Methods and tools for analysis and management of risks and regulatory compliance in the healthcare sector: the hospital at home – HaH

Changing or creating an organisation means creating a new process. Each process involves many risks that need to be identified and managed. The main risks considered here are procedural and legal risks. The former are related to the risks of errors that may occur during processes, while the latter are related to the compliance of processes with regulations. Managing the risks implies proposing changes to the processes that allow the desired result: an optimised process. In order to manage a company and optimise it in the best possible way, not only should the organisational aspect, risk management and legal compliance be taken into account, but it is important that they are all analysed simultaneously with the aim of finding the right balance that satisfies them all. This is the aim of this thesis, to provide methods and tools to balance these three characteristics, and to enable this type of optimisation, ICT support is used. This work isn’t a thesis in computer science or law, but rather an interdisciplinary thesis. Most of the work done so far is vertical and in a specific domain. The particularity and aim of this thesis is not to carry out an in-depth analysis of a particular aspect, but rather to combine several important aspects, normally analysed separately, which however have an impact and influence each other. In order to carry out this kind of interdisciplinary analysis, the knowledge base of both areas was involved and the combination and collaboration of different experts in the various fields was necessary. Although the methodology described is generic and can be applied to all sectors, the case study considered is a new type of healthcare service that allows patients in acute disease to be hospitalised to their home. This provide the possibility to perform experiments using real hospital database.

Smart Textile Sensors for Healthcare Monitoring

Wearable electronic textiles are an emerging research field playing a pivotal role among several different technological areas such as sensing, communication, clothing, health monitoring, information technology, and microsystems. The possibility to realise a fully-textile platform, endowed with various sensors directly realised with textile fibres and fabric, represents a new challenge for the entire research community. Among several high-performing materials, the intrinsically conductive poly(3,4-ethylenedioxythiophene) (PEDOT), doped with poly(styrenesulfonic acid) (PSS), or PEDOT:PSS, is one of the most representative and utilised, having an excellent chemical and thermal stability, as well as reversible doping state and high conductivity. This work relies on PEDOT:PSS combined with sensible materials to design, realise, and develop textile chemical and physical sensors. In particular, chloride concentration and pH level sensors in human sweat for continuous monitoring of the wearer's hydration status and stress level are reported. Additionally, a prototype smart bandage detecting the moisture level and pH value of a bed wound to allow the remote monitoring of the healing process of severe and chronic wounds is described. Physical sensors used to monitor the pressure distribution for rehabilitation, workplace safety, or sport tracking are also presented together with a novel fully-textile device able to measure the incident X-ray dose for medical or security applications where thin, comfortable, and flexible features are essential. Finally, a proof-of-concept for an organic-inorganic textile thermoelectric generator that harvests energy directly from body heat has been proposed. Though further efforts must be dedicated to overcome issues such as durability, washability, power consumption, and large-scale production, the novel, versatile, and widely encompassing area of electronic textiles is a promising protagonist in the upcoming technological revolution.

Integration of heterogeneous data sources and automated reasoning in healthcare and domotic IoT systems

In recent years, IoT technology has radically transformed many crucial industrial and service sectors such as healthcare. The multi-facets heterogeneity of the devices and the collected information provides important opportunities to develop innovative systems and services. However, the ubiquitous presence of data silos and the poor semantic interoperability in the IoT landscape constitute a significant obstacle in the pursuit of this goal. Moreover, achieving actionable knowledge from the collected data requires IoT information sources to be analysed using appropriate artificial intelligence techniques such as automated reasoning. In this thesis work, Semantic Web technologies have been investigated as an approach to address both the data integration and reasoning aspect in modern IoT systems. In particular, the contributions presented in this thesis are the following: (1) the IoT Fitness Ontology, an OWL ontology that has been developed in order to overcome the issue of data silos and enable semantic interoperability in the IoT fitness domain; (2) a Linked Open Data web portal for collecting and sharing IoT health datasets with the research community; (3) a novel methodology for embedding knowledge in rule-defined IoT smart home scenarios; and (4) a knowledge-based IoT home automation system that supports a seamless integration of heterogeneous devices and data sources.

