Evaluation of international standards for ECG-recording and storage for use in tele-medical services

This report is written to clarify which of the international standards for ECG recordings that can be used in tele-medical services, where the recordings should be transmitted by wireless telecommunication facilities and finally stored as information integrated into the patients Electronic Health Record (EHR). Some principals for recording, transmission and storage of digital vital signs parameters are highlighted and important aspects of wireless communication of recorded signals from biomedical sensors are described, in order to understand the significance and differences in the storing formats to be used. Even if most of the relevant standards are not yet ratified (the last meeting in ISO TC 251 WH6 was held in October 2005), the actual international standards SCP-ECG, MFER, FDAXML and DICIOM are defined and already widely adopted. In this report, these standards are briefly described and evaluated with respect to possible use in tele-medical services, and recommendations are given in order to obtain a reliable and secure communication solution. Requirements for integration of the ECG file formats into the EHR are briefly described, and it is given some recommendations for actual standards to be used in future solutions

BioSig: The Free and Open Source Software Library for Biomedical Signal Processing

BioSig is an open source software library for biomedical signal processing. The aim of the BioSig project is to foster research in biomedical signal processing by providing free and open source software tools for many different application areas. Some of the areas where BioSig can be employed are neuroinformatics, brain-computer interfaces, neurophysiology, psychology, cardiovascular systems, and sleep research. Moreover, the analysis of biosignals such as the electroencephalogram (EEG), electrocorticogram (ECoG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), or respiration signals is a very relevant element of the BioSig project. Specifically, BioSig provides solutions for data acquisition, artifact processing, quality control, feature extraction, classification, modeling, and data visualization, to name a few. In this paper, we highlight several methods to help students and researchers to work more efficiently with biomedical signals

Design of a secure architecture for the exchange of biomedical information in m-Health scenarios

