This work presents a next generation clinical architecture based on the Future Internet of Things for extending a patient’s environment to integrated clinical environments. It introduces technological innovations and advanced services which allow patient monitoring and supervision by remote centers, and personal multimedia platforms such as smart phones and tablets. From the hardware point of view, it consists of a platform/gateway named Monere, and a personal clinical device/sensor adaptor named Movital, used for the wireless integration of clinical devices through 6LoWPAN, and patient identification through RFID. Movital additionally supports communication capabilities to allow a secure, scalable and global integration of the sensors deployed at the patient’s environment.
This work presents a next generation clinical architecture based on the Future Internet of Things for extending a patient’s environment to integrated clinical environments. It introduces technological innovations and advanced services which allow patient monitoring and supervision by remote centers, and personal multimedia platforms such as smart phones and tablets. From the hardware point of view, it consists of a platform/gateway named Monere, and a personal clinical device/sensor adaptor named Movital, used for the wireless integration of clinical devices through 6LoWPAN, and patient identification through RFID. Movital additionally supports communication capabilities to allow a secure, scalable and global integration of the sensors deployed at the patient’s environment.
This work presents a next generation clinical architecture based on the Future Internet of Things for extending a patient’s environment to integrated clinical environments. It introduces technological innovations and advanced services which allow patient monitoring and supervision by remote centers, and personal multimedia platforms such as smart phones and tablets. From the hardware point of view, it consists of a platform/gateway named Monere, and a personal clinical device/sensor adaptor named Movital, used for the wireless integration of clinical devices through 6LoWPAN, and patient identification through RFID. Movital additionally supports communication capabilities to allow a secure, scalable and global integration of the sensors deployed at the patient’s environment.
Integration of Clinical Environments at Patients House
Antonio J. Jara, Miguel A. Zamora-Izquierdo, and Antonio F. Gmez-Skarmeta 1Abstract This work presents a next generation clinical architecture based on the Future I nternet of Things for extending a patients environment to integrated clinical environments. I t introduces technological innovations and advanced services which allow patient monitoring and supervision by remote centers, and personal multimedia platforms such as smart phones and tablets. From the hardware point of view, it consists of a platform/gateway named Monere, and a personal clinical device/sensor adaptor named Movital, used for the wireless integration of clinical devices through 6LoWPAN, and patient identification through RFI D. Movital additionally supports communication capabilities to allow a secure, scalable and global integration of the sensors deployed at the patients environment. This paper presents the architecture, and how it provides support for mobility and ubiquitous connectivity, extended devices integration, reliability, and in definitive offers a bridge between the sensors connected to the patient and the information systems, in conjunction with the user interfaces, in order to reach a Ubiquitous I ntegration of Clinical Environments. This solution is being deployed and evaluated in a clinic in Barcelona, and in Assisted Living Environments for patients with respiratory illnesses under the AI RE project. I ndex Terms Internet of Things, Sensor and RFID technologies for e-health, Architecture, Integrated Clinical Environment, Ambient Assisted Living. I. INTRODUCTION The evolution of technologies for, on the one hand, the identification of objects, with applications such as Radio Frequency Identification (RFID), and, on the other hand, for communication and consumer devices, providing solutions which offer ubiquitous access to information -such as wireless personal devices, embedded systems and smart objects-, together with the capabilities presented by the Future Internet with IPv6 protocol and technologies, such as IPv6 over Low Power Area Networks (6LoWPAN), which allow the Internet extension to small and smart devices. This
Manuscript received December 15th, 2011. The authors would like to thank the Spanish ministry for Industry, Tourism and infrastructure, and the ministry for education, social politic and sport for sponsoring the research activities under the grants AIRE Architecture for Insufficiency Respiratory Evaluation Project (TSI-020302-2010-95), and the FPU program (AP2009-3981). This work has been carried out by the Intelligent Systems group of the University of Murcia, awarded as an excellence researching group by the Fundacin Sneca (04552/GERM/06), and in the framework of the IoT6 European Project (STREP) from the 7th Framework Program (Grant 288445). Finally thanks to PhD. Fred Hosea from Kaiser Permanente, Mr. Miguel Yasuhiko Tsuchiya and Mr. Javier Sancho from Flowlab, and M.D. Bienvenido Barreiro and his team from the neuomology service, as such as the team from Centro de Atencin Primaria i.e. medical centre and Addom services from Mutua Terrasa. Antonio J. Jara, Miguel A. Zamora and Antonio F. G Skarmeta are with the Department of. Information and Communications Engineering (DIIC), Computer Science Faculty at the University of Murcia, ES-3100, Spain. (phone: +34-868-88-8771; fax: +34-868-88-4151; e-mail: jara@um.es). extension is a key element that is making it feasible to identify, sense, locate, and connect all the people, machines, devices and things surrounding us among them. These new capabilities for linking Internet with everyday sensors and devices, forms of communication among people and things, and exploitation of data capture, define the so called Future Internet of things (IoT) [1]. The IoT is considered one of the major communication advances in recent years, since it offers the basis for