Search results for: pacemakers follow-up

Authors: A. Mathieu, B. Aubry, E. Chhim, M. Jobe, M. Arnaud

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Present project consists in a study and a development of piezoelectric devices for supplying power to new generation pacemakers. They are miniaturized leadless implants without battery placed directly in right ventricle. Amongst different acceptable energy sources in cardiac environment, we choose the solution of a device based on conversion of the energy produced by pressure variation inside the heart into electrical energy. The proposed energy harvesters can meet the power requirements of pacemakers, and can be a good solution to solve the problem of regular surgical operation. With further development, proposed device should provide enough energy to allow pacemakers autonomy, and could be good candidate for next pacemaker generation.

Keywords: energy harvester, heart, leadless pacemaker, piezoelectric cells, pressure variation

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Authors: Antonio Lopez-Villegas, Rafael Bautista-Mesa, Emilio Robles-Musso, Daniel Catalan-Matamoros, Cesar Leal-Costa

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Objectives: The purpose of this trial was to evaluate the burden borne by and the costs to informal caregivers of users with telemonitoring of pacemakers. Methods: This is a controlled, non-randomised clinical trial, with data collected from informal caregivers, five years after implantation of pacemakers. The Spanish version of the Survey on Disabilities, Personal Autonomy, and Dependency Situations was used to get information on clinical and social characteristics, levels of professionalism, duration and types of care, difficulties in providing care, health status, economic and job aspects, impact on the family or leisure due to informal caregiving for patients with pacemakers. Results: After five years of follow-up, 55 users with pacemakers finished the study. Of which, 50 were helped by a caregiver, 18 were included in the telemonitoring group (TM) and 32 in the conventional follow-up group (HM). Overall, females represented 96.0% of the informal caregivers (88.89% in TM and 100.0% in HM group). The mean ages were 63.17 ± 15.92 and 63.13 ± 14.56 years, respectively (p = 0.83) in the groups. The majority (88.0%) of the caregivers declared that they had to provide their services between 6 and 7 days per week (83.33% in TM group versus 90.63% in HM group), without significant differences between both groups. The costs related to care provided by the informal caregivers were 47.04% higher in the conventional follow-up group than in the TM group. Conclusions: The results of this trial confirm that there were no significant differences between the informal caregivers regarding to baseline characteristics, workload and time worked in both groups of follow-up. The costs incurred by the informal caregivers providing care for users with pacemakers included in telemonitoring group are significantly lower than those in the conventional follow-up group. Trial registration: ClinicalTrials.gov NCT02234245. Funding: The PONIENTE study, has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: costs, disease burden, informal caregiving, pacemaker follow-up, remote monitoring, telemedicine

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Authors: Antonio Lopez-Villegas, Daniel Catalan-Matamoros, Remedios Lopez-Liria

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Objectives: The purpose of this study was to analyze clinical data, health-related quality of life (HRQoL) and functional capacity of patients using a telemonitoring follow-up system (TM) compared to patients followed-up through standard outpatient visits (HM) 5 years after the implantation of a pacemaker. Methods: This is a controlled, non-randomised, nonblinded clinical trial, with data collection carried out at 5 years after the pacemakers implant. The study was developed at Hospital de Poniente (Almeria, Spain), between October 2012 and November 2013. The same clinical outcomes were analyzed in both follow-up groups. Health-Related Quality of Life and Functional Capacity was assessed through EuroQol-5D (EQ-5D) questionnaire and Duke Activity Status Index (DASI) respectively. Sociodemographic characteristics and clinical data were also analyzed. Results: 5 years after pacemaker implant, 55 of 82 initial patients finished the study. Users with pacemakers were assigned to either a conventional follow-up group at hospital (HM=34, 50 initials) or a telemonitoring system group (TM=21, 32 initials). No significant differences were found between both groups according to sociodemographic characteristics, clinical data, Health-Related Quality of Life and Functional Capacity according to medical record and EQ5D and DASI questionnaires. In addition, conventional follow-up visits to hospital were reduced in 44,84% (p < 0,001) in the telemonitoring group in relation to hospital monitoring group. Conclusion: Results obtained in this study suggest that the telemonitoring of users with pacemakers is an equivalent option to conventional follow-up at hospital, in terms of Health-Related Quality of Life and Functional Capacity. Furthermore, it allows for the early detection of cardiovascular and pacemakers-related problem events and significantly reduces the number of in-hospital visits. Trial registration: ClinicalTrials.gov NCT02234245. The PONIENTE study has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: cardiovascular diseases, health-related quality of life, pacemakers follow-up, remote monitoring, telemedicine