Analytics and optimization for emergency healthcare processes

This thesis deals with the analysis and management of emergency healthcare processes through the use of advanced analytics and optimization approaches. Emergency processes are among the most complex within healthcare. This is due to their non-elective nature and their high variability. This thesis is divided into two topics. The first one concerns the core of emergency healthcare processes, the emergency department (ED). In the second chapter, we describe the ED that is the case study. This is a real case study with data derived from a large ED located in northern Italy. In the next two chapters, we introduce two tools for supporting ED activities. The first one is a new type of analytics model. Its aim is to overcome the traditional methods of analyzing the activities provided in the ED by means of an algorithm that analyses the ED pathway (organized as event log) as a whole. The second tool is a decision-support system, which integrates a deep neural network for the prediction of patient pathways, and an online simulator to evaluate the evolution of the ED over time. Its purpose is to provide a set of solutions to prevent and solve the problem of the ED overcrowding. The second part of the thesis focuses on the COVID-19 pandemic emergency. In the fifth chapter, we describe a tool that was used by the Bologna local health authority in the first part of the pandemic. Its purpose is to analyze the clinical pathway of a patient and from this automatically assign them a state. Physicians used the state for routing the patients to the correct clinical pathways. The last chapter is dedicated to the description of a MIP model, which was used for the organization of the COVID-19 vaccination campaign in the city of Bologna, Italy.

Pedagogy of healthcare interactions. A study on pediatric well-child visits as culture-oriented and culture-making sites

This study investigates interactions between parents and pediatricians during pediatric well-child visits. Despite constituting a pivotal moment for monitoring and evaluating children’s development during the critical ‘first thousand days of life’ and for family support, no study has so far empirically investigated the in vivo realization of pediatrician-parent interactions in the Italian context, especially not from a pedagogical perspective. Filling this gap, the present study draws on a corpus of 23 videorecorded well-child visits involving two pediatricians and twenty-two families with children aged between 0 and 18 months. Combining an ethnographic perspective and conversation analysis theoretical-analytical constructs, the micro-analysis of interactions reveals how well-child visits unfold as culture-oriented and culture-making sites. By zooming into what actually happens during these visits, the analysis shows that there is much more than the “mere” accomplishment of institutionally relevant activities like assessing children’s health or giving parents advice on baby care. Rather, through the interactional ways these institutional tasks are carried out, parents and pediatricians presuppose, ratify, and transmit culturally-informed models of “normal” growth, “healthy” development, “good” caring practices, and “competent” parenting, thereby enacting a pervasive yet unnoticed educational and moral work. Inaugurating a new promising line of inquiry within Italian pedagogical research, this study illuminates how a) pediatricians work as a “social antenna”, bridging families’ private “small cultures” and broader socio-cultural models of children’s well-being and caregiving practices, and b) parents act as agentive, knowledgeable, (communicatively) competent, and caring parents, while also sensitive to the pediatrician’s ultimate epistemic and deontic authority. I argue that a video-based, micro-analysis of interactions represents a heuristically powerful instrument for raising pediatricians’ and parents’ awareness of the educational and moral density of well-child visits. Insights from this study can constitute a valuable empirical resource for underpinning medical and parental training programs aimed at fostering pediatricians’ and parents’ reflexivity.

Internet of healthcare (law): privacy and data protection aspects in an internet of everything

The purpose of this research study is to discuss privacy and data protection-related regulatory and compliance challenges posed by digital transformation in healthcare in the wake of the COVID-19 pandemic. The public health crisis accelerated the development of patient-centred remote/hybrid healthcare delivery models that make increased use of telehealth services and related digital solutions. The large-scale uptake of IoT-enabled medical devices and wellness applications, and the offering of healthcare services via healthcare platforms (online doctor marketplaces) have catalysed these developments. However, the use of new enabling technologies (IoT, AI) and the platformisation of healthcare pose complex challenges to the protection of patient’s privacy and personal data. This happens at a time when the EU is drawing up a new regulatory landscape for the use of data and digital technologies. Against this background, the study presents an interdisciplinary (normative and technology-oriented) critical assessment on how the new regulatory framework may affect privacy and data protection requirements regarding the deployment and use of Internet of Health Things (hardware) devices and interconnected software (AI systems). The study also assesses key privacy and data protection challenges that affect healthcare platforms (online doctor marketplaces) in their offering of video API-enabled teleconsultation services and their (anticipated) integration into the European Health Data Space. The overall conclusion of the study is that regulatory deficiencies may create integrity risks for the protection of privacy and personal data in telehealth due to uncertainties about the proper interplay, legal effects and effectiveness of (existing and proposed) EU legislation. The proliferation of normative measures may increase compliance costs, hinder innovation and ultimately, deprive European patients from state-of-the-art digital health technologies, which is paradoxically, the opposite of what the EU plans to achieve.

