Search results for: medical device security
7832 A Medical Vulnerability Scoring System Incorporating Health and Data Sensitivity Metrics
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
Procedia PDF Downloads 1667831 A Review on the Re-Usage of Single-Use Medical Devices
Authors: Lucas B. Naves, Maria José Abreu
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Reprocessing single-use device has attracted interesting on the medical environment over the last decades. The reprocessing technique was sought in order to reduce the cost of purchasing the new medical device, which can achieve almost double of the price of the reprocessed product. In this manuscript, we have done a literature review, aiming the reuse of medical device that was firstly designed for single use only, but has become, more and more, effective on its reprocessing procedure. We also show the regulation, the countries which allows this procedure, the classification of these device and also the most important issue concerning the re-utilization of medical device, how to minimizing the risk of gram positive and negative bacteria, avoid cross-contamination, hepatitis B (HBV), and C (HCV) virus, and also human immunodeficiency virus (HIV).Keywords: reusing, reprocessing, single-use medical device, HIV, hepatitis B and C
Procedia PDF Downloads 3927830 Cooperative Jamming for Implantable Medical Device Security
Authors: Kim Lytle, Tim Talty, Alan Michaels, Jeff Reed
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Implantable medical devices (IMDs) are medically necessary devices embedded in the human body that monitor chronic disorders or automatically deliver therapies. Most IMDs have wireless capabilities that allow them to share data with an offboard programming device to help medical providers monitor the patient’s health while giving the patient more insight into their condition. However, serious security concerns have arisen as researchers demonstrated these devices could be hacked to obtain sensitive information or harm the patient. Cooperative jamming can be used to prevent privileged information leaks by maintaining an adequate signal-to-noise ratio at the intended receiver while minimizing signal power elsewhere. This paper uses ray tracing to demonstrate how a low number of friendly nodes abiding by Bluetooth Low Energy (BLE) transmission regulations can enhance IMD communication security in an office environment, which in turn may inform how companies and individuals can protect their proprietary and personal information.Keywords: implantable biomedical devices, communication system security, array signal processing, ray tracing
Procedia PDF Downloads 1147829 Improving Research Collaborations in Medical Device Development in Korea from an SMEs’ Perspective
Authors: Yoon Chung Kim
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In this coming aging society, medical device industry is expected to become one of the major industries. Since developing medical devices usually requires technology convergence, research collaboration is important, especially for some small and medium enterprises (SMEs) that do not have enough R&D resources in each related field. Collaboration in medical device development has some unique properties. Since it requires convergence technology, collaboration with different fields, and different types of people are often required. Since it requires clinical test, the development process usually takes longer and collaboration with hospitals is also required. However, despite these importance and uniqueness, collaboration in medical device development has not yet been widely studied. Thus, our research focuses on investigating collaborations in medical device development. For our research, we conducted surveys and interviews, especially with SMEs’ perspective in Korea. The result and discussion will be presented with a major impact factors for collaboration result, as well as future strategies that will improve and strengthen collaboration process in medical devices.Keywords: medical device, SME, research collaboration, development, clinical
Procedia PDF Downloads 3297828 Design and Implementation of a Cross-Network Security Management System
Authors: Zhiyong Shan, Preethi Santhanam, Vinod Namboodiri, Rajiv Bagai
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In recent years, the emerging network worms and attacks have distributive characteristics, which can spread globally in a very short time. Security management crossing networks to co-defense network-wide attacks and improve the efficiency of security administration is urgently needed. We propose a hierarchical distributed network security management system (HD-NSMS), which can integrate security management across multiple networks. First, we describe the system in macrostructure and microstructure; then discuss three key problems when building HD-NSMS: device model, alert mechanism, and emergency response mechanism; lastly, we describe the implementation of HD-NSMS. The paper is valuable for implementing NSMS in that it derives from a practical network security management system (NSMS).Keywords: network security management, device organization, emergency response, cross-network