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Authors: Leena Korpinen, Rauno Pääkkönen, Fabriziomaria Gobba, Vesa Virtanen

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The number of persons with implanted cardiac pacemakers (PM) has increased in Western countries. The aim of this paper is to investigate the possible situations where persons with a PM may be exposed to extremely low frequency (ELF) electric (EF) and magnetic fields (MF) that may disturb their PM. Based on our earlier studies, it is possible to find such high public exposure to EFs only in some places near 400 kV power lines, where an EF may disturb a PM in unipolar mode. Such EFs cannot be found near 110 kV power lines. Disturbing MFs can be found near welding machines. However, we do not have measurement data from welding. Based on literature and earlier studies at Tampere University of Technology, it is difficult to find public EF or MF exposure that is high enough to interfere with PMs.

Keywords: cardiac pacemaker, electric field, magnetic field, electrical engineering

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Authors: C. Bala Prashanth Reddy, B. Abhinay, C. Sreekar, D. V. Shobhana Priscilla

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The project aims in designing an emergency pacemaker which is capable of giving shocks to a human heart which has stopped working suddenly. A pacemaker is a machine commonly used by cardiologists. This machine is used in order to shock a human’s heart back into usage. The way the heart works is that there are small cells called pacemakers sending electrical pulses to cardiac muscles that tell the heart when to pump blood. When these electrical pulses stop, the heart stops beating. When this happens, a pacemaker is used to shock the heart muscles and the pacemakers back into action. The way this is achieved is by rubbing the two panels of the pacemaker together to create an adequate electrical current, and then the heart gets back to the normal state. The project aims in designing a system which is capable of continuously displaying the heart beat and blood pressure of a person on LCD. The concerned doctor gets the heart beat and also the blood pressure details continuously through the GSM Modem in the form of SMS alerts. In case of abnormal condition, the doctor sends message format regarding the amount of electric shock needed. Automatically the microcontroller gives the input to the pacemaker which in turn gives the shock to the patient. Heart beat monitor and display system is a portable and a best replacement for the old model stethoscope which is less efficient. The heart beat rate is calculated manually using stethoscope where the probability of error is high because the heart beat rate lies in the range of 70 to 90 per minute whose occurrence is less than 1 sec, so this device can be considered as a very good alternative instead of a stethoscope.

Keywords: missing R wave, PWM, demand pacemaker, heart

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Authors: Robin Singh, Jing-Chiou Liou

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The Internet of Things (IoT) devices are being used heavily as part of our everyday routines. Through improved communication and automated procedures, its popularity has assisted users in raising the quality of work. These devices are used in healthcare in order to better collect the patient’s data for their treatment. They are generally considered safe and secure. However, there is some possibility that some loopholes do exist which manufacturers do need to identify before some hacker takes advantage of them. For this study, we focused on two medical IoT devices which are pacemakers and hearing aids. The aim of this paper is to identify if there is any likelihood of these medical devices being hijacked and used as a botnet in Distributed Denial-Of Service attacks. Moreover, some mitigation strategies are being proposed to better secure

Keywords: cybersecurity, DDoS, IoT, medical devices

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Authors: B. Petrović, M. Petrović, L. Rutonjski, I. Djan, V. Ivanović