the development of independent cooperative services and applications. An extensive research on using this concept in different areas such as building automation, Intelligent Transport Systems, and healthcare is being carried out. For example, its potential for mobile health applications has been recently reported in [2], showing its potential from the identification capacities for drugs identification [3], and its communication capabilities to offer ubiquitous therapy by providing wireless and mobility capabilities for personal devices and smart objects, in addition to allowing the collection of data anytime and anywhere [4]. An example of an application where these capabilities are exploited for chronic diseases management is presented in the solution for diabetes, found in [5]. However, even when specific solutions are located for IoT [2,5] and wireless networks [6], no study to date presents a platform to address this concept and offer support for ubiquitous personalized healthcare. This work goal is to exploit the aforementioned IoT capabilities in order to build a platform for personalized healthcare in the patients environment. In this respect, this platform goal is the extension of those environments towards a clinical environment. Thereby, it can be reached, what we have defined as, a Ubiquitous I ntegration of Clinical Environments. This denomination is inspired, firstly, in the ubiquitous feature, because it is not only oriented towards hospitals and specialized clinical environments, but also towards patients environments, such as the patients house, senior citizen residence, or gym, and mobile environments such as an ambulance, mobile clinics, and travel health services, where support for mobility is going to be required. Secondly, the term is inspired in integration, since it is focused on its integration and interoperability with the current information infrastructure and e-Health platforms, instead of offering an additional alternative for the market. This integration factor is the key element, since as it was mentioned by Dr Najeeb Al-Shorbaji, director of knowledge management and sharing at the World Health Organization, It cannot be viewed as a standalone proposition and must be seen as a subset of e- health, which in turn is an integral part of a more general, comprehensive healthcare strategy, encompassing all security, ethical and standards issues. This integrator spirit is fundamental for the current Internet and IoT. Furthermore, and in order to reach a proper integration, application-level interoperability among clinical devices and the existing platforms is required, together with security and privacy support since medical data are highly sensitive.
Therefore, our platform aims to support ubiquitous and mobile healthcare, as well as integration of the deployed home platform and clinical devices in the current e-Health infrastructure, interoperability, security and privacy based on the integration of IoT technologies for patients sensors. Ubiquitous I ntegration of Clinical Environments defines complex design challenges and requirements, which need a bottom-up approach, from the clinical devices and network infrastructure to the e-Health platforms. At the e-Health platforms level, several projects are found to reach a unified Electronic Health Record among different hospitals, organizations and countries, as well as a definition of personalized services, electronic prescription, support Personal Health Record, and collaborative Decision Support Systems. However, we do not see the next-generation of devices, gateways and systems which offer the capabilities required to provide the bottom support for the pursued solution as being so developed. For that purpose, the specifically built platform which is installed in the patients environment, denominated Monere, presents multi-technology support. This platform can be considered as a gateway, which is what the ISO/IEEE 11073-20601 Personal Health Data Exchange Protocol (HDP) [7] defines as IEEE manager. This links between the clinical devices located at the patients house and the external network, and carries out additional administrative functions such as configuration management, reliability monitoring, live performance metrics, and support for risk. The connection of the clinical sensors (sources) to Monere is through their native technology, e.g. wired technologies such as serial, USB or wireless such as Bluetooth and ZigBee. In addition, Monere is complemented by a clinical device integrator (adaptor), called Movital, which is like an IEEE agent following the HDP protocol. Movital extends current sensors to a mobile and wireless device. This offers the support for the device lifecycle management and complex network transactions such as mobility support, in addition to offering the adapter functionality from native protocol to a suitable protocol, denominated YOAPY, for the requirements and constrains from 6LoWPAN technology. Finally, Movital also offers the integration of a RFID reader to identify the patient and caregivers, or loads the patient's profile from the personal health card. In particular, the new capabilities and functionalities for the clinical devices and design issues considered for the proposed network infrastructure have been defined by a group of experts from clinical technology, hospitals and assisted living, to satisfies the requirements from patients monitoring and e-Health platform integration. All these requirements and considerations are presented in the next section, which defines the additional functionalities needed for the clinical devices to reach the defined Ubiquitous Integrated Clinical Environments. Section IV presents the architecture showing the integration of patients environment with the current platforms. This integration is satisfied with the developed gateway (Monere), and clinical device integrator (Movital), which are presented in Sections V and VI, respectively. Finally, Section VII presents the use case of the proposal for assisted living of fragile patients with serious breathing problems from AIRE project with the performance evaluation of the communications protocols defined for the different clinical sensors integrated from the mentioned scenario.
