E-Healthcare Systems and Wireless Communications: Current and Future Challenges Mohamed K. Watfa University of Wollongong in Dubai, UAE
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Library of Congress Cataloging-in-Publication Data
E-healthcare systems and wireless communications: current and future challenges / Mohamed K. Watfa, editor. p.; cm. Includes bibliographical references and index. Summary: “This book explores the developments and challenges associated with the successful deployment of e-healthcare systems, including pervasive wireless communications, wearable computing, context-awareness, sensor data fusion, artificial intelligence, neural networks, expert systems, databases, and security”--Provided by publisher. ISBN 978-1-61350-123-8 (h/c) -- ISBN 978-1-61350-124-5 (eISBN) -- ISBN 978-1-61350-125-2 (print & perpetual access) 1. Medical informatics. 2. Internet in medicine. I. Watfa, Mohamed, 1981[DNLM: 1. Medical Informatics. 2. Information Systems. 3. Internet. 4. Telecommunications. W 26.5] R858.E285 2012 610.285--dc23 2011015753
British Cataloguing in Publication Data A Cataloguing in Publication record for this book is available from the British Library. All work contributed to this book is new, previously-unpublished material. The views expressed in this book are those of the authors, but not necessarily of the publisher.
Editorial Advisory Board Hend Alqamzi, United Arab Emirates University, UAE Franca Delmastro, IIT Institute, CNR, Italy Tamer ElBatt, Nile University, Egypt Imad H. Elhajj, American University of Beirut, Lebanon Juanita Fernando, Australasian College of Health Informatics, Australia Hassan Ghasemzadeh, University of Texas at Dallas, USA Sandeep Gupta, Arizona State University, USA Kamal Jaafar, University of Wollongong in Dubai, UAE Kanav Kahol, Arizona State University, USA Wathiq Mansoor, American University in Dubai, UAE Mila Mihaylova, Lancaster University, UK Tridib Mukherjee, Arizona State University, USA Nidal Nasser, University of Guelph, Canada Nicholas Omoregbe, Covenant University, Nigeria Giovanni Pioggia, Institute of Clinical PhysiologyNational Research Council (CNR), Italy Francoise Sailhan, Conservatoire National des Arts et Metiers (CNAM), France Francoise Sailhan, Conservatoire National des Arts et Metiers (CNAM), France Chi-Sheng (Daniel) Shih, National Taiwan University, Taiwan Adel Taweel, Kings College, UK Krishna Venkatasubramanian, University of Pennsylvania, USA Mohamed Watfa, University of Wollongong in Dubai, UAE
Table of Contents
Preface..................................................................................................................................................viii Acknowledgment.................................................................................................................................. xii Section 1 Introduction to E-Healthcare Systems Chapter 1 Challenges of Mobile Health Applications in Developing Countries...................................................... 1 Nikhil Yadav, University of Notre Dame, USA Christian Poellabauer, University of Notre Dame, USA Chapter 2 Legal Issues in E-Healthcare Systems................................................................................................... 23 Jawahitha Sarabdeen, University of Wollongong in Dubai, UAE Chapter 3 Healthcare Applications for Clinicians.................................................................................................. 49 Mohamed K. Watfa, University of Wollongong in Dubai, UAE Hina Majeed, University of Wollongong in Dubai, UAE Tooba Salahuddin, University of Wollongong in Dubai, UAE Chapter 4 RFID Applications in E-Healthcare....................................................................................................... 70 Mohamed K. Watfa, University of Wollongong in Dubai, UAE Manprabhjot Kaur, University of Wollongong Dubai, UAE Rashida Firoz Daruwala, University of Wollongong Dubai, UAE
Section 2 Security and Privacy Issues in E-Healthcare Systems Chapter 5 Security and Privacy in Body Sensor Networks: Challenges, Solutions, and Research Directions........100 Wassim Itani, American University of Beirut, Lebanon Ayman Kayssi, American University of Beirut, Lebanon Ali Chehab, American University of Beirut, Lebanon Chapter 6 Is Your Automated Healthcare Information Secure?........................................................................... 128 Mhamed Zineddine, AlHosn University, UAE Chapter 7 Cyber Physical Security Solutions for Pervasive Health Monitoring Systems................................... 143 Krishna K. Venkatasubramanian, University of Pennsylvania, USA Sidharth Nabar, University of Washington, USA Sandeep K. S. Gupta, Arizona State University, USA Radha Poovendran, University of Washington, USA Section 3 Real Life Efforts towards the Deployment of E-Healthcare Systems Chapter 8 Android-Based Telemedicine System for Patient-Monitoring............................................................. 164 M. A. Matin, North South University, Bangladesh Riaz Rahman, North South University, Bangladesh Chapter 9 Rural E-Health Infrastructure Development........................................................................................ 179 Ali Zalzala, Hikma Group Ltd, UAE Stanley Chia, Vodafone Group R&D, USA Laura Zalzala, Bucharest Academy of Economic Studies, Romania Subrat Sahu, Pandit Deendayal Petroleum University, India Suresh Vaghasiya, Pandit Deendayal Petroleum University, India Ali Karimi, Trans Technology Group, USA Chapter 10 Design and Deployment of a Mobile-Based Medical Alert System.................................................... 210 N.A. Ikhu-Omoregbe, Covenant University, Nigeria A.A. Azeta, Covenant University, Nigeria
Chapter 11 A Mobile Phone-Based Expert System for Disease Diagnosis............................................................ 220 Olufemi Moses Oyelami, Covenant University, Nigeria Chapter 12 Portable Wireless Device for Automated Agitation Detection............................................................ 236 George E. Sakr, American University of Beirut, Lebanon Imad H. Elhajj, American University of Beirut, Lebanon Mohamad Khaled Joujou, American University of Beirut, Lebanon Sarah Abboud, American University of Beirut, Lebanon Huda Abu-Saad Huijer, American University of Beirut, Lebanon Section 4 Open Research Challenges in E-Healthcare Systems Chapter 13 Prioritization of Patient Vital Signs Transmission Using Wireless Body Area Networks................... 257 Baozhi Chen, Rutgers University, USA Dario Pompili, Rutgers University, USA Chapter 14 Adapting Medical Content to the Terminal Capabilities of Wireless Devices.................................... 288 Spyros Panagiotakis, Technological Educational Institution of Crete, Greece Robert Agoutoglou, Technological Educational Institution of Crete, Greece Kostas Vassilakis, Technological Educational Institution of Crete, Greece Chapter 15 Situation-Aware Ambient Assisted Living and Ambient Intelligence Data Integration for Efficient Eldercare.............................................................................................................................................. 315 Werner Kurschl, Upper Austria University of Applied Sciences, Austria Mario Buchmayr, Upper Austria University of Applied Sciences, Austria Barbara Franz, Upper Austria University of Applied Sciences, Austria Margit Mayr, Upper Austria University of Applied Sciences, Austria Chapter 16 Advanced Video Distribution for Wireless E-Healthcare Systems...................................................... 349 Anna Zvikhachevskaya, Lancaster University, UK Lyudmila Mihaylova, Lancaster University, UK Chapter 17 A Cooperative Routing Algorithm to Increase QoS in Wireless E-Healthcare Systems..................... 375 Sabato Manfredi, University of Naples Federico II, Italy
Chapter 18 Towards Achieving Semantic Interoperability In eHealth Services.................................................... 388 Adel Taweel, King’s College London, UK Brendan Delaney, King’s College London, UK Stuart Speedie, King’s College London, UK Chapter 19 A Centralized Real-Time E-Healthcare System for Remote Detection and Prediction of Epileptic Seizures................................................................................................................................................ 402 Dung V. Pham, The University of Melboune, Australia Malka N. Halgamuge, The University of Melbourne, Australia Thas Nirmalathas, The University of Melbourne, Australia Bill Moran, The University of Melbourne, Australia Chapter 20 A Full-Body Wireless Wearable UWB-Based Human Motion Capture and Gait Analysis System........434 Heba Shaban, Arab Academy for Science, Technology & Maritime Transport, Egypt Mohamad Abou El-Nasr, Arab Academy for Science, Technology & Maritime Transport, Egypt R. Michael Buehrer, Virginia Polytechnic Institute and State University, USA About the Contributors..................................................................................................................... 460 Index.................................................................................................................................................... 473
viii
Preface
Over the last decade, there has been a dramatic increase in the utilization of wireless technologies in healthcare systems as a consequence of the wireless, ubiquitous, and pervasive communications revolution. The emerging information and wireless communication technologies in health and healthcare lead to e-Health systems, also known as e-Healthcare, which have been drawing increasing attention in the public and have gained strong support from government agencies and various organizations. Originally, telemedicine, the use of electronic communication for the exchange of images, data, audio, or other information to provide healthcare services between remote locations, was a rapidly growing application of wireless technologies. Nowadays, the advances in wearable computing, bioengineering, wireless sensors networks, mobile devices, and wireless communications have paved the way to new definitions of e-Health systems, moving from original telemedicine systems to the integration of existent specialized medical technologies with pervasive technologies. In order to make future e-Health systems a reality, a strong cooperation among several diverse research areas in engineering is vital. These areas include research in bioengineering, Body Area Networks (BANs), wearable sensors, microprocessors, wireless communications, wired communications, data mining, data processing, security, and many other diverse areas. For example, one of the major research challenges in the design of future healthcare systems is the design of reliable wireless and pervasive communications protocols. Wireless communications for healthcare systems calls for innovation in Information and Communications Technology to facilitate reliable, comprehensive, and high quality healthcare. The requirements for safe signal propagation characteristics, low network latency, low packet loss, high quality image and video transmission, and the need for safe, secure, and dependable operation imposes a number of research challenges on the design of the e-Health Systems. The new technologies in this era offer many advantages over old healthcare systems; from efficiencies in the hospital clinic to new ways to monitor patient health and disease progression. They also open up possibilities of new health enhancement systems for the future. However, the design of e-Health systems comes with a set of newly emerged challenges due to requirements for accuracy, security, and privacy of electronic health information, strict regulatory compliance, low network latency, low packet loss, high availability, small device size with power constraints, and multi-hop short-distance communications. The goal of this book is to explore the developments and current/future challenges in the successful deployment of future e-Healthcare Systems. The book combines the research efforts in different disciplines from pervasive wireless communications, wearable computing, context-awareness, sensor data fusion, artificial intelligence, neural networks, expert systems, databases, security and privacy. This book will be a pioneer reference in this field and will resonate sharply with researchers who have been craving a unified reference in the field of e-Healthcare Systems.
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The book is divided into four sections; each section groups several related e-Healthcare research topics, starting with a brief introduction to current e-Healthcare Systems and challenges, and finally, concluding this book with general research problems of E-Healthcare systems.
Section 1: Introduction to E-Healthcare Systems The first section of the book, Introduction to e-Healthcare Systems, presents introductory materials that are preparatory for what we describe in the rest of the book. It details the basic infrastructure and architecture of e-Healthcare systems highlighting the possible challenges associated with such an architecture. Also, innovative e-Healthcare applications for clinicians and the use of RF-ID in the current e-Healthcare systems are discussed. The developing world faces numerous challenges in realizing the infrastructure and technical expertise required to adopt mobile health solutions and applications. In Chapter 1, e-Healthcare challenges in the developing world are discussed and existing problems and risks in realizing Mobile Health applications and services are highlighted. The adoption of e-Healthcare system does not seem to be flourishing as expected due to various barriers. One such barrier is an inadequate level of legal protection or unawareness of availability of laws and regulations that address the e-Healthcare system. Chapter 2 investigates the present status of law relating to privacy, product liability, jurisdiction of courts in e-health care disputes, and professional negligence. Computer-based applications at diverse healthcare sites have led to many improvements over a prolonged period of time. Some of these advances include efficiency (in comparison to paper based data), effectiveness (in terms of support in the various processes carried out at the healthcare setting), and more categorized data. Chapter 3 discusses the possible benefits and challenges offered by Web-based applications for clinicians. Healthcare organizations are exploiting RFID to maximize use of tools and equipment, keep tabs on medicinal drugs, boost patient flow, and plug gaps in patient safety. Chapter 4 discusses a number of singular RFID applications that have been successfully developed or are in late development stages in the healthcare industry.
Section 2: Security and Privacy Issues in E-Healthcare Systems The second section of the book, Security and Privacy Issues in E-Healthcare Systems, provides a comprehensive survey of the state of the art research in the field of security and privacy of e-Healthcare Systems. The field of implantable medical devices (IMDs) has witnessed a rapid proliferation and increased success in the past ten years. This noticeable success in the field of IMDs and the major advancements in wireless sensor network algorithms and applications, have stimulated the emergence of specialized biological networks termed as Body Sensor Networks (BSNs). Chapter 5 presents a comprehensive survey of the state of the art research in the field of Body Sensor Networks security and privacy. Personally identifiable healthcare information automated by the healthcare industry can be stolen, intercepted, altered, and misused. Acceptable safeguards, therefore, have to be in place in order to ensure the privacy and protection of this information. Chapter 6 discusses how without governmental intervention, it seems unlikely that the healthcare industry will voluntarily implement any safeguards.
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Our society has been facing considerable challenges in recent years. Increasing traffic congestion, energy scarcity, climate change and many other issues have taken a turn for the worse and need urgent attention. One such area is providing quality healthcare to people, the primary focus of Chapter 7. Chapter 7 presents a novel perspective on securing Pervasive Health Monitoring Systems called Cyber Physical Security (CYPSec) solutions
Section 3: Real Life Efforts towards the Deployment of E-Healthcare Systems The third section of the book, Real Life Efforts towards the Deployment of E-Healthcare Systems, presents various attempts towards the successful implementation of e-healthcare applications and systems. As mobile phones become more powerful and perform more complex interactions between mobile devices to resident software and other server-based software, they have been recognized as effective tools for telemedicine, and the merging of the Internet and mobile computing introduces new opportunities and challenges in telemedicine sector. Chapter 8 describes the development and implementation of Android-based telemedicine system for patient-monitoring. Chapter 9 describes international humanitarian efforts for the deployment of technology in healthcare centers in developing countries. The study in the chapter reports the proceedings for providing a comprehensive system that will define public health in villages. Patients find it hard to keep track of scheduled meetings with medical personnel. This could have adverse impacts on patients’ health, especially for those with chronic diseases. Chapter 10 presents the design, deployment, and evaluation of a mobile-based medical alert system (MAS) for managing diseases where adherence or compliance is paramount for effective treatment. Different expert systems for diagnosing diseases have been developed; however, they are either standalone or Web-based systems. Chapter 11 presents a disease diagnosis system that can be accessed via mobile phones to cater for the needs of the vast majority of users in places where healthcare is inadequate. The advanced worldwide use of mobile and wireless networks has made them widely used in many current and emerging healthcare services. Chapter 12 provides an overview of existing portable medical devices. The chapter then focuses on portable automated agitation detection where the design and prototyping of a device capable of portable wireless agitation detection is detailed.
Section 4: Open Research Challenges in E-Healthcare Systems The fourth and last section of the book, presents a number of open research challenges in e-Healthcare Systems including ambient assisted living, communication protocols, and real time E-healthcare systems research Chapter 13 proposes a novel in-network solution to prioritize the transmission of patient vital signs using wireless Body Area Networks. The solution relies on a distributed priority scheduling strategy based on the current patient condition and on the vital sign end-to-end delay and reliability requirements. In e-Healthcare systems, the knowledge of terminal capabilities is essential for service provision. Chapter 14 focuses on the issue of dynamic adaptation of medical services and content to the terminal capabilities of the requesting device so that with a generic service design, all possible client devices can be served.
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Various projects within the Ambient Assisted Living (AAL) domain have proven that remarkable results can be achieved by using wireless sensor technology and mobile devices for data collection. Chapter 15 gives an overview about AAL, healthcare related standards and state of the art approaches for data integration Quality of Service (QoS) is the ability to provide certain priorities to different classes of e-health applications, users, or data flows, or to guarantee a certain level of performance to a data flow such as a required bit rate, delay, jitter, packet dropping probability and/or bit error rate. Chapter 16 is dedicated to the development and investigation of IEEE 802.16, a technology which would allow healthcare services with good QoS. The recent increased interest in distributed and flexible wireless pervasive applications has drawn great attention to WNCS (Wireless Networked Control Systems) architectures based on WSANs (Wireless Sensor and Actuator Networks). Chapter 17 is concerned with the performance evaluation of a cooperative routing algorithm QBAR (Queue Based Ad hoc Routing algorithm) for wireless e-Healthcare systems. One common and primary vision of e-Health is to achieve “seamless” interoperability between eHealth systems. Chapter 18 presents a service-based approach that utilizes domain ontologies, combined with extensible problem models, enriched with domain terminology and knowledge services, to enable autonomous data governance and semantic interoperability. Epilepsy is one of the most common serious neurological disorders, affecting about 60 million people worldwide. Chapter 19 presents the applications, requirements, solutions, and further research problems for a Centralized Real-time E-Healthcare System (CREHS) for Epilepsy patients. Gait analysis is the systematic study of human walking. Chapter 20 proposes an accurate full-body wireless wearable human locomotion tracking system using UWB radios with specific application to clinical gait analysis. Mohamed K. Watfa University of Wollongong in Dubai, UAE
xii
Acknowledgment
The work presented in this book has been made possible through the hard work of the contributors who kept the deadlines and were always enthusiastic. I would also like to thank my editorial assistant for her continuous and prompt help through every stage in the publication of this book. A special thanks also goes to the contributors’ universities, institutions and organizations who allowed them the valuable time to pursue their research interests. I dedicate this book to my family and many friends. I would like to start by thanking God for his blessings and for sending me two angels from heaven, my beautiful wife, Diana, and my little Genius, Walid. I also present a special feeling of gratitude to my loving parents, Khalil and Habiba whose words of encouragement and push for tenacity ring in my ears. My sister Lana and her gift artist husband Pikasso, my sisters in law Maya and Douja and my idol brothers Walid and Ali who have never left my side and are very special. I would also like to thank the current UOWD president, Prof. Rob Whelan who has bigger dreams for UOWD than those set for it before he joined it. He has a research mentality and an innovative plan which would set UOWD as one of the top research universities in the region and hopefully I will play my part in his plan. Mohamed K. Watfa University of Wollongong in Dubai, UAE
Section 1
Introduction to E-Healthcare Systems
1
Chapter 1
Challenges of Mobile Health Applications in Developing Countries Nikhil Yadav University of Notre Dame, USA Christian Poellabauer University of Notre Dame, USA
ABSTRACT Global health care has become an enormous industry worldwide, where trends such as aging populations, environmental and climate changes, catastrophic events, and the spread and evolution of diseases pose significant challenges. With the rapid growth of information technology (IT), wireless technologies, and mobile services, health care processes are able to increasingly benefit from new technological advances and applications built on top of them. Specifically, the area of “Mobile Health” or mHealth, which leverages mobile phone functionality to provide medical and public health services, has become a very promising trend. Wireless and mobile technologies have great potential in improving patient care, reducing costs, streamlining processes, allowing adherence to regulations, and many other health-related activities. However, the developing world faces numerous challenges in realizing the infrastructure and technical expertise required to adopt mHealth solutions and applications. In this chapter, we focus on these challenges in the developing world and highlight existing problems and risks in realizing mHealth applications and services. This chapter also proposes various solutions to overcome these problems.
INTRODUCTION Technological advances such as the Internet, mobile and personal communication devices, wireless technologies, and portable sensor devices are continuing to revolutionize the fields of health
care and wellness. Today’s medical field is very different from just a decade ago as exemplified by the use of medical informatics, modern testing techniques, and novel surgical equipment. The rapid proliferation of the Internet is also altering the traditional relationship between doctors and
DOI: 10.4018/978-1-61350-123-8.ch001
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Challenges of Mobile Health Applications in Developing Countries
their patients. More and more people rely on the Internet to address their health and wellness needs concerns and the Internet is making it possible for patients to assume much greater responsibility for their health care (M. S. Ballas, 2001). For example, according to the Pew Internet and American Life Project, more than 80% of Americans already search online for answers to their health questions with 8 million search queries every day (S. Fox, 2006). Particularly mHealth has the potential to transform the way we obtain and use health and wellness-related information. The area of mHealth is typically considered to be a sub-segment of eHealth and relies on the pervasiveness of mobile devices and mobile communications to provide anytime and anywhere health services and information. Examples include the electronic delivery of health care information to patients, practitioners, and researchers, the real-time monitoring of vital signs, clinical health data collection using mobile devices, and mobile telemedicine. The mHealth trend has been enabled by the incredible proliferation of cell phones in all parts of the world, thereby facilitating access to various online resources, including health care information and services. During the 2010 Mobile World Congress, the CEO of Google reminded us that half of all Internet connections are from mobile devices and more than half of all online search queries in emerging markets (such as health care) come from mobiles. As an example to illustrate the potential of mobile technology, he further described the experiences of two survivors of the devastating earthquake that hit Haiti in January 2010, one of them using an iPhone application to learn how to treat his own wounds and another buried victim who used her mobile to update her Facebook status to alert rescuers as to her whereabouts. Such mobile eHealth systems and applications can be particularly beneficial in developing countries, where the health care system faces significant challenges. For example, for various reasons, health care workers struggle to provide
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satisfactory care for their patients. Such reasons include the cost of communication and transportation, lack of scheduling, recording, and appropriate reminders, and poor technology and infrastructure. These deficiencies have severe consequences, e.g., in Nigeria, 26% of HIV patients fail to continue their treatment, and in sub-Saharan Africa, more than 50% of infants do not complete their vaccine series for diphtheria-tetanus-pertussis. These problems could be addressed with improved Mobile Health technology, e.g., health-care workers would be able to more efficiently visit patients in their homes, while instantly accessing these patients’ health records using their mobile applications. However, technology constraints are also a concern in developing countries. While cell phones have become omnipresent, coverage and connectivity remain significant challenges, e.g., only about 60% of Africans are within reach of a signal. While coverage for voice communication continues to increase, data communication remains unreliable, of poor quality, or even nonexistent. The lack of reliability makes it difficult for health care workers operating in the field to utilize the vast array of emerging health applications. Moreover, the access to even the most basic health information is problematic and without it, the quality of health care remains at unacceptable levels. This chapter discusses the many challenges faced in the development and deployment of Mobile Health applications. While problematic for Mobile Health systems anywhere, the focus of this chapter is on the current state and future potential of Mobile Health in developing countries. Such challenges include: • • • • • •
Technological challenges Infrastructure requirements Socioeconomic challenges Security and privacy concerns Analytical challenges Other barriers such as languages, structural, health literacy, quality, etc.
Challenges of Mobile Health Applications in Developing Countries
The chapter will also discuss the different uses of mobile technology. While there have been numerous efforts on providing health care using mobile devices, there has also been an increasing interest in mobile technology as data logging devices. For example, such mobile devices can give patients the ability to input their vital signs and other health-related information (symptoms, side effects of medications, etc.) into medical logging applications, which can be used to obtain longitudinal health records for better analysis. Other existing and potential health applications include systems that are used to perform in-field health diagnosis by health care workers, storing essential medical information for access in emergencies, systems that provide instant access to health insurance information, and applications that obtain health-related contextual information based on patient queries or proactively based on the health records of the patient. For such systems, a variety of questions must be answered, including the following: •
•
•
In terms of infrastructure, what sort of hardware and software are needed to realize the full potential of these Mobile Health applications, specifically in developing countries, e.g., what cell phones and software are needed on the mobile user side to provide easy communication between health personnel and users? Further, what sort of data storage and data dissemination are needed on the health care provider’s side? And how will connectivity issues be addressed? Allowing record logging facilities on the phone poses security challenges as well. How can patient logging and recording be done safely and securely? How can security be enforced in case these phones fall into the wrong hands? What is the resistance to the adoption and usage of these kinds of systems, e.g., due to already existing technologies/mechanisms
for health record access or due to privacy/ security concerns and other barriers (economic, quality, health literacy)?
Health Challenges in Developing Countries Developing countries face an assortment of health challenges, ranging from lack of infrastructure needed to provide health care to all sectors of the population, to new and evolving diseases, which become more resistant to drug treatment than their parent diseases, to the discovery that diseases that are more or less containable in the developed world are capable of becoming epidemic in the developing world (www.worldwatch.org, 2006). Further, the developing world faces a shortage of health care workers and adequate tools for diagnosis of diseases in order to administer proper and timely treatment. The shortage of hospitals, lack of easily commutable routes to health care facilities, and various economic constraints for people in remote areas prevent them from obtaining proper health care diagnosis and have led to an increased mortality rate. While one of the most important aspects of health care (related to population and socio-economic development) is reproductive health (I. P. Chudi, 2011), the maternal mortality rates in many countries are very high, e.g., the World Health Organization estimates an average of 1000 deaths per 100,000 live births in developing countries. According to the Federal Ministry of Health in Nigeria (FMOH, 2003), only 13.9% of the estimated annual births in that country take place in health care facilities, which appears to be primarily due to the lack of accessibility. In countries with poor infrastructure (chaotic transportation systems, inaccessible roads), it may take days for a patient to reach a health care facility. Another challenge is that many diseases evolve and become more resistant to drugs. An example of this is the avian influenza virus H5N1, whose recent outbreaks have claimed many lives. The emergence of epidemics such as HIV/AIDS has
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Challenges of Mobile Health Applications in Developing Countries
revealed containment problems in developing communities due to the lack of proper education and prevention measures. While the HIV/AIDS epidemic has been reined in to some extent in developed countries, it is expected to remain a significant and widespread problem in developing countries. For example, a report by the Worldwatch Institute (Worldwatch Institute, 2005) predicts that nearly 74 million workers worldwide could die from AIDS-related causes by 2015. Recent studies (www.knowabouthealth.com, 2010) have shown that heart disease and cancer are also reaching epidemic proportions in the developing world. A study with contributions by 500 of the world’s top epidemiologists, sanitation experts, and public health practitioners (D. T. Jamison et al., 2006) outlines four key challenges faced by the public health sector in developing countries. Specifically, these experts notice an epidemiological shift towards “lifestyle” diseases (e.g., a rising number of deaths are due to tobacco and alcohol use and injuries). Further, this study argues that non-communicable diseases (e.g., cancer, circulatory-system ailments) are soon expected to replace infectious diseases and child malnutrition as main contributors to mortality rates. Various other challenges contribute to the many health care problems in the developing world. There have been increased deaths in communities where outbreaks of communicable and completely avoidable diseases such as tuberculosis (TB) and malaria have gone undetected and rapidly infected other parts of the population due to lack of proper medical treatment and drugs. The rise in population far outweighs the rate at which health care can be administered to the population. Many developing countries face severe sanitation challenges, which negatively impact economic development and poverty reduction efforts [D. T. Jamison et al., 2006]. Another major challenge is the fact that language barriers exist due to the geographic and cultural diversity of these places. It is time consuming and difficult to convey customized assistance
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to people due to lack of proper communication facilities and interpreters to convey medical terms in easy to understand linguistic terms.
State of Mobile Health Systems and Applications Mobile phone adoption is a source of tremendous growth across the entire world, e.g., many countries (Japan, Hong Kong) have a cell phone penetration of over 100% (i.e., multiple cell phones per subscriber). Close to 70% of the world’s mobile phone users now reside in the developing world and there are millions of new mobile phones added every year due to the affordability and ease of acquisition of new handsets. Recent ITU reports (http://www.itu.int, 2010) estimate that in 2010 the number of mobile phone subscribers will hit 5 billion. While countries like India and China will lead in the number of the mobile phone subscribers, developing nations will keep pace with the global growth rate, which has been between 20 to 30% annually since 2000 (see Figure 1, (source: ITU/ICT indicators database)). As a consequence of this trend, the new medical field called Mobile Health (mHealth) has emerged, which leverages mobile technology to provide novel and creative health services. A key motivation for mHealth is the ability to access information anytime and anywhere and the use of mobile devices to log and store patient information. Many new technologies based on cell phones open the doors for novel mHealth systems for remote diagnostics, location-aware services and point-of-care systems, body sensor networks, and remote patient monitoring. These technologies also have a great potential to promote healthy lifestyles, improve decision-making by health professionals and patients, and enhance health care quality by improving access to medical and health information, while also facilitating communication in general.