Patient data sharing for the improvement of healthcare and medical research: towards a moral duty of patients to share health-related data?

The project answers to the following central research question: ‘How would a moral duty of patients to transfer (health) data for the benefit of health care improvement, research, and public health in the eHealth sector sit within the existing confidentiality, privacy, and data protection legislations?’. The improvement of healthcare services, research, and public health relies on patient data, which is why one might raise the question concerning a potential moral responsibility of patients to transfer data concerning health. Such a responsibility logically would have subsequent consequences for care providers concerning the further transferring of health data with other healthcare providers or researchers and other organisations (who also possibly transfer the data further with others and other organisations). Otherwise, the purpose of the patients’ moral duty, i.e. to improve the care system and research, would be undermined. Albeit the arguments that may exist in favour of a moral responsibility of patients to share health-related data, there are also some moral hurdles that come with such a moral responsibility. Furthermore, the existing European and national confidentiality, privacy and data protection legislations appear to hamper such a possible moral duty, and they may need to be reconsidered to unlock the full use of data for healthcare and research.

Advancing digital healthcare research and machine learning-aided knowledge extraction amidst the COVID-19 pandemic

The rapid progression of biomedical research coupled with the explosion of scientific literature has generated an exigent need for efficient and reliable systems of knowledge extraction. This dissertation contends with this challenge through a concentrated investigation of digital health, Artificial Intelligence, and specifically Machine Learning and Natural Language Processing's (NLP) potential to expedite systematic literature reviews and refine the knowledge extraction process. The surge of COVID-19 complicated the efforts of scientists, policymakers, and medical professionals in identifying pertinent articles and assessing their scientific validity. This thesis presents a substantial solution in the form of the COKE Project, an initiative that interlaces machine reading with the rigorous protocols of Evidence-Based Medicine to streamline knowledge extraction. In the framework of the COKE (“COVID-19 Knowledge Extraction framework for next-generation discovery science”) Project, this thesis aims to underscore the capacity of machine reading to create knowledge graphs from scientific texts. The project is remarkable for its innovative use of NLP techniques such as a BERT + bi-LSTM language model. This combination is employed to detect and categorize elements within medical abstracts, thereby enhancing the systematic literature review process. The COKE project's outcomes show that NLP, when used in a judiciously structured manner, can significantly reduce the time and effort required to produce medical guidelines. These findings are particularly salient during times of medical emergency, like the COVID-19 pandemic, when quick and accurate research results are critical.

Hemorrhagic Shock Secondary To Button Battery Ingestion.

Button battery ingestion is a frequent pediatric complaint. The serious complications resulting from accidental ingestion have increased significantly over the last two decades due to easy access to gadgets and electronic toys. Over recent years, the increasing use of lithium batteries of diameter 20 mm has brought new challenges, because these are more detrimental to the mucosa, compared with other types, with high morbidity and mortality. The clinical complaints, which are often nonspecific, may lead to delayed diagnosis, thereby increasing the risk of severe complications. A five-year-old boy who had been complaining of abdominal pain for ten days, was brought to the emergency service with a clinical condition of hematemesis that started two hours earlier. On admission, he presented pallor, tachycardia and hypotension. A plain abdominal x-ray produced an image suggestive of a button battery. Digestive endoscopy showed a deep ulcerated lesion in the esophagus without active bleeding. After this procedure, the patient presented profuse hematemesis and severe hypotension, followed by cardiorespiratory arrest, which was reversed. He then underwent emergency exploratory laparotomy and presented a new episode of cardiorespiratory arrest, which he did not survive. The battery was removed through rectal exploration. This case describes a fatal evolution of button battery ingestion with late diagnosis and severe associated injury of the digestive mucosa. A high level of clinical suspicion is essential for preventing this evolution. Preventive strategies are required, as well as health education, with warnings to parents, caregivers and healthcare professionals.