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Objective: Cardiac pacemakers are very sensitive to radiotherapy treatment from two sources: electromagnetic influence from the medical linear accelerator producing ionizing radiation- influencing electronics within the pacemaker, and the absorption of dose to the device. On the other hand, patients with cardiac pacemakers at the place of a tumor are rather rare, and single clinic hardly has experience with the management of such patients. The widely accepted international guidelines for management of radiation oncology patients recommend that these patients should be closely monitored and examined before, during and after radiotherapy treatment by cardiologist, and their device and condition followed up. The number of patients having both cancer and pacemaker, is growing every year, as both cancer incidence, as well as cardiac diseases incidence, are inevitably growing figures. Materials and methods: Female patient, age 69, was diagnozed with valvular cardiomyopathy and got implanted a pacemaker in 2005 and prosthetic mitral valve in 1993 (cancer was diagnosed in 2012). She was stable cardiologically and came to radiation therapy department with the diagnosis of right breast cancer, with the tumor in upper lateral quadrant of the right breast. Since she had all lymph nodes positive (28 in total), she had to have irradiated the supraclavicular region, as well as the breast with the tumor bed. She previously received chemotherapy, approved by the cardiologist. The patient was estimated to be with the high risk as device was within the field of irradiation, and the patient had high dependence on her pacemaker. The radiation therapy plan was conducted as 3D conformal therapy. The delineated target was breast with supraclavicular region, where the pacemaker was actually placed, with the addition of a pacemaker as organ at risk, to estimate the dose to the device and its components as recommended, and the breast. The targets received both 50 Gy in 25 fractions (where 20% of a pacemaker received 50 Gy, and 60% of a device received 40 Gy). The electrode to the heart received between 1 Gy and 50 Gy. Verification of dose planned and delivered was performed. Results: Evaluation of the patient status according to the guidelines and especially evaluation of all associated risks to the patient during treatment was done. Patient was irradiated by prescribed dose and followed up for the whole year, with no symptoms of failure of the pacemaker device during, or after treatment in follow up period. The functionality of a device was estimated to be unchanged, according to the parameters (electrode impedance and battery energy). Conclusion: Patient was closely monitored according to published guidelines during irradiation and afterwards. Pacemaker irradiated with the full dose did not show any signs of failure despite recommendations data, but in correlation with other published data.

Keywords: cardiac pacemaker, breast cancer, radiotherapy treatment planning, complications of treatment

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Authors: Teguh Sugiarto

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Background: This study aims to explore the fraud that occurred in the financial statements using the Benford distribution law of 1st and 2nd case study of PT AKR Corporindo Tbk. Research Methods: In this study the authors use the first digit of the analysis and the analysis of the second digit of Bedford’s law. Having obtained the results of the analysis of the first and second digits, authors will make the difference between implementations using the scale above and below 5%. The number that has the level of difference in the range of 5% above or below, then a financial report in may, to analyse in the followup to the direction of the audit investigation, and authors assume happens a confusion in the financial statements. Findings: From research done, we found that there was a difference in the results of the appearance of the first digit of the number with the proper use of Benford's law, according to PT AKR Corporindo financial reports Tbk for the fiscal year 2006-2010, above and below the level the difference in set 5%. Conclusions: From the research that has been done, it can be concluded that on PT AKR Corporindo financial report 2006, 2007, 2008, 2009 and 2010, there is a level difference of appearance of numbers according to Benford's law is significant, as presented in the table analysis.

Keywords: Benford law, first digits, second digits, Indonesian company

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Authors: Charlotte Lülf

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Migration flows cannot be tackled by single states but need to be addressed as a transnational and international responsibility. However, the current international framework staggers. Widely excluded from legal protection are people that flee from the indiscriminate effects of an armed conflict as well as people fleeing natural disasters. This paper as part of an on-going PhD Project deals with the current and partly contradicting approaches to the protection of so-called war- and climate refugees in the European Union. The analysis will emphasize and evaluate the role of the European judiciary to define, redefine and potentially expand legal protection. Changing jurisprudential practice of national and regional courts will be assessed, as will be their dialogue to interpret the international obligations of human rights law, migration laws and asylum laws in an interacting world.