Fig. 1. Ubiquitous Integrated Clinical Environments Architecture. II. DESIGN ISSUES AND REQUIREMENTS FOR UBIQUITOUS INTEGRATED CLINICAL ENVIRONMENTS This solution has been designed, evaluated and validated by a multidisciplinary group of experts from Mutua Terrassa (Spain) under the frame of the AIRE project, for clinic environments from Clnica del Valls in Barcelona (Spain), through the Intelligent Beds project, and clinical technology considerations from Kaiser Permanente Innovation Labs (USA), and Flowlab (Europe). This determines the requirements for the integration of clinical devices with information systems. Figure 1 presents the requirements considered for the Ubiquitous Integration of Clinical Environments platform, by nurses, physician and caregivers (marked in green), by clinical technology experts, and by our own experience (marked in violet). Over which management services are defined for communication and interoperability. Finally, high level and value-added services from each specific healthcare provider are built. The first consideration from the caregivers group is the need for integration of clinical devices in the patients environment in order to carry out distant monitoring of patient status, and personalized/adaptive home therapy. The second consideration is that the clinical devices to be integrated should be the current available clinical sensors; therefore backward compatibility and flexibility in the platform to integrate existing devices are required. In addition, the third issue is the support of ubiquitous and mobility-proof networks to keep patients connected anytime/anywhere. This factor is highly relevant to link the different patients environments, which are linked through the Mobility management service. It is mentioned in case it cannot be supported, since continuous monitoring is highly chaotic during the day. A support night-time monitoring could be also interesting regarding chronic diseases, since the night situation is considered to be equivalent to the situation during the day in these cases. Therefore, it shows the interest in integrating them in the patients bed for continuous monitoring and logging. The fourth one is the need to identify the patient and the caregiver who is attending the patient when a measure is carried out. This is required for environments with multiple patients such as senior living residences, and for therapies requiring regular visits from caregivers. This requirement is
highly interesting IoT capabilities are able to solve it with RFID integration [8]. The last issue from physicians was the integration of patient monitors, i.e. compound devices, in addition to simple ones, since they use this kind of device. It provides correlated and synchronized values, and higher accuracy. From the clinical technology experts and our experience, we defined the mentioned requirements in the Introduction in order to reach this integration, which corresponds to interoperability among devices with different systems. For that purpose, we have been focused on integrating current devices and supporting devices compliant with standards such as ISO/IEEE 11073-20601 Personal Health Data Exchange Protocol (HDP), which is the specialized profile designed to allow interoperability between medical, healthcare and fitness devices from different vendors. In addition, we are considering the new versions for coming devices based on HL7v3, and Integrated Clinical Devices (ICD-10), since expandability is another feature considered to keep up the pace with technological progression and to support a smooth continual improvement process. The other requirement that this group presented had to do with data security and privacy, and with the integration of the Identity Management platform to carry out the Access and Consent Management of doctors and other systems to the patients health information, i.e. carry out the access policy matrix for privilege management. This is required to guarantee security, privacy, anonymous consultation and the patients privacy, integrity of the information and patient confidentiality. Finally, issues regarding scalability, for processing of large amounts of medical data for a growing population; availability and robustness, since a system failure can put lives at risk, in medical environments; and economies of scale, i.e. new services should be based on existing modules in order to leverage the related platform investment. For this last purpose the proposal is definition of generic services for linking with the specific high level services from each healthcare provider. The last one considers from both sides that physicians and nurses do not want to use new applications to access these new services, but they prefer to integrate them in their existing solutions. Otherwise, they are not going to use them frequently. III. RELATED WORKS The current situation of clinical devices from hospital and assisted living environments is focused on stand-alone devices with basic network connectivity, and on manual configuration and limited interoperability with manufacturer protocols and proprietary implementations. We require a new generation of solutions oriented to devices completely connected with full duplex communication, having Internet support at device level, as well as extended application level interoperability, support for remote management, administrative functions, and auto-configuration is required, since it will allow reach scalable and ubiquitous healthcare. We can find the development of platforms and technical solutions for continuous/intermittent monitoring of vital signs in home setting location for specific chronic diseases as those which are defined by the ALADDIN project [9] for dementia management, the home medical gateway presented in [10] for Obstructed Sleep Apnea (OSA) patients to monitor and improve their sleep quality, and finally the long-term healthcare system for physiological monitoring presented in [11]. These solutions are distinguished by integration of a set of specific sensors through their property protocol, based on Bluetooth or USB/Serial, which is far from the interoperability, administrative functions, mobility and security support elements which are required. With regard to interoperability, we can find some commercial solutions to integrate devices compliant with the HDP, such as the Bluegiga AP3201 e-Health Gateway, Everyware Medical Gateway, and the Vignet pilot, which provide a Connected Health platform for mobile phones, PCs and gateways to connect any medical device with servers or services available over the network. The problem of these solutions is that, even when interoperability is being solved, it is limited to HDP devices; it does not satisfy the requirement of integrating device heterogeneity; and it extends already existing e-Health platforms, instead of proposing new ones. In short, this new generation of interoperable e-Health platforms and clinical devices requires significant scaling of clinical technology management and services, in addition to high integration requirements. In this respect, the state-of- the-art technology to address these requirements presents Future Internet as a medium to integrate clinical devices, offering new administrative functions, and also empowering deployments with connectivity and scalability capabilities, not only from Internet, but also Machine to Machine (M2M) communications, and finally IoT [12]. This network evolution towards a full Internet connectivity solution for everywhere and in everything provides capacities to build intelligent environments [13], and to solve the presented design issues, in order to reach the Ubiquitous Integrated Clinical Environments. IV. ARCHITECTURE OVERVIEW The architecture is presented in Figure 2 shows, on the one hand, the Environment Integration Platform (EIP), composed of the Monere platform in the patients house to provide a global connectivity and management capacity, and the Movital nodes which have been designed to work with devices for medical purpose from different vendors. In addition to transmitting vital signs data, these elements offer administrative functions for medical error reduction, fault detection, remote device management and, in short, their own integration into the system lifecycle. On the other hand, this architecture presents as it is also integrated with existing information systems, such as the Hospital Information System (HIS), and the Service Providers System (SPS) to develop services from healthcare providers, as well as with other systems for context management, and intelligent analysis of patient status. Finally, it presents as could be integrated with the Identification Management System (IdM) in order to provide scalable security and privacy support. A. Hardware platforms The descriptions of Monere and Movital are presented in Sections V and VI, respectively. They are the key elements to introduce the IoT in clinical environments. Monere is the gateway and manager to support ubiquitous data collection and access, whereas Movital is the combination of the IoT- based communication and identification technologies for wireless and mobile integration of clinical devices.
