary research conclusion, which still has many open ends and fascinating opportunities for further explorations. Now, without further ado, let the travel towards pervasive ethics through design start

Risk of employing an evolvable production system

Nowadays manufacturing companies are facing a more challenging environment due to the unpredictability of the markets in order to survive. Enterprises need to keep innovating and deliver products with new internal or external characteristics. There are strategies and solutions, to different organisational level from strategic to operational, when technology is growing faster in operational level, more specifically in manufacturing system. This means that companies have to deal with the changes of the emergent manufacturing systems while it can be expensive and not easy to be implement. An agile manufacturing system can help to cope with the markets changeability. Evolvable Production Systems (EPS) is an emergent paradigm which aims to bring new solutions to deal with changeability. The proposed paradigm is characterised by modularity and intends to introduce high flexibility and dynamism at shop floor level through the use of the evolution of new computational devices and technology. This new approach brings to enterprises the ability to plug and unplug new devices and allowing fast reformulation of the production line without reprogramming. There is no doubt about the advantages and benefits of this emerging technology but the feasibility and applicability is still under questioned. Most researches in this area are focused on technical side, explaining the advantages of those systems while there are no sufficient works discussing the implementation risks from different perspective, including business owner. The main objective of this work is to propose a methodology and model to identify, classify and measure potential risk associated with an implementation of this emergent paradigm. To quantify the proposed comprehensive risk model, an Intelligent Decision system is developed employing Fuzzy Inference System to deal with the knowledge of experts, as there are no historical data and sufficient research on this area. The result can be the vulnerability assessment of implementing EPS technology in manufacturing companies when the focus is more on SMEs. The present dissertation used the experts’ knowledge and experiences, who were involved in FP7 project IDEAS, which is one of the leading projects in this area

Home-based rehabilitation of the shoulder using auxiliary systems and artificial intelligence: an overview

Advancements in modern medicine have bolstered the usage of home-based rehabilitation services for patients, particularly those recovering from diseases or conditions that necessitate a structured rehabilitation process. Understanding the technological factors that can influence the efficacy of home-based rehabilitation is crucial for optimizing patient outcomes. As technologies continue to evolve rapidly, it is imperative to document the current state of the art and elucidate the key features of the hardware and software employed in these rehabilitation systems. This narrative review aims to provide a summary of the modern technological trends and advancements in home-based shoulder rehabilitation scenarios. It specifically focuses on wearable devices, robots, exoskeletons, machine learning, virtual and augmented reality, and serious games. Through an in-depth analysis of existing literature and research, this review presents the state of the art in home-based rehabilitation systems, highlighting their strengths and limitations. Furthermore, this review proposes hypotheses and potential directions for future upgrades and enhancements in these technologies. By exploring the integration of these technologies into home-based rehabilitation, this review aims to shed light on the current landscape and offer insights into the future possibilities for improving patient outcomes and optimizing the effectiveness of home-based rehabilitation programs.info:eu-repo/semantics/publishedVersio

Proceedings of the COST Action TU1403 : Adaptive Facades Network Final Conference

info:eu-repo/semantics/publishedVersio

Systems Support for Trusted Execution Environments

Cloud computing has become a default choice for data processing by both large corporations and individuals due to its economy of scale and ease of system management. However, the question of trust and trustoworthy computing inside the Cloud environments has been long neglected in practice and further exacerbated by the proliferation of AI and its use for processing of sensitive user data. Attempts to implement the mechanisms for trustworthy computing in the cloud have previously remained theoretical due to lack of hardware primitives in the commodity CPUs, while a combination of Secure Boot, TPMs, and virtualization has seen only limited adoption. The situation has changed in 2016, when Intel introduced the Software Guard Extensions (SGX) and its enclaves to the x86 ISA CPUs: for the first time, it became possible to build trustworthy applications relying on a commonly available technology. However, Intel SGX posed challenges to the practitioners who discovered the limitations of this technology, from the limited support of legacy applications and integration of SGX enclaves into the existing system, to the performance bottlenecks on communication, startup, and memory utilization. In this thesis, our goal is enable trustworthy computing in the cloud by relying on the imperfect SGX promitives. To this end, we develop and evaluate solutions to issues stemming from limited systems support of Intel SGX: we investigate the mechanisms for runtime support of POSIX applications with SCONE, an efficient SGX runtime library developed with performance limitations of SGX in mind. We further develop this topic with FFQ, which is a concurrent queue for SCONE's asynchronous system call interface. ShieldBox is our study of interplay of kernel bypass and trusted execution technologies for NFV, which also tackles the problem of low-latency clocks inside enclave. The two last systems, Clemmys and T-Lease are built on a more recent SGXv2 ISA extension. In Clemmys, SGXv2 allows us to significantly reduce the startup time of SGX-enabled functions inside a Function-as-a-Service platform. Finally, in T-Lease we solve the problem of trusted time by introducing a trusted lease primitive for distributed systems. We perform evaluation of all of these systems and prove that they can be practically utilized in existing systems with minimal overhead, and can be combined with both legacy systems and other SGX-based solutions. In the course of the thesis, we enable trusted computing for individual applications, high-performance network functions, and distributed computing framework, making a <vision of trusted cloud computing a reality