The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug Administration (FDA), for example, has recently proposed a discussion paper to address some of these issues. But it misses an important point: we argue that regulators like the FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition

Using System Analysis and Personas for e-Health Interaction Design

Today, designers obtain more central roles in product and service development (Perks, Cooper, & Jones, 2005). They have to deal with increasingly complicated problems, like integrating the needs of various stakeholders while taking care about social, ethical and ecological consequences of their designs. To deal with this demanding design situation, they need to apply new methods to organize the available information and to negotiate the stakeholder’s perspectives. This paper describes how systems analysis supports the design process in a complex environment. In a case study, we demonstrate how this method enables designers to describe user requirements for complex design environments while considering the perspectives of various stakeholders. We present a design research project applying cybernetic systems analysis using the software ''System-Tools'' (Vester, 2002). Results from the analysis were taken to inform the design of an electronic patient record (EPR), considering the particularities of the German health care system. Based on the analysis, we developed a set of requirements for every stakeholder group, detailing the patients' perspective with persona descriptions. We then picked a main persona as reference for the EPR design. We describe the resulting design sketch and discuss the value of cybernetic systems analysis as a tool to deal with complex social environments. The result shows how the method helps designers to structure and organize information about the context and identify fruitful intervention opportunities for design. Keywords: E-Health; System Analysis, Cybernetics; Personas.</p

Foggy clouds and cloudy fogs: a real need for coordinated management of fog-to-cloud computing systems

The recent advances in cloud services technology are fueling a plethora of information technology innovation, including networking, storage, and computing. Today, various flavors have evolved of IoT, cloud computing, and so-called fog computing, a concept referring to capabilities of edge devices and users' clients to compute, store, and exchange data among each other and with the cloud. Although the rapid pace of this evolution was not easily foreseeable, today each piece of it facilitates and enables the deployment of what we commonly refer to as a smart scenario, including smart cities, smart transportation, and smart homes. As most current cloud, fog, and network services run simultaneously in each scenario, we observe that we are at the dawn of what may be the next big step in the cloud computing and networking evolution, whereby services might be executed at the network edge, both in parallel and in a coordinated fashion, as well as supported by the unstoppable technology evolution. As edge devices become richer in functionality and smarter, embedding capacities such as storage or processing, as well as new functionalities, such as decision making, data collection, forwarding, and sharing, a real need is emerging for coordinated management of fog-to-cloud (F2C) computing systems. This article introduces a layered F2C architecture, its benefits and strengths, as well as the arising open and research challenges, making the case for the real need for their coordinated management. Our architecture, the illustrative use case presented, and a comparative performance analysis, albeit conceptual, all clearly show the way forward toward a new IoT scenario with a set of existing and unforeseen services provided on highly distributed and dynamic compute, storage, and networking resources, bringing together heterogeneous and commodity edge devices, emerging fogs, as well as conventional clouds.Peer ReviewedPostprint (author's final draft

Uncovering treatment burden as a key concept for stroke care: a systematic review of qualitative research

&lt;b&gt;Background&lt;/b&gt; Patients with chronic disease may experience complicated management plans requiring significant personal investment. This has been termed ‘treatment burden’ and has been associated with unfavourable outcomes. The aim of this systematic review is to examine the qualitative literature on treatment burden in stroke from the patient perspective.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Methods and findings&lt;/b&gt; The search strategy centred on: stroke, treatment burden, patient experience, and qualitative methods. We searched: Scopus, CINAHL, Embase, Medline, and PsycINFO. We tracked references, footnotes, and citations. Restrictions included: English language, date of publication January 2000 until February 2013. Two reviewers independently carried out the following: paper screening, data extraction, and data analysis. Data were analysed using framework synthesis, as informed by Normalization Process Theory. Sixty-nine papers were included. Treatment burden includes: (1) making sense of stroke management and planning care, (2) interacting with others, (3) enacting management strategies, and (4) reflecting on management. Health care is fragmented, with poor communication between patient and health care providers. Patients report inadequate information provision. Inpatient care is unsatisfactory, with a perceived lack of empathy from professionals and a shortage of stimulating activities on the ward. Discharge services are poorly coordinated, and accessing health and social care in the community is difficult. The study has potential limitations because it was restricted to studies published in English only and data from low-income countries were scarce.&lt;p&gt;&lt;/p&gt; &lt;b&gt;Conclusions&lt;/b&gt; Stroke management is extremely demanding for patients, and treatment burden is influenced by micro and macro organisation of health services. Knowledge deficits mean patients are ill equipped to organise their care and develop coping strategies, making adherence less likely. There is a need to transform the approach to care provision so that services are configured to prioritise patient needs rather than those of health care systems