Fig. 2. Architecture overview: platform integration with the current Information Technology Infrastructure.
B. Information Systems The information systems considered range from integration of inherited systems from current deployments, such as the Hospital Information System, and the results from previous works, such as Context Management Framework, to the definition of new Services Provider System (SPS) so as to define the personalized services from healthcare providers, such as Personal Health Record, health status monitoring, e- booking services etc. - Hospital Information System (HIS) usually adopts native integration with that currently deployed in the hospital. It offers support for the Electronic Health Record management, but it can also provide administration and control of human resources, clinical divisions in hospitals etc. From a research perspective, the current tendency of the HIS is the standard CEN/ISO 13606, which is based on OpenEHR, and is defined to satisfy the European standard requirements for clinical data interoperability. From a commercial perspective, it is the extended Clinical Document Architecture (CDA) from HL7. - Context Management Framework (CMF) are built for tracking patients health at home, and any difficulties encountered in daily activities. It is based on event processing; identifying patterns over events is always done by context of time, space and relationship between events that make up the pattern, such as the time between two high blood pressure measurements and two different lab results for the same patient. The solution from European projects such as SPICE, Sensei, and Florence, could be examples of CMF. - Knowledge Base Systems (KBS) will be specified as managing large data volumes which may be generated from various sources with heterogeneous formats, and with semantics, synchronicities, accuracies, trust and reliability. They will be critical to underpin remote consultations of large communities of patients. There are existing low-level data fusion techniques for automated pre-processing of data to identify and model important trends and anomalies in data from monitoring devices. These can refer to some of the KBS developed in previous projects, such as our previous work for insulin therapy in diabetic patients [5], and ALADDIN for dementia [9]. C. Security Management This architecture integrates, through Movital, a suitable security stack based on Elliptic Curve which has been optimized for embedded IoT devices [14] to support and improve security primitives, and identification management, for communication with clinical devices. This ensures the patients privacy, and security of information. In addition, the Identity Management System can be integrated to offer security, privacy and Identity Management (IdM) features for communication with other systems, ensuring anonymous consultation from external doctors, patient privacy, integrity of information, etc. [15]. This part is relevant to reach ubiquitous healthcare, since it offers support for policy regulations, and also implements interoperability among HIS from different hospitals, institutions and even nations under the frame of the project epSOS, where European regulations for Electronic Health Record interoperability implementation are defined.
V. MONERE: MONITORING, CONNECTING &WATCHING Monere is a word from ancient Latin that means watching, adverting and alerting. These are our goals after continuous monitoring through this multi-protocol card which connects a set of clinical devices, environmental sensors and systems through various communication protocols, so as to provide the capabilities to reach the mentioned goals with the support for ubiquitous data collection and global access. This not only offers the functionalities of IEEE manager, but also facilitates the retrieval of information from the different clinical sources, as well as the integration of information with the Information Infrastructure.
Fig. 3. Monere platform with the communication board and the integrated touch screen.
This platform is presented in Figure 2, which is based on the 32-bit processor ARM9@400Mhz supporting Linux OS, with 256MB LPDDR RAM memory, and 256MB NAND memory. This offers Ethernet 10/100Mbps (A), two USB 2.0 ports (B), four Serial RS232 ports (C), Bluetooth 2.1 with HDP profile compliant with BlueGiga (D), GPRS from WaveCom (E), ZigBee/6LoWPAN from Jennic (F), 24 inputs/outputs among digitals/analogs/relays (G), a compact flash support for data logging (H), and a touch screen LCD (I). Finally, there are some other interesting capabilities for continuous monitoring, such as a real-time watch, five high precision timers, two analog/digital converters for analog signal processing, a random number generator for security seeds, and IPv6 stack support. Monere offers a new dimension of networked and scalability capabilities to reach a higher interoperability, medical error reduction, and remote device management (monitor and repair). It also connects all kinds of devices such as sensors, and patient monitors, and collects context information such as patients activity, including factors such as environmental status. Monere platform is a modular hardware, and its drivers are based on Linux OS, making the upgrading of platform components feasible without having to reconfigure all the other ones. This makes it more robust and expandable. Furthermore, a previous version of Monere has been deployed already in a building automation solution [16], and it is being piloted at a hospital, showing its availability and robustness capabilities. In addition, this architecture presents a hierarchical deployment, where several Monere are deployed, e.g. one per clinical bed or room, where a system is taking care of another one, in order to reduce points of failure and make it highly available. This also offers the capacity for continuous monitoring and logging by using the Information Infrastructure through Internet and, at a local level, by having the support of the mentioned compact flash for offline deployments, or in case of connection disruption. This system has a very flexible and open connectivity support for clinical devices, via RS232 and Bluetooth Health Device Profile (HDP) compliancy, which is supported by iWRAP firmware by BlueGiga. Bluetooth has been considered for the integration of sensors into this gateway, since it is used as a secure and reliable connection in a variety of medical applications. The implementations have been typically based on Bluetooth SPP and on the manufacturers specific proprietary implementations; however, since the definition of the ISO/IEEE 11073-20601 Personal Health Data Exchange Protocol, and IEEE 11073- 104xx device specializations, the application level interoperability is being extended among different clinical and collection devices, such as the ones presented here, from different manufacturers. Additionally, under this work clinical devices are adapted to 6LoWPAN (IPv6 over Low Power Wireless Personal Area Networks), a protocol defined by the Internet Engineering Task Force (IETF) which extends Wireless Sensor Networks to Internet, adding IEEE 802.15.4 a layer to support IPv6. 6LoWPAN presents advantages as regards previous solutions based on Bluetooth, because with this protocol the value is transmitted directly without any user interaction, i.e. user does not need to set up a mobile phone or similar. That feature is interesting for elderly patients who are not accustomed to new technologies, as well as for the extension of coverage from a range of 10-15 to over 100 meters, allowing monitoring of users during usual activities at home, i.e. Activities Daily Living (ADL). Finally, this platform is an integrator of information provided by sensors through the different protocols, which parses and translates the application layers received in IPv6 packets or native protocols, into an application level interoperable framework based on HDP for clinical devices. Monere is being integrated with CEN/ISO 13606 for the interoperability with the Information Systems, as an alternative to the current communications based on HL7.
