Novel sensor technology integration for outcome-based risk analysis in diabetes

Novel sensor-based continuous biomedical monitoring technologies have a major role in chronic disease management for early detection and prevention of known adverse trends. In the future, a diversity of physiological, biochemical and mechanical sensing principles will be available through sensor device 'ecosystems'. In anticipation of these sensor-based ecosystems, we have developed Healthcare@Home (HH) - a research-phase generic intervention-outcome monitoring framework. HH incorporates a closed-loop intervention effect analysis engine to evaluate the relevance of measured (sensor) input variables to system-defined outcomes. HH offers real-world sensor type validation by evaluating the degree to which sensor-derived variables are relevant to the predicted outcome. This 'index of relevance' is essential where clinical decision support applications depend on sensor inputs. HH can help determine system-integrated cost-utility ratios of bespoke sensor families within defined applications - taking into account critical factors like device robustness / reliability / reproducibility, mobility / interoperability, authentication / security and scalability / usability. Through examples of hardware / software technologies incorporated in the HH end-to-end monitoring system, this paper discusses aspects of novel sensor technology integration for outcome-based risk analysis in diabetes

The reality of home remote patient monitoring: A thesis on the nature, dynamics and effects of telehealth

Chronic diseases are very complex conditions in which two or m ore disease processes may coexist. Managing patients with chronic conditions represents a major challenge to public health, since eighty per cent of GP consultations are related to these groups. Further more, five per cent of them represent roughly forty two per cent of the total acute day bed occupancy. Nowadays, the tendency is to bring patients from high levels of care to primary care and home settings. In this scenario, telehealth is one of the methods that can be used to improve and provide access to remote patient monitoring at home. This is important for patients with chronic diseases as it can help to recognise any signs of deterioration, provide health education and support management of their condition. Potentially, telehealth can reduce deaths, emergency visits, A&E visits, elective admissions, bed stays and costs. This can be done by designing and implementing telehealth interventions that help reduce unnecessary referrals to specialised services and monitor patients remotely at home. However, there is not a unique framework for designing telehealth interventions. In order to design a robust, accurate and reliable telehealth intervention, a number of important factors have to be taken into account. A review of three systematic reviews, and an in-depth investigation of a case study based on an EU funded project, were used to gather the evidence for telehealth interventions. These were used to identify the main components of the framework proposed. The investigation focused primarily on home monitoring for patients with diabetes, asthma, hypertension and COPD. We concluded that factors such as usability, safe intervention, patients’ individual requirements, training, safe interventions, ease of use, data integration, development of procedures and allocation of appropriate staff are important components that need to be considered in order to satisfy a robust framework

Holistic System Design for Distributed National eHealth Services

publishedVersio

Real-time signal detection and classification algorithms for body-centered systems

El principal motivo por el cual los sistemas de comunicación en el entrono corporal se desean con el objetivo de poder obtener y procesar señales biométricas para monitorizar e incluso tratar una condición médica sea ésta causada por una enfermedad o el rendimiento de un atleta. Dado que la base de estos sistemas está en la sensorización y el procesado, los algoritmos de procesado de señal son una parte fundamental de los mismos. Esta tesis se centra en los algoritmos de tratamiento de señales en tiempo real que se utilizan tanto para monitorizar los parámetros como para obtener la información que resulta relevante de las señales obtenidas. En la primera parte se introduce los tipos de señales y sensores en los sistemas en el entrono corporal. A continuación se desarrollan dos aplicaciones concretas de los sistemas en el entorno corporal así como los algoritmos que en las mismas se utilizan. La primera aplicación es el control de glucosa en sangre en pacientes con diabetes. En esta parte se desarrolla un método de detección mediante clasificación de patronones de medidas erróneas obtenidas con el monitor contínuo comercial "Minimed CGMS". La segunda aplicacióin consiste en la monitorizacióni de señales neuronales. Descubrimientos recientes en este campo han demostrado enormes posibilidades terapéuticas (por ejemplo, pacientes con parálisis total que son capaces de comunicarse con el entrono gracias a la monitorizacióin e interpretación de señales provenientes de sus neuronas) y también de entretenimiento. En este trabajo, se han desarrollado algoritmos de detección, clasificación y compresión de impulsos neuronales y dichos algoritmos han sido evaluados junto con técnicas de transmisión inalámbricas que posibiliten una monitorización sin cables. Por último, se dedica un capítulo a la transmisión inalámbrica de señales en los sistemas en el entorno corporal. En esta parte se estudia las condiciones del canal que presenta el entorno corporal para la transmisión de sTraver Sebastiá, L. (2012). Real-time signal detection and classification algorithms for body-centered systems [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/16188Palanci

Dia-Continua: An Information System for Type 1 Diabetes Consultation. (Interoperability, Privacy, and Information Quality on a FHIR-Based Information System for Type 1 Diabetes Consultations based on Patient-Generated Health Data)