Challenges of Mobile Health Applications in Developing Countries
Figure 1. Worldwide mobile subscribers 2000-2010
A recent UN report entitled “mHealth for Development” (United Nations, 2008) categorizes the mHealth field into 6 distinct areas: Education and awareness, which uses mobile phones to send health alerts to subscribers to make them more aware of disease symptoms and treatment options relevant to their health history and geographic area. Project Masiluleke in South Africa is an example of a project in this area. It uses text messaging to build awareness about AIDS and encourages testing and treatment to halt the disease’s spread. Due to the social stigma attached to the disease, using mobile phones allows a private setting for interested parties to gain more awareness about the disease. Over a million calls have been answered relating to the disease and that these answers are provided using local languages has been particularly well received. There are various similar projects in Mexico (e.g., Vidanet and Cardionet), India (Freedom HIV/AIDS), and many other developing countries. Some use interactive games to educate people as this has been shown to be a good way to sustain interest.
mHealth helpline projects allow users to call a helpline number to get medical counseling and advice. There are various such implementations across the globe. Diagnostic support, treatment support, and training: Applications in this domain focus on providing health care workers training in diagnosing patients and to support medical experts and hospitals in their activities. Some mobile applications in this area make use of decision trees to ascertain the exact disease and treatment. For example, the Tele-doc program in India equips health workers with mobile hand-held devices, allowing them to communicate with doctors using a web application, e.g., in order to obtain medication or to obtain help in diagnosing patients. Similar programs, such has TRACnet in Rwanda and Nacer in Peru, have also been implemented along similar lines. Disease surveillance and outbreak tracking: These mHealth applications rely on mobile phones’ ability to transmit data quickly and reliably with high efficiency. Data concerning diseases like
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Challenges of Mobile Health Applications in Developing Countries
TB, malaria, etc., can help health organizations better track the regions where these diseases have emerged and target medical resources to these geographic areas more effectively. AESSIMS and Voxiva Health Watch are some of the surveillance programs currently active in this field. Chronic disease management and treatment compliance applications: Some diseases require a strict medical regimen to be followed to avoid complications for individual patients. Health care workers can monitor patients and immediately identify symptoms in patients that require urgent attention. Poor medication adherence leads to increasingly poor health outcomes for patients, therefore, text messages sent by physicians to their patients have shown to increase medical adherence. Examples of this approach include the WelTel program in Kenya and Diabediario in Mexico. Remote Data Collection: Projects in this area aim to link hospitals and health care workers with data collectors and databases that house medical information. This is especially useful for government policy makers who can use the data to make decisions on where to assign medical resources and to identify which areas need more attention. In all these areas, a growing number of developing countries use mobile technology to address these health needs. A recent study on various Mobile Health care applications in developing
countries [United Nations, 2008] provided an overview of 51 mHealth programs that are either currently operating or slated for implementation in the near future. Figure 2 shows the geographic and application area breakdown of these programs.
Challenges and Promises of Mobile Health Systems in Developing Countries The mHealth Alliance (http://www.mHealthalliance.org/, 2010) was founded in 2009 by the Rockefeller Foundation, UN Foundation, Vodafone Foundation, GSM Association, and PEPFAR (President’s Emergency Plan for AIDS Relief) to advance innovation and impact in the health field using information technology, e.g., by establishing open standards-based health technology platforms and by prototyping and helping deploy sustainable and scalable mHealth solutions. This alliance will be a major contributor to encouraging and building mHealth systems to improve access, efficiency, and the quality of health care services in the developing world. The continuing proliferation and advancement of cell phones (and smart phones) will continue to push mHealth to become an integral part of health care delivery (see Table 1). However, mHealth also faces various barriers and challenges that must be overcome, including the poor infrastructure
Figure 2. Distribution of mHealth programs by location and application area (United Nations, 2008)
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Challenges of Mobile Health Applications in Developing Countries
support in many developing countries e.g., lack of signal, lack of high-bandwidth communications (such as 3G networks), cost (infrastructure deployment, voice/data communications), and policy constraints. There is a particular risk of mHealth not realizing its full potential due to small-scale implementations and pilot projects with limited reach. A report by The Earth Institute at Columbia University reported deployment barriers in five different categories (mHealth Alliance, 2010): •
•
Treatment compliance focuses on the communication between health care provider and patients. While there have been various studies on treatment compliance, there is a lack of large-scale and longitudinal trials, particularly focusing on low-income families, that are necessary to provide the
•
opportunities for successful behavioral changes and interventions. Data collection and disease surveillance can benefit from mobile technology through the reduced cost and time necessary for mobile-based approaches, but also reduced error rates. A key barrier in mobile-based data collection and disease surveillance is the lack of coherence within health information systems and the lack of policies to guide the data flows, which prevent that the information collected within health service delivery can be used for disease surveillance. Health information systems allow health workers and the general population to access health information, but also support routine data collection and reporting as
Table 1. Evolving capabilities of mobile technologies Current Mobile Technologies
Advancement Issue
Future Mobile Technologies
Hardware
• Suitable for basic mHealth services • Easy access to web (through GPRS) and wireless networks where available • Speed is a limiting factor for some applications • Intuitive touch support and enhanced graphic display quality on most smartphones
• WiMAX chipset standardized across PCs and mobile devices
• Larger displays; solar charging to increase battery life • Increased intelligence unifying mobile phone and computer capabilities • More context aware features to personalize mobile phone user experience
Software
• Abundance of software for mobile phones and laptops • Open source software available for mobile operating systems like Android
• Java Virtual Machines (JVM) and Open-Source Systems (OSS)
• Reduced development times and costs
Network
• Good cellular coverage in urban areas, less coverage in rural areas • Broadband Internet access still limited due to high costs and geography
• Increased bandwidth for newer applications
• More universal wireless Internet access and network transparency
Standards
• Lack of standards governing Mobile Health services; these require policy decisions
• New standards for spreading mobile access and licensing decisions
• Diverse services and more partnerships between providers and service industries
Services
• Education and awareness programs • Data collections • Remote Monitoring • Disease tracking
• (All of the above)
• More sophisticated diagnosis and consultation for mHealth services • More personalized and context aware mHealth services • Effective use of health care resources and workers
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Challenges of Mobile Health Applications in Developing Countries
•
•
well as point-of-care support tools. Key challenges in the deployment of health information systems include clinician resistance, cost, inadequate infrastructure, staff workload, under-staffing, power shortages, and network breakdowns. Disease prevention and health promotion using mobile technology includes approaches such as telephone counseling, email or SMS reminders, hotlines, providing access to educational resources, and efforts to increase physical activities. Common barriers in this area include the limitations of SMS (maximum of 160 characters for messages), time limits for voice calls, translation of messages from one language to another, limited technical and mobile phone provider support, and security/privacy concerns. Use of mobile technologies in emergencies is very scarce in developing countries, but has the potential to increase access to emergency care or support for disaster management and recovery. However, the main barrier to the development of a comprehensive emergency response system is the significant capital investment (medical vehicles, information technology) required.
It is important to also realize that developed and developing countries can benefit mutually from each other in realizing Mobile Health systems. Developed countries have an abundance of resources to study and implement Mobile Health systems. Research is performed both academically and at an industrial level in developed countries to strategize, design, and implement Mobile Health systems. Such projects are often funded through government institutions and various suborganizations. The developing world can make use of technologies developed in this way (saving themselves considerable effort in the research and development phases) and expend resources only
8
in the deployment of these technologies. On the other hand, the developed world can gauge the effectiveness of their deployed technologies in these settings by getting real-world feedback, and also gain better access to data and patients that could help them continually improve their technology for a more global reach. Testing technologies in a less than ideal setting can help in drastically improving the technologies for a wider audience. This relationship is shown in Figure 3.
CASE STUDIES OF HEALTH CHALLENGES In this section, we survey existing approaches in information technology (IT) that focus on providing and assisting health care. While the IT infrastructure even in the developed world still leaves a lot to be desired, the IT infrastructure in the developing world is often very poor and major hurdles still need to be crossed to provide the required scale and reliability.
Health Databases Centralized health databases are very important in understanding the causes of an illness and in analyzing trends that can be used to ease suffering from information learned about an individual, disease, or specific population. It is very important to ensure that developing countries are not left out in the database design decisions of centralized health databases (WHO, 2000) occurring in the developed world. Many private firms and organizations are helping governments in designing and maintaining such databases in the developed world. A good example of this is happening in Iceland, where the government awarded deCODE genetics a license to maintain the genealogical database of the entire population. It becomes very important that the skills and expertise gained through such projects can be used to aid developing countries in similar projects in the future. In developing countries,
Challenges of Mobile Health Applications in Developing Countries
Figure 3. Research/development/deployment relationship between developed and developing countries
there is a lack of proper regulatory frameworks for centralized health database design. There is also a scarcity of technical expertise and proper education and sophistication for such databases. Many private agencies and firms, usually in the developed world, contribute immensely to the data gathering for such databases. A good example of one such firm is HDS (Healthcare Data Solutions), which allows access to a full database (privately maintained) using smartphone applications to over 100,000 medical prescribers, providing information about doctor’s offices, names, hospitals, and pharmacies in the United States. There are many other firms that also collect statistical information about diseases. As another example, the World Health Organization (WHO) currently maintains the Global Health Observatory (http://www.who.int/gho/ en/, 2010), which is open to governments and organizations. It is an interface that provides access to various health data and analyses. It also provides access to a full health database, which lists (among other statistics): mortality, the burden of disease, infectious diseases, risk factors, and health expenditures. This work is commendable, but with respect to the developing world, proper education on interpreting this data and how to effectively use it to analyze local health needs and health preparedness are needed.
Treatment and Tracking of Outpatients It is very important to track and assess the symptoms and treatment regimes for patients living with life threatening diseases such as HIV/AIDS. Such tracking can lead to an improvement in the quality of life and can also lead to early detection of potential relapses in patient health. Such palliative care is hard to come by in developing countries. Most developing countries provide care to such patients in outpatient settings, with almost no steps being taken to provide palliative care to the suffering population. Countries such as Vietnam have tried to integrate palliative care into existing treatment services (Kimberly Green et al., 2010), but the vision for a proper policy on how to achieve this is often muddled. There is no clear guidance on how to operationalize this sort of integration. A recent survey tested the success of palliative care intervention in clinics, which included tools to assess and treat pain and other symptoms, mental health and social support screening, counseling services, etc. The survey received positive responses in favor of the success of this intervention in clinics. There are technological hurdles to achieve this care remotely for outpatients without them having to visit a clinic physically and to monitor their own statistics. 9
Challenges of Mobile Health Applications in Developing Countries
This is again due to a lack of proper education and the scarcity of remote monitoring tools and methods (e.g., as could be provided using mobile phone applications). A great innovation for treatment and tracking of patients, beds, staff, and mobile equipment is the GE AgileTrac system, which can be used locally to track hospital resources and ensure that the right resources are available in a hospital at the right place and at the right time. Using this technology, GE has been able to optimize care delivery in multiple facilities leading to cost savings of up to 30% (http://agiletrac.gehealthcare. com, 2010). A similar technology is required for tracking outpatients in developing countries and also to allow more local small-scale hospitals to tie up with bigger better equipped hospitals to allow for medical consultation and palliative care. Using mobile phone technology to achieve this appears to be a very feasible solution.
•
•
•
•
•
•
Challenges in Successful Vaccinations Vaccinations are critical in preventing infectious diseases and associated mortality in developing countries. There have been several successes, e.g., vaccines against smallpox have eradicated the disease, polio is on the verge of eradication, and there is a rapid reduction in many childhood infections. Developing countries have lagged behind in adopting vaccines that were developed many years back in the developed world. Vaccines against prevalent diseases like chicken pox, hepatitis A, and pneumococcal infections are only now becoming available in the developing world. Even though these vaccines are available now, there are many hindrances in the administration of successful vaccination programs due to a variety of reasons (Prianka Mukhopadhyay and Bhaskar Paul, 2009):
10
•
Most vaccines are very expensive for rural developing populations (e.g., HPV vaccine). It is often difficult to reach the target population and effectively communicate the effectiveness of the vaccines with them. Inadequate health care infrastructure, poor maintenance of cold chain, and injection safety concerns. Limited resources and family constraints on vaccinating against multiple diseases cause them to select only a few vaccines, or to completely ignore all of them. Failure in secondary prevention methods, e.g., HPV screening or visual inspection in the country. There are various religious and cultural barriers, misconceptions, and taboos associated with accepting vaccines in the developing world. Doctors, parents, adolescents, and entire populations hold certain views preventing them from vaccine acceptance, e.g., a vaccine against a sexually transmitted disease for higher risk groups may cause people to ostracize them or question sexual behavior. Lack of political will by local leaders to accept foreign medical practices.
The expensive pricing of vaccines is one of the biggest challenges against successful administration of the vaccines. One of the proposed ways to overcome this is to allow compensation for research and development performed locally through clinical trials of the vaccine and by making the market more competitive for the vaccine by making it available to different pharmaceutical companies. Building local and regional clinical trials and vaccine production capability without the need for importing the vaccine are promising options.
Challenges of Mobile Health Applications in Developing Countries
By using existing networks of trained staff, cold chains and logistics, clinics, and outreach services, developing countries can go a long way in meeting vaccination targets. Some countries already have immunization networks and services like family planning, and pre and post-natal care. Combining these systems with vaccine delivery and education can definitely provide more effective adoption and administration of vaccines. Education programs running in parallel can go a long way in clearing confusions and dispel myths about some vaccines, making people more aware of the benefits of various vaccines.
In-Field Data Collections Governments of developing countries lack proper capacities for registering health-related data and this is a major hindrance that stops them from implementing proper policies. More efforts are needed to increase the ability of institutions to collect, analyze, and report health and population data. It is also necessary to train health personnel working in the field to deal with survey data and qualitative techniques to help them do their job better. Programs are needed to encourage institutionalization (www.nap.edu, 2010) through on the job training, data processing systems training, workshops on data analysis, and the provision of proper data collection equipment, e.g., mobile devices handed out to health care professionals with logging software to report data to a centralized database. A good example of a system relaying health information in rural areas and allowing health care workers to log patient data is the AEDSATELLIFE system (http://www.healthnet.org/, 2010). It equips health care personnel with PDA systems and allows them to wirelessly transfer health information using customized data collection software to their local clinics. These clinics are required by the program to then regularly send data on public health programs and routine epidemiological data to regional health centers for
analysis. AED-SATELLIFE allows even remote areas to be able to register data. The GATHERdata application developed by AED allows data collected on a mobile device to be turned into useful information with real time access and automated analysis and reporting support. The system has been implemented in Uganda and was also successfully introduced in Mozambique and South Africa.
Collaborative Medical Applications In offering assistance to remote patients, it is necessary to seek expert opinion and advice in topics that may not be within the expertise of local health care professionals. When offering palliative care, access to such information can be critical. It is vital to have a network of physicians, pharmacists, doctors, and hospitals available to remote patients through their local health care provider at all times. However, lack of proper communication links and lack of training how to properly use collaborative medical devices have been problems preventing the adoption of these applications. More training is required to properly use such applications and to encourage governments to spend more on the technological infrastructure to allow them to realize their full potential.
CHALLENGES IN THE DEPLOYMENT OF MOBILE HEALTH APPLICATIONS Mobile technology has reached a stage where traditional health practices can be modernized through their usage. Though this technology has been and is being adopted at a large scale by physicians in the developed world, there are major challenges that prevent their widespread adoption in the developing world. It is important to point out that developing countries today face a steady growth in chronic diseases and the burden of communicable diseases as well. Mobile Health
11
Challenges of Mobile Health Applications in Developing Countries
technology is a promising direction forward in responding to both of these disease challenges. The rapid proliferation of mobile phones and their wide availability in developing countries means that more traditional health care services can be realigned with their usage. In effect, mHealth can relieve the resource burden on more traditional health care service providers like local hospitals and clinics and can play an important role at regional, community, and individual levels. There are however many shortcomings and associated challenges in the successful deployment and usage of these technologies at a wide scale in developing countries. In this section we highlight these challenges.
Technological Challenges Today, most of the world’s population lives within proximity of a cell phone tower. The major challenges associated with technology are related to technology adoption. There are logistical, political, cultural, and financial barriers when trying to implement technology improvements targeted at the mHealth sector. A lot of the developing world is on the underprivileged side of the digital divide. There is either a severe lack or nonexistence of hospital legacy systems in developing nations, which could be used to host mHealth services such as patient records for retrieval over mobile phones, etc. Unlike in the developed world, where medical records are increasingly electronic, medical records are still paper based in the developing world. For mHealth initiatives that monitor individual patients, this is a problem, since electronic medical history access is a prerequisite to monitor patients requiring palliative care or with a history of medical ailments related to their present condition. To replace existing systems may be met with an opposition to change. In the developing world, the proliferation of expensive smartphones is also not that dominant for the general population. It is important for governments and policymakers to invest substantially in the training of health care
12
workers in the use of new systems, to educate them of their benefits, and to either upgrade or overhaul outdated legacy systems and adapt them to the new technological needs for mHealth initiatives.
Infrastructure Challenges A large section of the developing world still lacks access to proper medical facilities such as hospitals and clinics. A solution implemented in many countries is the introduction of mobile clinics to travel to remote areas to deliver medical care. There is also a need to continue the expansion of wireless Internet and cellular data infrastructure to keep up with the rapid increase of cell phone users in previously inaccessible terrains. To implement an mHealth environment, it is essential to form the necessary foundation for the inexpensive and inefficient exchange of data, even in the remotest of places. In countries like Malawi, this has been a challenge due to the country’s cell phone operators’ high charge on general data services and rural voice services (http://www.infodev.org, 2003). In terms of wireless infrastructure, the cost of wireless phones and Wireless Local Loop (WLL) services is a third of the more traditional copper or landline services. A wireless connection cannot be stolen compared to traditional copper-wire infrastructure. It is necessary for governments to cautiously invest in these technologies, which will form the backbone of future mHealth applications. These new technologies can offer developing nations an opportunity to leapfrog the digital divide. It is important for governments and policy makers to invest in wireless infrastructure and to introduce standardization and interoperability for structured health data. Governments also need to define what mHealth means within the national health system. Telecom providers need to be rewarded for provision of mHealth services. In cases where people cannot afford handsets, free handsets and loaned mobiles need to be provided. To convince opposing parties of the need of infrastructure expansion, a proof of concept by using the simplest available
Challenges of Mobile Health Applications in Developing Countries
technology on existing infrastructure needs to be demonstrated. By coupling cell phones with Wi-Fi infrastructure and traditional data services, the full potential of Mobile Health deployment could be realized.
Socioeconomic Challenges In the developing world, there are very steep socioeconomic gaps across families and individuals. It is necessary to seek maximum participation across all social classes to maximize the effectiveness of mHealth applications. To realize the full potential of Mobile Health in the community there needs to be an awareness of the economic and social advantages of these technologies. Sometimes, cultural beliefs keep people in under-served communities from actively participating in sharing their health information for fear of being ostracized in their community. It is necessary to start mHealth education initiatives to educate people on the full benefits of Mobile Health technology. For people who cannot afford mobile phones, provisions need to be made to loan them phones to allow them in improving their lifestyle and realizing the benefits of such solutions.
Security and Privacy Challenges Medical records are confidential pieces of data and it is very important to protect them. With the growth of mHealth applications, there has been an explosion of many useful applications, systems, and tools. As with personal computers in the early days, a lot of isolated high potential tools are emerging. However, since mHealth is still in its infancy, these tools need additional integration and security in order to protect confidential medical records (Stanford, V., 2002). The HIPAA (Health Insurance Portability Accountability Act) of 1996 has changed the legal scenario for the access and sharing of such medical records. A challenge faced by health care IT executives and mHealth system providers is to bring their systems
into compliance as quickly as possible. There are security risks beyond conventional networks when using Mobile Health applications because these devices are prone to being misplaced or stolen. System designers need to enforce security features on the phone, including biometric, fingerprint, or password authentication when a Mobile Health session is initiated. The operating system (OS) of a mobile phone needs to be engineered to be resistant to tampering. It is necessary to use authentication and encryption over wireless mediums to avoid misuse of confidential medical records. There are more commercial products becoming available to protect viral data on lost and stolen devices as well. Asynchrony’s PDA Bomb, Tealpoint’s Teallock, and TrustDigital’s PDA Secure are just a few of these. They allow enforcement of security policies and data/application encryption. There is a need in developing countries to adopt a layered security hierarchy in consultation with hospital organizations. There is also a need for a thorough review and discussion of all the associated security loopholes in mHealth systems and to have security checkpoints at each level of medical record access. Some applications have the ability to destruct data on tampering, which is a good example of preventing misuse of information once a mobile device falls into the wrong hands.
Analytical Challenges It is necessary to provide real-time analysis and evaluation of a patient’s health statistics and physiological data logged from remote mobile devices and there has been a lot of research on how to accomplish this (Danielle Apiletti et al., 2009; Valeriy Nenov et al., 1996). This kind of analysis enables automatic learning of different behavioral models tailored to specific diseases and patients. Frameworks for analyzing instantaneous data streams over a sliding time window have been proposed to allow ubiquitous monitoring over mobile devices. Previous work (Danielle Apiletti et al., 2009) proposed an algorithm for
13
Challenges of Mobile Health Applications in Developing Countries
real-time analysis of physiological data on a mobile device, allowing medical staff to monitor patients’ data without being near them physically. In the developing world, the expertise to analyze such data is found lacking. Existing medical staff is not trained to perform analysis of such data such as a rural inhabitant’s insulin levels recorded through a glucose monitor that transmits this data through a mobile phone to a health care provider. Proper analysis can reduce hospital visits and enable affordable access to medical care right at home. One of the major challenges in developing countries is that up-to-date health trend data is not maintained and is not in electronic form. The infrastructure to properly analyze certain patients and diseases based on their medical history is found to be non-existent at times. Significant effort needs to be spent to standardize health records across the board in a format and structure that can be analyzed effectively. Staff needs to be trained to analyze these records, provide suitable and realtime feedback when required, and validate the effectiveness of their response. It is also necessary to equip remote patients with the right tools in the form of mobile devices and health monitoring apparatuses such as glucose monitoring and blood pressure monitoring devices. A significant effort also has to be spent on standardizing the reporting process and reaching a consensus on which software and hardware tools to use to maximize effectiveness of the reporting process. Many of the challenges facing the adoption and implementation of electronic health records also apply to mobile personal health records. Providers that eventually need to be involved have to be assured that information from the electronic and/ or mobile personal health records will be available for analysis at all times and that they will be able to access data much more efficiently. Such information will be more readily available than a manual data-entry system for the same records.
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Language and Literacy Challenges In most parts of the developing world the people who are most in need of medical support are also illiterate. That is, these applications need to communicate with their users in a language that can be easily understood in a local language. This challenge also needs to be addressed if mHealth applications are to be successfully deployed. Helping people with poor reading skills to access health-related information on a mobile-based application is a daunting task. Applications that can use alternatives such as voice messaging for such a target population can be a possible solution. More research needs to be carried out along these lines, e.g., in some applications, text enlargement or graphics can be used for people with poor literacy skills or visually impaired people (many older people who require medical aid fall in this category), to guide them in medical matters such as which prescription drugs to take. Companies providing mHealth technology need to invest significantly in research so that all sections of society can benefit from these mHealth innovations. In terms of local language support, there are translation processes that need to be followed to maximize the quality of information in a language appropriate to a targeted population. A good example of such an application is one that allows a phone call to be made (or received) in a particular language. Such a translation process has the potential to bridge the language and literacy gap.
Structural Challenges There are also structural barriers to the growth of mHealth. In developing nations, there is a lack of players with the required expertise to undertake mHealth initiatives, since existing organizations do not have a track record implementing these kinds of applications. The mHealth revolution
Challenges of Mobile Health Applications in Developing Countries
is very dynamic in nature and it is important for all providers, patients, payers, and health planners to comprehend the change in this model, which would allow access to resources at any time and place including at a point of care. One of the organizations advocating this change is the “mHealth Initiative”. Health care providers need to understand that communication-based care allows them to connect better to patients, payers, colleagues, and resources. Patients need to learn how to use mobile devices to maximize health and wellness benefits by being very engaged and better informed about the mobile applications being deployed. All stakeholders in the mHealth field need to work on standards, policies, and functionalities so that all the necessary structural changes and adjustments to existing health care infrastructure can be implemented.
Quality of Health Care Challenges In current platforms supporting mHealth applications, services are delivered in a best-effort fashion, since there are no guarantees on the delivered Quality-of-Service (QoS). Allowing health care professionals to support anyplace, anytime monitoring of vital signs and providing real-time feedback poses questions on how the quality of relayed information can be improved. In (Katarzyna Wac et al., 2006), the authors explore QoS issues of an mHealth service platform. They propose using context information, which is information related to a serviced user’s actual situation (e.g., location, time, current health status) to improve the delivered QoS. Using an example of a monitoring telemedicine application for epilepsy in a 2.5/3G network scenario, they show that indeed the QoS of delivered information can be improved. One of the challenges is to address what kind of context information to collect that may be used in mHealth service platforms to improve the QoS of delivered content. Even in the developed world, there are currently no
strict mHealth QoS requirements, and this can be attributed to a general lack of understanding of the pros and cons of these kinds of services. QoS requirements need to guarantee that in case of an emergency, an associated health care center can react in time to bring medical assistance to a patient. There may also be differences in the QoS requirements based on different situations, e.g., an emergency situation versus a non-emergency one. In developing countries, health care professionals need to be informed as to the nature of end-user service QoS requirements, and from which service platform they will be derived. These requirements affect service performance (e.g., delay, jitter), expected security level, acceptable price, etc. Hence, it may be necessary to reach a general consensus as to what context information needs to be maintained to satisfy required, agreed upon QoS metrics. Initiatives in educating health care personnel on how to maintain and infer such information to improve delivered QoS needs to be addressed at structural and all other possible levels.
Legal Challenges Health records are confidential pieces of information and there are various legal issues that need to be addressed to sanitize their handling and dissemination in a Mobile Health scenario. Acts such as the HIPAA (Health Insurance Portability and Accountability Act) in the United States need to be implemented if no counterparts are already available in the developing world. This in itself poses a challenge, as there may be a lengthy legislation process to ensure the confidentiality of patient records. In the USA, passing the HIPAA took over a decade and there are still rules that need to be resolved for national identifiers and security. In developing countries such a process may take many years due to political instability and lack of an efficient legislative body. Responding to such an act means that hospitals and physicians need to review their operations pertaining to location
15
Challenges of Mobile Health Applications in Developing Countries
of medical records, access to them, and access to health information databases. They need to revise information release authorization procedures and inform patients regarding their health information usage. Legal compliance has to be sought from the billing applications to the network security when transferring this information. There is more than likely going to be an opposition to any legislation trying to enforce these rules. A possible solution would be to involve just a few health care providers initially before explosive growth can be experienced warranting legislation.
Other Challenges In (Cheng et al., 2010), the authors identify barriers to the acceptance of mobile devices for recording of sensitive personal data in a low-resource country (specifically Angola in Southern Africa). Angolans were given PDAs and discussed whether they had any concerns with disclosing HIV/AIDSrelated sexual risk behaviors to interviewers using a PDA. A majority of the participants were very reluctant to use the PDAs and opposed to the idea of discussion on the disease. Past historical events in developing countries also form suspicious perceptions about “outsiders” and technological innovation originating from them. Angola is recovering from a 27-year civil war, and a consequence is that there is a commonly held belief that foreign intervention is the reason that the war continued for so long. Countries with such beliefs will not be willing to adopt new Mobile Health initiatives, since they are based on so called “western” technology. A proof of concept is needed to make the benefits clear to local inhabitants and to ensure them that such solutions will only prove to be an advantage to them.
