Non-medical Devices Research Articles

Chatbots in medicine: certification process and applied use case.

Chatbots are computer programs designed to engage in natural language conversations in an easy and understandable way. Their use has been accelerated recently with the advent of large language models. However, their application in medicine and healthcare has been limited due to concerns over data privacy, the risk of providing medical diagnoses, and ensuring regulatory and legal compliance. Medicine and healthcare could benefit from chatbots if their scope is carefully defined and if they are used appropriately and monitored long-term. The confIAnce chatbot, developed at the Geneva University Hospitals and the University of Geneva, is an informational tool aimed at providing simplified information to the general public about primary care and chronic diseases. In this paper, we describe the certification and regulatory aspects applicable to chatbots in healthcare, particularly in primary care medicine. We use the confIAnce chatbot as a case study to explore the definition and classification of a medical device and its application to chatbots, considering the applicable Swiss regulations and the European Union AI Act. Chatbots can be classified anywhere from non-medical devices (informational tools that do not handle patient data or provide recommendations for treatment or diagnosis) to Class III medical devices (high-risk tools capable of predicting potentially fatal events and enabling a pre-emptive medical intervention). Key considerations in the definition and certification process include defining the chatbot's scope, ensuring compliance with regulations, maintaining security and safety, and continuously evaluating performance, risks, and utility. A lexicon of relevant terms related to artificial intelligence in healthcare, medical devices, and regulatory frameworks is also presented in this paper. Chatbots hold potential for both patients and healthcare professionals, provided that their scope of practice is clearly defined, and that they comply with regulatory requirements. This review aims to provide transparency by outlining the steps required for certification and regulatory compliance, making it valuable for healthcare professionals, scientists, developers, and patients.

The regulatory status of health apps that employ gamification

Smartphone applications are one of the main delivery modalities in digital health. Many of these mHealth apps use gamification to engage users, improve user experience, and achieve better health outcomes. Yet, it remains unclear whether gamified approaches help to deliver effective, safe, and clinically beneficial products to users. This study examines the compliance of 69 gamified mHealth apps with the EU Medical Device Regulation and assesses the specific risks arising from the gamified nature of these apps. Of the identified apps, 32 (46.4%) were considered non-medical devices; seven (10.1%) were already cleared/approved by the regulatory authorities, and 31 (44.9%) apps were assessed as likely non-compliant or potentially non-compliant with regulatory requirements. These applications and one approved application were assessed as on the market without the required regulatory approvals. According to our analysis, a higher proportion of these apps would be classified as medical devices in the US. The level of risk posed by gamification remains ambiguous. While most apps showed only a weak link between the degree of gamification and potential risks, this link was stronger for those apps with a high degree of gamification or an immersive game experience.

Principles of Interoperability of Diabetes Devices.

Better interoperability is essential to derive maximum benefit from connected wireless diabetes devices. The need for this feature of diabetes devices is supported by trends in designing better performance for three types of devices: nonmedical devices, medical devices, and diabetes devices. First, interoperability is a standard attribute for the performance of nonmedical devices contained in smart systems that can sense and actuate. Second, interoperability is now mandated by the US Department of Health and Human Services as carried out by the Office of the National Coordinator for Health Information technology (ONC) and the US Food and Drug Administration (FDA) to improve the performance of all medical devices. Third, new guidance from the FDA and nongovernmental professional organizations are intended to promote interoperability because this feature will improve the performance of all diabetes devices. Wireless devices perform best when they are interoperable, and this is particularly true for diabetes devices.