El paradigma de m-Salud (salud móvil) aboga por la integración masiva de las más avanzadas tecnologías de comunicación, red móvil y sensores en aplicaciones y sistemas de salud, para fomentar el despliegue de un nuevo modelo de atención clínica centrada en el usuario/paciente. Este modelo tiene por objetivos el empoderamiento de los usuarios en la gestión de su propia salud (p.ej. aumentando sus conocimientos, promocionando estilos de vida saludable y previniendo enfermedades), la prestación de una mejor tele-asistencia sanitaria en el hogar para ancianos y pacientes crónicos y una notable disminución del gasto de los Sistemas de Salud gracias a la reducción del número y la duración de las hospitalizaciones. No obstante, estas ventajas, atribuidas a las aplicaciones de m-Salud, suelen venir acompañadas del requisito de un alto grado de disponibilidad de la información biomédica de sus usuarios para garantizar una alta calidad de servicio, p.ej. fusionar varias señales de un usuario para obtener un diagnóstico más preciso. La consecuencia negativa de cumplir esta demanda es el aumento directo de las superficies potencialmente vulnerables a ataques, lo que sitúa a la seguridad (y a la privacidad) del modelo de m-Salud como factor crítico para su éxito. Como requisito no funcional de las aplicaciones de m-Salud, la seguridad ha recibido menos atención que otros requisitos técnicos que eran más urgentes en etapas de desarrollo previas, tales como la robustez, la eficiencia, la interoperabilidad o la usabilidad. Otro factor importante que ha contribuido a retrasar la implementación de políticas de seguridad sólidas es que garantizar un determinado nivel de seguridad implica unos costes que pueden ser muy relevantes en varias dimensiones, en especial en la económica (p.ej. sobrecostes por la inclusión de hardware extra para la autenticación de usuarios), en el rendimiento (p.ej. reducción de la eficiencia y de la interoperabilidad debido a la integración de elementos de seguridad) y en la usabilidad (p.ej. configuración más complicada de dispositivos y aplicaciones de salud debido a las nuevas opciones de seguridad). Por tanto, las soluciones de seguridad que persigan satisfacer a todos los actores del contexto de m-Salud (usuarios, pacientes, personal médico, personal técnico, legisladores, fabricantes de dispositivos y equipos, etc.) deben ser robustas y al mismo tiempo minimizar sus costes asociados. Esta Tesis detalla una propuesta de seguridad, compuesta por cuatro grandes bloques interconectados, para dotar de seguridad a las arquitecturas de m-Salud con unos costes reducidos. El primer bloque define un esquema global que proporciona unos niveles de seguridad e interoperabilidad acordes con las características de las distintas aplicaciones de m-Salud. Este esquema está compuesto por tres capas diferenciadas, diseñadas a la medidas de los dominios de m-Salud y de sus restricciones, incluyendo medidas de seguridad adecuadas para la defensa contra las amenazas asociadas a sus aplicaciones de m-Salud. El segundo bloque establece la extensión de seguridad de aquellos protocolos estándar que permiten la adquisición, el intercambio y/o la administración de información biomédica -- por tanto, usados por muchas aplicaciones de m-Salud -- pero no reúnen los niveles de seguridad detallados en el esquema previo. Estas extensiones se concretan para los estándares biomédicos ISO/IEEE 11073 PHD y SCP-ECG. El tercer bloque propone nuevas formas de fortalecer la seguridad de los tests biomédicos, que constituyen el elemento esencial de muchas aplicaciones de m-Salud de carácter clínico, mediante codificaciones novedosas. Finalmente el cuarto bloque, que se sitúa en paralelo a los anteriores, selecciona herramientas genéricas de seguridad (elementos de autenticación y criptográficos) cuya integración en los otros bloques resulta idónea, y desarrolla nuevas herramientas de seguridad, basadas en señal -- embedding y keytagging --, para reforzar la protección de los test biomédicos.The paradigm of m-Health (mobile health) advocates for the massive integration of advanced mobile communications, network and sensor technologies in healthcare applications and systems to foster the deployment of a new, user/patient-centered healthcare model enabling the empowerment of users in the management of their health (e.g. by increasing their health literacy, promoting healthy lifestyles and the prevention of diseases), a better home-based healthcare delivery for elderly and chronic patients and important savings for healthcare systems due to the reduction of hospitalizations in number and duration. It is a fact that many m-Health applications demand high availability of biomedical information from their users (for further accurate analysis, e.g. by fusion of various signals) to guarantee high quality of service, which on the other hand entails increasing the potential surfaces for attacks. Therefore, it is not surprising that security (and privacy) is commonly included among the most important barriers for the success of m-Health. As a non-functional requirement for m-Health applications, security has received less attention than other technical issues that were more pressing at earlier development stages, such as reliability, eficiency, interoperability or usability. Another fact that has contributed to delaying the enforcement of robust security policies is that guaranteeing a certain security level implies costs that can be very relevant and that span along diferent dimensions. These include budgeting (e.g. the demand of extra hardware for user authentication), performance (e.g. lower eficiency and interoperability due to the addition of security elements) and usability (e.g. cumbersome configuration of devices and applications due to security options). Therefore, security solutions that aim to satisfy all the stakeholders in the m-Health context (users/patients, medical staff, technical staff, systems and devices manufacturers, regulators, etc.) shall be robust and, at the same time, minimize their associated costs. This Thesis details a proposal, composed of four interrelated blocks, to integrate appropriate levels of security in m-Health architectures in a cost-efcient manner. The first block designes a global scheme that provides different security and interoperability levels accordingto how critical are the m-Health applications to be implemented. This consists ofthree layers tailored to the m-Health domains and their constraints, whose security countermeasures defend against the threats of their associated m-Health applications. Next, the second block addresses the security extension of those standard protocols that enable the acquisition, exchange and/or management of biomedical information | thus, used by many m-Health applications | but do not meet the security levels described in the former scheme. These extensions are materialized for the biomedical standards ISO/IEEE 11073 PHD and SCP-ECG. Then, the third block proposes new ways of enhancing the security of biomedical standards, which are the centerpiece of many clinical m-Health applications, by means of novel codings. Finally the fourth block, with is parallel to the others, selects generic security methods (for user authentication and cryptographic protection) whose integration in the other blocks results optimal, and also develops novel signal-based methods (embedding and keytagging) for strengthening the security of biomedical tests. The layer-based extensions of the standards ISO/IEEE 11073 PHD and SCP-ECG can be considered as robust, cost-eficient and respectful with their original features and contents. The former adds no attributes to its data information model, four new frames to the service model |and extends four with new sub-frames|, and only one new sub-state to the communication model. Furthermore, a lightweight architecture consisting of a personal health device mounting a 9 MHz processor and an aggregator mounting a 1 GHz processor is enough to transmit a 3-lead electrocardiogram in real-time implementing the top security layer. The extra requirements associated to this extension are an initial configuration of the health device and the aggregator, tokens for identification/authentication of users if these devices are to be shared and the implementation of certain IHE profiles in the aggregator to enable the integration of measurements in healthcare systems. As regards to the extension of SCP-ECG, it only adds a new section with selected security elements and syntax in order to protect the rest of file contents and provide proper role-based access control. The overhead introduced in the protected SCP-ECG is typically 2{13 % of the regular file size, and the extra delays to protect a newly generated SCP-ECG file and to access it for interpretation are respectively a 2{10 % and a 5 % of the regular delays. As regards to the signal-based security techniques developed, the embedding method is the basis for the proposal of a generic coding for tests composed of biomedical signals, periodic measurements and contextual information. This has been adjusted and evaluated with electrocardiogram and electroencephalogram-based tests, proving the objective clinical quality of the coded tests, the capacity of the coding-access system to operate in real-time (overall delays of 2 s for electrocardiograms and 3.3 s for electroencephalograms) and its high usability. Despite of the embedding of security and metadata to enable m-Health services, the compression ratios obtained by this coding range from ' 3 in real-time transmission to ' 5 in offline operation. Complementarily, keytagging permits associating information to images (and other signals) by means of keys in a secure and non-distorting fashion, which has been availed to implement security measures such as image authentication, integrity control and location of tampered areas, private captioning with role-based access control, traceability and copyright protection. The tests conducted indicate a remarkable robustness-capacity tradeoff that permits implementing all this measures simultaneously, and the compatibility of keytagging with JPEG2000 compression, maintaining this tradeoff while setting the overall keytagging delay in only ' 120 ms for any image size | evidencing the scalability of this technique. As a general conclusion, it has been demonstrated and illustrated with examples that there are various, complementary and structured manners to contribute in the implementation of suitable security levels for m-Health architectures with a moderate cost in budget, performance, interoperability and usability. The m-Health landscape is evolving permanently along all their dimensions, and this Thesis aims to do so with its security. Furthermore, the lessons learned herein may offer further guidance for the elaboration of more comprehensive and updated security schemes, for the extension of other biomedical standards featuring low emphasis on security or privacy, and for the improvement of the state of the art regarding signal-based protection methods and applications

