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The clinical use of 3D printed patient specific orthopaedic cast is of wide interest. However, design and production have problems such as production time, which can take up to 35 h, and standardized procedure considering that there are medical devices that must comply mandatory and/or voluntary standards. Moreover, the proposed procedures do not fully consider the traceability of this innovative medical device design to comply with standards and industrial proposes. The aim of this work is to propose a semi-automatic workflow for the production of the 3D printed orthopaedic casts. The procedure is oriented towards a reduction time in different phases (as scan setting, designing technique, printing orientation) of the production flow. The workflow is compliant with recognized quality standards for the production of additive manufactured medical devices. This approach offers the possibility to introduce new 3D printed medical devices in clinical practice as well as to design an optimized industrial workflow.

During COVID-19 emergency the majority of health structures in Europe saturated or nearly saturated their availabilities already in the first weeks of the epidemic period especially in some regions of Italy and Spain. The aim of this study is to analyse the efficiency in the management of hospital beds before the COVID-19 outbreak at regional level in France, Germany, Italy and Spain. This analysis can indicate a reference point for future analysis on resource management in emergency periods and help hospital managers, emergency planners as well as policy makers to put in place a rapid and effective response to an emergency situation. The results of this study clearly underline that France and Germany could rely on the robust structural components of the hospital system, compared to Italy and Spain. Presumably, this might have had an impact on the efficacy in the management of the COVID-19 diffusion. In particular, the high availability of beds in the majority of the France regions paired with the low occupancy rate and high turnover interval led these regions to have a high number of available beds. Consider also that this country generally manages complex cases. A similar structural component is present in the German regions where the number of available beds is significantly higher than in the other countries. The impact of the COVID-19 was completely different in Italy and Spain that had to deal with a relevant large number of patients relying on a reduced number of both hospital beds and professionals. A further critical factor compared to France and Germany concerns the dissimilar distribution of cases across regions. Even if in these countries the hospital beds were efficiently managed, the concentration of hospitalized patients and the scarcity of beds have put pressure on the hospital systems.

As the Italian health system is regionally based, COVID-19 emergency actions are based on a general lockdown imposed by national authority and then management at local level by 21 regional authorities. Therefore, the pandemic response plan developed by each region led to different approaches. The aim of this paper is to analyze whether differences in patient management may have influenced the local course of the epidemic. The analysis on the 21 Italian regions considers the strategies adopted in terms of hospitalization, treatment in the ICU and at home. Moreover, an in-depth analysis was carried out on: Lombardia, which adopted a hospitalization approach, Veneto, which tended to confine patients at home, and Emilia Romagna, which adopted a mixed hospitalization-home based approach. The majority of regions implemented a home-based approach, while the hospital approach was followed in three regions (Lombardia, Piemonte, and Lazio), mainly limited to the first period of the outbreak. All regions in the later phases tended to reduce hospitalization, preferring to confine patients at home. This comparison, highlighting the different phases of the pandemic, outlined that the adoption of home-based practices contributed to limiting infection rates among patients and health professionals as well as decreasing the number of deaths.

This extended abstract sets up the scene of the KONFIDO project in a clear way. In particular, it: i) defines KONFIDO objectives and draws KONFIDO boundaries; ii) identifies KONFIDO users and beneficiaries; iii) describes the environment where KONFIDO is embedded; iv) provides a bird's eye view of the KONFIDO technologies and how they will be deployed in the pilot studies of the project; and v) presents the approach that the KONFIDO consortium will take to prove that the proposed solutions work. KONFIDO addresses one of the top three priorities of the European Commission regarding the digital transformation of health and care in the Digital Single Market, i.e. citizens' secure access to their health data, also across borders. To make sure that KONFIDO has a high-impact, its results are exposed to the wide public by developing three substantial pilots in three distinct European countries (namely Denmark, Italy, and Spain).