Fig. 4. Movital device to adapt the devices to the Internet of Things, top picture is top view and bottom picture is cross view.
VI. MOVITAL: MOBILE VITAL SIGNS MONITORING This architecture needs to support the integration and adaptation of clinical devices to IoT technologies, since it is required to provide ubiquitous connectivity. For that reason, Monere platform is completed with a mobile and wireless device in order to integrate clinical devices, Movital (mobile vital sign monitoring). It is presented in Figure 4. Movital adapts basic communication technologies such as USB/RS232/IrDA (A) to 6LoWPAN, to allow interaction of the collected data with other entities of the architecture. It also integrates RFID technology to allow the identification of patients to personalize the services, and identification of physician for responsibility issues, which is required for environments with multiple patients, such as senior residence, to link data to patient and physician identity. As a result, Movital is the combination of the mentioned new generation technologies, including SkyeModule M2, from SkyeTek (B) for contactless identification (RFID and NFC), and module Jennic JN5139 for 6LoWPAN (C). The size of Movital has been minimized to a credit card size for an easier integration. Furthermore, it is powered with reachable lithium batteries to optimize lifetime. This leads to a compact module which acts as an efficient information exchange gateway between clinicians, patients and information infrastructure. In order to ensure the Quality of Privacy (QoP) and Security, Movital offers security capacities through symmetric-key encryption AES 128 bits, integrity based on CRC16-ITT, and asymmetric-key encryption based on Elliptic Curve Cryptography (ECC), in order to adapt public key algorithms and support low cost, high performance, and secure authentication [14]. These capacities are required since privacy is the most relevant issues in healthcare and IoT, due to openness and ubiquity features. Movital also offers support for mobility, which has been solved with a novel mobility protocol. This supports mobile monitoring in patients environments, as well as in critical situations e.g. refineries [17]. Mobility is one of the major advantages from IoT for ubiquitous healthcare solutions. Movital also presents a flexible use with a unique module of several sensors; for that reason, we have included a switch to select the device in a determined moment (D). Finally, as it has been mentioned, Movital function is focused on the integration of clinical devices, offering a solution with backward compatibility, since the clinical devices defined by clinical partners. Some examples of integrated sensors are found in Figure 5, where patient monitors are integrated, something which is not usually considered for this kind of solution, but it was required. Specifically, Movital is offering a new generation of clinical devices with advanced capabilities. The usual sensors found in the market are denominated simple, i.e. a clinical device which offers a single function with low network impact, administration and integration, such as the 3-lead electrocardiogram by Medlab (Figure 5.H), which, in turn, is extended with Movital in order to reach complex clinical devices. Complex clinical devices not only integrate some administrative functions, they also offer high network capabilities such as Ambulo (Figure 5.D), the blood pressure sensor by A&D (Fig. 5.E), the ear thermometer by Clever (Figure 5.G), and the 7-leads ECG by CardioBlue (Figure 5.I).
Fig. 5. Top: Patient monitor with an adapted version of Movital integrated, and in the bottom: wearable, portable clinical devices
The next level which is not usually considered for this solution is the compound, i.e. patient monitors, which presents a multifunction device evolving medium technology, with medium integration, management requirements, and network capabilities. For example, the VITRO patient monitor by Medlab in top Figure 5. This monitors multiple vital signs, from non-invasive blood pressure (NIBP) to pulse-oximeter and heart rate. This also carries out an algorithm that amplifies real pulses and suppresses artefacts. These modules also have been extended with a version of Movital in the communications box (A), which includes the 6LoWPAN transceiver by Jennic (B), and a RFID reader to identify patient/nurse (C). Finally, the compound-complex defines a multiple function system, with highly evolving technology, high administrations, networks and integration capabilities, and even supports clinical decision making. This level is only reached with the Movital and the Monere platforms, since they are able to carry out local and remote processing with intelligent information systems to detect anomalies and evaluate patients status. An example of this is intelligent insulin therapy developed by Movital with the glucometer presented in Figure 5.F [5], which is connected via IrDA to Movital and a touch-screen for user interaction with the intelligent system, and the solution for continuous ECG analysis for the module from Figure 5.H [18].