Innovative techniques in the treatment of penile strangulation: a case report

Introduction and importance: Penile strangulation is a medical emergency characterized by the encirclement of the penis by an external object, resulting in circulatory compromise. Case presentation: A 35-year-old male presented with penile pain and urinary obstruction due to the inability to remove the ring. Upon examination, the ring was firmly lodged at the base of the penis, causing significant swelling and discoloration in the distal region. Interventions and outcomes: Initial attempts to cut the ring using standard tools were unsuccessful, leading to the engagement of a rescue team equipped with an air cutter. The cutting procedure, complicated by the ring’s thickness and hardness and the significant edema, took ~90 min. Safety measures, including the use of a surgical brain spatula and forceps, were employed to protect the penile skin from damage during the operation. Relevance and impact: This case underscores the necessity for timely intervention in penile strangulation cases and highlights the effectiveness of collaboration with specialized rescue teams equipped with appropriate cutting tools. It also emphasizes the importance of safety considerations when employing nonmedical devices in medical emergencies. The patient experienced a favorable outcome, with significant improvement in swelling and discoloration postprocedure, and no complications during follow-up. This report contributes to the limited but crucial literature on managing penile strangulation, particularly regarding the methods and timeframes for safely removing constricting objects.

Beyond duodenoscope-transmitted infections: Analysis of surface bioburden and UV-C mitigation within a tertiary care endoscopy unit

An inpatient endoscopy unit is a care hub for patients from throughout the hospital and can be the site of healthcare-associated infections (HAIs). Shared surfaces and other nonmedical devices (keyboards) have been increasingly recognized as sites of pathogen transmission. Beyond standard cleaning of high-touch target areas, we queried whether the addition of automated devices delivering low-intensity doses of ultraviolet (UV)-C radiation could further reduce bioburden in an academic endoscopy unit. Bioburden on previously identified high-touch/communal surfaces was measured before and after the installation of automated, low-intensity UV-light emitting devices (UV Angel) that passively monitor and disinfect targeted surfaces with Ultraviolet-C light (UV-C) light. High-touch sites (keyboards) had a baseline bacterial contamination of >80%, whereas individual procedure rooms and common areas had a >57% contamination rate. Following the implementation of automated UV-C light decontamination, bioburden was reduced on average by >91% at high-touch surfaces and within procedure rooms. Nonsterile hubs of patient care could serve as sites of "silent" HAI transmission. We have identified high-touch surfaces within an endoscopy unit that have a high bioburden of bacterial contamination and demonstrated that the installation of passive, automated UV-C light disinfection devices can reduce bioburden significantly, possibly mitigating HAI transmission between patients.

Emvolio - A battery operated portable refrigerator preserves biochemical and haematological integrity of biological samples in preclinical studies.

Background: Emvolio is a non-medical device, indigenously developed portable refrigeration for maintaining the internal temperature 2-8˚C. The Indian Patent Office has granted patent for applications such as preservation and transport of medicines, vaccines, food, beverages, dairy etc. Further, use of Emvolio can be utilized in transport and store biologicals to preserve their biochemical and cellular integrity. The objective of this study was to evaluate the biochemical and haematological integrity of biological samples such as rat blood, serum and liver. Methods: The steady temperature was maintained inside the Emvolio, and it was compared to that of thermocol and polypropylene boxes aided with frozen gel packs. The blood and liver samples were isolated from Wistar rats and kept in Emvolio, thermocol and polypropylene boxes for 10 hrs, and the temperature was monitored. The blood parameters, namely red blood cells (RBC), white blood cells (WBC), platelets, haematocrit, haemoglobin, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC) and red cell distribution width (RDW), serum parameters like alanine transaminase, alkaline phosphatase, total protein, albumin, creatine kinase, blood urea nitrogen and liver parameters like superoxide dismutase (SOD), glutathione (GSH), catalase were estimated and compared. Results: Emvolio maintained a constant inner temperature range of 2-8˚C, whereas a significant temperature variation was seen in thermocol and polypropylene boxes. There was no significant deviation in the parameters tested when samples were kept in Emvolio for six hours compared to the zero hour readings. In contrast, there was a significant deviation among the parameters for the samples kept in thermocol and polypropylene boxes for six hours compared to zero hour parameters. Conclusions: Emvolio maintained constant temperature and preserved the biological integrity of rat blood, serum and liver. Thus, Emvolio can be efficiently used as a biological sample carrier, especially in preclinical studies.

Comparative study of video recordings of non-medical devices in laparoscopic surgery: a cross-sectional study.