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OPPORTUNITIES IN MOBILE HEALTH CARE Case Study I: EpiSurveyor DataDyne is a non-profit that focuses on information and communication technologies for public health. One of its tools, a free software package called EpiSurveyor (http://www.episurveyor.org, 2010) can be used to quickly design and deploy health surveys based on handheld mobile phones. The goal is to allow health workers to become fully self-sufficient in the programming, designing, and deploying such surveys, eliminating the need for costly outside consultants and manual data entry. It provides support for the surveillance of diseases to evaluating treatments to monitoring the success of treatments in preventing outbreaks and improving health. The primary goal of EpiSurveyor is to tackle a key challenge of Mobile Health in the developing world, i.e., the lack of data necessary to understand the health of the population, to identify the need for required programs, to identify the key health issues, and to develop effective intervention programs. The majority of health data is still collected on paper, which is time-consuming and errorprone. EpiSurveyor addresses the main obstacle to efficient and effective data collection, i.e., the lack of appropriate software to put questionnaires onto handheld devices that also provide simple data transfer capabilities to desktop computers (without the need for technical expertise or programming skills). Using this technology it is now possible for developing countries to collect their own nationallevel health statistics. Currently, DataDyne works with the World Health Organization and participating ministries of health, the United Nations Foundation, and Vodafone Foundation Technology Partnership in training and equipping health care
Challenges of Mobile Health Applications in Developing Countries
workers in more than 20 sub-Saharan African countries with the tools to make smart decisions about critical public health issues, making it easier to combat deadly diseases and save lives (http:// www.medicalnewstoday.com, 2009).
Case Study II: FrontlineSMS FrontlineSMS (http://www.frontlinesms.com/, 2010) is an open-source software that allows users to send text messages to individuals or groups of people (which can be useful for fieldwork and during surveys) through mobile phones. The advantage of FrontlineSMS is that it does not need the Internet. It turns any two mobile devices, such as a laptop, mobile device, or modem, into a two-way group communication hub. The major advantage of FrontlineSMS is that it can operate in any area where there is a mobile signal. Surveys can be targeted at a very large audience and responses can be collected using text messaging. The application allows data to be exported to Excel spreadsheets for analysis later. This application is being used by NGOs in the developing world and since the software is free, it is very simple to get started using existing infrastructure.
Case Study III: AED-SATELLIFE AED-SATELLIFE (http://www.healthnet.org/, 2010) is a perfect example of how mobile phones can be used for better health in low resource environments as frequently found in the developing world. This program has worked with local and international NGOs and bilateral/multilateral institutions working on development and data collection tools using mobile sets and a wireless communication link to a remote computer. They are now capable of packaging local and international medical information and to put it in the hands of personnel in areas where electricity, telephone lines, and books are scarce and Internet connectivity is still not a reality. In Uganda and Mozambique, AED-SATELLIFE has been used
very successfully. In Uganda, it provides a perfect example of how government organizations like Uganda Chartered HealthNet (UCH) and local academic institutions such as the Makerere University Faculty of Medicine can work together to establish infrastructure for mHealth. A network of handheld computers and mobile access points has been built in these countries using existing cellular networks and wireless access points to deliver health care information between health care workers and remote health centers. Initial studies show that their platform is easy to adopt by new users and that it can increase access to up-to-date information on diseases such as HIV/ AIDS or malaria, but also on other health issues such as child and maternal health. The GatherData platform is part of AED-SATELLIFE and is used in capturing pertinent health information, alerting patients, and analyzing and reporting their health data using mobile phones. Guide is another component of AED-SATELLIFE. It is the content management system used to collect large clinical documents into a readable format on small mobile screens.
Case Study IV: Wearable Health Sensors Singapore, though not a developing country, is in the process of modernizing its health care practices as part of the Intelligent Nation (iN2005) program (http://www.ida.gov.sg, 2010), administered by the Information Development Authority of Singapore. In the Changi General Hospital (CGH), patients are monitored using wearable health sensors using Bluetooth and WLAN technologies to communicate patient information to hospital staff. Although this idea is more appropriate for use in the developed world, it is a good indication and testing ground for the true potential of mHealth elsewhere. CGH has successfully used this infrastructure to allow self-administered monitoring, real-time communication between patients and caregivers, and security and confidentiality of
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Challenges of Mobile Health Applications in Developing Countries
patient data. A great deal can be learned through the implementation of this system and the future mapping of such an approach into more remote areas of the developing world.
FUTURE DEVELOPMENTS AND CHALLENGES In (Esko Alasaarela et al., 2009), it has been shown that the future of mHealth services faces more serious challenges arising from process change than from technical aspects. This problem is amplified in developing countries due to the rigidness of government policies and the opposition to “western” influences and technology. The results highlighted showed that usability of the mobile interface takes precedence over issues that were thought to be more relevant, like security of patient data.
Health Care Provision Developing countries usually have limited health care budgets as compared to their more wealthy counterparts. It is important to keep in mind the goals that the financing and provision of health care needs to cater to. These goals include: providing health care to the poorest of populations which cannot afford proper health care; minimizing and avoiding surplus spending on health care; allowing personalized care to patients based on their individual conditions and preferences. Such goals can drive the design of a good system for health care while trying to ensure that mHealth services are accessible to all sections of the population.
Wireless Communications Though cell tower coverage has significantly improved in the developing world, there are still some areas that suffer from poor coverage. In critical situations where health support is needed in real-time, it is essential to have a functional active wireless link between the mobile devices of the 18
health care provider and the patient. To achieve uniform and good cell phone coverage and signal strength all across a developing country remains a challenge. For countries with vast geographical areas and pockets of remote populations, it is necessary to link these areas with the rest of the cellular backbone so that they are not left behind in the mHealth revolution.
Health Sensing mHealth solutions of the future will incorporate wearable sensors interfacing to mobile phones to sense patient conditions. In (Hassan Ghasemzadeh et al., 2009), the authors look at the various challenges associated with the challenges involved in developing mobile systems for biomedical applications. Body sensor networks (BSNs) collect physiological data from patients and perform distributed and collaborative processing. The challenge in these systems is that since they are constrained in computation, communication, and storage, it is desirable to have effective mobile computing and resource allocation techniques. Also, these devices should be relatively unobtrusive, wearable, and comfortable. Systems developed today can be used in rehabilitation, sports medicine, geriatric care, gait analysis, balance evaluation, and sports training. When designing sensing capabilities in mHealth solutions, the following questions need to be answered: what sort of sensors should be used; how many should be used; and how frequently should they operate? Also, in developing countries where literacy levels are low, how easy would it be for someone to use these health sensors to monitor their own health? There needs to be significant training to allow patients to use BSNs to monitor their health in a simple and effective way, while being relatively cheap to implement and operate remotely. There are already a multitude of applications available to perform cardiac and glucose monitoring, but also many options for portable and wearable vital signs monitoring.
Challenges of Mobile Health Applications in Developing Countries
Remote Health Care and Home Monitoring Solutions for remote health care and home monitoring find particular application for the elderly, where relatives need to keep tabs on their health and constantly monitor if they are following their medical regime. People tend to forget things when they age or in a certain medical condition, so it is necessary that any mHealth system for home monitoring require as little user input as possible and carry out reporting as unobtrusively as possible. In addition to this, technology is also intended to strengthen the long-term involvement of patients in the health care reporting process. Making technologies intuitive, enjoyable, and educational to use for communicating with concerned families and health care teams is a challenge as well. By introducing more novel communication approaches like e-mail, video conferencing, SMS and MMS messages, and other techniques to communicate (apart from periodic mail delivery and phone calls), patients can get more involved in reporting their health care to family and be monitored as well. Touch screens and more intuitive services can also be handed out to people with little IT experience to get involved in health monitoring. At the minimum, patients and their health care providers need to be educated on how to use these technologies.
CONCLUSION Though mHealth applications promise great potential in improving health care in developing countries, there remain many challenges in their effective deployment and usage. Process change challenges are much more difficult to overcome than technical challenges. Upgrading existing health care IT infrastructure in developing countries and adding new infrastructure is a very difficult task when health budgets are limited. There is also a resistance to new technologies imported from the developed world. Technically, usability
of the mobile interface is very important when designing an mHealth solution. Since, there are diverse population and language groups in developing countries, it is important to customize these interfaces in more local languages and also support more intuitive and graphical interfaces that can be perceived in the same way across different groups. It is important to involve all stakeholders, from patients to health care providers to IT and cellular firms to see the benefits of transitioning to the mHealth paradigm. It is vital for governments in these countries to provide the leadership and political will to make the change a success. Societies need to elevate their lifestyle expectations and patients need to be more responsible for their health monitoring. At the same time, health care organizations need to be convinced that upgrading their IT infrastructure to deal with mHealth solutions can go a long way in enhancing the management of chronic diseases. It can help prevent illnesses and communicable diseases in the future. There are some shining examples of using wireless technologies in health care in the developed world for disease management. Diseases like AIDS, diabetes, and influenza play a major part in the way pharmaceutical and health care providers operate on a daily basis. This needs to be realized for the developing world too. Through some of the case studies in this chapter, we have shown that significant progress has been made in certain countries like Uganda to manage the monitoring of these diseases. As already pointed out, significant resources need to be expended on realizing the technical infrastructure for mHealth. Collaborating with other governments that have significant expertise in the area of mHealth could prove to be very useful in the long run. Since mHealth is still in its infancy, a lot can be learned from the experiences by people from different geographical regions and population groups. Significant effort also has to be expended on training both subscribers of these services and the actual professionals providing health care to 19
Challenges of Mobile Health Applications in Developing Countries
them, to allow effective and real-time advice and support to patients who require it the most. There are legal challenges in realizing the full potential of mHealth applications as well. Legislation is not as streamlined in the developing world. Even in the developed world, legislation to bring change to health services has taken many years, and is a continually ongoing process. Such processes may be stalled indefinitely in the developing world. Legal hurdles, e.g., protecting the privacy of health records and having standards in place for their access may take many years to resolve. However, significant progress has been made in protecting records in the developed world and similar policies could be implemented in the developing world. In general, the advantages of realizing mHealth solutions make it promising to look at facing these challenges and coming up with solutions to resolve them with minimum resistance. Improved health care monitoring can go a long way in assisting patients with chronic disease, thereby improving their lifestyle. It can also cut down costs for populations who have poor access to hospitals and it is a challenge to reach such health care providers. Being able to monitor your own health, get real-time feedback based on this monitoring over a mobile phone (application), is a great way to cut down on travel and diagnosis costs for poor populations who cannot afford these services. Communicable diseases can also be tracked and stopped from spreading once diagnosed using mHealth applications. Though the challenges are significant, the benefits gained from the deployment of Mobile Health applications far outweigh them. By allocating sizable budgets to realize the infrastructure, training, and technical expertise for these applications, their positive impacts can definitely go a long way in alleviating the suffering of people with chronic diseases while also improving the lifestyle of countless others. Anyone with access to a mobile phone, which is becoming more and more commonplace in today’s world, stands to benefit.
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REFERENCES AED. (2010). Satellife: Center for health information and technology. Retrieved from http://www. healthnet.org/ Alasaarela, E., Nemana, R., & DeMello, S. (2009). Drivers and challenges of wireless solutions in future healthcare. In Proceedings of the 2009 International Conference on eHealth, Telemedicine, and Social Medicine (pp. 19-24). Apiletti, D., & Baralis, E. (2009). Real time analysis of physiological data to support medical applications. IEEE Transactions on Information Technology in Biomedicine, 13(3), 313–321. doi:10.1109/TITB.2008.2010702 Ballas, M. S. (2001). The impact of the Internet on the healthcare industry: A close look at the doctor-patient relationship, the electronic medical record, and the medical billing process. The Einstein Journal of Biology and Medicine; EJBM, 48(2), 79–83. Cheng, K. G., Ernesto, F., Ovalle-Bahamón, R., & Truong, K. (2010). Social and cultural barriers to accepting mobile devices for collection of health data in sub-saharan Africa. In the Proceedings of the Workshop on Interactive Systems in Healthcare (pp. 21-24). Chudi, I. P. (2011). Healthcare problems in developing countries. Medical Practice and Reviews, 1(1), 9–11. Datadyne Epi Surveyor. (2009). The fastest, easiest, least expensive way to collect data on mobile phones. Retrieved from http://www.episurveyor. org/user/index Federal Ministry of Health (FMOH). (2003). National study on essential obstetric care facilities in Nigeria. Abuja, Nigeria. Fox, S. (2006). Online health search. Pew Internet and American Life Project.
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Frontline, S. M. S. (n.d.). Frontline SMS allows you to text message with large groups of people anywhere there is a mobile signal. Retrieved from http://www.frontlinesms.com Ghasemzadeh, H., & Jafari, R. (2009). Sensing health: Challenges in designing mobile sensory platforms for healthcare monitoring. Santa-Cruz, CA, USA: In HotMobile. Green, K., Tuan, T., Hoang, T. V., Trang, N. N., Ha, N. T., & Hung, N. D. (2010). Integrating palliative care into HIV outpatient clinical settings: Preliminary findings from an intervention study in Vietnam. Journal of Pain and Symptom Management, 40(1), 31–34. doi:10.1016/j.jpainsymman.2010.04.006 Healthcare, G. E. (2010). Performance solutions: AgileTrac. Retrieved from http:// agiletrac. gehealthcare. com/ ?gclid=COSNvLDD9aMCFQ pV5wod8l2_0w Healthy Living. (2010). Developing countries at risk of unstoppable cancer epidemic. Retrieved from http://www.knowabouthealth.com/developed-countries-at-risk-of-unstoppable-cancerepidemic/5580/ IDA. (2010). iN2015 Master plan. Retrieved from http:// www. ida. gov. sg/ About% 20us/ 20070903145526. aspx InfoDev. (2003). The wireless Internet opportunity for developing countries. InfoDev, Wireless Internet Institute, United Nations Information and Communication Technology Task Force joint publication. Retrieved from http://www.infodev. org/en/Publication.24.html ITU. (2008). Committed to connecting the world. Retrieved from http://www.itu.int
Jamison, D. T., Breman, J. G., Measham, A. R., Alleyne, G., Claeson, M., & Evans, D. B. … Musgrove, P. (2006). Disease control priorities in developing countries (2nd ed.). Washington, DC: World Bank. ISBN: 0-8213-6179-1 Medical News Today. (2009). Open source mobile technology software reinventing health care in developing countries. Retrieved from http://www. medicalnewstoday.com/articles/147941.php mHealth Alliance. (2010). Barriers and gaps affecting mHealth in low and middle income countries. The Earth Institute. New York, NY: Columbia University. mHealth Alliance. (2011). Mobilizing innovation for global health. Retrieved from http:// www. mHealthalliance. org Mukhopadhyay, P., & Paul, B. (2009). Introducing HPV vaccine in developing countries - Addressing the challenge. Indian Journal of Community Medicine, 34(4), 370–371. doi:10.4103/09700218.58407 Nenov, V., & Klopp, J. (1996). Remote analysis of physiological data from neurosurgical ICU patients. Journal of the American Medical Informatics Association, 3(5), 318–327. doi:10.1136/ jamia.1996.97035023 Stanford, V. (2002). Pervasive health care applications face tough security challenges. Pervasive Computing, IEEE, 1(2), 8–12. doi:10.1109/ MPRV.2002.1012332 The National Academies Press. (2011). Session IV: Institutionalizing data collection in host countries. Retrieved from http://www.nap.edu/openbook. php?record_id=5442&page=21 United Nations. (2008). Case study: Connecting health clinics and remote health workers (Uganda).
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United Nations. (2010). mHealth for Development (Report). 2008. Wac, K., van Halteren, A., Bults, R., & Broens, T. (2007). Context-aware QoS provisioning in an m-health service platform. [University of Geneva, Switzerland.]. IJIPT, 2(2), 102–108. doi:10.1504/ IJIPT.2007.012373 World Health Organization (WHO). (2000). ... Bulletin of the World Health Organization, 78(5).
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World Health Organization (WHO). (2011). Global Health Observatory (GHO): Public health and environment. Retrieved from http://www. who.int/gho/en/ World Watch Institute. (2011). Study highlights four key health challenges in developing countries: China struggling with all. Retrieved from http:// www.worldwatch.org/node/3910 Worldwatch Institute. (2005). ... Vital Signs, 2005.
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Chapter 2
Legal Issues in E-Healthcare Systems Jawahitha Sarabdeen University of Wollongong in Dubai, UAE
ABSTRACT E-healthcare systems through electronic medical records (EMRs), electronic prescribing and decision support systems endeavour to reduce the cost and errors in healthcare, while facilitating easy access to it. However the adoption of e-healthcare systems does not seem to be flourishing as expected due to various barriers. One of such barriers is an inadequate level of legal protection or unawareness of availability of laws and regulation that addresses the e-healthcare system. The objective of the study of this chapter was to investigate the present status of law relating to privacy, product liability, jurisdiction of courts in e-health care disputes and professional negligence. The study recommends that the existing offline and e-commerce laws should be interpreted to address many e-healthcare concerns even though specific e-healthcare laws are not enacted by many nations.
INTRODUCTION High technological development in information and communication technology has enabled the public to carry out various medical related activities via Internet. Creation, modelling, management and sharing of health data and knowledge to support data analysis and timely decision making in
medicine and health care created various opportunities and challenges to the healthcare providers and the patients. The move towards e-healthcare in various countries is envisaged to reduce the cost of provision of healthcare, improve quality of care and reduce medical errors. In addition, it gives the public the information they need to make informed choices about their health and
DOI: 10.4018/978-1-61350-123-8.ch002
Copyright © 2012, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.
Legal Issues in E-Healthcare Systems
their healthcare. It also helps to develop capacity to process very large volumes of data for public health surveillance quickly and efficiently to allow early detection of threats (e.g. flu outbreaks, adverse drug reactions). In the process, there are all relevant information about the patient that is stored in the computer system of the medical practitioner and other related parties for record and reference purposes. However, storing such information in the computer or system is not at all secured due to the availability of technology that may circumvent or get access to the said information. This could be a threat to the privacy and security of the patient. Regulatory compliance and liability issues arising from the use of information technologies and possibility of privacy and other related violation in health care industry should be given important consideration. That is because the progression of e-health industry is dependent upon and influenced by the rapidly changing advances in law. Major issues in adopting e-healthcare system lie in patient privacy, trust, product liability and negligence in handling medical data. These concerns are affecting the adoption rate and usage of these e-healthcare systems. Unless deliberate efforts are taken to secure these systems from design to implementation most of the development achieved to date may not be realized and rolled out to the real world. A 2006 survey found that 75% of the physicians agreed that e-health in US could help to reduce errors while 70% of them felt that it could help to increase productivity. The survey further noted that implementation and adoption of e-health are lacking in many countries including USA and European countries due to various barriers. One of such barriers is a lack of legal protection on protection of privacy and other liability issues (Anderson & Balas, 2006). Thus this chapter of the book will analyze four legal issues of concern. The analysis will include the legal framework adopted by European Union, USA and UK where necessary. The four legal issues are privacy, product liability, jurisdiction of
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courts in e-health care disputes and professional negligence. It is worth mentioning that e-health encompasses e-commerce, e-marketing, and all forms of medical services, decision support and e-business intelligence in health care and the ehome care application. Specific laws addressing all the issues of health care system are not available in many countries. So, it is common to see that the offline laws and e-commerce laws are being extended and interpreted by the courts and authors to cover cases of common in nature. For example European Union’s Directive on Data Protection can be extended to cover medical data too. This chapter where necessary will analyse offline laws and e-commerce laws which can be extended to elaborate e-health issue.
PRIVACY PROTECTION IN E-HEALTHCARE SYSTEM Medical records are lifetime history of every patient. Thus proper recording, keeping and retrieving remain burdensome but necessary for accurate medical assessment and clinical interventions. Clear and quality records are also important for better communications between medical professionals, patients, care takers and other relevant stakeholders. Various studies suggested that privacy concern was an issue that requires legal protection as technology could be used to misuse health data with ease without cost. Data of patients could be easily collected and used or misused without their consent. The success of the implementation of e-healthcare system to a great extent depends on the availability of legal protection. The term privacy is from the Latin word “privatus” which means withdraw from public life, and or to have seclusion from the public (Raymond, 1978). Privacy is recognised as a fundamental right in Article 12 of the United Nation’s Universal Declaration of Human Rights 1948 despite the fact that there is no single acceptable definition is available. Article 12 of the
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said Declaration stipulates that “no one shall be subjected to arbitrary interference with his privacy, family, home, or correspondence, nor to attack upon his honour and reputation. Everyone has the right to the protection “. Warren and Brandeis in 1890 mentioned that this right refers as one’s personality that provides for the protection of the person and for securing to the individual what Judge Cooley “right to be let alone” (Warren & Brandeis, 1890). They further asserted that regardless of the extrinsic value of one’s ideas, thoughts or creations “the individual is entitled to decide whether that which is his shall be given to the public”. Right to privacy may also be defined as a “condition of being protected from unwanted access by others, physical access, personal information or attention” (Bonavia, & Morton, 1998). This right further defined to include the elements of secrecy, anonymity and solitude. Privacy ensures that nobody obtains information of a person, pays attention to it, and gains access to a person without his consent. Privacy can be divided into information or data privacy, bodily privacy, communications privacy and territorial privacy. Among all the types of privacy the information or data privacy has become one of the most crucial issues of great concern following the advances of Information and Communication Technology (ICT). More and more people use ICT to get medical services. In the course of these activities, huge amount of private information is being generated, and that the information generated is used to build personal profiles. The ability of the technology to build up personal profile in a matter of minutes, at minimal cost deters the netizens from full utilization of the technology in particular for e-health purposes. Personal data privacy that the users of e-health systems are concerned includes individual’s claim to control the collection, disclosure and use of personal data. Information or data privacy allows the individuals to determine when, and to what extent, information about them is communicated to others. For instance Electronic Health Records
(EHR) based system provides efficiency; cost effectiveness and fault-proof data for medical diagnoses, treatment and related purposes. In home care application based wireless body sensor networks, patients are remotely monitored and provided consultation. The concerned patient also receives other medical services based on the date transmitted from him to the medical practitioner. In EHR medical records are created, stored, transferred and accessed digitally. It is a central piece of information. It would have medical data like radiology images, laboratory test results, medication, billing history etc. EHR will be stored in remote servers like primary health care providers, monitoring centres and data are also being exchanged for emergency response, research and other related purposes (Jan, Fang & Yuguang, 2010). These medical data are highly confidential and any abuses can cause difficulties for patients in getting insurance and employment. It also could lead to discrimination for having certain types of illnesses. In the body sensor networks patients’ location privacy should be guaranteed whenever emergency responses are not required. Otherwise it is possible to track patients’ whereabouts through IP addresses of PDA used in wireless body sensors. In addition to protection of patients’ location privacy, any medical related communication should also be anonymous. Most of the companies do data profiling using various technologies, when they collect and analyse the data for present and future use. Data profiling involves profile generation and application. In data profile generation, the data are processed and analyzed in search of patterns, sequences, relationship etc. The result would be a set of assumptions based on some probability. The application is making of decision about persons based on the profile generated. The profiling depends on data from various sources. The data could be collected directly from data subject or from data bases maintained by third party. These data could be a mixture of facts and opinions.
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Legal Issues in E-Healthcare Systems
Since profiling enables the identification or location of potential customers and their medical conditions, it is also being used in developing more individualised or personalised marketing strategies. However, it could potentially violate right to privacy (Davis, 2003). Data profiling may lead to unnecessary discrimination. For instance different people could be offered different prices based on assumed characteristics of illnesses or selected patients could be denied of opportunities of purchasing products or services that are made available for others. Additionally when data are collected from various sources, the data could be incomplete or irrelevant in relation to what the profile intended to use or represent. Therefore it would not be reasonable to rely on databases which are built up based on assumption and probabilities (Davis, 2003). Cookies are also used to invade privacy of ehealth system users. The cookies collect user’s web browsing information and store the information onto the user’s hard drive. The information will be sent automatically or retrieved by the web sites to track their online activities in order to build a market profile of computer users. Some companies even trade the information as commodity to other marketing companies to target individuals with customized advertisements tailored to their specific interests and needs (Sessler, 2005). In the suit of Federal Trade Commission of US v. Microsoft, the Microsoft’s Passport Service came under attack. This service aims to make online shopping easier by storing passwords and credit card numbers. However, the service by Microsoft did not protect its users’ personal information sufficiently, and that the service tracked the user’s web-browsing habits without their knowledge. Microsoft agreed to enhance its security system for the service but the system will undergo independent review every two years, for a period of 20 years (The Star-in Tech, 2002). In another case of Universal Image Inc v. Yahoo, Inc, the plaintiff applies for an order declaring whether the exercise of Yahoo and its subsidiary
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collecting information from Internet user using cookies violates the law. According to the court, the activity does violate the laws as it enable the defendant and its subsidiary to watch, spy, conduct surveillance analyze the habits, inclinations, preferences and tastes, and monitor “identified” persons visiting its web sites without consent, agreement or permission of users (Abu Bakar & Hajar, 2002). Once the data or information was acquired using varies technologies, the data becomes the property of the companies or institutions. It can be stored, manipulated, and sold without patients’ knowledge or consent. When DoubleClick acquired Abacus (a direct marketing company), there was public outrage about the possibility of breach of information privacy. Despite this, the acquisition went ahead and DoubleClick began combining and cross referencing personal information from the web browsing habits of the users with the database of marketing firm. Following the continuous pressure from the users, the state government and the Federal Trade Commission, DoubleClick had suspended its matching practices in March 2000 (Reidenberg, 2001). As public and the regulators know the intended collection and use of the information, they had forced the company to abandon such collection and use. If it is done without the knowledge of these people there is no chance of knowing what information is being collected used and misused. Selling of private data or information is becoming one of the hot businesses. Especially company’s database with e-health information can be considered as an asset for sale in case of liquidation. Breaches may also occur when the companies or institutions obtain more information than they need to meet consumer expectation. They may manipulate and transfer the potential information to other companies or institutions which may use it improperly, unfairly or for purposes other than those consented to by the individuals. This phenomenon has created concerns of information privacy of e-health consumers. The concern of privacy abuse especially personal data is having a
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direct impact on corporate profit. Therefore, if the businesses want to keep defection rate low, they need to give adequate protection for the privacy protection (Ctverdialogue.com, 2001). On this issue, Pichler stated that revenues in e-activities have not met the expectation at all, at least not in all part of the world. According to him the principle reason up to date that contributed for the failure to meet the target is a lack of trust and confidence in the marketplace (Picher, 2000). The ability of the technology to build up personal profile in a matter of minutes, at minimal cost deters the netizens and in particular the e-health users from full utilization of the technology. As a response to this, the European Union passed the European Union Directive on Personal Data Protection in 1995 (EU Directive), which was adopted by the member countries, establishing comprehensive standards for the prevention of the unauthorized dissemination of personal information among various companies both inside and outside. The EU Directive was praised as an effort to provide better protection for Net users’ privacy and to harmonize domestic laws in order to promote unifying market in EU. However, the Directive had repeatedly come under strong criticism on the prohibition of transfer of personal data to a third country which does not have adequate protection for such information. The Directive is seen as unilaterally decided and having extraterritorial implication which is different from OECD Guideline for Privacy. The implication of the Directive is, however, far-reaching. Now there are two types of grouping among the countries relating to regulation of personal data. The first type of countries has taken initiatives to amend the existing law or to enact new law concerning data protection. The second type of countries is insisting on having less regulation on data privacy or no regulation. Malaysia falls in the first category which elected to enact a similar new legislation. The Directive in article 3.1 requires that the processing of personal data wholly or partly by automatic or manual means should be in compli-
ance with the guidelines and the rules which are applicable to both public and private sector. The Directive places certain privacy principles to be complied with whenever personal data are collected held, processed or used by the user. The principles in article 6 are: 1. The personal data must be processed fairly and lawfully. Therefore, the data must always be obtained from the data subject directly. The collection of data using the new technology without the express consent will also be in contrary to this principle. However, article 3.2 excludes the requirement of obtaining data from the data subject directly if the data is collected for operations concerning public security, defence, State security, and the activities of the State in areas of criminal law and journalistic purposes. 2. The collection must be for specified explicit and legitimate purposes: This provision requires that the data is not to be processed in a manner inconsistent with the purpose for which they were obtained. 3. The data collected must be adequate, relevant and not excessive in relation to the purpose, for which the data was collected: The data users should not collect more than adequate information for the required purpose. Once the purpose of collecting the information ceases, the personal data must be erased, unless erasure is prohibited by any law. In Community Charge Registration Officers of Runnymede Borough Council, South Northamptonshire District Council and Harrow Borough Council v Data Protection Registrar (DA/90 24/49/3), the tribunal found that whilst the holding of some additional information was permissible in certain circumstances, the holding on a database of a substantial quantity of property information obtained from voluntary answers on the canvass forms was far more than was necessary for the purpose.