Procedia PDF Downloads 1687827 Product Design and Development of Wearable Assistant Device
Authors: Hao-Jun Hong, Jung-Tang Huang
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The world is gradually becoming an aging society, and with the lack of laboring forces, this phenomenon is affecting the nation’s economy growth. Although nursing centers are booming in recent years, the lack of medical resources are yet to be resolved, thus creating an innovative wearable medical device could be a vital solution. This research is focused on the design and development of a wearable device which obtains a more precise heart failure measurement than products on the market. The method used by the device is based on the sensor fusion and big data algorithm. From the test result, the modified structure of wearable device can significantly decrease the MA (Motion Artifact) and provide users a more cozy and accurate physical monitor experience.Keywords: big data, heart failure, motion artifact, sensor fusion, wearable medical device
Procedia PDF Downloads 3507826 Analysis of Practical Guidelines for Mobile Device Security in Indonesia Based on NIST SP 1800-4
Authors: Mardiyansyah Mardiyansyah, Hendrik Maulana, Eka Kurnia Sari, Imam Baehaki, Mohammad Agus Prihandono
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Mobile device has become a key feature in Indonesian society and the economy, including government and private sector. Enterprises and government agencies already have a concern about mobile device security. However, small and medium enterprises (SME) do not have that sense yet, especially the new startups company. Indonesia has several laws, regulations, and standards for managing security in mobile devices. Currently, Indonesian information security policies have not been harmonized, each government organization and large enterprise has its own rules and policies. It leads to a conflict of interest among government agencies. This will certainly cause ineffectiveness in the implementation of policies. Therefore, an analysis of various government policies, regulations, and standards related to information security, especially on mobile devices, is carried out. This analysis is conducted to map the existing regulatory policies and standards into practical guidelines regarding NIST's information security to show the effectiveness of NIST SP 1800-4 towards existing policies. This work focused on the mapping of the NIST SP 1800-4 framework towards existing regulations, standards, and guidelines in Indonesia. The research approach is literature study to identify existing regulations, standards, and guidelines then the regulation mapped into the NIST SP 1800-4 framework and analyzed whether the framework could be applied to the organization in Indonesia. Finally, the finding and recommendations by documenting the security characteristics can be concluded. Based on the research finding, some of the regulations, standards, and guidelines in Indonesia are relevant to the elements in the NIST SP 1800-4 framework. From mapping analysis, the strength and weakness of mobile device security in Indonesia can be reported. It also can be concluded that the application of NIST SP 1800-4 can improve the effectiveness of mobile device security policies in Indonesia.Keywords: mobile security, mobile security framework, NIST SP 1800-4, regulations
Procedia PDF Downloads 1527825 Forensic Challenges in Source Device Identification for Digital Videos
Authors: Mustapha Aminu Bagiwa, Ainuddin Wahid Abdul Wahab, Mohd Yamani Idna Idris, Suleman Khan
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Video source device identification has become a problem of concern in numerous domains especially in multimedia security and digital investigation. This is because videos are now used as evidence in legal proceedings. Source device identification aim at identifying the source of digital devices using the content they produced. However, due to affordable processing tools and the influx in digital content generating devices, source device identification is still a major problem within the digital forensic community. In this paper, we discuss source device identification for digital videos by identifying techniques that were proposed in the literature for model or specific device identification. This is aimed at identifying salient open challenges for future research.Keywords: video forgery, source camcorder, device identification, forgery detection
Procedia PDF Downloads 6317824 Supporting Embedded Medical Software Development with MDevSPICE® and Agile Practices
Authors: Surafel Demissie, Frank Keenan, Fergal McCaffery
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Emerging medical devices are highly relying on embedded software that runs on the specific platform in real time. The development of embedded software is different from ordinary software development due to the hardware-software dependency. MDevSPICE® has been developed to provide guidance to support such development. To increase the flexibility of this framework agile practices have been introduced. This paper outlines the challenges for embedded medical device software development and the structure of MDevSPICE® and suggests a suitable combination of agile practices that will help to add flexibility and address corresponding challenges of embedded medical device software development.Keywords: agile practices, challenges, embedded software, MDevSPICE®, medical device