Laparoscopic surgery is the approach of choice for multiple procedures, being laparoscopic cholecystectomy one of the most frequently performed surgeries. Likewise, video recording of these surgeries has become widespread. Currently, the market offers medical recording devices (MRD) with an approximate cost of 2000 USD, and alternative non-medical recording devices (NMRD) with a cost ranging from 120 to 200 USD. To our knowledge, no comparative studies between the available recording devices have been done. We aim to compare the perception of the quality of videos recorded by MRD and NMRD in a group of surgeons and surgical residents. A cross-sectional study was conducted using an online survey to compare recordings from three NMRDs (Elgato 30fps, AverMedia 60fps, Hauppauge 30fps) and one MRD (MediCap 20fps) during a laparoscopic cholecystectomy. The survey assessed: definition of anatomical structures (DA), fluidity of movements (FM), similarity with the operating room screen (ORsim), and overall quality (OQ). Descriptive and nonparametric analytical statistics tests were applied. Results were analyzed using JMP-15 software. Forty surveys were collected (80% surgeons, 20% residents). NMRDs scored significantly higher than MRD in DA (p = 0.003), FM (p < 0.001), ORsim (p < 0.001), and OQ (p < 0.001). One NMRD was chosen as the highest quality device (70%), and MRD as the poorest (78%). No significant differences were found when analyzing by surgical experience. In terms of recording laparoscopic procedures, non-medical video recording devices (NMRDs) outperformed medical-grade recording device (MRD) with a higher overall score. This suggests that NMRDs could serve as a cost-effective alternative with superior video quality for recording laparoscopic surgeries.

Using adenosine triphosphate bioluminescence level monitoring to identify bacterial reservoirs during two consecutive Enterococcus faecium and Staphylococcus capitis nosocomial infection outbreaks at a neonatal intensive care unit

IntroductionThis study aimed to assess the role of adenosine triphosphate (ATP) bioluminescence level monitoring for identifying reservoirs of the outbreak pathogen during two consecutive outbreaks caused by Enterococcus faecium and Staphylococcus capitis at a neonatal intensive care unit (NICU). The secondary aim was to evaluate the long-term sustainability of the infection control measures employed one year after the final intervention measures.MethodsTwo outbreaks occurred during a 53-day period in two disconnected subunits, A and B, that share the same attending physicians. ATP bioluminescence level monitoring, environmental cultures, and hand cultures from healthcare workers (HCW) in the NICU were performed. Pulsed-field gel electrophoresis (PFGE) typing was carried out to investigate the phylogenetic relatedness of the isolated strains.ResultsFour cases of E. faecium sepsis (patients A-8, A-7, A-9, B-8) and three cases of S. capitis sepsis (patients A-16, A-2, B-8) were diagnosed in six preterm infants over a span of 53 days. ATP levels remained high on keyboard 1 of the main station (2076 relative light unit [RLU]/100 cm2) and the keyboard of bed A-9 (4886 RLU/100 cm2). By guidance with the ATP results, environmental cultures showed that E. faecium isolated from the patients and from the main station’s keyboard 1 were genotypically indistinguishable. Two different S. capitis strains caused sepsis in three patients. A total 77.8% (n = 7/9) of S. capitis cultured from HCW's hands were genotypically indistinguishable to the strains isolated from A-2 and A-16. The remaining 22.2% (n = 2/9) were genotypically indistinguishable to patient B-8. Three interventions to decrease the risk of bacterial transmission were applied, with the final intervention including a switch of all keyboards and mice in NICU-A and B to disinfectable ones. Post-intervention prospective monitoring up to one year showed a decrease in blood culture positivity (P = 0.0019) and catheter-related blood stream infection rate (P = 0.016) before and after intervention.ConclusionATP monitoring is an effective tool in identifying difficult to disinfect areas in NICUs. Non-medical devices may serve as reservoirs of pathogens causing nosocomial outbreaks, and HCWs' hands contribute to bacterial transmission in NICUs.