Keywords: human rights law, asylum law, migration, refugee protection

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Authors: Sahra Setorg

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The purpose of this study was to determine the effect of meta-cognitive therapy on meta-cognitive defects and emotional regulation in industrial substance dependence patients. This quasi-experimental research was conducted with post-test and two-month follow-up design with control and experimental groups. The statistical population consisted of all industrial Substance dependence patients refer to addictive withdrawal clinics in Esfahan city, in Iran in 2013. 45 patients were selected from three clinics through the convenience sampling method and were randomly divided into two experimental groups (15 crack dependences, 15 amphetamine dependences) and one control group (n=15). The meta-cognitive questionnaire (MCQ) and difficulties in emotional regulation questionnaire (DERS) were used as pre-test measures and the experimental groups (crack and amphetamine) received 8 MC therapy sessions in groups. The data were analyzed via multivariate covariance statistic method by spss-18. The results showed that MCT had a significant effect in improving the meta-cognitive defects in crack and amphetamine dependences. Also, this therapy can increase the emotional regulation in both groups (p<0/05).The effect of this therapy is confirmed in two months followup. According to these findings, met-cognitive is as an interface and important variable in prevention, control, and treatment of the new industrial substance dependences.

Keywords: meta-cognitive therapy, meta-cognitive defects, emotional regulation, substance dependence disorder

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Authors: Soujanya Pasumarthi

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Inverse docking is a relatively new technique that has been used to identify potential receptor targets of small molecules. Our docking software package MDock is well suited for such an application as it is both computationally efficient, yet simultaneously shows adequate results in binding affinity predictions and enrichment tests. As a validation study, we present the first stage results of an inverse-docking study which seeks to identify potential direct targets of PRIMA-1. PRIMA-1 is well known for its ability to restore mutant p53's tumor suppressor function, leading to apoptosis in several types of cancer cells. For this reason, we believe that potential direct targets of PRIMA-1 identified in silico should be experimentally screened for their ability to inhibitcancer cell growth. The highest-ranked human protein of our PRIMA-1 docking results is oxidosqualene cyclase (OSC), which is part of the cholesterol synthetic pathway. The results of two followup experiments which treat OSC as a possible anti-cancer target are promising. We show that both PRIMA-1 and Ro 48-8071, a known potent OSC inhibitor, significantly reduce theviability of BT-474 breast cancer cells relative to normal mammary cells. In addition, like PRIMA-1, we find that Ro 48-8071 results in increased binding of mutant p53 to DNA in BT- 474cells (which highly express p53). For the first time, Ro 48-8071 is shown as a potent agent in killing human breast cancer cells. The potential of OSC as a new target for developing anticancer therapies is worth further investigation.

Keywords: inverse docking, in silico screening, protein-ligand interactions, molecular docking

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Authors: A. Bruce Janati, Muhammad Umair Khan, Naif Alghassab, Ibrahim Alzeir, Assem Mahmoud, M. Sammour

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Rationale: Lennox-Gastaut syndrome(LGS) is an electro-clinical syndrome composed of the triad of mental retardation, multiple seizure types, and the characteristic generalized slow spike-wave complexes in the EEG. In this article, we report on two patients with LGS whose brain MRI showed dysgenesis of corpus callosum(CC). We review the literature and stress the role of CC in the genesis of secondary bilateral synchrony(SBS). Method: This was a clinical study conducted at King Khalid Hospital. Results: The EEG was consistent with LGS in patient 1 and unilateral slow spike-wave complexes in patient 2. The MRI showed hypoplasia of the splenium of CC in patient 1, and global hypoplasia of CC combined with Joubert syndrome in patient 2. Conclusion: Based on the data, we proffer the following hypotheses: 1-Hypoplasia of CC interferes with functional integrity of this structure. 2-The genu of CC plays a pivotal role in the genesis of secondary bilateral synchrony. 3-Electrodecremental seizures in LGS emanate from pacemakers generated in the brain stem, in particular the mesencephalon projecting abnormal signals to the cortex via thalamic nuclei. 4-Unilateral slow spike-wave complexes in the context of mental retardation and multiple seizure types may represent a variant of LGS, justifying neuroimaging studies.