Background Increased digitalization of healthcare comes along with the cost of cybercrime proliferation. This results to patients’ and healthcare providers' skepticism to adopt Health Information Technologies (HIT). In Europe, this shortcoming hampers efficient cross-border health data exchange, which requires a holistic, secure and interoperable framework. This study aimed to provide the foundations for designing a secure and interoperable toolkit for cross-border health data exchange within the European Union (EU), conducted in the scope of the KONFIDO project. Particularly, we present our user requirements engineering methodology and the obtained results, driving the technical design of the KONFIDO toolkit. Methods Our methodology relied on four pillars: (a) a gap analysis study, reviewing a range of relevant projects/initiatives, technologies as well as cybersecurity strategies for HIT interoperability and cybersecurity; (b) the definition of user scenarios with major focus on cross-border health data exchange in the three pilot countries of the project; (c) a user requirements elicitation phase containing a threat analysis of the business processes entailed in the user scenarios, and (d) surveying and discussing with key stakeholders, aiming to validate the obtained outcomes and identify barriers and facilitators for HIT adoption linked with cybersecurity and interoperability. Results According to the gap analysis outcomes, full adherence with information security standards is currently not universally met. Sustainability plans shall be defined for adapting existing/evolving frameworks to the state-of-the-art. Overall, lack of integration in a holistic security approach was clearly identified. For each user scenario, we concluded with a comprehensive workflow, highlighting challenges and open issues for their application in our pilot sites. The threat analysis resulted in a set of 30 user goals in total, documented in detail. Finally, indicative barriers of HIT acceptance include lack of awareness regarding HIT risks and legislations, lack of a security-oriented culture and management commitment, as well as usability constraints, while important facilitators concern the adoption of standards and current efforts for a common EU legislation framework. Conclusions Our study provides important insights to address secure and interoperable health data exchange, while our methodological framework constitutes a paradigm for investigating diverse cybersecurity-related risks in the health sector. Electronic supplementary material The online version of this article (10.1186/s12911-018-0664-0) contains supplementary material, which is available to authorized users.

Many cervical spine pathologies involve degeneration of the stabilizing mechanisms of vertebrae segments and often cause pain. Abnormal intervertebral motion is an indication for surgery. Currently, spinal fusion surgery is widely adopted to fix the instable vertebral segments but recently, disk arthroplasty is more and more adopted as an alternative to restore normal kinematics and biomechanics of the sick segment and to reduce development of symptomatic adjacent-level degeneration. This study aims to measure intervertebral kinematics by means of image processing of X-ray fluoroscopy videos, which are able to screen patient's neck spontaneous movements of flexion-extension. Vertebrae trajectories are estimated by using image template matching techniques. Then, continuous-time intervertebral kinematics is computed by using spline interpolation. The results, obtained by using real fluoroscopy videos, reveal the possibility of obtaining in vivo information about the continuous evolution of motion of the implanted prosthesis and adjacent segments.

The objective of this work was to study the use of electrical impedance spectroscopy (EIS) measurement to characterize muscle electrical properties in different conditions. In vivo EIS measurements were carried out in the range 1-60 kHz on 32 forearm flexor muscles of healthy volunteers. Each subject underwent to a protocol consisting of three trials: rest condition, isometric contraction, 4 min relaxation. Measured data were fitted with Cole-Cole equivalent electrical circuit using the complex nonlinear least square method. Finally, the relative variations from the steady state of the electrical parameters of the equivalent electrical circuit were estimated. Results obtained are in agreement with the hypothesis that, in the frequency range considered, the current preferentially flows through the extracellular fluid, being the component of intracellular resistance negligible. Among circuital parameters, in fact, the relative variations from steady state of R0 changed highly significant (p < 0.001) both during contraction and after 4 min relaxation.

The Electrical Impedance Spectroscopy (EIS) measurements, in addition to being used for research purposes, are increasingly spreading in clinical setting. Thanks to the improvement of electronic and information technology, the necessary equipment is becoming increasingly simple and small, suitable for example for home care applications. In this work, the characteristics of a smartphone based system for impedance measurements are described. Besides, it is tested its reliability by measuring resistors of known values which fall in the range of bioimpedance. The proof demonstrator, here assessed, consists of a prototypal analogic, low-power chip capable of performing impedance measurements at different frequencies, a hardware support for the connection with a standard smartphone and an application properly developed. After its final validation, the proof demonstrator could be useful to design wearable devices for sport and consumer electronic.

