Ebook: pHealth 2015

The pHealth 2015 Conference is the 12th in a series of scientific events bringing together expertise from medical, technological, political, administrative, and social domains, and even from philosophy or linguistics. It opens a new chapter in the success story of the series of international conferences on wearable or implantable micro and nano technologies for personalized medicine by presenting keynotes, invited talks, oral presentations, and short poster presentations provided by close to 100 authors from 20 countries from various parts of the world. Starting in 2003 with personal health management systems, pHealth conferences have evolved to truly interdisciplinary and global events by covering technological and biomedical facilities, legal, ethical, social, and organizational requirements and impacts as well as necessary basic research for enabling future proof care paradigms. Thereby, it combines medical services with public health, prevention, social and elderly care, wellness and personal fitness to establish participatory, predictive, personalized, preventive, and effective care settings. By this way, it has attracted scientists, developers, and practitioners from various technologies, medical and health disciplines, legal affairs, politics, and administration from all over the world. The conference brought together health services vendor and provider institutions, payer organizations, governmental departments, academic institutions, professional bodies, but also patient and citizens representatives.

Smart mobile systems such as microsystems, smart textiles, smart implants, sensor-controlled medical devices, and innovative sensor and actuator principles and techniques as well as related body, local and wide area networks up to Cloud services have become important enablers for telemedicine and ubiquitous pervasive health as the next generation health services. Social media and gamification have added even further knowledge to pHealth as an eco-system.

OECD has defined four basic areas to be managed in the new care model: address the big data challenges; foster meaningful innovation; understand and address the potential new risks; and support concerted effort to un-silo communities for a virtual care future. The multilateral benefits of pHealth technologies for all stakeholder communities including patients, citizens, health professionals, politicians, healthcare establishments, and companies from the biomedical technology, pharmaceutical, and telecommunications domain gives enormous potential, not only for medical quality improvement and industrial competitiveness, but also for managing health care cost.

The pHealth 2015 Conference thankfully benefits from the experience and the lessons learned from the organizing committees of previous pHealth events, particularly 2009 in Oslo, 2010 in Berlin, 2011 in Lyon, 2012 in Porto, 2013 in Tallinn, and 2014 Vienna. The 2009 conference brought up the interesting idea of having special sessions, focusing on a particular topic, and being organized by a mentor/moderator. The Berlin event in 2010 initiated workshops on particular topics prior to the official kick-off of the conference. Lyon in 2011 initiated the launch of socalled dynamic demonstrations allowing the participants to dynamically show software and hardware solutions on the fly without needing a booth. Implementing preconference events, the pHealth 2012 in Porto gave attendees a platform for presenting and discussing recent developments and provocative ideas that helped to animate the sessions. Highlight of pHealth 2013 in Tallinn was the special session on European projects' success stories, but also presentations on the newest paradigm changes and challenges coming up with Big Data, Analytics, Translational and Nano Medicine, etc. Vienna in 2014 focused on lessons learned from international and national R&D activities and practical solutions, and especially from the new EU Framework Program for Research and Innovation, Horizon 2020. Beside reports about technology transfer support and building ecosystems and value chains to ensure better time to market and higher impact of knowledge-based technologies, the acceptability of solutions, especially considering security and privacy aspects have been presented and deeply discussed.

The pHealth 2015 Conference addresses mobile technologies, knowledge-driven applications and computer-assisted decision support, but also apps designed to support elderly as well as chronic patients in their daily and possibly independent living. Invited contributions consider fundamental scientific and methodological challenges of adaptive, autonomous, and intelligent pHealth approaches, the new role of patients as consumers and active party with growing autonomy and related responsibilities, but also requirements and solutions for mHealth in low- and medium income countries. It aims at sharing experiences and results, and opening up for the future. The pHealth 2015 presentations are complemented by demonstrations of practical artifacts and solutions as well as by a students' poster competition. More insights in the pHealth challenge are provided by a Satellite Conference of NovaMedTech.

Embedded Sensor Systems for Health, NovaMedTech, and HL7 Sweden, but – following a long-term tradition – also the Working Groups “Electronic Health Records (EHR)”, “Personal Portable Devices (PPD)” and “Security, Safety and Ethics (SSE)” of the European Federation for Medical Informatics (EFMI) have been actively involved in the preparation and realization of the pHealth 2015 Conference.