Keywords: EEG, Lennox-Gastaut syndrome, corpus callosum , MRI

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Authors: Abiodun Musbau Lawal, Benjamin Oladapo Olley

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Long Distance Truck Drivers (LDTDs) have been found to be a high-risk group in the spread of HIV/AIDS globally; perhaps, due to their high Sexual Risk Behaviours (SRBs). Interventions for reducing SRBs in trucking population have not been fully exploited. A quasi-experimental control group pretest-posttest design was used to assess the efficacy of psycho-education and behavioural skills training in reducing SRBs among LDTDs. Sixteen drivers rivers were randomly assigned into either experimental or control groups using balloting technique. A questionnaire was used as an instrument for data collection. Repeated measures t-test and independent t-test were used to test hypotheses. The intervention had a significant effect on the SRBs among LDTDs at post-test(t{7}=6.01, p<.01) and at followup (t{7}=6.42, p<.01). No significant difference in sexual risk behaviour of LDTDs at post-test and at follow-up stage. Similarly, intervention had significant effects on sexual risk behaviour at post-test (t {14}=- 4.69, p<.05) and at follow-up (t {14}= -9.56, p < .05) respectively. At post-test and follow-up stages, drivers in experimental group reported reduced SRBs than those in the control group. Drivers in an experimental group reported lower sexual risk behaviour a week after intervention as well as at three months follow-up than those in the control group. It is concluded that HIV/AIDS preventive intervention that provides the necessary informational and behavioural skills content can significantly impact long distance truck drivers sexual risk behaviours.

Keywords: HIV/AIDS interventions, long distance truck drivers, Nigeria, sexual risk behaviours

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Authors: Nadir A. Carreon, Christa Sonderer, Aakarsh Rao, Roman Lysecky

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With the advent of complex software and increased connectivity, the security of life-critical medical devices is becoming an increasing concern, particularly with their direct impact on human safety. Security is essential, but it is impossible to develop completely secure and impenetrable systems at design time. Therefore, it is important to assess the potential impact on the security and safety of exploiting a vulnerability in such critical medical systems. The common vulnerability scoring system (CVSS) calculates the severity of exploitable vulnerabilities. However, for medical devices it does not consider the unique challenges of impacts to human health and privacy. Thus, the scoring of a medical device on which human life depends (e.g., pacemakers, insulin pumps) can score very low, while a system on which human life does not depend (e.g., hospital archiving systems) might score very high. In this paper, we propose a medical vulnerability scoring system (MVSS) that extends CVSS to address the health and privacy concerns of medical devices. We propose incorporating two new parameters, namely health impact, and sensitivity impact. Sensitivity refers to the type of information that can be stolen from the device, and health represents the impact on the safety of the patient if the vulnerability is exploited (e.g., potential harm, life-threatening). We evaluate fifteen different known vulnerabilities in medical devices and compare MVSS against two state-of-the-art medical device-oriented vulnerability scoring systems and the foundational CVSS.

Keywords: common vulnerability system, medical devices, medical device security, vulnerabilities

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Authors: Liudmila Garzanova, Lidia Ananyeva, Olga Koneva, Olga Ovsyannikova, Oxana Desinova, Mayya Starovoytova, Rushana Shayahmetova, Anna Khelkovskaya-Sergeeva