Foetal heart rate variability (FHRV) is important in foetal wellbeing assessment. However, a gold standard for its evaluation is not yet available. Here, a rather new methodology, the empirical mode decomposition (EMD), is proposed to decompose FHR signal in its components. To test the reliability of this methodology, we employed simulated FHR signals, “clean” and noisy, with characteristics defined a priori and computed two indices of foetal health, the sympatho-vagal balance (SVB) and the standard deviation of FHR signal (ASD). Results obtained in comparison between values set for the simulation and those estimated after EMD demonstrated that EMD could be useful for evaluation of FHRV components directly in time domain. The error in the indices estimation was on average just over 1% for SVB and zero for ASD. In presence of noise, the error in ASD estimation was below 8% whereas that in SVB evaluation increases becoming almost 30%.

Home care (HC) consists of providing a high quality health services to patients in their homes through the use of caregivers and appropriate technologies. HC is a complex system that can be decomposed in simple sub-processes, activities and actors to be better designed, managed and improved. This work presents an attempt to model the activities related to test and management of technologies in the HC care service provided by Local Heath Unit ASL NA1 (Naples, Italy) covering a population of one million inhabitants. The modeling was done using a set of methods / diagrams to describe the process from multiple point of views. Each one allows the identification of resources and constraints to perform the activities. The set of different diagrams has clarified many aspects of test and management of the devices in HC and it has facilitated the fulfillment of operative procedures that will regulate activities in provide HC service.

Risk analysis (RA) plays an important role in the development of safety-critical healthcare systems and numerous methods have been specifically designed for the risk analysis. As a matter of fact, these processes are complex, composed by many sub-processes and characterized by the presence of sophisticated technologies used in diagnoses and therapies. According to these considerations, the Clinical RA (CRA) techniques derive from those used in other complex industrial systems, adapted on concepts and settings typical of healthcare. Often the industrial risk analysis methods combine more risk analysis methods with the advantage of obtaining multi-views analysis exploiting the different focus points of each method. In this work, a particular critical aspect of home care service with high level of assistance has been analysed using the combination of Failure Mode Effects and Criticality Analysis (FMECA) and Healthcare Failure Mode Effects Analysis (HFMEATM). The results show that the use of both methods increases the efficiency of analysis because it highlights a more complete and effective set of criticalities and vulnerabilities. �� 2014 IEEE.

Foetal heart rate variability is widely considered an important parameter to assess foetal reactivity and wellbeing. Traditional approaches to analyze foetal heart rate and its variability, such as Time and Frequency Domain Analyses, have shown some limitations, due to their inability to highlight nonlinear dynamics potentially relevant. Hence, in the last decades, nonlinear analysis methods have gained a growing interest and the integration of parameters derived from these techniques and traditional ones could be a way to improve the assessment of foetal development and/or distress. In this work, we proposed a comparison between new index obtained with a nonlinear analysis (Symbolic Dynamic Analysis) and more traditional parameters computed by the power spectral density of the foetal heart variability signals (Frequency Domain Analysis). A dataset of 579 cardiotocographic signals from healthy foetuses, recorded from the 24th to the 42th gestation week, was examined using both above-mentioned methods. The obtained results demonstrate that Symbolic Dynamics, as much as Frequency Domain Analysis, could be a useful tool in foetal development assessing. �� 2014 IEEE.

Risk management in healthcare represents a group of various complex actions, implemented to improve the quality of healthcare services and guarantee the patients safety. Risks cannot be eliminated, but it can be controlled with different risk assessment methods derived from industrial applications and among these the Failure Mode Effect and Criticality Analysis (FMECA) is a largely used methodology. The main purpose of this work is the analysis of failure modes of the Home Care (HC) service provided by local healthcare unit of Naples (ASL NA1) to focus attention on human and non human factors according to the organization framework selected by WHO.