The history and challenges of SCP-ECG: the standard communication protocol for computer-assisted electrocardiography

Ever since the first publication of the standard communication protocol for computer-assisted electrocardiography (SCP-ECG), prENV 1064, in 1993, by the European Committee for Standardization (CEN), SCP-ECG has become a leading example in health informatics, enabling open, secure, and well-documented digital data exchange at a low cost, for quick and efficient cardiovascular disease detection and management. Based on the experiences gained, since the 1970s, in computerized electrocardiology, and on the results achieved by the pioneering, international cooperative research on common standards for quantitative electrocardiography (CSE), SCP-ECG was designed, from the beginning, to empower personalized medicine, thanks to serial ECG analysis. The fundamental concept behind SCP-ECG is to convey the necessary information for ECG re-analysis, serial comparison, and interpretation, and to structure the ECG data and metadata in sections that are mostly optional in order to fit all use cases. SCP-ECG is open to the storage of the ECG signal and ECG measurement data, whatever the ECG recording modality or computation method, and can store the over-reading trails and ECG annotations, as well as any computerized or medical interpretation reports. Only the encoding syntax and the semantics of the ECG descriptors and of the diagnosis codes are standardized. We present all of the landmarks in the development and publication of SCP-ECG, from the early 1990s to the 2009 International Organization for Standardization (ISO) SCP-ECG standards, including the latest version published by CEN in 2020, which now encompasses rest and stress ECGs, Holter recordings, and protocol-based trials

e-SCP-ECG+ Protocol: An Expansion on SCP-ECG Protocol for Health Telemonitoring—Pilot Implementation

Standard Communication Protocol for Computer-assisted Electrocardiography (SCP-ECG) provides standardized communication among different ECG devices and medical information systems. This paper extends the use of this protocol in order to be included in health monitoring systems. It introduces new sections into SCP-ECG structure for transferring data for positioning, allergies, and five additional biosignals: noninvasive blood pressure (NiBP), body temperature (Temp), Carbon dioxide (CO2), blood oxygen saturation (SPO2), and pulse rate. It also introduces new tags in existing sections for transferring comprehensive demographic data. The proposed enhanced version is referred to as e-SCP-ECG+ protocol. This paper also considers the pilot implementation of the new protocol as a software component in a Health Telemonitoring System

The Application of Computer Techniques to ECG Interpretation

This book presents some of the latest available information on automated ECG analysis written by many of the leading researchers in the field. It contains a historical introduction, an outline of the latest international standards for signal processing and communications and then an exciting variety of studies on electrophysiological modelling, ECG Imaging, artificial intelligence applied to resting and ambulatory ECGs, body surface mapping, big data in ECG based prediction, enhanced reliability of patient monitoring, and atrial abnormalities on the ECG. It provides an extremely valuable contribution to the field

Introduction to Facial Micro Expressions Analysis Using Color and Depth Images: A Matlab Coding Approach (Second Edition, 2023)