Fig. 6. Home Respiratory Therapy based on Ubiquitous Integrated Clinical Environments.
VII. EVALUATION: HOME RESPIRATORY THERAPY A. Scenario The experience and scenario evaluation started with the deployment of a previous version of the solution in Hospital Clnica del Valls (Barcelona). The deployment was composed of 14 rooms, where the platform was integrated in the headboard of the bed and continues being used nowadays b . Movital has been evaluated in assisted living environments for diabetes management [5], and the evaluation of the new version of the platform based on IoT is being carried out for home therapy of respiratory illnesses, such as Chronic Obstructive Pulmonary Diseases (COPD) under the AIRE project. This evaluation is focused on the validation of the design issues and integration aspects from the architecture. Figure 6 shows the architecture of the defined solution, where we consider clinical devices for different continuous and discrete vital signals, which are relevant for different respiratory illnesses. The first one is the wearable pulse oximeter Wrist OX2 by Nonin (Figure 6.A), which offers continuous oxygen saturation monitoring. This offers connectivity based on Bluetooth HDP, and its clinical purpose is relevant the majority of breathing problems, since oxygen saturation is directly related to insufficient respiration. This sensor connects directly to the Monere platform. Monere is integrated in the bed in collaboration with Industrias Pardo under AIRE project, since as it has been mentioned in Section II, continuous monitoring of patients during the night is highly relevant. The second integrated sensor is the patient monitor, CAP10 by Medlab (Figure 6.B) for continuous monitoring of CO2 level and breathing (i.e. capnography). This has been also integrated with Movital, such as VITRO. This also offers serial interface for connecting directly to the Monere platform in case of being deployed next to the patients bed. The third integrated sensor is the Peak Expired Flow (PEF) PF-100, by Microlife, to monitor lung capacity for asthma. This transmits discrete values via Moviital.
b Intelligent Beds project, video and pictures of the deployment: http://ants.inf.um.es/projects/ibeds/index.php, 2009.
Other portable sensors are also considered, like those carried out by the caregivers, since they require assistance from a specialist. The spirometer, used for periodic revision of the disease evolution, is an example. Portable devices integrate RFID to identify not only the patient who corresponds to the test carried out, but also the specialist who has attended the patient. Monere also controls the oxygen therapy through one analog input in order to monitor the oxygen flow. This integration for monitoring the home respiratory therapy compliance with a native interface from Monere, presents the capabilities and flexibility of the developed platform. In this respect, the IoT offers advantages for this solution, such as the capability of interconnecting the clinical devices through Bluetooh and 6LoWPAN, as well as the patients and caregivers identification through RFID. On the other hand, it offers the capability to interconnect the system not only with the neumology platform, for a frequent follow-up from the specialist, but also with the Hospital Information System to transmit information about the evolution of the patient, and finally with an intelligent information system, for automatic evaluation of patient evolution, and detection of any relevant anomaly. Finally, this also allows the interconnection with user interfaces such as smart phones and tablets. Figure 6.C and Figure 7, shows a snapshot of the application for consulting the patients vital signs status and evolution. In conclusion, Sections V and VI have presented how the proposed Monere and Movital platforms satisfy the requirements and design issues mentioned in Section II, with regard to communication issues such as scalability, robustness, security, privacy, expandability, availability, flexibility, and to features of the services, such as mobility and continuous logging, as well as monitoring. In addition, they include to specific requirements from the solution such as interoperability, backward compatibility for integration of the current clinical devices and patient monitors, as well as the identification of caregivers to address the responsibility of medical assistants and caregivers. Finally, this section presents how the integration of the presented platforms and clinical devices. The following subsections demonstrate the new services, capabilities, and advantages reached with the integration of the Future Internet of Things through WebServices and IPv6 for multimedia interface integration.
B. Multimedia User Interface The end user interface is focused mainly to be located at the new generation of smart devices such as smart phones (see Figure 6) and tablets (see Figure 7). In addition, it has been also defined an embedded user interface in the Movital (see Figure 5.H), and in the Monere (see Figure 3.I). These last two interfaces are mainly focused for management and configuration steps. The Android OS-based interfaces for the Google Nexus S, and the Samsung Galaxy Tab offer an intuitive and simple interface for the collection of the data through WebServices and IPv6 through the WiFI connection. It is not considered 3G, since it is not yet offering IPv6. The WebServices from the clinical devices point of view are based on CoAP WebServices [18] over 6LoWPAN, which are being offered by the Movital devices presented in the previous section. The integration of IPv6/Glowbal IP and WebServices in Movital is explained in [19]. In addition, it is being also considered the Near Field Communication (NFC) technology as a medium to transfer the data from the Google Nexus S application and the clinical devices [20]. This offers a user interface very intuitive, i.e. just approach, which is very interesting for elderly people. The interface is focused for the parameters from the AIRE project. The vital sign monitored are breathe per minute, etO2, and CAP curve from the capnografy (see Figure 6.B), Spo2 from the pulse-oximeter (see Figure 6.A), and finally Peak Expiratory Flow (PEF) from the peak flow meter (see Figure 6.C). In addition, it is considered an ECG from the solution [18] to measure the ECG and heart-rate. It can be seen that it is carried out a pre-diagnosis of the status of the patient, on the one hand for the ECG, and on the other hand for the Insufficiency Respiratory Evaluation (AIRe).