(286) Goldmember: A Novel Approach to Remove Entrapped Metal Rings Around a Penis

Abstract Introduction Penile strangulation with metal objects is a rare urologic emergency that can present considerable challenges. The treatment approach can vary depending on the type of constricting device, degree of injury, and available equipment. Prior medical reports document the use of various instruments such as bolt cutters, oscillating saws, and power drills. Our case demonstrates a safe and reproducible means to remove metal rings entrapped around a penis using the Midas Rex® drill. Objective To describe a novel treatment approach in penile strangulation with the use of the Midas Rex® drill. Methods A 70-year-old male with a history of paranoid schizophrenia presented to our institution’s emergency department with urinary retention and penile pain due to the placement of five rings onto the penis two weeks prior. On exam, he had swelling of the glans and skin necrosis underneath the rings (Figure 1). After initial bedside attempts to remove the rings proved unsuccessful, he was promptly taken to the operating room. Further attempts to remove the rings using orthopedic pin cutters were also unsuccessful. Next, the Midas Rex® drill (Figure 2a) was used to cut each ring into two segments. The penis was protected from traumatic and thermal injury with careful retraction and continuous irrigation (Figure 2b). All five rings were successfully removed without sustaining iatrogenic injuries (Figure 2c). The injuries were limited to pre-existing superficial wounds of the penile skin (Figure 3a). A cystoscopy was performed and did not reveal any evidence of urethral injury. A suprapubic catheter (SPC) was placed to allow for urethral rest with 1,200 ml of urine drained. Postoperatively, the patient was stable and was transferred to the inpatient psychiatric unit the next day. After adjustment of his psychiatric medications and six days of observation, he was discharged. At his two-week urology follow-up, he had near-complete healing of the penile skin (Figure 3b). His SPC was also removed with low post-void residual noted. Results We present a case where mechanical methods could not be used to remove entrapped metal rings around a penis. In cases requiring the use of electrical tools, it is of utmost importance to protect the penis from iatrogenic injuries. Although the use of non-medical devices such as electric saws have been described in penile strangulation, they can often be bulky. Also, in several reports these devices have caused thermal injuries, leading to urethral strictures and urethrocutaneous fistulae. We were able to use the Midas Rex® drill, an instrument typically used in neurosurgical and orthopedic procedures, with excellent results. By using the diamond-tipped metal cutter attachment and powering the drill with compressed nitrogen set at 120 psi, all five metal rings were safely removed in under 30 minutes. Conclusions Penile strangulation represents a rare urologic entity requiring prompt removal of constricting devices to avoid ischemic complications. From our experience, we demonstrated that the Midas Rex® drill can be safely and expeditiously used to remove metal rings entrapped around a penis with minimal risk of iatrogenic injury. Disclosure No

IoT-Enabled WBAN and Machine Learning for Speech Emotion Recognition in Patients

Internet of things (IoT)-enabled wireless body area network (WBAN) is an emerging technology that combines medical devices, wireless devices, and non-medical devices for healthcare management applications. Speech emotion recognition (SER) is an active research field in the healthcare domain and machine learning. It is a technique that can be used to automatically identify speakers' emotions from their speech. However, the SER system, especially in the healthcare domain, is confronted with a few challenges. For example, low prediction accuracy, high computational complexity, delay in real-time prediction, and how to identify appropriate features from speech. Motivated by these research gaps, we proposed an emotion-aware IoT-enabled WBAN system within the healthcare framework where data processing and long-range data transmissions are performed by an edge AI system for real-time prediction of patients' speech emotions as well as to capture the changes in emotions before and after treatment. Additionally, we investigated the effectiveness of different machine learning and deep learning algorithms in terms of performance classification, feature extraction methods, and normalization methods. We developed a hybrid deep learning model, i.e., convolutional neural network (CNN) and bidirectional long short-term memory (BiLSTM), and a regularized CNN model. We combined the models with different optimization strategies and regularization techniques to improve the prediction accuracy, reduce generalization error, and reduce the computational complexity of the neural networks in terms of their computational time, power, and space. Different experiments were performed to check the efficiency and effectiveness of the proposed machine learning and deep learning algorithms. The proposed models are compared with a related existing model for evaluation and validation using standard performance metrics such as prediction accuracy, precision, recall, F1 score, confusion matrix, and the differences between the actual and predicted values. The experimental results proved that one of the proposed models outperformed the existing model with an accuracy of about 98%.