The book attempts to introduce a gentle introduction to the field of Facial Micro Expressions Recognition (FMER) using Color and Depth images, with the aid of MATLAB programming environment. FMER is a subset of image processing and it is a multidisciplinary topic to analysis. So, it requires familiarity with other topics of Artifactual Intelligence (AI) such as machine learning, digital image processing, psychology and more. So, it is a great opportunity to write a book which covers all of these topics for beginner to professional readers in the field of AI and even without having background of AI. Our goal is to provide a standalone introduction in the field of MFER analysis in the form of theorical descriptions for readers with no background in image processing with reproducible Matlab practical examples. Also, we describe any basic definitions for FMER analysis and MATLAB library which is used in the text, that helps final reader to apply the experiments in the real-world applications. We believe that this book is suitable for students, researchers, and professionals alike, who need to develop practical skills, along with a basic understanding of the field. We expect that, after reading this book, the reader feels comfortable with different key stages such as color and depth image processing, color and depth image representation, classification, machine learning, facial micro-expressions recognition, feature extraction and dimensionality reduction. The book attempts to introduce a gentle introduction to the field of Facial Micro Expressions Recognition (FMER) using Color and Depth images, with the aid of MATLAB programming environment.Comment: This is the second edition of the boo

Early diagnosis of disorders based on behavioural shifts and biomedical signals

There are many disorders that directly affect people’s behaviour. The people that are suffering from such a disorder are not aware of their situation, and too often the disorders are identified by relatives or co-workers because they notice behavioural shifts. However, when these changes become noticeable, it is often too late and irreversible damages have already been produced. Early detection is the key to prevent severe health-related damages and healthcare costs, as well as to improve people’s quality of life. Nowadays, in full swing of ubiquitous computing paradigm, users’ behaviour patterns can be unobtrusively monitored by means of interactions with many electronic devices. The application of this technology for the problem at hand would lead to the development of systems that are able to monitor disorders’ onset and progress in an ubiquitous and unobtrusive way, thus enabling their early detection. Some attempts for the detection of specific disorders based on these technologies have been proposed, but a global methodology that could be useful for the early detection of a wide range of disorders is still missing. This thesis aims to fill that gap by presenting as main contribution a global screening methodology for the early detection of disorders based on unobtrusive monitoring of physiological and behavioural data. The proposed methodology is the result of a cross-case analysis between two individual validation scenarios: stress in the workplace and Alzheimer’s Disease (AD) at home, from which conclusions that contribute to each of the two research fields have been drawn. The analysis of similarities and differences between the two case studies has led to a complete and generalized definition of the steps to be taken for the detection of a new disorder based on ubiquitous computing.Jendearen portaeran eragin zuzena duten gaixotasun ugari daude. Hala ere, askotan, gaixotasuna pairatzen duten pertsonak ez dira euren egoerataz ohartzen, eta familiarteko edo lankideek identifikatu ohi dute berau jokabide aldaketetaz ohartzean. Portaera aldaketa hauek nabarmentzean, ordea, beranduegi izan ohi da eta atzerazeinak diren kalteak eraginda egon ohi dira. Osasun kalte larriak eta gehiegizko kostuak ekiditeko eta gaixoen bizi kalitatea hobetzeko gakoa, gaixotasuna garaiz detektatzea da. Gaur egun, etengabe zabaltzen ari den Nonahiko Konputazioaren paradigmari esker, erabiltzaileen portaera ereduak era diskretu batean monitorizatu daitezke, gailu teknologikoekin izandako interakzioari esker. Eskuartean dugun arazoari konponbidea emateko teknologi hau erabiltzeak gaixotasunen sorrera eta aurrerapena nonahi eta era diskretu batean monitorizatzeko gai diren sistemak garatzea ekarriko luke, hauek garaiz hautematea ahalbidetuz. Gaixotasun konkretu batzuentzat soluzioak proposatu izan dira teknologi honetan oinarrituz, baina metodologia orokor bat, gaixotasun sorta zabal baten detekzio goiztiarrerako erabilgarria izango dena, oraindik ez da aurkeztu. Tesi honek hutsune hori betetzea du helburu, mota honetako gaixotasunak garaiz hautemateko, era diskretu batean atzitutako datu fisiologiko eta konportamentalen erabileran oinarritzen den behaketa sistema orokor bat proposatuz. Proposatutako metodologia bi balidazio egoera desberdinen arteko analisi gurutzatu baten emaitza da: estresa lantokian eta Alzheimerra etxean, balidazio egoera bakoitzari dagozkion ekarpenak ere ondorioztatu ahal izan direlarik. Bi kasuen arteko antzekotasun eta desberdintasunen analisiak, gaixotasun berri bat nonahiko konputazioan oinarrituta detektatzeko jarraitu beharreko pausoak bere osotasunean eta era orokor batean definitzea ahalbidetu du