Fig. 7. User Interface based on Galaxy Tab and connectivity through IPv6-based on wireless local area network (WLAN). C. Technical Evaluation The technical evaluation of the communication between Movital and Monere is based on YOAPY pre-processing module. This module is required, since it was initially concluded that the native RAW mode transmission from the clinical sensors presents an intensive quantity of information. Therefore, this produces a delay for real-time and continuous monitoring of vital signs. Since, this generates more information that technologies such as 6LoWPAN and Bluetooth are able to transmit. For that reason, YOAPY carries out a pre-processing and analyzes the relevant parts from the vital sign to compress the gathered RAW data, and make feasible its continuous and real-time transmission, YOAPY also presents optimizations regarding power consumption, and this introduces security, integrity, and privacy capabilities to the communication.
1) YOAPY for a wearable electrocardiogram (ECG)
The pre-process and ECG data compression methods can be found in current research literature. Some of the most relevant studies are based on wavelet-based. These approaches are focused on the QRS complex, which is a group of waves depicted on an ECG signal. QRS complex is the most important clinical part of the cardiology system and determines the normal or abnormal arrhythmia occurring in the heart (see Figure 8 for QRS complex identification). The problem is that wavelet-based method is not suitable for the constrained chips located at the platforms from the Internet of Things such as Movital. For that reason, this work proposes a simpler pre- processed based on representations of the waveform with the amplitude and times of each one of the significant points from the curve [21], i.e. P, Q, R, S and T points, since it is really the relevant information. Figure 8 presents the significant points from the curves, which are transmitted when it is considered the use of the YOAPY compression. The format presented in Table I consumes 10 bytes/sample, which means that 5 samples are transmitted in a frame. In addition, this pre-process makes the development of health status monitoring solutions easier.
Fig. 8. Representation of the pre-processed trace. Top corner is the reference. Points are P:green, Q:yellow, R:pink, S:blue, T:dark blue. a) Overload and payload size The overload is reduced by YOAPY where an ECG trace of 257 bytes is reduced to 10 bytes (see Table I). Therefore, considering the available payload of 76bytes [19]; 6 frames are required per sample in the original format. The new format allows the inclusion of 5 samples in a frame.
Reference wave trace
TABLE I. FORMAT FOR ECG PRE-PROCESSED SAMPLES 0 1 2 3 4 5 6 7 BPM P Q R S T S_TP S_PQ 68 0x44 132 0x84 121 0x79 185 0xB9 122 0x80 144 0x90 151 0x97 9 0x09 S_QS S_ST S_RS Other samples (until a total of 5 samples, it is a fix number to avoid counters) 32 0x20 3 0x03 71 0x47
Thereby, this also allows to include security support. Specifically, it is considered two security levels; ECDSA, which requires a field of 16bytes for the digital signature, and AES-CCM-128 Link Layer Security, which requires 21bytes. They offer integrity and confidentiality, and an additional timestamp is considered to ensure freshness. Overload is summarized in Table II.
TABLE II. OVERLOAD EVALUATION BY SECURITY LEVELS & YOAPY Security Level Security Overload + Timestamp Available Payload #frames with RAW data #samples in a frame with YOAPY less 1 packet per sample AES-CCM 128bits Layer Security 23bytes + 2bytes = 25bytes 76bytes 25bytes = 51bytes 257/51 6 packets for a sample (51-1)/10 5 samples in one packet ECDSA 160bits based on ECC 16bytes + 2bytes = 18bytes 76bytes - 18bytes = 58bytes 257/58 5 packets for a sample (58-1)/10 5 samples in one packet b) Power consumption Power consumption of Movital is measured for the different operations. In normal conditions, Movital enters sleep mode for the sake of power saving, and the power consumption from the board is 0,72mA from a mere 0.06uA from the transceiver. When the sensor module wakes up, due to an abnormal event or periodical tasks, the Movital module enters a CPU doze mode, where consumption varies between 41mA and 48mA. UARTs are used for this mode, one for debugging and another to connect the clinical sensor. Finally, receiving and transmitting 6LoWPAN packets varies between 44m and 56mA. Power consumption is summarized in Table III. TABLE III. POWER/RADIO CHARACTERISTICS IN MOVITAL Power/Radio Mode Datasheet (D) and Application Note (AN) references [5] for 6LoWPAN transceiver Empirical value from oscilloscope in Movital Deep sleep current 1.6uA from D and 0.06uA from AN 0,72mA for any sleep mode, it is the lowest consumption. Sleep current with wake up (I/O and Timer) 2.8uA from D and 3,5uA from AN Active Processing, i.e. CPU Mode 2.85 + 0.285 per MHz, i.e. 7,41mA for 16Mhz CPU 41mA to 48mA, we are considering the maximum value equal to 48mA Active CPU and transceiver idle (CPU doze) 27,3mA from AN Radio transmit current 37mA from D and 38mA from AN 44mA to 56mA, we are considering the maximum value equal to 56mA Radio receive current 37mA from D and AN UART (Sensor connection) Additional current of 0.095mA for each o3wne from AN
Power consumption to transmit a 6LoWPAN packet is presented in the Figure 9, where this spends 34,2ms. It could be considered that for a frame of the maximum length i.e. 127bytes should spend a total time of 4,064ms (250kbps bandwidth). However, this consumes 30ms more because the time required to turn on the transceiver and the application of CSMA/CA algorithm to access the radio medium, i.e. Clear Channel Assessment (CCA), is performed to determine if the channel is currently in use. CCA takes 8 symbol periods (0.128 ms) to complete a assessment. Once the channel is assessed to be free, this sends the packet. After, it waits around 1.3ms, and then it switches again to the radio transceiver to receive the corresponding acknowledgement (ACK message). In conclusion, the relation between total transfer time and payload time is highly unbalanced (4ms/34ms). Therefore, our goal is to reduce the number of total frames.