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4. Personal data shall be accurate and, where necessary, kept up to data: The user of information must take all reasonable steps to make the data accurate and updated. What are reasonable steps depends on the circumstances of every case. 5. Personal data processed for any purpose or purposes shall not be kept for longer than is necessary for that purpose or those purposes. 6. Personal data shall be processed in accordance with the rights of data subjects. According to article 7 the EU Directive sets up the appointment of a Controller who is to ensure that the data quality principles are complied with. The Controller will only allow the processing of personal data if A. The subject consented unambiguously; B. Processing is necessary for the performance of a contract to which the data subject is a party; C. Processing is necessary for compliance with a legal obligation to which the Controller is subjected; D. Processing is necessary in order to protect the vital interest of the data subject; E. Processing is necessary for the performance of a task carried out in the public interest or in the exercise of official duty; and F. Processing is necessary for the purpose of the legitimate interests pursued by the controller or by the third party. 7. Appropriate technical and organizational measures shall be taken against unauthorized or unlawful processing of personal data and against accidental loss or destruction of, or damage to, personal data (article 17), and 8. Personal data shall not be transferred to a country or territory outside the European Union unless the country or territory ensures adequate level of protection for the rights and freedoms of data subjects in relation to processing of personal data. Article 25 (1) is
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considered as the most crucial section that received criticism from various sectors and agencies. What a third country requires is adequate protection which is more restrictive than the OECD Guidelines requirement for equivalent degree of protection. The adequacy of level of protection guaranteed by a third country shall be assessed based on the circumstances. Article 26(2) states that in deciding adequacy of protection consideration shall be given to the nature of the data, the purpose, and duration of the proposed processing operation or operations, the country of origin and country of final destination, the rule of law, and the professional rules and security measures implemented in that particular third county. The adequacy of level of protection guaranteed by a third country is to be determined by the Commission and such decision binds the member countries. The ambiguity under the Directive is whether the adequate level of protection must be satisfied by a country’s overall privacy law or particular categories of specified personal data. The Directive under article 26(1) also listed down circumstances in which the transfer of data may be allowed even if there is no adequate protection. The circumstances are: 1. The data subject consented unambiguously, 2. It is necessary for the performances of a contract between the data subject and the controller or the implementation of free contractual measures taken in response to the data subject’s request, 3. It is necessary for the conclusion or performance of a contract concluded in the interest of the data subject between the controller and a third party, 4. It is necessary on important public interest ground or for legal claims, and 5. It is necessary to protect the vital interest of the data subject.
Legal Issues in E-Healthcare Systems
It is to be noted that the above mentioned circumstances should only be used to the benefit of the data subject rather than to a third country data user. As per the directive a data user who has obtained personal data from any source and uses the personal data for direct marketing purposes shall cease to use it after the appointed date or if the data subject is so requested. The EU Directive provides considerable level of protection for personal data. The drawback of this Directive and the Clinical Trials Directives 2001/20/EC is that they are going to impinge upon the health research and public health monitoring. However, if the relevant organisations use anonymised data, there is no requirement of getting consent. The level of protection given to EU citizens is not available in many countries. In USA Health Insurance and Accountability Act (HIPAA) 1996 addresses the issue of medical privacy. It is intended to protect the confidentiality of patients’ health data. It requires the health services providers to enforce specific safeguard and consent procedures. Patients’ right to access to their medical data to ensure accuracy of data is ensured under this legislation. It also emphasises getting patients’ consent before sharing information for treatment, payment and health care operation. Separate authorisation from patients is necessary for non-health care purposes. However, in case of emergency the requirement could be waived. In Singapore, Electronic Medical Record Xchange (EMRX) was initiated by Health Ministry of Singapore to allow sharing of medical information. To protect privacy and security of medical data, doctors need National Registration Identity Card Number of the patients. However patient has no explicit right to control and dissemination of information about himself. The Ministry has less control over private hospitals and self regulation could be ineffective. The government is going to introduce password and smartcard system to prevent theft and other related breaches. However, appropriate amendment to the laws is necessary to allow patients to control the dissemination of their information (Tsai, 2010). Malaysia has been
since 1998 endeavouring to pass a legislation that could provide adequate protection for privacy, but due to pressure from the industries it has not come to pass yet. Due to these variations in the privacy legislation many users are sceptical about the real use of the systems.
Product Liability The e-healthcare system requires a continuous supply of products and services to various parties across boundaries using multiple suppliers or service providers. In the process there are concern as to validity of contract and the consequences and liability of parties in the breach of contract. In addition to contractual liability the tort liability of manufactures, suppliers and service providers are also important legal issues that need to be addressed, and this part will analyse the following issues: When an e-contract is formed? Does the law of sale of consumer goods and services apply to e-health product and services? How will the consumers and the professional users be protected? What are the liabilities of the e-health service providers? Does the ISP have any duties? Which country’s law would be applicable and which country’s court will decide the case. What are the liabilities in negligence?
Electronic Contract “Electronic contracts” may be said as legally enforceable promises or set of promises that are concluded using electronic medium (L. Kidd, & Daughtery, 2000). The UNICITRAL Model Law on Electronic Commerce, in Article 11, instead of defining an electronic contract, merely states that a contract can be made by exchanging data messages and when a data massage is used in the formation of contract, the validity of such contract should not be denied. However, the Article 2B of the US Uniform Commercial Code which was later incorporated into the Uniform Computer Information Transaction Act 1999 states that an electronic
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contract is a transaction formed by electronic messages in which the messages of one or both parties will not be reviewed by an individual as routine step in forming the contract. This explanation replaces the “writing” requirement with a “record” to equate electronic record with paper records and accepts electronically formed contract as valid. However, the US legislation in section 202 does not define electronic contract but only a description on the methods of forming a valid contract is available. The electronic or e-contracts may take the form of e-mail contracts or web contracts (Werner, 2000). In the first type of contract the sender of an offer or acceptance types the offer or acceptance and includes e-mail address then sends it to the recipient as it is done in an offline environment. In e-mail related contract, the e-mail may require the technical assistance of a third party who is called as Internet Service Provider (ISP). The ISP provides e-mail accounts and stores the message until the message is downloaded. A contract can be concluded exclusively by e-mail communication only or it can be mixture of web offer and e-mail acceptance. A web contract is concluded by mouse click. In a virtual shop the supplier will place an e-catalogue, the customer then has to tick a box to select particular item. In order to complete the order, the purchaser has to provide the credit card number and click “Pay” or “I Accept” or similar button. For a contract to be valid, the essential ingredients of a contract must be present. The essential elements are offer, acceptance, consideration, capacity and intention to create legal relation. The technology does not change the necessity of these elements to form an e-contract and anyone entering into any contracts for e-health related goods or services shall have all the elements present in their contract. However, it creates new problems and challenges. The applicability of the existing law to the new problems without modification is questionable. Turban (2000) pointed out that it is difficult to establish the elements of contract
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when the human elements in the processing of the transaction are removed and the contracting performed electronically. Therefore it is necessary to clarify that contract can be performed with intelligent agents without human involvement. An important issue to analyse in e-contract is about webvertishments. One may argue that usually the advertisement on the web site is considered as invitation to treat and not an offer. It is true that normal web advertisements which only receive the netizens’ offer can be considered as invitation to treat but there are other types of web advertisements that require positive action from the other party like providing with the credit card numbers and once provided the transaction is confirmed. Due to this type of webvertishments, one impact of the Internet is that the line between advertisements and legal offers has been blurred. On the Internet, thousands of web sites advertise their products or services but they also make offer that are legally binding if a consumer clicks the “yes” or “I accept” button, signifying the assent to the offer. The Internet advertisement may be considered as offers capable of creating a contract if a consumer assents to the advertisement. For example, an online medical store advertises its medicines. Prospective buyers browse the web site and select the medicines, which they intend to purchase. Once selected, the payment is made by credit card. With this a purchase is completed and the buyer merely waits for the items to be delivered. If the web store is considered as not making an offer, there would be no contract until the store owner either informs the buyer his intention of performance or performs the contract by sending the medicines ordered which will eventually slow down the Internet transactions. Here, the legislation needs to be amended to specify whether an online advertisement is an offer or advertisement to treat. Such a clarification is important for clarity purposes. The following 2 cases suggest that online advertisements could be considered as offer rather than invitation to treat.
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In Re Argos, case (unreported), Argos is a giant chain retailer. It mistakenly advertised on its web site the price of 21-inch televisions as £ 3 instead of £ 3,299. Almost one million orders were made before the mistake was noticed. One buyer alone placed an order for 1,700 television sets. Argos then argued that the advertisement was simply an invitation to treat or a mistake and therefore, refused to honour the purchase order. Eventually, the case was settled out of court (Sherriff, 1999). In another incident the WStore offered 99% discount on Kinda PCs. They advertised PC for just £ 12. The normal price of the PC was 1,200. Before the company rectified the mistake 2 customers placed their order. But the company insisted that they were not bound by the contract even if an automatic message of acceptance had been sent out to the customers. The company further argued that the parties are bound by the terms and conditions. One of the terms said that the company reserves the right to remedy any obvious mistakes in the listed prices by charging a proper commercial value price to rectify the error (Richardson, 2000). In this case the company did not argue that the webvertishment is an invitation to treat but had accepted that it was an offer but the parties were bound by the terms and conditions. The above cases show that the more specific the offer, however, the more likely the courts may interpret an advertisement as an offer. To avoid this many online companies offering health products or services make it clear that the web site advertisement is not meant to be an offer. In this regard the European Union Directive on E-Commerce (Directive 2000/31/EC) will be of great assistance. The Directive in article 11 states that a service provider’s offer that a consumer is accepting is a real offer and not an invitation to treat from the provider to make offers, and a real acceptance, and not an offer from the consumer. Cavanillas (2001) explained that the reason for this provision is to avoid giving the supplier or merchant a freehand to conclude the contract or not. On the Internet, the offeror can revoke an of-
fer using e-mail, but whether it can be revoked by placing a notice on a web site is doubtful. Since the revocation notice needs to be actually received by the offeree, a web display will probably not suffice. The offeror’s freedom in revoking an offer depends on how quickly the revocation is produced and the convenient means of producing evidence on the receipt of the revocation. It means until revocation of an offer is communicated to the consumers, the offer is to be taken as effective and it can be argued that placing of web notice on revocation is not valid. Another issue in any type of e-contract is adding new terms. If the offeree adds additional terms in the acceptance or requests a change in the offer, the offeree has made a counter offer and becomes the offeror (Hyde v. Wrench, 1840). The same offline rule is applicable when contracting online too. The question would be can an offeror introduce new terms to an offer after the original offer had been accepted? In Caspi v. Microsoft Network, L.L.C., the U.S. court accepted the validity of an additional clause after conclusion of a contract. Applying the above decision to an e-contract problem if the e-retailer introduced new terms when he delivered the goods with an option of cancellation of contract, the acceptor can accept the new terms or reject it by returning the goods within the specified period. If he fails to comply with, the court may hold that a valid contract was formed on the seller’s terms, even if there is no statutory provision to this effect. The next question to be addressed is when the contract is formed? As per Article 15 of the UNCITRAL Model Law on Electronic Commerce, an offer and acceptance will be effective at the moment the message enters an information system outside the control of the originator. Accordingly, the message is to be effective against the other party when the message was received and entered into the addressee’s information system. The acceptance will be effective once the acceptance has entered into the offeror’s information system. An acceptance is effective only when it comes to the
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knowledge of the offeror. In the case of Schelde Delta Shipping v. Astarte Shipping Ltd [1995] 2 Lloyd’s Rep. 249, the House of Lords held that if an acceptance is sent outside the normal business hours receipts are not effective until the opening of business the next day. Chissick pointed out that there is a possibility of holding an offeror liable if the e-mail acceptance arrives at a computer under the offeror’s control provided he is acting as an ISP. However, if he uses an ISP, the acceptance will be effective only after the e-mail is downloaded off server onto the computer. The medical practitioners who respond to e-mail queries could be bound by a contract when their clients download his e-mail responses. However, the Model Law in Article 15 states that unless otherwise agreed between the originator and the addressee, the time of receipt of a data message is when the message has “entered the information system of the addressee”. Article 15 seems like imposing greater degree of responsibility on the offeree to make sure that the message had entered the system. As long as it entered the system the contract is effective regardless of the fact that the message was downloaded or not. Following the explanation of Model law once the acceptance is received in the designated system or computer then the seller or offeror is responsible to arrange for prompt handling of message. Any mismanagement of message after it had been sent to the designated system falls on the offeror. The Model Law further states that if there is a designated information system but the message was sent to another system the data message is received when it was retrieved. The Article gives the impression that as long as the message is retrieved the message is received regardless of the fact that the message is read or not. The Hong Kong Electronic Ordinance on this issue states that when there was a designated information system but the message was sent to another system, the address of the electronic record would only be bound at the time it “comes to the knowledge of the addressee” (Stephenson, 2001).
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As regards to intention to create legal relation, the general presumption is that the business agreements are intended to face the legal consequences unless the parties specify otherwise. In the context of online contract, the existence of intent is normally automatic. However, an unclear or deceptive web site may dupe a consumer into making an unwanted contract. For example, an online supplier or service providers offering a digitised service may construct a web site which gives no purchasing information and merely displays the product and a “Save” or “Download Now” button. An unsuspecting customer will assume that the service is free and has no intention of creating a contract when the customer clicks the button. After the digitalized service has been delivered, the online merchant cannot demand payment because of the customer’s absence of intention to create legal relation. To avoid this, the law should ensure that commercial web sites explicitly state the prices and terms of their digitalised services or products. The customer should go through a sub-sequence of web pages detailing the terms and conditions of the transaction before making a purchase. The EU Council Directive on E-Commerce (87/102/EEC) requires 3 steps to be taken by the e-shop owner as a contractual process before concluding the contract. They are offer, acceptance and acknowledgement of receipt. This will ensure that the acceptor knows that he is entering into a contract and there will be legal consequences when there is a breach. One may argue that e-commerce lack contractual expressiveness like pushing of a button or shaking hands. The Directive considering this type of situation specifically requires in Article 10.2, the Member States to provide with ways to ensure that the parties can give their full and informed consent. It further requires providing an opportunity to e-consumers or buyers to detect and correct mistakes and errors. In other words there is requirement to take measures like “double clicks” in the e-commerce web site to ensure complete consent. In case of e-mail exchanges,
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even if it is less formal than written still can be considered binding if the parties can prove that they had the intention to be bound by law. Standard forms of contracts which are drawn by one party in a contract, normally by a stronger party like a vendor or medical institute or an insurance company, are accepted as valid provided that they are conscionable. The validity of such terms may depend on the following elements: 1. The respective bargaining powers of the contracting parties, 2. Whether the purchaser is being required to comply with regulations which are unnecessary, 3. Whether the purchaser duly understands the terms, 4. Whether undue influence or unfair tactic is being exercised, and 5. Whether the purchaser or consumer has any chance to get a similar service elsewhere. If all the conditions are fulfilled the court may enforce a standard form of contract. In UK the Unfair Contract Terms Act 1976 regulates the standard terms of contract. Usually, the court will not enforce a standard form of contract if the terms are not reasonable and the customers or purchasers are not aware of such terms. In e- contract, the issue is that whether the courts will consider online or other digital contracts as “writing”. The UK court in Derby & Co. Ltd. v. Weldon (No.6) [1991] 1 W.L.R. 652, held that computer databases (files) are valid documents and admissible in court. The US courts also attempted to extend writing to include digital forms. These decisions suggest that online and other digital contracts are “writing”. Another issue to be addressed is whether electronic form of contracts can be considered as “writing”. The electronic or online contracts exist only in computer memories or screens. They are not a deduction to a tangible form but are intangible composite of electronic, computer
code, and algorithms that lack any “fixed” status. The US Uniform Computer Information Act in section 201 avoids the usage of word “writing”, and uses “records” instead. The term “record” is more appropriate to online contracts as it retains the tangible form and it includes any information that is stored in an electronic or other medium which is retrievable in perceivable form. When it is retrieved the information may be temporary but capable of being recalled from a computer memory (L.Kidd & Daughtrey, 2000). The initiative taken by the US legislature will smooth the concerns of the e-consumers and the retailers and eventually boost the confidence of using e-health system. In an online transaction the users of e-health systems faces variety of scams and fraudulent “merchant” on the net (Australian Commotion & Consumer Commission, 1997). Pyramid schemes, chain letter, bogus business opportunities, miracle health or diet products to name a few of such fraudulent trading. While it can be argued that the examples of online scams and fraudulent merchant behavior stated above are in some way special since their mere contest should make users suspicious. There are other types of fraud that can occur in any “everyday” transaction. The clearest cases are where the goods or the services the patients paid for were never delivered. Since setting up a web-based ‘shop’ requires no much of start-up investment and incurs very low operating costs, the Internet appears to provide perfect environment for unethical trader (Federal Trade Commission, 1998). They can simply design a website offering various products or services that they do not actually have or can provide, or never intend to deliver. Before the victims realize the actual fact the ‘shop’ might already have closed down and “reopened” under different name and design targeting different users. Sometimes the fraudster does not set up her own online shop, but assumes the identity of a well known company and accepts orders and payments for products and services. This shows that there is a high possibility that the online users
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of various e-health services may face grievances more often than offline health users. Therefore, additional protection in place will create trust and confidence in dealing with the e-dossier. In traditional physician and patient relationship, the relationship is limited within geographical area along with licensed physicians and pharmacist. Malpractices in healthcare are rooted from physical contact, communication and prescription. With the emergence of e-health the issue of proximity or geography gets narrower and traditional relationship is declining. It is not necessary that the healthcare practitioners and the patients need to have face to face contact. The relationship now is of “click-loyalty” where parties may not have seen each other and they only used the technologies for the communications and treatments (Nicolas, 2000). Thus additional information like disclosure of place of business, full address, types of business, telephone and fax numbers, company registration number are very important so that the patients would be able to search on genuineness of the existence of the company and other information. The laws of the countries should be amended in making these requirements as compulsory. They also must include a provision that such disclosure cannot be waived by express agreement by the parties.
Digital Signature Other issues of electronic contracts entail validity of “digital signature” and authentication of contracting parties. A signature is the writing of some name or identifying mark on a document. However, a digital signature is not a signature but a process that uses encryption and algorithms to encode a document (US Uniform Computer Information Act, 1999, section 201(a) (6)). The process creates a product that identifies the person who uses the process. As the person using that particular process is only one or his agent, the other party can safely rely on that process or digital signature.
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Just as the definition of writing is extended to online and digital documents, signature also was broadened to include “digital signature”. In Re a Debtor (No.2021 of 1995), it was held that a faxed copy of a signature satisfied a relevant statutory signature requirement. The judge suggested that if the signature was digitalised and later appended to the fax, the document should be regarded as signed. The UNCITRAL Model Law also validates the use of digital signature. It prescribes that “where it requires a signature of a person, that requirement is met in relation to a data message if: A. Method is used to identify that a person and to indicate that person’s approval of the information contained in the data message; and B. That method is as reliable as was appropriate for the purpose for which the data message was generated or communicated, in the light of all the circumstance, including any relevant agreement” (UNCITRAL Model Law 1996, Article 6(1)). The digital signature is created and verified by cryptography, a branch of applied mathematics which transforms messages into seemingly unintelligible forms and back again. Under the Malaysian Digital Signature Act 1997, the digital signature uses public key cryptography which employs an algorithm using two different but mathematically related keys; one for creating a digital signature or transforming data into a seemingly unintelligible form, another key for verifying a digital signature or returning the message to its original form. The private key is known only to the signer and the public key is normally widely known and is used by a relying party to verify the signer’s digital signature. The law requires the private key holder to take reasonable care in handling the private key as the Certification Authority will not be responsible for any misuse of private key (Sarabdeen, 2001). As the key con-
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cept of signature is the authentication, the digital signature serves its purpose very well, as it is very difficult to forge. The digital signature provides a process to determine who sends a communication and determine the identity of the sender. If a digital signature provides information about whether the message has not been altered and identifies the sender, the sender will be unable to repudiate either the contents of the message or that it was sent by him. This will solve the problems of authentication and verification of the electronic contracts. It also provides confidentiality.
Jurisdiction of Courts As the community of Internet users for e-health purposes grows increasingly diverse, and the range of online interaction expands, disputes of every kind may be expected to occur. On-line contracts will be breached, on-line negligence can be committed, privacy invasion may occur. Although many of these disputes will be settled informally, others may require formal mechanisms for dispute resolution of their activities touch. When the parties concerned want to bring a formal action the questions like who is having jurisdiction to hear the case? How would a judgement be enforced against a defendant who is in another country? would arise. In other words, jurisdiction issues in the context of online e-health activities present one of the greatest challenges to the current system and the way of addressing disputes that involve two or more countries. The current laws regulating jurisdictional issues are applying geographical criteria. Accordingly, the courts will not expend its jurisdiction beyond its borders. The courts refuse to issue injunctions beyond its physical jurisdiction stating that there is a doubt about the enforcement of local laws and judgement in foreign jurisdiction and such exercise will create concern for freedom of expression (Bygrave & Svantesson, n.d). However, with the e-activities, geographical boundaries become meaningless. Exercise of jurisdiction over
person beyond geographical boundaries becomes a primary factor to be considered because of the borderless nature of e-activities. In EU countries, The Brussels Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters 1968 and Brussels II Regulation (Council Regulation (EC) No. 44/2001 of 22 December 2000 on Jurisdiction and the recognition and enforcement of judgments in civil and commercial matters) will be applicable in determining which court has civil jurisdiction and how judgments may be enforced. The Regulation updates the Convention to take accounts of the fact that commercial transaction over the Internet between traders and consumers are now in commonplace. The Regulation especially addresses the issue on whether a trader targeted or directed its products to a consumer in an Internet transaction. Brussels Convention and Regulation in Article 2 as a general rule of all types of contract state that the defendants should be sued in the country of domicile irrespective of their nationality. The provision presupposes that the defendant is domiciled in contracting state to the Convention, if he is not domiciled in the contracting state to the convention; jurisdiction is to be determined by domestic law as per Article 4. However, Art. 2(1) allows the parties to predetermine in the agreement as to which country’s court shall have jurisdiction to try a dispute between them. Both the Convention and the Regulation state in Article 5(1) that the claimants in a contract are required to sue the defendant in the courts of “the place of performance of the obligation” in question. The question is if the obligation is to be performed entirely online where would the place of performance? Additionally, not all countries follow this requirement of “the place of performance of the obligation”, implementing this requirement beyond EU may create difficulties. For example US courts require a nexus between the defendant and the place of performance and not “the place of performance of the obligation ” to establish jurisdiction (Donaldson, 2001).
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There is a significant exception to the rule of defendant’s domicile (Article 2) is available under the Conventions and Regulation. It allows the consumer to sue the defendant vendor in either the defendant’s domicile or the consumer’s own domicile. On the other hand, the consumer can only be sued in his own domicile. Article 14 states that a consumer may bring an action against the other party in a contract in the contracting state in which that party is domiciled or in the courts of contracting state in which he is himself domiciled. However, when a seller wants to bring an action against a consumer only in the courts in Contracting State in which the consumer is domiciled will have jurisdiction. If the consumer entered into a contract with the party who is not domiciled in the contracting state but has a branch, agency, or other establishment in one of the contracting state, the party shall, according to Article 13, in disputes arising out of the operations of branch, agency or establishment, be deemed to be domiciled in that state. Accordingly, in a dispute out of a transaction relating to e-health goods or services with a branch of a corporation, agency or other establishment the jurisdiction will be in the state in which the branch, agency or other establishment of the defendant is situated. When an e-health transaction is concluded via web site the issue is whether a web site is a “branch, agency or other establishment”. The Conventions and the Regulation are silent on this issue. However, the Recital 19 of the E-Commerce Directive addressing this issue in the context of e-commerce states that neither the place at which the technology supporting neither the web site nor the place where the web site is accessible may be considered to be the place of establishment of the company providing service via the Internet. The Recital makes it clear that the web site is neither a branch nor a place of business. Similarly the place where the web server is placed is not considered as place of business. When a consumer is involved in e-contract related dispute, the court in the user country will
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hear the case which is referred as country of destination as opposed to the traders’ country court (country of origin). Article 13(3) of the Brussels Convention states that: A. In the State of the consumer’s domicile the contract was preceded by a specific invitation addresses to him or by advertising; and B. The consumer took in that State the steps necessary for the conclusion of the event of a dispute.” Article 15, however, provides certain exceptions to general rule on user contracts: 1. The parties by an agreement which is entered into after the dispute has arisen can decide on the convenient forum; 2. The consumer can bring proceedings in courts other than those indicted in this provision; 3. Both parties whom at the time of consumer contracts domiciled or habitually resident in the same Contracting State, and which confers jurisdiction on the court of the State. The European Court of Justice stated that ” the special system established by article 13 of the Convention is inspired by the concern to protect the user as the party deemed to be economically weaker and less experienced in legal matters than the other party to the contract, and the consumer must not therefore be discouraged from suing by being compelled to bring his action before the courts in the Contracting State in which the other party to the contract is domiciled.” Geist, (1999) stressed that in deciding jurisdiction of e-dispute to be based on country of destination. Even if it introduces country of destination principle in selecting proper form to decide consumer dispute, the scope of the protection under the Convention is limited. The Convention extends protection for sale of goods to consumers and has limited protection for
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consumers who received supply of services. The distinction between goods and services created problem for e-consumers who are involved in buying digitalised services. The protection granted under the Convention applies only to consumer contracts that have an adequate connection with the consumer’s place of domicile. The consumer may only sue a vendor when: 1. The vendor has directed his commercial activity towards the State of the consumer’s domicile; 2. The consumer resided in the State at the time when he entered into the contract; 3. There is a close connection between the contract and the State of Consumer’s domicile such that; 4. The consumer has a reasonable expectation of being able to sue in his or her local court (Foss, and Bygrave, n.d.) A consumer who is situated in his own country of domicile when entering into a contract with a foreign vendor should usually be entitled to the local courts. If marketing is done via e-mail, this activity could be considered as directed at the state indicated by the e-mail address of the addressee. For example, ‘ae’ represents United Arab Emirates. In the case where the address to which the e-mail is sent does not have any indication to a country like ae or my, the vendor should be regarded as directing the e-mail to the addressee’s place of domicile, as the e-mail will be read in the country of domicile of the recipient. To determine the place where marketing occurs, it is important to determine the place where the marketing activities spreads but not where the vendor’s marketing activity begins. Article 13(1) (3) (b) requires that a customer must take in the State of his domicile ‘the steps necessary for the conclusion of the contract’. The steps may be the consumer is typing on a computer keyboard or clicking with a mouse. The steps must be those that are indispensable for conducting the contract.