Procedia PDF Downloads 2647823 Design and Implementation of a Nano-Power Wireless Sensor Device for Smart Home Security
Authors: Chia-Chi Chang
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Most battery-driven wireless sensor devices will enter in sleep mode as soon as possible to extend the overall lifetime of a sensor network. It is necessary to turn off unnecessary radio and peripheral functions, especially the radio unit always consumes more energy than other components during wireless communication. The microcontroller is the most important part of the wireless sensor device. It is responsible for the manipulation of sensing data and communication protocols. The microcontroller always has different sleep modes, each with a different level of energy usage. The deeper the sleep, the lower the energy consumption. Most wireless sensor devices can only enter the sleep mode: the external low-frequency oscillator is still running to wake up the sleeping microcontroller when the sleep timer expires. In this paper, our sensor device can enter the extended sleep mode: none of the oscillator is running and the wireless sensor device has the nanoampere consumption and self-awaking ability. Finally, these wireless sensor devices were deployed in a smart home security network.Keywords: wireless sensor network, battery-driven, sleep mode, home security
Procedia PDF Downloads 3077822 Analysis of Threats in Interoperability of Medical Devices
Authors: M. Sandhya, R. M. Madhumitha, Sharmila Sankar
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Interoperable medical devices (IMDs) face threats due to the increased attack surface accessible by interoperability and the corresponding infrastructure. Initiating networking and coordination functionalities primarily modify medical systems' security properties. Understanding the threats is a vital first step in ultimately crafting security solutions for such systems. The key to this problem is coming up with some common types of threats or attacks with those of security and privacy, and providing this information as a roadmap. This paper analyses the security issues in interoperability of devices and presents the main types of threats that have to be considered to build a secured system.Keywords: interoperability, threats, attacks, medical devices
Procedia PDF Downloads 3337821 Enhanced Visual Sharing Method for Medical Image Security
Authors: Kalaivani Pachiappan, Sabari Annaji, Nithya Jayakumar
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In recent years, Information security has emerged as foremost challenges in many fields. Especially in medical information systems security is a major issue, in handling reports such as patients’ diagnosis and medical images. These sensitive data require confidentiality for transmission purposes. Image sharing is a secure and fault-tolerant method for protecting digital images, which can use the cryptography techniques to reduce the information loss. In this paper, visual sharing method is proposed which embeds the patient’s details into a medical image. Then the medical image can be divided into numerous shared images and protected by various users. The original patient details and medical image can be retrieved by gathering the shared images.Keywords: information security, medical images, cryptography, visual sharing
Procedia PDF Downloads 4147820 Photoplethysmography-Based Device Designing for Cardiovascular System Diagnostics
Authors: S. Botman, D. Borchevkin, V. Petrov, E. Bogdanov, M. Patrushev, N. Shusharina
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In this paper, we report the development of the device for diagnostics of cardiovascular system state and associated automated workstation for large-scale medical measurement data collection and analysis. It was shown that optimal design for the monitoring device is wristband as it represents engineering trade-off between accuracy and usability. The monitoring device is based on the infrared reflective photoplethysmographic sensor, which allows collecting multiple physiological parameters, such as heart rate and pulsing wave characteristics. Developed device use BLE interface for medical and supplementary data transmission to the coupled mobile phone, which process it and send it to the doctor's automated workstation. Results of this experimental model approbation confirmed the applicability of the proposed approach.Keywords: cardiovascular diseases, health monitoring systems, photoplethysmography, pulse wave, remote diagnostics
Procedia PDF Downloads 4927819 Intrusion Detection System Based on Peer to Peer
Authors: Alireza Pour Ebrahimi, Vahid Abasi