The Burden Of Eclampsia: Results From A Multicenter Study On Surveillance Of Severe Maternal Morbidity In Brazil.

Maternal mortality (MM) is a core indicator of disparities in women's rights. The study of Near Miss cases is strategic to identifying the breakdowns in obstetrical care. In absolute numbers, both MM and occurrence of eclampsia are rare events. We aim to assess the obstetric care indicators and main predictors for severe maternal outcome from eclampsia (SMO: maternal death plus maternal near miss). Secondary analysis of a multicenter, cross-sectional study, including 27 centers from all geographic regions of Brazil, from 2009 to 2010. 426 cases of eclampsia were identified and classified according to the outcomes: SMO and non-SMO. We classified facilities as coming from low- and high-income regions and calculated the WHO's obstetric health indicators. SPSS and Stata softwares were used to calculate the prevalence ratios (PR) and respective 95% confidence interval (CI) to assess maternal characteristics, clinical and obstetrical history, and access to health services as predictors for SMO, subsequently correlating them with the corresponding perinatal outcomes, also applying multiple regression analysis (adjusted for cluster effect). Prevalence of and mortality indexes for eclampsia in higher and lower income regions were 0.2%/0.8% and 8.1%/22%, respectively. Difficulties in access to health care showed that ICU admission (adjPR 3.61; 95% CI 1.77-7.35) and inadequate monitoring (adjPR 2.31; 95% CI 1.48-3.59) were associated with SMO. Morbidity and mortality associated with eclampsia were high in Brazil, especially in lower income regions. Promoting quality maternal health care and improving the availability of obstetric emergency care are essential actions to relieve the burden of eclampsia.

Bisphosphonate-related Osteonecrosis Of The Jaw: A Review Of The Literature.

Bisphosphonates (BPs) are a class of drugs used to treat osteoporosis and malignant bone metastasis. BPs show high binding capacity to the bone matrix, especially in sites of active bone metabolism. The American Society for Bone and Mineral Research defines BRONJ as an area of exposed bone in the maxillofacial region that has not healed within 8 weeks after identification by a healthcare provider in a patient who is receiving or has been exposed to a bisphosphonate and has not had radiation therapy to the craniofacial region. Bisphosphonate-related osteonecrosis of the jaw (BRONJ) can adversely affect quality of life, as it may produce significant morbidity. The American Association of Oral and Maxillofacial Surgeons (AAOMS) considers as vitally important that information on BRONJ be disseminated to other dental and medical specialties. The purpose of this work is to offer a perspective on how dentists should manage patients on BPs, to show the benefits of accurately diagnosing BRONJ, and to present diagnostic aids and treatments strategies for the condition.

Advancing Bag-of-visual-words Representations For Lesion Classification In Retinal Images.

Diabetic Retinopathy (DR) is a complication of diabetes that can lead to blindness if not readily discovered. Automated screening algorithms have the potential to improve identification of patients who need further medical attention. However, the identification of lesions must be accurate to be useful for clinical application. The bag-of-visual-words (BoVW) algorithm employs a maximum-margin classifier in a flexible framework that is able to detect the most common DR-related lesions such as microaneurysms, cotton-wool spots and hard exudates. BoVW allows to bypass the need for pre- and post-processing of the retinographic images, as well as the need of specific ad hoc techniques for identification of each type of lesion. An extensive evaluation of the BoVW model, using three large retinograph datasets (DR1, DR2 and Messidor) with different resolution and collected by different healthcare personnel, was performed. The results demonstrate that the BoVW classification approach can identify different lesions within an image without having to utilize different algorithms for each lesion reducing processing time and providing a more flexible diagnostic system. Our BoVW scheme is based on sparse low-level feature detection with a Speeded-Up Robust Features (SURF) local descriptor, and mid-level features based on semi-soft coding with max pooling. The best BoVW representation for retinal image classification was an area under the receiver operating characteristic curve (AUC-ROC) of 97.8% (exudates) and 93.5% (red lesions), applying a cross-dataset validation protocol. To assess the accuracy for detecting cases that require referral within one year, the sparse extraction technique associated with semi-soft coding and max pooling obtained an AUC of 94.2 ± 2.0%, outperforming current methods. Those results indicate that, for retinal image classification tasks in clinical practice, BoVW is equal and, in some instances, surpasses results obtained using dense detection (widely believed to be the best choice in many vision problems) for the low-level descriptors.