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Objectives. There is very few data on changes of the musculoskeletal manifestations (artritis, arthralgia, muscle weakness, etc.) in systemic sclerosis (SSc) on rituximab (RTX) therapy. The aim of our study was to assess the severity of the musculoskeletal involvement in SSc patients (pts) and its changes during RTX therapy. Methods. Our study included 103 pts with SSc. The mean followup period was 12.6±10.7 months. The mean age was 47±12.9 years, female-87 pts (84%), the diffuse cutaneous subset of the disease had 55 pts (53%). The mean disease duration was 6.2±5.5 years. All pts had interstitial lung disease (ILD) and were positive for ANA, 67% of them were positive for antitopoisomerase-1. All patients received prednisolone at a dose of 11.3±4.5 mg/day, immunosuppressants at inclusion received 47% of them. Pts received RTX due to the ineffectiveness of previous therapy for ILD. The cumulative mean dose of RTX was 1.7±0.6 grams. Arthritis was observed in 22 pts (21%), arthralgias in 47 pts (46%). Muscle weakness was observed in 17 pts (17%). Tendon friction rubs was established in 7 pts (7%). The results at baseline and at the end of the follow up are presented in the form of mean values. Results. There was an improvement of all outcome parameters and musculoskeletal manifestations on RTX therapy. There was a decrease in the number of pts with arthritis from 22 (21%) to 10 (9%), a decrease in the number of pts with arthralgias from 47 (46%) to 31 (30%). The number of pts with muscle weakness decreased from 17 (17%) to 7 (7%). The number of pts with tendon friction rubs decreased from 7 (7%) to 3 (3%). The creatine phosphokinase decreased from 365.5±186 to 70.8±50.4 (p=0.00006). The C-reactive protein (CRP) decreased from 23.2±31.3 to 8.62±7.4 (p=0.001). The dose of prednisolone was reduced from 11.3±4.5 to 9.8±3.5 mg/day (p=0.0004). Conclusion. In our study, musculoskeletal involvement was detected in almost half of the patients with SSc-ILD. There was an improvement of musculoskeletal manifestations despite a small cumulative dose of RTX. We also managed to reduce the dose of glucocorticosteroids. The improvement of musculoskeletal manifestations was accompanied by a decrease in laboratory parameters - creatine phosphokinase and CRP. RTX is effective option for treatment of musculoskeletal manifestations in SSc.

Keywords: arthritis, musculoskeletal involvement, systemic sclerosis, rituximab

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Authors: Nir Nissim, Erez Shalom, Tomer Lancewiki, Yuval Elovici, Yuval Shahar

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Background: A Medical Device (MD) is an instrument, machine, implant, or similar device that includes a component intended for the purpose of the diagnosis, cure, treatment, or prevention of disease in humans or animals. Medical devices play increasingly important roles in health services eco-systems, including: (1) Patient Diagnostics and Monitoring; Medical Treatment and Surgery; and Patient Life Support Devices and Stabilizers. MDs are part of the medical device eco-system and are connected to the network, sending vital information to the internal medical information systems of medical centers that manage this data. Wireless components (e.g. Wi-Fi) are often embedded within medical devices, enabling doctors and technicians to control and configure them remotely. All these functionalities, roles, and uses of MDs make them attractive targets of cyber-attacks launched for many malicious goals; this trend is likely to significantly increase over the next several years, with increased awareness regarding MD vulnerabilities, the enhancement of potential attackers’ skills, and expanded use of medical devices. Significance: We propose to develop and implement Cyber-Med, a unique collaborative project of Ben-Gurion University of the Negev and the Clalit Health Services Health Maintenance Organization. Cyber-Med focuses on the development of a comprehensive detection framework that relies on a critical attack repository that we aim to create. Cyber-Med will allow researchers and companies to better understand the vulnerabilities and attacks associated with medical devices as well as providing a comprehensive platform for developing detection solutions. Methodology: The Cyber-Med detection framework will consist of two independent, but complementary detection approaches: one for known attacks, and the other for unknown attacks. These modules incorporate novel ideas and algorithms inspired by our team's domains of expertise, including cyber security, biomedical informatics, and advanced machine learning, and temporal data mining techniques. The establishment and maintenance of Cyber-Med’s up-to-date attack repository will strengthen the capabilities of Cyber-Med’s detection framework. Major Findings: Based on our initial survey, we have already found more than 15 types of vulnerabilities and possible attacks aimed at MDs and their eco-system. Many of these attacks target individual patients who use devices such pacemakers and insulin pumps. In addition, such attacks are also aimed at MDs that are widely used by medical centers such as MRIs, CTs, and dialysis engines; the information systems that store patient information; protocols such as DICOM; standards such as HL7; and medical information systems such as PACS. However, current detection tools, techniques, and solutions generally fail to detect both the known and unknown attacks launched against MDs. Very little research has been conducted in order to protect these devices from cyber-attacks, since most of the development and engineering efforts are aimed at the devices’ core medical functionality, the contribution to patients’ healthcare, and the business aspects associated with the medical device.

Keywords: medical device, cyber security, attack, detection, machine learning

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