Patient-generated health data (PGHD) is required to monitor chronic conditions like Type 1 Diabetes (T1D). This data includes information from medical devices like insulin pumps and continuous glucose monitors and lifestyle insights from commercial wearables devices such as smartwatches. To improve the quality of medical consultations, we need a unified information system that can integrate PGHD. Designing such a system will pose several challenges. The system should be able to navigate through fragmented information and the complexities of various data formats, proprietary interfaces, and storage methods while ensuring robust security, privacy, and adherence to data ownership principles. It should also enable controlled data sharing with healthcare providers (HCPs) and external entities such as national registries and informal caregivers. This dissertation details designing, developing, and testing an information system for individuals with T1D. The project involved integrative research in health informatics, collaboration with international projects, and collaboration with experienced users and HCPs to address three research questions. These questions focused on interoperability, the security and privacy of the information collected, and the quality of the information presented during consultations. The result is Dia-Continua, a Fast Healthcare Interoperability Resources (FHIR)-based information system with a microservices architecture orchestrated through Kubernetes on an Infrastructure as a Service (IaaS) platform. The system integrates data from various diabetes management devices, questionnaires, and PGHD. Furthermore, using SMART on FHIR for authorization and authentication enables data sharing and reuse with national registries and informal caregivers. Eleven interviews with HCPs evaluated Dia-Continua's new functionalities and information quality. Despite the limitations due to proprietary device systems, the system was assessed positively by HCPs, highlighting the need for a system like Dia-Continua that includes physical activity, sleep, and stress in medical consultations. Dia-Continua is a significant step for a patient-centred model for consultations in T1D. Future work should expand the system's model to other chronic diseases.Utviklingen av medisinske konsultasjoner for kroniske tilstander, spesifikt Type 1 Diabetes (T1D), avhenger i stor grad av pasientgenererte helsedata (PGHD). Disse dataene inkluderer informasjon fra medisinsk utstyr slik som insulinpumper, CGM, samt livsstils data fra kommersielt utstyr som sensorer på smartklokker og smarte ringer. Et helhetlig informasjonssystem som kan integrere PGHD er nødvendig for å forbedre informasjonskvalitet under medisinske konsultasjoner. Imidlertid bør et slikt system være i stand til å la brukeren navigere gjennom fragmentert informasjon og komplekse heterogene dataformater, proprietære grensesnitt og lagringsmetoder, samtidig som systemet sikrer robust sikkerhet, personvern og ivaretakelse av prinsipper for eierskap til data. Systemet bør også muliggjøre kontrollert deling av data med helsepersonell og eksterne aktører slik som nasjonale registre (Noklus) og pasientens omsorgspersoner. Denne avhandlingen beskriver design, utvikling, testing og evaluering av et nytt informasjonssystem for T1D basert på pasientens egne data. Prosjektet har involvert ulike samarbeidspartnere og profesjoner, samt samarbeid med internasjonale prosjekter, erfarne brukere og HP for å adressere de tre forskningsspørsmålene i prosjektet. Ett av resultatene er systemet Dia-Continua, et Fast Healthcare Interoperability Resources (FHIR)-basert informasjonssystem med en Microservice arkitektur orkestrert gjennom Kubernetes på en infrastruktur som en tjenesteplattform (Azure). Systemet integrerer data fra ulike diabetesenheter, spørreskjemaer og andre sensorer. Videre, ved å bruke «SMART on FHIR» for autorisasjon og autentisering, muliggjøres deling og gjenbruk av data med nasjonale registre og uformelle omsorgspersoner. Elleve intervjuer med helsepersonell ble gjort for å evaluere Dia-Continua sine nye funksjonaliteter, samt dets informasjonskvalitet. Til tross for begrensningene på grunn av proprietære standarder, ble systemet positivt mottatt av HP. Informantene understreket behovet for et system som Dia-Continua som inkluderer fysisk aktivitet, søvn og stress i medisinske konsultasjoner. Dia-Continua er et betydelig skritt fram mot en pasientsentrert modell for konsultasjoner i T1D. Fremtidig arbeid bør utvide systemets modell til andre kroniske sykdommer

An ontology-driven architecture for data integration and management in home-based telemonitoring scenarios