This step must be taken while the consumer is in the domicile of his State. Art.15 of the Regulation of Brussels replaces article 13 of the Convention. Article 13 was considered lacking elements to address e-related issues. Therefore the EU countries had adopted Brussels II in the year 2000 to address those weaknesses and to provide special protection to e-consumers considering their vulnerability and unequal bargaining power. According to Article 15 of the Brussels II, the courts of the country of the consumer’s domicile has jurisdiction in a dispute concerning a consumer. The Article states that in matters relating to contract concluded by a person, the consumer, for a purpose which can be regarded as being his trade or profession, jurisdiction shall be determined by this section without prejudice to Article 4 and 5 (5) if: 1. It is a contract for the sale of goods on instalment credit terms; 2. It is a contract for a loan repayable by instalments, or for any other form of credit, made to finance the sale of goods; or 3. In all other cases, the contract has been concluded with a person who pursues commercial or professional activities in the Member State of the consumer’s domicile or, by any means, directs such activities to that Member State, and the contract falls within the scope of such activities. Where a consumer enters into a contract with a party who is not domiciled in a member State but has a branch, agency or other establishment in one of the member State, that party shall, in disputes arising out of the operations of that branch, establishment, be deemed to be domiciled in that Member State. The Brussels II had deleted Article 13(3) (b) of the Brussels Convention as this provision of the Article did not seem to cover the situation where a consumer is habitually resident in one State but concludes a contract while in another
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country, or takes some of the necessary steps in one country and some in another. With the removal of this provision a consumer will be able to sue the vendor in the court of the consumer’s country even if a consumer might purchase in the supplier’s country. The amendment makes it easier for the consumers to sue Internet based marketing companies for any breach in the consumers’ Home State. However, the problems with the amendment are: 1. They will be held liable if they carry out business via interactive web sites. Unfortunately, the Commission does not elaborate on what is exactly meant by an interactive web site. 2. Whether digitalized products are good or services not explained under the new amendment; 3. It also failed to address whether a ‘web site may constitute a ‘branch, agency or other establishment (Article 15 (2)); and 4. Article 13(1) (3) (b) dispenses with the requirement that ‘the consumer took in that State the steps necessary for the conclusion of the contract. Now, even if the consumer enters an online contract outside his country of origin he will still be able to sue in his country of origin. What is the meaning of ‘advertising’ or ‘specific invitation’ is not available, advertisement may be considered as a sort of promotion which intended to use for the increasing product sales. Therefore, the protection can be applied. Invitation sent to consumers via e-mail highly likely to be considered as specific invitations as the e-mails are addressed to the consumers’ personal addresses. However, an advertisement in the web site can be considered, as specific invitation is not clear. Under this provision, the activity concern must be an advertisement, a specific invitation or promotional activity that must have occurred in the State where the consumer is domiciled. And these marketing activities must have directed to or at the State. When it comes to marketing over 38
Internet, the vendor may be intended to direct the marketing at most countries where the web site could be accessed and used to have some transactions. When it comes to web sites the question is whether setting up a web site amounts to “advertising” or “directing” the contents to the consumers. The webvertisments unlike the traditional modes of advertisements does not always jump out to the consumers. If the customer is active he searches various web sites and “pulled” the products to him or sometimes the products have been pushed to him through e-mail advertisement. When a web site offer products and ship their products worldwide, the owners have to prepare to be sued in any part of the world where they have customers. When the web site offers various language options, is that web site targeting the countries in which those languages are widely spoken? In case if a vendor neither knows nor ought to have known that the other party with which he contracts is in fact a consumer, Article 15 is not applicable. Concomitantly, if the purchaser represents himself as acting in the course of business or he misrepresents his country of domicile, the protection will be excluded. The amendments to Brussels Convention were welcomed since the amendments allow the consumers to sue in their home country thereby will be able to avoid unnecessary cost of suing in foreign countries and will help to avoid the vendors setting up their businesses in states with lax consumer protection laws (Donaldson, 1999). However, the problem would be: 1. Businesses are expected to be knowledgeable about the plethora of consumer protection regulations and laws of all countries in the world, especially on the supply and sale of health related products and services; 2. It is difficult for businesses to prevent users in a specific location from transacting; 3. It goes against to the efforts of creating innovative, practical, non-regulatory, global mechanism that empower consumers (gip. org, 1999).
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As the parties have freedom of contact, they may stipulate in contract in which the dispute should be adjudicated should any dispute emerge. The court must have power over parties and subject matter over the claims involved in the matter to enter an enforceable judgment against the parties in litigation However, the industries are not happy with the amendments. They argue that the amendment instead of updating the convention it changes the status quo of the Convention, the amendment will subject the businesses to foreign jurisdiction even if they have no connection with that particular country except the presence of mere web site. They also argue that the amendment imposes a heavy burden on the businesses to be aware of and comply with laws of all member countries and the amendment goes against the principle of another EU directive: E-Commerce Directive which reflects country of origin principle. It is to be noted that the E-Commerce Directive is not applicable to consumer transactions. And the purpose of this Directive is to boost e-commerce without altering the position as regards consumers and levels of consumer protection.1 Therefore, the argument as to contradiction between the Brussels II and E-Commerce Directive is not correct. It is further argued that the country of origin principle should be applied. This is because by buying from Internet, one may have obtained something which would not be available from offline; or the consumer paid a much lower price than he would have done if it had been specially imported for him. Therefore, economic benefit should justify the loss of individual protection and therefore applying caveat emptor will be justifiable (kentlaw.edu, n.d.). It is also said that applying country of origin will help the medium-sized businesses, which want to take advantage of e-commerce with less cost and diverse consumers. However, it is counter argued that to cope with the jurisdictional problem, it is possible to have filtering system that would bar the e-consumers with certain Internet Protocol (IP) addresses form transacting.
By virtue of the Brussels Convention and Brussels II Regulation enforcement of judgment of among EU member counties is easily be enforced but beyond EU, there is a need for mutual enforcement treaties. In the absence of such treaties, the courts in foreign countries may refuse to enforce foreign judgments that are based on legal principles or standard different from their own. For example the House of Lords in Berezovsky v. Michaels [2000] 2 All ER 986 acknowledged that an award of damages by an English Court in an English libel case may not be enforceable in US. In the case of Fiona Shevill and Ors v. Presse Alliance SA [1997] Ch.293 a newspaper was suit concerning an article distributed to several European States instead of ruling that all states have jurisdiction, the court held that jurisdiction is limited to courts of those States where was known. The laws and regulations that address e-commerce can be extended to cover transactions or dealings relating to e-health products and services. The courts in UK under common law may claim jurisdiction if a defendant can be physically served with a claim form i.e. writ. In the case of Pearce v. Ove Arup [1997] Ch.293 the English court decided that it is entitled to hear a dispute involve foreigners on the basis that the defendant domiciled in England. In the case of partnership and corporation, if they have a place of business in England, a claim form may be served at the location irrespective of the fact partners are UK or not. This allows the local courts to exercise jurisdiction over foreigners doing business in UK. In the case of South India Shipping Co. Ltd v. Export-Import Bank of Korea [1985] 3 All E.R. 216, the court had stated that the court would see whether the corporation is ‘here’. If it is, it can be served. In order to determine they are ‘here’, the court will ascertain whether the business is carried on here and at a definite place. If the plaintiff is a foreign consumer, he can easily use the English courts to sue any on-line vendor with a place of business in England. Similarly an e-commerce vendor also can file a suit in England if the consumer is presence in England provided 39
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the forum is relevant to the issue in question. If a contract is created in England, the English court has jurisdiction over dispute concerning it. The English courts have also jurisdiction if breach occur in England. If the breach is due to the failure to perform a contractual obligation and the place of agreed performance was England, the English court will have jurisdiction. The Brussels Convention and English Law in RSC, Order 11, Rule 2a allow an express jurisdiction clause to override all other determinations of jurisdiction. The Brussels Convention, however to protect the consumers Article 17 prohibits the parties to select courts of vendors’ county to hear and dispose a case involving consumer contracts. Thus, the provision allows an e-health user to do forum shopping and select the best advantageous form to hear and decide the case of his concern in EU countries. However, such a luxury is not available for the consumers in other countries. Therefore many would be demotivated in utilising the e-health facilities or shopping e-health products or services, because the laws are neither in existence nor available to address the borderless electronic frontier.
Negligence When the businesses, contracted with the e-consumers for supply of medical goods and services, and subsequently supplied, do not correspond to the terms of contact, the e-consumers can bring an action against the infringer in contract provided the parties are privy to contract. However, if a consumer decided to bring an action against a manufacturer or service provider, he may bring an action negligence tort in many countries that follow commonwealth legal system. A negligence tort is simply an accident that occurs when someone fails to pay attention and therefore, harms another person or thing. The tortfeasor neither wishes nor believes that his action will cause the damage but in fact, it caused harm or injury. The duty in negligence against a manufacturer was
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first established in the UK case of Donoghue v. Stevenson [1932] AC 562. In this case, the plaintiff and a friend visited a café and the friend bought a bottle of a ginger beer from the cafe owner. The owner opened the bottle, which was made of dark opaque glass, and poured some of the ginger beer into tumbler. Unsuspecting, the plaintiff drank the contents, but when her friend refilled the tumbler, the remains of a decomposing snail floated. The plaintiff suffered shock and severe gastro-enteritis as a result. As she cannot sue the retailer for compensation because she had not bought the ginger beer, she sued the manufacturer for her injury. The House of Lords held that she would be entitled to succeed if she could prove her allegation. Lord Atkin in this case stated that a manufacture that produces items which reach the consumers without an intermediary needs to make sure the items are safe. Accordingly “a manufacturer of products, which he sells in such a form as to show that he intends them to reach the ultimate consumer in the form in which they left him with no reasonable possibility of intermediate examination, and with the knowledge that the absence of reasonable care in the preparation or putting up of the products will result in an injury to the consumer’s life or property, owes a duty to the consumer to take that reasonable care” (Donoghue v. Stevenson [1932] AC 562, p. 599). This case also established the general duty of care where the manufacturers also were placed. The general duty of care is called as neighbourhood principle. The principle was formulated in the following word: “You must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour. Who then is my neighbour? The answer seems to be persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being affected when I am directing my mind to the acts or omissions which are called in question”. According to this principle, a person owes a duty of care to anybody who is so closely and directly affected by the
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action or omission of another person. Therefore, the effect of this application is that a person is not liable for every injury, which results from his carelessness (Keenan, 2000). When the manufacturers’ products harmed or injured the consumer or anybody who comes within the foreseeability range, then only the consumers will be able to claim compensation for their suffering. In addition to duty of care, breach of duty and foreseeability, causation is also should be established in proving negligence liability. The principle in this decision was later extended to others who ought to foresee that failure to take reasonable care might harm consumers regardless whether the consumers were offline or online. This coverage may include retailers, repairers, to those who hire out products, and those responsible for testing and certification of products (Scott, & Black, 2000). The general principle established by Lord Atkin had also been extended to promotional activities, which involves supply of free sample of products or services. In Hawkins v. Coulsdon and Purley VDC [1954]1 QB 319, p. 333, the court said that “suppose a manufacturer of a special soap sends out samples by way of gift to members of the public, and owing to the negligence in manufacturer a user of the soap suffers from dermatitis, surely there is a cause of action”. Manufacturer or producer liabilities generally occur due to his defective design or products, when those products cause damage or injury. Defective design happens when the engineering processes used by a company to design a product is faulty, resulting in a product that is unnecessarily dangerous. Defect in products occurs when a product is not manufactured as designed. In defective products, there is no wrong with the product’s overall design but the manner in which it is assembled is flawed. Manufacturing defects problem is usually not common in all of the items, which was assembled by the company but rather happen in few products only. In the context of products, the duty is extended to cover products from human consumption, pharmaceuticals, household appliances, toys to other equipment.
As to the negligent liability of service providers including the professional advisers, the court extended the application of negligence beginning with the case of Hedley Byrne v, Heller & Partners [1964] AC 465. This case established that when the negligent statement of the defendant caused loss, the defendant was held liable in negligence. The liability established in the case Donoghue v. Stevenson, and subsequent extension of this liability to cover others is part of English common law. The above case is not concern about the liability of an e-health product manufacturer or e- health service provider, however, the decision shows that in order to succeed the plaintiff must prove that the damage he is claiming is caused due to defendant’s negligence together with other elements of negligence. The negligent claim could be brought to the court if the online products or advisory services rendered caused required damage or injury to the user. Bainbridge suggests that if computer software cause damage to consumers, the computer program writers and manufactures of the software could be held liable. In the case of computer hardware, a person suffering loss due to negligence could be able claim from the manufacturer regardless of the fact that the equipment was bought from a dealer (Bainbridge, 2004). The manufacturer is duty bound to produce goods or products that are safe. If there is any manufacturing defect that caused any injury, then the burden of proof is on the plaintiff to show that there is a duty on the particular manufacturer to produce the goods safe. Lord Wilberforce in Anns v. Merton London Borough Council (1990) 1 All ER 568 discredited two-stage test for establishing the existence of duty of care. The first stage requires that the court to ask whether there was sufficient proximity between the parties that the harm suffered by the plaintiff was reasonably foreseeable. In the second stage, the court will consider whether the duty should be restricted or limited for reasons of economic, social or public policy. A third test was established in the case of Caparo Industries Plc. v. Dickman [1971] 1 QB
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88 where it was shown that the courts needs to consider whether it is fair just and reasonable in all the circumstances to impose a duty of care. The cases suggest that to determine the liability of the manufacturers the court will look into the likelihood of the defective product or service causing damage and the seriousness of the injury plus the economic and social considerations. In addition to the above, the manufacturer’s level of skill and knowledge at the time the product was marketed are also will be taken into account in determining whether there is a duty. Thus it is to be noted that the consumers will not be able to recover anything from the manufacturer if they have succeeded in showing that they have used the state-of-the art information or technology at the time the products were sent to the market. In the case of Vacwell Engineering Co. Ltd v. BDH Chemicals Ltd the consumer managed to claimed damages as the court was not convinced of the adequacy of the use of state-of-the art information and technology. In this case an explosion caused by a chemical reaction that resulted when an industrial chemical came contact with water. The defendants were held liable for failing to warn of the explosive quality of the chemical. Even if the defendant were not actually unaware of the hazard at the time when the product was marketed, according to the court the defendant could have discovered if they had conducted a sufficient investigation of the potential hazards of the chemical before marketing. However, the manufacturer’s liability is limited to known or ought to have known defects and not unknown and not discoverable defects. If the manufacturer improves his product’s safety than the products in the market, the issue is, does he have a duty of care in relation to existing products already out on the market? Generally, if the product is reasonably safe when it first put on the market, there is no duty. Nevertheless, in exceptional cases depending on the extent of the danger a recall or renovation can be feasible and necessary. Recall is only inevitable when the product in the market
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is extremely dangerous. Manufacturer’s liability can be extended to negligence in the production process. In this circumstance the manufacturer must show that he did all what a reasonable man in his position should have done to try to avoid the injury or damage. In Grant v. Australian Knitting Mills [1963] AC 85 the manufacture was held liable in negligence for the failure to remove sulphites from underpants. In addition, when research or other subsequent events reveals or confirm previously unsuspected or insufficient danger, campaign or warning to individuals is inevitable (Das, 2000). When the hazard came to light, necessary precautions, repairs, or alterations are to be taken as soon as reasonably practicable. Placing appropriate warning is the primary liability of the manufacturers. It is much easier for the plaintiff to establish negligence in failure to warn cases where a duty arises whenever a product is defective or dangerous, and the manufacturer had known or ought to have known of the defect. However, in limited circumstances, a manufacturer may be considered have acted reasonably by relying on an intermediary to pass on a warning to ultimate consumer. In Holmes v. Ashford [1950]2 All ER 76, the plaintiff suffered from dermatitis after having her hair dyed at a hairdresser. The manufacturer was not found liable for negligence as they had supplied labels and brochures warning and recommending a prior skin test, which unfortunately were not on the plaintiff. However, the law imposes a duty on the manufacturer to check or test the component part for safety before incorporating them into their products. Checking or testing is particularly important when it is shown that the component manufacturer is not reputable. The fact that manufacturing defects only a small number of products is not a defence. However, a manufacturer may claim exemption of liability if he can prove an appropriate system for ordering suitable raw materials and components taking reasonable steps by testing and inspecting to ensure the final product is safe. Generally, it
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may be difficult on the part of the consumer to prove the existence of the defect at the time the products left the manufacturer’s control. In case of the Donoghue v. Stevenson the containers were sealed, therefore, it was not a problem to pinpoint that the defect would have happened in the factory. However, if it involved a complex process and more than one product, it would be difficult to say that the defects had occurred in certain factory. In Evans v. Triplex Safety Glass Co.Ltd. [1936] 1 All ER 283, the claim against the windscreen manufacturer failed because the plaintiff had not discharged the onus of proving negligence on the part of the defendant. In deciding a case of negligence the court may consider the surrounding circumstances. The likelihood of the consumers loosing the case increases with the length of time the product was out of manufacturer’s control before it injured the plaintiff; the number of other parties who came into contact with it; and how easily it could have been interfered with (Howells, 1999). The longer the product was out of the manufacturer’s control before it injured the plaintiff, the harder it would be to prove the case of negligence. “Reasonable opportunity of intermediate examination” may exempt the manufacturer from liability. However, the mere chance of examination of goods does not, in itself, exempt the manufacturer from liability. He can be held liable if the defect in goods remained there, at the time when the plaintiff used it. Apart from the liability of manufacturer of product, a component manufacturer also owes a duty to the consumers. Apart from this, both hardware and software failure may cause great loss to the users or to third parties who relied on the fact that the system should be reliable. Developers of hardware and software may be held liable if the product they produce is defective and the defectiveness was the primary reason for the damage caused. If a claimant is injured because of defendant’s negligent operation of his computer system, the claimant may sue the defendant in negligence. This is because
the defendant will be performing some function affecting the claimant, and the computer system will merely be the means by which he performs the function. In Coastal States Trading v. Shell Pipeline Corp., Shell Corporation commenced a specified computerised procedure for submitting the written request of its customers. Due to data entry error by a Shell computer employee, the order of Coastal Company went to another company and Coastal sued Shell for negligence. The court examined all the elements of negligence and found that the defendant owes duty of care to customers, by not training the employee’s adequately, the plaintiff suffered damage and therefore, the defendant was asked to pay damages.
Service Providers and Professional Advisors There are a number of service providers and the professionals conducting businesses through the World Wide Web. There are certain types of companies or individuals who offer only services like medical advising. There are other types of companies and persons they sell product and provide installation and consultation services. When such services and advice given were defective or wrong, the victimised consumer will be able to bring an action against the service provider or professional advisor as the duty owed to the consumers was not fulfilled. This can be possible irrespective of the fact that the service providers or professional advisors had used the end users through electronic medium. In the case of Howard v. Furness Houlder Ltd., the defendants had assembled a valve upside down in a boiler, were held liable for plaintiff who was scalded by escaping steam. The installers, according to the court, had duty to test or inspect the defects, if the defects were known prior to installation. The tort liability on service provider may occur when the negligence of the provider caused harm in the form of personal injury, death, or property damage.
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However, there will be problem in claiming compensation or succeeding in negligence against the service providers or professional advisors if the harm caused is only financial loss which is bound to happen in case of negligent statements. Under general law of negligence pure economic loss will not be compensated. Economic loss is either loss of profit or the reduction in value of an item of property (Scott & Black, 2000). Nonetheless, in certain exceptional cases, the court may allow recovering economic loss provided that the defendant knew that the recipient would rely on the negligence statement that he made and the reliance was detrimental to the plaintiff. In the case of Hedley Byren & Co. v. Heller [1964] AC 465 the House of Lords held that under limited circumstances a professional making statement might owe a duty of care. Further, the court agreed that there could be liability for negligent misstatement causing financial loss, even in the absence of contractual relationship. Thus any medical practitioner who comes within the exception can be held responsible. The House of Lords stated that in negligent statement cases, there has to be a “special relationship” between the maker of the statement and the person injured by it. It is not a contractual relationship but a relationship where the maker of the statement knows it will be relied on, and not beyond that to those persons whom he might foresee relying on it. Here the test to apply is not the foresee test but knowledge test (Keenan, 2000). Thus the test for causing loss due to negligent statement is narrower than the test applied for negligent act causing physical injury. As regards the expert system, the system is generally used to manipulate simple data to the level of making reasoned judgement. The computer is programmed with judgement rules so that it can draw upon its enormous data banks of experience and apply logic and interference, and institution can reach a reasoned solution to a particular problem. The expert system is so complicated which relies on highly qualified professional who can synthesise decision rules. The manufacturers, 44
programmers and the experts of companies or institution utilising the expert system owe duty of care to the consumers. However, the burden of proof that the damage or complication suffered by a respective consumer was due to system failure is on the consumer. However, Burgunder (2001) suggested that when the expert system is used for medical treatment and the system provides an inaccurate diagnosis or treatment that leads to detrimental medical complications, then it should be easy to prove that the expert system had a defect making it unreasonably dangerous. Whoever goes online needs to be affiliated with an ISP who acts as a gatekeeper for accessing the Web. An ISP can be a big company having millions of customers or it can be of a small Mom & Pop business. An ISP may provide one or more or all of the following services: 1. An electronic mail server which enables customers and third parties to send and receive e-mail; 2. A newsgroups server which enables customers and third parties to send and receive email in topical forums in which other interested Internet users also participate; 3. A list server which enables customers and others to subscribe to a mailing list on a particular topic using email; 4. A World Wide Web server which enables customers to publish web pages; 5. A File Transfer Protocol (FTP) server which enables customers to publish electronic files and allow others to retrieve them; 6. An Internet Relay Chat (IRC) server which enables customers to chat with other users in real time (bitlaw.com, n.d.). When the ISPs’ above-mentioned services are used by the customers for infringing copyrighted materials or defaming someone or posting prohibited and objectionable materials online, the ISPs may be held liable. The liabilities of an ISP for content prepared and for communication sent by others will arise from the services, which the ISP
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provides for its customers. Generally, the ISPs are being sued for the wrong or damage done by others because it is hard to sue someone whose whereabouts in unreachable. The clients who post infringing materials may be mobile or otherwise, are difficult to track down. Therefore, the victims have the tendency of initiating legal action against the ISPs, as many ISPs are corporate entities with fixed places of business. In addition, the third party who posted the infringing or negligent materials online may be lacking financial resources to pay a substantial liability judgement. Therefore, the attention is shifted from the individual clients who had wronged to ISPs who have financial capacity to bear financial liabilities, as they are well qualified as deep pockets. In case of release of computer viruses like Melissa, ILOVEYOU, the question is can the ISP be held liable for the damage caused by the viruses as it had facilitated the communication of viruses? To date, it seems that applying negligence tort to virus caused damage has been difficult because it is not clear who should be held liable for the damage. Proving causation is also very difficult. In addition the damage caused by the viruses is huge. For instance, the ILOVEYOU virus had caused damage worth $10 billion around globe. Similarly in August 7, 1996 there was an online crash at American Online (AOL) (New York Times, 1996). Thousands of companies were left without e-mail capabilities and a host of other services. Many lost thousands of dollars as a result. Should this economic loss be recoverable by AOL users? In deciding the negligent liability the court would need to look at the question of who is most capable of taking effective precautions to prevent the attacks. It is most likely that the courts will impose liability on those who are most capable of taking effective precautions if they fail to do so. In the event that the ISP is going to be held liable for such an extensive liability they will go bankrupt (Miller, & Jents, 2002). Therefore, there is a high chance that the court for policy consideration may exempt the liability from negligent liability and the victimised consumers may not be able to recover
any loss caused. If it is proven that the medical institution was acting as ISP, the institution can be held liable for not taking adequate measure. However, there is a possibility that the ISP as publisher of negligent statement may be held responsible if a reader of its publication is seriously injured, died or suffered damage to his personal property after acting upon or using the content contained in the materials posted in its server. The publisher of Soldier of Fortune magazine was held liable for the death caused by a “hit man” following the magazine’s publication of an advertisement for a professional mercenary, styled as a “gun for hire” (Rich, n.d.). The publisher ISP is duty bound to provide adequate instructions, advice or warning if the publication contains inherently danger, and the reader by using or acting upon the information got injured or harmed or died. However, the ISP can escape liability if it is proven that the ISP had an editor experienced in dealing with negligent publication conducted an independent review of the contents of the publication or included adequate warning to the reader with regard to the content of the publication. The warning must advise the reader that his or her failure to follow instruction is dangerous or includes potential risks. They may show that the warning given is specific and it was placed in the margin or apparent places of that section with an appropriate symbol to make the reader aware that this section contains information that could cause serious injury or death. Negligence tort has provided an avenue for the e-health system users to bring an action against a manufacturer or service provider for damage suffered by him due to his defective products or design or services or wrongful advice. However, there are a number of problems in making full use of this remedy. The very basic problem of negligence tort is due to complex in procedural and evidential issues (Rachagan, 1992). Without knowledge of industry practice and technology, it will be difficult to prove exactly which particular act or omission owed caused injury. The negligence tort only provides benefit to the e-health system 45
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users, when there is physical or property injury or death. It does not cover emotional injury. Even financial loss is covered only in limited cases. The major problem on this tort in benefiting the e-health system users is that the user alleging negligence needs to show fault of the defendant. Proving fault in the electronic environment on a specific defendant is extremely difficult, as there are a number of parties ranging from manufacturer, service provider, ISP, portal site operators, search engines to Intranet operator are involved. In the event that if fault is proven, still he will not be able to recover any damages if the defendant is insolvent. Therefore, not only finding fault but also a solvent defendant is important to get some compensation for the damage or injury done to the innocent e-health system users. Failure of finding an insolvent defendant will deprive the plaintiff from getting any compensation. The other problem according to the Pearson Commission’s report is that the tort claimants were not adequately compensated for all the injury. Accordingly, 60% of the successful claimants between 1973-1976 obtained awards of less than 500 pounds and only 1% got over 1000 pounds. The other difficulty that discourages the claimant from suing in negligence is the longer period that the case takes to settle. A longer period is necessary to prove negligence, as it is involved process of investigation, expert consultation, interviewing, and commissioning of technical experts. That means, the claimant needs to put up more money if he decided to proceed with the litigation. Due to this many try to settle outside court even if the compensation he receives is less than what he deserves. Basically the claimant in a negligent suit needs to battle between three uncertainties: Uncertainty concerning the court’s ruling on liability; uncertainty as to the payment of cost; and Uncertainty whether an offer will be issued, so that an early settlement can be agreed and it will help avoiding trial and the cost.
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According to Civil Justice Review of UK, the risk of bearing all the cost is substantial; as such the claimants choose to settle the claims out of court. This risk is heavier on economically weaker party; therefore they are induced to settle it short of trail (Sarabdeen, 2009). The claim in negligence to certain extent will only be able to protect the e-consumers. There are people who argue that negligence tort is very useful to the consumers since it can operate as deterrent mechanism to future negligence. This acts as deterrence in the sense that the legal proceeding together with the adverse publicity may affect the business, and when the liability is established, it can be costly to redesign or recall the products or services. However, it should be noted here, with the deterrent effect of negligence, that the plaintiff will not be able to benefit from the damage or injury suffered. The concern is whether the law of negligence tort is in a position to compensate the suffering of the plaintiff satisfactorily?
CONCLUSION The analysis of various laws and regulations reveals that the level of protection available for e-health service users is not adequate. This would necessarily suggest that existing laws need to be amended or else fresh legislation be made available to provide better protection. The following could be taken as possible recommendations to meet this purpose. The laws on e-contract in many countries are not modified to suit electronic transaction. Liability of e-producers and service providers should be regulated by statutes in general as there are restrictions in recovering damages under negligence tort. Economic loss should also be addressed adequately by legislative amendments. Many countries failed to address the issue on privacy in their relevant laws adequately. Thus following the EU Directive of Data Protection would facilitate the adoption of
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e-health system in a greater extent. Similarly the EU Countries are having the opportunity to adopt a better regulation in term of jurisdiction of the courts in deciding online disputes and enforcing the judgement. It is needless to say that such cooperation among various nations is necessary to build the confidence and the trust of e-health system users to maximise the benefit to everyone.