Employers skill survey : case study : health and social care

"This report examines the relationship between service delivery strategies and processes, and the deployment of skills, recruitment problems and skill gaps within selected sub-sectors of health and social care. The sub-sectors within health are physiotherapy and radiography. Within social care the focus is on care of the elderly (both residential and domiciliary care). Although subject to similar drivers and associated pressures, the two sub-sectors of health and social care display markedly different characteristics, particularly in terms of service delivery strategies, qualification frameworks and utilisation of skills. In simple terms, the health and social care subsectors considered within this report may be thought of as being situated at opposite poles of the ‘skills spectrum’: with radiography and physiotherapy characterised by high level skills, while care of the elderly is traditionally associated with low level skills. Hence, the two sub-sectors are discussed separately throughout this report. The greater complexity and range of skills required in the two health sub-sectors is reflected in the comparative length of the two sections of the report" - page 9

Electronic Health Records: Cure-all or Chronic Condition?

Computer-based information systems feature in almost every aspect of our lives, and yet most of us receive handwritten prescriptions when we visit our doctors and rely on paper-based medical records in our healthcare. Although electronic health record (EHR) systems have long been promoted as a cost-effective and efficient alternative to this situation, clear-cut evidence of their success has not been forthcoming. An examination of some of the underlying problems that prevent EHR systems from delivering the benefits that their proponents tout identifies four broad objectives - reducing cost, reducing errors, improving coordination and improving adherence to standards - and shows that they are not always met. The three possible causes for this failure to deliver involve problems with the codification of knowledge, group and tacit knowledge, and coordination and communication. There is, however, reason to be optimistic that EHR systems can fulfil a healthy part, if not all, of their potential

A conceptual analytics model for an outcome-driven quality management framework as part of professional healthcare education

BACKGROUND: Preparing the future health care professional workforce in a changing world is a significant undertaking. Educators and other decision makers look to evidence-based knowledge to improve quality of education. Analytics, the use of data to generate insights and support decisions, have been applied successfully across numerous application domains. Health care professional education is one area where great potential is yet to be realized. Previous research of Academic and Learning analytics has mainly focused on technical issues. The focus of this study relates to its practical implementation in the setting of health care education. OBJECTIVE: The aim of this study is to create a conceptual model for a deeper understanding of the synthesizing process, and transforming data into information to support educators’ decision making. METHODS: A deductive case study approach was applied to develop the conceptual model. RESULTS: The analytics loop works both in theory and in practice. The conceptual model encompasses the underlying data, the quality indicators, and decision support for educators. CONCLUSIONS: The model illustrates how a theory can be applied to a traditional data-driven analytics approach, and alongside the context- or need-driven analytics approach

The Emergent Logic of Health Law

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching fifty million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this Article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently needed to guide reform. My core proposition is that the law of health care provision is best understood as an emergent system. Its contradictions and dysfunctions cannot be repaired by some master design. No one actor has a grand overview—or the power to impose a unifying vision. Countless market players, public planners, and legal and regulatory decisionmakers interact in oft-chaotic ways, clashing with, reinforcing, and adjusting to each other. Out of these interactions, a larger scheme emerges—one that incorporates the health sphere’s competing interests and values. Change in this system, for worse and for better, arises from the interplay between its myriad actors. By quitting the quest for a single, master design, we can better focus our efforts on possibilities for legal and policy change. We can and should continuously survey the landscape of stakeholders and expectations with an eye toward potential launching points for evolutionary processes—processes that leverage current institutions and incentives. What we cannot do is plan or predict these evolutionary pathways in precise detail; the complexity of interactions among market and government actors precludes fine-grained foresight of this sort. But we can determine the general direction of needed change, identify seemingly intractable obstacles, and envision ways to diminish or finesse them over time. Dysfunctional legal doctrines, interest group expectations, consumers’ anxieties, and embedded institutional and cultural barriers can all be dealt with in this way, in iterative fashion. This Article sets out a strategy for doing so. To illustrate this strategy, I suggest emergent approaches to the most urgent challenges in health care policy and law—the crises of access, value, and cost