Ozone Decontamination of Medical and Nonmedical Devices: An Assessment of Design and Implementation Considerations.

The control of infectious diseases can be improved via carefully designed decontamination equipment and systems. Research interest in ozone (a powerful antimicrobial agent) has significantly increased over the past decade. The COVID-19 pandemic has also instigated the development of new ozone-based technologies for the decontamination of personal protective equipment, surfaces, materials, and indoor environments. As this interest continues to grow, it is necessary to consider key factors affecting the applicability of lab-based findings to large-scale systems utilizing ozone. In this review, we present recent developments on the critical factors affecting the successful deployments of industrial ozone technologies. Some of these include the medium of application (air or water), material compatibility, efficient circulation and extraction, measurement and control, automation, scalability, and process economics. We also provide a comparative assessment of ozone relative to other decontamination methods/sterilization technologies and further substantiate the necessity for increased developments in gaseous and aqueous ozonation. Modeling methodologies, which can be applied for the design and implementation of ozone contacting systems, are also presented in this review. Key knowledge gaps and open research problems/opportunities are extensively covered including our recommendations for the development of novel solutions with industrial importance.

Emvolio - A battery operated portable refrigerator preserves biochemical and haematological integrity of biological samples in preclinical studies

Background: Emvolio is a non-medical device, indigenously developed portable refrigeration for maintaining the internal temperature 2–8˚C. The Indian Patent Office has granted patent for applications such as preservation and transport of medicines, vaccines, food, beverages, dairy etc. Further, use of Emvolio can be utilized in transport and store biologicals to preserve their biochemical and cellular integrity. The objective of this study was to evaluate the biochemical and haematological integrity of biological samples such as rat blood, serum and liver. Methods: The steady temperature was maintained inside the Emvolio, and it was compared to that of thermocol and polypropylene boxes aided with frozen gel packs. The blood and liver samples were isolated from Wistar rats and kept in Emvolio, thermocol and polypropylene boxes for 10 hrs, and the temperature was monitored. The blood parameters, namely red blood cells (RBC), white blood cells (WBC), platelets, haematocrit, haemoglobin, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC) and red cell distribution width (RDW), serum parameters like alanine transaminase, alkaline phosphatase, total protein, albumin, creatine kinase, blood urea nitrogen and liver parameters like superoxide dismutase (SOD), glutathione (GSH), catalase were estimated and compared. Results: Emvolio maintained a constant inner temperature range of 2–8˚C, whereas a significant temperature variation was seen in thermocol and polypropylene boxes. There was no significant deviation in the parameters tested when samples were kept in Emvolio for six hours compared to the zero hour readings. In contrast, there was a significant deviation among the parameters for the samples kept in thermocol and polypropylene boxes for six hours compared to zero hour parameters. Conclusions: Emvolio maintained constant temperature and preserved the biological integrity of rat blood, serum and liver. Thus, Emvolio can be efficiently used as a biological sample carrier, especially in preclinical studies.

Device-related pressure ulcers: SECURE prevention. Second edition.

Device-related pressure ulcers: SECURE prevention. Second edition.

Emvolio - A battery operated portable refrigerator preserves biochemical and haematological integrity of biological samples in preclinical studies

Background: Emvolio is a non-medical device, indigenously developed portable refrigeration for maintaining the internal temperature 2–8˚C. The Indian Patent Office has granted patent for applications such as preservation and transport of medicines, vaccines, food, beverages, dairy etc. Further, use of Emvolio can be utilized in transport and store biologicals to preserve their biochemical and cellular integrity. The objective of this study was to evaluate the biochemical and haematological integrity of biological samples such as rat blood, serum and liver. Methods: The steady temperature was maintained inside the Emvolio, and it was compared to that of thermocol and polypropylene boxes aided with frozen gel packs. The blood and liver samples were isolated from Wistar rats and kept in Emvolio, thermocol and polypropylene boxes for 10 hrs, and the temperature was monitored. The blood parameters, namely red blood cells (RBC), white blood cells (WBC), platelets, haematocrit, haemoglobin, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC) and red cell distribution width (RDW), serum parameters like alanine transaminase, alkaline phosphatase, total protein, albumin, creatine kinase, blood urea nitrogen and liver parameters like superoxide dismutase (SOD), glutathione (GSH), catalase were estimated and compared. Results: Emvolio maintained a constant inner temperature range of 2–8˚C, whereas a significant temperature variation was seen in thermocol and polypropylene boxes. There was no significant deviation in the parameters tested when samples were kept in Emvolio for six hours compared to the zero hour readings. In contrast, there was a significant deviation among the parameters for the samples kept in thermocol and polypropylene boxes for six hours compared to zero hour parameters. Conclusions: Emvolio maintained constant temperature and preserved the biological integrity of rat blood, serum and liver. Thus, Emvolio can be efficiently used as a biological sample carrier, especially in preclinical studies.