This proceedings volume covers 3 keynotes and 2 specially invited talks, but also 23 oral presentations selected from more than 50 submissions to the pHealth 2015 conference, and 8 poster presentations. All submissions have been carefully and critically reviewed by at least two independent experts from other than the authors' home countries, and additionally by at least one member of the Scientific Program Committee. The performed highly selective review process resulted in a full papers rejection rate of more than 50%, thereby guaranteeing a high scientific level of the accepted and finally published papers. The editors are indebted to the acknowledged and highly experienced reviewers for having essentially contributed to the quality of the conference and the book at hand.

Both the pHealth 2015 Conference and the publication of the pHealth 2015 proceedings at IOS Press would not have been possible without the supporters and sponsors Health Level 7 International (HL7 International), Embedded Sensor Systems for Health, NovaMedTech, and European Federation for Medical Informatics (EFMI).

The editors are also grateful to the dedicated efforts of the Local Organizing Committee members and their supporters for carefully and smoothly preparing and operating the conference. They especially thank all team members from the School of Innovation, Design and Engineering, Mälardalen University, Västerås, Sweden, for their dedication to the event.

Bernd Blobel, Maria Lindén, Mobyen Uddin Ahmed

(Editors)

Our Healthcare systems worldwide are facing grand challenges that can be addressed by intelligent, miniaturized and interconnected devices. Many of today's pharmaceutical drugs create bigger problems than solutions, as drugs help only 40% of the patients and kill, in the USA alone, over 100,000 people per year. The widespread use of antibiotics has led to new strands of bacteria that defy all known antibiotics and kill well over 100,000 people yearly in the world. Outbreaks of infections by new viruses and anti-resistant bacteria are expected with even more grave consequences. The quality of food around the world is steadily deteriorating, as the soils are becoming depleted of essential nutrients and contain increasing amounts of pesticides, herbicides and fungicides. Our environment is burdened with 2.5 billion tonnes of chemicals per year that accumulate in the soil, groundwater, rivers and seas, and eventually end up in our food and our drinking water. As a consequence, there is a strong increase in the incidence of diseases hardly known fifty years ago. In parallel, an increasing number of people are taking the responsibility for their health and well-being in their own hands and are looking for mobile and in-obtrusive ways to objectively monitor their health status. The development of intelligent, miniaturized systems, by the heterogeneous integration of technologies such as micro- and nano-electronics, photonics, biotechnology, materials and information & communication, addresses these issues and has received intensive public support in the EU over the past two decades in the FP6 and FP7 programs. Proven concepts and functional prototypes exist with the potential to create new opportunities to improve our healthcare systems, in particular personalized or precision medicine. These device concepts offer unique abilities to sense, detect, analyze, communicate, respond, and monitor phenomena from the macro (e.g. body, tissues) to the nano scale (e.g. molecules, genes) on the spot, with short response times. For the majority of the projects, the planning for the next phase of prototype validation, through product design, supply chain setup, user targeting, clinical validation and commercial roll-out is now taking full attention. However, significant hurdles exist in the successful translation of the new technology to new products. As these technologies are new-to-the-world the resulting products carry a high risk, often necessitating the creation of new companies. Therefore the EU has developed the Horizon 2020 program as a framework for technology development and new business creation. Horizon 2020 is focusing on support for technology transfer, and on building ecosystems and value chains to ensure shorter times-to-market, thus enabling a higher impact of knowledge-based technologies. This paper will argue the necessity of developing these new class of devices, discuss its state-of-the-art, and the challenges for the implementation of Horizon 2020 and the new opportunities in intelligent miniaturized systems for pHealth.

The paradigm changes health systems are faced with result in highly complex and distributed systems requiring flexibility, autonomy, but first of all advanced interoperability. In that context, understanding the architecture of the system to be supported as well as the process to meet the intended business objectives is crucial. Unfortunately, there is a lot of confusion around the term architecture, which doesn't facilitate the integration of systems. Using a reference architecture model and framework, relevant existing architectural approaches are analyzed, compared and critically discussed, but also harmonized using a reference architectural model and framework.