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Recently by the extension of internet usage, Research on the intrusion detection system takes a significant importance. Many of improvement systems prevent internal and external network attacks by providing security through firewalls and antivirus. In recently years, intrusion detection systems gradually turn from host-based systems and depend on O.S to the distributed systems which are running on multiple O.S. In this work, by considering the diversity of computer networks whit respect to structure, architecture, resource, services, users and also security goals requirement a fully distributed collaborative intrusion detection system based on peer to peer architecture is suggested. in this platform each partner device (matched device) considered as a peer-to-peer network. All transmitted information to network are visible only for device that use security scanning of a source. Experimental results show that the distributed architecture is significantly upgradeable in respect to centralized approach.Keywords: network, intrusion detection system, peer to peer, internal and external network
Procedia PDF Downloads 5477818 Bring Your Own Device Security Model in a Financial Institution of South Africa
Authors: Michael Nthabiseng Moeti, Makhulu Relebogile Langa, Joey Jansen van Vuuren
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This paper examines the utilization of personal electronic devices like laptops, tablets, and smartphones for professional duties within a financial organization. This phenomenon is known as bring your own device (BYOD). BYOD accords employees the freedom to use their personal devices to access corporate resources from anywhere in the world with Internet access. BYOD arrangements introduce significant security risks for both organizations and users. These setups change the threat landscape for enterprises and demand unique security strategies, as conventional tools tailored for safeguarding managed devices fall short in adequately protecting enterprise assets without active user cooperation. This paper applies protection motivation theory (PMT) to highlight behavioral risks from BYOD users that may impact the security of financial institutions. Thematic analysis was applied to gain a comprehensive understanding of how users perceive this phenomenon. These findings demonstrates that the existence of a security policy does not ensure that all employees will take measures to protect their personal devices. Active promotion of BYOD security policies is crucial for financial institution employees and management. This paper developed a BYOD security model which is useful for understanding compliant behaviors. Given that BYOD security is becoming a major concern across financial sector, it is important. The paper recommends that future research could expand the number of universities from which data is collected.Keywords: BYOD, information security, protection motivation theory, security risks, thematic analysis
Procedia PDF Downloads 317817 Cyber-Med: Practical Detection Methodology of Cyber-Attacks Aimed at Medical Devices Eco-Systems
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
Procedia PDF Downloads 3567816 Device to Alert and Fire Prevention through Temperature Monitoring and Gas Detection
Authors: Dêivisson Alves Anjos, Blenda Fonseca Aires Teles, Queitiane Castro Costa
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Fire is one of the biggest dangers for factories, warehouses, mills, among other places, causing unimaginable damage, because besides the material damage also directly affects the lives of workers who are likely to suffer death or very serious consequences. This protection of the lives of these people should be taken seriously, always seeking safety. Thus investment in security and monitoring equipment must be high, so you can prevent or reduce the impacts of a possible fire. Our device, made in PIC micro controller monitors the temperature and the presence of gas in the environment, it sends the data via Bluetooth device to a developed in LabVIEW interface saves these data continuously and alert if the temperature exceeds the allowed or some gas is detected. Currently the device is in operation and can perform several tests, as well as use in different areas for which you need anti-fire protection.Keywords: pic, bluetooth, fire, temperature, gas, LabVIEW
Procedia PDF Downloads 5327815 A Fuzzy Decision Making Approach for Supplier Selection in Healthcare Industry
Authors: Zeynep Sener, Mehtap Dursun
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Supplier evaluation and selection is one of the most important components of an effective supply chain management system. Due to the expanding competition in healthcare, selecting the right medical device suppliers offers great potential for increasing quality while decreasing costs. This paper proposes a fuzzy decision making approach for medical supplier selection. A real-world medical device supplier selection problem is presented to illustrate the application of the proposed decision methodology.Keywords: fuzzy decision making, fuzzy multiple objective programming, medical supply chain, supplier selection
Procedia PDF Downloads 4517814 New Advanced Medical Software Technology Challenges and Evolution of the Regulatory Framework in Expert Software, Artificial Intelligence, and Machine Learning
Authors: Umamaheswari Shanmugam, Silvia Ronchi
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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems
Procedia PDF Downloads 887813 Hyperchaos-Based Video Encryption for Device-To-Device Communications
Authors: Samir Benzegane, Said Sadoudi, Mustapha Djeddou
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In this paper, we present a software development of video streaming encryption for Device-to-Device (D2D) communications by using Hyperchaos-based Random Number Generator (HRNG) implemented in C#. The software implements and uses the proposed HRNG to generate key stream for encrypting and decrypting real-time video data. The used HRNG consists of Hyperchaos Lorenz system which produces four signal outputs taken as encryption keys. The generated keys are characterized by high quality randomness which is confirmed by passing standard NIST statistical tests. Security analysis of the proposed encryption scheme confirms its robustness against different attacks.Keywords: hyperchaos Lorenz system, hyperchaos-based random number generator, D2D communications, C#
Procedia PDF Downloads 3717812 Enhanced Model for Risk-Based Assessment of Employee Security with Bring Your Own Device Using Cyber Hygiene
Authors: Saidu I. R., Shittu S. S.
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As the trend of personal devices accessing corporate data continues to rise through Bring Your Own Device (BYOD) practices, organizations recognize the potential cost reduction and productivity gains. However, the associated security risks pose a significant threat to these benefits. Often, organizations adopt BYOD environments without fully considering the vulnerabilities introduced by human factors in this context. This study presents an enhanced assessment model that evaluates the security posture of employees in BYOD environments using cyber hygiene principles. The framework assesses users' adherence to best practices and guidelines for maintaining a secure computing environment, employing scales and the Euclidean distance formula. By utilizing this algorithm, the study measures the distance between users' security practices and the organization's optimal security policies. To facilitate user evaluation, a simple and intuitive interface for automated assessment is developed. To validate the effectiveness of the proposed framework, design science research methods are employed, and empirical assessments are conducted using five artifacts to analyze user suitability in BYOD environments. By addressing the human factor vulnerabilities through the assessment of cyber hygiene practices, this study aims to enhance the overall security of BYOD environments and enable organizations to leverage the advantages of this evolving trend while mitigating potential risks.Keywords: security, BYOD, vulnerability, risk, cyber hygiene
Procedia PDF Downloads 767811 Secrecy Analysis in Downlink Cellular Networks in the Presence of D2D Pairs and Hardware Impairment
Authors: Mahdi Rahimi, Mohammad Mahdi Mojahedian, Mohammad Reza Aref
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In this paper, a cellular communication scenario with a transmitter and an authorized user is considered to analyze its secrecy in the face of eavesdroppers and the interferences propagated unintentionally through the communication network. It is also assumed that some D2D pairs and eavesdroppers are randomly located in the cell. Assuming hardware impairment, perfect connection probability is analytically calculated, and upper bound is provided for the secrecy outage probability. In addition, a method based on random activation of D2Ds is proposed to improve network security. Finally, the analytical results are verified by simulations.Keywords: physical layer security, stochastic geometry, device-to-device, hardware impairment
Procedia PDF Downloads 1827810 Modelling and Simulation of Single Mode Optical Fiber Directional Coupler for Medical Application
Authors: Shilpa Kulkarni, Sujata Patrikar
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A single-mode fiber directional coupler is modeled and simulated for its application in medical field. Various fiber devices based on evanescent field absorption, interferometry, couplers, resonators, tip coated fibers, etc, have been developed so far, suitable for medical application. This work focuses on the possibility of sensing by single mode fiber directional coupler. In the preset work, a fiber directional coupler is modeled to detect the changes taking place in the surrounding medium optoelectronically. In this work, waveguiding characteristics of the fiber are studied in depth. The sensor is modeled and simulated by finding photocurrent, sensitivity and detection limit by varying various parameters of the directional coupler. The device is optimized for the best possible output. It is found that the directional coupler shows measurable photocurrents and good sensitivity with coupling length in micrometers. It is thus a miniature device, hence, suitable for medical applications.Keywords: single mode fiber directional coupler, modeling and simulation of fiber directional coupler sensor, biomolecular sensing, medical sensor device
Procedia PDF Downloads 2737809 Management and Evaluation of Developing Medical Device Software in Compliance with Rules