Construction Of A Manual Of Work Processes And Techniques From Centro De Dispensação De Medicamentos De Alto Custo (cedmac), Hospital De Clínicas, Unicamp.

The Centers for High Cost Medication (Centros de Medicação de Alto Custo, CEDMAC), Health Department, São Paulo were instituted by project in partnership with the Clinical Hospital of the Faculty of Medicine, USP, sponsored by the Foundation for Research Support of the State of São Paulo (Fundação de Amparo à Pesquisa do Estado de São Paulo, FAPESP) aimed at the formation of a statewide network for comprehensive care of patients referred for use of immunobiological agents in rheumatological diseases. The CEDMAC of Hospital de Clínicas, Universidade Estadual de Campinas (HC-Unicamp), implemented by the Division of Rheumatology, Faculty of Medical Sciences, identified the need for standardization of the multidisciplinary team conducts, in face of the specificity of care conducts, verifying the importance of describing, in manual format, their operational and technical processes. The aim of this study is to present the methodology applied to the elaboration of the CEDMAC/HC-Unicamp Manual as an institutional tool, with the aim of offering the best assistance and administrative quality. In the methodology for preparing the manuals at HC-Unicamp since 2008, the premise was to obtain a document that is participatory, multidisciplinary, focused on work processes integrated with institutional rules, with objective and didactic descriptions, in a standardized format and with electronic dissemination. The CEDMAC/HC-Unicamp Manual was elaborated in 10 months, with involvement of the entire multidisciplinary team, with 19 chapters on work processes and techniques, in addition to those concerning the organizational structure and its annexes. Published in the electronic portal of HC Manuals in July 2012 as an e-Book (ISBN 978-85-63274-17-5), the manual has been a valuable instrument in guiding professionals in healthcare, teaching and research activities.

A Decade Of Malaria During Pregnancy In Brazil: What Has Been Done Concerning Prevention And Management.

In Brazil, malaria remains a disease of major epidemiological importance because of the high number of cases in the Amazonian Region. Plasmodium spp infections during pregnancy are a significant public health problem with substantial risks for the pregnant woman, the foetus and the newborn child. In Brazil, the control of malaria during pregnancy is primarily achieved by prompt and effective treatment of the acute episodes. Thus, to assure rapid diagnosis and treatment for pregnant women with malaria, one of the recommended strategy for low transmission areas by World Health Organization and as part of a strategy by the Ministry of Health, the National Malaria Control Program has focused on integrative measures with woman and reproductive health. Here, we discuss the approach for the prevention and management of malaria during pregnancy in Brazil over the last 10 years (2003-2012) using morbidity data from Malaria Health Information System. Improving the efficiency and quality of healthcare and education and the consolidation of prevention programmes will be challenges in the control of malaria during pregnancy in the next decade.

Infertility Care And The Introduction Of New Reproductive Technologies In Poor Resource Settings.

The overall prevalence of infertility was estimated to be 3.5-16.7% in developing countries and 6.9-9.3% in developed countries. Furthermore, according to reports from some regions of sub-Saharan Africa, the prevalence rate is 30-40%. The consequences of infertility and how it affects the lives of women in poor-resource settings, particularly in developing countries, has become an important issue to be discussed in reproductive health. In some societies, the inability to fulfill the desire to have children makes life difficult for the infertile couple. In many regions, infertility is considered a tragedy that affects not only the infertile couple or woman, but the entire family. This is a position paper which encompasses a review of the needs of low-income infertile couples, mainly those living in developing countries, regarding access to infertility care, including ART and initiatives to provide ART at low or affordable cost. Information was gathered from the databases MEDLINE, CENTRAL, POPLINE, EMBASE, LILACS, and ICTRP with the key words: infertility, low income, assisted reproductive technologies, affordable cost, low cost. There are few initiatives geared toward implementing ART procedures at low cost or at least at affordable cost in low-income populations. Nevertheless, from recent studies, possibilities have emerged for new low-cost initiatives that can help millions of couples to achieve the desire of having a biological child. It is necessary for healthcare professionals and policymakers to take into account these new initiatives in order to implement ART in resource-constrained settings.