The development of a sustainable, high-quality, affordable health care is today a high priority for many actors in the society. This is to ensure that we will continue to afford to care for the growing portion of elderly in our population. One solution is to enable the individual's power over her own health or illness, and participation in her own care. There are evidently opportunities with the rapid development of eHealth and wearable sensors. Tracking and measuring vital data can help to keep people out of the hospital. Loads of data is generated to help us understand disease, to provide us with early diagnostics and warnings. It is providing us with possibilities to collect and capture the true health status of individuals. Successful technologies demonstrate savings, acceptance among users and improved access to healthcare. But there are also challenges. Implementing new technologies in health care is difficult. Researchers from around the world are reporting on similar problems, such as reimbursement, interoperability, usability and regulatory issues. This paper will discuss a few of these implementation challenges as well as a few of the efforts in meeting them. To conclude, eHealth solutions can contribute to patient empowerment and a sustainable health care. Our assumption is however, that as long as we do not face the implementation challenges and invest in overcoming the pressing obstacles, society will not be able, or willing, to pay for the solutions.

Health is wide concept covering a person's physical, mental and social well-being. Traditionally, regulated healthcare has been the main source for curative and preventive service offered to patients. Healthcare is in transition, however. Paradigms such as patient empowerment and patient in the centre as well as in-home care service are changing processes and locations healthcare services are offered. Parallel to healthcare, new service models such as pHealth, ubiquitous healthcare, and digital medicine are developing. In the near future, technology enables the creation of a personal digital health dossier (e.g. digital patient and virtual patient model) for any individual. This dossier is stored and used in the unsecure information space. This all means that the traditional paternalistic patient model where patient is a passive object for regulated healthcare services will not work in future pHealth and digital health anymore. Instead, the new patient role (e.g. pHealth user or health consumer role) is dynamic, context-aware and participatory. The pHealth user can also have many roles at the same time, such as the role of informed chooser, decision maker, and personal health coordinator. This requires that the pHealth user can make information-based meaningful decisions before starting to use health services, and that he or she can trust on service providers by having evidence-based and reliable information about the quality and health impact of the services offered. A big challenge is that pHealth and digital health take place in unsecure information space where current healthcare specific laws, regulations, and medical ethics are insufficient to guarantee users' autonomy and privacy as well as the application of fair information and ethical principles when processing personal health information. A new ethical, legal and technical framework is needed. One of the prerequisites successful pHealth and digital health has to meet is the possibility to create information based on trustworthy relationship between service user and service providers. Furthermore, a trusted information platform is inevitable.

Recent studies demonstrate the potential of Mobile Health (mHealth) to improve quality of care and efficiency in low- and middle- income countries (LMIC). However, strong evidence of their impact, especially in large scale projects is still missing. The objective of this paper is to provide an overview about the current status of mHealth in LMIC, and to identify Requirements and possible Strategies to strength their health systems. A search in Pubmed was performed, which resulted in 427 articles. Restricting the search to review papers published during the last 5 years, 72 publications were identified and characterized, and the more relevant articles analyzing mHealth use, impact and/or adoption in LMIC from a more generic perspective were analyzed in detail. Finally, based on the literature, and complemented with the authors own reflections and experience, mHealth challenges and strategies were identified and presented according to the WHO Health Systems Framework which identifies six main lines of action to improve the performance of health systems: service delivery, health workforce, health information systems, essential medical products and technologies, health financing and governance.

This study aims at proposing an efficient method for automated electrocardiography (ECG) artifact removal from surface electromyography (EMG) signals recorded from upper trunk muscles. Wavelet transform is applied to the simulated data set of corrupted surface EMG signals to create multidimensional signal. Afterward, independent component analysis (ICA) is used to separate ECG artifact components from the original EMG signal. Components that correspond to the ECG artifact are then identified by an automated detection algorithm and are subsequently removed using a conventional high pass filter. Finally, the results of the proposed method are compared with wavelet transform, ICA, adaptive filter and empirical mode decomposition-ICA methods. The automated artifact removal method proposed in this study successfully removes the ECG artifacts from EMG signals with a signal to noise ratio value of 9.38 while keeping the distortion of original EMG to a minimum.