Authors: Arash Sepehri bonab
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One of the regions of critical development in medical devices has been the part of the software - as an indispensable component of a therapeutic device, as a standalone device, and more as of late, as applications on portable gadgets. The chance related to a breakdown of the standalone computer program utilized inside healthcare is in itself not a model for its capability or not as a medical device. It is, subsequently, fundamental to clarify a few criteria for the capability of a stand-alone computer program as a medical device. The number of computer program items and therapeutic apps is persistently expanding and so as well is used in wellbeing education (e. g., in clinics and doctors' surgeries) for determination and treatment. Within the last decade, the use of information innovation in healthcare has taken a developing part. In reality, the appropriation of an expanding number of computer devices has driven several benefits related to the method of quiet care and permitted simpler get to social and health care assets. At the same time, this drift gave rise to modern challenges related to the usage of these modern innovations. The program utilized in healthcare can be classified as therapeutic gadgets depending on the way they are utilized and on their useful characteristics. In the event that they are classified as therapeutic gadgets, they must fulfill particular directions. The point of this work is to show a computer program improvement system that can permit the generation of secure and tall, quality restorative gadget computer programs and to highlight the correspondence between each program advancement stage and the fitting standard and/or regulation.Keywords: medical devices, regulation, software, development, healthcare
Procedia PDF Downloads 1087808 Lightweight and Seamless Distributed Scheme for the Smart Home
Authors: Muhammad Mehran Arshad Khan, Chengliang Wang, Zou Minhui, Danyal Badar Soomro
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Security of the smart home in terms of behavior activity pattern recognition is a totally dissimilar and unique issue as compared to the security issues of other scenarios. Sensor devices (low capacity and high capacity) interact and negotiate each other by detecting the daily behavior activity of individuals to execute common tasks. Once a device (e.g., surveillance camera, smart phone and light detection sensor etc.) is compromised, an adversary can then get access to a specific device and can damage daily behavior activity by altering the data and commands. In this scenario, a group of common instruction processes may get involved to generate deadlock. Therefore, an effective suitable security solution is required for smart home architecture. This paper proposes seamless distributed Scheme which fortifies low computational wireless devices for secure communication. Proposed scheme is based on lightweight key-session process to upheld cryptic-link for trajectory by recognizing of individual’s behavior activities pattern. Every device and service provider unit (low capacity sensors (LCS) and high capacity sensors (HCS)) uses an authentication token and originates a secure trajectory connection in network. Analysis of experiments is revealed that proposed scheme strengthens the devices against device seizure attack by recognizing daily behavior activities, minimum utilization memory space of LCS and avoids network from deadlock. Additionally, the results of a comparison with other schemes indicate that scheme manages efficiency in term of computation and communication.Keywords: authentication, key-session, security, wireless sensors
Procedia PDF Downloads 3187807 New Advanced Medical Software Technology Challenges and Evolution of the Regulatory Framework in Expert Software, Artificial Intelligence, and Machine Learning
Authors: Umamaheswari Shanmugam, Silvia Ronchi, Radu Vornicu
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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that are able to use the large amount and variety of data generated during healthcare services every day. As we read the news, over 500 machine learning or other artificial intelligence medical devices have now received FDA clearance or approval, the first ones even preceding the year 2000. One of the big advantages of these new technologies is the ability to get experience and knowledge from real-world use and to continuously improve their performance. Healthcare systems and institutions can have a great benefit because the use of advanced technologies improves the same time efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and also to protect patients’ safety. The evolution and the continuous improvement of software used in healthcare must take into consideration the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device approval, but they are necessary to ensure performance, quality, and safety, and at the same time, they can be a business opportunity if the manufacturer is able to define in advance the appropriate regulatory strategy. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems.