Medical Identification and Sensing Technology for Assisting and E-Health Monitoring Systems for Disabled and Elderly Persons

This research gives an overview of numerous kinds of identification and sensor technology that have been shown to improve the standard of living of older persons in hospital and home settings. Recent advancements in semiconductors and microsystems have enabled the creation of low-cost medical equipment, which are used by various persons as prevention and E-Health Monitoring (EHM) tools. Remote health management, which relies on wearable and non-invasive sensing devices, controllers, and current information and communication technology, provides cost-effective solutions that enable individuals to remain in their familiar homes while being safeguarded. Additionally, when preventative actions are implemented at home, costly medical centers are becoming available for use by intensive care patients. Patients' vital physiological indicators may be monitored in real time by remote devices, which can also watch, analyze, and, most importantly, offer feedback on their health problems. To translate different types of vital indicators into electrical impulses, sensors are employed in computerized healthcare and non-medical devices. Life-sustaining implants, preventative interventions, and long-term E-Health Monitoring (EHM) of handicapped or unwell patients may all benefit from sensors. Whether the individual is in a clinic, hospital, or at home, medical businesses, such as health insurers, want real-time, dependable, and precise diagnostic findings from sensing devices that can be examined virtually.

Internet of Medical Things (IoMT): Overview, Taxonomies, and Classifications

Recent research efforts have created rapid advances in the field of the Internet of Things (IoT) in terms of communication protocols, sensing technologies, computing capabilities, next-generation wireless technologies, big data and AI techniques, and on-device, edge, cloud processing. These advances created a paradigm shift and generated a wide range of potential opportunities for a new major field known as the Internet of Medical Things (IoMT), as well as subfields like mobile Health (mHeatlh) and digital or electronic Health (eHealth). This paper provides an overview of the Internet of Medical Things and presents a classification to define the primary users and their roles and involvement in smart healthcare systems. The paper then presents taxonomy on the deployment scales of different healthcare environments, from personal healthcare to widescale connected healthcare systems. The overview also discusses the n-tier architecture of IoMT, then presents a set of taxonomies and classifications on the different medical devices used in healthcare systems as well as non-medical devices used to provide context-aware information about the surrounding environment. The paper then concludes the overview by presenting the different healthcare-related applications and services, a comparison between traditional and smart healthcare systems, and the different obstacles and challenges in the field of IoMT to guide the development of new services and devices. Many survey papers in the literature focused on similar points; however, up to our knowledge, this is the first paper to present taxonomies and classifications for these IoMT essential topics. The presented taxonomies and classifications provide the manufacturers of medical devices and the developers of healthcare services a deeper understanding of the healthcare systems’ landscape to address different requirements and demands.

Potential Usefulness of Tracking Head Movement via a Wearable Device for Equilibrium Function Testing at Home

Many studies have reported the use of wearable devices to acquire biological data for the diagnosis and treatment of various diseases. Balance dysfunction, however, is difficult to evaluate in real time because the equilibrium function is conventionally examined using a stabilometer installed on the ground. Here, we used a wearable accelerometer that measures head motion to evaluate balance and examined whether it performs comparably to a conventional stabilometer. We constructed a simplified physical head-feet model that simultaneously records “head” motion measured using an attached wearable accelerometer and center-of-gravity motion at the “feet”, which is measured using an attached stabilometer. Total trajectory length (r = 0.818, p -false discovery rate [FDR] = 0.004) and outer peripheral area (r = 0.691, p -FDR = 0.026) values measured using the wearable device and stabilometer were significantly positively correlated. Root mean square area values were not significantly correlated with wearable device stabilometry but were comparable. These results indicate that wearable, widely available, non-medical devices may be used to assess balance outside the hospital setting, and new approaches for testing balance function should be considered.