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Burgunder, B. (Ed.). (2001). Legal aspects of managing technology. Ohio, USA: Thomson Learning.
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Munir, A. B. (1999). Cyber law: Policies and challenges. Kuala Lumpur, Malaysia: Butterworth Asia. Pichler, R. (2000). Trust and reliance—Enforcement and compliance: Enhancing consumer confidence in the electronic market place. Retrieved on October 12, 2010, from http://www.law.stanford. edu/library/special/rfus.thesis.pdf Rachagan, S. (1992). Consumer law reform - A report. Malaysia: Selangor and Federal Territory Consumers’ Association. Raymond, W. (1978). Keywords: A vocablary of culture and society. London, UK: Fantana Press. Reidenberg, R. (2001). E-commerce and transAtlantic privacy. Houston Law Review, 38, 717. Reuters (2000). Supreme Court uphold ISP ruling, (p. 1). Retrieved on October 13, 2010, from http:// www.wired.com/news/politics/0,1283,36012,00. html Rich, L. (n.d.). Publisher liability: Incitement & negligent publication. Retrieved on October 13, 2010, from http://library.lp.findlaw.com/ articles/file/00102/000149/title/subject/topic/ injury%20%20tort%20law_defamation/libel/ slander/filename/i Sarabdeen, J. (2001). E-banking: Malaysian legal paradigm. INAP Conference Proceedings 2001 (pp. 416-422), Tokyo, Japan. Sarabdeen, J. (2009). E-consumer redress mechanism for negligence in Malaysia – A survey analysis. IBIMA Business Review, 4(3), 16–20. Scott, C., & Black, J. (2000). Cranston’s consumers and the law. London, UK: Butterworths. Sessler, J. B. (1997). Computer cookies control: Transaction generated information. Journal of Law and Policy, 5, 627–633.
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Sherriff, L. (1999). Argos £ 3 TV fiasco provokes test-case lawsuit. Retrieved on October 13, 2010, from http://www. theregister.co.uk/content/archive/6632.html Stephenson, P., & Kwan, A. (2007). Cyberlaw in Hong Kong. Hong Kong: Lexis Nexis. Terry, P. N. (2000, Fall). Structural and legal implications in e-health. Journal of Health Law, 33(4), 1–9. The County Court of Paris. (2001). Union of French Jewish Students and League Against Racism and Anti-Semitism v. Yahoo! Inc. and Yahoo France. Yahoo Case Reports, 1(3), 110-120. The Star-In Tech. (2002, August 13). FTC: Microsoft misled consumers, made false claims. The Star-In Tech (p. 8). Tsai, S. F. (2010). Security issues in e-health care. Journal of Medical and Biological Engineering, 30(4), 209–214. doi:10.5405/jmbe.30.4.04 Turban, L. K. (2000). Electronic commerce: A managerial perspective. Upper Saddle River, NJ: Prentice Hall. Warren, S., & Brandeis, L. D. (1890). The right to privacy. Harvard Law Review, 4(5), 193. doi:10.2307/1321160 Werner, J. (2000). E-Commerce Co. UK – Local rules in Global Net: Online business transactions and the applicability of traditional English contract law rules. International Journal of Communications Law & Policy, 6, 1–10.
ENDNOTE 1
Article 1(4) of the E-Commerce Directive clearly states that the directive does not establish additional rules on private international law nor does it deal with the jurisdiction of Courts.
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Chapter 3
Healthcare Applications for Clinicians Mohamed K. Watfa University of Wollongong in Dubai, UAE Hina Majeed University of Wollongong in Dubai, UAE Tooba Salahuddin University of Wollongong in Dubai, UAE
ABSTRACT Computer-based applications at diverse healthcare sites have led to many improvements over a prolonged period of time. Some of these advances include efficiency (in comparison to paper based data), effectiveness (in terms of support in the various processes carried out at the healthcare setting), and more categorized data. The application built for a particular healthcare setting should complement the workflow in progress. Some of the issues that one would be concerned about at some point of designing such an application consist of data privacy, minimal bias offered by a system (i.e. in terms of searching and decision-making), a user friendly GUI, and an efficient integration of the new system with the existing standard application at the health based setting being considered. Clinical Informaticians have been considerably effective at replacing paper-based medical data with healthcare applications. Presently, the theme of interest for biomedical IT systems comprises of Web based and wireless healthcare provisions. To explore into this area of research, we begin by familiarizing the audience with the theme of healthcare applications in Section 1. This is followed by listing and discussing the advantages provided by generic computerized systems developed primarily for the assistance of physicians in Section 2.1. In Section 2.2, we consider possible challenges that these applications induce. Section 3.1 comprises of DOI: 10.4018/978-1-61350-123-8.ch003
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Healthcare Applications for Clinicians
the possible benefits offered by Web-based applications for clinicians, whereas Section 3.2 focuses on the challenges offered by Web-based applications. Section 4.1 delivers an overview on the subject of wireless healthcare technology in regard to physicians whereas Section 4.2 lists and defines its benefits in detail. Section 4.3 gives a brief coverage to wireless healthcare devices that could be of significance to clinicians. Furthermore, Section 4.4 consists of a clarified consideration of wireless applications that currently provide assistance to certified physicians, followed by Section 4.5, focusing on its challenges. We conclude this chapter in Section 5, providing an insight of how the future of generic, Web-based, and wireless technologies could lead to added development in our lives as clinicians or patients.
1. INTRODUCTION Over the years, interactive computer-based systems have provided crucial support to clinics, hospitals and other health-based centers. These systems have continued to influence the manner in which clinical tasks are organized and fulfilled in terms of performing tests, diagnosis procedures, treatment methods, as well as storing, analyzing and accessing patient and staff information. At the present time, the computer-based systems used in healthcare settings of high standards are the result of joint efforts of clinicians, software developers and clinical informaticians hence triggering the outcome of the desired system to outdo that of existing applications. (Pagliari, 2007) Acquiring input from professionals of diverse qualifications and expertise who aim towards the same goal, offer various advantages as the result of added involvement. Healthcare systems, whether in the form of desktop applications or mobile applications, have managed to replace paper-based systems to a large extent. One of the major themes of interest for biomedical IT systems, in today’s time, comprises of web-based and wireless healthcare facilities. Reasons include wide access vicinity, and quick and easy access of information.
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2. COMPUTER-BASED HEALTHCARE APPLICATIONS FOR CLINICIANS 2.1. Benefits BioTIFF Health specialists radically benefit by a means of having their medical data of interest to be organized with relevance. The BioTIFF holds various such advantages. The BioTIFF is an application which comprises of encapsulating a number of images of standard TIFF (Tagged Image File Format) in a computerized ‘envelope’ or a ‘container’. For instance if a set of 20 photographs of a blood cancer patient are to be obtained, the entire set of 20 photographs would then be placed in an envelope named ‘bloodcancer.tif’. (2006) Within the envelope, one will find the images bloodcancer1.tif, bloodcancer2.tif, and so on. (2006) Further, elements within the envelope can locate the affected or damaged areas and are able to record the observed findings. (Medicine 2.0, 2008) According to (Medicine 2.0, 2008), the BioTIFF technology comprises of “... molecular, cellular, anatomical, and biomedical coordinate systems...” (Pagliari, 2007) which aid in measuring the improving health of the involved patients
Healthcare Applications for Clinicians
with respect to the illness of concern. (Medicine 2.0, 2008) Another quality the BioTIFF possesses is that it allows for users to constantly document and store their observations and comments which change with variations in progress. (Medicine 2.0, 2008) These benefits yield the BioTIFF to become an ideal application for medical doctors whose work entirely revolves around work-related scenarios similar to the instance provided above.
MyOpenCare MyOpenCare is a system designed for healthcare specialists to share their take on a cure for (a) patient(s) of a particular type of illness. The to-be shared data would have to be entered in the form of a graph comparable to a fishbone diagram. (Medicine 2.0, 2008) The graphs appear similar especially when it is required to illustrate more than one way of cure; i.e.: displaying 2 branches stemming from the same root. (Medicine 2.0, 2008) The graphs would be designed using a piece of software embedded in the system. (Medicine 2.0, 2008) This shows that MyOpenCare triggers medical doctors specialized in different fields to broaden their medical horizons by taking a vast set of ideas into perspective. Apart from that, MyOpenCare also retains a good-quality interface for graph design. In light of that, the user would be required to follow the diagram as a whole from start to finish, simply by following the stems in order. (Medicine 2.0, 2008)
NextGen® ‘NextGen® Inpatient Clinicals’ is a softwarebased company known for designing and providing hospitals, clinics and other interested parties with health-based applications. (Wikipedia, 2010) NextGen offers various applications which assist the clinicians at a substantial level by efficiently
fulfilling their tasks. (2010) A few of the applications include:
NextGen Computer Physician Order Entry (CPOE) As its name suggests, the CPOE allows the clinicians to access and select from a vast range of categories, the records of which have already been characterized; i.e. comparable to a combo box together with all the necessary attributes. (NextGen, 2010) These categories include treatment procedures, medicine for prescription and allocation, and lab names and codes. (NextGen, 2010) The clinician also has the privilege to view previous orders made at the CPOE. (NextGen, 2010) With an increasing use of such applications, researchers will have the data and the resources to evaluate and analyze the statistics based on the quantity of usage of a specific medicine, in light of a particular illness. (NextGen, 2010) Some of the other factors that the statistics could be evaluated on include the racial profile of the patients and the count of an explicit prescription on a weekly/ monthly basis.
NextGen Pharmacy Information System The NextGen Pharmacy Information System offers the clinicians to administer their pharmaceutical items. (NextGen, 2010) It facilitates the supervision of medications along with the supervision of medicine-related records and stocks. (NextGen, 2010) Based in The United States, this system also assures that it turns to the First Data Bank on a regular basis. (NextGen, 2010) The First Data Bank, also established in the U.S is renowned for providing healthcare database services to healthbased settings. (n.d.) The data to be modified and its details can be grasped from the First Data Bank when needed, the responses of which are instantaneous. (NextGen, 2010)
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Healthcare Applications for Clinicians
NextGen Laboratory Information System The NextGen Laboratory Information System comprises of a set of appealing characteristics in addition to a user-friendly graphical interface. (NextGen, 2010) The application also has the capability of being extended and customized, best suited for the practical environment of the clinical setting of importance. (NextGen, 2010) Further, it has been designed to maintain a high level of performance throughout its use so as not to offer any unconstructive traits in terms of effectiveness of the system. (NextGen, 2010) The NextGen Laboratory System is constructed as a client-server association, where users are prompted in an occurrence of the system’s capability of authorizing the user to resume awaiting tasks. (NextGen, 2010)
NextGen Therapy Management This system consists of pre-entered information about therapies, where the main focus entails an individual’s diet regime, respiratory system, and issues with verbal communication. (NextGen, 2010) With the help of this system, a therapy plan may be produced and printed according to the patient’s necessities. (NextGen, 2010) This is concluded as the result of pre-defined data playing an essential role for the system, whether it is in the form of a treatment procedure or that of a patient record. (NextGen, 2010) Physicians are able to access and generate medical therapies most suited to the patient, by viewing and examining patient details through the application.
NextGen Mobility As discussed later on in this chapter, wireless characteristics of healthcare systems offer various benefits to physicians working in diverse medical departments. NextGen Mobility allows the physician to view and update information on the CPOE using specific mobile devices. (NextGen, 2010)
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These devices support models of some of the most commonly used cell phone companies including Palm, Blackberry and iPhone. (NextGen, 2010) The NextGen Mobility system also allows the clinician to access co-NetGen subsystem features such as the CPOE without difficulty. (NextGen, 2010) Remote access to the clinic-based system will offer clinicians the benefit of system access without having to be bodily present on the clinical premises.
NextGen Physician Portal The NextGen Physician Portal allows the physicians to view patient records without delay. (NextGen, 2010) This would be highly effective in situations requiring retrieval of patient data urgently. (NextGen, 2010) Additionally, the portal can be tailored to satisfy the needs of the physician involved. (NextGen, 2010) Another advantage of this facility is that it sustains its ethical values. The physician portal acts in accordance with the Health Insurance Portability and Accountability Act (HIPAA), including good quality privacy measures. (NextGen, 2010)
2.2. Challenges Mobile Vs Fixed Computer Use When it comes to designing an application addressing clinicians’ needs, the choice of hardware devices on which the application is to be built should be conceptualized in accordance with the clinic setup. While considering the optimal device for a clinical setting, the role and responsibilities of the clinicians in question must be analyzed. According to ‘Mobile and Fixed Computer Use by Doctors and Nurses on Hospital Wards: Multimethod Study on the Relationships Between Clinician Role, Clinical Task, and Device Choice’ (Andersen, P., et al. 2009), over 90% of nurses seemed most comfortable using laptops, while the majority of doctors preferred to use desktop
Healthcare Applications for Clinicians
PCs. Since the study did not observe clinical tasks to occur in static settings (Andersen, P., et al. 2009), the laptops appeared to be the perfect choice. What pleased the nurses most was the ability to accompany the laptops where needed. (Andersen, P., et al. 2009) Strangely enough, the laptops with larger screens were easier to move around as compared to those with smaller screens. (Andersen, P., et al. 2009) This is because those with smaller screens offered more table space, which at times would get occupied by clinical substances, causing the view of the laptop screens to be partially concealed. (Andersen, P., et al. 2009) Laptops equipped with styli seemed to be extremely suitable for pharmacists. (Andersen, P., et al. 2009) This was so because pharmacists could easily write their observations and other information in their own handwriting (Andersen, P., et al. 2009) using the stylus. When needed, the tablet PC would convert the handwritten text into digital text. (Andersen, P., et al. 2009) Further, the pharmacists felt at ease while carrying the tablet PCs for their rounds. (Andersen, P., et al. 2009) On the other hand, doctors who were relatively stationary had a preference for standard PCs. (Andersen, P., et al. 2009) These observations prove that the actual design of the device, whether physical or graphical, has a considerable effect for clinicians in regard to usage of that device. (Andersen, P., et al. 2009) It is a constant challenge to find a design which perfectly suits the arrangements and obligations of a particular environment. The key is to consider all possibilities, conduct interviews, and to carry out other evaluations along with the help of professionals.
Physicians’ Approach to Manage Patient Hesitation With respect to an application requiring direct patient interaction with the system, it might be awkward for the patients to respond to each query as a requirement of the system. For instance, a patient that visits the clinical premise with a certain form
of sickness may not prefer answering questions which are irrelevant to the illness for which he/she has visited the clinic, as an obligation. (Ahmad, F. et al., 2010) A system which requires patients to fill a computerized form before meeting the assigned doctor may also seem unnecessary from a patient’s point of view. (Ahmad, F. et al., 2010) This application would then notify the patient of any indicators of a particular illness, and the risks associated with it. (Ahmad, F. et al., 2010) The system would generate a list of suggestions, risks, and comments of the possible symptoms the patient might be undergoing. On one hand patients would be reluctant in regard to discussing an issue which they had not made an appointment for, while on the other hand, the physician would have to manage patient consultation time effectively. (Ahmad, F. et al., 2010) This is because discussing added computer-generated comments may be more time consuming. Further, allocating an equal amount of time for every consultation would be difficult to manage. (Ahmad, F. et al., 2010)
Biased Application Designs Applications such as search engines which are built specific to clinicians’ needs may trigger clinicians to search for queries in a way that may lead to biased search results, leading to biased decision making. Some of the most commonly designed search engines include resource-based search engines, referring to a search engine which gives the user the authority to select a resource prior to searching for a query, so as to make the search relevant purely for the selected resource. Interestingly enough, studies showed that clinicians using resource-based search engines tend to search for the same query for various resources, instead of searching for different queries for the same resource. (Lau, A.YS. et al., 2010) In the midst of performing searches using a resourcebased search engine, clinicians felt the need to compare the search results of the same query with those of different resources. (Lau, A.YS. et
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Healthcare Applications for Clinicians
al., 2010) Normally this search behaviour would not be expected as a clinician would be expected to limit his/her search, filtered by the resource of concern. For the reason that search results of a task-based search engine are not restricted to a particular resource, clinicians obtain a set of search results which could comprise of a combination of resources as a response to the same query. (Enrico, C. et al., 2008) This proves that task based search engines would be ideal for physicians who are mostly occupied with other work-related assignments and find it difficult to manage their time. (Enrico, C. et al., 2008) The study also showed that physicians using a resource-based engine explored more search queries than those using task-based search engines. (Enrico, C. et al., 2008)
Research-Based Innovation: A Clinician’s Challenge These days it is noticed that clinicians spend a great deal of time and money, coming up with new ideas of technical requirements in a healthcare setting, based on medical research. The combination of skill and knowledge they hold is capable of simulating various scenarios that are possible to occur in a clinical environment. (Stead, W et al, 2009) The aim is to combine clinician needs along with the planned initiative in regard to biomedicine. (Stead, W et al, 2009) Once the initial design is finalized by the clinician, technological help is searched for. During these processes, it is likely that a patient’s perspective is missed out on. (Stead, W et al, 2009) Having an insight to the ideas being considered can cause the patient to assist at ranking the necessities and their motives, along with the consequences of taking up each path, by significance. (Stead, W et al, 2009) Once the patients grasp the medical basics that are required to understand the functions of the system in question, they should be given access to the implications in terms of viewing a patient’s
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medical information as it gets updated by i.e.: using a certain tool of the application. (Stead, W et al, 2009) This way it will be easy for them to figure out what events trigger what outcomes. (Stead, W et al, 2009) An enhanced understanding of the system and its requirements will lead to the patients providing better suggestions.
Electronic Health Records (EHR) Electronic health records purely symbolize the data which comprises of a patient’s personal details in addition to the specifications of their health status, in electronic form. They key benefit of the EHR is that they offer all clinicians within a single healthcare setting with the access of medical information concerning a patient. (Ann, D, 2010) Apart from this, the electronic element of patient health records has the provision to relay the user from a health record to online databases, consultants, and other forms of medical aid. (Gurley, L et al, 2004) The EHR also possesses a significant shortcoming. Presently, a consistent representation of an EHR is nonexistent. (Gurley, L et al, 2004) EHRs could offer more benefits once standardized. Representing the majority of users of EHRs, clinicians could work towards one consistent EHR version, leaving room for slight customization dependent on the working mannerisms of a specific group of clinical staff. (Gurley, L et al, 2004) Another problem the EHR holds is that individuals, i.e.: clinical staff may find it difficult to adapt to the user-interface and design of the EHR system. (Ann, D, 2010) Having every staff member in a clinical setting to be able manage utilizing an EHR system without any inconvenience may not always be the case. In addition to that, an EHR is quite costly and is likely to waste much of the physician’s precious time as it requires one to evaluate and document the observed phenomena. (Ann, D, 2010)
Healthcare Applications for Clinicians
3. WEB-BASED HEALTHCARE APPLICATIONS FOR CLINICIANS 3.1. Benefits It is observed that a vast majority of the young as well as the fairly mature individuals of today’s generation have reasonably good IT skills, as the result of regular usage of computers and other IT devices, especially when it comes to using the internet and mainly, email. Patient-physician communication through e-mails broadens the scope from a physician’s perspective and a patient’s perspective education-wise, challenge-wise, interaction-wise and profession-wise. (Singh, H. et al., 2009)
Source of Payment and Comparison The internet is considered vital amongst clinicians, as it is a direct means of trouble-free payments of medical devices and equipment. (The Frabotta Company, 2010) Physicians may simply browse through various catalogues until they find the perfect piece of i.e.: equipment. This would be followed by paying for all the selected items in their electronic trolley using a credit card. The selected items would not take too long to be shipped to the already mentioned premise. What is more is that the owners of the clinical setting would be required to use an automated internetbased appliance to fulfil many transactions at once, thus minimizing their administrative expenses. (Guadagnino, C, 2008,) These appliances could also offer real-time checks against prescription providers and other forms of online medical assistance.(Guadagnino, C, 2008,)
Interactive Symptom Assessment and Collection (ISAAC) The Interactive Symptom Assessment and Collection (ISAAC) is an online application designed by Cancer Care Ontario (CCO) keeping up to a
good standard, built for users who wish to check if they have any symptoms of cancer via the web. (Medicine 2.0, 2008) The main process requires a resident in Ontario to go through an interactive procedure on a touch-screen PC at a cancer centre nearest to them. (Medicine 2.0, 2008) However some users may not find it suitable to be physically present a cancer centre for many reasons, including transportation problems. Further, a client uncertain of being a cancer victim may find it beneficial to primarily take into consideration a test from an authentic web based source, without having anybody in their household to get worried. As a solution to this, the ISAAC can also be accessed online, where the same procedure takes place. The idea is to enquire if the patients have any signs of the 9 common cancer indicators, and how critical those signs are. (Medicine 2.0, 2008) The information entered by the patients is then conveyed to and received, both by clinicians and the CCO. (Medicine 2.0, 2008) According to clinicians who have been a part of ISAAC, using the ISAAC at home is an enhanced way of approaching cure, as it is commonly known that when in doubt of being a cancer victim, it is best to report to a doctor without delay. (Medicine 2.0, 2008) This is because patient input through the ISAAC can be accessed by clinicians almost instantaneously. (Medicine 2.0, 2008) Instant feedback from the patients helps them remember exactly how they feel, which could possibly lead to a discovery of new symptoms. (Medicine 2.0, 2008) Clinicians are pleased with viewing patient information in the form of graphs with respect to treating the patients accurately, whilst examining the print-screens of their progress over a period of time represented in graphical notation. (Medicine 2.0, 2008)
3.2. Challenges The internet is referred to as the world’s largest social networking tool (MacDonald) by many, outshining all the other forms of interaction. (Cain, M et al, 2000) The number of individuals
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Healthcare Applications for Clinicians
who have joined well-known online networking sites is larger than the total number of residents of just about any country of the world. (2010) From the point of view of health awareness, the public is exposed to excess information and outlook, including the latest ways of dealing with illnesses and the optimal ways of interacting with patients. (Cain, M et al, 2000) The American Medical Association (AMA) is one of many companies that not only maintain a high standard while acting upon their duties but also offer online consultations. (Cain, M et al, 2000)
Privacy Online users also have access to joining medical forums and websites where people facing similar health problems may relate to one another, being their pillars of support through times of ill health. There are times when it is required of the user to share personal medical details online. Situations like these may cause the user to think twice before doing so. (Cain, M et al, 2000) When at a clinic, patients feel at ease sharing their medical specifications with the physician, not being concerned about its privacy. This may be dependent on the reputation of the clinic/hospital the patient visits. However when it comes to posting one’s personal medical information on web-based sites, patients seem to have trust issues with that. Setting up appointments with one’s physician, discussing symptoms of illnesses the patient is undergoing, and asking for prescription all involve posting of private health-related data. (Cain, M et al, 2000) These areas of concern include hacking of an online account and how comfortable the recipient is about sharing the sender’s information with other individuals at the recipient’s end. (Cain, M et al, 2000) In each of these cases, the patient’s medical input on the website would be looked upon by uninvited people. Another debatable concern in the world of online healthcare is that of credit card payments on the World Wide Web. (Cain, M et al, 2000) The last thing a user wants is to have
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their credit card number seen by an uninvited party, which if done could lead to several financial inconveniences. (Cain, M et al, 2000) While some are satisfied with online privacy policies, the issue appears to remain a concern for many. Therefore privacy concerns related to the internet could trigger the clinical staff to rethink paying for such facilities. (James, M, 2002)
Communication via E-mail Even though it is found that the majority of the working class handles computerized gadgets with ease, many individuals deem rather difficult to deal with situations where it is required for them to have direct interaction with IT devices. Also, if patients are given a set of instructions from their physicians online, the level of clarity may possibly be low as a result of lesser human contact and interference. An instance of decreased human contact includes treatment procedures involving a pre-requisite where physicians communicate with their patients via email. (Singh, H. et al., 2009) The level of clarity has even more chances of declining when patients of an older age, i.e.: over 65 years of age, (Singh, H. et al., 2009) are of main concern to physicians. A reason behind why patients would want to engage themselves in such an interaction could involve maintaining good terms with a doctor they physically visited in the past i.e.: a family doctor. Communication in regard to medical queries and advice in such scenarios may to a certain extent be affected by numerous aspects in reference to the physician. If the physician is not in a good state of mind for whichever reason, it can have an impact on the manner in which the e-mail is phrased. (Singh, H. et al., 2009) Also, the matter of payment can be expected to have a significant impact on the physician’s motivation levels. (Singh, H. et al., 2009) If the healthcare setting the physician works for pays him/her a large sum of money for the focus of conversing with patients via e-mail, it could lead to a high level of motivation for the physician
Healthcare Applications for Clinicians
to share recommendations of importance to the patient. The same reason of motivation could lead to the physician spending more time and paying more attention towards each patient involved. Furthermore, authorities of hospitals and clinics may possibly have to revise the guidelines concerning payment in regard to doctor-patient web-based interactions in their codes of conduct. (Singh, H. et al., 2009) Further, it may not always be a good idea to rely on the email mechanism when in need of urgent updates or replies. (Sands, D, 2008) This drawback could come about as a result of the time the email was sent. If the sender and recipient are in areas of different time zones for whichever reason, and the sender sent the email at an odd hour from the recipient’s approach, the recipient is least likely to respond to the mail immediately. This in turn would waste both the sender’s and recipient’s time. (Sands, D, 2008) A better alternative would be a direct telephone call. (Sands, D, 2008)
Exposure to the Underprivileged Despite the fact that the internet serves as a helping hand to many individuals belonging to a middle class, most of the individuals who are part of the working class do not have the means to experience internet facilities. (James, M, 2002) With the growth of technology, patient-physician interactions have also developed. The inclination of patient-physician online interaction may affect those who are unable to afford web services and would prefer physically visiting a doctor when in need. If patient-physician interactions in the next few years turn completely web-oriented, people who are not used to computers would have a tough time trying to communicate with a clinician in a concise approach. Further, there is a significant window between those who cannot afford computers and related services, and those who utterly rely on these provisions. (James, M, 2002) Finding and providing a balanced healthcare solution to this problem would be reasonably problematic.
ISAAC In spite of offering numerous advantages to a cluster of cancer patients together with healthcare specialists, the ISAAC triggers several challenge to clinicians. Often, it is essential to keep track of doctor’s comments, expert suggestions, and patient progress in written form alongside the patient progress in graphical form. One area of improvement for the ISAAC is the availability of an option for taking into account written comments and observations beside the charts. (Medicine 2.0, 2008) This way the graphs would be easier to follow, as the clinician would have a good understanding of what was observed and felt while the data was being entered into the system. Also, measuring patient progress through the inspection of graphs was found to be unrealistic. (Medicine 2.0, 2008) Adding to that, clinicians and patients might have to face a certain level of difficulty considering the means of interaction between the two. (Medicine 2.0, 2008) Absence of direct human contact, such as a communication gap, in the doctor-patient relationship can cause individuals on either sides of the link to face discomfort.