Procedia PDF Downloads 897806 Security Features for Remote Healthcare System: A Feasibility Study
Authors: Tamil Chelvi Vadivelu, Nurazean Maarop, Rasimah Che Yusoff, Farhana Aini Saludin
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Implementing a remote healthcare system needs to consider many security features. Therefore, before any deployment of the remote healthcare system, a feasibility study from the security perspective is crucial. Remote healthcare system using WBAN technology has been used in other countries for medical purposes but in Malaysia, such projects are still not yet implemented. This study was conducted qualitatively. The interview results involving five healthcare practitioners are further elaborated. The study has addressed four important security features in order to incorporate remote healthcare system using WBAN in Malaysian government hospitals.Keywords: remote healthcare, IT security, security features, wireless sensor application
Procedia PDF Downloads 3067805 Highly-Efficient Photoreaction Using Microfluidic Device
Authors: Shigenori Togashi, Yukako Asano
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We developed an effective microfluidic device for photoreactions with low reflectance and good heat conductance. The performance of this microfluidic device was tested by carrying out a photoreactive synthesis of benzopinacol and acetone from benzophenone and 2-propanol. The yield reached 36% with an irradiation time of 469.2 s and was improved by more than 30% when compared to the values obtained by the batch method. Therefore, the microfluidic device was found to be effective for improving the yields of photoreactions.Keywords: microfluidic device, photoreaction, black aluminum oxide, benzophenone, yield improvement
Procedia PDF Downloads 2427804 Analysis of Security Vulnerabilities for Mobile Health Applications
Authors: Yuli Paola Cifuentes Sanabria, Lina Paola Beltrán Beltrán, Leonardo Juan Ramírez López
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The availability to deploy mobile applications for healthcare is increasing daily thru different mobile app stores. But within these capabilities the number of hacking attacks has also increased, in particular into medical mobile applications. The security vulnerabilities in medical mobile apps can be triggered by errors in code, incorrect logic, poor design, among other parameters. This is usually used by malicious attackers to steal or modify the users’ information. The aim of this research is to analyze the vulnerabilities detected in mobile medical apps according to risk factor standards defined by OWASP in 2014.Keywords: mHealth apps, OWASP, protocols, security vulnerabilities, risk factors
Procedia PDF Downloads 5177803 Development of Affordable and Reliable Diagnostic Tools to Record Vital Parameters for Improving Health Care in Low Resources Settings
Authors: Mannan Mridha, Usama Gazay, Kosovare V. Aslani, Hugo Linder, Alice Ravizza, Carmelo de Maria
Abstract:
In most developing countries, although the vast majority of the people are living in the rural areas, the qualified medical doctors are not available there. Health care workers and paramedics, called village doctors, informal healthcare providers, are largely responsible for the rural medical care. Mishaps due to wrong diagnosis and inappropriate medication have been causing serious suffering that is preventable. While innovators have created many devices, the vast majority of these technologies do not find applications to address the needs and conditions in low-resource settings. The primary motive is to address the acute lack of affordable medical technologies for the poor people in low-resource settings. A low cost smart medical device that is portable, battery operated and can be used at any point of care has been developed to detect breathing rate, electrocardiogram (ECG) and arterial pulse rate to improve diagnosis and monitoring of patients and thus improve care and safety. This simple and easy to use smart medical device can be used, managed and maintained effectively and safely by any health worker with some training. In order to empower the health workers and village doctors, our device is being further developed to integrate with ICT tools like smart phones and connect to the medical experts wherever available, to manage the serious health problems.Keywords: e-health for low resources settings, health awareness education, improve patient care and safety, smart and affordable medical device
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