This study aims to reproduce the effect of motor-unit synchronization on surface EMG recordings during vibratory stimulation to highlight vibration evoked muscle activity. The authors intended to evaluate, through numerical simulations, the changes in surface EMG spectrum in muscles undergoing whole body vibration stimulation. In some specific bands, in fact, vibration induced motion artifacts are also typically present. In addition, authors meant to compare the simulated EMGs with respect to real recordings in order to discriminate the effect of synchronization of motor units discharges with vibration frequencies from motion artifacts. Computations were performed using a model derived from previous studies and modified to consider the effect of vibratory stimulus, the motor unit synchronization and the endplates-electrodes relative position on the EMG signal. Results revealed that, in particular conditions, synchronization of MUs' discharge generates visible peaks at stimulation frequency and its harmonics. However, only a part of the total power of surface EMGs might be enclosed within artifacts related bands (± 1 Hz centered at the stimulation frequency and its superior harmonics) even in case of strong synchronization of motor units discharges with the vibratory stimulus.

While performing physiological functions, muscles modify their intrinsic characteristics. As has already successfully done in various clinical fields, the technique of electrical impedance spectroscopy (EIS) measurement can be applied in order to study tissue changes. The aim of this study was to study changes in the electrical properties of muscular tissues due to an isometric contraction and successive relaxation. For this work, the electrodes lay out and trials protocol were carefully designed, also according to studies concerning muscle fatigue. A device previously tested and employed for in vivo EIS measurements was used. Impedance measurements were carried out on the forearm flexor muscles in a group of sixteen healthy adult subjects. In order to have a quantitative index of spectral impedance variation, the relative variation of the area under curve of Nyquist plots was computed to study the different muscle states under consideration (rest, contraction and 4 min after contraction). The index introduced showed itself to be sensitive to different muscular conditions. Results from healthy subjects showed statistically significant differences in the impedance data in the various muscle conditions under examination. �� 2013 Na����cz Institute of Biocybernetics and Biomedical Engineering.

The main challenges in sensor network based monitoring systems are the control and management of complex modules and elements interacting among them and with the environment. This work presents and validates a design model for monitoring and diagnosis systems based on sensor networks exploiting potentialities of the holonic approach. The holonic structure is designed with the final goal to guarantee the performances and the functionalities required by the application scenario of road and work vehicles rental companies. Actually they are interacting and geographically distributed systems. The capabilities of cooperation among modules, hierarchical organization, modularity and reliability of holonic design are exploited. Diagnosis of monitored events is coded and validated through an ad hoc ontology. The design does not give assumption on the physical architecture of holons but only on their capacities/properties, therefore it can be reused in different physical and hardware resources. The case studies confirm the capability of our design to be quickly transferred to programmers and coded in firmware and software.

A method based on electrochemical impedance spectroscopy (EIS) for the diagnosis of prosthesis osseointegration was proposed by the authors in previous works [P. Arpaia, F. Clemente, A. Zanesco, Low-invasive diagnosis of metallic prosthesis osseointegration by electrical impedance spectroscopy, IEEE Trans. Instrum. Meas. 56 (3) (2007) 784-789; P. Arpaia, F. Clemente, C. Romanucci, Impedance spectroscopy-based measurement of cochlear prosthesis osseointegration: in vivo test procedure and characterization, in: Proceedings of IMTC 2007, Warsaw (Poland), pp. 1786-1791]. In this paper, the design, the implementation, and the metrological characterization of a microcontroller-based prototype conceived as a stand alone instrument to be used for in vivo clinical applications are presented. Particulars on the preliminary experimental results of laboratory evaluation are presented. © 2008 Elsevier Ltd. All rights reserved.

In this paper, a digital-measurement method for low-invasive clinical diagnosis of metallic prosthesis osseointegration is proposed. Electrical impedance spectroscopy is exploited to characterize the quality of the tissue at the interface between the bone and the prosthesis. The method overcomes current resolution limits of biological electrical-impedance analysis by means of several polarization levels. Electrical modeling through an equivalent circuit is used to define a quantitative index of osseointegration. In vitro experimental results of the proposed method validation show its sensitivity and its effectiveness in low-depth prostheses, such as in dentistry applications. © 2007 IEEE.