Adapting non-medical applications for medical use: Ethical limits, coverage, and validation

The widespread adoption of smartphones and other mobile devices amongst healthcare providers opened new possibilities arising from the use of non-medical apps, social media, meeting platforms, and non-medical devices with intended medical purposes, thus expanding the communication and imaging chat systems between these professionals and their patients, as well as amongst healthcare professionals. However, adapting non-medical applications, social media, videoconference platforms and devices for medical use present potential limitations, barriers, and risks, which should be fully recognized to reduce crossing the fine line between ethical and unethical. In the herein study, we analyse the ethical limits, coverage, and validation of non-medical applications adapted for medical use.Level of evidence: IV (evidence from well-designed case-control or cohort studies).

Hybrid-based framework for COVID-19 prediction via federated machine learning models.

The COronaVIrus Disease 2019 (COVID-19) pandemic is unfortunately highly transmissible across the people. In order to detect and track the suspected COVID-19 infected people and consequently limit the pandemic spread, this paper entails a framework integrating the machine learning (ML), cloud, fog, and Internet of Things (IoT) technologies to propose a novel smart COVID-19 disease monitoring and prognosis system. The proposal leverages the IoT devices that collect streaming data from both medical (e.g., X-ray machine, lung ultrasound machine, etc.) and non-medical (e.g., bracelet, smartwatch, etc.) devices. Moreover, the proposed hybrid fog-cloud framework provides two kinds of federated ML as a service (federated MLaaS); (i) the distributed batch MLaaS that is implemented on the cloud environment for a long-term decision-making, and (ii) the distributed stream MLaaS, which is installed into a hybrid fog-cloud environment for a short-term decision-making. The stream MLaaS uses a shared federated prediction model stored into the cloud, whereas the real-time symptom data processing and COVID-19 prediction are done into the fog. The federated ML models are determined after evaluating a set of both batch and stream ML algorithms from the Python’s libraries. The evaluation considers both the quantitative (i.e., performance in terms of accuracy, precision, root mean squared error, and F1 score) and qualitative (i.e., quality of service in terms of server latency, response time, and network latency) metrics to assess these algorithms. This evaluation shows that the stream ML algorithms have the potential to be integrated into the COVID-19 prognosis allowing the early predictions of the suspected COVID-19 cases.

Improving Healthy Aging by Monitoring Patients’ Lifestyle through a Wearable Device: Results of a Feasibility Study

Population aging is related to a huge growth in healthcare and welfare costs. Therefore, wearable devices could be strategic for minimizing years of disability in old age and monitoring patients’ lifestyles and health. The purpose of this study was to assess the feasibility of using smart devices to monitor patients’ physical activity in a primary care setting. To assess the acceptance of this novel technology from the point of view of both patients and healthcare professionals, two questionnaires (one paper-based and one ex-novo developed) were administered to 11 patients with type 2 diabetes mellitus and a non-compliant behavior towards the therapeutic indications of their general practitioner (GP). Seven participants would continue to use a wearable activity tracker to monitor their health. We observed that 75% of patients reported a device’s characteristics satisfaction level of over 80% of the total score assigned to this dimension. No differences were observed in the questionnaire’s scores between the two professionals categories (GPs and nurses). Three dimensions (equipment characteristics, subjective norm, perceived risks, perceived ease-of-use and facilitating conditions) correlated > 0.5 with the device’s acceptability level. Some weak correlations were observed between healthcare professionals’ perception and patients’ parameters, particularly between the dimensions of collaboration and web interface ease-of-use and patients’ median number of steps and hours of sleep. In conclusion, despite the limited number of subjects involved, a good acceptance level towards these non-medical devices was observed, according to both patients’ and healthcare professionals’ impressions.