In this paper, four different signal processing algorithms which can be applied to reduce the noise from a MEMS-gyroscope-based computer head mouse are presented. MEMS-gyroscopes are small, light, cheap and widely used in many electrical products. MultiPos, a MEMS-gyroscope-based computer head mouse system was designed for persons with movement disorders. Noise such as physiological tremor and electrical noise is a common problem for the MultiPos system. In this study four different signal processing algorithms were applied and evaluated by simulation in MATLAB and implementation in a dsPIC, with aim to minimize the noise in MultiPos. The algorithms were low-pass filter, Least Mean Square (LMS) algorithm, Kalman filter and Weighted Fourier Linear Combiner (WFLC) algorithm. Comparisons and system tests show that these signal processing algorithms can be used to improve the MultiPos system. The WFLC algorithm was found the best method for noise reduction in the application of a MEMS-gyroscope-based head mouse.

Sedentary work is very common today. The aim of this pilot study was to attempt to differentiate between typical work situations and to investigate the possibility to break sedentary behavior, based on physiological measurement among office workers. Ten test persons used one heart rate based activity monitor (Linkura), one pulse oximeter device (Wrist) and one movement based activity wristband (Fitbit Flex), in different working situations. The results showed that both heart rate devices, Linkura and Wrist, were able to detect differences in heart rate between the different working situations (resting, sitting, standing, slow walk and medium fast walk). The movement based device, Fitbit Flex, was only able to separate differences in steps between slow walk and medium fast walk. It can be concluded that heart rate measurement is a promising tool for quantifying and separating different working situations, such as sitting, standing and walking.

Burnout is scientifically a work related syndrome which consists of three dimensions: emotional exhaustion, depersonalization and reduced professional efficacy. Different instruments for the diagnosis of burnout exist, accompanied by many associated problems, however. This paper describes a proposal aiming at supporting the diagnosis of burnout using measures complementary to the Maslach Burnout Inventory (MBI). It specifically focuses on emotions detection to provide useful information that contributes to the decision making process about the syndrome.

Chronic diseases such as Type 2 Diabetes Mellitus (T2DM) constitute a big burden to the global health economy. T2DM Care Management requires a multi-disciplinary and multi-organizational approach. Because of different languages and terminologies, education, experiences, skills, etc., such an approach establishes a special interoperability challenge. The solution is a flexible, scalable, business-controlled, adaptive, knowledge-based, intelligent system following a systems-oriented, architecture-centric, ontology-based and policy-driven approach. The architecture of real systems is described, using the basics and principles of the Generic Component Model (GCM). For representing the functional aspects of a system the Business Process Modeling Notation (BPMN) is used. The system architecture obtained is presented using a GCM graphical notation, class diagrams and BPMN diagrams. The architecture-centric approach considers the compositional nature of the real world system and its functionalities, guarantees coherence, and provides right inferences. The level of generality provided in this paper facilitates use case specific adaptations of the system. By that way, intelligent, adaptive and interoperable T2DM care systems can be derived from the presented model as presented in another publication.

The development of software supporting inter-disciplinary systems like the type 2 diabetes mellitus care requires the deployment of methodologies designed for this type of interoperability. The GCM framework allows the architectural description of such systems and the development of software solutions based on it. A first step of the GCM methodology is the definition of a generic architecture, followed by its specialization for specific use cases. This paper describes the specialization of the generic architecture of a system, supporting Type 2 diabetes mellitus glycemic control, for a pharmacotherapy use case. It focuses on the behavioral aspect of the system, i.e. the policy domain and the definition of the rules governing the system. The design of this architecture reflects the inter-disciplinary feature of the methodology. Finally, the resulting architecture allows building adaptive, intelligent and complete systems.

The aim of this work has been to develop a technical support enabling home-based motor training after stroke. The basis for the work plan has been to develop an interactive technical solution supporting three different groups of stroke patients: (1) patients with stroke discharged from hospital with support from neuro team; (2) patients with stroke whose support from neuro team will be phased out and (3) patients living with impaired motor functions long-term. The technology has been developed in close collaboration with end-users using a method earlier evaluated and described [12]. This paper describes the main functions of the developed technology. Further, results from early user-tests with end-users, performed to identify needs for improvements to be carried out during further technical development. The developed technology will be tested further in a pilot study of the safety and, usefulness of the technology when applied as a support for motor training in three different phases of the post-stroke rehabilitation process.

Depression is the most prevalent clinical disorder and one of the main causes of disability. This makes early detection of depressive symptoms critical in its prevention and management. This paper presents and discusses the development of Psychologist in a Pocket (PiaP), a mental mHealth application for Android which screens and monitors for these symptoms, and–given the explicit permission of the user–alerts a trusted contact such as the mental health professional or a close friend, if it detects symptoms.