4. WIRELESS HEALTHCARE APPLICATIONS FOR CLINICIANS 4.1. Overview Where web-based applications for healthcare have proved to be a turning point in the field of healthcare, wireless technologies have further revolutionized healthcare applications which makes it extremely useful for health professionals yet challenging for developers. Wireless applications in the healthcare industry have completely transformed the way patients are treated and have helped in changing the entire clinical workflow. It is observed commonly that hospital data related to patients is not available within quick reach of the clinicians inside the hospital when
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Healthcare Applications for Clinicians
needed due to the dispersion of information at multiple sites in the hospital (Gibbs, 2009). Even with wired IT healthcare systems, the clinician is unable to access the data outside the hospital premises (Gibbs, 2009). This gives rise to the need to accommodate wireless technologies in the hospital environment, in order to make the hospital practices efficient and to improve the quality of care delivered in many ways (Gibbs, 2009). Experts concluded that there are not enough wireless solutions for clinicians in the healthcare industry, and the mobile applications that have been developed for doctors, are not perceived as useful enough by the doctors. (Alasaarela, 2008) Hence wireless technology in healthcare does not meet the doctors’ demands/requirements and there exists a demand for such wireless applications in healthcare that would efficiently assist the health professionals in their healthcare tasks, would be easily adjustable in the current state at the hospital and would aim towards positive improvement of the healthcare practices. (Alasaarela, 2008)
4.2. Benefits Improved Hospital Staff Communication Communication among the hospital staff is greatly improved with the use of wireless technologies. The required staff member can be easily contacted through the wireless network, thus increasing efficient time usage (Cisco System Inc.) and increasing staff productivity (Motorola, 2006). When empowered with handheld devices connected to wireless network, the doctors can remain in contact with each other virtually anywhere within or outside the hospital premises (Igbokwe, n.d.; Motorola, 2006). They can send and receive patient details and results of procedures in the hospital at any time (Igbokwe, n.d.). Response time in a medical disaster situation is also reduced and is more frequent and reliable (Igbokwe, n.d.).
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On-the-Go Access to Patient Information Mobile access to patient information is another featured benefit of wireless networks in healthcare organizations. Patient information can be immediately accessed and reviewed via handheld devices at the patient bedside (Fiser, 2004), thus saving the clinicians’ time for critical tasks. Clinicians can access the patient’s laboratory results and other information on their wireless devices from anywhere within network range (Business Wire, 2004). According to Hockaday (2007 cited in Nursing Standard, 2008), one of the important benefits of wireless solutions in hospitals is the immediate availability of patient information when needed at the point of care. When doctors have on-the-go access to patient information, it has also proved to reduce the treatment time of patients and has led to an increase in the mobility of the clinician (Igbokwe, n.d.).
Increased Patient Satisfaction Wireless applications in healthcare also allow clinicians to treat a greater number of patients in a lesser amount of time (Motorola, 2006). Patients are more satisfied with their experiences and the quality of care-giving at the hospital (Motorola, 2006). Up-to-date patient information translates into non-delayed patient treatment (Motorola, 2006).
Improved Clinical Decision Making Wireless access to patient information means that the required information is accurate and is readily available. According to Dr. Heslop (n.d. cited in Motorola, 2006) the hospital staff tends to make more efficient clinical decisions for their patients when required information can be accessed quickly.
Healthcare Applications for Clinicians
Improved Clinical Workflow
Security of Patient Data
Using wireless technology in hospitals has improved the overall clinical workflow. Physicians empowered with smart wireless devices utilize their time well by monitoring patients instead of wasting hours with wired networks to access patient information (Fiser, 2004; Motorola, 2006). Patient details and critical information can be viewed at the patient bedside (Fiser, 2004).
Where security of critical patient data is a barrier to the adoption of wireless applications in some healthcare organizations, it has proved to be a driving factor for most of the healthcare organizations. Healthcare professionals are able to quickly access required patient information through secure wireless networks by providing proper authentication details (Nursing Standard, 2008). Authorized remote login is also available for most of the applications which allows data to be accessed securely outside the hospital premises (Nursing Standard, 2008). Implementation of proper security standards ensures greater security when compared to wired Ethernet networks (Nursing Standard, 2008).
Reduced Medication Errors The use of wireless technology in healthcare has helped in reducing critical medical errors. When the hospital staff is equipped with wireless access to correct patient information, medical error are reduced (Business Wire, 2004). The IT manager at the Children’s Memorial Hospital of Chicago has reported that the nurses have observed an increase in the accuracy of the entire clinical management (Havenstein, 2005). Wireless access to the latest information on patient records reduces the tendency of doctors to perform likely mistakes such as suggesting incorrect treatment strategies (Motorola, 2006).
Improved Prescription Management The process of prescription management has improved with the use wireless prescription applications. Apart from the transfer of electronic prescriptions to the pharmacies, the physicians can also view the drugs prescribed to the patient earlier (Gibbs, 2009) and check for adverse effects, allergies and efficiency of the medication currently prescribed (Igbokwe, n.d.). With the deployment of these applications on a mobile device, the whole process can be managed at the patient’s bedside (Igbokwe, n.d.).
4.3. Devices Healthcare professionals use handheld devices like Smart Phones, Tablet PCs, Notebooks (Gibbs, 2009) and Personal Digital Assistants (PDAs) for common tasks. However as tasks get more complex, task-specific devices would be used. As new applications are built, the use of Tablet PCs is increasing.
4.4. Current Applications in Wireless Healthcare There are various different kinds of wireless applications in the healthcare industry specific to the clinicians and other health professionals, including physicians, doctors, and obstetricians, for improving clinical workflow to provide better healthcare to patients. Numerous companies that develop healthcare-specific software applications joint-venture with companies specializing in wireless technologies, in order to integrate their software with portable devices. Mobile access to patient health records is the second most important and credible wireless application in the healthcare industry. (Alasaarela,
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Nemana & DeMello, 2009) There are many wireless solutions available in the technology market to empower clinicians to access patient health records from a portable device inside the hospital environment. These mobile healthcare applications make clinical information easily accessible for the clinicians and provide a number of digital solutions to improve hospital workflow (Business Wire, 2010).
Cisco and Imatis Mobile Care Solution Cisco is one of the leading companies that provide solutions for digitizing healthcare by integrating wireless technologies into the clinical workflow. Imatis AS offers software solutions for the healthcare industry that connect clinicians, clinical workflow, patient data and systems within a healthcare organization. In order to create a true mobile-care environment, together Cisco and Imatis enhance the use of wireless IP phones and different mobile devices including PDAs, by providing Mobile Care for optimization of information workflow and collaboration within the hospital environment. The Mobile Care Solution by Cisco and Imatis helps in streamlining communication between the clinical staff which reduces the time to locate the required staff for a patient. It improves access to the information requested by the clinician, with the availability of wireless network coverage in the hospital. The staff is sent alerts regarding preparing rooms for new incoming patients, retrieving a wheelchair or contacting security. Hence, as wastage of time is reduced in non-clinical activities, there is ample time for improving patient satisfaction and treatment by attending to them. Hospital functions and workflows are well-organized and enhanced by faster communication rapid information share among the hospital staff. (Cisco System Inc.)
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OnCallData – A Wireless Healthcare Application by InstantDx InstantDx is a company in Gaithersburg, Maryland, that offers practical software solutions in medicine. InstantDx observed a physician’s daily set of tasks and developed a software namely OnCallData based on two important, repetitive tasks, prescription writing and laboratory tests review.(Seshadri, et al., 2001) This software allows prescriptions to be transferred electronically to the pharmacies (Seshadri, et al., 2001). Dan Hesse, CEO at Sprint Nextel, stated that in the United States e-prescription could make an annual saving of about 27 billion US dollars in the health care industry (Hesse, 2010). Since the prescriptions are transferred electronically, the problem of illegible handwriting is also resolved (Hesse, 2010). The laboratory test results are delivered from laboratories to the physician on any web-capable device. (Seshadri, et al., 2001) Moreover, the software is “device agnostic”, it does not depend on any single device to receive data, any web-capable device would serve the purpose. (Seshadri, et al., 2001) Apple’s iPhone 3G is acting as a platform for multiple wireless medical applications to assist doctors at the point of care. Apple is also interacting with various companies that develop and implement medical applications for portable devices, to integrate their software with Appe’s devices. A number of hospitals are using iPhones to connect their medical staff together and to connect them with their patients within the hospital, wirelessly. iPhone’s smart usability features is another reason of its rapid adoption in the healthcare industry, namely the expanded screen size and scroll and zoom capabilities. iPhone helps in increasing meaningful communication among the healthcare community that leads to proficient medical team work “at bedside and beyond”, as well as improved patient care.(Apple, n.d.) Below are some of the software applications for iPhone that are is use in hospitals around the world.
Healthcare Applications for Clinicians
Apple and AirStrip Technologies Solution – AirStrip OB AirStrip Technologies provides software applications for portable mobile devices in the healthcare industry. AirStrip, together with Apple, provides obstetricians (OBs) with real-time wireless access to the mother and the baby’s historical waveform data, on Apple iPhone 3G.(Zabre, 2008) In addition to that, OBs can also remotely access the contraction patterns and fetal heart tracings from the hospital’s labor unit on their iPhone 3G.(Zabre, 2008) (Sarasohn-Kahn, 2010) The OB’s meaningful interaction with the hospital’s labor unit is increased when the patient can be remotely monitored using the AirStrip OB application on Apple iPhone.(Sarasohn-Kahn, 2010) The application also eases usability by using the iPhone’s multitouch capabilities for quick enlargement and scrolling through critical data.(Zabre, 2008) It has truly “evolutionized the way obstetricians conduct their practice”(Zabre, 2008)
Apple and Epocrates Epocrates, Inc. offers mobile and web-based applications to support clinical decision making at the point of care thereby providing qualitative and secure patient care. It offers software applications deployed on various mobile devices including Apple iPhone 3G (www.epocrates. com). Doctors at Doylestown hospital make use of certain medical reference applications on their iPhone including Epocrates Essentials.(Apple, n.d.) The process of accessing patient information, explaining diseases, conveying lab test results and providing medicinal information to the respective patient can be done immediately from the iPhone when the doctor visits the patient.(Apple, n.d.) The Epocrates application also checks interactions between different drugs given to the patient simultaneously (Apple, n.d.), and can even suggest alternate medication strategies (www.epocrates. com). Moreover, it provides information related
to a number of diseases instantly (www.epocrates. com). It is capable of identifying pills of unknown origin, by searching through a huge database of description of pills (www.epocrates.com).
Wireless ePrescription Solution by Sprint and DrFirst Sprint is a provider of integrated communication services specifically to healthcare organizations around the globe. DrFirst, a provider of services and solutions on wireless devices to the healthcare professionals, joined with Sprint to make Rcopia, the wireless ePrescription application, available to the healthcare market (PR Newswire, 2004). This application is integrated with Sprint PCS Vision Smart Devices (PR Newswire, 2004). The wireless prescription management system assists most of the care providers involved in the process of prescription management including physicians, practitioners and assistants (PR Newswire, 2004). It handles the main functions of a prescription system efficiently, namely creating, editing, saving and electronic delivery of prescriptions through Sprint Smart Devices (PR Newswire, 2004). This system has greatly reduced medication errors and has proved to save physician’s time for other important tasks (PR Newswire, 2004). Moreover, to avoid security breaches data is handled by implementing proper security measures (PR Newswire, 2004). According to the director of healthcare marketing at Sprint Business Solutions, patient care is greatly improved by using Sprint’s unique mobility solutions (PR Newswire, 2004).
4.5. Challenges to the Adoption of Wireless Technology in Healthcare Healthcare organizations have been quite reluctant to adopt wireless solutions due to certain challenges/barriers that are associated with the use of wireless technologies. When looking forward to developing a useful and functional healthcare
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Healthcare Applications for Clinicians
application, these challenges should be taken into consideration.
Confidentiality of Hospital/Patient Data One of the concerns is the security of hospital data (Paradiso, 2005) as well as ensuring secure data exchange (Havenstein, 2005). Havenstein reports that in some hospitals of North California Sutter Health has installed wireless networks (Havenstein, 2005). To resolve the security issue, when using handheld devices for viewing patient records, the only thing the doctors are able to download is the “view of a screen” (Havenstein, 2005), which does not let them make amendments to patient’s sensitive data. Also wireless local area networks in hospitals are secured so they cannot be used as a public Wi-Fi site (Havenstein, 2005). According to reference (Alasaarela, Nemana & DeMello, 2009) security of patient data is not considered as one of the most severe challenges.
Interface Usability In a study by Gururajan, Baig and Kerr (2008) on “wireless technology in Pakistani healthcare setting”, the results showed that usability of wireless devices was an important issue towards achieving a better standard of clinical performance Difficult data entry and poor interface design have been reported to be the key barriers to adoption (). In order to ensure that the new technology would be accepted and would be actually used by the clinicians, the interface of the application should be effectively designed. (Gururajan, Baig & Kerr, 2008) An effective design could be defined as the one that allows easy navigation and formatted display of the required information on the wireless handheld device. (Gururajan, Baig & Kerr, 2008) A poor interface design not conforming to human-computer interface principles may also lead to incorrect interpretation of results that would lead to new forms of medication errors instead of
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reducing them. (Gururajan, Baig & Kerr, 2008; Stead & Lin, 2009) According to another survey conducted at the Healthcare Information and Management Systems Society (HIMSS) 2008 conference, the interviewees rated the level of difficulty for “usability of the mobile user interface” as moderate, and it was seen as the most difficult challenge when compared to “security of patient data” and other technical challenges.(Alasaarela, Nemana & DeMello, 2009) William Stead (2009) observes another noticeable factor in regard to interface usability. He puts forth the fact that majority of the applications are designed and implemented automate business processes that basically provide digital forms for activities currently carried out on paper (Stead & Lin, 2009). Clinical acts resulting from the clinicians’ personal cognition or experience are not taken into consideration (Stead & Lin, 2009). Stead insists that the routine procedures of the targeted users are also not supported well-enough by the system. (Stead & Lin, 2009)
Clinical Process Change The process changes that take place in a healthcare organization with the adoption of new wireless technologies are seen as a challenge more difficult than technical challenges. (Alasaarela, Nemana & DeMello, 2009) Some clinicians show resistance to adapt to the technology change because they believe that it is difficult to replace routine clinical processes with digitized processes as these processes strengthen the bonds between the patient and the doctor, and reflect uniqueness upon the healthcare industry. (The Mobile Health Crowd, n.d.) According to another survey conducted at the HIMSS08 conference, the challenge that was regarded as extremely difficult is “process change from the doctor’s point of view” and it’s level of difficulty scores way more than technical challenges. (Alasaarela, Nemana & DeMello, 2009)
Healthcare Applications for Clinicians
High Costs
An important barrier in the way of deploying a wireless network in a hospital environment is the fact that any such activity has to be carefully managed without disrupting the care process at the hospital. This is the reason why installation of a wireless network in a hospital is more complicated when compared with the installation of such a network in any other environment (Havenstein, 2005).
expect as proper feedback. (Gustafson, D. H., 2007) The application in question could make such queries and their responses more concise and organized. One of the attributes the system could possess is to generate a list of medical phenomena, mechanisms and activities to be cautious of, which would be vital for the patient’s relatives to be familiar with. (Gustafson, D.H., 2007) The clinician could select a generic illness/cause of death from, i.e.: a combo box on the appliance, followed by selecting an option to create a to-do list, and a not to-do list for the clinicians to convey to the patient’s relatives. The not to-do list would assist the patient’s relatives at comprehending actions that could unintentionally harm the patient. (Gustafson, D.H., 2007) Initially this could start off as an application owned by clinicians, which over a period of time could become customized to be utilized as an appliance to be used directly by the patient’s family and friends.
5. FUTURE DIRECTIONS
Existing Applications being Catered to Other Healthcare Departments
Another challenging factor affecting the practice of wireless technology in healthcare environment is the cost associated with software packages, server implementations and upgrades and maintenance of the wireless network (Fischer & Stewart, 2002).
Deploying Wireless Networks without Disruption
5.1. Future of Generic and WebBased Applications for Clinicians Applications for Helping Patients and their Relatives Deal with Issues of Dying and Death In addition to the suggestions mentioned above, it would be interesting to develop an application which could help determine reasons of dying of a patient, and all possible precautions that must be carried out when dealing with the patient. (Gustafson, D. H., 2007) It is common knowledge that once people become aware of their relative/friend suffering from a severe form of illness, they tend to be confused in terms of what exact measures are to be followed subsequent to the medical findings. This often results in the relatives of the patient constantly pursuing the assigned doctor, not knowing accurately what to ask and what to
In addition to overcoming existing challenges with the intensification of technologic aid in the biomedical world, clinical experts could extend existing healthcare systems to departments not being catered by them at present. For instance, the ISAAC which distinctly caters to cancer patients today could be extended and customized for patients of other departments of healthcare. Having an authentic online base to check for symptoms of a vast array of illnesses or diseases would be much appreciated by patients. It would not take an excessive amount of time to take the tests for signs of an illness at their respective houses. A positive result would then strike them to visit a physician without delay. Triggering healthcare opportunities for those who do not have access to or who do not relate to the provisions being offered in today’s time would be reasonably challenging.
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Healthcare Applications for Clinicians
Patient-Clinician Communication in the Future Over the past few decades we have witnessed a noticeable change in the means of interaction encompassing a patient and a clinician. It went from the patient being bodily present at the clinic, to physicians coming over at the patient’s residence for check-ups, to communicating with one another via e-mail, all the way to the physicians being able to examine the patient’s medical details, and giving online consultations and prescriptions. Currently, patients consult with their physician for a fixed amount of time, and take back with them the physician’s advice, strongly relying on their memory. In case of the patient being doubtful of something which was said during that consultation, the patient would refer back to the clinician to get a clear response to the query. This would lead to an increase in confusion and a waste of time for individuals on both ends of the spectrum, especially for clinicians as they deal with busy schedules. (Stead, W et al, 2009) A solution to this problem would be a recording of the consultation (Stead, W et al, 2009), a copy of which could be kept with individuals on either side of the physician-patient equation. The patient could have access to a video recording, an audio recording, or simply a text print of whatever was said during the meeting. (Stead, W et al, 2009) This way the physicians would be able to allocate more time to patients who have a need of further support. (Stead, W et al, 2009) They would also be able to fit in more number of patients in their daily consultation and/or testing schedules. (Stead, W et al, 2009) In the initial stages, clinics may simply offer a summary of the clinician-patient meeting. (Stead, W et al, 2009) Before leaving the medical premises, the patient could post-read the transcript with the clinician to clear any doubts there and then. (Stead, W et al, 2009) However, the copy of the consultation, whether in video, audio, or textual forms, could lead to further difficulties. (Stead, W et al, 2009) Both the patient
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and the clinician would have to abide by a clear set of regulations in light of privacy policies (Stead, W et al, 2009) and other ethical challenges that may arise in the clinical setting.
Video Prescriptions It is collectively known that physicians are constantly found working dynamically, sometimes even outside their work hours. In such cases, it would be close to impossible to find time for work apart from patient consultations. As a solution to busy schedules and travelling problems, physicians could recommend certain instructions to the patient in video form. (Edward, H., 2004) In cases where the physician has consulted the patient once, he/she can recommend the patient a suitable video prescription according to availability, instead of having the patient visit the clinic premises again. These video prescriptions could be based on modern internet provisions, and the patients could view the video on their television screens. (Edward, H., 2004) Physicians could either recommend another doctor’s videos or self-made videos. In some scenarios such as the physician having to leave town, he/she could simply let their assistant know what video is to be transmitted to which patient and when. However for live consultation, this would still be a problem. Video conferencing consultations could also become the norm amongst patients and physicians in the future. (Edward, H., 2004) The ideal modernized internet would possess remarkably high speeds and thus would be facilitate aiming towards live video prescriptions on a television screen. (Edward, H., 2004)
Content-Based Retrieval Digital images contribute significantly to numerous branches of biomedicine, some of which include radiology and cardiology. (Muller, H et al, 2003) Content-based image retrieval essentially refers to retrieval based on texture, shape,
Healthcare Applications for Clinicians
and other parallel features of the image in question as opposed to retrieval based on its textual observations and remarks. (Wikipedia, 2010) In light of clinical practices, researchers have argued in favour of increased expansion and application of Picture Archiving and Communication System (PACS). (Muller, H et al, 2003) PACS provides the user with quick access and retrieval of images, in addition to its cost-effective storage and the offers a facility of more than one users being able to access one image from different sources, at the same time. (Wikipedia, 2010) Clinicians using the PACS would use it as a storage system for their images more than anything else. (Muller, H. et al, 2003) In the recent future, it would be interesting to see clinicians being able to compare intact images with one another based on content, using PACS. (Muller, H. et al, 2003) In regard to medical images, there is still insufficient information on clinician requirements. (Muller, H. et al, 2003) Added research comprising of conducting studies and surveys to get first-hand information from clinicians would be necessary when it comes to content-based retrieval.
2009), make relative interpretations and suggest suitable treatment strategies. As the demand of mobile healthcare increases and as health professionals are getting used to benefit from technology, new applications based on new technologies are emerging in the market. With more technology advancements in the healthcare industry, the future of healthcare is carved by robust wireless technology to optimize the level of care of patients at lower costs. It also aims to empower physicians to efficiently perform their hospital activities by providing an improved wireless hospital environment. Wireless technologies are technologies are transforming the way healthcare is delivered and will continue to do so in the future. Dan Hesse, CEO at Sprint Nextel, mentions that despite the different challenges in the way of adopting wireless technologies in healthcare, health professionals are making an effort to automate their practices using wireless technologies as a means to provide their patients with qualitative, improved and faster care (Business Wire, 2010).
5.2. Future of Wireless Technology in Healthcare
REFERENCES
At present there are a number of useful applications deployed on portable devices to assist clinicians in delivering quality care to patients and improving the workflow in a hospital environment. A few years back, executive staff in the hospital banned the use of devices requiring wireless connectivity for the fear of interference of wireless signals with medical equipment.(Zatloukal, 2008) Today, medical applications on wireless devices are a necessity in the healthcare industry. Clinicians and technologists favor wireless technology equally (Zatloukal, 2008); and delivering healthcare without technology, wireless or otherwise, cannot be imagined. The use of information technology in healthcare practices is required exhaustively in order to control and distribute healthcare information (Stead & Lin,
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Healthcare Applications for Clinicians
Seshadri, K., Liotta, L., Gopal, R., & Liotta, T. (2001). A wireless Internet application for healthcare, CBMS (pp.0109), In Proceedings of the 14th IEEE Symposium on Computer-Based Medical Systems. Retrieved on September 6th, 2010, from http:// www. computer. org/ portal/ web/ csdl/ doi/10.1109/CBMS.2001.941706 Singh, H., Fox, S. A., Petersen, N. J., Shethia, A., & Street, R. L., Jr. (2009). Older patients’ enthusiasm to use electronic mail to communicate with their physicians: Cross-sectional survey. Journal of Medical Internet Research, 11(2). Retrieved on September 5th, 2010, from http:// www. jmir. org/ 2009/2/e18/#ref16 Stead, W., & Lin, H. (Eds.). (2009). Computational technology for effective health care: Immediate steps and strategic directions. National Library of Medicine. Retrieved on September 6th, 2010, from http://www.nlm.nih.gov/pubs/reports/ comptech_prepub.pdf The Frabotta Company. (2010). About.com, physicians welcome increased role for the Internet. Retrieved on September 5th, 2010, from http://mentalhealth.about.com/library/sci/0301/ blmdint301.htm The Mobile Health Crowd. (n.d.). 101 things to do with a mobile phone in healthcare. Retrieved on September 6th, 2010, from http://www.themobilehealthcrowd.com/?q=node/8
Triple Tree. (2009). Wireless and mobile health, report and survey © 2009. Retrieved September 6th, 2010, from http://www.celltrak.com/downloads/TripleTree%20-%202009% 20mHealth. pdf Wikipedia. (2010). Content-based image retrieval. Retrieved on September 5th, 2010, from http://en.wikipedia.org/wiki/Content-based_image_retrieval Wikipedia. (2010). NextGen healthcare Information Systems. Retrieved on September 5th, 2010, from http://en.wikipedia.org/wiki/NextGen_Healthcare_Information_Systems Wikipedia. (2010). Picture archiving and communication system. Retrieved on September 5th, 2010, from http://en.wikipedia.org/wiki/ Picture_archiving_and_communication_system Zabre, E. (2008). Advance to the 21st Century with the iPhone 3G. iPhone Life, 1(1). Retrieved on September 6th, 2010, from http://www.iphonelife. com/issues/oct08/MobileMedical Zatloukal, C. (2008). Wireless is more. A comprehensive network strategy can trump wireless challenges for healthcare enterprises. Health Information Technology, July. Retrieved on September 6th, 2010, from http://www.allbusiness.com/ health-care/health-care-overview/11420434-1. html
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Chapter 4
RFID Applications in E-Healthcare Mohamed K. Watfa University of Wollongong in Dubai, UAE Manprabhjot Kaur University of Wollongong Dubai, UAE Rashida Firoz Daruwala University of Wollongong Dubai, UAE
ABSTRACT Pervasive healthcare is the ultimate goal of all healthcare facilities and e-healthcare is the most talked about medical assistance these days. Healthcare organizations are exploiting RFID to maximize use of tools and equipment, keep tabs on medicinal drugs, boost patient flow and plug gaps in patient safety. RFID technology has become a hot topic in all scientific areas and is entitled as a major enabling technology for the automation of many work processes involved in the health sector. This chapter talks about many singular RFID applications that have been successfully developed or are in development, particularly the ones designed for the healthcare industry. It also discusses issues related to technology and healthcare and measures to overcome them. Furthermore, the chapter gives insight on the future of RFID technology and what more it has to offer to the healthcare community in the future.
INTRODUCTION Radio Frequency Identification, also known as RFID is grouped under the broad category of automatic identification technologies. RFID is a system that transmits identity information of a living or non-living thing, wirelessly via radio
waves. A typical RFID system comprises a tag and reader. An RFID tag contains a microchip attached to a radio antenna mounted on a substrate and it can store up to 2 kilobytes of data. An RFID reader also contains an antenna with which it can retrieve data stored on the tags and then sends the data in digital form to a computer system.
DOI: 10.4018/978-1-61350-123-8.ch004
Copyright © 2012, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.
RFID Applications in E-Healthcare
RFID has been in use for over a decade, but until recently, its application was limited. Today, RFID is being used for not hundreds but thousands of applications such as (Thornton, 2006, pp.33-35): • • • • • • • • • • • •
Supply chain including wholesale and retail inventory management Item-level tagging of consumer goods on retail shelves Contactless payment systems at the retail point of sale Asset tracking like luggage, medicines, equipment, etc. Pharmaceutical anti-drug counterfeiting People, livestock and wildlife tagging Automobile keyless start systems Passport and border control Toll payment system Access control Smart cards Logistics
The healthcare industry is a substantial market for RFID applications since healthcare facilities today face limited resources and rising expenses. Emerging information technologies like the RFID technology can offer means to measure and control the resources and workflow processes in order to improve patient care. As every other technology, RFID too has its pros and cons. People, that is, organizations, developers, consumers or researchers are concerned about the privacy and security threats that it puts forth. Users feel vulnerable because of the concerns (privacy/security/technical) that exist with RFID. Measures have been found to overcome these issues, but they are not yet strong enough to eliminate these threats completely. However despite these shortcomings, RFID seems to have a welcoming future especially in healthcare wherein several new RFID applications are being developed repeatedly. Throughout the chapter, the progress of RFID over the years has been analyzed; the advantages and disadvantages are discussed; impact of the technology on the
healthcare industry and the threats and concerns posed by it along with their measures; the future of RFID in healthcare is also talked about towards the end of the chapter.
BACKGROUND What is RFID? RFID, the short for Radio Frequency Identification is a wireless communication technology that identifies living or non-living things. It is one of the many automatic identification technologies which unlike others, uses radio frequency waves to transfer identifying information between tagged objects and readers. Although, it was originally designed to transmit identity information over a RF filed, RFID technology has grown to encompass a wider range of applications as mentioned earlier in the chapter – asset tracking, supply chain management, work process validation, secure access control, etc. which incorporate additional sensors and processing to allow for a wide array of complimentary data such as location, temperature, proximity information to conveyed (Kamel & Liang, 2009).