Fig. 9. Power analysis for the transmision of a 6LoWPAN packet carried out with the Tektronix DPO 7104C and a shunt resistance of 10 0.5%. It is presented V:yellow, I:blue, and Power:orange. c) Lifetime and Latency from security Once the power consumption of a sensor node is measured for each frame, then the number of frames required for the ECG wave transmission is estimated, and the lifetime for a battery can be derived. Assuming an ECG contains 70bpm, the device requires 0,3125s of CPU for each second to receive the data from the sensor, i.e. ECG with a sample frequency of 300Hz and a speed of 9600bps. Hence, the basic power consumption is: 0,313s48mA+(10,313s-s)0,72mA = (15,5-0,72)mAs (2) This also requires the consumption during the time , which is the required to encrypt and transmit the packet. The encryption time depends on the security level. The time it takes AES-CCM-128 to encode 51bytes from payload (64bytes, since 16bytes multiple is required) is 61ms. This is not suitable for the RAW data, since it only can transfer 16 frames per minute and 420 frames are required. But, it is suitable with the 14 frames per minute required after YOAPY module pre-processing. 14(0,034s56mA+0,061s48mA) =67,8mAM=1,13mAs =1,3328s for each minute = 0,022s for each second (3) Total consumption=15,5-0,720,022+1,13 0,022=15,51mAs
The battery capacity is measured in milliamps hours (mAH). This device has 2 x AAA batteries with 800mAH drive to continuously transmit packets for more than 100 hours (AES-CCM-128 security and YOAPY pre-processing). Lifetime=28003600/15,51=371373s=4days 7h 10 m (4) It is concluded the suitability for continuous data transmission applying symmetric key cryptography based on AES, and the Elliptic Curve Cryptography, also proposed under AIRE project in [14], for establishing the session, since the digital signature with the optimized ECC stack is 765ms. This latency makes ECDSA unsuitable for the continuous monitoring.
2) YOAPY for the other devices from AIRE
This section presents another two examples of YOAPY for continuous sensors. Regarding to discrete sensors such as temperature and peak flow sensor, it is only requiring a byte for temperature value, and the peak flow sensor only two bytes for PEF value, since this version is not calculating FEV, therefore they present a very low requirements. a) Patient monitor with ECG and Pulse-oximeter In addition, to the ECG, it has been integrated the patient monitor PEARL100 from medlab. This offers a different format, since this offers the ECG wave and SPo2 value. In this occasion, it is also analyzed the wave processing peaks from the QRS complex. YOAPY format for PEARL100 clinical sensor is presented in the Table IV. TABLE IV. FORMAT FOR PEARL100 0 1 2 3 4 5 6 7 BPM P Q R S T S_P S_PQ S_QRS S_ST S_T SPo2 b) Capnography The capnography CAP10 from medlab is offering three relevant values, breath per minute, etCO2, and the etCO2 wave. This last one can be seen in the bottom part from the Figure 7. The wave for each breath has a size of 300-350 bytes. Therefore, it is already required to compress it. The relevant points from the etCO2 wave are the beginning of the inspiration (point left) and the end of this (point right). For this is required, 2 bytes for the left point, and 3 bytes for the right point (since it is over 300 the value, therefore this requires 2 bytes). The format is presented in the Table V. TABLE V. FORMAT FOR CAP10 0 1 2 3 4 5 6 7 etCo2 Breaths per minute (BPM) Point left X Point left Y Point right X (LSB) Point right X (MSB) Point right Y
VIII. CONCLUSIONS Ubiquitous Integrated Clinical Environment platform based on the IoT offers support for large scale connectivity with different medical devices, as well as integration with information systems, and continuous monitoring of patients status. It also improves accessibility to clinical services, compatibility and ubiquity, enhancing citizen mobility, and guarantees access to medical information, anywhere and anytime. Proof of this is the extension of e-Health to mobile Health (m-Health) with multimedia platforms such as the presented based on smart phones and tablets, which allows an ubiquitous access to the patients status and evaluation through Internet. Monere and Movital hardware resources make this integration feasible through seamless communication flows between heterogeneous devices, hiding the complexity of the end-to-end heterogeneity to communication service, and supporting security and mobility. 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