All text inputted electronically–such as short message services, emails, social network posts–is analyzed based on keywords related to depression based on DSM-5 and ICD criteria as well as Beck's Cognitive Theory of Depression and the Self-Focus Model. Data evaluation and collection happen in the background, on-device, without requiring any user involvement. Currently, the application is in an early prototype phase entering initial clinical validation.

Falls are the second leading cause of accidental injury deaths worldwide. In this paper, it is intended to define methodologies that permit the evaluation of two potential factors which might have an impact on fall risk, these are: visual and hearing loss. The aim of the work developed is not to replace clinic visits, but to offer the user the means to continue the tracking of his vision and hearing at home, during the long time intervals between clinical tests. Tests conducted in a sample of our target users indicate a good ability to measure vision and hearing using an android smartphone and the proposed methodologies. While some tests require further validation, promising results were achieved in the most common tests for vision and hearing, presenting a good correlation between the system's results when compared to the traditional tests (for distance visual acuity) and the data gathered from the users (for hearing tests).

The motivation for these experiments was to investigate the amount and type of protein adsorption on surfaces that can be used as protective coatings on membrane based in vivo devices. Adsorption of proteins to a selection of biocompatible coatings (titanium oxide, diamond-like carbon, parylene C) and typical construction materials for Micro Electro Mechanical Systems (silicon, silicon nitride), were investigated during in vitro tests. The samples were incubated in human liver extract and bovine serum albumin (BSA) for up to 12 hours. The amount of protein adsorption was found to be low for all surfaces. Measurements of bound Iodine-125 labeled BSA, showed a protein adsorption of up to 0.2 μg BSA/cm². The specific proteins adsorbed to the surfaces after incubation in human liver extract were identified using mass spectrometry. Most of the identified adsorbed proteins were intracellular, but plasma proteins like Immunoglobulin (Ig) and serum albumin as well as hemoglobin were also identified.

Problem: Cardiovascular diseases (CVD) are the number one cause of death globally. According to WHO (World Health Organization), 80% of these deaths occur in low- and middle-income countries. CVDs are associated to risk factors such as obesity, smoking, sedentary lifestyle, and others. The scientific community keeps searching for new parameters, like ECG signal analysis, to improve cardiovascular risk evaluation.

Objective: This article aims at providing a systematic review of developed mobile Electrocardiogram (ECG) systems and the relevance of ECG for the assessment of cardiovascular risk.

Methods: A systematic review of two databases (PubMed and IEEEXplore) was carried out.

Results: This article provides an analysis of 10 studies describing mobile ECG systems developed in the last 10 years, and 6 studies analyzing the effectiveness of ECG as a parameter to assess cardiovascular risk.

Conclusions: The systematic review demonstrated that there are no mobile ECG systems used for cardiovascular risk assessment. Furthermore, the review indicates that there is scientific evidence about the effectiveness of ECG as a parameter for cardiovascular risk evaluation, but only in some specific cases.

Bringing brain research tools like EEG devices out of the lab into the pockets of practitioners and researchers may fundamentally change the way we perform diagnostics and research. While most of the current techniques are limited to research clinics and require excessive set-up, new consumer EEG devices connected to standard, off-the-shelf mobile devices allow us to lift these limitations. This allows neuropsychological assessment and research in mobile settings, possibly even in remote areas with limited accessibility and infrastructure, thus bringing the equipment to the patient, instead of bringing the patient to the equipment.

We are developing an Android based mobile framework to perform EEG studies. By connecting a mobile consumer EEG headset directly to an unmodified mobile device, presenting auditory and visual stimuli, as well as user interaction, we create a self-contained experimental platform. We complement this platform by a toolkit for immediate evaluation of the recorded data directly on the device, even without Internet connectivity. Initial results from the replication of two Event Related Potentials studies indicate the feasibility of the approach.

In this paper, the development process of an eating aid is described. The assistive devices must be worth using. To achieve this, the starting point has been the users need. The development started from the needs of an individual person, the inventor of the aid. The development has been about increasing the positive experience of the aid and decrease negative experience through an iterative development process. The development includes several evaluations, described in the paper, and as a conclusion, it is important to include the users throughout the development process.