How it Works? RFID system architecture consists of: a tag attached to items, animals or persons; a reader that creates an RF field to detect radio waves and a computer network to connect the readers. An RFID tag consists of a microchip that stores identity information and a metal coil that acts as an antenna to communicate the information via radio waves. The tags can be classified based on their energy source into active and passive. Active tags have their own transmitter and power source that enables them to run their microchip’s circuitry and broadcast signals to the readers. Passive tags, on the other hand, do not have their own power source and instead they scavenge power from the
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electromagnetic radiation emitted from the readers. Passive tags can operate over longer periods of time, but can only transmit signals over a shorter range. Active tags, however cannot function once their embedded power source runs out, but can transmit signals over longer distances. RFID tags are composed of various materials, have different capabilities, come in many shapes and are available in different sizes ranging from as small as a grain of rice to as big as a six-inch ruler. These tags can be applied on to any item like boxes, cases and pallets or embedded in identification documents or even human and animal tissue for the purpose of tracking or identification. An RFID reader is an active device that is used to read information stored in tags or transmit information to a tag. The reader consists of an antenna, either internal or external which continuously emits radio waves so that the RFID tag can respond to it by sending back their embedded information. This information is generally known as the Electronic Product Code (EPC) and is usually the identifier of the object, person or animal onto which the tag is applied. The readers also have a processor to decode the signals and the identity information received from the tags. RFID readers can either be stationary – positioned at a specific point like at the entrance/exit of a gate or they can be integrated into handheld computers making them handy and portable. There are several RFID readers today in the market with varying reading ranges. Many RFID readers can even read up to 2000 tags per second simultaneously. Most new readers also have Ethernet, Wi-Fi or USB ports.
RFID system architecture is incomplete without middleware. Middleware is the software that resides between the RFID readers and enterprise applications. It takes the raw data from the reader, filters the data (since a reader might read the same tag 100 times per second) and then passes the useful data to the backend systems. Middleware plays an important role in the RFID system by getting the right information and then sending it to the right application at the right time. The market is filled with many RFID middleware products – all perform some basic filtering and might also do some additional functions (Thornton, 2006, p.16). The main goal of an RFID system is to carry information on a tag and retrieve it with a reader through a wireless connection. As shown in Figure 1, the antenna on the tag and reader continuously emits RF signals at a given frequency. When a reader comes into contact with these signals, the tag is activated and it communicates wirelessly with the reader through the modulation of the transmittance frequencies and then the tag sends the data to the reader. The capabilities of an RFID system depend on the carrier frequency at which the information is transported. These frequency allocations are generally managed through legislations and regulations set by individual governments. Due to government regulations, different parts of the electromagnetic spectrum are assigned for different purposes, as a result of which, a number of bands are used around the world for RFID applications (Roberts, 2006, p.20). Table 1 of this chapter shows the commonly used frequency ranges for RFID. Different frequencies
Table 1. Frequency Bands and Applications Frequency Band
Read Range
Typical Applications
LF
90%) and comparably small intervals ( 0 then x belongs to class 1 and if d(x, w, b) < 0 then x belongs to class 2. The weight vector and the bias are obtained by minimizing the following equation: Ld(a)=0.5aTHa-f Ta
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Portable Wireless Device for Automated Agitation Detection
subject to the following constraints: yTa = 0; a > 0 where H denotes the Hessian matrix given by:H = yiyj (xixj) and f is the unit vector f = [1, 1...1]T. Having the solutions a0i of the dual optimization problem will be sufficient to determine the weight vector and the bias using the following equation: l
w = ∑ aoi yi xi i =1
b=
1 N
N
1
∑ y i =1
i
− x Ti w
where N represents the number of support vectors. The linear classifier presented above has limited capabilities since it is only used with linearly separable data while in most practical applications data is not linearly separable. The nonlinear data has to be mapped to a new feature space of higher dimension using a suitable mapping function Φ which is of very high dimension, potentially infinite. Fortunately, in all the equations, this function appears only in the form of a dot product. From the theory of reproducing kernel Hilbert spaces (Aronszajn, 1950), which is beyond the scope of this chapter, a kernel function is defined as: K (x i , x j ) = Φ (x i ) Φ (x j ) T
By replacing the dot product in all the previous equations, the non-linear hyperplane is determined. This remarkable characteristic of the kernel transformation gives the ability for support vector machines to operate on multi-dimensional data without affecting the processing time. Indeed in the linear case, the processing time is roughly the time needed to invert the Hessian matrix which is
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of 0(n3) where n is the number of training points. Since the transformation from the linear to the non-linear case is performed by the simple kernel transformation, the dimension of the Hessian matrix is not changed and hence the processing time is the same, thus its applicability and high performance with multi-dimensional data. Previous work done by our team has shown that subject independent agitation detection was possible, by monitoring three vital signs: HR, GSR and RTD and using SVM it was possible to detect the agitation state of subject even if the device was not trained on that specific subject. This was achieved with an accuracy that reached 84% (Sakr, et al., 2008). The limitation of the method was the issue of the “gray zone”. The gray zone is the transitional phase where the subject is passing from one state to another. Within this area fall more than 95% of the detection errors of the method. Another work done by our team has also shown that using SVM with a hierarchical architecture that takes into consideration the distance between the two classes and hence giving the SVM a “zooming” ability, gave high accuracy reported at 95.1%, which was higher than what was previously reported in the literature. Also in this case the errors that were falling in the “gray zone” were of high percentage (Sakr, et al., 2009). In order to further improve accuracy we introduced a new confidence measure on the decision of a support vector machine. This new confidence measure is used to modify a single 2-class SVM classifier into multi-level 2-class SVM classifier architecture. This new architecture is used for agitation detection and yields, using the same training set, higher accuracy than a single 2-class SVM classifier.
Multi-Level SVM The proposed confidence measure is based on a dimension proposed by Vapnik and Chervonenkis which was named after them: the VC dimension.
Portable Wireless Device for Automated Agitation Detection
By definition, the VC dimension is the capacity of the learning algorithm to shatter points in the input space (Vapnik, 1998). Formally it is the cardinality of the largest set of points that an algorithm can shatter. The importance of the VC dimension is that it appears explicitly in the bound on the total error of an algorithm. The total error of the learning machine is the sum of the training error (empirical error) and the testing error (generalization error):
ε = εemp + ε g where εemp is the training error, and εg is the generalization error (Vapnik, 1998). eemp can be made arbitrarily small by choosing a machine with a VC dimension at least equal to the number of training points. In order to decrease the training error, one has to increase the VC dimension. If a machine can split all the training points without any errors, it will have εemp= 0. Vapnik has established a bound on the testing error given by: n 2l VC [ln( ) + 1 − ln( )] VC 4 εg < l where l is the number of training data, VC is the VC dimension (referred to as h in some references), and 1 - η is the probability for which this last equation holds. This inequality shows that the error is bounded by an increasing function of the VC dimension, and thus a trade-off should be made between the empirical error and the generalization error. Although it is extremely difficult and sometimes impossible to compute the VC dimension of a certain algorithm, a bound on the VC dimension has been established and will be very useful in building the confidence measure. Vapnik states that a bound on the VC dimension is given by: 2
VC < w D 2
where D is the minimum radius of the sphere that contains all the training points and ||w|| is the norm of the weight vector that SVM is minimizing. ||w|| is given by (Vapnik, 1998): w
2
n
= ∑ ai i =1
This bound is important in two ways: it is easy to compute, and Burges has shown that the true VC is closely related to this bound. In particular he showed that, most of the time, the true minimum of the VC dimension is obtained when this bound is minimal (Burges, 1998). Notation. The following notations will be used in the definitions and propositions that follow: X = {x1, x2,...xn} is the set of training vectors where xi ∈ Rm and Y = {y1, y2,...yn} is their corresponding class where yi ∈ {-1, 1}.
S(X, Y) is any learning algorithm trained by training vectors X with class Y, and where all the parameters of S are set.
D is the radius of the smallest sphere that englobes all the training points, and w is the weight vector of the hyperplane. z is an unlabeled vector and d(z) ∈ {-1, 1} is its prediction. Xz is the set of training points X to which z is appended, Xz= {X, z}. Y-1 is the set of labels Y to which (-1) is appended: Y-1= {Y, -1}, and Y1 is the set of labels Y to which (1) is appended: Y1= {Y, 1}. Based on the notation presented, Xz represents a new training set that contains X to which z is added. Y-1 is the set of labels formed by Y to which (-1) is added. This means that we are assuming
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Portable Wireless Device for Automated Agitation Detection
that z is a training point having the label (-1). While Y1 assumes that z has the label (1). It is now necessary to define a quantity that estimates the confidence in each of the assumptions (z belongs to class 1 or class -1). Note that: to every S(X, Y) corresponds a unique couple (D, w). This can be justified by the fact that D is unique and depends on the training points X, and w is a single valued function of S, X and Y. Since the VC dimension is closely related to its upper bound, its upper bound, VCmax will be used. Definition. Given S(X,Y) and an unseen vector z, the measure of confidence on the decision d(z) by S(X,Y) is given by: C (z ) = d (z ) VC Smax (X z ,Y−1 ) −VC Smax (X z ,Y1 )
The proposed multi-level SVM is a two-class classifier based on cascading two SVMs. The first SVM (SVM-1) is trained by “easily classifiable” points while the second one (SVM-2) is trained by not “easily classifiable” points. An “easily classifiable” point is defined as follows: Definition. Let X be the set of training points and x ∈ X is one specific training point. x is said to be easily classifiable iif C(x) > 0. Note that the confidence is computed by SVM-1. The output of this architecture is defined as follows: Definition. Let z be an input of unknown class, then: −1 Class = 1
d1 (z ) < 0 and C 1(z ) > 0 or d2 (z ) < 0 and C 1(z ) < 0 d1(z ) > 0 and C 1(z ) > 0 or d2 (z ) > 0 and C 1(z ) < 0
An unknown point z is classified by SVM-1 and a measure of confidence is then generated. If SVM-1 is confident of its decision then this decision will be the final one. If SVM-1 is not 250
confident then the point is sent to SVM-2 and its decision will be the final decision. Note that this architecture is recursive and could be extended to SVM-n, and the unknown point will go deep in the architecture until the decision made by SVM-j is confident and then its decision will be the final one. In agitation detection application, two SVMs were enough to classify all the points.
EXPERIMENTAL RESULTS The following section summarizes the experimental results of the device and the detection algorithm.
Device The device was tested using the prototype for sensor accuracy and repeatability. For this purpose the following experimental setups were made.
Temperature Accuracy and Repeatability To test the accuracy of the RTD sensor, a temperature calibrator from Omega was used. The calibrator gives the ability to fix a temperature with high accuracy. The RTD sensor is then inserted in the calibrator, and the result extracted from our device is compared with the value fixed on the calibrator, this is repeated 3 times. It is worth noting that the temperature range needed for the device is skin temperature range which is limited in extreme cases between 20oC and 40oC. The Table 1. Experimental results for the temperature sensor Calibrator Temp (oC)
Measured Temp (oC)
Accuracy (%)
Repeatability (%)
25
24.85
99.40
99.98
30
29.88
99.60
99.97
35
34.84
99.55
99.99
40
39.87
99.675
99.99
Portable Wireless Device for Automated Agitation Detection
experimental results for accuracy and repeatability per temperature are given in Table 1. The overall accuracy obtained is 99.55% and the overall repeatability is 99.98%. This result shows that the RTD sensor has a high accuracy over the range of skin temperature as well as high repeatability.
GSR Accuracy and Repeatability The same procedure used for the RTD sensor is used for the GSR sensor. Eleven different resistors in the range of 100KΩ to 1MΩ were used to test the accuracy of the GSR sensor. The resistors were placed between the two electrodes. The true value of the resistor was measured using a multi-meter. This experiment was repeated ten times. The experimental results for accuracy and repeatability per conductance used are given in Table 2. The overall accuracy and repeatability obtained is 98.51% and 99.9% respectively.
Heart Rate Accuracy To find the heart rate accuracy a Labview VI was developed to simulate the heart beats. The heart pulses were simulated by a pulse frequency generator of adjustable frequency. The output of the VI was transmitted via output channel zero
of the NI-DAQ USB 6009. Output channel zero is connected to RF6 in place of the heart rate sensor. The frequency of the generator is modified between 0.7Hz and 3Hz which are the two extreme limits of the frequency of the heart beat. At the same time, the inter-beat interval is generated by the device. This experiment was repeated 10 times. The average accuracy of the inter-beat interval measurement was 100% with an average repeatability of 100%.This demonstrates great performance for inter beat interval measurement.
Agitation Detection One effective way of inducing stress safely into healthy subjects is the Stroop Color-Word Interference Test. The Stroop test requires subjects to say out loud the color of words spelling out color names that do not match. It has been shown that this test induces anxiety symptoms [14]. The Stroop Color-Word Interference Test in its classical version has been widely used as a psychological or cognitive stressor that can safely induce controlled limited stress in subjects. Previous research has indicated that by adding task pacing to the Stroop test, physiological responses intensify. Three sets of PowerPoint slides were used to conduct the Stroop test while the physiological parameters are monitored. First set is called the color blocks
Table 2. Experimental results for the GSR sensor Actual Cond. (µS)
Measured Cond. (µS)
Accuracy (%)
Repeatability (%)
10.00
10.23
97.70
99.96
5.00
5.09
98.20
99.96
3.33
3.36
99.10
99.94
2.50
2.49
99.80
99,93
2.00
1.96
98.00
99.90
1.66
1.68
98.80
99.90
1.42
1.39
97.89
99.89
1.25
1.27
98.40
99.89
1.16
1.18
98.26
99.78
1.00
1.01
99.00
99.89
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Portable Wireless Device for Automated Agitation Detection
(show a block of color only), second set is called congruent word slides (word and color matches), third set is called incongruent word slides (words do not match color presented). The test included 60 randomly set color blocks (1min) where subjects are to name out loud the color they see, 60 randomly set congruent word slides (1min) where subjects are to read out loud the word they see, and finally 120 randomly set incongruent word slides (2min) where subjects are to name the color of the word they see (not read the word). Each slide is set to show for one second. If subjects missed a slide they were asked to move on to the next one. The overall objective of the subject was to get as many correct answers as they can. Subjects were asked to complete the Trait Scale State-Trait Anxiety Inventory (T-STAI) before and after the test. The two STAI filled up by a subject allowed us to validate their state. Data from subjects that demonstrated stress using the T-STAI analysis was used to evaluate the accuracy of the detection algorithms. Each patient had 240 samples (RTD, GSR, IBI) taken synchronously corresponding to the 3 Stroop test slides. In total 58 subjects were tested. It is worth noting that in order to test the architecture efficiently in a statistically significant way the following results correspond to computations done off line. The K-fold cross-validation technique was used. The 58 subjects are subdivided into groups of 2 which yields 29 folds. In order to show the robustness of this architecture against over fitting, only 1 fold is taken for training and the remaining folds are used for validation. From the training fold, a subset X of 80 triplets (ST, GSR, IBI) is chosen randomly. X is used to train a traditional single SVM using the Gaussian kernel function, and all the samples of the remaining 28 folds were used to test its accuracy. The same set X was split into two sets X1 and X2. SVM-1 was trained using X1 while SVM-2 was trained using X2 and the samples from the remaining 28 folds were used in the testing procedure. The
252
comparison of the performance of a single SVM with the performance of the multi-level SVM is valid because in both cases, the same training set X is used. The average accuracy for the proposed architecture reached 91.4% with a standard deviation of 1.71% while the average accuracy for the normal SVM reached 90.9% with a standard deviation of 1.94%.
CHALLENGES AND FUTURE RESEARCH The challenges for portable and intelligent devices can be divided into technical and non-technical. As any portable technology, size and weight are a primary concern. For medical applications, this constraint is more stringent as these would be devices used by the elderly or weaker subjects. In addition, the operational life of the device and its power consumption are a concern. Such devices would be expected to operate for years with minimal intervention. Human interfacing is another major challenge as the device must be “transparent” to the subject with no impact on daily activities. This is where the role of wireless technology becomes even more important in reducing the wires running along the body of the subject. Obviously, all this has to be accomplished without compromising the performance of the device in the measurements and decisions taken. A challenge specific to devices detecting a subject’s state is ground truth definition. For example, in the case of agitation detection, how can we define the exact point of agitation onset even when the subject is under direct observation? The standard in human subject testing is to define this point at the introduction of a stressor. However, this is not always the exact point as some subjects might be exhibiting agitation symptoms prior to the stressor introduction or vice versa. On a different note, clearly whenever a system is introduced to the medical field, especially one that autonomously
Portable Wireless Device for Automated Agitation Detection
and continuously collects personal data, privacy is a primary concern. Security becomes more of a concern when these portable devices are active; such as in the case of administering medication when certain conditions are detected. With such devices, there is a concern of malicious behavior and liability to the manufacturer. We believe that these challenges will define some of the future research directions. Research areas will include: •
•
•
•
Miniaturization of physiological sensors to facilitate mounting and interfacing. We expect research in MEMs and NEMs to target the development of noninvasive miniature sensors. Development of sensors capable of short range secure wireless communication. This would enable devices to measure different parameters potentially at different point on the subject’s body without the need for wires. Development of devices capable of harvesting energy from the subject’s body and/or motion. This would enable prolonged operation with no concern for processing demands. Development of intelligent devices capable of predicting specific conditions and potentially autonomously carrying out intervention. For example, detect the onset of agitation and carry out calming actions.
CONCLUSION This chapter presented a discussion of the advances in portable medical devices in general. The focus was on portable agitation detection, where previous research was detailed. The design and implementation of a portable wireless device for agitation detection was presented. The SVM based method of agitation detection was discussed. Experimental results demonstrated the very high
accuracy and repeatability of the device prototype in measuring physiological parameters and the accuracy of the algorithm in detecting agitation. We believe that such a technology, if commercialized, would play a significant role in the care for Alzheimer’s patients.
ACKNOWLEDGMENT This research was funded by the American University of Beirut University Research Board, Dar Al- Handassah (Shair & Partners) Research Fund, and the Rathman (Kadifa) Fund. We would like to thank Dr. Cheryl Riley-Doucet and Dr. Debatosh Debnath from Oakland University for providing the data used in this research.
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Portable Wireless Device for Automated Agitation Detection
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Chapter 13
Prioritization of Patient Vital Signs Transmission Using Wireless Body Area Networks Baozhi Chen Rutgers University, USA Dario Pompili Rutgers University, USA
ABSTRACT Triage is the process of prioritizing patients based on the severity of their condition when resources are insufficient. Hospitals today are equipped with more and more electronic medical devices. This results in possibly high level of electromagnetic interference that may lead to the failure of medical monitoring devices. Moreover, a patient is usually moved between different hospital settings during triage. Accurate and quick prioritization of patient vital signs in such environments is crucial for making efficient and real-time decisions. In this chapter, a novel in-network solution to prioritize the transmission of patient vital signs using wireless body area networks is proposed; the solution relies on a distributed priority scheduling strategy based on the current patient condition and on the vital sign end-to-end delay/reliability requirement. The proposed solution was implemented in TinyOS, and its performance was tested in a real scenario.
INTRODUCTION The rapid growth of wireless technologies and personal area networks enables the continuous healthcare monitoring of mobile patients using compact sensors that collect and evaluate body parameters and movements. These sensors, limited
in memory, energy, computation, and communication capabilities, are strategically deployed on a patient, forming a cluster that is called Wireless Body Area Network (WBAN) (Norgall, Schmidt, & von der Grun, 2004). Many works based on WBANs have been proposed that focus on designing wireless sensors for a single vital sign
DOI: 10.4018/978-1-61350-123-8.ch013
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Prioritization of Patient Vital Signs Transmission Using Wireless Body Area Networks
and on developing pervasive healthcare systems to monitor vital signs of multiple patients. In this chapter, we focus on providing a networking solution for in-hospital triage, which is the process of prioritizing patients based on the severity of their condition. This process facilitates the ability of the medical team to treat as many patients as possible when resources are insufficient for all to be treated immediately. Existing devices for monitoring patient vital signs are mostly wired, often depend on direct user interaction, have a limited analytic capability, require manual archiving even of digital data sources, and have limited capability to propagate data to the next destination on the patient’s path. This is particularly critical in in-hospital settings. Accurate and reliable monitoring of patient’s vital signs during this period is crucial for making efficient and error-free triage decisions. During triage, emergency service providers need to rapidly assess the injured patient and determine the need for trauma center care. In addition to challenges of acquiring patient data, trauma triage is now limited by a reliance on human interpretation of acquired patient data, which requires the emergency service team be adequately trained. During triage (especially for mass casualty scenarios), this may greatly delay the treatment of patients in critical conditions. Using existing technology, the inhospital environment lacks effective methods for prioritizing information streams, evaluating timedependent trends, managing incomplete data, and providing effective alerts. Current limitations of patient monitoring represent an important barrier for developing improved trauma triage methods. To seamless transfer the data when patients are moved between different settings such as the injury scene, the emergency department, and other locations in the hospital, wireless technologies should be used. However, the explosive growth of wireless technologies brings in an important problem. For example, wireless communication and networking devices are being deployed almost everywhere at an incredible speed, resulting in increased spec-
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trum use by a variety of heterogeneous devices, standards, and applications. This holds especially true for the unlicensed Industrial, Scientific, and Medical (ISM) bands that host a number of heterogeneous networks such as Bluetooth, ZigBee, IEEE 802.11b/g. Because radio waves centered at the same frequency emitted from the wireless devices interfere with each other, coexistence of them has become an important issue in order to ensure that wireless services can maintain their desired performance requirements. For instance, in a critical environment such as medical emergency scenarios it is extremely important to avoid the failure of the medical devices that may be caused by radio frequency interference. With an ever-increasing use of electronics in medical devices of all kinds as well as many wireless communication devices in medical environments, some unforeseen problems are arising: the interactions between the products emitting the electromagnetic (EM) energy and sensitive medical devices. Even the devices themselves can emit EM energy, which can react with other devices or products. It has been reported that medical devices may fail to operate correctly due to the existence of electromagnetic interference (Silberberg, 1993). To guarantee wireless services in such environments, it is necessary to design a system that can handle such interference. Existing research on wireless healthcare systems has focused on the design of purpose-specific one-BAN system (Chen, Black, Khan, & Jamshaid, 2008; Dabiri, Vahdatpour, Noshadi, Hagopian, & Sarrafzadeh, 2008) (i.e., system used on one patient), in-BAN data processing/fusion (Li & Tan, 2008; Weisenberg, Cuddihy, & Rajiv, 2008), and improvement of network performance metrics such as throughput and energy efficiency (Li & Tan, 2007; Varshney, 2008). In addition, emergency services have been considered in (Malan, Fulford-Jones, Welsh, & Moulton, 2004; Varshney, 2008). While these studies have proposed solutions to access patient healthcare data in real time, no research
Prioritization of Patient Vital Signs Transmission Using Wireless Body Area Networks
multiple patients and prioritizes data transmission based on patient’s condition and data content. Based on the patient’s condition, which in this chapter we assume to be already diagnosed, patients are categorized into three classes, “Red”, “Yellow”, and “Green”, each indicating the level of treatment needed, i.e., “immediate”, “delayed”, and “minimal”, respectively. Categorization of one patient into one of these three classes can be achieved by using data aggregation algorithms within one BAN. Moreover, these algorithms should jointly consider all the vital signs taken from one patient since using only few vital signs is generally not sufficient to perform the diagnosis of a patient. For example, injury severity assessment of neurological status (e.g., level of consciousness and motor activity) should be made by looking at both vital signs such as pulse, blood pressure, and respiratory rate, as well as the movement activities (normal vs. abnormal). We have proposed a solution to classify the movements of a patient using multiple sets of tri-axial accelerometers (using IMote2 and Shimmer sensors) attached to different parts of the body in (Varkey & Pompili, 2009), which will be further extended for patient status classifications. In this chapter, we focus on the e2e transmission of vital signs instead of patient status clas-
has focused on prioritizing the transmission of healthcare data over the wireless network in the electromagnetic interference (EMI) environment under the constraints of both the patient condition and the data content, i.e., the type of measurement (temperature, O2 saturation, blood pressure and pulse, heart rate variability, etc.), which is critical in emergency services. Different types of healthcare data are of different importance during in-hospital triage, as shown in Table 1. Here delay is the time from source sensors to destination medical devices such as medical terminals, Personal Digital Assistants (PDAs), and cell phones, i.e., the end-to-end (e2e) delay. In an in-hospital environment, proper prioritization of critical vital signs is crucial for efficient and real-time triage. Obviously, vital signs from patients in critical situation should be served first with guaranteed service quality. Patients in different emergency conditions have different service requirements: a patient who needs more immediate service should be given higher priority, i.e., his/her vital signs should be transmitted with higher e2e reliability and lower delay. In order to provide a networking solution that performs real-time in-hospital triage on multiple patients under EMI environment, in this chapter we propose a new interference-aware WBAN system that continuously monitors vital signs of
Table 1. Bit Rate and Delay Requirements of Healthcare Data (IEEE EMBS, 2008) Data Source
Bit Rate [bps]
Delay [s]
Sampling Rate [Hz]
Electrocardiogram (ECG)
1–8
120
63
Non-invasive Cuff
0.05
30-120
0.025
Cardiac Output [L/min]
1k
120
0.02
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Prioritization of Patient Vital Signs Transmission Using Wireless Body Area Networks
sifications. Specifically, we aim at maximizing the e2e reliability of these three traffic classes while meeting the delay requirements. Here reliability is defined as the ratio of the number of received data packets (containing vital sign information) at the sink (or base station) and the number of total packets sent from a source node. Our solution focuses on a wireless communication network with light and moderate congestion, as categorized in Table 2, where γR, γY, and γG are the current reliability of “red”, “yellow”, and “green” patients, respectively. When the network is in no congestion status, in fact, the use of standard protocols is enough to guarantee the services to all patients. On the other hand, when the network is in heavy congestion status, additional mechanisms are needed to guarantee the service to patients under critical conditions. For example, transmission of vital signs from patients in non-critical conditions can be held on until the congestion becomes less severe (e.g., adopting source rate control). Moreover, adaptive sampling techniques consisting in reducing the sampling rates of the sensors deployed on patients under non-critical conditions can be applied in order to reduce the traffic. Once the overall traffic is reduced, our solution, which is tailored for light or moderate congestion, can be applied to guarantee e2e Quality of Service (QoS). Therefore, we focus on providing a solution for light and moderate congestion; in these states, using our communication solution, the services to the patients under critical conditions can be guaranteed. To sum up, the objectives of our work are: •
•
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Provide a communication solution for inhospital networks with light and moderate congestion. Maximize the reliability for all three classes of traffic while guaranteeing their e2e delay requirements.
•
Provide partial cognitive radio (Mitola & Maguire, 1999) capability to sensors in order to avoid EMI.
In order to achieve these objectives, a crosslayer communication solution is proposed to offer a prioritization service and to maximize reliability while meeting the e2e delay requirement based on the patient’s condition and data content. Our solution adopts a modular design: the modules include Medium Access Control (MAC), Routing, and Scheduling. Each module is individually designed to meet the domain-specific requirements; then, the three modules are jointly optimized to obtain the best performance possible. The quality of multiple channels is considered in the MAC and routing modules, which leads to the interferenceaware design of Multi-channel Quality-based MAC (MQ-MAC) and Channel Quality Based Routing (CQBR). Moreover, a two-level data packet scheduling scheme is proposed to maximize the reliability for all three classes of traffic while guaranteeing their e2e delay requirements. These modules are also designed to be of low complexity so that resource-limited sensors can run them. Note that we aim at providing a solution to situations where the traffic is near to the network capacity. Our solution is based on the well-known Crossbow’s wireless sensors IMote2/TelosB, which use the IEEE 802.15.4/ZigBee standard (IEEE Computer Society, 2006). To improve the network performance, our solution can be easily migrated to other high-speed wireless platforms such as 802.11b/g/n.
Table 2. Network Congestion Types Congestion Type
Network Condition
No Congestion
γR = γY = γG =1
Light Congestion
γR = γY =1, γG