The shift from traditional medical care to the use of new technology and engineering innovations is nowadays an interesting and growing research area mainly motivated by a growing population with chronic conditions and disabilities. By means of information and communications technologies (ICTs), telemedicine systems offer a good solution for providing medical care at a distance to any person in any place at any time. Although significant contributions have been made in this field in recent decades, telemedicine and in e-health scenarios in general still pose numerous challenges that need to be addressed by researchers in order to take maximum advantage of the benefits that these systems provide and to support their long-term implementation. The goal of this research thesis is to make contributions in the field of home-based telemonitoring scenarios. By periodically collecting patients' clinical data and transferring them to physicians located in remote sites, patient health status supervision and feedback provision is possible. This type of telemedicine system guarantees patient supervision while reducing costs (enabling more autonomous patient care and avoiding hospital over flows). Furthermore, patients' quality of life and empowerment are improved. Specifically, this research investigates how a new architecture based on ontologies can be successfully used to address the main challenges presented in home-based telemonitoring scenarios. The challenges include data integration, personalized care, multi-chronic conditions, clinical and technical management. These are the principal issues presented and discussed in this thesis. The proposed new ontology-based architecture takes into account both practical and conceptual integration issues and the transference of data between the end points of the telemonitoring scenario (i.e, communication and message exchange). The architecture includes two layers: 1) a conceptual layer and 2) a data and communication layer. On the one hand, the conceptual layer based on ontologies is proposed to unify the management procedure and integrate incoming data from all the sources involved in the telemonitoring process. On the other hand, the data and communication layer based on web service technologies is proposed to provide practical back-up to the use of the ontology, to provide a real implementation of the tasks it describes and thus to provide a means of exchanging data. This architecture takes advantage of the combination of ontologies, rules, web services and the autonomic computing paradigm. All are well-known technologies and popular solutions applied in the semantic web domain and network management field. A review of these technologies and related works that have made use of them is presented in this thesis in order to understand how they can be combined successfully to provide a solution for telemonitoring scenarios. The design and development of the ontology used in the conceptual layer led to the study of the autonomic computing paradigm and its combination with ontologies. In addition, the OWL (Ontology Web Language) language was studied and selected to express the required knowledge in the ontology while the SPARQL language was examined for its effective use in defining rules. As an outcome of these research tasks, the HOTMES (Home Ontology for Integrated Management in Telemonitoring Scenarios) ontology, presented in this thesis, was developed. The combination of the HOTMES ontology with SPARQL rules to provide a flexible solution for personalising management tasks and adapting the methodology for different management purposes is also discussed. The use of Web Services (WSs) was investigated to support the exchange of information defined in the conceptual layer of the architecture. A generic ontology based solution was designed to integrate data and management procedures in the data and communication layer of the architecture. This is an innovative REST-inspired architecture that allows information contained in an ontology to be exchanged in a generic manner. This layer structure and its communication method provide the approach with scalability and re-usability features. The application of the HOTMES-based architecture has been studied for clinical purposes following three simple methodological stages described in this thesis. Data and management integration for context-aware and personalized monitoring services for patients with chronic conditions in the telemonitoring scenario are thus addressed. In particular, the extension of the HOTMES ontology defines a patient profile. These profiles in combination with individual rules provide clinical guidelines aiming to monitor and evaluate the evolution of the patient's health status evolution. This research implied a multi-disciplinary collaboration where clinicians had an essential role both in the ontology definition and in the validation of the proposed approach. Patient profiles were defined for 16 types of different diseases. Finally, two solutions were explored and compared in this thesis to address the remote technical management of all devices that comprise the telemonitoring scenario. The first solution was based on the HOTMES ontology-based architecture. The second solution was based on the most popular TCP/IP management architecture, SNMP (Simple Network Management Protocol). As a general conclusion, it has been demonstrated that the combination of ontologies, rules, WSs and the autonomic computing paradigm takes advantage of the main benefits that these technologies can offer in terms of knowledge representation, work flow organization, data transference, personalization of services and self-management capabilities. It has been proven that ontologies can be successfully used to provide clear descriptions of managed data (both clinical and technical) and ways of managing such information. This represents a further step towards the possibility of establishing more effective home-based telemonitoring systems and thus improving the remote care of patients with chronic diseases

Mobile Health Technologies

Mobile Health Technologies, also known as mHealth technologies, have emerged, amongst healthcare providers, as the ultimate Technologies-of-Choice for the 21st century in delivering not only transformative change in healthcare delivery, but also critical health information to different communities of practice in integrated healthcare information systems. mHealth technologies nurture seamless platforms and pragmatic tools for managing pertinent health information across the continuum of different healthcare providers. mHealth technologies commonly utilize mobile medical devices, monitoring and wireless devices, and/or telemedicine in healthcare delivery and health research. Today, mHealth technologies provide opportunities to record and monitor conditions of patients with chronic diseases such as asthma, Chronic Obstructive Pulmonary Diseases (COPD) and diabetes mellitus. The intent of this book is to enlighten readers about the theories and applications of mHealth technologies in the healthcare domain

Strategic Intelligence Monitor on Personal Health Systems (SIMPHS): Market Structure and Innovation Dynamics

Personal Health Systems (PHS) and Remote Patient Monitoring and Treatment (RMT) have the potential to alter the way healthcare is provided by increasing the quantity and quality of care. This report explores the current status of PHS and, more specifically of the RMT market in Europe. It addresses the question of how these technologies can contribute facing some of the challenges standing in front of the European healthcare delivery systems causes by higher demand pressures through chronic diseases and demographic change combined with diminishing resources for health care. An uptake and diffusion of these services would potentially lead to benefits through a reduction in death rates, and avoid recurring hospitalisation in a cost-effective manner. Yet the report identifies different categories of barriers hampering a full deployment of RMT in Europe. In the concluding part the reports provides a number of tentative policy options specifically aimed at fostering EU-wide deployment of RMT/PHS.JRC.DDG.J.4-Information Societ

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